Cancellation Order Establishes Existing Stocks Requirements for Sulfoxaflor

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.”