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 CHE MICA L SAF ETY AND P O L LUT I ON 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 va

rieties 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 ass ociated 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 ofthe 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 ofthe 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 a s late potato blight)
. The EUP is authorized o nly 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 effi cacy and specificity ofthe transgenes, evaluation of agronomic performance and optimization, production of sample material for environmental risk assessme nt, 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 of40 CFR Part 172. The EPA reviewed the health and environmental safety ofVNT l protein and has determined that adverse effects are not expected to man and nontarget organisms, including federally listed threatened and endangered s pecies, as a result ofthe experiments to be performed under this EUP. Any pesticide treatments (e.g., herbicides ) ofthe plants under the EUP must have app li cable registration s . The Section G review ofthis EUP is enclosed (US EPAJBPPD review from K. Martin to K. Haymes, 02/03 11 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 ofthis Federal permitdoes 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 ofthe States in which you will conduct your experimental program ofthe specific testing program (when, where, how much, etc.). Failure to do so may result in revocation or modification ofthis EUP. You must comply with all requirements ofthe U SDNAPHIS as they apply to the proposed testing. You must provide notice to the State pesticide regulatory agency at least 72 hours before you u se the EUP. You must also provide a copy ofthis authorization letter and stamped label , as well as the non-confide ntial 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 ofthis 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 amo unt of seed potatoes and protein expected to be used in each state. The amount of seed pota toes is calculated by multiplying the acres by the planting density (i.e., 2 , 500 lb/A). The maximum amount ofYNTI protein is the product o f the amount of seed potatoes (pounds ) and the protein percent expres s io n ( see U S EPNBPPD review from K. Martin to to K. Haymes, 02/03 / 15)
.The amount (pound s) of seed potatoes expected to be planted in the following I 0 states over the duration ofthe EUP shall not exceed the amount in Table I. Table 1. Acreage, Amount of Seed potatoes, and Maximum Amount of Protein by Sta te Acres Amt of PIP Material Sta tes PIP Non

-PIP lb PIP Potato Lb g. AI Seed Florida 5
.00 2.0 12 , 500 0.000375 0
. 1 70 Ida ho 45.25 9.0 1 13 , I25 0
. 00339 1.54 Michigan 62.75 25.1 156 , 875 0
. 0047I 2.I3 Minnesota I5.00 6 37 , 500 O.OOI I 3 0.510 Nebraska 1 ,000.00 400 2 , 500 ,000 0.0750 34.02 Ne vada 10.00 4 25 , 000 0.0007 50 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 Or egon 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 Wi sconsin 55
. 00 22.0 I37 , 500 0.004 13 1.87 TOTAL 1 ,285
.25 505 3 ,213,125 0.0964 43.72
2. J.R. Simplot Company is propos i ng 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 max imum amount of protein for each trial , according to these protocol s, are provided in Table 2.



### 2Table 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 beari ng 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 mu st 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 solel y for commercial seed increase are prohibited. 8. J.R. Simplot Company must follow the containment procedures described in th e Section G for the EUP (see MRID# 494416-01 and the amended submissions) to ensure no contamination ofthe human and an imal food supp ly by the VNTI protein or genet ic material. 

### 3Should you have questions or concerns regarding the issuance ofthis 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.

Enclo s ure s (s tamped label) Sincerely,

Kimberly Nesci, Chief, Microbial Pesticides Branch Biopesticide and Pollution Prevention Division
.



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