UNITED STATES ENVIRQNMENTAL·.PROTECTION AGENCY 

WASHINGTON; D.c .· 20460 

September 21 , 2015 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: 

FROM: 

THROUGH: 

TO: 

EPA File Symbol 8917-EUP-2 (Rpi-vnt1 gene that expresses the VNT1 protein in 

InnateTM 2.0 branded potato varieties). Section G Acreage Calculation: Second 

Amendment 

EPA Reg. N2: 8917-EUP-2 

PC Code: 006355 

Company: J.R. Simplot 

MRID: None 

Decision N2: 506540 

DP N2: 428291 

Kathleen Martin, M.S.E.S.; Chemist,fr <1/'zf/ tS 

Microbial Pesticides Branch 

Biopesticides and Pollution Prevention Di14on~ 

Alan Reynolds, M.S.; Team Leader I I . Microbial Pesticides Branch 0£./L,, 

Biopesticides and Pollution Prevention Division 

Kenneth Haymes, Ph.D.; Regulatory Action Leader 

Microbial Pesticides Branch 

Biopesticides and Pollution Prevention Division 

In May 2014,the Agency issued an experimental use permit (EUP) to J.R. Simplot Company for 

the testing of a new plant-incorporated protectant (PIP) technology: the Rpi-vnt1 gene that expresses 

the VNT1 protein in Innate TM 2.0 branded potato varieties. Rpi-vnt1 gene confers resistance to 

Phytophthora infestans, an oomycete, which is the causal agent of Late Blight. Late Blight is known to 

be a major disease of potatoes in North America and throughout the world. 

In February 2015, the Agency amended the permit to add three states and increase the PIP 

acres from 96.75 to 1285.25. Simplot is now seeking to amend the permit a second time to add 5,200 

more acres and 26 states. Provided in the attached Data Evaluation Record are the section G 

calculations for this second amendment. The document includes summary information from the original 

permit and the first amendment. 
Data Evaluation Record 

Reviewed by: Kathleen Martin, M.S.E.sflJ''I/Jt/ q/1.t/ 15 

Secondary Review: Alan Reynolds, M.S. 

STUDY TYPE: Amended Section G acreage calculations for 8917-EUP-2 

TEST GUIDELINE: Not applicable 

MRID: NA 

DP BARCODE: 428291 

TEST MATERIAL: the Rpi-vnt1 gene that expresses the VNT1 protein in InnateTM 2.0 branded potato varieties 

SPONSOR: J.R. Simplot Company 

TESTING NA 

FACILITY: 

TITLE OF 2016 Experimental Use Permit 8917-EUP-G, Section G: pSIM1678 (containing Rpi-vnt1 ) 

REPORT: Transformed Potato. June 30, 2015. 11 pp. 

2016 Experimental Use Permit 8917-EUP-G, Section G: pSIM1678 (containing Rpi-vnt1) 

Transformed Potato. 16 pp. 

AUTHORS: Matthew Pence, Ph.D. 

SUBMISSION June 30, 2015 

DATES: August 26, 2015 

CONCLUSION: Acceptable 

CLASSIFICATION: Acceptable 

GOOD LAB 

PRACTICE: Not applicable 

BACKGROUND 

J.R. Simplot Company is seeking to amend its experimental use permit (EUP) for the testing of 

a new plant-incorporated protectant (PIP) technology: the Rpi-vnt1 gene that expresses the VNT1 

protein in Innate TM 2.0 branded potato varieties; they assert that this trait confers resistance to the plant 

pathogen Phytophthora infestans (commonly known as late blight). Briefly, the regulatory history 

of 8917-EUP-2 is: 

Original EUP. In January 2014, Simplot (2014) requested an EUP to test its PIP 

technology on about 100 acres in 10 states. 

First Amendment to EUP. The following January, Simplot (2015a) sought to amend the 

permit by adding about 1,300 more acres and three more states (for a total of 13). 

Second Amendment to EUP. Simplot (2015b,c) is now proposing to amend the permit a 

second time to add 5,200 more acres and 13 states (total of 26). 

Provided below is the Section G review for the 2nd amendment. For the Agency's Section G review for 

the original permit and the P 1 amendment, see U.S. EPA 2014 and 2015a. 

DER-2 
REVIEW1 

States and Acres. Table 1 illustrates the increasing number of states participating in the 

experimental trials. The original permit allowed testing to occur in 1 O states. Under the proposed 

amendment, a total of 26 states will be involved. Table 1 also provides a summary of the PIP acres. 

Table 2 shows the proposed PIP and nonPIP acreage for the 26 states while Table 3 parses this 

information by protocol. In total, Simplot is proposing to add 5,200 PIP acres and 376 nonPIP acres. 

Amount of PIP Material. Table 4 and Table 5 are detailed tables showing the number of PIP 

acres, pounds of PIP potato seed expected to be cultivated, and the amount of PIP material in the 

potato seed (in lb and kg); Table 4 provides the data by state while Table 5 shows it by protocol. The 

increased acres will amount to 13 million lb of PIP seed potato which will contain 0.39 lb of PIP protein. 

Table 4 and Table 5 compare the study parameters among the original permit, and the amendments. 

The calculations assume a planting density of 2,500 lb seed/acre and a PIP protein concentration of 

0.3 ppb. For more details regarding these calculations (including formulas), see the original permit and 

1st amendment reviews (U.S. EPA 2015a,b). 

Protocols. Simplot is conducting their investigation using Research and Development (R & D), 

Agronomy Optimization, and Regulatory protocols. For the original and 1st amendments, Simplot 

provided a detailed breakout of the R & D protocol (Simplot 2014, 2015a) while for the 2nd amendment, 

they grouped them (U.S. EPA 2015b). The following graphic illustrates this difference: 

2nd Amendment Protocols: Original and 151 Amendment Protocols: 

t

Rpi-vnt1 Late Blight Line Selection 

Research and Development Rpi-vnt1 Late Blight Efficacy and Specificity 

Rpi-vnf 1 Late Blight Demonstration 

Agronomy Optimization{ 4Rpi-vnt1 Late Blight Agronomy Optimization 

Regulatory{ Rpi-vnt1 Late Blight Environmental Risk Assessment and Composition 

CONCLUSION 

J.R Simplot is proposing to amend 8917-EUP-2 by doubling the number of states (from 13 to 

26) and adding a four-fold increase to their existing permitted acreage; two-thirds of the increase is 

from five states: Michigan, Idaho, Nebraska, Utah, and Wisconsin. In summary, Simplot intends to 

plant about 6,600 PIP acres containing 0.49 lb of PIP material over the course of their investigation. 

EPA agrees with Simplot's calculations and proposed additional acreage (PIP and nonPIP). 

Many of the states they are adding are geographically and climatologically different (e.g., Maine) from 

the states currently under the permit. This will provide Simplot with broader data with which to assess 

the their new plant-incorporated protectant (PIP) technology: the Rpi-vnt1 gene that expresses the 

VNT1 protein in InnateTM 2.0 branded potato varieties. 

1Note: Of the five tables below, three (Tables 1, 4, and 5) provide the corresponding data for the 

original permit and the two amendments. 

DER-3 
Table 1 Comparing States and Total PIP Acres Among 

the OriQinal and Amended Permits 

Original EUP 1 st Amendment 2nd Amendment 

Planting Period 

January to January to January 2016 

October, 2014 October, 2015 to April 2017 

States 

Idaho Idaho Idaho 

Michigan Michigan Michigan 

Nebraska Nebraska Nebraska 

New York New York New York 

North Carolina North Carolina North Carolina 

North Dakota North Dakota North Dakota 

Oregon Oregon Oregon 

Pennsylvania Pennsylvania Pennsylvania 

Washington Washington Washington 

Wisconsin Wisconsin Wisconsin 

Nevada Florida 

Florida Minnesota 

Minnesota Nevada 

Arizona 

California 

Colorado 

Hawaii 

Illinois 

Indiana 

Kansas 

Maine 

Missouri 

New Mexico 

South Carolina 

Texas 

Utah 

1 O states 13 states 26 states 

96.75 PIP acres 1,285.25 PIP acres 5,200 PIP acres 

DER-4 
DER-5 

Table 2 Acreage Distribution Among the 26 States 

AZ 

CA 

co 

FL 

HI 

ID 

IL 

IN 

KS 

ME 

Ml 

MN 

MO 

NC 

ND 

NE 

NM 

NV 

NY 

OR 

PA. 

SC 

TX. 

UT. 

WA. 

WI 

TOTAL: 

PIP 

10 

50 

10 

50 

10 

700 

10 

10 

10 

30 

600 

300 

50 

50 

130 

800 

10 

400 

50 

400 

30 

10 

50 

700 

130 

600 

5,200 

Table 3 Proposed Acre 

Research and Development. 

Agronomy Optimization. 

Regulatory. 

TOTAL: 

Non PIP Total 

5 15 

10 60 

5 15 

10 60 

1 11 

50 750 

5 15 

5 15 

5 15 

5 35 

50 650 

15 315 

5 55 

10 60 

10 140 

50 850 

5 15 

10 410 

5 55 

10 410 

5 35 

5 15 

10 60 

50 750 

10 140 

25 625 

376 5,576 

aqe Distribution Amonq the Three Prot 

PIP Non PIP Total 

15 10 25 

35 20 55 

5,150 346 5,496 

5,200 376 5,576 

ocols 
Table 

AZ 

CA 

co. 

FL 

H, 

ID 

IL 

IN 

KS 

ME. 

7. 

t 

M, 

MN: 

MO. 

NC. 

ND. 

NE. 

NM 

NV: 

J; 

1, 

NY: 

OR. 

PA 

SC. 

TX. 

UT: 

WA 

WI I 

T OTAL 

DER-6 

..... L..I J "-' \. \,,,4 1,- , # \-1 -'-J J # \1 11 --ll t,, - · I _ .. _ .. _. ---- ,,_, , , ~ · ·- • ·· ·· - - - - .. 

Original Permit 151 Amendment 

PIP 

Amt of PIP PIP 

Amt of PIP 

PIP Material PIP Material 

Acres 

Potato Acres 

Potato 

Seed (lb) lb Al gAI Seed (lb) lb Al gAI 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

NA NA NA NA 5 12,500 3.75E-04 0.170 

NA NA NA NA NA NA NA NA 

10.75 26,875 8.06E-04 0.366 45.25 113,125 3.39E-03 1.54 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

6.75 16,875 5.06E-04 0.230 62.75 156,875 4.71E-03 2.13 

NA NA NA NA 15 37,500 1.13E-03 0.510 

NA NA NA NA NA NA NA NA 

2 5,000 1.50E-04 0.068 2 5,000 1.50E-04 0.068 

3 8.E-+-03 2.25E-04 0.102 16.5 41 ,250 1.24E-03 0.561 

60 2.E-+05 4.50E-03 2.04 1,000 2,500,000 7.50E-02 34.0 

NA NA NA NA NA NA NA NA 

NA NA NA NA 10 25,000 7.50E-04 0.340 

2 5,000 1.50E-04 0.068 2 5,000 1.50E-04 0.068 

0.5 1,250 3.75E-05 0.017 53 132,500 3.98E-03 1.80 

2.75 6,875.00 2.06E-04 0.094 7.75 19,375 5.81E-04 0.264 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

NA NA NA NA NA NA NA NA 

6 15,000 4.50E-04 0.204 11 27,500 8.25E-04 0.374 

2 5,000 1.50E-04 0.068 55 137,500 4.13E-03 1.87 

95.75 239,375 7.18E-03 3.26 1285.25 3,213,125 9.64E-02 43.7 

- -

2nd Amendment Total Over the Duration of the EUP 

Amt of PIP PIP Amt of PIP 

PIP PIP Potato Material PIP Material 

Acres Seed (lb) Acres 

Potato 

lb Al gAI Seed (lb) lb Al g AI 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

50 125,000 3.75E-03 1.70 50 125,000 3.75E-03 1.70 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

50 125,000 3.75E-03 1.70 55 125,000 4.13E-03 1.87 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

700 1,750,000 5.25E-02 23.8 756 1,890,000 5.67E-02 25.7 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

30 75,000 2.25E-03 1.02 30 75,000 2.25E-03 1.02 

600 1,500,000 4.50E-02 20.4 669.5 1,673,750 5.02E-02 22.8 

300 750,000 2.25E-02 10.2 31 5 787,500 2.36E-02 10.7 

50 125,000 3.75E-03 1.70 50 125,000 3.75E-03 1.70 

50 125,000 3.75E-03 1.70 54 135,000 4.05E-03 1.84 

130 325,000 9.75E-03 4.42 149.5 373,750 1.12E-02 5.09 

800 2,000,000 6.00E-02 27.2 1,860 4,650,000 1.40E-01 63.3 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

400 1,000,000 3.00E-02 13.6 410 1,025,000 3.08E-02 13.9 

50 125,000 3.75E-03 1.70 54 135,000 4.05E-03 1.84 

400 1,000,000 3.00E-02 13.6 453.5 1,133,750 3.40E-02 15.4 

30 75,000 2.25E-03 1.02 40.5 101 ,250 3.04E-03 1.38 

10 25,000 7.50E-04 0.340 10 25,000 7.50E-04 0.340 

50 125,000 3.75E-03 1.70 50 125,000 3.75E-03 1.70 

700 1,750,000 5.25E-02 23.8 700 1,750,000 5.25E-02 23.8 

130 325,000 9.75E-03 4.42 147 367,500 1.10E-02 5.00 

600 1,500,000 4.50E-02 20.4 657 1,642,500 4.93E-02 22.4 

5,200 13,000,000 3.90E-01 177 6,581 16,452,500 4.9E-01 224 
Table 5 Bv Prat . I: A A t of Potato-Seed ~lb) dA t of PIP Protein {lb and - -

Original Permit 151 Amendment 2nd Amendment Total Over the 

Duration of the EUP 

Protocol Amt of PIP Amt of PIP Amt of PIP Amt of PIP 

PIP Material PIP Material PIP Material PIP PIP Material PIP Potato 

PIP Potato PIP Potato Potato 

Original and 1s1 2nd Acres Acres Acres Acres Seed (lb) lb Al gAI -- Seed (lb) lb Al gAI -- Seed (lb) lb Al g Al -- Seed (lb) lb Al g Al Amendment Amendment 

Rpi-vnt1 Late Blight 

Line Selection 5.5 13,750 4.13E-04 0.187 6 15,000 4.50E-04 0.204 26.5 66,250 1.99E-03 0.901 

Rpi-vnt1 Late Blight ~ Research & Efficacy and 0.75 1,875.00 5.63E-05 0.026 0.75 1,875 5.63E-05 0.026 15 37,500 1.13E-03 0.510 1.50 3,750 1.13E-04 0.051 

Specificity Development 

Rpi-vnt1 Late Blight 20 50,000 1.50E-03 0.680 96 240,000 7.20E-03 3.27 116.00 290,000 8.?0E-03 3.95 Demonstration 

Agronomy A~ronomy 

Rp;.,m/1 t.,O Bl0h~ 

Optimization Optimization 

3.5 8,750.00 2.63E-04 0.119 3.5 8,750 2.63E-04 0.119 35 87,500 2.63E-03 1.19 42.0 105,000 3.15E-03 1.43 

Rp;~11 c,• Blgh} Environmental Risk R ulato 66 165,000 4.95E-03 2.25 1,179 2,947,500 8.84E-02 40.1 5,150 12,875,000 3.86E-01 175.20 6,395 15,987,500 4.80E-01 217.56 Assessment and eg ry 

Composition 

TOTAL 98.75 239,375 7.18E-03 3.26 1,285.25 3,213, 125 9.62E-02 43.7 5,200 13,000,000 3.90E-01 176.90 6,581 16,452,500 4.94E-01 223.88 

DER-7 
REFERENCES 

Simplot. 2014. Experimental Program Submission for Experimental Use Permit 8771 . Product: 

Potato Late Blight Resistance Gene (also known as Rpi-vnt1). J.R. Simplot Company Plant Sciences. 

Boise, Idaho. January 20, 2014. 104 pp. MRID 493166-09. 

Simplot. 2015a. Modified Section G for Experimental Use Permit 8917-EUP-E. Product: Potato Late 

Blight Resistance Gene (also known as Rpi-vnt1 ). J.R. Simplot Company Plant Sciences. Boise, 

Idaho. January 27, 2015. 19 pp. NO MRID. 

Simplot. 2015b. Letter from Matthew Pence, Regulatory Manager J.R. Simplot Company to Kimberly 

Nesci, Chief Microbial Pesticides Branch Office of Pesticide Programs U.S. Environmental Protection 

Agency. RE: extension of EUP 8917-EUP-2. June 30, 2015. 31 pp. 

Simplot. 2015c. 2016 Experimental Use Permit 8917-EUP-G, Section G: pSIM1678 (containing 

Rpi-vnt1 ) Transformed Potato. Experimental Use Permit: 8917-EUP-G. J. R. Simplot Company Plant 

Sciences. Boise, Idaho. August 26, 2015. 13 pp. 

U.S. EPA. 2014. Memorandum from Kathleen Martin to Shanaz Bacchus. EPA File Symbol 

8917-EUP-R (Rpi-vnt1 gene that expresses the VNT1 protein in InnateTM 2.0 branded potato varieties). 

Section G Acreage Calculations. MRID 493166-09. DP N2: 418275. Decision N2: 485977. 

U.S. Environmental Protection Agency Office of Pesticide Programs. April 17, 2014. 

U.S. EPA. 2015a. Memorandum from Kathleen Martin to Kenneth Haymes. EPA File Symbol 

8917-EUP-E (Rpi-vnt1 gene that expresses the VNT1 protein in InnateTM 2.0 branded potato varieties). 

Section G Acreage Calculation: Amendment to the 2014 Permit: increased acres and states. 

U.S. Environmental Protection Agency Office of Pesticide Programs. January 28, 2015. 

U.S. EPA. 2015b. Personal Communication between Kenneth Haymes, EPA and Simplot. 

U.S. Environmental Protection Agency Office of Pesticide Programs. September 16, 2015. 

DER-8