' .. ~ t 

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 891 7-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 .; Chemistllllj ~ztf tS 

Microbial Pesticides Branch 

Biopesticides and Pollution Prevention Div on(j___ 

Alan Reynolds, M.S.; Team Leader 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 rM 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.sfiJit/ q/1.tftj 

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 Innate TM 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: August26, 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 r M 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 151 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 10 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-vnt1 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 Innate TM 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 
DER-4 

Table 1 Comparing States and Total PIP Acres Among 

th e 0 ng1na . . I an d A d d P men e erm1 .t s 

Original EUP 

January to 

October, 2014 

Idaho 

Michigan 

Nebraska 

New York 

North Carolina 

North Dakota 

Oregon 

Pennsylvania 

Washington 

Wisconsin 

10 states 

96.75 PIP acres 

1 st Amendment 

Planting Period 

January to 

October, 2015 

States 

Idaho 

Michigan 

Nebraska 

New York 

North Carolina 

North Dakota 

Oregon 

Pennsylvania 

Washington 

Wisconsin 

Nevada 

Florida 

Minnesota 

13 states 

1,285.25 PIP acres 

2 nd Amendment 

-

January 2016 

to April 2017 

Idaho 

Michigan 

Nebraska 

New York 

North Carolina 

North Dakota 

Oregon 

Pennsylvania 

Washington 

Wisconsin 

Florida 

Minnesota 

Nevada 

Arizona 

California 

Colorado 

Hawaii 

Illinois 

Indiana 

Kansas 

Maine 

Missouri 

New Mexico 

South Carolina 

Texas 

Utah 

26 states J 

5,200 PIP acres 

~------------~-------------L------
DER-5 

Table 2 A ere age o· IS t n ·b UIOn r A mong th e 26 St a tes 

AZ 

CA 

co 

FL 

HI 

10 

IL 

IN 

KS 

ME 

Ml 

MN 

MO 

NC 

NO 

NE 

NM 

NV 

NY 

OR 

PA 

sc 

TX 

UT 

WA 

WI 

TOTAL 

I 

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. 

Non PIP I Total I 

I 

5 15 

10 I 60 

5 15 

10 60 

1 11 

50 750 

5 15 

5 15 -

5 15 

5 35 

50 I 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 

.b . A age Distn ut1on mong t h e Th ree P ro tocols 

PIP I Non PIP Total 

15 I 10 25 

35 I 20 55 

5,150 I 346 I 5,496 

TOTAL: ~~ ___ 5_,2_0_0 __ ~ ___ 3_7_6 __ ~ ___ 5_,5_7_6 __ ~ 
Table 

Original Permit 

PIP 

Acres 

NA 

NA 

-

NA 

NA 

' NA 

AZ 

CA 

co 

FL 

H 

ID 

IL 

IN 

KS 

ME 

M. 

. 10.75 

I. 

MN 

MO 

NY. 

OR 

PA 

sc. 

TX 

UT: 

WA 

WI I 

NA 

NA 

f---

NA 

NA 

6.75 

NA 

NA 

2 

3 

60 

~ NA 

-

NA 

-

2 

0.5 

-

2.75 

NA 

NA 

NA 

6 

2 

PIP 

Potato 

Seed (lb) 

NA 

NA 

NA 

NA 

NA 

26,875 

NA 

NA 

NA 

NA 

16,875 

NA 

NA 

5,000 

8E+03 

2.E+05 

NA 

NA 

5,000 

1,250 

6,875.00 

NA 

NA 

NA 

15,000 

5,000 

TOTAL 95.75 1 239,375 

DER-6 

Amt of PIP 

Material 

lb AI gAl 

NA NA 

NA NA 

·-

NA NA 

NA NA 

NA NA 

8.06E-04 0.366 

NA NA 

NA NA 

NA NA 

NA NA 

5.06E-04 0.230 

NA NA 

NA NA 

1.50E-04 0.068 

2.25E-04 0.102 

4.50E-03 2.04 

NA NA 

NA NA 

1.50E-04 0.068 

3.75E-05 0.017 

2.06E-04 0.094 

NA NA 

NA NA 

NA NA 

4.50E-04 0.204 

1.50E-04 0.068 

7.18E-03 3.26 

' , . 

151 Amendment 

PIP Amt of PIP PIP Material Potato Acres Seed (lb) lb AI g Al 

NA NA NA NA 

NA NA NA NA 

NA NA NA NA 

5 12,500 3.75E-04 0.170 

NA NA NA NA 

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 

62.75 156,875 4.71E-03 2.13 

15 37,500 1.13E-03 0.510 

NA NA NA NA 

2 5,000 1.50E-04 0.068 

16.5 41 ,250 1.24E-03 0.561 

1,000 2,500,000 7.50E-02 34.0 

NA NA NA NA 

10 25,000 7.50E-04 0.340 

2 5,000 1.50E-04 0.068 

53 132,500 3.98E-03 1.80 

7.75 19,375 5.81E-04 0.264 

NA NA NA NA 

NA NA NA NA 

NA NA NA NA 

11 27,500 8.25E-04 0.374 

55 137,500 4.13E-03 1.87 

1285.25 3,213,125 9.64E-02 43.7 

2"d Amendment Total Over 

Amt of PIP P

PIP PIP Potato Material PIP 

Po

Acres Seed (lb) lb AI gAl Acres See

10 25,000 7.50E-04 0.340 10 25

50 125,000 3.75E-03 1.70 50 12

10 25,000 7.50E-04 0.340 10 25

-

50 125,000 3.75E-03 1.70 55 12

-

10 25,000 7.50E-04 0.340 10 25

700 1,750,000 5.25E-02 23.8 756 1,8

10 25,000 7.50E-04 0.340 10 25

-

10 25,000 7.50E-04 0.340 10 25

10 25,000 7.50E-04 0.340 10 25

f- 

30 75,000 2.25E-03 1.02 30 75

600 1,500,000 4.50E-02 20.4 669.5 1,6

r---- 

300 750,000 2.25E-02 10.2 315 78

50 125,000 3.75E-03 1.70 50 12

50 125,000 3.75E-03 1.70 54 13

130 325,000 9.75E-03 4.42 149.5 37

800 2,000,000 6.00E-02 27.2 1,860 4,6

I10 25,000 7.50E-04 0.340 10 25

400 1,000,000 3.00E-02 13.6 410 1,0

50 125,000 3.75E-03 1.70 54 13

400 1,000,000 3.00E-02 13.6 453.5 1,1 

30 75,000 2.25E-03 1.02 40.5 10

10 25,000 7.50E-04 0.340 10 25

-

50 125,000 3.75E-03 1.70 50 12

700 1,750,000 5.25E-02 23.8 700 1,7

-

130 325,000 9.75E-03 4.42 147 36

-

600 1,500,000 4.50E-02 .20.4 657 1,6

5,200 13,000,000 3.90E-01 177 6,581 16,4
Table 5 Bv Prot 

' 

1: A --

, 

A t of Potato-Seed (lb) ' ,. dA t of PIP Protein (lb and ' 

Original Permit 151 Amendment 2nd Amendment 

Protocol Amtof PIP Ami of PIP Amtof PIP 

PIP Material PIP Material PIP Material P

PIP Potato PIP Potato PIP Potato 

Original and 1st 2"d Acres Acres Acres Ac

Seed (lb) lbAI gAl -- Seed (lb) lbAI gAl -- Seed (lb) lbAI g AI -

Amendment Amendment 

Rpi-vnt1 Late Blight 

Line Selection 5.5 13,750 4.13E-D4 0.187 6 15,000 4.50E-D4 0.204 2

Rpi-vnt1 Late Blight Research & Efficacy and 0.75 1,875.00 5.63E-D5 0.026 0.75 1,875 5.63E-D5 0.026 15 37,500 1.13E-D3 0.510 1

Specificity Development 

Rpi-vnt1 Late Blight 20 50,000 1.50E-D3 0.680 96 240,000 7.20E-D3 3.27 11

Demonstration 

-

Agronomy Rp;.,/1 c.re 

Optimization Optimtzalion 3.5 8,750.00 2.63E-D4 0.119 3.5 8,750 2.63E-D4 0.119 35 87,500 2.63E-D3 1.19 4

'-'" ""'"} Environmental Risk R ulato 66 165,000 4.95E-D3 2.25 1,179 2,947,500 8.84E-D2 40.1 5,150 12,875,000 3.86E-D1 175.20 6,

Assessment and eg ry 

Composition 

TOTAL 98.75 1 239,375 7.18E.Q3 3.26 1,285.25 3,213,125 9.62E.Q2 43.7 3.90E.Q1 176.90 6,

DER-7 
REFERENCES 

Simplot. 2014. Experimental Program Submission for Experimental Use Permit B771 . 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 Innate TM 2.0 branded potato varieties). 

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