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.

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

T EST GUIDELINE : Not applicable

M RID : NA

DP BARCODE : 419124

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

S PONSOR : J.R. Simplot Company

T ESTING

FACILITY : NA

T ITLE OF

REPORT 1 : 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 Unpublished study prepared by J.R. Simplot Company. 104p.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 Unpublished study prepared by J.R. Simplot Company. 19p.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.

A UTHORS 1 : Susan Collinge, Ph.D. Tracy A. Rood (January 2015 submissions)

S UBMISSION

DATES : January 30, 2014 January 20, 2015 January 26 and 27, 2015

C ONCLUSION : Acceptable

C LASSIFICATION : Acceptable

G OOD LAB

PRACTICE : Not applicable

1 The original submission was augmented three times to provide bo rder and non-PIP; t herefore, 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

1 The original submission (Simplot 2014) was amended th ree 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 an d Specificity Trials (Regulatory)

3.0 Rpi-vnt1 Late Blight Environmental Ri sk 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	Prote in	(in	pounds	and	grams)

݋ݐܽݐ݋ܲ	݂݋	ݐ݊ݑ݋݉ܣ ൌ ݁݅݊ݐ݋ݎܲ	݈ܾ ሺ ݈ܾ ሻ ,where	,ݐ݁݀݅݁݊ݎ݊݃ܫ	݁ݒ݅ݐܿܣ	% ൈ

%	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.DER-4Table 2By State: Acres, Amount of Potato Seed (lb), and Amount of PIP Protein (lb, grams)2014 2015 TOTAL (2014 + 2015)PIPAcres1lb PIPPotatoSeedAmt of PIP MaterialAcreslb PIPPotatoSeedAmt of PIP MaterialPIP Acreslb PIPPotatoSeedAmt of PIP Materiallb AI g AI PIP NON-PIP lb AI g AI lb AI g AIFlorida NA NA NA NA5.002.012,5000.0003750.1705.00 12,500 0.000375 0.170Idaho 10.75 26,875 0.000806 0.36645.259.0113,1250.003391.5456.00 140,000 0.00420 1.905Michigan 6.75 16,875 0.000506 0.23062.7525.1156,8750.004712.1369.50 173,750 0.00521 2.364Minnesota NA NA NA NA15.00637,5000.001130.51015.00 37,500 0.00113 0.510Nebraska 60.00 150,000 0.00450 2.041,000.004002,500,0000.075034.021,060.00 2,650,000 0.0795 36.06Nevada NA NA NA NA10.00425,0000.0007500.34010.00 25,000 0.000750 0.340New York 2.00 5,000 0.000150 0.06802.000.85,0000.0001500.06804.00 10,000 0.000300 0.136North Carolina 2.00 5,000 0.000150 0.06802.000.85,0000.0001500.06804.00 10,000 0.000300 0.136North Dakota 3.00 7,500 0.000225 0.10216.506.641,2500.001240.56119.50 48,750 0.00146 0.663Oregon 0.500 1,250 0.0000375 0.017053.0021.2132,5000.003981.8053.50 133,750 0.00401 1.820Pennsylvania 2.75 6,875 0.000206 0.09367.753.119,3750.0005810.26410.50 26,250 0.000788 0.357Washington 6.00 15,000 0.000450 0.20411.004.427,5000.0008250.37417.00 42,500 0.00128 0.578Wisconsin 2.00 5,000 0.000150 0.068055.0022.0137,5000.004131.8757.00 142,500 0.00428 1.939TOTAL95.75 239,375 0.00718 3.26 1,285.25 505 3,213,125 0.0964 43.72 1,381.00 3,452,500 0.104 46.981NOTE: 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 3By Protocol: Acres, Amount of Potato Seed (lb), and Amount of PIP Protein (lb, grams)2014 2015GRAND TOTAL (2014+2015)Acreslb PIPPotatoSeedAmt of PIP MaterialAcreslb PIPPotatoSeedAmt of PIP MaterialAcreslb PIPPotatoSeedAmt of PIP MaterialPIPNON-PIP1lb gPIPNON-PIPlbgPIPNON-PIPlb g1.0 Rpi-vnt1 LateBlight Line Selection5.50 0.880 13,750 0.000413 0.1876.002.4015,0000.0004500.20411.50 5.48 28,750 0.000863 0.3912.0 Rpi-vnt1 Late BlightEfficacy and Specificity0.750 0.120 1,875 0.0000563 0.02550.7500.2001,8750.00005630.02551.50 0.720 3,750 0.000113 0.05103.0 Rpi-vnt1 Late Blight EnvironmentalRisk Assessment and Composition3.50 0.560 8,750 0.000263 0.1193.501.408,7500.0002630.1197.00 3.36 17,500 0.000525 0.2384.0 Rpi-vnt1 Late BlightAgronomy Optimization66.00 10.56 165,000 0.00495 2.251,179.004762,947,5000.088440.111,245.00 436.56 3,112,500 0.0934 42.355.0 Rpi-vnt1 Late BlightDemonstration20.00 3.20 50,000 0.00150 0.68096.0025.0240,0000.007203.27116.00 36.20 290,000 0.00870 3.95TOTAL95.75 15.32 239,375 0.00718 3.26 1,285.25 505.00 3,213,125 0.0964 43.72 1,381.00 482.32 3,452,500 0.104 46.981See 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 eas y-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)

.

2 The original submission (Simplot 2014) was amended th ree times (Simplot 2015a,b,c) because border and non-PIP acres were left out of the original submission.