On June 6, 2023, a coalition of environmental and agricultural labor groups lead by the Center for Food Safety filed a lawsuit against the Environmental Protection Agency (“EPA”) to challenge the agency’s registrations for the herbicides Enlist One and Enlist Duo (collectively, “Enlist products”). Specifically, the plaintiffs claim that EPA’s 2022 decision to extend the registrations for Enlist One and Enlist Duo for an additional seven years violated both the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), and the Endangered Species Act (“ESA”). This is not the first lawsuit to challenge EPA’s registration of Enlist products. In 2020, the Ninth Circuit Court of Appeals issued a decision in a case challenging EPA’s 2017 registration of Enlist Duo. There, the court upheld the registration, with a stipulation that EPA reevaluate the potential harm that Enlist Duo may cause to monarch butterflies. In this latest lawsuit, the plaintiffs are once again asking the court to overturn the registrations of Enlist One and Enlist Duo.
Background
Enlist One and Enlist Duo are both herbicides manufactured by Corteva that contain the choline salt of 2,4-dichlorophenozyacetic acid choline salt (“2,4-D”), an active ingredient that is used to control broadleaf weeds, including glyphosate-resistant weeds like Palmer amaranth, also known as pigweed. Enlist Duo contains the active ingredients 2,4-D and glyphosate, which allows for control of both broadleaf and grass weeds. Both Enlist products are registered for use on corn, soybean, and cotton crops that have been genetically engineered to be resistant to 2,4-D. Enlist products may also be used on conventional corn crops, and on uncultivated fields before planting any corn, soybean, or cotton crops, up to emergence.
Before a pesticide may be legally sold or used in the United States, it must be registered under FIFRA. Specifically, FIFRA requires that no pesticide be sold in the United States until EPA approves a label with instructions on how to use the pesticide. To approve a pesticide label, EPA must make a finding that using the pesticide in the manner described on the label will not cause “unreasonable adverse effects on the environment.” 7 U.S.C. § 136a(c)(5)(C). FIFRA clarifies that “unreasonable adverse effects on the environment” refers to “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” 7 U.S.C. § 136(bb). If a party believes that EPA has improperly registered a pesticide for use, FIFRA allows them to challenge the registration decision in federal court. 7 U.S.C. § 136n. When reviewing a registration decision, judges are directed to uphold the decision if it is “supported by substantial evidence when considered on the record as a whole.” 7 U.S.C. § 136n(b). Courts have determined that the “substantial evidence” requirement is met when EPA relies on “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion even if it is possible to draw to inconsistent conclusions from the evidence.” Nat. Res. Def. Council v. EPA, 857 F.3d 1030 (9th Cir. 2017).
Under the ESA, all federal agencies are directed to conserve those species listed under the ESA as either threatened or endangered. 16 U.S.C. § 1531(c). To achieve that goal, the ESA requires all federal agencies to consider possible impacts to listed species prior to carrying out an “agency action.” An “agency action” is further defined as any action an agency has “authorized, funded, or carried out[.]” 16 U.S.C. § 1536(a)(2). This includes pesticide registration decisions. If the agency determines that its actions “may affect” listed species, then it must initiate formal consultation. 50 C.F.R. § 402.14(a). Formal consultation requires the agency carrying out the action to work with either the U.S. Fish and Wildlife Service (“FWS”) or the National Marine Fisheries Service (“NMFS”) to determine the possible impacts of that action to listed species. 16 U.S.C. § 1536(a)(2). The goal of formal consultation is to ensure that an agency action will neither “jeopardize” the continued existence of a listed species, or destroy or adversely modify designated critical habitat. 16 U.S.C. § 1536(a)(2). The ESA also prohibits federal agencies from making any “irretrievable and irreversible commitment of resources with respect to the agency action which has the effect of foreclosing the formulation or implementation of any reasonable and prudent alternative measures” during the consultation process. 16 U.S.C. § 1536(d); 50 C.F.R. § 402.09. In other words, the ESA directs agencies to maintain the status quo during the consultation process by not carrying out any part of the agency action that would prevent introducing any mitigation measures or alternative actions intended to reduce harm to listed species.
Enlist Duo was first registered under FIFRA in 2014 for use on Enlist-resistant corn and soybean crops. Although Enlist Duo was originally registered in only six states, that registration was eventually expanded to include thirty-four states, and to allow use on Enlist-resistant cotton. In 2017, EPA registered Enlist One for the first time. Enlist One was registered for use in the same states and on the same crops as Enlist Duo. Months after EPA expanded the Enlist Duo registration and registered Enlist One, environmental plaintiffs petitioned the Ninth Circuit to review EPA’s registration decision for Enlist Duo, arguing that the decision violated both FIFRA and the ESA. According to the plaintiffs, EPA had violated FIFRA by registering Enlist Duo without substantial evidence to support the conclusion that registering the herbicide would not cause “unreasonable adverse effects on the environment.” The plaintiffs also claimed that EPA had violated the ESA by failing to consult with FWS over the registration decision. Ultimately, the Ninth Circuit ruled in favor of EPA. While the Ninth Circuit did conclude that EPA had failed to consider how the possible destruction of milkweed on fields where Enlist Duo was sprayed would impact monarch butterflies, it determined that EPA had complied with all other aspects of FIFRA and declined to vacate the registration. Instead, the Ninth Circuit upheld the Enlist Duo registration, with instructions to EPA to review the potential impacts to monarch butterflies. To learn more about the Ninth Circuit’s decision, click here.
On January 11, 2022, EPA announced that it was registering Enlist One and Enlist Duo for another seven years. As part of its decision, EPA approved new use labels for both Enlist products that included new mitigation measures intended to reduce runoff and risks to pollinator species. That registration decision prompted the current lawsuit.
New Lawsuit
The plaintiffs in Ctr. for Food Safety v. U.S. Envt’l Protection Agency, No. 1:23-cv-01633 (D. D.C., June 6, 2023) claim that EPA’s 2022 decision to register Enlist One and Enlist Duo for an additional seven years violated both FIFRA and the ESA. Many of the arguments raised by the plaintiffs in the present case are similar to the arguments raised by plaintiffs in the previous Enlist lawsuit.
FIFRA Claims
In their complaint, the plaintiffs allege that EPA violated FIFRA by failing to support its registration decision for Enlist One and Enlist Duo with “substantial evidence.” Specifically, the plaintiffs claim that EPA failed to support its registration decision with substantial evidence by: (1) understating the risks and costs that the registration decision would have to human health and the environment; (2) overstating the claimed benefits of registering the Enlist products; and (3) improperly relying on ineffective mitigation measures.
According to the plaintiffs, EPA understated the risks and costs of its registration decision by both failing to accurately assess some risks, while entirely ignoring others. First, the plaintiffs claim that EPA underestimated both the current and future usage of Enlist products, thus underestimating the overall impact of registering the products. Next, the plaintiffs claim that EPA failed to assess how registering the Enlist products will contribute to pesticide-resistant weeds. Increased glyphosate-resistance as well as possible future 2,4-D resistance were both generally acknowledged by EPA as part of the registration decision, but the plaintiffs argue that EPA should have examined that risk more thoroughly. The plaintiffs also claim that EPA failed to fully consider the impacts of runoff damage, spray drift damage, and the direct exposure risks to animal and plant species that would result from registering the Enlist products. Finally, the plaintiffs claim that EPA failed to consider the full impacts to human health, specifically noting that in 2022, the Ninth Circuit directed EPA to revisit its human health risk assessment for glyphosate after concluding that EPA had failed to support its conclusion that glyphosate was not likely to cause cancer. Learn more about that decision here.
Next, the plaintiffs argue that EPA overstated the benefits associated with registering the Enlist products. Specifically, the plaintiffs claim that EPA “exaggerated” how effective the Enlist products are against weeds that are resistant to pesticides, particularly glyphosate. According to the plaintiffs, EPA failed to consider how further use of Enlist One and Enlist Duo would accelerate 2,4-D resistance in weeds, and how further use of Enlist Duo would increase glyphosate resistance. Because EPA failed to take future pesticide resistance into account, the plaintiffs argue that the agency overstated the benefits of registering the Enlist products.
Finally, the plaintiffs claim that EPA relied on ineffective mitigation measures intended to reduce risks associated with runoff and spray drift. In its ecological risk assessments for 2,4-D and for glyphosate, EPA found potential risks to plant and animal species both on and off the application site. To mitigate those risks, EPA included mitigation measures on the 2022 labels for both Enlist products. Those mitigation measures include a 30-foot buffer intended to reduce spray drift, and a variety of runoff reduction measures that users could choose from. The plaintiffs allege that EPA did not consider evidence showing that the 30-foot buffer, which has been included in previous Enlist labels, did not reduce spray damage. The plaintiffs also claim that EPA failed to consider the likelihood of noncompliance with the runoff reduction measures since the Enlist label allows applicators to choose from a selection of different runoff restrictions. Because EPA failed to consider these risks, the plaintiffs argue that they have relied on ineffective mitigation measures.
By failing to fully consider the potential risks and benefits associated with registering Enlist One and Enlist Duo, and by relying on faulty mitigation measures, the plaintiffs argue that EPA has failed to support its 2022 registration decision with the substantial evidence necessary to substantiate the conclusion that registering the Enlist products will not cause “unreasonable adverse effects on the environment.”
ESA Claims
The plaintiffs also allege that EPA violated the ESA by delaying consultation with FWS over its 2022 decision to register Enlist One and Enlist Duo for an additional seven years, and by making an “irreversible or irretrievable commitment of resources” prior to the end of the consultation process.
Under the ESA, any agency carrying out an agency action is required to consider the impacts of that action to listed species. 16 U.S.C. § 1536(a)(2). If the agency determines that the action “may affect” a listed species, then it is required to formally consult with either FWS or NMFS to determine whether any mitigation measures are needed to prevent jeopardizing the existence of a listed species or destroying designated critical habitat. 50 C.F.R. § 402.14(a). During formal consultation, the ESA directs agencies not to make any “irreversible or irretrievable commitment of resources” that could prevent the implementation of any mitigation measures identified during consultation. 16 U.S.C. § 1536(d); 50 C.F.R. § 402.09.
Here, the plaintiffs argue that EPA failed to initiate formal consultation over its decision to register the Enlist products until one day before approving the registration decision. The plaintiffs claim that EPA should have initiated formal consultation as soon as it concluded that registering the Enlist products “may affect” listed species. By waiting to initiate formal consultation, the plaintiffs argue that EPA violated the ESA. Additionally, the plaintiffs argue that by approving the registration decision prior to formal consultation being completed, EPA has violated the ESA by making an irreversible and irretrievable commitment of resources. By allowing use of the Enlist products, which EPA has concluded “may affect” listed species, before FWS completes its formal consultation, the plaintiffs argue that EPA has failed to maintain the status quo.
Going Forward
Should the court side with the plaintiffs, it is possible that the registrations for both Enlist One and Enlist Duo could be vacated. However, it is also possible that this court could reach a conclusion similar to the one reached by the Ninth Circuit in 2020, where it upholds the registrations but orders EPA to review certain aspects of its analysis. In recent years, various courts have found that EPA has violated the ESA by failing to initiate formal consultation prior to registering a pesticide for use. This string of cases has prompted EPA to revisit its strategy for ESA compliance when making pesticide decisions. In its 2020 Enlist decision, the Ninth Circuit ruled only on the plaintiffs’ FIFRA claims, declining to consider the ESA arguments. It is currently not clear whether the court in the current lawsuit will consider the plaintiffs’ ESA claims.
At this point, the lawsuit is still in its earliest stages, with EPA having yet to file an answer to the plaintiffs’ complaint. It is also unclear how long the case could take to move through the court system, meaning it could be some months before the court hears oral argument and issues an opinion.
To read the plaintiffs’ complaint in Ctr. for Food Safety v. U.S. Envt’l Protection Agency, click here.
To read the text of FIFRA, click here.
To read the text of the ESA, click here.
For more National Agricultural Law Center resources on pesticides, click here.