I011 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Approval of New Food Use Safener with Tolerance or Exemption From Tolerance
Below is the fee for your selected Fee Category for Fiscal Years 2020-2021
|Action Code||Description||FY'20-FY'21 Fee||Decision Time (months)|
|I011||Approval of new food use safener with tolerance or exemption from tolerance (2) (8)||$627,568||24|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$313,784|
|75% waiver||You pay ---->>>>>||$156,892|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application that proposes a food use approval for a safener (a chemical that selectively protects crop plants against herbicide injury) that is not contained in any pesticide product registered for use in or on food. The use may require the establishment of or the exemption from the requirement of a tolerance under section 408 of the FFDCA. The application must contain a petition to establish tolerances or exemptions from the requirement of a tolerance for all food/feed commodities for which food use approval is sought as well as the submission of data supporting the petition. 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 an approval in this category, the dependent application must identify the pending 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 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 inert ingredient applicant.
If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active ingredient.
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.