In 2014, the Environmental Protection Agency (“EPA”) registered a pesticide called Enlist Duo under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). Manufactured by Dow AgroScience (“Dow”), Enlist Duo contains two active ingredients, 2,4- dichlorophenoxyacetic acid (“2,4-D”) and glyphosate. Both 2,4-D and glyphosate are used to control broad-leaf plants, and 2,4-D in has been used to combat weeds that have developed a resistance to glyphosate. However, 2-4-D is known to be volatile, meaning droplets of 2-4,D can vaporize into the air and drift off-target. Because of its volatility, 2,4-D has primarily been used as a pre-emergent, meaning it would be applied to the ground before planting to clear a field of weeds. EPA’s registration of Enlist Duo in 2014 was the first time a 2,4-D pesticide was registered for use over the top of crops. Following the 2014 registration of Enlist Duo, multiple lawsuits were filed in the United States Court of Appeals for the Ninth Circuit challenging EPA’s decision.
Background
The 2014 registration allowed Enlist Duo to be used in six states on newly released corn and soybean varieties that Dow had genetically engineered to be resistant to 2,4-D. Following the 2014 registration of Enlist Duo, multiple lawsuits were filed in the United States Court of Appeals for the Ninth Circuit challenging EPA’s decision. In 2015, EPA amended the 2014 registration to include nine additional states. The lawsuits challenging the 2014 registration were amended to challenge EPA’s 2015 actions along with the initial 2014 registration. At that time, those lawsuits were consolidated into one. While the claims in that case were waiting to be heard by the court, EPA was made aware of data collected by Dow about Enlist Duo that EPA had not considered in its 2014 decision. EPA asked the court to vacate the registration of Enlist Duo and send it back to EPA so the agency could redo the registration process with the new data in order to reach a more accurate decision on registration. The court agreed, vacating the 2014 and 2015 decisions and sending the Enlist Duo registration back to EPA for further review.
In 2017, EPA released a document titled “Final Registration of Enlist Duo Herbicide” (Final Registration). That document reaffirmed EPA’s decisions to register Enlist Duo for use in fifteen states on 2,4-D resistant soybean and corn seeds, and expanded the use of Enlist Duo on 2,4-D resistant seeds to thirty-four total states. Following EPA’s 2017 decision, two lawsuits were filed alleging that the decision violated FIFRA and the Endangered Species Act (“ESA”). Nat’l Family Farm Coal. v. U.S. Envt’l Prot. Agency, No. 17-70810 (9th Cir. Mar. 21, 2017), and Nat. Res. Def. Council v. Pruitt, No. 17-70817 (9th Cir. Mar. 21, 2017) have been consolidated into one case. This means that although the plaintiffs will file separate briefs and make their own arguments, the court will issue one opinion to decide the matter.
Nat’l Family Farm Coal. v. U.S. Envt’l Prot. Agency
In their complaint before the Ninth Circuit, a group of environmental organizations lead by the National Family Farm Coalition (“NFFC”) argues that EPA’s decision to register Enlist Duo violated both the ESA and FIFRA. According to NFFC, EPA violated the ESA by failing to consult with either Fish and Wildlife Service (“FWS”) or the National Marine Fisheries Service (“NMFS”), the two agencies responsible for administering the ESA, on the effects that the Final Registration decision would have on endangered species. Additionally, NFFC argues that EPA violated FIFRA by applying the wrong legal standard for the kind of registration that it used to register Enlist Duo, and by failing to make statutorily required findings.
Section 7 of the ESA requires federal agencies to consult with either FWS or NMFS if the agency is taking an action that “may affect” any listed species or designated critical habitat. The “may affect” standard is extremely low, and requires federal agencies to engage in consultation if an action has any change of affecting a listed species or critical habitat. NFFC argues that EPA’s decision to register Enlist Duo met the ESA’s “may affect” standard because endangered species and critical habitat are found in all thirty-four of the states that EPA has registered Enlist Duo for use in. Therefore, EPA should have engaged in ESA consultation over its decision to register Enlist Duo.
NFFC also argues that EPA used the wrong legal standard when deciding whether to engage in ESA consultation. Instead of applying the ESA’s “may affect” standard, EPA applied the FIFRA “unreasonable adverse effects on the environment standard.” When registering a pesticide for use, FIFRA requires EPA to determine that the pesticide “will not generally cause unreasonable adverse effects on the environment” which FIFRA defines as “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.” The FIFRA standard differs from the ESA standard because FIFRA requires EPA to weigh all of the costs and benefits of registering a pesticide to determine if there will be an unreasonable adverse effect. The ESA prohibits cost-benefit balancing and requires consultation any time a listed species may be affected by an agency action. NFFC argues that EPA violated the ESA by applying the FIFRA standard when determining whether to engage in ESA consultation over its decision to register Enlist Duo.
Finally, NFFC argues that EPA’s Final Registration decision violated FIFRA by applying the wrong legal standard and failing to make required findings. Under FIFRA, a pesticide can be either unconditionally or conditionally registered. An unconditional registration requires EPA to conclude that registering the pesticide “will not generally cause unreasonable adverse effects on the environment.” A conditional registration is used to register a new use of an already registered pesticide and requires EPA to find that “(i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.” According to NFFC, EPA identified the Final Registration decision issued in 2017 as a conditional registration, but instead of making the two conclusions required for conditional registration, EPA applied the standard for unconditional registration to conclude that the Final Registration decision would not “generally cause unreasonable adverse effects.” Additionally, NFFC argues that even if EPA had applied the correct standard for conditional registration, EPA would still have violated FIFRA because the Final Registration was not supported by substantial evidence. When EPA issues an order under FIFRA, it must support the order with “substantial evidence.” NFFC argues that EPA failed to support its conclusion that 2,4-D volatilization from Enlist Duo would not unreasonably affect the environment with substantial evidence because the study EPA based that conclusion on was “deficient.”
Nat. Res. Def. Council v. Pruitt
In its complaint before the Ninth Circuit, the National Resources Defense Council (“NRDC”) also argue that EPA’s Final Registration decision violated FIFRA. According to NRDC, EPA violated FIFRA by registering Enlist Duo in 2017 as a conditional pesticide when that type of registration is reserved for pesticides which were already unconditionally registered under FIFRA. NRDC also argues that EPA violated FIFRA by failing to support the Final Registration with substantial evidence.
Under FIFRA, conditional registrations are used to register new uses of already registered pesticides. Unconditional registrations are used to register pesticides that have never been registered under FIFRA. The Final Registration decision is a conditional registration, meaning that Enlist Duo should have already been registered under FIFRA. EPA states that it registered Enlist Duo as a conditional new use of for 2,4-D choline salt. Because the active ingredients in Enlist Duo have already been unconditionally registered under FIFRA, EPA claims that it can conditionally register Enlist Duo as a new use of those ingredients. NRDC disagrees. It argues that EPA did not register 2,4-D choline salt, it registered Enlist Duo which NRDC claims is a new combination of 2,4-D and glyphosate that should have been unconditionally registered under FIFRA.
NRDC also argues that EPA failed to support the Final Registration with substantial evidence. This argument is similar it to the argument being raised by NFFC. However, instead of claiming that a study EPA relied on is defective, NRDC claims that EPA lacked substantial evidence to conclude that registering Enlist Duo would not “significantly increase the risk of any unreasonable adverse effect on the environment.” According to NRDC, EPA could not make that conclusion because it failed to consider all the evidence about the effects of 2,4-D and glyphosate on monarch butterflies. Monarch butterflies are not currently listed under the ESA, but a court has ordered FWS to decide whether to list the monarch by the end of 2020.
Possible Impacts
If the Ninth Circuit rules in favor of the plaintiffs in the Enlist Duo litigation, it could result in a decision that instructs EPA to apply the ESA “may affect” standard whenever it registers a pesticide under FIFRA. Currently, EPA applies the FIFRA “unreasonable adverse effects on the environment standard” when determining whether to engage in ESA consultation over a pesticide registration. This means that EPA will only perform ESA consultation if it concludes that registration of a pesticide will result in unreasonable adverse effects to a listed species after weighing the costs and benefits of registering the pesticide. This is a higher threshold than the ESA standard which would require EPA to consult on a pesticide registration any time that registration “may affect” a listed species or designated critical habitat. If the Ninth Circuit decides that the ESA standard is what should have been applied in this case, it is possible that EPA will have to apply the ESA standard to all pesticide registration decisions going forward. This could result in pesticide registrations taking longer, and involving more limitations to protect listed species.
The current litigation involving dicamba-based pesticides in the Ninth Circuit could have an impact on the FIFRA issue raised by NFFC. In Nat’l Family Farm Coal. v. U.S. Envtl. Prot. Agency, No. 19-70-115 (9th Cir. 2020), NFFC argued that EPA had failed to support the registration of three dicamba-based pesticides, XtendiMax, FeXapan, and Engenia, with substantial evidence. Specifically, NFFC argued that there was not enough substantial evidence to show that the registrations would not result in “unreasonable adverse effects on the environment.” In a decision issued on June 3, 2020, the court concluded that EPA had failed to support its finding that the registrations of the pesticides would not cause unreasonable adverse effects because EPA under-stated the risks of registration that it had identified, and failed to identify three other risks that it should have considered. Understated risks included the amount of acreage that had been planted with dicamba-resistant seeds, and failure to estimate the amount of damage caused by dicamba. Unacknowledged risks included the complexity of the labels, the social effects that dicamba had on farming communities, and the economic effects of marketing dicamba-based pesticides for use with dicamba-resistant seeds.
If the Ninth Circuit relies on the court’s decision in the dicamba litigation, when deciding the Enlist Duo litigation, it may conclude that EPA did fail to support the Enlist Duo registration with substantial evidence if the agency did not appropriately consider the risks identified in the dicamba case. More information about that decision, including the ruling itself, can be found here.
All the plaintiffs in the Enlist Duo litigation have asked the court to vacate the registration of Enlist Duo. Should the court find in favor of the plaintiffs and vacate the registration, it would likely result in Enlist Duo no longer being registered under FIFRA. Pesticides that are not registered under FIFRA may not be sold or distributed, which would throw use of Enlist Duo into question. It is also possible that the Enlist Duo litigation could have affect how EPA registers pesticides going forward depending on how the court resolves the issues raised in the case.
To read the NFFC complaint, click here.
To read the NRDC complaint, 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.
For more National Agricultural Law Center resources on the ESA, click here.