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.
By Sheryl Lindros Dolan
On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.
By Timothy D. Backstrom
In a wide-ranging decision issued on August 13, 2014, in Center for Biological Diversity v. EPA (N.D. Cal.) (often referred to as the “Mega ESA” case), Magistrate Judge Spero has dismissed most of the claims by the Plaintiffs that the U.S. Environmental Protection Agency (EPA) failed to consult or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) in connection with EPA’s registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a variety of pesticides. This decision is significant not only for its findings concerning judicial review of consultations under the ESA, but also for the potential effect on challenges to generic reregistration decisions, and on individual product actions based on those EPA decisions. Registrants should carefully consider the impact of this decision on potential challenges to EPA actions involving their products. A copy of the decision is available online.
The ESA claims that were dismissed fall in three principal categories: (1) claims concerning Reregistration Eligibility Decisions (RED) for which the general six-year statute of limitations has expired; (2) claims concerning REDs that are reviewable only in the Court of Appeals under FIFRA Section 16(b) and that were not brought in that court within the applicable 60-day period; and (3) claims based solely on Plaintiffs’ allegations that EPA retains ongoing discretionary control over pesticide registration. Claims by the Plaintiffs that currently survive this decision, at least pending further submissions by the Parties, include claims concerning EPA’s reregistration of specific pesticide products, and claims concerning EPA’s failure to reinitiate consultation for any pesticidal active ingredients that were subject to prior Biological Opinions issued by the Fish and Wildlife Service (FWS) for which the process of reregistration is not yet complete.