Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. CampbellLisa 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.

Commentary

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.   SeeNinth 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.

Discussion

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.

 

 


 
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