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By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom

On January 25, 2016, in a significant development in the case involving the continued registration of DowAgrosciences LLC’s (DowAgro) Enlist Duo product, the U.S. Court of Appeals for the Ninth Circuit in Case Nos. 14-73353, et al. (consolidated), denied the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur of the Enlist Duo registration, but granted EPA’s motion to remand its decision granting that registration.  DowAgro’s December 7, 2015, response to the EPA motions stated that DowAgro had “absolutely no problem with the requested remand to allow the agency to review that information, and hereby consents to such relief.”  DowAgro did oppose EPA’s request that the court vacate the registration, arguing that EPA was attempting to circumvent the normal cancellation process by having the court vacate the registration.  The case will now be remanded to EPA, and the Enlist Duo registration remains nominally in place.  The court’s order allows EPA to consider further action to vacate the registration, but this appears unlikely since DowAgro has previously indicated that it is willing to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.”  After reviewing the new information concerning synergistic effects recently submitted by DowAgro, EPA will then make a new decision concerning the registration of Enlist Duo.

The court also denied DowAgro’s motion to strike the Natural Resources Defense Council’s (NRDC) December 17, 2015, reply in support of EPA’s motion for vacatur and remand.  DowAgro moved to strike NRDC’s reply because NRDC’s pleading was more of a “reply brief” than a response, and a “litigant has no right to file a ‘reply’ brief in support of a motion filed by another party.”  DowAgro’s motion to strike included a request to the court to grant it leave to respond to NRDC’s filing as well as a proposed response brief.  This procedural question is now moot because the court has acted on the EPA motions and the registration has been remanded to EPA.

More information on the recent case proceedings is available in our blog entry EPA Replies in Support of its Motion for Voluntary Vacatur and Remand.


 

By Lisa M. Campbell and Timothy D. Backstrom

On December 17, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), the U.S. Environmental Protection Agency (EPA) filed a reply in support of its motion for voluntary vacatur and remand of its decision granting a registration to intervenor DowAgroSciences LLC (DowAgro) for Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  DowAgro responded to the motion by agreeing that remand is appropriate but opposing vacatur as an effort to circumvent the normal cancellation process, while the petitioners Center for Food Safety, et al. (CFS) filed a response supporting the motion for vacatur.  More information on the DowAgro and CFS responses is available in our blog entry DowAgro and Center for Food Safety File Responses to EPA’s Motion for Voluntary Vacatur and Remand.

In its reply, EPA rejects the argument by DowAgro that it is trying to “short-circuit” the normal cancellation procedures under FIFRA.  Citing recent Ninth Circuit precedent on vacatur, EPA argues that “vacatur would be more protective of the environment during the time in which EPA evaluates the new information, and Dow has failed to demonstrate any disruptive consequences of vacatur.” 

EPA also takes issue with certain statements by CFS that it characterizes as “erroneous or irrelevant.”  EPA contradicts assertions by CFS that EPA overlooked important evidence concerning the synergistic effects of Enlist Duo’s principal ingredients, that EPA determined that Enlist Duo will not protect endangered non-target plants, that EPA has violated the ESA, and that EPA is approaching synergistic effects as a new issue.  EPA also objects to the efforts of CFS to introduce an extra-record newspaper article.

This case will continue to be watched closely, as there is widespread industry concern about EPA’s effort to use a judicial process in lieu of normal adjudicatory procedures and about EPA’s substantive approach to evaluating synergistic efficacy data.  In this regard, it is noteworthy that the issue of potential synergistic effects is relatively narrow and does not appear to be among the purported deficiencies in the EPA decision originally cited by the petitioners. 


 

By Lisa M. Campbell, Lisa R. BurchiJames V. Aidala, and Timothy D. Backstrom

On December 7, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated) Intervenor Dow AgroSciences, LLC (DowAgro) filed a response, and Petitioner the Center for Food Safety, et al. (CFS, et al.) filed joinder in and response to the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur and remand of EPA’s registration of DowAgro’s Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as a response to DowAgro’s Fact Sheet, a public statement made by DowAgro after EPA’s motion was filed. 

DowAgro’s response calls EPA’s motion a “Dr. Jekyll & Mr. Hyde” motion.  The request for remand, DowAgro states, is “uncontroversial” and will allow the agency to review the new information that may bear on the pesticide registration.  DowAgro thus does not object to the remand and believes ultimately that “the new information cited by respondents has no impact on the validity of the existing registration.”

On the other hand, DowAgro argues that EPA’s request to vacate the registration is “novel and unlawful.”  DowAgro states that EPA is trying to “short-circuit [the FIFRA] regulatory scheme and abdicate the responsibilities Congress assigned to the agency.”  Specifically, DowAgro argues this case is “closely analogous” to the Reckitt Benckiser case (762 F. Supp. 2d 34 (D.D.C. 2011), where the court did not allow EPA to circumvent the statutory cancellation regime, finding that FIFRA Section 6 “establishes a detailed, multistep process that EPA must follow when it wants to cancel or suspend a registration.”  Id. at 42 (emphasis in original).  DowAgro states that the court must “limit its relief to a remand for the agency to exercise primary jurisdiction to review the new information and decide what additional steps, if any, are warranted.”  While EPA reviews the additional information, DowAgro has agreed to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.”

CFS, et al.’s filing asserts that vacatur is the appropriate remedy.  CFS, et al. states that EPA now “has an opportunity -- a mandate -- to meet its duties under FIFRA and the ESA, and ensure Enlist Duo’s safety.”  CFS, et al. “not only agree, but believe EPA greatly downplays the potential for harm by focusing only on the buffers and terrestrial plants,” and states that the “potential for harm far outweighs any likely economic disruption to Intervenor Dow.”

Commentary

The outcome of the issue raised by EPA’s motion, and DowAgro’s position that EPA should not be permitted to “bypass” regulatory cancellation procedures is of significant interest to all pesticide registrants.  This case will be closely watched not only because Enlist Duo is a major new product for Dow and a new tool in the herbicide-tolerant crop world, but also because of the potentially precedential process that EPA’s motion seeks with regard to pesticide registrations. 

More information on EPA’s motion is available in our blog entry EPA Files Motion for Voluntary Vacatur and Remand of Enlist Duo Registration.