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Registration Service Fees
Questions on Biopesticides
Resources
Questions and Answers on:Current as of October 2007
- 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 a PIP.
1. Please provide some clarification between registration service fees for a protein versus an active ingredient.
A protein may be an active ingredient. Many of these are plant-incorporated protectants (PIPs), but not all of them. A protein might also be an inert in a product. There are some inerts 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.
2. For a PIP, what is the timeline from the first experimental use permit (EUP) to commercial registration?
If the EUP is submitted separately from the section 3 application, the timeline will depend upon when the section 3 application is submitted to the Agency. If the EUP and the section 3 applications are submitted simultaneously and the Agency determines that a meeting of the FIFRA Scientific Advisory Panel is not needed, the current decision time review period is 21 months. In this same situation, if an SAP meeting is necessary, the current decision time review period is 24 months.
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.