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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

Action Code Description FY14/15
Fee
Decision Time
(months)
A528 Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2) $ 21,273 15

Do you plan to request either of the following types of waivers?


50% waiver You pay ---->>>>> $ 10,637  
75% waiver You pay ---->>>>> $ 5,319  

To pay the fee shown above, go to http://www.pay.gov and follow the instructions.

How to submit your application directly to EPA.


Action Code Interpretation
Experimental Use Permit (EUP) application for a new food use(s) for any U. S. registered active ingredient that is currently not registered for the proposed 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). Increases in exposure such as a dosage rate increase or different method of application that will result in a temporary tolerance increase belong to this category.

Examples of food uses could include:

  • Pre- and post-harvest use on crops (other than agricultural fungicides and aquatic herbicides, which are handled as conventional pesticides).
  • Animal drinking water treatment (meat, meat by-products and/or milk tolerance exemption)
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers and disinfectants)
  • Use in the production of food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article (conveyor belt - claims to kill bacteria that are on articles that come in contact with belt or a lubricant with claims that the lubricant kills bacteria)
  • Treatment of raw agricultural commodities in a food processing facility (FDA food additive regulation)
  • Process water treatment in a food handling facility to control a pest in the water (FDA food additive regulation-EPA dietary risk assessment)

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 experimental use permit. 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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