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. Campbell, Timothy D. Backstrom, and Lisa R. Burchi

On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos.  The court opted instead to afford EPA a three month extension, stating that “this is the final extension, and the court will not grant any further extensions." 

EPA sought the six month extension on June 29, 2016, to allow time for EPA to complete two scientific analyses that may bear on EPA’s conclusions in the final rule, and to request further public comment before taking final action on a prior proposal to revoke all chlorpyrifos tolerances.  The two analyses that EPA wanted to complete are:  (1) a refined drinking water assessment that may allow EPA “to develop more tailored risk mitigation for some regions of the country,” and (2) an evaluation of the epidemiological data for chlorpyrifos to determine whether EPA should retain the point of departure based on acetylcholinesterase (AChE) inhibition in the proposed rule.

The court concluded that EPA’s request for a six month extension “is not justified in light of EPA’s history in this matter as well as the court’s previous extensions.”  The court stated that EPA’s request was "another variation on a theme 'of partial reports, missed deadlines, and vague promises of future action' that has been repeated for the past nine years,” and that “nothing has changed that would justify EPA’s continued failure to respond to the pressing health concerns presented by chlorpyrifos."

The court ordered EPA to take final action on its proposal to revoke tolerances for chlorpyrifos by March 31, 2017.  A further status report by EPA will be due in November 2016.

EPA’s updated analysis of the epidemiological data for chlorpyrifos will be a matter of considerable interest.  After EPA issued a proposed rule utilizing a point of departure for chlorpyrifos based on AChE inhibition, EPA issued a blanket determination based on the epidemiological data for chlorpyrifos in which EPA decided to retain the Food Quality Protection Act (FQPA) safety factor for all organophosphate (OP) pesticides.  This FQPA determination could cause EPA to conclude that the tolerances for chlorpyrifos must be revoked regardless of the outcome of the refined drinking water assessment. 

EPA later proposed to use an alternative point of departure for chlorpyrifos based on biomonitoring data from one of the chlorpyrifos epidemiology studies, but the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met on April 19-21, 2016, and recommended against this new approach.  In its request for an extension, EPA stated that the FIFRA SAP might recommend a “hybrid approach” to adjusting the point of departure for AChE inhibition.  The FIFRA SAP meeting minutes do not appear to include such a hybrid recommendation.

In a related development, EPA has reached an agreement with the Columbia Center for Children’s Environmental Health (CCCEH) regarding the release of raw data from one of the chlorpyrifos epidemiology studies.  During the FIFRA SAP meeting, concerns were raised regarding use of the CCCEH study without access to the underlying raw data.  In an April 19, 2016, letter to Dr. Linda P. Fried, Dean of the Mailman School of Public Health at Columbia University, EPA requested that CCCEH provide access to the underlying data.  In her response dated May 18, 2016, Dr. Fried offered to work with EPA “to determine if we can develop one or more data sets that can be properly de-identified, consistent with our obligation to protect the privacy of our research subjects, and that will also enable EPA to conduct its own analyses in order to address its transparency goals” or, in the alternative, offered to allow EPA staff to review the original data “in a secure data enclave onsite at Columbia.”  In its June 27, 2016, response, EPA stated that the offer to allow EPA staff to review the underlying data at a secure site did not resolve issues concerning the transparency of EPA’s analysis.  This correspondence is available in EPA Docket ID EPA-HQ-OPP-2008-0850. While EPA maintained it is “unnecessary” for CCCEH and EPA to develop redacted data sets, EPA accepted CCCEH’s offer to develop such data sets.

Commentary

EPA’s request for a six month extension was filed on June 29, 2016, two days after it accepted the offer by CCCEH to develop redacted data sets for the CCCEH epidemiology study.  Moreover, the FIFRA SAP meeting minutes issued on July 20, 2016, do not appear to provide the guidance that EPA had expected concerning a potential “hybrid” approach to adjusting EPA’s proposed point of departure for AChE inhibition.

Given the lesser extension granted by the court, it is questionable whether EPA will have sufficient time to review adequately the redacted underlying data sets offered by CCCEH, or even to determine whether those redacted data sets are adequate for this review, and to make any determination based on such data before EPA issues a supplementary proposal based on the refined drinking water assessment and the updated epidemiology assessment.  The court has stated that it will entertain no further extension requests, so EPA must complete its work expeditiously to allow time for comment before final action is due on March 31, 2017.


 

By Lisa M. Campbell and Timothy D. Backstrom
 
On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.”  Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y Campesinos Unidos del Noroeste (PANNA, et al.) filed an administrative petition in 2009 asking EPA to conduct pesticide-specific drift assessments and to impose interim buffer zones to protect children from pesticide drift.
 
The Circuit Court agreed with EPA’s contention that the petitioners do not have jurisdiction to review the reregistration and tolerance determinations previously made by EPA pursuant to the Food Quality Protection Act (FQPA), because such challenges are now time barred.  EPA agreed with the petitioners that it should consider potential risks from spray drift as part of the registration review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The petitioners argued that EPA had thereby acknowledged legal error when it previously reregistered food-use pesticides, but EPA has vigorously contested that premise.  In 2014, EPA issued a proposal describing the methodology for assessing risk from pesticide drift that EPA will use prospectively in making registration review decisions.
 
The petitioners requested that EPA adopt interim relief by imposing uniform buffer zones for all pesticides that are registered for application by ground sprayers, broadcast, or aerial application, and that may cause certain human health effects.  EPA rejected this request for across-the-board buffer zones as unscientific and inefficient and likely to result in a misallocation of EPA resources.  The Circuit Court concluded that “substantial evidence” supports EPA’s decision to deny this interim relief, stating that “[t]he record suggests that the risk of exposure to pesticide draft depends on a number of factors, including pesticide toxicity, the method of application, the size of pesticide droplets, and weather conditions,” and “adequately supports EPA’s conclusion that the imposition of uniform buffer zones is not the most ‘scientifically appropriate’ method for mitigating the risk of exposure to pesticide drift.”


Commentary


The Circuit Court has clearly recognized that uniform buffer zones like those sought by the petitioners would not be “scientifically appropriate.”  While this decision is both welcome by industry and constructive, the evaluation of potential exposure and risk from pesticide drift during the registration review process for individual pesticides will likely remain controversial.

More information on EPA’s spray drift policy is available in our memorandum Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions.


 

By Lisa M. Campbell and Timothy D. Backstrom

On May 11, 2016, the U.S. Court of Appeals for the Ninth Circuit issued an unpublished memorandum decision in an environmental justice case, Garcia v. McCarthy, Case No. 14-15494, that many have been watching closely.  The Ninth Circuit affirmed a decision by the U.S. District Court dismissing the Plaintiffs’ Complaint for lack of subject matter jurisdiction.  The District Court case involved an effort by the original complainants (parents of Latino school children) to obtain judicial review of a decision by the U.S. Environmental Protection Agency (EPA), to enter into a voluntary compliance agreement with the California Department of Pesticide Regulation (CDPR).  The original administrative complaint filed in 1999 alleged that CDPR “authorized the use of methyl bromide and other pesticides in a fashion that had a disproportionately harmful effect on Latino school children in violation of Title VI.”  Although EPA made an initial finding of a prima facie violation of Title VI, Plaintiffs asserted that EPA did not inform the complainants of the status of their complaint while the matter was being investigated and did not allow them to participate in settlement negotiations.

In challenging EPA’s settlement with CDPR, Petitioners alleged that EPA acted arbitrarily and capriciously by limiting its investigation to methyl bromide exposure between 1995 and 2001, and by failing to allow for Plaintiffs’ participation in settlement negotiations.  The Ninth Circuit followed the Supreme Court enforcement discretion case Heckler v. Cheney, 470 U.S. 821 (1985), finding that EPA’s decision to settle the matter was also committed to EPA discretion by law.  The Ninth Circuit stated:

  • [Petitioners’ allegations] are entirely untethered to any statutory provision or regulation implementing Title VI.  None of the statutes or regulations cited by plaintiffs provide a meaningful standard for defining the limits of EPA’s discretion in investigating a complaint, and none require EPA to permit plaintiffs to participate in EPA’s settlement negotiations. EPA’s plenary authority to either accept, reject, or refer a complaint to another federal agency, 40 C.F.R. § 7.120(d)(1)(i), must necessarily include the lesser power to determine the scope of the investigation in the event the complaint is accepted.

Commentary

EPA’s original decision finding a prima facie violation of Title VI by CDPR was surprising and concerning to many.  The current challenge to EPA’s decision to resolve the complaint through a voluntary settlement with CDPR raised additional environmental justice concerns.  Some industry observers were concerned about the possibility that the Ninth Circuit might view EPA’s decision to exclude the complainants from settlement discussions with disfavor.  The decision by the Ninth Circuit to affirm the District Court’s dismissal means that EPA will retain substantial discretion to negotiate appropriate settlements, even though it determines a Title VI complaint is meritorious.


 

By Lisa M. Campbell and Timothy D. Backstrom

On March 28, 2016, a three-judge panel in the U.S. Court of Appeals for the Ninth Circuit, Case Nos. 15-71207, et al. (consolidated) issued an order denying the Petitioners’ March 10, 2016, motion asking the court to adjudicate their challenges to the Environmental Protection Agency’s (EPA) registration of the pesticide Enlist Duo during remand of the registration decision to EPA, as well as their alternative request that the court stay issuance of its mandate and retain jurisdiction pursuant to the original petition for review.  The brief three-sentence order did not offer any explanation as to why the court denied the relief requested by the Petitioners.

The Petitioners’ March 10, 2016, motion stated that it is “appropriate to adjudicate those arguments now, because Enlist Duo remains on the market during the limited remand, causing petitioners continued harm.”  In support of their motion, Petitioners argued that the purpose of the remand was to address the “narrow question” of “synergistic effects of Enlist Duo’s two main ingredients on non-target plants,” and that an ultimate decision by EPA on this narrow issue “may have no bearing on the arguments petitioners have already briefed in this Court.”  Petitioners also argued that the registrant and intervenor Dow AgroSciences LLC (DowAgro) has “reneged on its promise to the Court not to sell Enlist Duo” during the remand.

EPA and DowAgro both filed responses on March 21, 2016, opposing the Petitioners’ motion.  EPA’s response to the motion stated that the court’s order remanding the matter to EPA was general in scope, and “EPA may properly choose to revisit the issues raised in Petitioners’ briefs while it also considers the new information provided by Dow regarding the synergistic effects of Enlist Duo’s two active ingredients.”  Thus, if the court were to consider the Petitioners’ claims during remand, “the Court would be advising EPA as to the outcome of its remand work, which is contrary to the Court’s function.”  EPA also opposed the request to stay the mandate and retain jurisdiction “because Petitioners will have ample opportunity to challenge any new agency action that EPA issues after concluding its remand work.”

DowAgro’s response stated that “[t]his Court’s order did not limit the scope of the remand, so the agency is free to alter, amend, or supersede the existing registration.”  DowAgro also argued that adjudicating petitioners’ claims during remand would lead to improper “piecemeal review” because “petitioners’ challenges to the original registration may be substantially altered or mooted entirely.”  With respect to the Petitioners’ allegation that DowAgro “reneged” on a promise not to sell Enlist Duo during the remand, DowAgro stated that this offer was only for “the interim period while this Court was considering the remand motion, not the indefinite period the matter was on remand to the agency.”

More information regarding the court’s original remand order is available in our blog item Ninth Circuit Denies EPA Motion for Vacatur, Grants EPA Motion for Remand.

Commentary

It would have been, in the view of many, surprising for the court to agree to adjudicate Petitioners’ claims concerning the registration decision for Enlist Duo during the period that decision is remanded to EPA for further action.  Similarly, it is not surprising to many that the court declined to retain jurisdiction, since the remand to EPA will not operate to constrain the ability of the Petitioners to raise the same claims in the event that EPA decides to issue a new registration for Enlist Duo following remand.

It is not clear at this juncture whether EPA will be inclined to reconsider its views concerning any of the Petitioners’ claims during the remand process.  Petitioners likely will, however, have another opportunity to seek review concerning their claims, assuming they participate in the administrative process during remand, and EPA does not alter its original decision in a manner that moots those claims.


 

By Lisa M. Campbell and Lisa R. Burchi

On March 10, 2016, the U.S. Environmental Protection Agency (EPA) filed a motion to dismiss for lack of subject matter jurisdiction and a supporting memorandum of law (Memorandum) in Anderson v. McCarthy, Case No. 3:16-cv-00068 (N.D. Cal. filed Jan. 6, 2016).  In support of its motion, EPA states that the District Court lacks jurisdiction because three of the four claims stated in the complaint “seek review of a guidance document that does not constitute ‘final agency action’ reviewable under the Administrative Procedure Act [APA] or the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA],” and that the remaining claim “which asserts a failure to regulate under and enforce [FIFRA], fails because Plaintiffs have not identified a clearly imposed duty on the part of EPA to take some discrete action to regulate under or enforce the Act.”

The Complaint was filed by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners) who requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the “treated article” exemption under FIFRA.  Petitioners argue, in part, that the following language from EPA’s 2013 Inspection Guidance (Guidance) provides a new interpretation of the scope of the “treated article”:

                  Inspectors may also take into account any locations of treated seed planting when identifying locations of potential pesticide sources. Note: Treated seed (and any resulting dust-off from treated seed) may be exempted from registration under FIFRA as a treated article and as such its planting is not considered a “pesticide use.” However, if the inspector suspects or has reason to believe a treated seed is subject to registration (i.e., the seed is not in compliance with the treated article exemption), plantings of that treated seed may nonetheless be investigated.

The Complaint argues that this Guidance improperly expanded the scope of the treated article exemption and was in effect an unlawful rule issued without prior notice and comment. The Complaint seeks an order from the District Court declaring, in part, that “unregistered seeds do not fit within the ‘treated article’ exemption from pesticide regulation in 40 CFR § 152.25(a) and must be regulated as pesticidal products under FIFRA.”

With regard to the scope of the treated article exemption, EPA in its Memorandum states that the language from the Guidance, which is for the use of inspectors and not the general public, is:

               [A] far cry from prescribing the law or policy as to exemption of treated seed as a treated article under 40 C.F.R. § 152.25(a), as they in no way implement, interpret, or prescribe law or policy. Instead, this language in the Inspection Guidance is but one recommendation to inspectors who are investigating all possible sources of pesticides, including treated seed.

EPA further argues that the “note” in its Guidance is “nothing more than the unremarkable reiteration of EPA’s longstanding view of the treated article exemption in 40 C.F.R. § 152.25(a).”  EPA states that the applicability of the treated article exemption has been discussed publicly by EPA since 2003 in an document published jointly by EPA and Canada Pest Management Regulatory Agency entitled “Harmonization of Regulation of Pesticide Seed Treatment in Canada and the United States.”  In that document, EPA states that it “plainly indicates that where the conditions of the treated article exemption are met, ‘[s]eeds for planting which are treated with pesticides registered in the U.S. are exempt from registration as pesticides and may be freely distributed and sold within the U.S.’”  Thus, EPA states that Petitioners “have failed to meet their burden to demonstrate that the Inspection Guidance (or any other action) constitutes “final agency action” as that term is used in the APA, and thus they have not met their burden of demonstrating jurisdiction.”

On March 16, 2016, Intervenor-Defendants CropLife America, the American Seed Trade Association, the American Soybean Association, the National Cotton Council of America, the National Association of Wheat Growers, the National Corn Growers Association, and the Agricultural Retailers Association filed to join EPA’s Motion to Dismiss.

More information on the complaint is available in our blog item EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA.


 

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. BurchiJames 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.”

Commentary

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. 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.


 
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