by:Peggy Kirk Hall, Associate Professor, Agricultural & Resource Law
Published on Thursday, June 04, 2020
Dicamba has had its share of legal challenges, and a decision issued yesterday dealt yet another blow when the Ninth Circuit Court of Appeals vacated the product’s registration with the U.S. EPA. In doing so, the court held that the EPA’s approval of the registration violated the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), which regulates the use of herbicides and other chemicals in the U.S. Here’s a summary of how the court reached its decision and a few thoughts on the uncertainty that follows the opinion.
The challenge: EPA’s approval of three dicamba products
We first have to step back to 2016, when the EPA approved three dicamba-based products– Monsanto’s XTendiMax, DuPont’s FeXapan, and BASF’s Engenia–as conditional use pesticides for post-emergent applications in 34 states, including Ohio. Although dicamba has been around for years, the approval came after the companies reformulated dicamba to make it less volatile and in anticipation of the development of dicamba tolerant soybean and cotton seeds. The agency conducted a risk assessment and concluded that if used according to the label restrictions, the benefits of the dicamba products outweighed “any remaining minimal risks, if they exist at all.” The EPA also provided that the registrations would automatically expire if there was a determination of an unacceptable level or frequency of off-site dicamba damage.
Before the conditional registrations were set to automatically expire in late 2018, the EPA approved requests by Bayer CropScience (previously Monsanto), Cortevo (previously DuPont) and BASF to conditionally amend the registrations for an additional two years. The approval came despite widespread concerns about dicamba drift and damage during the 2017 growing season. To address those concerns, EPA chose not to conduct a new risk assessment and instead adopted additional label restrictions that had been proposed by Monsanto/Bayer to minimize off-field movement of dicamba. Many states added restrictions for dicamba use that exceeded the label restrictions, including banning any use of the product during certain periods.
Several organizations challenged the EPA’s dicamba registration approvals. The National Family Farm Coalition, Center for Food Safety, Center for Biological Diversity, and Pesticide Action Network North America filed suit against the EPA, claiming that the agency violated both FIFRA and the Endangered Species Act in approving the product registrations. Monsanto requested and was granted permission to intervene in the case.
The Ninth Circuit’s review
To approve the request to amend the dicamba registrations, FIFRA required the EPA to make two conclusions: first, that the applicant had submitted satisfactory data related to the proposed additional use of the pesticide and second, that the approval would not significantly increase the risk of unreasonable adverse effects on the environment. The task before the Ninth Circuit Court of Appeals was to review the EPA’s 2018 decision and determine whether there was substantial evidence to support the EPA’s conclusions and amend the registrations.
The conclusion that drew the most attention from the court was the EPA’s determination that amending the dicamba registrations for two years would not cause unreasonable adverse effects on the environment. The court determined that the EPA erred in making this conclusion when it substantially understated several risks of dicamba registration, such as:
Misjudging by as much as 25% the amount of acreage on which dicamba would be used in 2018.
Concluding that complaints to state departments of agriculture could have either under-reported or over-reported the actual amount of dicamba damage, when the record clearly showed that complaints understated the amount of damage.
Failing to quantify the amount of damage caused by dicamba, “or even to admit that there was any damage at all,” despite having information that would enable the EPA to do so.
But that’s not all. The court pointed out that the agency had also “entirely failed to acknowledge other risks, including those it was statutorily required to consider,” such as:
The risk of substantial non-compliance with label restrictions, which the court noted became “increasingly restrictive and, correspondingly, more difficult to follow” and to which even conscientious applicators could not consistently adhere.
The risk of economic costs. The court stated that the EPA did not take into account the “virtually certain” economic costs that would result from the anti-competitive effect of continued dicamba registration, citing evidence in the record that growers were compelled to adopt the dicamba products just to avoid the possibility of damage should they use non-dicamba tolerant seed.
The social costs of dicamba technology to farming communities. The court pointed out that a farmer in Arkansas had been shot and killed over dicamba damage, that dicamba had “pitted neighbor against neighbor,” and that the EPA should have identified the severe strain on social relations in farming communities as a clear social cost of the continued registration of the products.
Given the EPA’s understatement of some risks and failure to recognize other risks, the Court of Appeals concluded that substantial evidence did not support the agency’s decision to grant the conditional registration of the dicamba products. The EPA “failed to perform a proper analysis of the risks and resulting costs of the uses,” determined the court. The court did not address the Endangered Species Act issue.
A critical point in the decision is the court’s determination of the appropriate remedy for the EPA’s unsupported approval of the dicamba products. The EPA and Monsanto had asked the court to utilize its ability to “remand without vacatur,” or to send the matter back to the agency for reconsideration. The remedy of “vacatur,” however, would vacate or void the product registrations. The court explained that determining whether vacatur is appropriate required the court to weigh several criteria, including:
The seriousness of the agency’s errors against the disruptive consequences of an interim change that may itself be changed,
The extent to which vacating or leaving the decision in place would risk environmental harm, and
Whether the agency would likely be able to offer better reasoning on remand, or whether such fundamental flaws in the agency’s decision make it unlikely that the same rule would be adopted on remand.
The court’s weighing of these criteria led to its conclusion that vacating the registrations of the products was the appropriate remedy due to the “fundamental flaws in the EPA’s analysis.” Vacating the registrations was not an action taken lightly by the court, however. The judges acknowledged that the decision could have an adverse impact on growers who have already purchased dicamba products for the current growing season and that growers “have been placed in this situation through no fault of their own.” Clearly, the court places the blame for such consequences upon the EPA, reiterating the “absence of substantial evidence” for the agency’s decision to register the dicamba products.
The court raised the issue we’re all wondering about now: can growers still use the dicamba products they’ve purchased? Unfortunately, we don’t have an immediate answer to the question, because it depends largely upon how the EPA responds to the ruling. We do know that:
FIFRA § 136a prohibits a person from distributing or selling any pesticide that is not registered.
FIFRA § 136d allows the EPA to permit continued sale and use of existing stocks of a pesticide whose registration is suspended or canceled. The EPA utilized this authority in 2015 after the Ninth Circuit Court of Appeals vacated the EPA’s registration of sulfoxaflor after determining that the registration was not supported by substantial evidence. In that case, the EPA allowed continued use of the existing stocks of sulfoxaflor held by end-users provided that the users followed label restrictions. Whether the agency would find similarly in regards to existing stocks of dicamba is somewhat unlikely given the court’s opinion, but remains to be seen. The EPA’s 2015 sulfoxaflor cancellation order at: https://www.epa.gov/sites/production/files/2015-11/documents/final_cancellation_order-sulfoxaflor.pdf
While the U.S. EPA registers pesticides for use and sale in the U.S., the product must also be registered within a state in order to be sold and used within the state. The Ohio Department of Agriculture oversees pesticide registrations within Ohio, and also regulates the use of registered pesticides.
If the EPA appeals the Ninth Circuit’s decision to the U.S. Supreme Court, the agency would likely include a request for a “stay” that would delay enforcement of the court’s Order.
Bayer strongly disagrees with the decision but has paused its sale, distribution and use of XtendiMax while assessing its next step and awaiting EPA direction. The company states that it will “work quickly to minimize any impact on our customers this season.” Bayer also notes that it is already working to obtain a new registration for XtendiMax for the 2021 season and beyond, and hopes to obtain the registration by this fall. See Bayer’s information T: https://www.roundupreadyxtend.com/Pages/xtendimax-updates.aspx
BASF and Corteva have also stated that they are awaiting the EPA’s reaction to the decision, and will “use all legal remedies available to challenge this Order.”
Syngenta has clarified that its Tavium Plus VaporGrip dicamba-based herbicide is not part of the ruling and .that the company will continue selling that product.
For now, all eyes are on the U.S. EPA’s reaction to the Ninth Circuit’s decision, and we also need to hear from the Ohio Department of Agriculture. Given the current state of uncertainty, it would be wise for growers to wait and see before taking any actions with dicamba products. We’ll keep you posted on any new legal developments. Read the court’s decision in National Family Farm Coalition et al v. U.S. EPA AT: https://farmoffice.osu.edu/sites/aglaw/files/site-library/Ninth_Circuit_Dicamba_Registration_Petition.pdf