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**~** t 

### UNITED STATES ENVIRQNMENTAL · PROTECTION AGENCY 

### WASHINGTON ; D . c . · 20460

September 21 , 2015 OFFICE OF CH EMI CAL SAFETY AND POLLUTION PRE V ENT IO N


### MEMORANDUM SUBJECT:

FROM : THROUGH : TO : EPA File Symbol 891 7 -EUP-2 ( Rpi-vnt1 gene 

### that expresses the VNT1 protein in Innate TM 2.0 branded potato v arieties ) . Section G Acreage Calculation: Second Amendment EPA 

### Reg . N2 : 8917-EUP-2 

### PC Code: 006355 C ompany : J . R . Simplot MRID : None Decision N2 : 506540 DP 

### N 2: 4 28291 

### Kathleen Martin , M . S . E . s .; Chemistllllj



# ~ztf tS Microbial Pesticides Branch Biopesticides and Pollution Prevent i on

**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 Leade r 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 confe rs resistance to Phytophthora infe s tans , 

### an oomycete , which is the causal agent o f La t e Blight. Late Bl i ght i s 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 inc rease 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 . Pro vided in the attached Data Evaluat ion Record are the sect i on G calculations for this second amendment. The document includes summary i nformation 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 fo r 8917- E UP-2 T EST GUIDELINE : Not applicable MRID : NA DP BAR CO DE : 428291 TEST MATERIAL: the 

### Rpi-vnt1 gene that expresses the VN T1 protein in I nnate TM 

### 2 . 0 branded potato v arieties SP O NSOR : J . R. Simplot Company

TESTING NA FACILITY : TITLE O F 2016 Experimental Use Permit 8917-EUP-G , Section G : pSIM1678 (co ntain i ng 

### Rpi-vnt1 ) REPORT: Transformed Potat o . June 30 , 2015 . 11 pp . 2016 Experimental Use Perm i t 8917-EUP-G , Section G : pSIM1 678 ( co nta in i ng 

### Rpi-vnt1 ) Transfo rm ed Potato . 16 pp . AUTHORS : Matthew Pence , Ph . D . SUBM I SSION June 30 , 2015 DATES : August26 , 2015 CONCLUSION : Acceptable CLASS IFI CA TI O N : Acceptable G OOD LAB PRACT I CE : N ot applicable 

### BACKGROUND J . R. Simplot Company i s seeking to amend its experimental use perm i t ( EUP ) for the testing of a new plant-incorporated protectant ( PIP ) technology : the Rpi-vnt1 

### gene that e x presses the VNT1 protein in Innate r M 

### 2 . 0 branded potato varieties ; they assert that this trait confers resistance to the plant pathogen Phytophthora infe sta n s 

### (commonly known as late blight) . Briefly , the regu lato ry 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 , Simp lo t (2 015a) 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 perm i t a second time to add 5 , 200 more acres and 13 states ( total of 26). Provided below is the Section G review for the 2 n d amendment. For the Agency ' s Section G rev iew for the original permit and the 1 51 

### amendment , see U . S . EPA 2014 and 2015a .
DER - 2

### REVIEW 1 

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

### Protocols . Simplot is conducting their investigation using Research and Development (R 

### & D ) , Agronomy Optimization , and Regulato ry protocols . For the original and 1 st amendments , Simplot provided a detailed breakout of the R 

### & D protocol (Simplot 2014 , 2015a) while for the 2 nd amendment , they grouped them ( U . S . EP A 2015b ). The following graphic illustrates this difference : 2 nd 

### Amendment Protocols: Original and 1 51 

### 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 Op timization 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 co urse of their investigation . EPA agrees with Simplot ' s calculations and proposed additional acreage (P IP 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 .

1 

### Note : Of the five tables below , three (T ables 1 , 4 , 

### and 5) provide the corresponding data for the

o riginal permit and the two amendments . DER-3

### DER-4 

### Table 1 Comparing States and Total PIP Acres Among th 0 . . I d A d d P . t e ng1na an men e erm1 s Original EUP January to Oc t ober , 2014
I daho Mich ig an Nebraska New York North Ca r o lina North Dakota Oregon Pennsylvania Was h i n gto n Wisconsin

10 s t ates 96 . 75 PIP acres 1 st 

### Amendment P l anting P eri o d January to October , 2015 

### S tates

Idaho Michigan Nebraska New Yo rk N o rth Carol in a North Dakota Oregon Pennsy lv ania Was h i ng ton Wiscons in

Nevada Flor i da M i nnesota

13 states 1 , 2 85 . 25 PIP acres 2 nd 

### Amendment

- January 2016 to A p r i l 2017
Idaho Michigan Nebraska Ne w York North Caroli n a N orth Dakota Oregon Pennsylvania Washing t on Wisconsin

F l or i da Minnesota

Nevada A riz o na Ca l ifornia Colorado

Hawaii Illinois Indiana Kansas Maine Missouri New Mexico So uth Ca r o l ina Texas

Utah 26 states 

# J 5 , 200 PIP ac r es

**~------------ ~--**  **-----------L------**

### DER-5 

### Table 2 A ere age 

# o · t 

## · b 

# r A IS n UIOn mong th 26 St tes e a 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 P IP 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 

### h Th mong t e ree P tocols ro 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 P e rmit

P I P Acres N A NA
-

NA N A

' NA AZ C A c o FL H ID IL I N KS ME M. . 10 . 75

I . MN M O NY. OR P A sc. TX U T : W A W I I N A N A f---

N A NA 6.75 N A NA 2 3 60 **~** NA -

N A -

2 0.5
-

2 . 75 NA N A N A 6 2 PI P Po t a t o S eed ( l b ) NA N A N A N A N A 26 , 87 5 NA N A NA NA 16,875 N A NA 5,000 8 E+ 03 2. E +05 N A NA 5 , 000 1 , 2 50 6 , 87 5 .00 NA NA NA 1 5 , 000 5,000

T OT AL 95 .7 5 1 239 , 375
DE R -6 Am t of P I P M at e r ia l lb A I gA l N A NA N A N A ·-

N A N A N A NA NA N A 8.06 E -0 4 0 . 366 N A N A NA NA NA NA NA N A

5 . 06 E -0 4 0 . 230 NA NA NA N A

1 . 50 E -0 4 0 . 068

2 . 25 E -0 4 0 . 1 0 2

4 . 50 E -0 3 2 .0 4 NA N A NA N A

1 . 50 E -0 4 0.06 8 3.7 5 E -0 5 0.0 1 7

2 . 06 E -0 4 0 . 09 4 N A NA N A NA NA N A

4 . 50E-0 4 0 . 20 4

1 . 50 E -0 4 0 . 068

7 . 18 E -03 3 . 26 ' , .

1 5 1 Amendm e nt

PI P A mt o f PIP

P IP M at eri al

P o t a t o Ac r es See d ( lb ) l b A I g A l NA NA NA NA NA NA NA NA

NA NA NA NA

5 12 , 500 3 .7 5 E -0 4 0 . 170 NA NA NA NA

4 5 . 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 . 7 1 E-03 2 . 13

15 37 , 500 1 . 1 3 E -03 0 .510

N A NA NA N A

2 5 ,000 1 . 50E-04 0 . 068

16 . 5 41 , 250 1 . 2 4 E-03 0 . 5 61

1 ,000 2 , 500,000 7 . 50 E -02 3 4 .0

NA N A NA NA

1 0 25 , 000 7. 50E-04 0.340

2 5 , 000 1 . 50E-04 0 .06 8

53 132 , 500 3.98E-0 3 1 .80

7 . 75 1 9,375 5 . 8 1 E-0 4 0 . 264 NA NA NA NA

NA NA NA NA

NA N A N A N A

1 1 27 , 500 8 .2 5E-04 0 . 374

55 137 , 500 4 . 13 E -03 1 . 87 1285.25 3,213 , 12 5 9 . 6 4E -02 4 3.7 2 "d Am e ndment Total Over t he Duration of the EUP

Am t o f PI P PI P A mt of P I P

PI P PI P Po t a to M ate ri a l P I P M ate r ial

P o tat o

Ac re s See d ( l b) l b A I gA l Ac r es See d ( l b ) lb A I gA l

10 25 , 00 0 7. 50 E -0 4 0. 34 0 10 25 ,00 0 7 . 50 E-04 0 . 3 4 0

50 12 5,000 3.7 5E -03 1.7 0 5 0 1 25 ,000 3.7 5E -03 1 . 70

10 2 5 , 000 7. 5 0 E -0 4 0.3 40 1 0 2 5 ,0 0 0 7 . 50E -0 4 0 . 3 4 0

-

5 0 125 , 0 00 3 . 75E -03 1.70 55 125 , 0 00 4 . 13E -03 1 . 8 7

-

10 25 , 000 7.50 E -0 4 0.3 40 10 25 ,000 7 . 5 0E -0 4 0 . 3 4 0

700 1 , 750,000 5 . 25E -02 2 3 . 8 756 1 , 890,000 5 . 67 E -02 25 . 7

10 2 5 , 000 7. 5 0 E -0 4 0 .3 4 0 10 25,000 7 . 50 E -0 4 0.3 4 0

-

1 0 25,000 7. 50E-04 0 . 3 4 0 1 0 25 , 0 00 7. 5 0 E -0 4 0.3 4 0

1 0 25 , 000 7. 50E-04 0 . 34 0 1 0 2 5 , 000 7 . 50 E -0 4 0 . 3 4 0

f- -

30 75 , 000 2 . 25E -03 1 . 0 2 30 75 , 000 2 . 2 5 E -03 1 . 0 2

--

60 0 1 , 500,000 4 . 5 0 E -02 20 .4 669 . 5 1 , 673 , 750 5 . 02 E -0 2 22 . 8

r---- - -

30 0 75 0 ,0 0 0 2 . 25 E -02 1 0.2 3 15 7 87 , 5 0 0 2 . 36 E -0 2 1 0 . 7

50 125 , 0 0 0 3 . 75 E -03 1 . 70 50 125 , 000 3.7 5 E -03 1 .70

50 12 5,000 3. 7 5 E -03 1 . 7 0 54 1 3 5 , 000 4 . 05 E -03 1 . 84

130 3 2 5,000 9. 75E -03 4 . 42 1 4 9 . 5 37 3,750 1 . 12E -02 5 . 09

800 2 ,0 0 0,0 0 0 6.00 E -0 2 27 . 2 1 , 860 4 ,6 50 , 000 1 . 40E - 01 63.3

I1 0 25,000 7 . 5 0E-0 4 0 . 34 0 10 2 5 , 00 0 7 . 50 E -0 4 0 . 3 40

4 00 1 ,000,000 3 . 00E-02 13 . 6 4 10 1,0 2 5 , 000 3 . 08E-02 1 3.9

50 1 25,000 3.7 5E -03 1 . 70 5 4 1 35,000 4 . 0 5 E-03 1 . 8 4

4 00 1 , 0 00,000 3. 0 0 E -02 1 3.6 4 53.5 1 ,1 33 , 75 0 3.4 0 E - 02 1 5 .4

30 75 , 0 00 2 . 2 5E -03 1 . 02 4 0.5 1 0 1 ,250 3.0 4E -03 1 . 38

1 0 2 5 , 000 7 . 50 E -0 4 0 . 3 4 0 10 2 5 , 000 7 . 5 0E -0 4 0 . 3 4 0

- -

50 1 25 , 000 3.75 E -03 1 . 70 50 1 2 5 , 000 3.7 5E -03 1 . 70

7 00 1 , 7 50 ,00 0 5 . 2 5 E -02 23 . 8 700 1 ,7 5 0,0 0 0 5.25E-0 2 23. 8

-

1 30 325,0 0 0 9.75 E -03 4 . 4 2 1 4 7 367 , 500 1 . 1 0E-02 5.00

-

600 1 ,50 0 , 000 4.50 E -02 .20.4 657 1 , 64 2,500 4 . 93 E -02 22.4

5,2 0 0 13 , 000,000 3.90 E -01 177 6 , 581 1 6 ,45 2 , 500 4 . 9 E -01 22 4

-Table5BvProt'1:A--,AtofPotato-Seed(lb)',.dAtofPIPProtein(lband'OriginalPermit151Amendment2ndAmendmentTotalOvertheDurationoftheEUPProtocolAmtofPIPAmiofPIPAmtofPIPAmtofPIPPIPMaterialPIPMaterialPIPMaterialPIPPIPMaterialPIPPotatoPIPPotatoPIPPotatoPotatoOriginaland1st2"dAcresAcresAcresAcresSeed(lb)lbAIgAl--Seed(lb)lbAIgAl--Seed(lb)lbAIgAI--Seed(lb)lbAIgAIAmendmentAmendmentRpi-vnt1LateBlightLineSelection5.513,7504.13E-D40.187615,0004.50E-D40.20426.566,2501.99E-D30.901Rpi-vnt1LateBlightResearch&Efficacyand0.751,875.005.63E-D50.0260.75 1,8755.63E-D50.0261537,5001.13E-D30.5101.503,7501.13E-D40.051SpecificityDevelopmentRpi-vnt1LateBlight2050,0001.50E-D30.68096240,0007.20E-D33.27116.00290,0008.70E-D33.95Demonstration-AgronomyRp;.,/1c.reOptimizationOptimtzalion3.58,750.002.63E-D40.1193.58,7502.63E-D40.1193587,5002.63E-D31.1942.0105,0003.15E-D31.43'-'"""'"}EnvironmentalRiskRulato66165,0004.95E-D32.251,1792,947,5008.84E-D240.15,15012,875,0003.86E-D1175.206,39515,987,5004.80E-D1217.56AssessmentandegryCompositionTOTAL98.751239,3757.18E.Q33.261,285.253,213,1259.62E.Q243.73.90E.Q1176.906,58116,452,5004.94E-D1223.88DER-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. Simp l ot Company Plant Sciences . Boise , Idaho . January 20 , 2014 . 104 pp . MRID 493166-09 . S i mplot. 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. Simp l ot Company to Kimber l y Nesci , Chief Microbial Pesticides Branch Office of Pesticide Programs U . S . Env i ronmental P r ote c tion Agency . RE : extension of EUP 8917-EUP-2 . June 30 , 2015 . 31 pp . Simplot. 2015c . 2016 Experimental Use Permit 8917-EUP-G , Sect i on G : pSIM1678 ( con t aining Rpi-vnt1 ) Transformed Potato . Experimental Use Permit: 8917-EUP-G . J . R. Simp l ot Company P l ant Sciences . Boise , Idaho . August 26 , 2015 . 13 pp . U . S . EPA. 2014 . Memorandum from Kathleen Martin to Shanaz Bacchus . EPA F i le Symbol 8917 -EUP-R ( Rpi-vnt1 gene 

### that expresses the VNT1 protein in Innate TM 2 . 0 branded potato va r iet i es ). Section G Acreage Calculations . MRID 493166-09 . DP NQ : 418275 . Dec i s i on NQ : 485977 . U . S . Env i ronmental Protection Agenc y Office of Pesticide Programs . Apr il 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 Innate TM 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 S i mplot. U . S . Environmental Protection Agenc y Office of Pesticide Programs . September 16 , 2015 .

DER-8