UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

FEB 0 It 2015 

Tracy Rood, Senior Regulatory Manager 

J.R. Simplot Company 

5369 West Irving Street 

Boise, ID 83 706 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Plant Incorporated Protectant (PIP) with the VNTl protein and the genetic material (Rpi-vntl 

gene from plasmid pSIM 1678) necessary for its production in InnateTM 2.0 branded potato 

varieties for research on resistance to Phytophtora infestans (commonly known as late potato 

blight). 

EPA Experimental Use Permit No. 8917-EUP-2 

Application Dated: February 9, 2015 

Effective Dates: From the stamped date through December 31, 2015 (includes planting and associated 

activities e.g., collection of field data, harvesting, processing). 

Quantity Authorized: 3,213,125 pounds of seed potatoes containing 0.0964 pound (9.64xl0·

3 tb. Vntl 

protein (see Table 1). 

Acres: 1285.25 acres, including Rpi-vntl Plant Incorporated Protectant and 505 maximum border 

acreage of control or other non-transformed potatoes. 

Dear Ms. Rood: 

On the basis of the information furnished by the applicant and the annexed program, the U.S. Environmental 

Protection Agency (EPA) hereby issues the subject Experimental Use Permit (EUP) under section 5 of the Federal 

Insecticide, Fungicide, and Rodenticide Act to test the Plant Incorporated Protectant (PIP) with the VNTl protein 

and the genetic material (Rpi-vntl gene from plasmid pSIM 1678) necessary for its production in InnateTM 2.0 

branded potato varieties for research on resistance to Phytophtora infestans (commonly known as late potato 

blight). The EUP is authorized only in the States of Florida (FL), Idaho (ID), Michigan (MI), Minnesota (MN) 

Nebraska (NE), Nevada (NV), New York (NY), North Carolina (NC), North Dakota (ND), Oregon (OR), 

Pennsylvania (PA), Washington (WA) and Wisconsin (WI). It allows line selection trials, testing the efficacy and 

specificity of the transgenes, evaluation of agronomic performance and optimization, production of sample 

material for environmental risk assessment, and composition studies and to test the commercial viability of 

experimental PIP events and assess appropriate fungicide programs. 

Shipment and use under this permit are subject to the provisions of 40 CFR Part 172. The EPA reviewed the 

health and environmental safety ofVNTl protein and has determined that adverse effects are not expected to man 

and nontarget organisms, including federally listed threatened and endangered species, as a result of the 

experiments to be performed under this EUP. 

Any pesticide treatments (e.g., herbicides) of the plants under the EUP must have applicable registrations. The 

Section G review ofthis EUP is enclosed (US EPAJBPPD review from K. Martin to K. Haymes, 02/0311 5). 

Prior to shipment and/or use of the subject PIP potato, you must consult with the pesticide regulatory officials 

and, if applicable, the biotechnology regulatory officials of the States in which you will conduct your 

experimental program, and obtain a State permit or license if such is required. Issuance of this Federal permit 
does not negate the need for permission from individual States. Prior to initiating this experimental program in 

any State, you are required to notify the lead Agency of the States in which you will conduct your experimental 

program of the specific testing program (when, where, how much, etc.). Failure to do so may result in revocation 

or modification of this EUP. You must comply with all requirements ofthe USDNAPHIS as they apply to the 

proposed testing. 

You must provide notice to the State pesticide regulatory agency at least 72 hours before you use the EUP. You 

must also provide a copy of this authorization letter and stamped label, as well as the non-confidential portion of 

the Section G Experimental Program, to all cooperators, participants and users prior to the initial pesticide use 

made in accordance with the EUP. The EPA will notify the relevant EPA Regions of the approval of this EUP by 

sending copies of this approval letter to them. 

Conditions under which the EPA is issuing this EUP are as follows: 

I. The total acreage and amount of PIP seed potatoes to be used shall not exceed the quantity authorized by this 

EUP: 1285.25 acres, including YNTI Plant Incorporated Protectant and 505 maximum border acreage of 

control or other non-transformed potatoes (see Table I). The table also shows the amount of seed potatoes and 

protein expected to be used in each state. The amount of seed potatoes is calculated by multiplying the acres 

by the planting density (i.e., 2,500 lb/A). The maximum amount ofYNTI protein is the product of the 

amount of seed potatoes (pounds) and the protein percent expression (see US EPNBPPD review from K. 

Martin to to K. Haymes, 02/03/15).The amount (pounds) of seed potatoes expected to be planted in the 

following I 0 states over the duration of the EUP shall not exceed the amount in Table I. 

Table 1. Acreage, Amount of Seed potatoes, and Maximum Amount of Protein by State 

Acres Amt of PIP Material 

States PIP Non-PIP lb PIP Potato Lb g. AI Seed 

Florida 5.00 2.0 12,500 0.000375 0.170 

Idaho 45.25 9.0 113,I25 0.00339 1.54 

Michigan 62.75 25.1 156,875 0.0047I 2.I3 

Minnesota I5.00 6 37,500 O.OOI I3 0.510 

Nebraska 1,000.00 400 2,500,000 0.0750 34.02 

Nevada 10.00 4 25,000 0.000750 0.340 

New York 2.00 0.8 5,000 0.000150 0.0680 

North Carolina 2.00 0.8 5,000 0.000150 0.0680 

North Dakota 16.50 6.6 41,250 O.OO I24 0.561 

Oregon 53.00 2I.2 . I32,500 0.00398 1.80 

Pennsylvania 7.75 3.I 19,375 0.00058I 0.264 

Washington 11.00 4.4 27,500 0.000825 0.374 

Wisconsin 55.00 22.0 I37,500 0.00413 1.87 

TOTAL 1,285.25 505 3,213,125 0.0964 43.72 

2. J.R. Simplot Company is proposing to use five protocols, as described in the enclosed BPPD K. Martin 

review of 02/03/20 I5. The number of acres, amount of potato seed, and maximum amount of protein for each 

trial, according to these protocols, are provided in Table 2. 

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Table 2. By Protocol: Acres, Amount of Potato Seed (lb), and Amount of PIP Protein (lb, grams) 

Acres: Amount of PIP Material 

Protocol PIP NON-PIP lb PIP 

Potato Seed Lb g. 

1.0 Rpi-vntl Late Blight Line 6.00 2.40 15,000 0.000450 0.204 

Selection Line Selection 

2.0 Rpi-vntl Late Blight Efficacy 0.750 0.200 1,875 0.0000563 0.0255 and Specificity 

3.0 Rpi-vntl Late Blight 

Environmental 3.50 I.40 8,750 0.000263 0.119 

Risk Assessment and Composition 

4.0 Rpi-vntl Late Blight 1,179.00 476 2,947,500 0.0884 40.11 Agronomy Optimization 

5.0 Rpi-vntl Late Blight 96.00 25.0 240,000 0.00720 3.27 Demonstration 

TOTAL 1,285.25 505.00 3,213,125 0.0964 43.72 

3. J.R. Simplot Company will immediately notify the EPA of any findings from the experimental uses that 

have a bearing on safety (i.e., EPA requires reporting of any adverse effects from the use of, or exposure 

to, the pesticide). J .R. Simp lot Company will also keep records of production, distribution and 

performance, and make the records available on request to any authorized officer or employee of the 

Environmental Protection Agency. 

4. J.R. Simplot Company must provide a final report within 180 days of the expiration ofthe permit. The 

final report must include all ofthe items set forth in 40 CFR 172.8(b) and report on the following 

information: 

• A State-by-State breakdown of actual acreage per protocol; 

• A State-by-State breakdown of actual locations per protocol; 

• Any changes to the stated program, including approved changes to study protocols; 

• A list of specific counties where studies took place. 

5. Per 40 CFR 172.4(b)(v), J.R. Simplot Company must provide the name(s) and street address(es) of all 

cooperators as soon as available and prior to planting. J.R. Simplot Company must record any changes to 

this information in an updated report and submit that report prior to planting. 

6. The label submitted in connection with this application is acceptable and must accompany all shipments 

of potato seed under this EUP subsequent to receiving this approval. Labels must also be in the 

possession of the user at the time of application. A stamped copy is enclosed for your records. 

7. This EUP is not a limited seed increase registration under section 3 ofFIFRA, and plantings solely for 

commercial seed increase are prohibited. 

8. J.R. Simplot Company must follow the containment procedures described in the Section G for the EUP 

(see MRID# 494416-01 and the amended submissions) to ensure no contamination ofthe human and 

animal food supply by the VNTI protein or genetic material. 

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Should you have questions or concerns regarding the issuance of this permit, please contact Dr. Kenneth Haymes, 

of the Biopesticides and Pollution Prevention Division, by email at haymes.kenneth@epa.gov or by phone (703) 

347-0398. 

Enclosures (stamped label) 

Sincerely, 

Kimberly Nesci, Chief, Microbial Pesticides Branch 

Biopesticide and Pollution Prevention Division. 

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