Simplot:  8917‐EUP‐1  

DP 419124

January 2015

DER-1 

Data Evaluation Record 

Reviewed by: Kathleen Martin, M.S.E.S. 

Secondary Review: Alan Reynolds, M.S. 

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

TEST GUIDELINE: Not applicable 

MRID: NA 

DP BARCODE: 419124 

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

SPONSOR: J.R. Simplot Company 

TESTING 

FACILITY: 

NA 

TITLE OF 

REPORT1: 

Sections A through G product Characteristics and Experimental Program 

Submission for Experimental Use Permit B740: Product: Potato Late Blight 

Resistance Gene (also known as Rpi-vnt1). Unpublished study prepared by 

J.R. Simplot Company. 104p. January 30, 2014. 

Modified Section G for Experimental Use Permit 8917-EUP-E for Potato Late Blight 

Resistance Gene (also known as Rpi-vnt1). Unpublished study prepared by 

J.R. Simplot Company. 19p. January 20, 2015. 

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 26, 2015. 19 pp. NO MRID. 

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. 

AUTHORS1: Susan Collinge, Ph.D. 

Tracy A. Rood (January 2015 submissions)

SUBMISSION 

DATES: 

January 30, 2014 

January 20, 2015 

January 26 and 27, 2015

CONCLUSION: Acceptable

CLASSIFICATION: Acceptable 

GOOD LAB 

PRACTICE: Not applicable 

1The original submission was augmented three times to provide border and non-PIP; therefore, there is one original and two 

amended submissions. 

 
Simplot:  8917‐EUP‐1  

DP 419124

January 2015

DER-2 

BACKGROUND: In May 2014 the Agency issued an experimental use permit (EUP) to J.R. Simplot 

Company for testing of a new plant-incorporated protectant (PIP) technology: the 

Rpi-vnt1 gene that expresses the VNT1 protein in InnateTM 2.0 branded potato 

varieties. They are now asking to amend the original EUP to: add Florida, 

Minnesota, and Nebraska; and increase the PIP acreage from 96.75 to 1285.25 

(Simplot 2014).1

 To readily see the differences between the original vs. amended EUP, all the data 

tables provide a side-by-side comparison. Table 1 provides an overall summary; 

Table 2 show the acres, amount of potato seed, and amount of protein by state while 

Table 3 provides it by protocol. 

Table 1 Key Study Parameters: 

Original vs. Amended EUP 

Original EUP Amended EUP

Planting 

Period: 

January to 

October, 2014

January to 

October, 2015

States: 10 13 

Florida — 

Idaho  

Michigan  

Minnesota — 

Nebraska  

Nevada — 

New York  

North Carolina  

North Dakota  

Oregon  

Pennsylvania  

Washington  

Wisconsin  

PIP 

Acres: 96.75 1285.25

Planting 

Density: 2,500 lb/A 2,500 lb/A 

Percent Trait 

Expression: 3.010-6 3.010-6

 

1The original submission (Simplot 2014) was amended three times (Simplot 2015a,b,c) because border and nonPIP acres were left out of the original submission. 
Simplot:  8917‐EUP‐1  

DP 419124

January 2015

DER-3 

ACRES. J.R. Simplot is proposing to increase the PIP acreage from 96.75 to 1285.25 acres. More 

than three-quarters of this increase is due to Nebraska, where Simplot would like to increase 

the PIP acreage from 60 to 1,000; see Table 2. 

PROTOCOLS: This EUP is being conducted using five protocols as listed below; descriptions of 

each are provided in the original Section G calculations (U.S. EPA 2014). 

1.0 Rpi-vnt1 Late Blight Line Selection Trials (R&D) 

2.0 Rpi-vnt1 Late Blight Efficacy and Specificity Trials (Regulatory) 

3.0 Rpi-vnt1 Late Blight Environmental Risk Assessment and Composition (Regulatory) 

4.0 Rpi-vnt1 Late Blight Agronomy Optimization Trials (Commercial) 

5.0 Rpi-vnt1 Late Blight Demonstration Trials (Commercial) 

EQUATIONS: The following equations were used to calculate the amount of potato seed (lb) 

 expected to be used in this EUP and the amount of PIP protein. The planting 

 density and percent active ingredient were provided by J.R. Simplot. 

Equation 1	 Calculating	Amount	of	Potato	Seed	(in	pounds)	

	where	,࢚࢟࢏࢙࢔ࢋࡰ	ࢍ࢔࢏࢚࢔ࢇ࢒ࡼ ൈ	 ࢙ࢋ࢘ࢉ࡭ ൌ ࢕࢚ࢇ࢚࢕ࡼ	࢈࢒

Planting	Density	=	ଶ,ହ଴଴	୪ୠ	୔୭୲ୟ୲୭	ୗୣୣୢ

୅ୡ୰ୣ

		

 Equation 2 Calculating	Amount	of	Protein	(in	pounds	and	grams)	

		,where	,ݐ݁݀݅݁݊ݎ݊݃ܫ	݁ݒ݅ݐܿܣ	% ൈ ሻ݈ܾሺ	݋ݐܽݐ݋ܲ	݂݋	ݐ݊ݑ݋݉ܣ ൌ ݁݅݊ݐ݋ݎܲ	݈ܾ

%	Active	Ingredient	=	0.000000030;	and		

	 	 	 	 1	lb≡453.6	g	

DATA TABLES: In the following tables the acronyms are defined as follows: 

 “NA” means that the data are ’not applicable,’ because the state 

 was not part of original EUP; 

lb = pounds; g = grams; and 

AI = active ingredient. 
Table 2 By State: Acres, Amount of Potato Seed (lb), and Amount of PIP Protein (lb, grams) 

2014 2015 TOTA

PIP 

Acres1

lb PIP 

Potato 

Seed 

Amt of PIP Material Acres lb PIP 

Potato 

Seed 

Amt of PIP Material 

PIP Acres

lb 

Po

Se

 lb AI g AI PIP NON-PIP lb AI g AI 

Florida NA NA NA NA 5.00 2.0 12,500 0.000375 0.170 5.00 12

Idaho 10.75 26,875 0.000806 0.366 45.25 9.0 113,125 0.00339 1.54 56.00 140

Michigan 6.75 16,875 0.000506 0.230 62.75 25.1 156,875 0.00471 2.13 69.50 173

Minnesota NA NA NA NA 15.00 6 37,500 0.00113 0.510 15.00 37

Nebraska 60.00 150,000 0.00450 2.04 1,000.00 400 2,500,000 0.0750 34.02 1,060.00 2,65

Nevada NA NA NA NA 10.00 4 25,000 0.000750 0.340 10.00 25

New York 2.00 5,000 0.000150 0.0680 2.00 0.8 5,000 0.000150 0.0680 4.00 10

North Carolina 2.00 5,000 0.000150 0.0680 2.00 0.8 5,000 0.000150 0.0680 4.00 10

North Dakota 3.00 7,500 0.000225 0.102 16.50 6.6 41,250 0.00124 0.561 19.50 48

Oregon 0.500 1,250 0.0000375 0.0170 53.00 21.2 132,500 0.00398 1.80 53.50 133

Pennsylvania 2.75 6,875 0.000206 0.0936 7.75 3.1 19,375 0.000581 0.264 10.50 26

Washington 6.00 15,000 0.000450 0.204 11.00 4.4 27,500 0.000825 0.374 17.00 42

Wisconsin 2.00 5,000 0.000150 0.0680 55.00 22.0 137,500 0.00413 1.87 57.00 142

TOTAL 95.75 239,375 0.00718 3.26 1,285.25 505 3,213,125 0.0964 43.72 1,381.00 3,45

 1NOTE: In 2014 the NON-PIP Acres were only provided by protocol; see Table 3 for the 2014 and 2015 NON-PIP acres by protocol. Table 3 By Protocol: Acres, Amount of Potato Seed (lb), and Amount of PIP Protein (lb, grams)

2014 2015 GRA

 Acres lb PIP 

Potato 

Seed 

Amt of PIP Material Acres lb PIP 

Potato 

Seed 

Amt of PIP Material Acres 

 PIP NON- PIP1 lb g PIP NON- PIP lb g PIP N

1.0 Rpi-vnt1 Late 

Blight Line Selection 5.50 0.880 13,750 0.000413 0.187 6.00 2.40 15,000 0.000450 0.204 11.50 5

2.0 Rpi-vnt1 Late Blight 

Efficacy and Specificity 0.750 0.120 1,875 0.0000563 0.0255 0.750 0.200 1,875 0.0000563 0.0255 1.50 0

3.0 Rpi-vnt1 Late Blight Environmental 

Risk Assessment and Composition 3.50 0.560 8,750 0.000263 0.119 3.50 1.40 8,750 0.000263 0.119 7.00 3

4.0 Rpi-vnt1 Late Blight 

Agronomy Optimization 66.00 10.56 165,000 0.00495 2.25 1,179.00 476 2,947,500 0.0884 40.11 1,245.00 43

5.0 Rpi-vnt1 Late Blight 

Demonstration 20.00 3.20 50,000 0.00150 0.680 96.00 25.0 240,000 0.00720 3.27 116.00 3

TOTAL 95.75 15.32 239,375 0.00718 3.26 1,285.25 505.00 3,213,125 0.0964 43.72 1,381.00 48

1See U.S. EPA 2014 where the NON-PIP acres for 2014 are listed. 
DER-5 

CONCLUSION: J.R. Simplot is asking the Agency to amend their existing EUP for testing of a new 

plant-incorporated protectant (PIP) technology to add three states and increase to 

amend the original EUP to: add Florida, Minnesota, and Nebraska; and increase the 

PIP acreage from 96.75 to 1285.25 (Simplot 2014).2 EPA agrees with Simplot’s 

calculations. 

DISCUSSION: Regarding the submission format, J.R. Simplot did a very nice job organizing the 

Section G submission. The clear tables and discussion of the overall 

experimental plan made the submission easy-to-follow. Additionally, Simplot 

provided the 2014 data along with that of 2015; this was especially helpful. 

For future submissions, the NON-PIP and/or border acres need to be submitted. 

The lack of these data were the reason for the amended submission. Certain data 

tables (e.g., Tables 1a, 1b, and 1c; Simplot 2015a,b) can be combined into one 

table, though this is not a requirement and J.R. Simplot may have a good reason for 

separating them. Finally, I encourage Simplot is encourage to contact the Agency if 

they have any questions regarding submission format. 

REFERENCES 

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 No: 418275. Decision No: 485977. 

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

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. NOTE: This is the original submission. 

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 20, 2015. 19 pp. NO MRID. NOTE: This is the first modification of the original 

(original submission: MRID 493166-09: February 20, 2014). 

Simplot. 2015b. 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 26, 2015. 19 pp. NO MRID. NOTE: This is the second modification of the original 

(original submission: MRID 493166-09: February 20, 2014). 

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

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

January 27, 2015. 19 pp. NO MRID. NOTE: This is the third modification of the original (original 

submission: MRID 493166-09: February 20, 2014). 

 

2The original submission (Simplot 2014) was amended three times (Simplot 2015a,b,c) because border and 

 non-PIP acres were left out of the original submission.