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 and Margaret R. Graham

On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances.  82 Fed. Reg. 27254.  EPA states that this test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the  common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”  EPA states that this guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.”  This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting.

EPA issued the draft guideline on February 14, 2012.  This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012.  EPA indicates that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public.  EPA states that the revisions include the following:

  • Decreasing the number of individuals and replicates tested;
  • Rescinding the recommendation to test each field strain for its resistance ratio; and including a resistance management statement;
  • Clarifying the agency's Good Laboratory Practices (GLP) requirements;
  • Reducing the recommended length of time individuals are exposed to insecticides;
  • Recommending individuals to be observed up to 96 hours after treatment; and
  • Revising the statistical analyses recommendations.

EPA has also placed two other relevant documents in the docket:


 

By Lynn L. Bergeson and Carla N. Hutton

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration.  NRDC v. EPA, No. 15-72308.  The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named NSPW-L30SS (NSPW).  The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW is in the public interest.” 

When EPA granted the conditional registration, EPA did so on the basis that NSPW had a lower application rate and a lower mobility rate when compared to conventional-silver pesticides, and thus had the potential to reduce environmental loading and risk caused by silver release.  Petitioners disputed these facts.  While the court found that substantial evidence supports EPA’s findings that NSPW has lower application and mobility rates, the court agreed that the third premise, that current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products, “impermissibly relies on unsubstantiated assumptions.”  According to the court, EPA cites no evidence in the record to support its assumption that current users of conventional-silver pesticides will switch to NSPW (“the substitution assumption”), but contends that it will occur as a “logical matter.”  The court states that the lack of evidence supporting the substitution assumption is problematic in light of EPA’s other unsupported assumption, that there will be no new products.  The court notes that EPA assumes current users of conventional-silver pesticides will switch to NSPW because of its benefits, but that these same benefits will not prompt manufacturers to incorporate NSPW into new products.  EPA could have proved these assumptions, but without evidence in the record to support the assumptions, the court states that it “cannot find that the EPA’s public-interest finding is supported by substantial evidence as required by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”  According to the court, the public interest finding is an “essential prerequisite to conditional registration,” and EPA failed to support that finding for NSPW with substantial evidence.  The court vacated the conditional registration in whole, and did not consider the remaining issues raised by petitioners. 

More information will be available in Bergeson & Campbell, P.C.’s memorandum Appellate Court Vacates Conditional Nanosilver Registration.


 

By Lynn L. Bergeson and Margaret R. Graham

In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the CEO of the National Association of State Departments of Agriculture (NASDA) posted by Bloomberg’s BNA Daily Environment Report, Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been completed which would allow state lead pesticide agencies to successfully implement the rule changes.”  EPA has not yet issued any formal delay notifications. 

The May 11, 2017, letter was sent in response to a February 17, 2017, letter from NASDA (February 21, 2017, per the NASDA website) that requested EPA to extend the WPS “until at least January 2, 2018, or until adequate enforcement guidance, educational materials, and training resources have been completed and the state lead agencies have the tools, time, and resources necessary to effectively implement the rule changes and assist the regulated community with compliance activities.”  This letter was not submitted in the WPS docket in response to a request for comment, but pursuant to a NASDA membership decision.  NASDA states in the letter that the new WPS regulations require “significant additional staff time to provide sufficient outreach to workers, handlers, applicators, agricultural employers, trainers and other stakeholders,” and that “the enhanced compliance and record keeping requirements require a robust delivery and understanding of educational resources and training materials to assist [state lead agencies] and the regulated community in understanding, complying, and enforcing the new requirements.”

The WPS final rule including updates and revisions to the existing worker protection regulations for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) became effective on January 1, 2016, and on January 4, 2017, agricultural employers and handler employers were required to comply with all of the new requirements set forth in the final rule – with the exception of two requirements that would be implemented not before January 2018.  More information on the final rule is available in our blog item EPA Publishes Worker Protection Standard Final Rule.


 

By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham

On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos.  The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision.   

The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.”  Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”

  1. How did Mr. Pruitt reach the decision he announced on March 29, 2017? What was the timeline leading up to this decision? With whom did he communicate within EPA, the White House, or elsewhere in the Administration? With which outside entities did he communicate? Specifically, did Mr. Pruitt have any communication with staff or representatives of Dow Chemical or any pesticide industry trade groups including CropLife America?
  2. What was the rationale for Mr. Pruitt's decision, and why did he reverse an agency decision that had been years in the making? How was this rationale developed? Was it based on any new information or evidence?
  3. Was Mr. Pruitt's decision consistent with the requirements of the Administrative Procedures Act? Did he provide appropriate notice and comment and appropriately consider all relevant comments and information?
  4. Was Mr. Pruitt's decision consistent with the requirements of the FFDCA, which establishes a standard that, to maintain a pesticide tolerance, there must be "reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical petitition to revoke tolerances.pdf residue"? Has the EPA met the "reasonable certainty [of] no harm" standard in the law? Why did Mr. Pruitt note that chlorpyrifos was "widely used" when he announced his decision? Was this "wid[e] use" a factor in Mr. Pruitt's decision, and, if so, was this appropriate under the law? What other factors were taken into consideration by Mr. Pruitt?
  5. Is the EPA accurately and transparently presenting information to the public with regard to previous EPA actions concerning chlorpyrifos? For example, the EPA website for chlorpyrifos on January 2, 2017 contained information indicating that EPA "proposed to revoke all chlorpyrifos tolerances," and contained a link with detailed information about the health risks and the reasons for the EPA action.  This reference to the proposed ban, and the link to the detailed EPA analysis are no longer available on the chlorpyrifos web page, and the link to the analysis (as of April 3, 201 7) now gives a "Page Not Found" error.

Commentary

This letter not surprisingly continues the debate over the appropriate regulatory status of chlorpyrifos.  Those disappointed by the recent EPA decision, apparently including Senator Warren and Representative Pallone, want to press EPA to explain in more detail not only the reasons for the decision not to revoke chlorpyrifos tolerances at this time, but also the rationale EPA used to rebut what they believe to be the decision-making record that EPA had accumulated over the last two to three years.

The explanation that the arrival of new leadership at EPA with the Administration led to a change in position is perhaps only part of the answer.  The change in Administration did not change the underlying statutory requirements governing EPA’s registration, reregistration, and tolerance decisions, and EPA relied on these requirements as the basis for its decision not to make a decision at this time, as discussed in EPA Denies Petition to Ban Chlorpyrifos.

EPA’s response to any investigation initiated by this letter, as well as the OIG response, will be watched closely by all stakeholders.


 

By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham

In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina granted in part a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement.  Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274.  The claims at issue (Counts V and VI of Plaintiff’’s complaint) were based on the Defendants’ use of Syngenta’s label.  The court stated that it was granting this part of Defendants’ motion “because the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) precludes copyright protection for the required elements of pesticide labels . . . of me-too registrants.”

Counts V and VI of Plaintiff’s complaint stated that Defendant copied and used substantial portions of Syngenta’s copyrighted work, and that this infringement is “willful and knowing.”  The Defendants’ motion for summary judgment stated with regard to the copyright infringement counts of the complaint:

  • Counts V and VI fail as a matter of law because Defendants’ labels comply with applicable federal regulations and contain language that is mandated by federal law.  Moreover, under settled law, the portions of Plaintiff’s labels that Plaintiff asserts Defendants have copied are not entitled to federal copyright protection.  Finally, to the extent that any portions of Plaintiff’s labels are entitled to copyright protection, Defendants’ copying is permitted under the fair use doctrine.  

The order states that “in enacting FIFRA, Congress intended narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.”  The court expressly rejects the lengthy 2005 decision issued by the District Court for the Eastern District of Pennsylvania, which reached a different conclusion in a similar case, stating that it finds the analysis in that decision “unconvincing.”  FMC Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539, 555-71 (E.D. Pa. 2005).  The court states:  “FIFRA contemplates that a ‘me-too’ applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright.”

Of interest, the court states that its grant of the summary judgment motion with respect to the copyright claims does not need to take into account an expert report or declarations by, among others, former EPA Office of Pesticide Programs (OPP) officials Debra Edwards and Lois Rossi, filed by Defendants because “the Court is granting the summary judgment motion on legal grounds unrelated to the proffered evidence.” 

Plaintiff filed its complaint on March 27, 2015.  The complaint included seven counts against Defendants:  the infringement of four patents in violation of 35 U.S.C. § 271(a) (Counts I-IV), the two copyright infringement counts (Counts V-VI), and a violation of the Unfair and Deceptive Trade Practices Act (N.C. Gen. Stat § 75-1.1) (Count VII).  Count VII of the complaint was dismissed on August 12, 2016, and on March 24, 2017, the court granted Plaintiff’s motion for summary judgment regarding the infringement of two of the four patents; a decision on the infringement of the remaining two patents is still pending.

Commentary

This opinion, which squarely rejects the 2005 conclusion of another district court, is likely to be of controversy and is the most recent decision in a long-standing debate on this issue between basic registrants and me-too registrants.  EPA in the past has appeared to side with the me-too registrants.  For example, in an August 3, 2005, letter to the Chemical Producers and Distributors Association (CPDA), written in response to the FMC decision, EPA stated that it “has been the practice of [OPP] since the enactment of FIFRA section 3(c)(7)(a) in 1978 to strongly encourage ‘me-too’ product labels to be identical or substantially similar to the labels of the products on which their registrations are based.”  In that letter, EPA stated further:  “Conveying application instructions and safety messages for similar products in different ways increases the likelihood that the product will be misused.”  EPA at the time noted that there were over 650 mostly “me-too” products for just one herbicide (2,4,-D) -- and that having 650 products each having to say some of the required use instructions differently would be impossible.

Nonetheless, some elements of the label might be viewed as proprietary -- the “look and feel” of a product label, perhaps certain fonts, and trademarked product name (as opposed to the active ingredient name).  It remains to be seen whether the April 10, 2017, order is the last judicial word on this subject or whether the issue will continue to be litigated.  It is an issue that all registrants should monitor closely.  


 

By Lisa M. Campbell and James V. Aidala

On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances.  In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances.  Petitioners state that EPA’s response to the petition (the order) is “no response at all and not what this Court ordered EPA to do,” and asks the court to “grant further mandamus relief, giving EPA 30 days to act on its findings that chlorpyrifos exposures are unsafe and to establish deadlines for the next steps in the revocation and cancellation processes for chlorpyrifos.”  Specifically, Petitioners request that the court order EPA to:

  1. Take regulatory action within 30 days on its finding that chlorpyrifos is unsafe and “make it abundantly clear that what is required within 30 days is final regulatory action based on the neuro-developmental and other risks posed by chlorpyrifos exposures”;
  2. Resolve objections to its final regulatory action within 60 days, as opposed to “as soon as practicable after receiving the arguments of the parties,” because, Petitioners assert, EPA otherwise may put off their response for a long period of time;
  3. Require EPA to issue a notice of intent to cancel all chlorpyrifos uses within 60 days, “consistent with its risk assessments and findings that chlorpyrifos is unsafe,” as it has “found drinking water contamination from all chlorpyrifos uses, including nonfood uses, and will need to take regulatory action to end such uses in addition to stopping food uses”; and
  4. File six-month status reports until the tolerance revocation process and the cancellation proceedings are complete. 

Commentary

It is no surprise that the Petitioners who were disappointed by EPA’s denial of the petition one week ago have now continued their advocacy against the use of chlorpyrifos.  As we note in our previous blog item EPA Denies Petition to Ban Chlorpyrifos, EPA articulated its reason for the denial as of this time, but this in itself did not articulate its determination that the registration and associated tolerances met the requirements of the Food Quality Protection Act (FQPA).  EPA’s response to this latest legal skirmish will be of interest, as will the court’s response to it.  .

More information on the proceedings is available on our blog under key word chlorpyrifos.


 

By Lynn L. BergesonJames V. Aidala, and Margaret R. Graham

On February 14, 2017, in the House of Representatives, Rep. Rodney Davis (R-IL) introduced H.R. 1029, the “Pesticide Registration Enhancement Act of 2017,” which reauthorizes the Pesticide Registration Improvement Act (PRIA).  H.R. 1029 was immediately referred to the Agriculture Committee and to the Energy and Commerce Committee; it was passed by the Agriculture Committee on February 16, 2017.  Per Agriculture Committee Chair Michael Conaway’s opening statement at the Business Meeting markup of H.R. 1029, changes to PRIA include “reasonable increases in registration fees, funding for Good Laboratory Practices, and a seven year reauthorization as opposed to the five-year reauthorizations of the past.”  H.R. 1029 would allow the U.S. Environmental Protection Agency (EPA) to collect up to 31 million in registration fees (up from 27.8 million) per year from fiscal years (FY) 2017-2023.  It also includes the following registration increases for FY2017 through FY2023:

  • The maximum annual fee for registrants holding 50 pesticide registrations or less would be $129,400 (up from $115,500);
  • The maximum annual fee for registrants holding over 50 pesticide registrations would be $207,000 (up from $184,800);
  • The maximum annual fee payable for a small business registrant holding 50 pesticide registrations or less would be $79,100 (up from $70,600); and
  • The maximum annual fee payable for a small business registrant holding over 50 pesticide registrations would be $136,800 (up from $122,100).

Commentary

PRIA represents a commitment by the pesticide registrants to help with the continued resource issues of the pesticide regulatory program.  This has become an issue of increased concern with the arrival of the Trump Administration after campaign rhetoric about eliminating EPA and cutting budgets.  Fees are seldom a popular topic, but an essential program component.  Without staff and resources to approve pesticide registrations, registrants would be left with new products destined to pile in EPA in-boxes.  PRIA is designed to help maintain some certainty and predictability to the review process.

Of some note is that in recent years Congress has appropriated funds at a level below the statutory minimum that originally was a line in the sand which, if breeched, would de-authorize EPA’s authority to charge application fees.  The regulated community has reluctantly supported Congressional action to lower this “minimum” level of funding to hold onto the programmatic progress which has been made since the first PRIA authorization.  This appears to be an uneasy acceptance of the budget realities surrounding federal spending on discretionary, non-defense expenditures.  


 

By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).  The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.”  The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.

The changes to test guidelines are varied.  Some of the changes include:

  • Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
  • Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
  • The addition of a limit test option to several acute invertebrate toxicity tests;
  • Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
  • Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.

The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing as a matter of federal policy.  EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines.  In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.


 

By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments.  EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance.  The two test methods are:

The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance.

The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.”  EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals.  In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.” 

The Draft Guidance also sets forth examples of acceptable label claims against public health biofilms and acceptable non-public health claims.  The examples of acceptable label claims against public health biofilms are:

  1. Kills 99.9999% of bacteria* in biofilm on a hard, non-porous surface;
  2. Kills a minimum of 99.9999% of bacteria* in biofilm;
  3. Reduces at least 99.9999% of bacteria* growing in biofilm;
  4. Formulated to kill 99.9999% of bacteria* in biofilm;
  5. Other related claims:
  • Kills biofilm bacteria*; and
  • Penetrates biofilm, killing the bacteria* living there.

*[List of bacteria “tested as a biofilm”; at a minimum, Pseudomonas aeruginosa and Staphylococcus aureus].

Examples of acceptable non-public health claims supported by appropriate efficacy data include:

  • Slimicide;
  • Cleans away microorganism slime/grunge;
  • Maintains control of slime; and
  • Controls slime-forming microorganisms.

Comments will be accepted until December 5, 2016.


 

By Lisa M. Campbell and Lisa R. Burchi

The following documents have been filed in the Anderson v. McCarthy proceedings in the U.S. District Court for the Northern District of California:  (1) U.S. Environmental Protection Agency’s (EPA) Notice of Motion and Motion for Summary Judgment; (2) Defendant-Intervenors CropLife America, et al.’s Notice of Motion and Motion for Summary Judgment; and (3) Plaintiffs’ Memorandum of Points and Authorities in Support of Motion for Summary Judgment.

EPA’s documents are of particular interest to those who have been following this case and are concerned about the assertions in the case regarding the treated article exemption.  In its motion, EPA argues that the Ninth Circuit lacks jurisdiction to hear Plaintiffs’ claims, as the “EPA guidance document they challenge is not a judicially reviewable agency action -- much less a final action -- regarding the regulatory status of treated seed,” and Plaintiffs “have not identified any discrete, mandatory duty or action that EPA has failed to perform under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” 

EPA’s main arguments in support of its motion include:

  1. Plaintiffs have not identified any final agency actions.  The Inspection Guidance is not an agency action, and even if the Inspection Guidance were an agency action, it is not final.
  2. Count II (Plaintiffs’ allegation of EPA’s failure to regulate and enforce FIFRA with respect to pesticide-treated seeds) must be dismissed because there is no nondiscretionary duty identified by Plaintiffs that is unreasonably delayed or unlawfully withheld.
  3. Enforcement of FIFRA is a discretionary action not subject to review.

In its motion, Defendant-Intervenors argue:  “Each of Plaintiffs’ claims constitutes an impermissible programmatic attack on EPA’s existing pesticide regulatory program --specifically, the interplay between EPA’s regulation of pesticides registered to be applied as seed treatments and what Plaintiffs characterize as its categorical application of the treated article exemption to the treated seed.  As a result, each of these claims is non-justiciable as a matter of law, entitling Defendants to summary judgment in their favor.”  Defendant-Intervenors note that pesticides used for seed treatments are subject to “rigorous, scientifically robust review and approval under FIFRA,” making Plaintiffs’ attempt to impose a regulatory process “entirely duplicative of EPA’s existing exercise of its authority under FIFRA, while having no impact on human health or environmental safety.”

Plaintiffs’ memorandum sets forth its arguments for why the court should “find in favor of Plaintiffs on their four claims for relief:  that EPA failed to enforce FIFRA against an entire class of pesticides; that EPA improperly amended the treated article exemption without following proper [Administrative Procedure Act (APA)] rulemaking procedures; that EPA’s exemption of neonicotinoid-coated seeds was ultra vires and/or arbitrary and capricious under the APA; and that EPA’s labeling requirements for unregistered pesticide-coated seed bags was arbitrary and capricious under the APA and FIFRA.”  Specifically, Plaintiffs address why they believe EPA has failed to enforce FIFRA against neonicotinoid-coated seeds, why this asserted failure amounts to what they believe is “an unlawful abdication of [EPA’s] statutory responsibilities” and why they believe “EPA’s failure to enforce FIFRA against neonicotinoid-coated seeds and pesticidal dust-off is a ‘consciously and expressly adopted general policy,’ which ‘amounts to an abdication of its statutory responsibilities’ that this Court has the power to remedy.”

A hearing on EPA’s motion was set for October 27, 2016, but due to scheduling conflicts has been rescheduled for November 3, 2016.  It will be important to monitor the court’s consideration of these important issues closely.   More information on these proceedings can be found in our pesticide blog items District Court Declines to Rule on Jurisdictional Issues in Neonicotinoid Case until Summary Judgment and EPA Requests Dismissal of Complaint For Lack of Subject Matter Jurisdiction.


 
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