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 Year 2013
| Decision Time
|R140||Additional food use; Indoor, Food/Food Handling (3) (4)||$ 40,518||15|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 20,259|
|75% waiver||You pay ---->>>>>||$ 10,130|
To pay the fee shown above, go to http://www.pay.gov and follow the instructions.
|Action Code Interpretation|
An application that proposes an additional indoor food use. This category includes a proposed indoor food use of any U. S. registered active ingredient for which there currently is a registered food use. The use requires the establishment of the exemption from the requirement of a tolerance under section 408 of the FFDCA. If residues are reasonably foreseeable or likely to occur in food or feed or around food, 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). Increases in exposure such as a dosage rate increase or different method of application will result in the application being treated as a new use. Indoor means that the proposed use is for use inside of manmade structures. Some examples of indoor food uses include: use in a food handling and/or processing establishment, use on food crops in a greenhouse, aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish, use in home gardens, and uses involving livestock, such as livestock housing, and livestock dips. The fee applies to each additional food use requested (i.e. the fee for this category is multiplied by 4 if 4 uses are proposed). If a crop group or subgroup is requested, the fee is based on the number of representative crops in that group or subgroup that are not currently registered. If all of the representative crops have been registered, then requesting the crop group will count as one additional use.
All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.
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 additional 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.
Amendment applications to add new use(s) to registered product labels are covered by the base fee for this category as long as they are all submitted in the same package. Each application for a new product and/or new inert approval submitted in this package, however, is subject to its own registration service fee. The only exception would be if the new use(s) were to be added only to a new product (no amendments to registered product labels in the application package) in which case the review of the one new product application would be covered by the base fee for the new uses.
Any new product or amendment to the proposed labeling, which contains the same new use(s), that is submitted subsequent to the submission of the new use application but prior to its decision review time expiration date, will be deemed a separate new use application subject to a separate fee and new decision review time. Any other information not requested or required by the Agency, that is submitted by the applicant to support the new use(s) application, which is received 21 days or more after the original application, will be assessed 25% of the full registration service fee for the new use(s) application.
Finally, if the new use(s) application include non-food (indoor and/or outdoor) and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use, and the longest decision review time applies to all of the new uses requested in the application.
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