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
|R180||Additional Food Use; Reduced Risk(3) (4)||$ 59,976||10|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 29,988|
|75% waiver||You pay ---->>>>>||$ 14,994|
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 food use. Additional food use includes a proposed food use for any U. S. registered active ingredient for which there currently is a registered food use. The use requires the establishment of, or 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). A different pattern of use that significantly changes or increases exposure such as a dosage rate increase or different method of application will result in the application being treated as a new use. 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. The fee applies to each additional food use requested up to 5 uses (i.e. the fee for this category is multiplied by 4 if 4 uses are proposed). If six or more additional food uses are requested in the application, fee category R200 applies. 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. Some unusual examples of outdoor uses are livestock uses, (i.e. ear tags), livestock dips, and feed through treatments of livestock.
A “reduced risk” 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( c)(10) (B) (-iv), whether the requested use(s) qualify as “reduced risk” when compared to currently registered pesticides for the same use(s). In the event that any uses do not qualify as reduced risk, the application will not receive the reduced risk decision timeframes. 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 R170, and the action will receive the R170 decision review timeframe.
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 2 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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