By Lisa M. Campbell and Timothy D. Backstrom

On November 12, 2015, the U.S. Environmental Protection Agency (EPA) issued a final cancellation order for all previously registered pesticide products containing the active ingredient sulfoxaflor, pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1).  The registrations for the sulfoxaflor products in question were cancelled effective on November 12, 2015, by an order issued by the U.S. Court of Appeals for the Ninth Circuit that vacated the original EPA decision to grant unconditional registrations for sulfoxaflor.  More information on the court’s order is available in our blog item Ninth Circuit Vacates EPA's Unconditional Registration for the Neonicotinoid Pesticide Sulfoxaflor Based on Hazard to Bees.  The stated purposes of the “cancellation order” issued by EPA are:  (1) to allow distribution or sale of existing stocks of cancelled products for the purpose of return to the manufacturer, proper disposal, or lawful export; and (2) to allow existing stocks of cancelled products in the possession of end-users to be used provided such use is consistent in all respects with the previously-approved labeling for the product.

Cancellation of all sulfoxaflor registrations was an automatic consequence of the order vacating the registrations under FIFRA issued by the court on September 10, 2015, which took effect on November 12, 2015, with the formal issuance of the court’s mandate.  In response to the court’s decision, EPA stated: “While the Agency had determined that the benefits of sulfoxaflor outweighed that uncertain risk when mitigation measures were applied, EPA will not second-guess the Court's conclusion that the registrations at issue in the case were not supported by substantial evidence.”  According to EPA, this unusual mechanism for cancellation created an anomalous situation, where all distribution or sale to remove existing stocks of sulfoxaflor from channels of trade would be unlawful, but all existing stocks of the now unregistered products in the hands of users could be used without even observing the original label directions.  The “cancellation order” issued by EPA is intended to address these anomalies.  Rather than attempting to issue an order that would preclude all use, EPA stated: “While EPA agrees that there is uncertainty about sulfoxaflor's risks to bees, EPA does not believe use of existing stocks of sulfoxaflor would significantly impact bees.”

Commentary

In recent years, EPA has begun to characterize existing stocks orders issued under authority of FIFRA Section 6(a)(1) as “cancellation orders.”  This allows EPA to enforce the terms of its existing stocks’ determinations under FIFRA Section 12(a)(2)(K).  The order governing existing stocks of sulfoxaflor illustrates the potential utility of this approach.

The petitioners who obtained an order vacating EPA’s unconditional registration of sulfoxaflor are likely to be unhappy about the decision of EPA to allow some stocks of sulfoxaflor already in the hands of end-users to be used in accordance with label directions they deem inadequate to protect pollinators.  On the other hand, EPA has pointed out that the use of unregistered pesticides is not normally regulated at all under FIFRA, so the order issued by EPA allowing some use of existing stocks of sulfoxaflor assures that users are required to follow the existing product labeling until the stocks have been exhausted.  EPA also states that disposal of existing stocks already in the hands of end-users would be difficult and costly, and that EPA disfavors imposing “restrictions on existing stocks unless the holders of stocks are notified of the restrictions and are likely to comply with them.”   

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By Timothy D. Backstrom, Lisa M. Campbell, and James V. Aidala

In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies.  Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids.  The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers.  The registrant Dow AgroSciences LLC (Dow) intervened in the action.

EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions.  EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies.  Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development.  The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.

EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012.  The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration.  EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment.  EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate.  The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures.  The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.”  The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”

EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1  was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant.  The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000.  Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.

Commentary

This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds.  The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.”  While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment.  Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.

This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment.  The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients.  In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.

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