Page:Sulfoxaflor - Final Cancellation Order.pdf/4

 If there are significant risk concerns associated with a cancelled pesticide, the policy statement states that the Agency will generally make a case-by-case determination as to whether to allow the continued sale or use of existing stocks of the pesticide. That determination, like the initial decision to register a pesticide, will focus on the social, economic, and environmental risks and benefits associated with such sale and use. But while the registration decision focuses almost exclusively on the risks and benefits associated with the use of the pesticide, the existing stocks determination is somewhat different because it focuses on product already manufactured and (in many cases) sold to others. Thus, EPA identified in the policy statement six factors it might consider in making such risk benefit decisions, including: 1) the quantity of existing stocks at each level of the channels of trade; 2) the risks resulting from the use of the existing stocks; 3) the benefits resulting from the use of such stocks; 4) the financial expenditures users and others have already spent on existing stocks; 5) the risks and costs of disposal or alternative disposition of the stocks; and 6) the practicality of implementing restrictions on distribution, sale, or use of the existing stocks. 56 Fed. Reg. at 29364.

In considering how to apply the policy to sulfoxaflor, EPA decided that the opinion of the Ninth Circuit Court of Appeals was a more important consideration than the standard six factors it generally considers. The sulfoxaflor registrations were terminated because of judicial action where the Court found the registrations were not supported by substantial evidence. In deciding to vacate the registrations rather than remand the matter to EPA without vacatur, the court, in its September 10, 2015 opinion, pointed to the precariousness of bee populations for its determination that leaving the registrations in place risks more potential environmental harm than vacating them. In remanding the registration to the Agency, the Court ordered EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees before issuing similar registrations.

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. The Court vacated those registrations ordering EPA to obtain further studies and data regarding the effects onof [sic] sulfoxaflor on bees, as required by EPA regulations. EPA has not yet obtained additional data nor has EPA assessed whether the currently available data could support a subset of uses without triggering the additional data that the Court determined were required for the registrations as EPA had approved them. Therefore, because the Court rejected EPA's conclusions that sulfoxaflor could be registered, the cancellation order issued today restricts sale and distribution of existing stocks of sulfoxaflor except for safe disposal, lawful export or to facilitate return to the manufacturer.

Nonetheless, some existing stocks of sulfoxaflor are also held by end-users. For users, EPA will allow continued use of sulfoxaflor, other than use by manufacturers for formulation into other pesticide products, provided that use is consistent with the previously approved­-labelingpreviously-approved labeling [sic] accompanying the product. 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. The previously-approved sulfoxaflor labeling contains extensive mitigation measures intended to reduce the risk of adverse effects on bees. This includes low maximum application rates, long intervals required between applications and for some crops