In a decision that turns largely on scientific methodology and reliable data, the Ninth Circuit Court of Appeals yesterday allowed continued registration of the Enlist Duo herbicide developed by Dow AgroScience (Corteva). Unlike last month’s decision that vacated registrations of three dicamba herbicides, the two-judge majority on the court held that substantial evidence supported the EPA’s decision to register the herbicide. Even so, the court sent one petition back to the EPA to further consider the impact of Enlist Duo on monarch butterflies in application areas. One dissenting judge would have held that the science used to support the Enlist Duo registration violates the Endangered Species Act.
The case began in 2014, when the same organizations that challenged the dicamba registrations (National Family Farm Coalition, Family Farm Defenders, Beyond Pesticides, Center for Biological Diversity, Center for Food Safety and Pesticide Action Network North America) and the Natural Resources Defense Council each filed petitions challenging the EPA’s registration of Enlist Duo. The EPA later amended the registration in 2015 and 2017, eventually allowing use of the herbicide on corn, soybeans and cotton in 34 states. The petitioners challenged the 2015 and 2017 registrations as well, and the Ninth Circuit consolidated the challenges into the case at hand.
The court’s opinion begins with an explanation of why it agreed with the parties who brought the challenges that they had the legal right to do so, or had “associational standing.” Likely of higher interest to our readers is how the court answered the questions of whether the EPA adequately examined the potential impacts of Enlist Duo under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the federal Endangered Species Act (ESA). Here’s what the court had to say about the petitioners’ claims under each law:
The FIFRA claims. The monarch butterfly issue was the only successful FIFRA claim advanced by the petitioners. The court agreed that the EPA didn’t properly assess adverse harm to monarch butterflies that would result from increased 2,4-D use on milkweed in application fields, despite evidence suggesting that the butterflies might be adversely affected. The EPA stated that it didn’t do so because the approval of Enlist Duo would not change the amount of milkweed being controlled by herbicides—those milkweeds would still be controlled with or without Enlist Duo. The court disagreed, stating that FIFRA required the agency to determine whether any effect was “adverse” before then determining whether the effect on the environment was unreasonable, which EPA didn’t do in regard to the monarch butterfly.
The court rejected all of the petitioners’ other arguments under FIFRA:
Applicable standards. Several claims that the EPA applied the wrong FIFRA registration standards failed. The agency correctly used the broader and more stringent standard, which was to determine whether the registration would cause any unreasonable adverse effects on the environment.
Increased glyphosate use. Petitioners also argued that the EPA erred in determining that approval of Enlist Duo would not cause unreasonable adverse effects on environment because glyphosate was already being used. The registration would only impact which glyphosate was being used but not how much glyphosate was in use. The court agreed with EPA’s assertion that due to the “nearly ubiquitous use” of glyphosate across the country before the approval of Enlist Duo registration, there would not be an increase in overall glyphosate use and no increased risks. Interestingly, the court distinguished increased use from new data about glyphosate use, stating that “this does not mean, of course, that new data about glyphosate will go unconsidered….”
Volatility risk. The court also rejected volatility risk arguments, one of the science-heavy parts of the opinion (begin at page 37 for a good read). The EPA had concluded the type of 2,4-D in Enlist Duo exhibits lower volatility and off-site vapor drift than other forms of 2,4-D. EPA reached this conclusion based several studies and data points: a laboratory study that examined degree of visual damage, six publicly available studies assessing plant growth and survival damage, data from a vapor flux study used to perform computer modeling to determine dose level and air concentration in order to predict adverse damages to plants off-field, a second type of modeling that assesses drift of wet and dry depositions, and atmospheric monitoring data. Petitioners claimed limitations to the studies and methodology used, contradictions between EPA scientists, failure to follow regulatory guidelines and to consider large enough field sizes in its modeling. The court commented that the evaluation of volatility “probably could have been better,” but found no evidence showing that EPA’s conclusion was wrong or that volatility fears had materialized since approval of the herbicide. The court explained that the agency may apply its expertise to draw conclusions from probative preliminary data and “it is not our role to second-guess EPA’s conclusion.”
Mixing risks. Petitioners also argued that Dow intended to mix Enlist Duo with glufosinate and EPA failed to account for the synergistic effect of such mixing. With no evidence other than an abandoned patent application for a mixed product by Dow, the court held that FIFRA doesn’t require an analysis of theoretical tank mixing but only that which is contemplated on the label.
Nearly all of the EPA’s FIFRA decisions were supported by substantial evidence, the court concluded, with the exception of the monarch butterfly analysis.
The ESA claims. Science is a recurring theme in the court’s analysis of the petitioners’ ESA arguments, and also the source of sharp disagreement on the court. ESA’s section 7 requires a determination of the biological impacts of a proposed action. ESA consultation among the agencies is required if determined that an agency’s action “may affect” a listed species or critical habitat in an “action area.” The petitioners claimed that EPA failed in its determination on several grounds, requiring the court to review whether the EPA’s determination was arbitrary, capricious, an abuse of discretion, or contrary to law. Here are the arguments, and the court’s responses:
“No effect” finding. The petitioners argued that the EPA erred in determining that Enlist Duo approval would have “no effect” on plant and animal species and the court responded with another lengthy science-heavy discussion of “risk quotient” methodology and legal requirements to use the “best scientific and commercial data available.” The EPA employed a risk quotient methodology to conclude that there would be exposure to the herbicide but that such exposure would not lead to an effect on plants and animals. The two judges in the majority were willing to defer to the agency on this conclusion and its dependence on the risk quotient methodology, but Judge Watford strongly disagreed. Pointing out that the National Academy of Sciences had advised the EPA that the risk quotient method was “scientifically unsound,” the dissent concluded that the data derived from the methodology did not qualify as “scientific data” and therefore violated the ESA. The majority stated that the risk quotient methodology doesn’t violate the duty to use the best scientific and commercial data available, which means that the EPA must not disregard available scientific evidence that is better and does not require the agency to conduct new tests or make decisions on data that doesn’t exist. Deference to the agency was warranted, said the majority, and restraint against second guessing or using the court’s judgment.
Action area. For its ESA determination, the EPA limited the “action area” to treated fields, while petitioners argued that the herbicide would drift beyond treated fields. Again turning to the EPA’s science, the court held that the agency had science-based reasons for limiting the target area. The EPA had appropriately accounted for drift through empirical data, mitigation measures, and label restrictions and no evidence in the record supported that the agency had made an error.
Critical habitat. The final argument advanced by petitioners was that EPA did not meet its duty to insure that there would be no “adverse modification” of critical habitat from the registration. Although there were 154 species with critical habitats in the states where Enlist Duo would be approved, EPA concluded that 176 of the species would not be in corn, cotton or soybean fields. Of the eight species remaining, the agency determined that there would be no modification to their critical habitats as a result of Enlist Duo registration because none of the species’ essential features or “primary constituent elements” were related to agriculture. Petitioners challenged the methodology EPA employed to reach this conclusion, but the court once again disagreed and deferred to the agency.
With only the monarch butterfly impact analysis in need of further study, the Ninth Circuit declined the petitioners’ request to vacate the Enlist Duo registration. The court chose instead to remand the petition without vacating the registration, stating that the EPA’s failure to consider harm to monarch butterflies was technical and not a “serious” error. Pointing also to the “disruptive” consequences of removing a pesticide that has been in use for over five years, the court stated that vacatur was not warranted when the EPA had substantially complied with FIFRA and fully complied with the ESA.
Enlist Duo registration will continue. The EPA must address evidence that its destruction of milkweed in fields harms monarch butterflies, however. The court advised the agency to “move promptly” in doing so.
Further action by the petitioners is likely. According to correspondence with DTN, the petitioners are disappointed and will fight the decision. They will likely also follow the EPA’s science quite closely as it reexamines the monarch butterfly issue.
Read the Ninth Circuit's decision National Family Farm Coalition et al v. U.S. EPA and Natural Resources Defense Council v. Wheeler, here.
In August, the Secretary of the Interior announced that the Trump Administration would be making revisions to the way the Endangered Species Act (ESA) is carried out under federal regulations. The move was made in part to further the Administration’s goal to “ease the regulatory burden” on citizens. The revised regulations apply to sections 4 and 7 of the ESA, which means they make changes to how species are listed as endangered, how critical habitat for species is determined, how threatened species are treated, and how the different federal agencies cooperate to carry out the ESA.
Revision of endangered, threatened, and critical habitat protections
The changes to how the ESA is carried out were made in three rulemakings published on August 27, 2019. One of the rules, available here, is meant to increase cooperation between federal agencies when carrying out the ESA (this rule is set to become effective on October 28). Changes made by the other two rules, available here, and here, are much more controversial because they have a great impact on how endangered and threatened species and their habitats are treated under federal regulations. The new rules went into effect on September 26, 2019. We discuss some of the biggest modifications below.
First, the rules change the term “physical or biological features” to “physical or biological features essential to the conservation of the species.” This change will likely diminish the number of natural features and areas that will be protected, since only those deemed essential to an endangered species will be protected. Similarly, the new rules give the federal government more leeway to determine when habitat is not critical habitat for species, which may result in less habitat being protected under the new iteration of the rules.
In yet another change, the new rules separate the discussion of “threatened” and “endangered” species within the regulatory text. Due to this uncoupling, some read the new version of the rule as stripping threatened species of protections they enjoyed when they were more closely related to endangered species. The new edition of the rules instead includes factors for determining whether a species can be listed as threatened, such as whether it is likely the species will become endangered in the “foreseeable future,” which will be determined on a case by case basis. Critics of the new rules believe that this language will give the government the discretion to overlook the effects of climate change on a species, which could play out over a period of time longer than the “foreseeable future.” Along the same lines, the rules also make it harder to ban certain activities in order to protect threatened species.
The rules weaken the ESA by allowing the federal government to take into account the actions of states, other nations, and local jurisdictions when listing and delisting species. In other words, if the species is being protected on another level of government or by another country, the U.S. government may be less inclined to protect the species; either by choosing not to list the species, or by removing its threatened or endangered status. Importantly, the new rules also allow “commercial information,” not just scientific information, to be considered when making a decision. Under the old rules, agencies were not allowed to consider the economic impacts of listing or delisting a species. On the whole, the rules seem to give the federal government a lot more discretion to determine that species or habitats should not be protected.
On September 25, 2019, the day before the new rules became effective, the attorneys general from 17 states, including Ohio’s neighbors Michigan and Pennsylvania, sued the Trump Administration in federal court over the changes to the rules. You can find the complaint here. The states assert that the rulemaking violates several federal statutes, including the Administrative Procedure Act, which governs federal administrative agencies. The states further claim that the weakening of protections for endangered and threatened species and their habitats will cause harm to their natural resources, harm to their citizens through environmental degradation, take away the current and future economic benefits of protected species, and increase costs for state governments.
Amidst all the rule changes and lawsuits, members of Congress have been working on their own potential changes to the ESA. Recently, the Congressional Western Caucus, a group of congress members from all around the country who are concerned with land use and resource rights, among other causes, introduced nineteen bills meant to “modernize” the ESA. If you’re interested in the specifics of each bill, they are listed on the Caucus’ website, here. Overall, the bills focus on fixing the ESA by implementing “defined recovery goals” for species, relying on “standardized…publically available” science, and allowing more involvement from states and stakeholders on endangered species decisions.
With action taking place on the administrative, legislative, and judicial levels of the federal government, the way the ESA is written and interpreted seems to be up in the air at present. We will be sure to update the Ag Law Blog with any developments.