Matthew Pence, Ph.D. 

Regulatory Manager 

J .R. Sim plot Company 

5369 West Irving Street 

Boise, ID 83 706 

UNITED ST ATES ENVIRONMENT AL PROTECTION 

AGENCY 

WASHINGTON , D.C 20460 

DEC 17 2015 

OFFICE OF CHEMICAL SAFETY 

AND POLL1JTION PREVENTION 

Subject: Amendment to the Experimental Use Perm it for VNT I. protein and the genetic material (Rpi-vntl gene 

from plasmid pSIM 1678J necessary for its production in InnateTM 2.0 branded potato varieti es for 

research on resistance to Phytophlora infestans (commonly known as late potato blight). 

EPA Experimental Use Permit No. 891 7-EUP-2 

Application Dated: June 30. 20 15 , Effective Dates: From the stamped date through Apri l I. 20 17 (incl udes planting a nd associated activ ities 

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

Quantity Authorized: 13,000.000 pounds of seed potatoes containing 0.390 pound (3.90E-01 ) lb. Vnt l 

protein (see Table 2). 

Acres: 5.576 acres total. including 5.200 acresRpi-vntl Pl a nt Incorporated Protectant and 376 maximum 

border acreage of control or othe r non-transformed potatoes. 

Dear Dr. Pence: 

On the basis of the information furnished by the applicant, the U .S. Environmental Protection Agency (EPA) 

hereby amends the subject Experimental Use Perm it (EU P) under section 5 of the Federal Insecticide, Fungicide, 

and Rodenticide Act to test a Plant Incorporated Protectant (Pl P) expressing the YNTI protein and the genetic 

materia l (Rpi-vntl gene from plasm id pSIM 1678) necessaly for its production in InnateTM 2.0 branded potato 

varieties. This EU P is being conducted for research on resistance to Phytophtora infestans (commonly known as late 

potato blight). Amendment s to the EU P are being made to increase the approved acreage and effective dates of the 

penn it. Th is amended EU P is authorized only in the States of Arizona (AZ), California (CA), Colorado (CO), 

Florida (FL). Hawaii (H I), Idaho (ID), Illinois (IL), Indiana (IN), Kansas (KS), Maine (ME), Michigan (Ml), 

Minnesota (MN), Missouri (MO), Nebraska (NE),Neva da (NY). New Mexico (NM). New York (NY), North 

Carol ina (NC), North Dakota (ND), Oregon (OR). Pennsylvania (PA), South Carolina (SC), Texas (TX), Utah 

(UT). Washington (WA) and Wisconsin (WT). lt a llows line selection trials. testing the efficacy and specificity of 

the transgenes, evaluation of agronomic performance and optimi zati on, production of sampl e material for 

environmenta l risk assessment, compositi on studies. and to test the comrnerc i a l viability of experi me nta l PIP 

events and assess appropriate fungicide programs. 

Shipment and use under this perm it are subject to the prov isions of 40 CFR Pait 172. The EPA reviewed the 

health and environ mental safety of VNT I protein and has determined that adverse effects are not expected to 

humans and non target organism s. including federally listed threatened and endangered species, as a result of the 

experiments to be performed under this EUP. 

Any pesticides (e.g., herbi c ides) used to treat the plants under the EU P must have applicable registration s. The 

Section G review of this EU P is enclosed (US EPA/BPPD review from K . Martin to K . Haymes, 9/21 /15). 
Prior to shipment and/or use of the subj ect PIP potato, yo u mu st consult with th e pe stic ide regulatory 

offi ci als a nd. if applicable. the biotechnology regul atory offi cials of the States in whi ch you wi ll conduct 

your experimental program, and obta in a State permit or license if such is required. Issuance of this Federal 

perm it does not negate the need for permission from indi vidual States. Prior to initiating this experimental 

program in any State, you a re required to notify the lead Agency of the States in whi ch you will condu ct 

your expe rim en tal program of the specific testing program (when. whe re, how much, etc.). Fai lure to do so 

may result in revocati on or modification of this EU P. You must com ply with a ll requirements of the 

USDA/APH IS as they appl y to the proposed testin g. 

You mu st provide notice to the State pesti c ide regul atory agency at least 72 hours before you use the EU P. 

Yo u must also prov ide a copy of this authorization letter and stamped label, as we ) 1 as th e non-confidential 

pottion of the Section G Experimental Program, to a ll cooperators. parti cipants and users pri or to the initia l 

pesticide use made in accordance with"the EU P. The EPA wil l notify the rel evant EPA Regions of th e 

approval of this EU P by sending copi es oftbis approval letter to them. 

Conditi ons under whi ch the EPA is issuing this EU P are as fo llows: 

I. The total acreage and amount of Pl P seed potatoes to be u sed shall not exceed the quantity authorized by 

this EU P: 5,576 acres. including 5.200 acres ofVNTI Plant Incorporated Protectant and 376 max im um 

border acreage of contro l or other non-tran sformed potatoes (see Table I). The acreage of seed potatoes 

planted in the fo llowing 26 states over the duration of the EUP sha ll not exceed the amount in Tabl e 1. 

Table 1. Proposed Acreage Distribution among the 26 States 

State PIP Non PIP Total 

AZ: 10 5 15 

CA: 50 10 60 

CO: IO 5 15 

Fl: 50 10 60 

HI: IO 1 11 

ID: 700 50 750 

IL: 10 5 LS 

IN: 10 5 15 

KS: 10 5 15 

ME: 30 5 35 

M l: 600 50 650 

A1N: 300 15 315 

MO: 50 5 55 

NC: 50 l O 60 

ND: 130 10 140 

NE: 800 50 850 

NM : 10 5 15 

NV: 400 10 410 

NY: 50 5 55 

OR: 400 10 41 0 

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State PIP Non PIP Total 

PA: 30 5 35 

SC: 10 5 15 

TX: 50 10 60 

UT: 700 50 750 

WA: 130 10 140 

WI: 600 25 625 

TOTA L: 5,200 376 5,576 

2. J.R. Simpl ot Company is propos.ing to use three protocols, as described in the enc losed BPPD review of 

t he Section G experimental program (9/2 1 /20 15). The number ofac res, amount of potato seed, and m 

maxi mum amount of prote in fo r each tria I, according to these protocols, are prov ided in Tabl e 2. The 

amount of seed potatoes is calcul ated by multip lying the acres by th e pl antin g density (i.e., 2,500 lb/ A). 

The max imum amount of VNTl prote in is the produ ct of the amoun t of seed potatoes (pounds) and the 

prote in percent expression (see US EPA BPPD rev iew from K . Martin to K. Haymes, 09/21/15). 

Table 2. Experimental Protocol: Acres and Amount of PIP Prote in (l b, gram s) 

Acres Amoun t of PIP Material 

Protocol 

PIP NON-P IP Lb a 

e,· 

Research and Deve lopment 15 10 l.13E-03 0.51 

Regul atory 35 20 2.63E-03 1. 19 

Agronomy Optimi zation 5.150 346 3.86E-Ol 175.20 

TOTAL 5,200 376 3.90E-Ol 176.90 

3. J.R. Simplot Company wi ll immedi ate ly notify the EPA ofany fi ndings from the expe rimenta l uses 

that have a bearing on safety (i.e .. EPA req uires reporting of any adve rse effects from the use of, or 

exposu re to, the pesticide). J.R. Simplot Company will also keep records of produ ction, d istribution 

and perfo rmance, and ma ke the records available on request to any authorized officer or empl oyee of 

the Environmental Protection Agency. 

4. J.R. Sim pl ot Company must prov ide a fin a l repoti within 180 days of the expiration of the permit. 

The fi nal repo11 must in c lu de all of the items set fo11h in 40 CFR 172.S( b) and report on t he 

fo ll owin g information: 

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A State-by-State breakdown of actual acreage per protocol: 

A State-by-State breakdown of actua l locations per protocol; 

Any changes to the stated program . incl uding 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 ava il ab le and prior to planting. J.R. Sim plot Company must record any 

changes to thi s informati on in an updated report and submit that repo ll prior to plant in_g. 

6. The label submitted in connection with this application is acceptab le and must accompany a ll 

shipments of potato seed under this EU P subs~quent to receivin g this approval. Labe ls must also 

be in the possession of the user at the time of planti ng. A stamped copy is enc losed for your 

records. 

7. This EUP is not a limited seed increas,e registration under section 3 of FIFRA, and planti ngs 

solely for commercial seed increase are prohi bited. 

8. J.R. Simplot Company mu st fol low the containment proced ures desc ri bed in the Section G (dated 

August 26, 2015) for the EU P. 

Should you have questions or concerns regarding the issua nce of this perm it. please contact Dr. Kenneth 

Haymes. of the Biopesticides and Po llution Prevention Di vision. by ema il at haymes.kenneth a epa.gov 

or by phone (703) 347-0398. 

Sincereh. 

Enclosures: EPA Section G review and stamped labe l 

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