On October 23, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Petitioner the Natural Resources Defense Council (NRDC) and Petitioners the Center for Food Safety, National Family Farm Coalition, Pesticide Action Network North America, Beyond Pesticides, Environmental Working Group, Center for Biological Diversity, and Earthjustice (CFS, et al.) (together, Petitioners) filed separate opening briefs in Case Nos. 14-73353 and 14-73359 (consolidated) arguing that the U.S. Environmental Protection Agency’s (EPA) registration orders approving Dow AgroScience’s Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on Enlist corn and soybeans should be overturned because they violate the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA).   EPA approved Enlist Duo for use in six states on October 15, 2014, and granted an amendment on March 31, 2015, to authorize use in an additional nine states.  In its brief, NRDC states that this case “presents a textbook example of an administrative agency that erred by entirely failing to consider not one, but two important aspects of the problem before it: human cancer risk and harm to monarch butterflies.”  NRDC notes that when EPA proposed on April 30, 2014, to register Enlist Duo, it stated that no new assessment is needed for glyphosate because use on herbicide-resistant crops is not a new use.  NRDC argues, however, that there are many new studies on glyphosate’s human health effects and impacts on monarch butterflies that have been published since EPA reregistered glyphosate-containing pesticides in 1993 (the date when NRDC states EPA last conducted comprehensive environmental and human health assessments for glyphosate). NRDC concludes by stating that “by failing to consider up-to-date science on glyphosate’s cancer risk, EPA again violated its statutory duty to ensure that registration of Enlist Duo would not cause ‘unreasonable adverse effects on the environment,' which includes an unreasonable risk to human health.”

In its opening brief, CFS, et al. argues that EPA violated FIFRA by failing to ensure Enlist Duo does not cause “any unreasonable adverse effects” on the environment, stating “EPA’s modelling showed risks to wildlife from Enlist Duo exceeding the Agency’s own risk thresholds.  Yet, EPA unlawfully ignored its own metrics by speculating, without record support, that real world exposures would be less than the impacts its own calculations revealed.”  CFS, et al. also focuses on ESA, arguing that EPA violated ESA by failing to consult with the U.S. Fish and Wildlife Service on the potential impacts from the pesticide on protected species and their critical habitat and by applying an “unlawful approach” to determine whether registration of Enlist Duo “may affect” listed species or critical habitats.

On the same day, NRDC filed a motion to supplement the record with three documents that it states were submitted to EPA, but were not considered by EPA before it issued its second Enlist Duo registration decision, stating that “EPA unlawfully failed to consider relevant and important information before determining whether registration of Enlist Duo will cause “unreasonable adverse effects” on human health.  The documents are:  (1) an article that the World Health Organization’s (WHO) International Agency for Research on Cancer published online on March 20, 2015, in which it states that glyphosate is “probably carcinogenic to humans”; (2) a statement that WHO published in conjunction with its cancer finding on March 20, 2015, stating that it not only evaluated EPA’s assessment of glyphosate’s cancer risk from the early 1990s, but also undertook “a comprehensive review of the latest available scientific evidence”; and (3) a letter that NRDC and other concerned parties sent to EPA on March 26, 2015, calling on EPA to reconsider its initial decision to register Enlist Duo for use in six states in light of the WHO’s cancer finding, and not to expand the Enlist Duo registration to additional states, which EPA had proposed to do.

Discussion

Petitioners’ arguments offered in these opening briefs are not unexpected, as pesticide products containing glyphosate have been challenged and controversial for many years.  Petitioners’ briefs acknowledge that EPA did not indicate when it last conducted environmental and human health assessments for glyphosate, and EPA may likely object to Petitioners' characterization that it last reviewed glyphosate in 1993. Indeed, in its fact sheet approving Enlist Duo, EPA states it conducted a “rigorous analysis” of all the scientific studies, considered all public comments, and used worst-case estimates when assessing the safety of Enlist Duo.  In addition, the briefs do not acknowledge that other agencies in the U.S. and abroad have reached conclusions similar to EPA’s, including but not limited to, the fact that just prior to EPA’s decision to register Enlist Duo the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its determination that three varieties of herbicide resistant corn and soybeans on which Enlist Duo will be applied are no longer considered regulated articles under its regulations governing the introduction of certain genetically engineered organisms because they are unlikely to pose a plant pest risk.

EPA and Dow AgroSciences’ answering briefs are due December 18, 2015, and optional reply briefs are due January 15, 2016.  Oral argument has not yet been scheduled.  More information on the recent history of the case is available in our Pesticide Blog item “Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.”

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