Registration Service Fees
Questions on Biopesticides
Current as of September 2012
- Please provide some clarification between registration
service fees for a protein versus an active ingredient
- For a PIP, what is the timeline from the first experimental
use permit (EUP) to commercial registration?
- Please explain the timing of scheduling and holding meetings
of the FIFRA Scientific Advisory Panel (SAP), the issuance of the SAP
final report, and how this impacts the decision time review period for
- What is the fee for a stacked PIP product?
A protein may be an active ingredient. Many of these are plant-incorporated protectants (PIPs), but not all of them are. A protein might also be an inert ingredient in a product. There are some inert ingredients associated with genetic engineering, but certainly some that are not just associated with PIPs or at least the protein is a major part of the active (i.e., milk whey). The fee schedule is based on active ingredients and not on the chemical class of the substance.
There are various possible scenarios that would affect the amount of time to commercial registration -- whether or not the EUP requires review by the FIFRA Scientific Advisory Panel, how soon after completion of the EUP the section 3 application is submitted, whether or not the section 3 application needs an SAP review. See Table 17 of the PRIA 3 Fee Table for the various PIP EUP and new PIP categories with their corresponding decision review times and fees.
3. Please explain the timing of scheduling and holding meetings of the FIFRA Scientific Advisory Panel (SAP), the issuance of the SAP final report, and how this impacts the decision time review period for a PIP.
The Agency has interpreted the time frames specified in PRIA to include all of the steps necessary to complete its review of an application for a PIP. In this instance, all of the steps involved in preparing for, holding, and awaiting the report of the SAP will be completed within the decision time review period.
Each PIP in a stacked product is a separate active ingredient and the fee will be based on the status of each PIP. For example: if a product that is the subject of an application contains two PIPs that are currently not contained in a registered product, the fee is twice the new active ingredient fee (if the application is for three PIPs, the fee is three times the new active ingredient fee, and so on). If the data for one PIP in the stack, however, supports the other new PIP in the stack and the applicant wants to request a discretionary refund per FIFRA Section 33(b)(8)(C) to take into account the decreased level of Agency work required to review the data, a separate application must be submitted for each active ingredient. Each application should reference the other application(s) in the comments section of the application form and in the cover letter with a request for a discretionary refund(s). Decisions on a discretionary refund request for a PIP are generally made once the data have been reviewed. Applicants should pay the fee specified by the fee category when submitting an application and any refunds will be issued after the Agency has determined the amount of work required. Applicants are advised to discuss possible discretionary refunds for a specific stacked PIP during pre-submission meetings. Applicants may also contact the Chief of the Microbial Pesticide Branch prior to submitting.