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, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala

On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor.  EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries.  EPA states that substantial data show that when sulfoxaflor is used according to the label, it poses no significant risk to human health and poses a lower risk to non-target wildlife, including pollinators, than other registered alternative products.  EPA’s registration decision is available at www.regulations.gov in Docket Number EPA-HQ-OPP-2010-0889-0570.

EPA’s decision follows an opinion issued on September 10, 2015, by the U.S. Court of Appeals for the Ninth Circuit vacating EPA’s 2013 unconditional registration for the pesticide sulfoxaflor, and remanding the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies.  That decision is discussed in our blog item available here. In response to that decision, EPA also issued a cancellation order that included provisions for the disposition of existing stocks of sulfoxaflor products.

After the decision of the Ninth Circuit Court of Appeals, EPA reevaluated the data and on October 14, 2016, approved sulfoxaflor end-use registrations for limited uses that did not include crops that attract bees.  EPA also has been granting emergency exemptions for sulfoxaflor since 2012, with the most recent emergency exemptions granted on June 17, 2019, for the use of sulfoxaflor to control tarnished plant bugs on cotton in 12 states, and to control sugarcane aphids on sorghum in 14 states.

In the July 12, 2019, decision adding new uses, restoring previous uses, and removing certain application restrictions, EPA states an unconditional registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(5) for new uses of sulfoxaflor is backed by substantial data, including numerous pollinator studies submitted by the registrant, Dow AgroSciences (DAS).  With specific regard to sulfoxaflor’s impact on bees, EPA states the following:

Since the vacatur in 2015, DAS has submitted numerous additional pollinator studies. The pollinator data requirements listed in 40 CFR 158.630 have all been submitted or waived. EPA’s risk assessment process for pollinators has evolved since those data requirements were promulgated and now EPA generally assesses risks to bees using a three-tier process based on a more robust data set as described in two guidance documents: “Guidance for Assessing the Risks of Pesticides to Bees” (USEPA 2014) and “Guidance on Exposure and Effects Testing for Assessing Risks to Bees” (USEPA 2016). For sulfoxaflor, all Tier I data have been submitted. Three additional Tier II semi-field (tunnel) studies and two colony feeding studies have been submitted. Pollen and nectar residue data have been submitted for multiple crops. The submitted data covers all of the requested use patterns. For those crops that did not have data specific to pollen and nectar residues, data was extrapolated as appropriate from other crops. All regulatory data requirements for assessing pollinators have now been addressed and the EPA has adequate data to demonstrate that there will be no unreasonable adverse effects to honey bees resulting from the expanded registration of sulfoxaflor.

EPA’s decision also removes previously imposed application restrictions:

• Removed the prohibition of use on crops grown for seed because EPA believes pollinator protection restrictions, including low use rates, will be in place regardless of whether the crop is grown for seed or for commodity harvest;
• Removed the restriction to post-bloom application for bee-attractive crops only when there is low risk or limited potential for exposure to bees;
• Removed the 12-foot buffer requirement because EPA believes the spray drift mitigation requirements on labels are adequate to limit drift; and
• Removed the 2016 restriction against tank mixing because EPA states data show that there is no additional risk when sulfoxaflor is tank mixed with other compounds.

EPA’s decision includes the following crop specific restrictions:

• Citrus: Only one application is allowed per year between 3 days before bloom and until after petal fall.
• Ornamentals: Only one application is allowed during bloom, and that bloom must not exceed a rate of 0.071 lb ai/acre.
• Pome Fruit, Stone Fruit, Tree Nuts and Pistachio: No application is allowed any time between 3 days prior to bloom and until after petal fall.
• Small Fruit Vine Climbing and Low Growing Berry, Tree Plantations: No application is allowed any time between 3 days prior to bloom and until after petal fall.

EPA found that the FIFRA standard for registration is met for the registration of sulfoxaflor on the uses approved, and that the benefits of these uses outweigh the risks, but also set specific label requirements including restrictions to minimize potential exposure to bees:

• Worker Protection:  “Applicators and other handlers must wear: Long-sleeved shirt and long pants, shoes plus socks, protective eyewear” and “Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of” 24 hours (for Transform WG label) and 12 hours (for Closer SC label).
• Environmental Hazards Statement:  “This product is highly toxic to bees and other pollinating insects exposed to direct treatment or to residues in/on blooming crops or weeds. Protect pollinating insects by following label directions intended to minimize drift and reduce pesticide risk to these organisms.”
• The RT25 (how long foliar residues of sulfoxaflor exhibit toxicity to honey bees):  “The RT25 for this product is less than or equal to 3 hours.”
• Directions for Use:  “Notifying known beekeepers within 1 mile of the treatment area 48 hours before the product is applied will allow them to take additional steps to protect their bees. Also, limiting application to times when managed bees and native pollinators are least active, e.g. 2 hours prior to sunset or when the temperature is below 50°F at the site of application will minimize risk to bees.”

Commentary

This new decision by EPA may finally be the culmination of a long and convoluted process to register sulfoxaflor.  The litigation that resulted in vacatur of the initial registrations began in 2013.  At the time the Ninth Circuit issued its decision in 2015, vacatur was viewed by many observers as a novel and radical response to an EPA decision to register a new pesticide.  Since that time, registrants and users of newly approved active ingredients have encountered more aggressive litigation in which vacatur is often cited as a possible remedy.  This has created more uncertainty and concern about product availability, even after EPA approves an eagerly anticipated new product to meet a pressing pest control need.  In the case of sulfoxaflor, EPA has clearly determined that the data submitted by DAS demonstrate that any risks to pollinators presented by sulfoxaflor will be less than the risks presented by currently registered insecticides sulfoxaflor is likely to replace. This determination concerning relative risk based on review of additional data should address the deficiencies in the EPA rationale found by the Court when it vacated the 2013 sulfoxaflor registrations.

Interestingly, the current EPA decision may raise a similar issue concerning the sufficiency of EPA’s rationale concerning the effects of sulfoxaflor on endangered species.  EPA states the following in its Decision Memorandum:

Endangered Species

EPA has not made an effects determination for sulfoxaflor. EPA is currently focusing most of its resources for assessing impacts to listed species on its registration review program for currently registered pesticides. EPA believes that, as a general matter, older pesticides present a greater degree of risk to listed species than most new chemistries, including sulfoxaflor, and that it is therefore environmentally preferable in most circumstances for EPA to assess the impacts of existing pesticides sooner in the process than newer pesticides that are designed to compete with more risky alternatives. EPA believes that is especially true for sulfoxaflor, where the alternatives include organophosphates, neonicotinoids and pyrethroids. As a result, EPA does not believe the environment or the public would be best served by delaying the registration of new uses for sulfoxaflor to complete consultation. Focusing the limited resources of EPA, the Fish and Wildlife Service and the National Marine Fisheries Service on completing a consultation on the effects of sulfoxaflor would by necessity come at the expense of putting more resources into evaluating – and consequently regulating, where appropriate – what EPA believes to be more toxic compounds, that, among other things, pose greater risk, to endangered species than does sulfoxaflor.

While it is clearly sensible for EPA and the Services to prioritize the limited resources available to make and to consult concerning effects determinations for endangered species by addressing existing pesticide classes that are likely to present the greatest risk before products with new chemistries that are intended to be more selective, it remains to be seen whether reviewing courts will be inclined to accept this type of rationale.  In particular, it will be interesting to see whether the sufficiency of this approach to endangered species determinations becomes an issue in any future litigation regarding sulfoxaflor or other newly registered active ingredients.

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By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential risk to terrestrial and aquatic plants from off-site spray drift, consistent with glyphosate’s use as a herbicide.”  Even with these potential risks, the PID states that “EPA concludes that the benefits outweigh the potential ecological risks when glyphosate is used according to label directions” and proposes certain risk mitigation strategies, including:

• “To reduce off-site spray drift to non-target organisms, the EPA is proposing certain spray drift management measures” with specific spray drift mitigation language to be included on all glyphosate product labels for products applied by liquid spray application;
• “To preserve glyphosate as a viable tool for growers and combat weed resistance, the EPA is … proposing that herbicide resistance management language be added to all glyphosate labels” and to require measures “for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds”;
• Inclusion on labels of a non-target organism advisory statement to alert users of potential impact to non-target organisms; and
• “EPA is also proposing certain labeling clean-up/consistency efforts to bring all glyphosate labels up to modern standards.”

EPA states that these measures were discussed with glyphosate registrants, who do not oppose the proposed risk mitigation measures outlined in the PID.

The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.  Public comments are due by July 5, 2019.  In addition to the PID, EPA is also posting to the glyphosate docket EPA’s response to comments on glyphosate’s usage and benefits (dated April 18, 2019), EPA’s response to comments on the human health risk assessment (dated April 23, 2018), and EPA’s response to comments on the preliminary ecological risk assessment (dated November 21, 2018). 

This PID was issued shortly after the Agency for Toxic Substances and Disease Registry’s announcement on April 8, 2019, of the opening of a docket on the draft toxicological profile for glyphosate.  84 Fed. Reg. 13922.  ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019.

Commentary

EPA’s PID and related documents, along with ATSDR’s draft profile and the peer review which will follow, can be expected to become part of the larger debate about the potential risks of glyphosate.  In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments.  See our December 19, 2017, blog item "EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment" for more information. 

EPA’s PID is interesting not only for the conclusions EPA reached following its review of data submitted by registrants in response to a data call-in (DCI) and following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) meeting to consider and review scientific issues related to EPA’s evaluation of the carcinogenic potential of glyphosate, but for the issues that remain to be addressed.  Notably, EPA states that it has not considered the petition filed on September 27, 2018, to reduce glyphosate’s tolerance because the petition was filed after the comment period for the human health and ecological risk assessments closed.  Instead, EPA plans to post the petition in the glyphosate docket and address the petition concurrently with the development of the Interim Registration Review Decision.

In addition, EPA has not in the PID or related documents addressed issues regarding its Endangered Species Act (ESA) assessment or its Endocrine Disruptor Screening Program (EDSP) activities.  EPA states it intends to complete an assessment of risk to ESA-listed species prior to completing its final registration review decision for glyphosate, and that it also will make an EDSP determination under Federal Food, Drug, and Cosmetic Act (FFDCA) Section 408(p) before completing its registration review.  EPA also notes that it continues to evaluate risks to pollinators, and that if it determines “that additional pollinator exposure and effects data are necessary to help make a final registration review decision for glyphosate, then the EPA will issue a DCI to obtain these data.”  Although there are significant areas that remain to be resolved, EPA issued the PID “so that it can (1) move forward with aspects of the registration review case that are complete and (2) implement interim risk mitigation.”

More information on glyphosate issues is available on our blog.

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By James V. Aidala and Margaret R. Graham, M.S.

On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was updating its Residual Time to 25% Bee Mortality (RT₂₅) Data Table with information it has collected since the table was first published in 2014.  EPA states that the “RT₂₅ data help farmers and beekeepers know about how long a specific pesticide may remain toxic to bees and other insect pollinators following foliar application to crops,” and the new data “reflect the results of studies the agency has analyzed as part of [its] routine pesticide regulatory activities.”  One example that EPA provides regarding how this new data will work is that farmers can now “choose pesticides that quickly lose their toxicity to bees,” and that applying the products in the evening “helps ensure that by morning the pests have been dealt with and blooming crops are safe for bees.” 

EPA states that RT₂₅ values are a function of a number of factors including application rate, physical-chemical properties, dissipation, crop, and pesticide formulation.  The values provided were compiled from registrant-submitted data submitted to fulfill the data requirement for Honey Bee (Apis mellifera) Toxicity of Residues on Foliage study (OCSPP Guideline 850.3030).  EPA states that the honey bee toxicity of residues on foliage study “is a laboratory test designed to determine the length of time over which field weathered foliar residues remain toxic to honey bees, or other species of terrestrial insects” and, depending on the chemical tested, “either the technical grade active ingredient or a specific formulation was tested using either the honey bee, alfalfa leaf cutting bee, or alkali bee.”  The data table lists the test material, the species tested, and the plant species on which residues were aged.

EPA plans to update the table annually as it collects additional data going forward.  More information on EPA’s actions intended to protect pollinators is available on EPA’s website.

Commentary

In addition to providing the residual toxicity values, the table also illustrates the wide range of toxicity values among the various pesticides.  RT₂₅ times for the different active ingredients can range between a few and over 500 hours to reach the RT₂₅ threshold.  Even different formulations using the same active ingredient can have a significant difference in toxicity values.  This illustrates the importance of reading the specific label instructions for a pesticide, even one that might be generally familiar to the user.

EPA’s publication of this information online also imposes a duty for EPA to continually update the table, especially to capture any changes in the information appearing in an earlier listing of the data.  If, upon further review or later data submissions there are changes to the table for a product, EPA will need to alert users to potentially important changes in the information.  Again, this illustrates the need for reading the label for each pesticide at the time of application, since some important information may have changed.

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By Lynn L. Bergeson

Bergeson & Campbell, P.C.’s (B&C^®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available.  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta^®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.

Happy New Year and enjoy reading our predictions!

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By James V. Aidala and Margaret R. Graham

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) which describes methods for addressing acute risks to bees from pesticides.  EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an acute risk, and with the goal of reducing potential impact of this effort on growers.”  EPA states that it will use its Tier 1 acute risk assessment to, in part, determine the products that trigger concerns about pollinator risk that the label restrictions are intended to address.  EPA will begin implementing this Policy in 2017 by sending letters to registrants describing steps that must be taken to incorporate the new labeling.  More information on the Mitigation Policy, including its supporting documents, and EPA’s response to comments submitted on the proposed policy, is available on www.regulations.gov under Docket ID EPA-HQ-OPP-2014-0818.

Also on January 12, 2017, EPA published preliminary pollinator-only risk assessments for the neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, and an update to its preliminary risk assessment for imidacloprid, published in January 2016.  EPA states that the preliminary assessments for clothianidin, thiamethoxam, and dinotefuran are similar to the preliminary pollinator assessment for imidacloprid, in that they showed that “most approved uses do not pose significant risks to bee colonies,” but “spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.”  As for the updated imidacloprid assessment, EPA states that is looked at potential risks to aquatic species, and identified some risks for aquatic insects.  Interested parties will have 60 days to comment on the preliminary risk assessments after notice is published in the Federal Register.  In terms of comments, EPA states that it is especially interested in getting input from stakeholders “on the new method for assessing potential exposure and risk through pollen and nectar.”  Links to risk assessment dockets for each individual insecticide are available on EPA’s website under Schedule for Review of Neonicotinoid Pesticides.  EPA states it is hopes to release the final neonicotinoid risk assessments by mid-2018.

Commentary

The revised Mitigation Policy has been long in coming since it was first released over eighteen months ago.  The delay in revising its approach reflects the complexity of the comments submitted, and EPA’s deliberateness in more finely crafting its policies, given the passage of time and other considerations.  This revised policy contains more flexibility and explicit discussion of the need for exceptions to blanket requirements in response to some of the comments received on the earlier proposal.  There remains significant public and regulator concern about the possible impacts on pollinators from pesticide use, however, there is currently less of a manic tone to EPA’s statements and actions.

For example, when discussing how EPA will approach changing the labels of the affected universe of pesticide products, there is a much less onerous tone and no specific deadlines for registrants to submit revised labels “or else.”  (The 2013 directives to registrants included demands for thousands of revised labels to be submitted within six weeks “or else” -- EPA would take “appropriate action” under FIFRA.)  EPA reminds us all that it retains authority to impose these new requirements broadly, a statement that will strike some as regulatory overreach, but the tone and approach is more in line with past EPA “guidance” about how it will approach a new or revised regulatory concern.   

Similar to what EPA previously concluded about imidacloprid, where that assessment concluded that the most controversial use -- corn seed treatments -- did not indicate a risk concern, EPA did include in its summary about the other three neonicotinoid pesticides that:

• The assessments for clothianidin, thiamethoxam, and dinotefuran, similar to the preliminary pollinator assessment for imidacloprid showed:  most approved uses do not pose significant risks to bee colonies.  However, spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.

This might unfairly be summarized as:  after years of regulatory analysis EPA has concluded that if insecticides come into direct contact with insects, there is likely to be a risk to the exposed insect. 

This conclusion would be too simplistic since EPA and other regulatory bodies have expressed concern about what unintended exposures to insecticides might cause, and more generally the possibility of colony level impacts on honeybee and other pollinator populations from pesticide use.  Some critics will continue to insist that EPA broaden its regulatory approach to more than just pesticides used for crops under contracted pollinator services.  The broader issue of pesticide drift and possible impacts on non-target species will continue to be a concern for all pesticides.

Perhaps the more deliberate consideration of needed data generation and assessment that seems to be the current approach will allow both more refined regulatory controls if needed, and a reduction in the sometimes hot rhetoric which has accompanied the pollinator issues.

Lastly, although this revised Mitigation Policy and the three new preliminary assessments are not unexpected next steps as part of the ongoing registration review program for pesticides, given their very late release -- less than ten days before the arrival of a new Administration -- some might question whether this is part of the “midnight regulations” pushing the political agenda of the outgoing Administration.  The new leadership may revise what has been released, and may come to different conclusions about any needed restrictions.  That said, the issue of whether certain pesticides are having a dangerous impact on honeybee populations will continue to be a concern for regulators both in the U.S. and globally.

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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 R. Burchi and Lisa M. Campbell

On January 22, 2016, Ontario released for consultation a draft Health Action Plan (Plan) to reduce losses of honeybees and other pollinators caused by several “stressors” stated in the Plan to include: (1) reduced habitat and poor nutrition; (2) diseases, pests, and genetics; (3) exposure to pesticides; and (4) extreme weather and climate change.  This action plan is part of a broader strategy to protect pollinators, with Ontario’s aim, in part, to reach an 80 percent reduction in the number of acres planted with neonicotinoid-treated corn and soybean seeds by 2017.   Other actions taken by Ontario related to pollinators and the regulation of corn and soybean seeds treated with neonicotinoids are discussed in our blog item Canadian Province Finalizes Neonic Reduction Rule. 

Comments can be submitted through the Environmental Registry until March 7, 2016.

The Plan “identifies potential actions that have been informed through an ongoing consultation process with key stakeholders and the broader public.”  For each of the four stressors identified as a cause of the pollinator decline, the Plan summarizes what information Ontario has gathered, what potential actions it is considering, and what potential additional action areas exist.  With regard to the exposure to pesticides, the Plan states the following regarding potential actions for Ontario to take and additional measures under consideration.

Potential Actions by the Province:

• Increase education and outreach activities to stakeholder groups on Best Management Practices (BMP) and integrated pest management to support the implementation of Ontario Regulation 63/09 under the Pesticides Act;
• Support integrated pest management training for growers;
• Enhance sector outreach to support beekeeper education around the use of appropriate pest treatments in-hive;
• Continue to work with industry to support agricultural production and land stewardship practices that reduce pollinator pesticides exposure;
• Explore opportunities to facilitate completion and launch of an e-tool to alert pesticide applicators of nearby beehives for the purpose of reducing bee exposures;
• Provide financial support for producers to acquire dust deflectors for planting equipment through the Great Lakes Agricultural Stewardship Initiative;
• Enhance provincial monitoring efforts to track changes in agricultural practices stemming from the implementation of Ontario Regulation 63/09; and
• Monitor neonicotinoid concentrations in the environment.

Potential Additional Action Areas:                        

• Profile and highlight BMPs for pesticide use in agriculture;
• Improve beekeeper education on the effectiveness of honey bee pest treatments; and
• Support research in selective breeding strategies for honey bees resistant to pests and diseases.

The Plan also discusses Ontario’s research and monitoring efforts, including its intent to align and leverage existing research programs and its consideration to launch a special “Call for Proposals” to “fund new pollinator health research projects to fill knowledge gaps for example, understanding how varroa infestations interact with other stressors, studying implications of climate change for Ontario’s pollinators and assessing the effectiveness of various land management practices.”

In addition to submitting comments on the Plan, Ontario also developed an online survey for input on what priorities should be the focus to improve pollinator health and what steps should be taken to improve pollinator health.

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