Plant-Incorporated Protectant EUPs - Preliminary Guidance

This document provides guidance on EPA requirements for field tests of biotechnology-derived crop plants which contain plant-incorporated protectants (PIPs). Embedded throughout this document are links to EPA forms and actual application examples in the public record. PIPs are pesticidal substances and the genetic material necessary to produce the substance when produced and used in living plants. These pesticidal substances (usually proteins) and their genetic material are regulated as pesticides by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetics Act (FFDCA).

Experimental Use Permits (EUPs) are issued under FIFRA section 5 to allow prospective registrants to generate information or data necessary to register a pesticide under section 3 of FIFRA. 40 CFR Part 172 contains detailed information on EUPs.

When Are EUPs Required?

EUPs are required for PIPs tested on a cumulative total of over 10 acres and/or when insufficient containment is present to prevent the PIP from entering food and feed supplies [40 CFR 172.3(c)]. EUPs are generally not required for laboratory or greenhouse tests [40 CFR 172.3(b)(1)]. Limited replicated field trials on a cumulative total of less than 10 acres do not require an EUP provided that a tolerance or exemption from a tolerance has been established for the PIP or adequate containment is in place to prevent the PIP from entering the food and feed supply [40 CFR 172.3(c)(1)(ii)]. The crop can be destroyed or fed to experimental animals also, but the pesticide must not end up in any food or feed intended for general consumption. These are the same regulations that apply to all other pesticides except pheromones.

Tolerance Exemption or Containment of PIP and PIP Pollen

For synthetic pesticides, the Agency may waive the requirement to establish a tolerance or tolerance exemption for an experimental pesticide if the applicant can guarantee that all food and feed commodities produced in the field test will be prevented from entering commerce (destroyed, fed to experimental animals, or held for future testing).

For PIPs, containment is more difficult. The harvested crop must not enter commerce and outcrossing of PIP pollen to surrounding crops must be prevented. Without a tolerance or tolerance exemption, prevention of outcrossing is necessary regardless of the acreage being tested in the field. The requirement is the same whether the test is 0.5 acres or 5000 acres. PIP containing food or feed is adulterated when there is no tolerance or tolerance exemption and is subject to seizure by the Food and Drug Administration.

For PIPs in food or feed crops, the Agency will only issue a PIP EUP if the applicant obtains a temporary tolerance under the FFDCA for residues of PIPs in food and feed commodities, the or adequate containment has been demonstrated including destruction of the crop before pollen is produced. EPA has allowed registrants to hold some seed for future testing and product development and the crop can be fed to experimental animals as long as they do not end up in the food supply.

Example- Petition Notice of Filing FR (PDF) (4 pp, 48 k, about PDF),
Example- Tolerance Petition (PDF) (18 pp, 703 k, about PDF),
Example- Temp Tolerance Final Rule FR (PDF) (6 pp, 59 k, about PDF),
Template- Petition Notice of Filing (PDF) (3 pp, 11 k, about PDF)

Transparency

The Agency maintains a transparent and interactive review process for its PIP EUP decisions and endeavors to involve all stakeholders--the manufacturers, the growers, and the public--to provide the public with confidence in EPA's regulatory decisions and provide U.S. farmers with the tools they need to continue to produce a safe and healthy food supply.

All PIP EUP application receipts and all EPA decisions to issue PIP EUPs are published in the Federal Register and public comment is received and considered. Electronic versions of the public dockets associated with these FR notices are available through EPA's electronic public docket and comment system, EPA Dockets, https://www.epa.gov/edocket.

Example- EUP FR Notice of Issuance (PDF) (2 pp, 39 k, about PDF)
Example- EUP FR Notice of Receipt (PDF)S (4 pp, 50 k, about PDF)

EUP applicants must classify each document that they submit according to the following.

"A" Non-Confidential documents releasable to anyone.

"B" Health & Safety Data (studies) documents releasable to persons who are able to sign Affirmation of Non-multinational Status form expressed in FIFRA section 10(g).

"C" Confidential documents claimed by the submitter. Requests for “C” documents will be processed under the Freedom of Information Act and EPA’s public information regulations at 40 CFR Part 2, subpart B.

Example- Classification Ltr

Unique PIP Confidentiality Requirements

As stated in 40 CFR Part 174.9 (Confidential business information claims for plant-incorporated protectant submissions), EPA will consider incomplete all plant-incorporated protectant submissions containing information claimed as CBI that are not accompanied by substantiation, and will suspend any applicable review of such submissions until the required substantiation is provided.

Seed Increase

Plantings solely for commercial seed increase are prohibited under an experimental use permit. In such cases, a limited seed increase registration under section 3 of FIFRA is required.

Application Contents

PIP EUP applications must contain or address the following:

Application for Experimental Use Permit, EPA Form 8570-17. Example- EUP Application Form (PDF) (1 pp, 574 k, about PDF), Form- EUP Application (2 pp, 241 k, about PDF)

A cover letter which contains the applicants classification of each document submitted as either “A,” “B,” or “C” as mentioned above. Example- Classification Ltr (PDF) (5 pp, 107 mb, about PDF)

Although not required, a compact disk containing electronic PDF files of all documents classified as “A” will significantly aid the Agency in making these available through e-docket. These documents must be loaded in e-docket by BPPD prior to publication of the Federal Register notice of receipt.

Purpose or objectives of proposed testing and a description in detail of the proposed experimental program (Section G). Applicants must indicate the states in which the proposed program will be conducted. Justification for the acreage requested is helpful. A table should be included which indicates the states to which the product is to be shipped, the acreage to be planted per state, along with the total pounds of PIP protein to be shipped. Another table indicating acreage to be planted by experiment should also be included.
Example- EUP Section G(PDF) (19 pp, 333 k, about PDF)

The name, street address, telephone number, and qualifications of all participants in the program (whether or not in the employ of the applicant) and and the manner in which supervision of the program will be accomplished. A participant is any person acting as a representative of the permittee and responsible for making available for use, or supervising the use or evaluation of an experimental pesticide to be applied at a specific application site. All participants must be designated prior to issuance of the permit. To change the participant requires amendment of the permit.

The name and street address of all cooperators, if available at the time the application is submitted or as soon as possible thereafter. Cooperators are persons who grant permission for an experimental use pesticide to be used on application sites which they own or control. Cooperator information must be provided prior to planting and in the final report. However, the permittee need not wait for Agency approval to change or add cooperators.

Information on prior testing - a description and the specific results of any appropriate prior
testing of the product conducted by the applicant to determine, (a) toxicity and effects in or on
any target organisms at the site of application, and (b) any forms of toxicity or effects on nontarget plants, animals and insects, at or near the site of application, or (c) any adverse effects on the environment.

The proposed method of storage and disposition of any unused and planted crops subject to the EUP.

Completed Confidential Statement of Formula, EPA Form 8570-4. Ranges of the PIP and PIP inert ingredient must be provided on a dry weight basis as a percentage of plant protein for the whole plant and for each plant organ, i.e. pollen, leaf, root, stem, grain or fruit. Form- CSF (PDF) (2 pp, 178 k, about PDF)

Supporting data and data matrix. Submitted data (3 copies) must be bound and formatted in accordance with the requirements of PR Notice 86-5. Example- EUP Data Matrix (PDF) (5 pp, 2.76 mb, about PDF), Form- Data Matrix (PDF) (3 pp, 69 k, about PDF)

UP label. All biotechnology-derived crop plants which contain PIPs shipped or used under an experimental use permit must be labeled (i.e. have the label on the bag of seeds during shipment and be in the possession of participants). The ingredient statement on PIP EUP labels should reflect the whole plant percentage on a dry weight basis. The CSF and label must agree. The inert marker need not be identified by name, but it’s percentage on a whole plant basis must be listed. The active and inert PIP ingredients do not need to add up to 100%. The label must also indicate the establishment registration number, except in those cases where application of the pesticide is made solely by the producer. S

Example- EUP Label (PDF) (2 pp, 112 k , about PDF)

Approval

Example- EUP Issuance Ltr (PDF) (3 pp, 23 k , about PDF)

Post Federal Approval

Reporting Requirements

The permittee must provide a final report within180 days of the expiration of the permit. The final report must include all of the items set forth in 40 CFR ' 172.8(b).

State Notification and Approval

Prior to shipment and/or use of the PIP containing crop, permittes must consult with the pesticide regulatory officials and, if applicable, the biotechnology regulatory officials of the State(s) in which their experimental program will be conducted, and obtain a State permit or license if such is required.

Distribution and Sale

Pesticides under experimental use permits may not be sold or distributed other than through participants in the approved experimental use program. They may not be advertised for sale. They may only be used at the application site of a cooperator in the program, and only in accordance with the terms and conditions of the experimental use permit.

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