I015 PRIA Fee Category

An application that proposes a food use approval for a new source of a safener (a chemical that selectively protects crop plants against herbicide injury) that has been previously approved for use in a pesticide product registered for use in or on food and for which there is an existing tolerance or exemption from the requirement of a tolerance under section 408 of the FFDCA. The application does not cite previously submitted generic data but rather seeks to satisfy generic data requirements by submitting new generic data. The proposed uses must already be on a currently registered products.  Examples of food uses include: use on foods, for example, corn or apples; aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish; uses on areas where food may be grown or raised such as pasture, rangeland, home garden, beehive; uses involving livestock, such as livestock housing, livestock dips, and livestock ear tags and food handling storage establishment premises and equipment (e.g. eating establishments, meat processing equipment, food handling equipment).

If another covered application intends to associate with and depend upon an already pending application for a safener approval in this category, the dependent application must identify the pending safener action with its inert approval tracking number assigned by the Agency, name of the safener that is pending and the safener’s applicant’s name. Due to CBI concerns, the Agency will not provide information to the applicant of the dependent covered application regarding the status of the pending safener approval action beyond information that must be shared to adjust decision review times for the dependent application as discussed below. All other information on the safener’s approval action MUST come from the safener applicant.

The decision review time due date for the dependent covered application will be extended to match the decision review time due date of the pending safener approval action, unless the decision review time due date for the dependent covered application is further out, in which case the dependent covered application will initially be subject to its own decision review time.