By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On July 6, 2022, the U.S. Environmental Protection Agency (EPA) released a proposed consent decree intended to resolve the case, Center for Food Safety, et al. v. U.S. Environmental Protection Agency (3:21-cv-09640-JSC), brought against EPA in the United States District Court for the Northern District of California alleging that EPA has unreasonably delayed responding to a petition for rulemaking relating to the regulatory exemption of pesticide treated seed.  87 Fed. Reg. 40233.

In accordance with EPA’s March 18, 2022, memorandum entitled “Consent Decrees and Settlement Agreements to Resolve Environmental Claims Against the Agency,” EPA issued a Federal Register notice providing the proposed consent decree to resolve Center for Food Safety, et al. v. U.S. Environmental Protection Agency and providing a comment period. Comments on the proposed consent decree from persons who are not named as parties to the litigation in question are due on or before August 5, 2022. The public can submit comments at www.regulations.gov in Docket ID Number EPA-HQ-OGC-2022-0511.

This case was filed in connection with a petition (Petition) from the Center for Food Safety on or around April 26, 2017, requesting that EPA amend 40 C.F.R. Section 152.25(a) to exclude seeds for planting coated with systemic pesticides intended to kill pests of the plant, or, in the alternative, publish a formal agency interpretation in the Federal Register stating that 40 C.F.R. Section 152.25(a) does not apply to seeds for planting coated with systemic pesticides intended to kill pests of the plant, and enforce the numerous pesticide registration and labeling requirements for each separate crop seed product that is coated with a neonicotinoid or other systemic insecticidal chemical (2017 Petition Requests). EPA requested public comment on the 2017 Petition and received approximately 100 substantive comments. On December 14, 2021, Plaintiffs filed a Complaint alleging that EPA's failure to respond to the Petition constitutes an unreasonable delay under Section 706(1) of the Administrative Procedure Act (APA), 5 U.S.C. 706(1).

Under the proposed consent decree, EPA would,  no later than September 30, 2022, either grant, deny, or grant in part and deny in part each of the Petition Requests. Court approval of this proposed consent decree would resolve all claims in this case except for the claim for the costs of litigation, including reasonable attorneys’ fees. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the APA or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Unless EPA or the Department of Justice determines that consent should be withdrawn, the terms of the proposed consent decree will be affirmed and entered with the court.

Commentary

The treated article exemption under FIFRA, as EPA has applied it over the years, has been relevant mostly to uncontroversial products such as shower curtains (the pesticide applied to such a product is intended to preserve the shower curtain and not considered using a pesticide when one uses the shower curtain). Meanwhile, the practice of coating seeds with pesticides became more controversial in recent years about possible impacts on honeybees from fugitive dust from neonicotinoid-treated crop seeds. The concern is whether such non-target movement of pesticide residues (the dust) might be partly responsible for the apparent decline in honeybee populations. Critics view EPA’s policy about treated articles as not incorporating a sufficiently robust assessment of the impacts of this pesticide use pattern -- that is, the dust from the treated seeds and the systemic nature of neonicotinoid products used this way have impacts that EPA “ignores” due to the treated article exemption.

Interestingly, any residues remaining in the food produced using such products still must meet the Food Quality Protection Act (FQPA) safety standard of “reasonable certainty of no harm” from consuming the food -- but critics view the neonicotinoid products as causing unreasonable environmental impacts -- even if the finished food product is safe. In this view, critics of the current treated article exemption definition argue that the environmental impacts of neonicotinoid pesticides are left insufficiently regulated. One problem EPA faces, however, is that the treated article exemption applies to a much larger universe of pesticide applications than seed treatments, so changes to better evaluate the environmental impact of neonicotinoids could impact other products currently not viewed as controversial. This partly explains why EPA has delayed its response to the Petition as it considers how to respond. Changes to the current policy could result in many more products or applications needing EPA review, which would expand the pesticide registration universe at a time when EPA struggles to meet evaluation deadlines for currently registered products. EPA now will have to decide how to move forward on this issue, which will likely have more complex implications for products beyond neonicotinoid pesticides.

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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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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.

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By Lisa M. Campbell and Lisa R. Burchi

On March 10, 2016, the U.S. Environmental Protection Agency (EPA) filed a motion to dismiss for lack of subject matter jurisdiction and a supporting memorandum of law (Memorandum) in Anderson v. McCarthy, Case No. 3:16-cv-00068 (N.D. Cal. filed Jan. 6, 2016).  In support of its motion, EPA states that the District Court lacks jurisdiction because three of the four claims stated in the complaint “seek review of a guidance document that does not constitute ‘final agency action’ reviewable under the Administrative Procedure Act [APA] or the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA],” and that the remaining claim “which asserts a failure to regulate under and enforce [FIFRA], fails because Plaintiffs have not identified a clearly imposed duty on the part of EPA to take some discrete action to regulate under or enforce the Act.”

The Complaint was filed by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners) who requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the “treated article” exemption under FIFRA.  Petitioners argue, in part, that the following language from EPA’s 2013 Inspection Guidance (Guidance) provides a new interpretation of the scope of the “treated article”:

                  Inspectors may also take into account any locations of treated seed planting when identifying locations of potential pesticide sources. Note: Treated seed (and any resulting dust-off from treated seed) may be exempted from registration under FIFRA as a treated article and as such its planting is not considered a “pesticide use.” However, if the inspector suspects or has reason to believe a treated seed is subject to registration (i.e., the seed is not in compliance with the treated article exemption), plantings of that treated seed may nonetheless be investigated.

The Complaint argues that this Guidance improperly expanded the scope of the treated article exemption and was in effect an unlawful rule issued without prior notice and comment. The Complaint seeks an order from the District Court declaring, in part, that “unregistered seeds do not fit within the ‘treated article’ exemption from pesticide regulation in 40 CFR § 152.25(a) and must be regulated as pesticidal products under FIFRA.”

With regard to the scope of the treated article exemption, EPA in its Memorandum states that the language from the Guidance, which is for the use of inspectors and not the general public, is:

               [A] far cry from prescribing the law or policy as to exemption of treated seed as a treated article under 40 C.F.R. § 152.25(a), as they in no way implement, interpret, or prescribe law or policy. Instead, this language in the Inspection Guidance is but one recommendation to inspectors who are investigating all possible sources of pesticides, including treated seed.

EPA further argues that the “note” in its Guidance is “nothing more than the unremarkable reiteration of EPA’s longstanding view of the treated article exemption in 40 C.F.R. § 152.25(a).”  EPA states that the applicability of the treated article exemption has been discussed publicly by EPA since 2003 in an document published jointly by EPA and Canada Pest Management Regulatory Agency entitled “Harmonization of Regulation of Pesticide Seed Treatment in Canada and the United States.”  In that document, EPA states that it “plainly indicates that where the conditions of the treated article exemption are met, ‘[s]eeds for planting which are treated with pesticides registered in the U.S. are exempt from registration as pesticides and may be freely distributed and sold within the U.S.’”  Thus, EPA states that Petitioners “have failed to meet their burden to demonstrate that the Inspection Guidance (or any other action) constitutes “final agency action” as that term is used in the APA, and thus they have not met their burden of demonstrating jurisdiction.”

On March 16, 2016, Intervenor-Defendants CropLife America, the American Seed Trade Association, the American Soybean Association, the National Cotton Council of America, the National Association of Wheat Growers, the National Corn Growers Association, and the Agricultural Retailers Association filed to join EPA’s Motion to Dismiss.

More information on the complaint is available in our blog item EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA.

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By Lisa M. Campbell and Timothy D. Backstrom

On January 6, 2016, a complaint was filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Northern District of California by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners).  The Petitioners allege that EPA has allowed “the ongoing sale and use of unregistered pesticide products”  because, they claim, EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be “treated articles” exempt from registration under 40 C.F.R. § 152.25(a).  Petitioners argue that a 2013 guidance document prepared by EPA for enforcement personnel investigating bee incidents improperly expanded the scope of the “treated article” exemption and was in effect an unlawful rule issued without prior notice and comment.

According to Petitioners, seeds coated with neonicotinoid pesticides should not be considered eligible for the “treated article” exemption because the neonicotinoid pesticide in the coating acts systemically to protect the growing plants after the seeds germinate, rather than to protect the seeds themselves.  Based on this analysis, Petitioners argue that each coated seed product is in fact a separate unregistered pesticide that has not been properly evaluated under FIFRA.  Petitioners also argue that pesticide loss from these coated seeds has a variety of collateral environmental effects, including effects on pollinators that EPA has not appropriately considered.

The Petitioners have requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the treated article exemption.  Petitioners also request that the District Court enjoin EPA from:  (1) allowing any new unregistered neonicotinoid-coated seeds of any crops; and (2) allowing any new unregistered seeds of any crops if they are coated with other systemic insecticides that cause pesticidal effects extending beyond the coated seed and plant itself.

Commentary

The potential consequences of a reviewing court finding that EPA has improperly construed or expanded the “treated article” exemption by including seeds coated with neonicotinoid insecticides are of significant concern.  Such a construction could require that EPA separately register each type of coated seed under FIFRA, regardless of whether EPA adequately evaluated the risks associated with seed treatment when each insecticide was first registered for this use.  EPA could seek dismissal of some or all of the Petitioner’s claims on jurisdictional grounds, arguing that the risks and benefits of seed treatment were considered at the time each neonicotinoid insecticide was registered for such use, and that the Petitioners should have sought prior review of those registration decisions in the Court of Appeals within the applicable 60-day window.  EPA may also object to the apparent failure of the Petitioners to exhaust their administrative remedies before challenging the policy embodied in the purported “rule,” and also to the Petitioners’ extensive reliance on extra-record evidence.

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