By Lisa M. Campbell, Lisa R. Burchi and Timothy D. Backstrom
On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-73353, the U.S. Environmental Protection Agency (Respondent; EPA) filed a motion for voluntary vacatur and remand of EPA’s registration, as amended, of Dow AgroSciences LLC’s (Dow) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants.
This 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.) (together, 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 EPA previous position that Dow’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. Specifically, EPA is in the process of evaluating information submitted to it by DAS 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.
EPA states that the claimed synergism could affect EPA’s “assessment of drift reduction measures for avoiding impacts to non-target organisms, including those listed as endangered.” EPA also states that it “cannot be sure, without a full analysis of the new information, that the current registration does not cause unreasonable effects to the environment, which is a requirement of the registration standard under FIFRA” and that its initial review “indicates that the 30-foot buffer included in the registration may not be adequate.”
DAS has until December 7, 2015, to file its response before the court will consider EPA’s motion to remand the registration. Although it has not completed its assessment, EPA states that if the court vacates the Enlist Duo registration, EPA will issue a cancellation order to regulate the sale, distribution, and use of existing stocks of Enlist Duo pursuant to FIFRA. This case is being considered for the March 2016 oral argument calendar but the exact date of oral argument has not been determined at this time. More information regarding this case is available in our blog items Environmental Groups File Opening Briefs Challenging EPA’s Decision to Register Enlist Duo and Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.
EPA’s request for remand with vacatur rather than a remand without vacatur is a severe action. EPA could have chosen to seek remand without requesting that the registration be vacated, and then demanded prompt revision of the buffer zone that EPA now believes may be inadequate to protect non-target plants from synergistic effects. EPA may have decided to send a message that there will be serious consequences when an applicant fails to submit all of the data in its possession that may be pertinent to EPA’s assessment of the statutory criteria for registration. In any case, Dow reportedly has stated that it does “not expect these issues to result in the long-term cancellation of the Enlist Duo product registration” and that Dow will “continue to prepare for commercial sales of Enlist Duo for the 2016 growing season with enthusiastic grower adoption."
By Lisa M. Campbell, Lisa R. Burchi, Timothy D. Backstrom, and James V. Aidala
On October 23, 2015, in the U.S. Court of Appeals for the Ninth Circuit, the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (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) decision to register 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 it violates 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. On August 11, 2015, the Court of Appeals denied motions for a stay pending review that were filed by these same environmental Petitioners on December 18, 2014, and February 6, 2015. See “Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.”
In its brief, NRDC notes that when EPA proposed to register Enlist Duo, it stated that no new assessment is needed for glyphosate because use of glyphosate on herbicide-resistant crops is not a new use. NRDC argues that there are many new studies concerning glyphosate’s human health effects and impacts on monarch butterflies since EPA reregistered glyphosate and last prepared comprehensive environmental and human health assessments in 1993. NRDC argues 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 their brief, CFS, et al. argue that EPA violated FIFRA by ignoring its own modelling indicating that risks to wildlife from Enlist Duo exceed EPA’s risk thresholds. CFS, et al. also focus on purported violations of the ESA, arguing that EPA improperly failed to consult with the U.S. Fish and Wildlife Service on the potential impacts of Enlist Duo on protected species and their critical habitat, and that EPA applied an “unlawful approach” to determine whether registration of Enlist Duo “may affect” listed species or critical habitats.
NRDC also filed a motion to supplement the record with three documents that it states were submitted to EPA, but it contends were not considered by EPA before it issued its registration decision for Enlist Duo. The documents include an article published by the World Health Organization’s (WHO) International Agency for Research on Cancer stating that glyphosate is “probably carcinogenic to humans”; a statement published by WHO in conjunction with its cancer finding, and a letter from NRDC and other concerned parties calling on EPA to reconsider its initial decision to register Enlist Duo in light of the WHO’s cancer finding.
Petitioners’ arguments in these opening briefs are not unexpected, as pesticide products containing glyphosate have been challenged and controversial for many years. In briefs opposing the prior stay motions by the Petitioners, EPA and the registrant Dow AgroSciences argued that registration of Enlist Duo will not lead to any increase in the use of glyphosate, and that EPA also considered all of the human health effects of 2,4-D before granting the registration. The Petitioners acknowledge that EPA did not state when it last conducted environmental and human health assessments for glyphosate, and EPA is likely to object to Petitioners' inference that EPA has not reviewed the environmental and health effects of glyphosate since 1993. In the fact sheet concerning its decision to register Enlist Duo, EPA states that 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 Petitioners do not discuss the determination by the the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), that three varieties of herbicide resistant corn and soybeans on which Enlist Duo will be applied are no longer considered regulated articles under 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 reply briefs are due January 15, 2016. Oral argument has not yet been scheduled.
By Lynn L. Bergeson, James V. Aidala, and Lisa R. Burchi
On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides. Specifically, IARC classified the herbicide glyphosate and the insecticides malathion and diazinon as probably carcinogenic to humans (Group 2A), and classified the insecticides tetrachlorvinphos and parathion as possibly carcinogenic to humans (Group 2B). IARC also found there is “limited evidence” that glyphosate can cause non-Hodgkin’s lymphoma and lung cancer in humans.
A summary of the final evaluations, together with a brief rationale, is published online in The Lancet Oncology; the detailed assessments will be published as Volume 112 of the IARC Monographs. IARC’s press release announcing its evaluation is available at http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf.
Monsanto, on behalf of glyphosate task forces in the U.S. and the European Union (EU), immediately voiced its vigorous disagreement with IARC’s conclusions, noting various scientific issues with IARC’s evaluation that resulted in a conclusion that has not been reached following review by the U.S. Environmental Protection Agency (EPA) and in the EU. Monsanto’s statement is available at http://news.monsanto.com/news/monsanto-disagrees-iarc-classification-glyphosate.
The IARC announcement with regard to glyphosate will further energize both sides of the debate about genetically modified organism (GMO) crops, since there are several crops that have been genetically engineered to be resistant to glyphosate. If some occupational risks are identified as needing possible further mitigation, the distinction between food safety issues and occupational risks may be lost in the rhetoric. Opponents of GMO crops and those who support GMO food product labels can be expected to cite the IARC designation regardless of any further clarification or nuance that the scientific debate over the data might provide. Defenders of the technology will insist that not only is the IARC designation wrong and misleading, but it is clearly at odds with numerous other conclusions reached by multiple competent governmental authorities concerning the safety of using glyphosate and especially consuming GMO crops.
Regardless of Monsanto’s rapid and detailed response, “dueling science” views are not helpful towards enhancing public confidence in the safety of the food supply, which is ultimately where this headline will be most influential. That will only add pressure on the review process and conclusions contained in the expected EPA registration review of glyphosate data scheduled for completion in 2015.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
Center for Food Safety v. EPA is a case in the U.S. Court of Appeals for the 9th Circuit (9th Circuit) that consolidates two petitions for review of a decision by the U.S. Environmental Protection Agency (EPA) to register the new herbicide product Enlist Duo for use in six Midwestern states. A group of non-governmental organizations filed one of the petitions and the Natural Resources Defense Council (NRDC) filed a separate petition. Enlist Duo combines the active ingredients glyphosate and 2,4-D. The registrant Dow AgroSciences (Dow) has intervened in the case. The petitioners focus primarily on the purported failure of EPA to consider properly the effects of Enlist Duo on certain endangered species.
Each petitioner has now filed a motion to stay the EPA action registering Enlist Duo due to Endangered Species Act (ESA) challenges. The first stay motion filed by NRDC is based primarily on the risk to monarch butterflies, and that stay motion has now been fully briefed. The other petitioners filed a separate stay motion focusing on whooping cranes and Indiana bats, but they waited until two weeks after EPA and Dow filed their briefs opposing the first stay motion. Before either stay motion was filed, Dow filed a motion seeking transfer of the case to the D.C. Circuit Court of Appeals. Arguing that the two independent successive stay motions were abusive, Dow later filed a motion to hold the briefing on the second stay motion in abeyance, pending a ruling on its transfer motion.
The 9th Circuit denied Dow’s motion to hold the briefing on the second stay motion in abeyance only three days later. This procedural ruling does not dispose of the underlying transfer motion, but it does suggest that the court is not inclined to transfer the case. If the case is not transferred, the court will ultimately consider and rule on both pending stay motions. The court’s interim order does not suggest how it views the pending stay motions. The petitioners have a heavy burden to show both a substantial likelihood of success on the merits and irreparable harm to obtain the requested interim relief. EPA and Dow contend that the petitioners have not established either of these things. Overall, this ESA challenge to a new genetically modified organism (GMO) product may indicate a new front in the ESA litigation arena, since new products have generally not been challenged under ESA requirements. 2,4,-D itself is not a new herbicide, so this case is not quite a challenge to a totally new active ingredient; such a challenge was made recently in the case of cyantraniliprole. CBD, et al. v. EPA, No. 14-00942 (D.D.C. filed Oct. 10, 2014). Challenges to new active ingredients and GMO products, however, could threaten to hinder the introduction of new products into the marketplace.