Pesticide Registration Improvement Extenstion Act (PRIA 3)
Fee Determination Decision Tree
Decision Tree Resources:
Below is the fee for your selected Fee Category for Fiscal Years 2014/2015
| Decision Time
|A440||New Use, First food use; establish tolerance exemption (2) (3) (4)||$ 30,390||21|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 15,195|
|75% waiver||You pay ---->>>>>||$ 7,598|
To pay the fee shown above, go to http://www.pay.gov and follow the instructions.
|Action Code Interpretation|
An application that proposes the first food use. First food use includes a proposed use for any U.S. registered active ingredient for which there is no registered “food use”. The use requires an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) or a food additive regulation or other clearance under section 409 of the FFDCA. If residues are reasonably foreseeable or likely to occur in or around food, either directly or indirectly, and the risks from all foreseeable residues are minimal, the application submission may need to include a petition to establish an exemption from tolerance for all food commodities covered by the pending registration application or if residues would not be subject to FFDCA section 408, documentation of an applicable food additive regulation or other clearance under section 409 of the FFDCA. Refer to the definition of a “food use” for the uses subject to this category. All uses (food and non-food) included in any original application or petition for a first food use and to establish tolerance exemptions are covered by the base fee for that application in this category if submitted within the original application.
All of the inerts used in the product must be either approved, pending with the Agency, or a new inert is submitted within the package for the applicable uses.
A maximum of five new products are covered by the base fee. After the first five new products, each application for an additional new product or new inert ingredient approval that is submitted within this first food use package is subject to the registration service fee for a new product or a new inert ingredient approval. All such associated applications that are submitted together will be subject to the first food use decision review time.
Until the first food use is approved, any subsequent application for another new use(s) containing the same active ingredient will be charged a first food use service fee and decision review timeframe.
If the applicant on his own initiative submits any additional information that was neither requested nor required by the Agency after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, the applicant will be charged an additional 25% of the full registration service fee for the first food use application.
If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
The Agency will provide the applicant with a pre-decisional determination 4 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested new use registration. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.
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