Page:Sulfoxaflor - Final Cancellation Order.pdf/3

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and they can prohibit use that would otherwise be lawful. They can also contain limitations or conditions on the sale, distribution, or use that the Administrator determines to be appropriate; one such limitation that EPA frequently applies to existing stocks is a condition that any authorization of use of such stocks is limited to use that is consistent with the previously­-approved labeling accompanying the product.

In the case of sulfoxaflor, the registrations are being vacated by court order, rather than cancelled by EPA itself. Nonetheless, the Agency believes that the Court's action in vacating the sulfoxaflor registrations is best viewed under FIFRA as a cancellation of those registrations under section 3 (because the vacatur is based upon the lack of substantial evidence to support the registrations under section 3 of FIFRA). EPA followed this same approach when registrations of spirotetramat were vacated by the U.S. District Court for the Southern District of New York. See Spirotetramat Final Cancellation Order, available at http://www2.epa.gov/ingredients-used­-pesticide-products/final-cancellation-order-issued-spirotetramat. See also Termilind Limited; Notice and Order of Revocation of Registrations, 62 Fed. Reg. 61890 (Nov. 19, 1997). The Agency is therefore issuing a cancellation order under FIFRA section 6(a)(1) that establishes provisions governing the disposition of existing stocks of previously-registered sulfoxaflor pesticide product.

In similar situations, the Agency has considered proceeding via Stop Sale, Use, and Removal Order (SSURO) rather than a cancellation order, but rejected this course of action. Section 136k(a) requires SSUROs to be " issued .. . to any person who owns, controls, or has custody" of the pesticide that is subj ect to the order, which order is effective as to that person only "after [he] recei[ves] ... that order." EPA interprets this language to require personal delivery to each such person. For such a widely used pesticide as sulfoxaflor, personal delivery would present enormous practical difficulties for EPA to ascertain the names and addresses of all such persons (including all end-users) and issue SSUROs to them, which the Agency does not believe is warranted in the instant circumstance.

In sum, EPA believes that it has the authority under FIFRA to issue a cancellation order establishing provisions for the disposition of existing stocks of sulfoxaflor. We turn next to the issue of whether, and to what extent, distribution, sale, or use of existing stocks of sulfoxaflor should be allowed.

Existing Stocks Determination

EPA issued in 1991 a policy statement outlining the considerations it generally applies in determining how to treat existing stocks in cancellation orders. See 56 Fed. Reg. 29362 (June 26, 1991). In general, if no significant risk concerns have been identified for a cancelled product, such as when a product is voluntarily cancelled, the policy statement suggests that the Agency will generally allow unlimited use of existing stocks, and unlimited sale by persons other than the registrant. A registrant will generally be allowed to continue to sell existing stocks for 1 year after the date cancellation is requested, or 1 year after the date the registrant has ceased to comply with the responsibilities that are placed upon registrants, whichever date is sooner. 56 Fed. Reg. at 29362, 29367.

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