Plant-Incorporated Protectant (PIP) Fee Issues
On this page:
- Clarification about registration service fees for a protein versus an active ingredient
- Timeline for PIPs from the first EUP to commercial registration
- Effects of the FIFRA SAP process on the review period for a PIP
- Stacked PIP product fees
The fee schedule is based on ingredients (active or inert) and not on the chemical class of the substance. A protein may be an active ingredient. Many but not all of these are plant-incorporated protectants (PIPs). A protein might also be an inert ingredient in a product. There are some inert ingredients associated with PIPs such as the marker protein phosphinothricin acetyltransferase, but some that are not (e.g., milk whey).
Various scenarios can affect the amount of time to commercial registration:
- Whether or not the EUP requires review by the FIFRA Scientific Advisory Panel (SAP).
- 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 4 Fee Table for the various PIP EUP and new PIP categories with their corresponding decision review times and fees.
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 and holding the meeting 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. 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 before submitting.