U.S. Court of Appeals for the Ninth Circuit Issued Two Separate Significant Decisions in Pesticide Cases (Part 1)

Written by Chloe Marie – Research Specialist

In recent weeks, the U.S. Court of Appeals for the Ninth Circuit handed down two separate decisions ruling on the pesticide registrations of dicamba and Enlist Duo.  In the first decision, issued on June 3, 2020, the court overruled a decision issued by the U.S. Environmental Protection Agency (EPA) to approve registration of the herbicide dicamba (National Family Farm Coalition, et al. v. U.S. EPA, et al., No. 19-70115).  The same court, however, on July 22, 2020, upheld the EPA’s registration approval of Enlist Duo – a pesticide developed by Dow Agrosciences, LLC, comprising an active ingredient combination of 2,4-dichlorophenoxyacetic acid (2,4-D) choline salt and glyphosate (National Family Farm Coalition, et al. v. U.S. EPA, et al., No. 17-70810).

We will provide in this article an overview of the reasoning and arguments with regard to the EPA registration review process set out by the Court of Appeals in the dicamba case, and a second article will address the court’s opinion in the Enlist Duo case.  In addition, and by way of background, we will provide a short overview of EPA’s registration review process for pesticides.

EPA’s Pesticide Registration Review Process

In the United States, one may distribute, sell or use a pesticide, only when EPA determines that the pesticide product is safe to use through a registration review process pursuant to Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 7 USC § 136a(c); 40 CFR § 152.100 et seq.

In order to register its product, a pesticide company must submit an application for registration with EPA and must include the following information and documentation: identity of the applicant and product, proposed product labeling, technical and scientific data materials specific to the product, and a statement concerning tolerances.  40 CFR § 152.50.  EPA may grant registration on an unconditional or conditional basis, depending on the completeness and reliability of the data presented as part of the application.  40 CFR § 151.111.

Unconditional Registration

The registration is unconditional provided that EPA reviews all available data relating to the pesticide product and establishes that no additional data is needed to substantiate the application.  40 CFR § 152.112.  EPA also must determine that the use of the pesticide product does “not generally cause unreasonable adverse effects on the environment.”  40 CFR § 152.112(e).  FIFRA defines the terms “unreasonable adverse effects on the environment,” in relevant part, 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 USC § 136(bb).

Conditional Registration

On the other hand, EPA can register or amend a pesticide registration on a conditional basis in certain specified circumstances where the application contains sufficient data and provided that the applicant will submit any missing or additional information or data needed.  These specified circumstances include a new use of an existing registered pesticide, a proposed pesticide that is identical or substantially similar to another registered pesticide, and for a new active ingredient not already contained in any registered pesticide. 40 CFR § 152.113 and § 152.114.

Every 15 years, EPA is responsible to determine whether any registered pesticide product, in light of new information, poses public health or environmental risks that may no longer be acceptable to the population.

Opinion Summary – National Family Farm Coalition, et al. v. U.S. EPA, et al., No. 19-70115)

Factual and Procedural Background

Dicamba was created by Monsanto and first registered in 1967.  This growth regulator herbicide is well-known among farming communities for its leaf “cupping” effect following exposure.  Dicamba also is a highly volatile herbicide and can lead to disastrous impacts on neighboring crops.  As a result, Monsanto as well as DuPont and BASF designed new dicamba-based herbicides, with less volatile compounds, for use on dicamba-tolerant (DT) soybeans and cotton crops.  In 2016, EPA granted conditional registrations of the new dicamba-based herbicides – Monsanto’s XtendiMax, DuPont’s FeXapan, and BASF’s Engenia – coupled with label restrictions and risk mitigation measures to avert the risk of environmental impacts.

During the 2017 growing season, however, several state departments of agriculture received a significant number of complaints from farmers and non-farmers about the still-drifting nature of dicamba, which damaged many neighboring fields and crops.  Consequently, EPA established additional label restrictions.  The 2018 growing season also was marked by great numbers of complaints received by state officials.

The three dicamba-based herbicide registrations were scheduled to expire by the end of the year 2018, and Bayer (formerly Monsanto), Corteva (formerly DuPont) and BASF each filed an application to amend their registrations for new uses of the herbicide products on DT-soybean and cotton.

EPA found two benefits from the over-the-top (OTT) use of dicamba on DT soybeans and cotton.  According to EPA, dicamba “provides an effective tool to treat especially noxious weeds … including glyphosate-resistant biotypes that threaten soybean and cotton production today.”  And “effective treatment of glyphosate-resistant weeds can help control the spread of resistance.”  On October 31, 2018, EPA granted the companies’ requests on a conditional basis for an additional period of two years.

The National Family Farm Coalition, the Center for Food Safety, the Center for Biological Diversity, and the Pesticide Action Network North America petitioned the U.S. Court of Appeals for the Ninth Circuit on January 11, 2019, for review of EPA’s 2018 decision to re-register the three herbicides for new uses.

Ninth Circuit’s Reasoning and Ruling

The Court of Appeals first reviewed the data examined by EPA in support of its decision and, even though it noticed some inadequacy, decided not to rule on this issue.

There are two cumulative requirements for granting conditional amendment of an existing registration: EPA must determine that 1) the applicant has submitted “satisfactory data” in support of its application; and 2) the amendment would not “significantly increase the risk of any unreasonable adverse effect on the environment.”  Here, the court concluded that there was no relevance in addressing whether the data was satisfactory because it concluded that EPA failed to meet the requirement of whether the registration of these herbicides for new uses would “not significantly increase the risk of any unreasonable adverse effect on the environment.”  In this regard, the court found that EPA “substantially” underestimated three risks that it had recognized to exist and “entirely” ignored three other risks.

“EPA substantially understated risks that it acknowledged”

First, the court opined that EPA did not adequately evaluate the seed acreage devoted to dicamba-tolerant (DT) plants in 2018, and hence underestimated the amount of dicamba used on post-emergent crops that same year.  According to the court, EPA was wrong to base its decision on a projection made by Monsanto that 40 million acres of DT soybeans would be planted in 2018 while, by October 31, 2018, the agency should have known exactly how many seeds had been planted.  The court noted that the record showed that not less than 50 million acres had been used for growing DT soybeans in 2018.

Second, the court determined that EPA’s conclusion that the amount of damages resulting from the use of dicamba had either been under-reported or over-reported to state departments of agriculture was not backed by any substantial evidence.  The court reasoned that “EPA’s purported agnosticism as to whether dicamba damage was under- or over-reported is contradicted by overwhelming record evidence that dicamba damage was substantially under-reported.”

Third and finally, the court held that EPA knowingly failed to acknowledge and quantify the harmful effects of over-the-top (OTT) application of dicamba herbicides even though such information was available through studies and presentations.  The court stated that “EPA had information from which it could have quantified dicamba damage, even if it could not have calculated with precision the reduction in yield caused by the damage.”

EPA “failed entirely to acknowledge other risks”

The court first found that there was a substantial risk of non-compliance with the 2018 EPA-mandated label for the 2019 and 2020 growing seasons as the restrictions associated with the label appeared to be very unrealistic, given their number.  The court described the label as “forty-pages long, with myriad instructions and restrictions” and declared that EPA voluntarily dismissed the record evidence showing that the 2018 label restrictions would make compliance very difficult for farmers.

Second, the court indicated that EPA did not take into consideration the economic and social costs of using the dicamba-based herbicides when completing its cost-benefit analysis.  The court pointed out that “EPA knew that Monsanto’s glyphosate-resistance trait, and accompanying glyphosate herbicide, had achieved a near-monopoly” and that many farmers would feel pressured to use dicamba-based products over the fact that “other seed technologies wouldn’t get a chance to ‘make an impact on weed resistance,’ as farmers increasingly adopted DT seeds out of fear over Dicamba drift.”  According to the court, this situation would result in anti-competitive effects that could not be allowed.

The court also observed that the use and resulting drift of dicamba-based herbicide into other fields created a “severe strain on social relations in farming communities where the new Dicamba herbicides are being applied.”  The court found that EPA failed to account for this social cost as part of its analysis despite extensive evidence.

For all these reasons, the Court of Appeals vacated the conditional registrations for the three dicamba-based herbicides and denied EPA’s and Monsanto’s request to remand without vacatur, which means that the conditional registrations are no longer effective.

The Court of Appeals justified this decision by stating that, “the ‘fundamental flaws’ in the EPA’s analysis are so substantial that it is exceedingly ‘unlikely that the same rule would be adopted on remand.’”

Understanding the impacts such decision would have on the farming community, the court declared “[w]e acknowledge the difficulties these growers may have in finding effective and legal herbicides to protect their DT crops if we grant vacatur.  They have been placed in this situation through no fault of their own.  However, the absence of substantial evidence to support the EPA’s decision compels us to vacate the registrations.”

EPA’s Reaction

In reaction to the court’s decision, EPA stated, “This ruling implicates millions of acres of crops, millions of dollars already spent by farmers, and the food and fiber Americans across the country rely on to feed their families,” and added “EPA is assessing all avenues to mitigate the impact of the Court’s decision on farmers.”

Subsequently, EPA issued on June 8, 2020, a cancellation order terminating the distribution, sale, and use of XtendiMax, Engenia, and FeXapan.  As a means of alleviating the effects of the court’s decision, EPA specified that “[t]his cancellation order authorizes limited distribution of existing stocks of Xtendimax, Engenia, and FeXapan by commercial applicators and authorizes all other sale or distribution of existing stocks only to facilitate return to the manufacturer or for proper disposal.  This cancellation order prohibits any use of existing stocks that is inconsistent with the previously-approved product labeling and prohibits use beyond July 31, 2020.”

 

This material is based upon work supported by the National Agricultural Library, Agricultural Research Service, U.S. Department of Agriculture.