Code of Federal Regulations Title 40. Protection of Environment § 40.152.113 Approval of registration under FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient

(1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application);

(2) Approval of the application would not significantly increase the risk of any unreasonable adverse effect on the environment;  and

(3) The criteria of § 152.112(a), (d), and (f) through (h) have been satisfied.

(1) The pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure;  and

(2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or feed crop for which there is available an effective alternative registered pesticide which does not meet the risk criteria associated with human dietary exposure. The determination of available and effective alternatives shall be made with the concurrence of the Secretary of Agriculture.