B640 PRIA Fee Category

PRIA 3 Fee Determination Decision Tree:

Amend Biopesticide Biochemical/Microbial New Use Registration


Below is the fee for your selected Fee Category for Fiscal Years 2016/2017

Action Code Description FY16/17 Fee Decision Time (months)
B640 First food use; petition to establish tolerance (2) $ 19,146 19

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

Waiver Pay Amount
50% waiver You pay ---->>>>> $ 9,573
75% waiver You pay ---->>>>> $ 4,787

To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.

How to submit your application directly to EPA.

Action Code Interpretation

An application for registration of a new use for a microbial or biochemical pesticide where there is a reasonable expectation or certainty that residues of the active ingredient could occur in human food, animal feed, or in livestock from the proposed use. The first food use requires the applicant to submit a petition to establish a tolerance for the active ingredient for the proposed use, and to submit data to demonstrate that dietary exposures to residues of the active ingredient at the tolerance level meet the FFDCA standard of reasonable certainty of no harm.

All uses included in any original application or petition for a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that 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 product containing the same active ingredient or an amendment to the proposed labeling 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.

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