On July 22, 2020, the Ninth Circuit Court of Appeals issued a final decision in Nat’l Family Farm Coal. v. U.S. Envt’l Prot. Agency, No. 17-70810 (9th Cir. 2020), the lawsuit challenging the Environmental Protection Agency’s (“EPA”) registration of the pesticide Enlist Duo under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). Enlist Duo is manufactured by Dow AgroSciences LLC (“Dow”), and contains a combination of two active ingredients – 2,4-dichlorophenoxyacetic acid (“2,4-D”) choline salt and glyphosate. Both 2,4-D and glyphosate have been registered under FIFRA for uses as pesticides for decades. Both are used to control broad-leaf plants, and 2,4-D has been used to combat weeds that have grown resistant to glyphosate. When combined, the two ingredients delay the development of weeds’ pesticide resistance and allows for pesticide use later in the growing season.
Enlist Duo was originally registered under FIFRA in October 2014. It was registered again in 2015, and 2017. The present lawsuit challenges the 2017 registration, and raises claims under both FIFRA and the Endangered Species Act (“ESA”). For an in-depth look at the arguments raised in the two complaints filed in Nat’l Family Farm Coal. v. U.S. Envt’l Prot. Agency, click here. Ultimately, the court upheld the 2017 registration for Enlist Duo. The court found in favor of EPA on almost every argument. However, the court did conclude that EPA had failed to properly assess harm to the monarch butterfly as a result of the increased use of 2,4-D on milkweed, the monarch butterfly’s host plant. As a result, the court has remanded the 2017 decision to EPA for the agency to address evidence that monarch butterflies may be harmed. By remanding the registration without vacating it, the court has permitted Enlist Duo to remain registered and available for use according to its label while EPA assesses the potential harm to the monarch.
The first argument addressed by the court was whether EPA had applied the wrong FIFRA standard when registering Enlist Duo in 2014. Under FIFRA, a pesticide can be either “unconditionally” or “conditionally” registered. Each registration has its own standard that gets applied accordingly. When EPA unconditionally registers a pesticide, it ensures that the pesticide will “not generally cause unreasonable adverse effects on the environment.” 7 U.S.C. § 136a.(c)(5). FIFRA defines “unreasonable adverse effects on the environment” 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.” 7 U.S.C. § 136(bb). When EPA conditionally registers or amends the registration of a pesticide, it must determine that “the applicant has submitted satisfactory data pertaining to the proposed additional use” and that “amending the registration in the manner proposed . . . would not significantly increase the risk of any unreasonable adverse effect on the environment.” 7 U.S.C. § 136a(c)(7)(B).
In this case, the plaintiffs argued that EPA stated in the registration documents that they were registering Enlist Duo under the “unconditional” standard, but incorrectly applied the “conditional” standard which is more lenient. The court disagreed. First, the court began by stating that the plaintiffs had waived the argument by not raising it in the initial lawsuit challenging the 2014 registration. Because the plaintiffs failed to raise the argument at the appropriate time, the court concluded that they could not raise the argument now. The court next stated that even if the argument had been raised at the right time, it was still not persuasive. According to the court, the 2014 registration was “plainly unconditional” because EPA both stated in the documents that it was an unconditional registration, and the evidence showed that EPA applied the unconditional registration standard by analyzing both the ecological and human risk of registering Enlist Duo.
The next FIFRA argument raised by the plaintiffs was that EPA lacked “substantial evidence” for its 2014, 2015, and 2017 registration decision because EPA failed to: “(1) properly assess harm to the monarch from an increased 2,4-D use on milkweed in target fields; (2) consider that Enlist Duo would increase the use of glyphosate over time; (3) correctly consider the volatility of Enlist Duo’s 2,4-D component; and (4) consider the synergistic effects of mixing Enlist Duo with glufosinate.” The court disagreed with the plaintiffs on all arguments except for one. According to the court, EPA had failed to properly assess harm to the monarch butterfly when it registered Enlist Duo.
Although EPA did assess some potential risks to the monarch in its registration decisions by considering the effects Enlist Duo would have to plants that were not intentionally sprayed with the pesticide, it did not go far enough. EPA failed to consider how the destruction of milkweed plants on fields where Enlist Duo would be sprayed would affect monarchs. During litigation, EPA argued that it did not have to consider the effects Enlist Duo would have on milkweed in target fields because farmers would control milkweed on those fields in some other way. Therefore, harm to milkweed on target fields would not be an “unreasonable adverse effect.” However, the court concluded that EPA failed to consider whether the potential harm to milkweed on target fields would be “adverse.” According to the court, EPA was required to determine whether any effect was “adverse” before determining whether the effect was “unreasonable.”
The court rejected the other three arguments the plaintiffs made for why EPA lacked “substantial evidence” for its registration decisions for Enlist Duo. According to the court, EPA was right to conclude that there would be no increase in the risk of unreasonable adverse effects as a result of glyphosate use when registering Enlist Duo because the crops Enlist Duo is used on have been genetically-engineered to be glyphosate-resistant and glyphosate use on those crops was “nearly ubiquitous” before 2014. The court next concluded that EPA did not fail to consider the volatility of Enlist Duo’s 2,4-D component because the 2,4-D in Enlist Duo is a choline salt which has a much lower volatility than other registered forms of 2,4-D. Finally, the court concluded that EPA had not failed to consider the synergistic effects of mixing Enlist Duo with glufosinate because it is unlawful to tank-mix Enlist Duo with any product that has not been listed on the website enlisttankmix.com, and glufosinate is not listed on that website.
The court rejected every FIFRA argument raised by the plaintiffs except for the claim that EPA failed to properly assess harm to the monarch butterfly as a result of registering Enlist Duo.
The plaintiffs argued that EPA applied the wrong standard when it concluded that registering Enlist Duo would not affect any species listed under the ESA. More precisely, the plaintiffs argue that when EPA applied the ESA “may effect” standard to determine whether registering Enlist Duo would harm listed species, it used FIFRA methods to reach a “no effect” conclusion.
Under the ESA, federal agencies are required to consult with either Fish and Wildlife Services (“FWS”) or National Marine Fisheries Services (“NMFS”), the two agencies responsible for administering the ESA, any time the federal agency takes an action that “may effect” a listed species. The “may effect” standard is considered to be a very low threshold that requires federal agencies to engage in consultation if an action has any chance of affecting a listed species or critical habitat.
Here, EPA concluded that the registration of Enlist Duo would have “no effect” on listed species. According to the plaintiffs, EPA reached that conclusion by applying “risk quotients” and “levels of concern” developed as part of compliance with the FIFRA “unreasonable adverse effects” standard. According to the plaintiffs, EPA’s use of the methodology developed for FIFRA compliance violated the ESA requirement that agencies “use the best scientific and commercial data available.” 16 U.S.C. § 1536(a)(2). The court disagreed. It noted that the purpose of that requirement is to ensure that the ESA is not applied “haphazardly” or on a speculative basis. The court also noted that courts are wary of overturning agency scientific determinations because such determinations belong to an agency’s “special expertise.” Ultimately, the court did not believe that the plaintiffs showed that EPA violated its duty to “use the best scientific and commercial data available” by using FIFRA methodology to reach a “no effect” conclusion under the ESA.
The court has sent the registration of Enlist Duo back to EPA for further analysis of possible harm to the monarch butterfly, but has chosen to keep the registration in place while EPA addresses that issue. This means that Enlist Duo will remain registered and available for use according to its label while EPA considers the potential harm to the monarch. The monarch butterfly is not currently listed under the ESA, but final decision on whether to list it is expected before the end of 2020. It is not clear how EPA’s analysis of potential harm to the monarch would change if the butterfly is listed.
The ESA claims that the plaintiffs raised in this case are similar to the ESA claims the same plaintiffs raised in Nat’l Family Farm Coal. v. U.S. Envtl. Prot. Agency, No. 19-70-115 (9th Cir. 2020), the lawsuit challenging the registration of several dicamba-based herbicides. While the court in the dicamba litigation did not reach those ESA claims in its decision, the court did reach them in the Enlist Duo litigation. While the arguments in the two cases are slightly different, in both cases the plaintiffs asserted that it was a violation of the ESA to apply FIFRA methodology or standards when EPA is determining whether to engage in ESA consultation. It is possible that the court’s conclusion here, that the FIFRA methodology did not violate the ESA, could indicate how a future court may rule on a similar argument.
The plaintiffs have stated an intention to challenge the court’s decision, and that they are considering their options moving forward, including asking for the case to be heard by the entire Ninth Circuit.
To read the decision in Nat’l Family Farm Coal. v. U.S. Envt’l Prot. Agency, click here.
To read more about Nat’l Family Farm Coal. v. U.S. Envt’l Prot. Agency, click here.
For more National Agricultural Law Center resources on pesticides, click here.