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, Lisa R. Burchi, and Margaret R. Graham

On February 22, 2018, the Superior Court of the State of California, County of Sacramento, issued a judgment granting petition for writ of mandate and declaratory and injunctive relief (Judgment) to suspend further chemical activities undertaken by the California Department of Food and Agriculture (CDFA) to control or eradicate pests under the Statewide Plant Pest Prevention and Management Program (the Project) until CDFA has certified a Program Environmental Impact Report (PEIR) that corrects violations of the California Environmental Quality Act (CEQA) identified in the court’s ruling.

CDFA is charged with promoting and protecting the state’s agricultural industry, and preventing the introduction and spread of injurious insect or animal pests, plant diseases, and noxious weeds.  Cal. Food & Agr. Code §§ 4011 401.51 403.  CDFA developed the Project to control targeted pests or pathogens, and includes activities such as pest rating (evaluation of a pest’s environmental, agricultural, and biological significance); identification, detection, and delimitation of new pest populations; pest management response (which may include eradication and/or control of new or existing pest populations); and prevention of the movement of pests into and within California.

The present case was brought after CDFA sought to comply with CEQA by preparing a single PEIR that provides a consolidated set of management practices rather than prepare Environmental Impact Reports (EIR) specific to particular pest management activities.  Petitioners alleged that CDFA violated CEQA by certifying the PEIR for the Project and in related proceedings that CDFA violated CEQA by subsequently expanding the Statewide Plant Pest Prevention and Management Program to allow increased use of certain pesticides (Merit 2F and Acelepyrn) for the treatment of Japanese beetles without adequate environmental review.

The numerous CEQA violations identified by the court are set forth in a Consolidated Ruling on Submitted Matters (Consolidated Ruling) issued January 8, 2018, and attached as Exhibit 1 to the Judgment.  The Consolidated Ruling discusses the following topics:

  • Does the PEIR’s tiering strategy violate CEQA?
  • Does CEQA require the Department to issue a Notice of Determination (NOD) anytime is carries out or approves a site-specific activity?
  • Does the PEIR contain an adequate project description?
  • Does the PEIR contain an adequate description of the baseline environmental setting?
  • Does the PEIR fail to adequately analyze environmental impacts?
  • Does the PEIR fail to adequately analyze the Project’s cumulative impacts?
  • Does the PEIR improperly defer mitigation measures or conceal them as Program Features?
  • Does the PEIR fail to adequately consider a range of reasonable alternatives to the Project?
  • Did the Department violate CEQA’s notice and consultation requirements?
  • Did the Department adequately respond to public comments on the DRAFT PEIR?
  • Did the Department properly use addenda to modify the PEIR?

The court found multiple, broad-based issues with the PEIR, including, for example, a decision that the PEIR violates CEQA “because it adopts an unlawful tiering strategy, granting the Department authority to implement a broad range of practices without evaluating the site-specific conditions to determine whether the environmental impacts were covered in the PEIR.”  The Consolidated Ruling also discusses particular failures of the PEIR.  Additionally, of potential interest is the court’s opinion with regard to whether the PEIR failed to disclose and analyze impacts on sensitive biological resources, which Petitioners argued was based on several grounds:  (i) an assumption that spraying “generally” will not occur near sensitive resources and fails to analyze potential impacts from pesticide drift; (ii) a conclusion, without substantial evidence, that the Project will have less-than-significant impacts on sensitive species; (iii) a conclusion, without substantial evidence, that traps and lures will not have significant impacts on non-target species; (iv) the use of improper thresholds of significance for impacts to pollinators and organic farming; and (v) a failure to define, disclose, and analyze impacts on wetlands.

The court did not find issues with the PEIR as it related to CDFA’s spraying assumptions and CDFA’s determinations of potential impacts on sensitive species, pesticide drift, or organic farming.  The court likewise rejected Petitioner’s other challenges to the PEIR’s analysis of biological impacts, including the PEIR's analysis of traps/lures and of the species evaluated in the Ecological Risk Assessment (ERA).

The court did, however, agree with Petitioners that the PEIR improperly ignored potentially significant impacts to pollinators.  The court stated that the PEIR considered impacts to pollinators significant only if (1) the pollinator species impacted were “special status,” or (2) the impacts would result in a secondary change in the physical environment (such as conversion of land from agricultural to non-agricultural use).  The PEIR did not consider whether the Project might adversely impact non-special-status pollinators, despite acknowledging that “healthy pollinator populations are critical to protecting the environmental quality and agricultural resources of the state,” and that “Colony Collapse Disorder” and “pollinator decline” are “ongoing ... serious” problems.  The court found that CDFA’s “‘voluntary’ actions to benefit pollinator species are not, by themselves, sufficient to justify the lack of analysis and enforceable mitigation measures for the potentially significant impacts to non-special-status pollinators.”

The immediate effect of this decision is the inability for CDFA to continue “chemical activities … to control or eradicate pests under the [Statewide Plant Pest Prevention and Management] Program except as authorized under CEQA independent of the PEIR.”  Should this decision stand, registrants and stakeholders should be interested in whether and how CDFA modifies the PEIR to support its pest control and management activities.


 

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 Timothy D. Backstrom

In two recent orders issued in the neonicotinoid seed treatment case Anderson v. McCarthy, the U.S. District Court for the Northern District of California declined to take immediate action in response to a motion by the U.S. Environmental Protection Agency (EPA) requesting that the Court dismiss the case for lack of subject matter jurisdiction.  This case involves allegations by a coalition of beekeepers, farmers, and non-governmental organizations (Petitioners) that EPA has incorrectly applied the treated article exemption to seeds coated with neonicotinoid pesticides.

The Court issued an order denying the EPA motion to dismiss on May 13, 2016.  In that order, the Court concluded that factual issues to be resolved in deciding whether a 2013 EPA guidance document constitutes a final reviewable action are so “intertwined” with the substantive issues in the case that it would be inappropriate to try to resolve the jurisdictional issues until after the filing of summary judgment motions.  The Court stated:

  • If the 2013 Guidance did consummate a new rule, and thus a final agency action, then defendants clearly violated federal law by failing to comply with rulemaking requirements.  If the 2013 Guidance did not constitute final agency action, then subject-matter jurisdiction is lacking, and the case must be dismissed.

In the May 13, 2016, order, the Court also stated that the decision to defer action on the jurisdictional issues was a “close call,” because “defendants put forth a strong argument in support of dismissal of the lawsuit at the Rule 12 stage.”

On May 23, 2016, EPA filed another motion requesting that the Court clarify the May 13, 2016, order.  In its clarification motion, EPA pointed out that the May 13, 2016, order addressed only three of the counts in the complaint challenging the 2013 Guidance, but did not address Count II, which alleged a general “failure to act” because EPA has not regulated neonicotinoid coated seeds as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  According to EPA, resolution of this count involves a “pure issue of law,” because the Petitioners “failed to identify any discrete, legally-required action that EPA has failed to perform.”

The EPA motion for clarification was scheduled to be heard on July 21, 2016, but the Court issued an order on July 14, 2016, vacating that hearing.  The new order stated that “defendants raised a fair point,” because “the Court’s order on the motion to dismiss failed to expressly come to grips with that part of the motion directed at the ‘failure to act’ claim for relief.”  Nevertheless, the Court concluded that “no harm will be done in postponing resolution of that issue until summary judgment.”

Commentary

Although the Court has declined to rule on any jurisdictional question concerning the Petitioners’ complaint posed by EPA until after the parties have filed their respective motions for summary judgment, this case may still be dismissed once the Court engages in the requisite fact-finding.  When the Court stated that EPA made a “strong argument” in support of immediate dismissal, it appeared to be a clear signal that this case may yet be resolved on jurisdictional issues.  The Court may decide based on the record whether the 2013 Guidance was intended to change or to modify the existing policy on applicability of the treated article exemption to coated seeds.  The Court may also consider whether or not EPA intended the policy set forth in the 2013 Guidance to be binding in deciding whether or not to bring subsequent enforcement actions.  In addition, the Court will need to consider whether it can review a general “failure to act” in the absence of any allegation that EPA was required to take some specific action.