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November 24, 2015

EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration And Other Recent FIFRA Developments

The ACTA Group

EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration: 
On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-7335, the U.S. Environmental Protection Agency (EPA) filed a motion to vacate voluntarily and remand its registration of Dow AgroSciences LLC’s (DowAgro) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. The case commenced in October 2014 when the Natural Resources Defense Council (NRDC) and other environmental groups, including the Center for Food Safety (CFS, et al.) (Petitioners), filed petitions for review challenging EPA’s decision to register Enlist Duo, a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D. Petitioners argued, in part, that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D. EPA’s motion reverses its previous position that DowAgro’s application for Enlist Duo satisfied the requirements for issuance of an unconditional registration under FIFRA Section 3(c)(5). EPA states that it is seeking a voluntary remand to reconsider the Enlist Duo registration in light of new information regarding potential synergistic effects referred to as “synergistic herbicidal weed control” between the two active ingredients — 2,4-D and glyphosate — contained in Enlist Duo on non-target plants. EPA is in the process of evaluating information submitted to it by DowAgro on November 9, 2015, in response to EPA’s request for all available information related to synergistic effects. EPA asserts that none of this information was submitted to EPA prior to EPA’s issuance of the Enlist Duo registration.

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

EPA Makes Available Supporting Documents For Endangered Species Biological Evaluations: 
On December 11, 2015, EPA’s Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated: chlorpyrifosdiazinon, and malathion. For each chemical, the following supporting documents are now available: problem formulation; fate and effects characterizations; and related appendices. The provisional models are available here.

EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process. The entire draft BEs for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016.

These BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences’ April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, which examined topics pertaining to tools and approaches for assessing the effects of proposed FIFRA actions on endangered and threatened species and their critical habitats, and provided recommendations.
USDA provided expertise on crop production and pesticide uses and assistance with the use of the National Agricultural Statistics Service Cropland Data Layer to help define the footprint of agricultural use patterns. The FWS and the NMFS will use the analyses and data from the biological evaluations and integrate it into their final Biological Opinions for the three chemicals due in December 2017.