iStock_000009538198_SmallOn September 10, 2015, in Pollinator Stewardship Council et al. v. EPA, the Ninth Circuit Court of Appeals invalidated US EPA’s unconditional registration of the insecticide sulfoxaflor, concluding that the scientific data relied upon by the agency regarding the product’s potential impact on honey bees did not support approval of the insecticide.  Sulfoxaflor, which is produced by Dow Agrosciences LLC (Dow), is intended to target the same receptors in insects as other neonicotinoid pesticides, but uses a different mechanism.  Opponents of neonicotinoids claim that they may harm honey bees and contribute to honey bee colony collapse disorder.

When analyzing Dow’s registration application for  sulfoxaflor under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), US EPA utilized its recently developed Pollinator Risk Assessment Framework (the Framework), which provides for  a two-tiered review process. Tier I consists of an initial assessment, which looks at laboratory-based toxicity data from studies involving individual bees to determine whether the pesticide poses a risk to bees. If US EPA affirmatively determines that the pesticide poses such a risk, Tier II semi-field studies are required to determine if usage would result in unreasonable adverse environmental effects. Tier II, unlike Tier I, is designed to examine the effects of the insecticide on bees in the environment, not in the laboratory, and focuses the analysis on the colony as a whole rather than individual bees.

US EPA initially concluded that additional semi-field studies were required before sulfoxaflor could receive unconditional approval under FIFRA. As a result, Dow submitted six semi-field studies to US EPA. After reviewing these studies, the Agency determined that additional studies were needed because the semi-field studies were “inconclusive” as to “brood development and long-term colony health.” Rather than deny the application outright, US EPA granted conditional approval for sulfoxaflor so that it could be sold while Dow conducted additional Tier II semi-field studies specifically focused on brood development and colony strength. Seven months later, however, US EPA elected to unconditionally register sulfoxaflor even though Dow had not completed the requested studies. The Agency determined that unconditional approval was warranted based on mitigation measures contained in the modified usage procedures for the insecticide.

Several bee-keeper groups challenged US EPA’s decision, claiming that it was not supported by substantial evidence in the record. The Ninth Circuit agreed, finding that the studies reviewed by US EPA were inconclusive and contained insufficient date to warrant unconditional approval.   The court also found that US EPA’s decision to grant unconditional approval was contradicted by its prior determination that the initial Tier II studies were insufficient to evaluate the effect of sulfoxaflor on brood development and long-term colony strength.  The court held that “[w]ithout sufficient data, the EPA has no real idea whether sufloxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”

The Ninth Circuit’s decision not only is a setback for US EPA’s implementation of its new Pollinator Risk Assessment  Framework, it comes at a time when the Agency is facing pushback against other actions it has proposed to address pollinator issues under President Obama’s June 2014 Memorandum creating a federal strategy to promote the health of honey bees and other pollinators.

On May 15, 2015, US EPA issued a notice seeking comments on a proposal to adopt mandatory pesticide label restrictions to protect bees from foliar application of pesticides that are acutely toxic. The label restrictions would restrict the application of acutely toxic pesticide products during bloom when bees are known to be present. The proposal also calls on states to develop locally-based pollinator protection plans.

Officials from the US Department of Agriculture (USDA) and the National Association of State Departments of Agriculture (NASDA) issued separate comments challenging the proposed rule in which they assert that US EPA failed to follow FIFRA procedures because the proposed rule did not establish a need for pesticide prohibitions using bee kill data, failed to consider the rule’s economic impacts on specialty crops, and would prevent farmers from following established best management practice for safely using pesticides without harming bees.  The comments submitted by USDA and NASDA echo criticisms levied by industry groups that urge US EPA to withdraw the proposed label changes.

The comment period for the proposed rule closed on August 28, 2015. Squire Patton Boggs will continue to monitor this rulemaking as well as the steps taken by US EPA to address sulfoxaflor (and similar pesticides) in light of the Ninth Circuit’s decision in Pollinator Stewardship Council.