Tips for Plant-Incorporated Protectant (PIP) Experimental Use Permit (EUP) Program Submission
- Additions to a PIP EUP program submission
- Recommendations for calculating PIP EUP acreage
- Use of seed produced under PIP EUPs
- Consultation with the Biopesticides and Pollution Prevention Division
Additions to a PIP EUP Program Submission
EUP Program Descriptions
The regulations at 40 CFR 172.4 contain the content requirements for applications for experimental use permits (EUPs). The Pesticide Registration Manual, Chapter 12 also describes the EUP application process.
In addition to these requirements, EPA finds the following information helpful in evaluating EUP requests related to plant-incorporated protectants (PIP):
- Proposed studies (test protocols and objectives) to be conducted under the EUP.
- Maximum acreage per state (sum of all studies).
- Maximum acreage per study (sum of all states).
- Estimated acreage per state for each study.
- Estimated number of locations per state for each study.
- Where a year-over-year acreage increase is requested for one or more studies, a justification for such increase.
- A clear explanation of acreage calculation, including a breakdown of EUP acreage designated for PIP test plants, registered PIPs, non-PIP plants, and border rows included within experimental blocks.
EUP Final Program Report
In addition to the EUP reporting requirements found in 40 CFR 172.8, EPA finds the reporting of the following information helpful in the PIP context:
- a state-by-state breakdown of actual locations per study; and
- any changes to stated program including approved changes to study protocols.
Recommendations for Calculating PIP EUP Acreage
We recommend that calculations of PIP EUP acreage include all of the following:
- PIP test plants, including plants containing registered PIPs.
- Non-PIP plants used for breeding purposes.
- Non-PIP plants that are not intentional recipients of a PIP (e.g., isoline control plots).
- Associated border rows contained within the test block(s), including border rows which outline the perimeter of the test block(s).
Use of Seed Produced Under PIP EUPs
40 CFR 172.2 states that “any person wishing to accumulate information necessary to register [a pesticide] under section 3 of [FIFRA] … may apply … for an experimental use permit.” Further, “[p]esticides under experimental use permits may not be sold or distributed other than through participants.…”
EPA has interpreted this to mean that an EUP cannot be obtained for the purpose of producing seed for future commercial seed sales. Seed increase for the purpose of commercial sale is only permitted under FIFRA section 3 commercial registrations that expressly allow it. That said, seed production and increase is acceptable under a PIP EUP when it is for the sole purpose of generating the seed that will be used in the research, breeding, and other trials that will be undertaken in order to accumulate the information necessary to support a registration. In this context, the seed increase is viewed as being an integral part of the research, breeding, and other trials that will take place under the EUP.
When reviewing Section G EUP program submissions, EPA must be able to clearly identify how requested acreage contributes to the accumulation of information necessary to register a pesticide. Consequently, with regard to seed production via breeding trials, it is recommended that the submission contain a clear explanation of why such trials are necessary for product registration.
Consultation with the Biopesticides and Pollution Prevention Division
The Biopesticides and Pollution Prevention Division encourages any potential applicant for a PIP EUP to consult with the Division scientists and regulatory managers before submitting an application. A potential applicant can contact Mike Mendelsohn, (mendelsohn.mike@epa.gov) Branch Chief, Emerging Technologies Branch, at 202-566-2395.