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 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, 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 Lynn L. Bergeson, James V. Aidala, and Lisa R. Burchi

On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides. Specifically, IARC classified the herbicide glyphosate and the insecticides malathion and diazinon as probably carcinogenic to humans (Group 2A), and classified the insecticides tetrachlorvinphos and parathion as possibly carcinogenic to humans (Group 2B). IARC also found there is “limited evidence” that glyphosate can cause non-Hodgkin’s lymphoma and lung cancer in humans.

A summary of the final evaluations, together with a brief rationale, is published online in The Lancet Oncology; the detailed assessments will be published as Volume 112 of the IARC Monographs. IARC’s press release announcing its evaluation is available at http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf.

Monsanto, on behalf of glyphosate task forces in the U.S. and the European Union (EU), immediately voiced its vigorous disagreement with IARC’s conclusions, noting various scientific issues with IARC’s evaluation that resulted in a conclusion that has not been reached following review by the U.S. Environmental Protection Agency (EPA) and in the EU. Monsanto’s statement is available at http://news.monsanto.com/news/monsanto-disagrees-iarc-classification-glyphosate.

The IARC announcement with regard to glyphosate will further energize both sides of the debate about genetically modified organism (GMO) crops, since there are several crops that have been genetically engineered to be resistant to glyphosate. If some occupational risks are identified as needing possible further mitigation, the distinction between food safety issues and occupational risks may be lost in the rhetoric. Opponents of GMO crops and those who support GMO food product labels can be expected to cite the IARC designation regardless of any further clarification or nuance that the scientific debate over the data might provide. Defenders of the technology will insist that not only is the IARC designation wrong and misleading, but it is clearly at odds with numerous other conclusions reached by multiple competent governmental authorities concerning the safety of using glyphosate and especially consuming GMO crops.

Regardless of Monsanto’s rapid and detailed response, “dueling science” views are not helpful towards enhancing public confidence in the safety of the food supply, which is ultimately where this headline will be most influential. That will only add pressure on the review process and conclusions contained in the expected EPA registration review of glyphosate data scheduled for completion in 2015.
 


 

By Lisa M. Campbell and Timothy D. Backstrom

 

In a March 9, 2015, decision in Perez v. Mortgage Bankers Ass'n., the U.S. Supreme Court unanimously held that an interpretative rule issued by an administrative agency does not require notice and opportunity for comment, even if the interpretative rule construes a substantive (or "legislative") rule previously issued by the agency and even if the interpretative rule alters a prior interpretation of the same rule. In the Perez decision, the Court explicitly overruled Paralyzed Veterans of America v. D.C. Arena, L.P., a 1997 decision by the U.S. Court of Appeals for the D.C. Circuit that held that notice and comment is required whenever an agency issues an interpretative rule altering a prior interpretation of a legislative rule, based on the premise that adopting a new interpretation of a rule is tantamount to an amendment of the underlying rule.

Pursuant to Administrative Procedure Act (APA) Section 553(b)(A), notice and comment rulemaking procedures do not apply to "interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice." In Perez, the Supreme Court concluded that "[t]he text of the APA answers the question presented." Finding the APA exemption for interpretative rules to be "categorical," the Court held that "it is fatal to the rule announced in Paralyzed Veterans." Since an agency can adopt an initial interpretative rule without notice and comment, it is "also not required to use those procedures when it amends or repeals that interpretive rule." The actual legal effect of this new ruling is likely to be limited in scope, because the Paralyzed Veterans decision only required an agency to use notice and comment procedures in those instances where the agency was both interpreting an underlying substantive regulation and revising or contradicting a prior interpretation of that regulation.

Although the APA does not define "interpretative rules," the general consensus is that such rules only are intended to announce how the agency intends to construe a particular statute or regulation. Interpretative rules are not supposed to have any independent force of law. While an agency must generally follow its own interpretation of a statute or regulation unless and until it has been revised, no party outside of the agency is required to conform to that same interpretation. This contrasts to a legislative rule, which binds parties other than the agency as well, and which can only be lawfully adopted after providing notice and opportunity for comment. A "statement of policy" has even less formality than an interpretative rule, because even the agency that issued a policy statement is free to deviate from that policy without formally withdrawing or revising it.

While the Supreme Court was unanimous in setting aside the Paralyzed Veterans precedent, the Court did not clearly resolve the question of how much judicial deference should be afforded to such agency interpretations. It can be argued that an interpretation adopted by an agency without notice and comment should be afforded a lesser degree of judicial deference, but there has been a general trend in recent years toward affording judicial deference to agency interpretations in situations where an underlying statute or regulation is ambiguous. In three concurring opinions, several conservative members of the Court (Scalia, Thomas, and Alito) signaled that they are willing to revisit the 1945 Supreme Court decision in Bowles v. Seminole Rock & Sand Co., a case holding that reviewing courts should generally defer to the agency's interpretation when construing an ambiguous regulation. Scalia's concurring opinion goes even further, indicating that he would like to revisit the general rule announced in the seminal 1984 precedent Chevron v. NRDC, which affords substantial judicial deference to an administrative agency in construing ambiguous statutory provisions. Unlike an administrative agency's interpretation of an ambiguous regulation, however, ambiguous statutory provisions will typically be construed in the context of promulgation of a substantive or legislative rule, and this type of exercise means that the agency's statutory construction can only be adopted after notice and comment.

On balance, it is possible that the Perez decision could encourage administrative agencies to issue new interpretative rules or even policy statements in lieu of using more elaborate notice and comment rulemaking procedures. Such an approach could be particularly tempting where an agency anticipates that a reviewing court is likely to give deference to its interpretation. After all, the principle that the public is not bound by an interpretative rule or policy statement will provide little solace if regulated parties must effectively presume that the agency's announced construction is correct.

This risk is mitigated somewhat by language in the majority opinion that makes it clear that a newly adopted agency interpretation may require greater substantive justification and be entitled to less judicial deference when it conflicts with a prior interpretation. Moreover, it is possible that the Perez decision could ultimately undermine Seminole Rock, a case that has encouraged reviewing courts to give administrative agencies a high degree of discretion when interpreting ambiguous provisions in their own rules. After all, when the agency is free to resolve clearly such ambiguities through amendments adopted through notice and comment rulemaking, there may be less justification for resolving the same ambiguities through non-binding interpretations.


 

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.


 
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