Thursday, June 4, 2020

Agricultural Law in the Spotlight - June 4, 2020

U.S. Appeals Court Invalidates FIFRA Registrations of Dicamba Products XtendiMax, Engenia and FeXapan.  

Written By:

Brook Duer, Staff Attorney

On June 3, 2020, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a decision overturning and vacating the U.S. Environmental Protection Agency’s October 31, 2018 approvals of conditional two-year amended product registrations of three dicamba herbicide products (Monsanto/Bayer’s XtendiMax, BASF’s Engenia and Corteva’s FeXapan) for over-the-top use on soybeans and cotton, effective immediately. National Family Farm Coalition, et al. v. EPA, No. 19-70115.  The Court held that the approvals violated the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq. 

Since the prior registrations for those products expired by December 2018, none of the three products have a valid registration at this time and are therefore prohibited from being used or sold in the U.S. for those purposes. 

Syngenta’s dicamba herbicide product approved for over-the-top use on soybeans and cotton, Tavium, was not a subject of the petition for review because it was first registered and marketed for this use in April 2019, after the petition for review was filed.

The disruption to farming activities for the 2020 growing season, for which planning, purchasing of seed, planting and scheduled herbicide use may have already been completed, was acknowledged by the Court in stating,

    “We are aware of the practical effects of our decision. Among other things, we are aware of the adverse impact on growers who have already purchased [dicamba-tolerant] soybean and cotton seeds and dicamba products for this year’s growing season, relying on the availability of the herbicides for post-emergent use . . . We 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.”  

The current FIFRA registration for Tavium for over-the-top use on soybeans and cotton is dated April 5, 2019, and remains valid until December 20, 2020.  The product can still be used and sold in the U.S. for those purposes at this time.  

 The Ninth Circuit panel succinctly summarized the reasons for its decision as follows:

 

   “We hold that the EPA’s October 31, 2018, decision, and the conditional new-use registrations of XtendiMax, Engenia, and FeXapan for use on DT soybean and cotton that are premised on that decision, violate FIFRA. As we will explain in more detail below, FIFRA provides two requirements for conditional amendment of an existing registration. The EPA must determine that (i) the applicant has submitted “satisfactory data,” and (ii) the amendment will not “significantly increase the risk of any unreasonable adverse effect on the environment.” 7 U.S.C. § 136a(c)(7)(B). We need not decide whether substantial evidence supports a finding that the applicants submitted satisfactory data—although, as we discuss below, the data have several flaws—because we hold that the EPA substantially understated risks that it acknowledged and failed entirely to acknowledge other risks.

The EPA substantially understated three risks that it acknowledged. The EPA substantially understated the amount of DT seed acreage that had been planted in 2018, and, correspondingly, the amount of dicamba herbicide that had been sprayed on post-emergent crops. Further, the EPA purported to be agnostic as to whether formal complaints of dicamba damage under-reported or overreported the actual damage, when record evidence clearly showed that dicamba damage was substantially under-reported. Finally, the EPA refused to estimate the amount of dicamba damage, characterizing such damage as “potential” and “alleged,” when record evidence showed that dicamba had caused substantial and undisputed damage.

The EPA also entirely failed to acknowledge three other risks. The EPA entirely failed to acknowledge record evidence showing the high likelihood that restrictions on OTT dicamba application imposed by the 2018 label would not be

followed. The EPA based its registration decision on the premise that the label’s

mitigation measures would limit off-field movement of OTT dicamba. These

measures became increasingly restrictive with each iteration of OTT dicamba

labels. Record evidence shows that the restrictions on the 2016 and 2017 labels

had already been difficult if not impossible to follow for even conscientious users;

the restrictions on the 2018 label are even more onerous. Further, the EPA entirely failed to acknowledge the substantial risk that the registrations would have anticompetitive economic effects in the soybean and cotton industries. Finally, the EPA entirely failed to acknowledge the risk that OTT dicamba use would tear the social fabric of farming communities.

   We therefore vacate the EPA’s October 31, 2018, registration decision and

the three registrations premised on that decision. Because our vacatur is based on

our holding under FIFRA, we do not reach the question whether the registration

decision also violates the Endangered Species Act.” 

Links to the decision and the current Tavium registration, as well as to the April 21, 2020, oral argument by the parties’ legal teams before the U.S. Court of Appeals for the Ninth Circuit, are provided at the links embedded herein, or at the following:

Decision

https://law.justia.com/cases/federal/appellate-courts/ca9/19-70115/19-70115-2020-06-03.html

Tavium FIFRA Registration

https://www3.epa.gov/pesticides/chem_search/ppls/000100-01623-20190405.pdf

Oral Argument:

https://www.ca9.uscourts.gov/media/view_video.php?pk_vid=0000017284



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




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