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 Susan M. Kirsch

On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published its draft National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges from the Application of Pesticides in the Federal Register, which applies to discharges of pesticides to waters of the United States.  EPA is requesting comments on the draft permit by March 11, 2016.  This draft 2016 pesticide general permit (PGP) is largely an updated version of the 2011 PGP, which will expire on October 31, 2016.  EPA’s permit would apply to Maine, New Hampshire, New Mexico, Idaho, and the District of Columbia; Puerto Rico and certain other territories; as well as Indian lands and federal facilities in other states that are covered by state-developed PGPs.  Separately, 46 states must update their existing permits, and some states have already begun this process or have already reissued permits within the last year.

The draft 2016 PGP retains coverage of the previous pesticide use patterns (mosquito/flying insect; weed and algae; animal pest; and forest canopy), and leaves unchanged the reliance on technology-based effluent limitations (TBELs) to satisfy permit requirements, which require proper maintenance and calibration of equipment along with visual inspections to minimize discharges and meet water quality standards and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label requirements.  The draft 2016 PGP also retains the distinctions in compliance requirements of “For-hire Applicators” and “Decision Makers,” and includes the same requirements for recordkeeping and reporting of adverse incidents.  The draft permit now mandates electronic reporting, which will make Notice of Intent (NOI) and Annual Report submissions public on EPA’s e-reporting website.  The draft permit retains the “joint and several liability” provision that would extend potential legal risks to all parties involved in decision-making and application of pesticides.  In spite of the lack of new or altered provisions, there are some aspects of the draft 2016 PGP that could signal an EPA policy change going forward, and could potentially appear in the final version of the permit.  These areas include:

  • Absence of a definition for “Waters of the U.S.,” which could create confusion as to the scope of jurisdiction;
  • An ongoing Endangered Species Act (ESA) consultation, which could expand the list of requirements included in the final permit;
  • Request for comments on whether water quality-based effluent limitations (WQBELs), such as water quality monitoring and fish tissue testing (i.e., laboratory studies), should be included in the final permit;
  • Request for comments on whether additional information should be included in NOI submissions, including whether the treatment area includes a source water for public drinking water supplies;  and
  • An expanded discussion of required compliance with all other applicable state and federal laws, including FIFRA storage and handling requirements, which could be perceived to attach Clean Water Act liability to a PGP permittee’s violations of FIFRA and other laws.

EPA’s webpage for pesticide NPDES permitting includes links to the draft permit, fact sheet, and Federal Register docket.


 

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 James V. Aidala and Margaret R. Graham

On December 11, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated:  chlorpyrifos, diazinon, and malathion.  For each chemical, the following supporting documents are now available:  problem formulation; fate and effects characterizations; and related appendices.  The provisional models are available here

EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process.  The entire draft biological evaluations for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016

These BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences’ April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, which examined topics pertaining to tools and approaches for assessing the effects of proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions on endangered and threatened species and their critical habitats, and provided recommendations.

USDA provided expertise on crop production and pesticide uses and assistance with the use of the National Agricultural Statistics Service Cropland Data Layer to help define the footprint of agricultural use patterns.  The FWS and the NMFS will use the analyses and data from the biological evaluations and integrate it into their final Biological Opinions for the three chemicals due in December 2017.

Commentary

This is the opening blow for developing the next round of the EPA-Services’ Endangered Species Act (ESA) assessment process.  This bolus of information, in the range of 30,000 pages, is the EPA part of the assessment process -- now to be examined by the Services to become the complete ESA assessment of the pesticide products and their possible impact.

It is less clear what these extensive efforts will achieve; in essence, it is likely to indicate little more than “everything affects everything.”  On the other hand, it will provide information useful to indicate where the greatest risks to certain species in specific habitats may lie.  Separately, the mere volume of the information and the amount of effort needed to produce it presents a daunting prospect for the ability of the government agencies (EPA and the Services) to further refine the process into anything resembling a timely and efficient process (not to mention the implications for any public review of the information or associated regulatory conclusions).


 

By Lisa M. Campbell and Timothy D. Backstrom

On December 7, 2015, in Case Nos. 14-1036 and 15-5168, the U.S. Court of Appeals for the D.C. Circuit issued an order denying the U.S. Environmental Protection Agency’s (EPA) motion for summary affirmance of an order issued by the D.C. District Court dismissing a complaint filed by Plaintiffs-Appellants Center for Biological Diversity, et al. (the Center) for lack of jurisdiction.  The Center’s complaint alleged that EPA violated the Endangered Species Act (ESA) and the Administrative Procedure Act (APA) by registering pesticides containing the new active ingredient cyantraniliprole without first consulting the U.S. Fish and Wildlife Service or the National Marine Fisheries Service.

EPA’s motion, filed on August 27, 2015, moved for summary affirmance of the district court’s order dismissing the complaint for lack of jurisdiction, stating that “the district court’s determination that exclusive jurisdiction over the Center’s claims lies in the courts of appeals under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act), Section 16(b), 7 U.S.C. § 136n(b), is so plainly correct that summary affirmance is warranted,” and “FIFRA’s special judicial review procedure applies to this case because the Center challenges EPA’s registration of cyantraniliprole, which is regulated by FIFRA.”  The Center argues that the district court has separate jurisdiction under the citizen suit provision of the ESA and/or that jurisdiction lies in the district court because there has been no public hearing under FIFRA Section 16(b).

The order denying the motion states that the “merits of the parties’ positions are not so clear as to warrant summary action.”  Opening briefs are due beginning January 19, 2016, and final briefs are due April 8, 2015.

Commentary

Although the general division of jurisdiction between U.S. district courts under FIFRA Section 16(a) and U.S. courts of appeal under FIFRA Section 16(b) has been construed differently, in general, since the 1986 D.C. Circuit decision Humane Society v. EPA, whether there has been a “public hearing” within the meaning of FIFRA Section 16(b) is determined based on the adequacy of the record for appellate review.  Since cyantraniliprole is a new active ingredient, EPA provided notice and an opportunity for comment under FIFRA Section 3(c)(4) before granting the registrations in question, so the record compiled by EPA appears to satisfy this test.  The decision of the D.C. Circuit to deny EPA’s motion for summary affirmance may reflect the stringent standard that must be met for such an action, rather than an indication of how the D.C. Circuit will ultimately rule on the merits. 


 

By Timothy D. Backstrom

 

On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified administrative record to support their contentions that the U.S. Environmental Protection Agency (EPA) improperly failed to consult the Fish and Wildlife Service (FWS) under Section 7 of the Endangered Species Act (ESA).  The plaintiffs in the Ellis case are individual beekeepers and non-governmental organizations, and two out of the six claims in their complaint allege a failure by EPA to consult under the ESA before registering or adding new registered uses for products containing two neonicotinoid pesticides, clothianidin and thiamethoxam.  Judge Chesney’s order was issued in response to separate motions by EPA and by industry intervenors Bayer Crop Science, Syngenta Crop Protection, and Croplife America to preclude the plaintiffs from utilizing extra record material to support their ESA claims.

 

Although EPA and the intervenors argued that the Court’s review of the ESA claims should be confined to the administrative record based on the Administrative Procedure Act (APA), Judge Chesney determined that extra record material may be used to support an allegation that an administrative agency failed to consult with the FWS as required by ESA Section 7.  The Judge based this holding on two cases decided in the Ninth Circuit, Washington Toxics Coalition v. EPA and Western Watersheds Project v. Kraayenbrink, which each held that extra record material may be properly considered in determining whether an agency improperly failed to consult under ESA Section 7.  The Judge rejected the contention by EPA and the intervenors that these two decisions were supplanted by Karup Tribe v. U.S. Forest Service, concluding that the “arbitrary and capricious” standard of review established by the APA is utilized to review the ESA claims, but the scope of review for these claims is not constrained by the APA.

 

The effect of this decision will be to allow the plaintiffs to present expert opinion and evidence concerning the claimed adverse effects of the two neonicotinoid pesticides on endangered and threatened species, including but not limited to pollinator species, that was not expressly considered by EPA when it decided to register these pesticides.  The plaintiffs will argue that such extra record material establishes that there was a sufficient basis to conclude that these pesticides “may affect” endangered or threatened species for EPA’s failure to consult FWS under the ESA to be arbitrary and capricious.  This preliminary ruling could materially affect review of the ESA counts because there is a substantial division of expert scientific opinion concerning the alleged adverse effects of neonicotinoid pesticides, and the Court may conclude that EPA did not afford adequate weight to some of this opinion.


 

By Lisa M. Campbell and Lisa R. Burchi

 

On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential. 

 

The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information be treated as confidential, and not included in the EFSA’s peer reviewed draft assessment report on potassium phosphonate.  The European Commission agreed with EFSA.  EFSA stated that under the Plant Protection Product Regulation No. 1107/2009 (and Article 14 of its predecessor Directive 91/414) and European Union (EU) Regulation No. 199/2011 setting forth procedures for reviewing certain active substances including EFSA’s peer review of draft assessment reports, confidential status cannot be extended to:  information on the composition of the substance at issue; the analysis method for that substance; the analysis methods for residues; the scientific information on the basis for the evaluation and risk assessments performed; and information already in the public domain.  After EFSA refused the confidentiality request, Luxembourg sought reconsideration by the European Commission, who found that the sanitization principles applied by EFSA “reflect a common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414/EEC.”

 

In its decision, the Court dismissed the lawsuit because Luxembourg brought the case against the European Commission when the appropriate party was EFSA.  The Court agreed with the Commission that the decision at issue was an act of and attributable to EFSA, stating that while the Commission “indicated to EFSA the legislation and principles applicable to the requests for confidentiality at issue, the fact remains that the Commission did not apply that legislation and those principles in order to determine those claims itself.”  The Court stated that Article 7(2) of Regulation No. 188/2011 grants EFSA to make confidentiality determinations “in its own right” and that Articles 12(1) and 60 of Regulation No. 1107/2009 show that EFSA is “competent to adopt a decision on a request for confidentiality.” 

 

While this decision does not provide certainty or guidance to industry regarding the type of information that can be claimed, and accepted, as confidential, it does add to a growing pool of cases addressing complex issues regarding the confidential treatment of information related to agrochemicals.  This includes, but is not limited to, the ongoing case following the European Court of Justice’s October 8, 2013, ruling that the European Commission erred by refusing access to documentation about the pesticide glyphosate.


 

By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.


On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.

This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.

To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.

 


 

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.


 


 

By Timothy D. Backstrom

On January 20, 2015, the National Marine Fisheries Service (NMFS) issued its latest Biological Opinion (BiOp) in a series of BiOps evaluating potential effects of pesticide use on salmon in the Pacific Northwest. When the U.S. Environmental Protection Agency (EPA) decides to permit continued registration of a pesticide (during reregistration or registration review), Endangered Species Act (ESA) Section 7(a)(2) requires EPA to determine, in consultation with the NMFS and/or the Fish and Wildlife Service (FWS), that continued registration is not likely to jeopardize the continued existence of any endangered or threatened species. Under current procedures, EPA scientists make an initial threshold determination whether or not continued registration “might” have such an effect, followed by referral to the FWS or the NMFS for formal consultation in those instances where that threshold is met.

The January 20, 2015, NMFS BiOp concerns the pesticides diflubenzuron, fenbutatin oxide, and propargite, and is one in a series of NMFS BiOps for Pacific salmon. As part of litigation that began in 2001, the Ninth Circuit Court of Appeals ordered EPA to determine whether it should have consulted with NMFS concerning reregistration of 55 specific pesticides. EPA subsequently initiated a formal consultation with NMFS for 37 of these 55 pesticides.

Like most of the prior BiOps, the latest NMFS BiOp recommends that EPA require the affected pesticide registrants to adopt buffer zones and other mitigation measures. The scientific methodology underlying the NMFS BiOps has been sharply criticized by industry and questioned by EPA. EPA has not yet adopted the measures recommended by NMFS in any of the previous BiOps. The BiOp for the pesticides chlorpyrifos, diazinon, and malathion was vacated and remanded to NMFS by the Fourth Circuit Court of Appeals on February 21, 2013. That decision was based in part on use of implausible assumptions in the NMFS model and on the decision of NMFS to recommend uniform buffer zones without regard to site-specific factors. Industry has criticized the latest BiOp on similar grounds. Some may also ask why NMFS did not utilize methodology like that recommended in 2013 by a panel of the National Academy of Sciences, but NMFS states that consultations with other agencies concerning a process to implement the NAS recommendations are still pending.
 


 

By Lisa M. Campbell

On December 15, 2014, the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), the U.S. Fish and Wildlife Service (FWS), and the National Marine Fisheries Service (NMFS) wrote a report to Congress on the status of Endangered Species Act (ESA) implementation in pesticide regulation. EPA, USDA, FWS, and NMFS seek to refine their approach to pesticide consultations in an effort to protect endangered and threatened species.

The report was required by the 2014 Farm Bill and summarizes actions carried out by the agencies since receiving the April 2013 National Academy of Sciences’ (NAS) report, entitled “Assessing Risks to Endangered and Threatened Species from Pesticides.”

Since receiving the NAS report, the agencies have:

* Built a collaborative relationship among the agencies;

* Clarified roles and responsibilities for the agencies;

* Improved stakeholder engagement and transparency during review and consultation processes;

* Held two joint agency workshops resulting in interim approaches for use in assessing risks to ESA-listed species from pesticides;

* Created a plan and schedule for applying the interim approaches to a set of pesticide compounds; and

* Hosted multiple workshops and meetings with stakeholders.

The full report is available at http://www.epa.gov/oppfead1/endanger/2014/esa-reporttocongress.pdf.
 


 
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