Pesticide Registration Improvement Extension 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
|R160||First Food Use; Reduced Risk (2) (3)||$ 251,669||16|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 125,835|
|75% waiver||You pay ---->>>>>||$ 62,918|
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 the establishment of, or the exemption from the requirement of a tolerance under section 408 of the FFDCA. The application submission must contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). All food uses included in any original application or petition for the first food use are covered by the base fee for the application in this category if submitted within the original application. 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, and uses involving livestock, such as livestock housing, livestock dips, and livestock ear tags.
A “reduced risk” (http://www.epa.gov/opprd001/workplan/reducedrisk.html) submission must accompany the application for registration. The Agency’s Reduced Risk Committee will evaluate the submission and make the determination, based on criteria and guidance listed in PR Notice 97-3 and in FIFRA 3(10) (B) (-iv), whether the requested use(s) qualify as “reduced risk” when compared to currently registered pesticides for the same use(s). The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate that the use/application is reduced risk, the Agency may reject reduced risk status. In the event that any uses do not qualify as “reduced risk” by decision of the Reduced Risk Committee, the application will not receive the reduced risk decision timeframes. The fee category will be changed to the category R150 and the action will receive the R150 decision review timeframe.
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.
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 first food 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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