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. Burchi, James 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.”
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.
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, Timothy D. Backstrom, and Susan Hunter Youngren, Ph.D.
On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos. EPA issued this proposal in response to an August 10, 2015, writ of mandamus by the U.S. Court of Appeals for the Ninth Circuit. The court granted this unusual relief in response to a 2007 administrative petition to cancel chlorpyrifos registrations or to revoke chlorpyrifos tolerances by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (together, Petitioners). The court’s August 10, 2015, order required that EPA do one of the following by October 31, 2015: (a) cancel the registrations of all pesticides containing chlorpyrifos; (b) issue a proposed or final rule to revoke chlorpyrifos tolerances; or (c) issue a full and final response to the administrative petition to cancel chlorpyrifos. More information on that decision is available in our blog item Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos.
In its announcement, EPA states that it “is not denying the petition because we are unable to make a safety finding based on the science as it stands currently. EPA is not issuing a final revocation rule because we have not proposed it and have not completed our refined drinking water assessment, leaving certain science issues unresolved.” The court also required EPA to provide the timeline for a final rule should EPA issue a proposed revocation by October 31, and EPA notified the court of an anticipated date for a final rule of December 2016. EPA will release a completed hazard assessment and a completed drinking water analysis for comment prior to issuance of any final rule.
Because EPA has not completed its hazard assessment and drinking water analysis, this means that EPA may resolve the “science issues” without the need for tolerance revocations. The proposal is based not on the risk posed by chlorpyrifos residues in food, but on the incremental risk posed by chlorpyrifos in drinking water in very specific and limited watersheds where chlorpyrifos is heavily used. EPA is required to consider such exposures in evaluating the safety of chlorpyrifos residues in food under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act (FQPA). If the tolerances are revoked, this will result in cancellation of the associated food uses of chlorpyrifos.
The chlorpyrifos registrant Dow AgroSciences and other pesticide industry representatives do not agree with the EPA analysis or the proposal to revoke the tolerances. In particular, questions have been raised about EPA’s decision to retain the use of a 10X FQPA safety factor for infants and children based on certain epidemiology studies. EPA has acknowledged that these studies have significant limitations and that they cannot identify a specific level of concern for quantitative risk assessment. EPA has previously reduced the FQPA safety factor for chlorpyrifos to one based on the completeness of the toxicological database. If the 10X FQPA safety factor were reduced to one or even to three, the results of the current risk assessment would be very different.
Additional information, including the pre-publication version of the proposed rule, is available here.
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.