### 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 Innate TM 2 . 0 branded potato varieties ). Section G Acreage Calculation : Second Amendment EPA Reg . N 2: 8 9 17- E UP- 2 PC Cod e : 00 63 55 Company : J . R . S implot 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 Di 14 on ~ 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 experimenta l use permit (E UP ) to J . R. Simplot Company for the testing of a new plant-incorporated protectant (PI P ) technology : the Rpi-vnt1 gene 

### that expresses the VNT1 protein in Innate T M 

### 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 e x presses the VNT1 protein in InnateTM 2 . 0 branded potato varieties SPONSOR : J . R . Simplot Company

TESTING NA F A

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

### Rpi-vnt1 ) REPORT : Transformed Potato. June 30 , 2015 . 11 pp . 2016 E x perimental 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 CONCLUSI O N : 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

### 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 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 1 st 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 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 . EPA 2015b ). The following graphic illustrates this difference : 2 nd 

### Amendment Protocol s: Original and 1 51 

### Amendment Proto c ols : 

# t

Rpi-vnt1 Late Blight Line Selection Research and Development 

### Rpi-vnt1 Late Blight Effica cy and Specificity 

### Rpi- vn f 1 Late Blight Demons t rati on 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 e x presses the VNT1 protein in InnateTM 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 r ig inal permit and t he two amendments . DER- 3

### T ab l e 1 Com p aring Sta t es and Total P IP Acres Among t h e OriQinal and Amended Pe r m its Or i ginal E U P 1 st 

### Ame n dment 2nd 

### Amendment P l an ti ng P eri o d 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 Pen n sylvania Washington Washington Washington Wisconsin Wisconsin Wisconsin Nevada Florida Florida Minnesota M i nnesota Nevada Arizona California C olorado

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 Sta t es 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 1 30 600 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 

### 1 0 410 5 35 5 15 10 60 50 750 1 0 140 25 625 376 5 , 576 

### aqe Distr i bution Amonq the Three Prot PIP Non PIP T otal 

### 15 10 25 35 20 55 5 , 150 346 5,496 5 , 200 376 5 , 576 

### ocols

### Table

AZ CA 

## co. FL H, ID I L IN KS M

E. 7 . t

M, MN: M

O. N

C. ND. N

E. NM NV : J ;

1 ,

NY : 

### OR. PA SC. 

### TX

. UT

: WA WI

I T OTA L 

### DER -6 ..... L..I J "-' \. \,,,4 1, - , # \- 1 -'-J J # \1 11 --ll t,, - · I _ .. _ .. _. ---- ,, _, , , ~ · ·- • ·· ·· - - - - .. 

### Original Perm i t 1 5 1 

### Amendment

P I P A m t of PIP P I P Amt of P I P PIP M at e ria l P I P M ateria l Ac r es Potato Ac re s Pota t o S e e d ( l b ) l b A l gAI See d ( lb) l b A l gA I 

## NA N A N A NA NA NA NA NA NA N A N A N A NA NA NA NA NA N A NA NA NA NA NA NA NA N A NA N A 5 12 ,5 0 0 3.75E-04 0. 170 

## NA NA N A N A NA NA NA NA 10.75 26 ,875 8 .06 E -0 4 0.366 4 5. 25 1 1 3, 125 3. 39 E-03 1 .54 

## N

A NA NA N A NA N A NA NA N

A NA NA NA NA NA NA NA N

A NA NA NA NA NA NA NA N

A NA NA NA NA NA NA NA 6. 75 1 6,875 5.06 E -0

4 0. 230 62.75 156 ,875 4.7 1 E-03 2. 13 

## N

A NA NA NA 1 5 3 7,500 1 . 13 E-03 0. 5 1 0 

## N

A NA NA NA N A NA NA NA 2 5,000 1 .50 E -0 4 0. 068 2 5, 000 1 . 50 E -0 4 0.0 6 8 3 8 .E- + -03 2. 25 E- 04 0. 102 16 .5 41 , 250 1 . 2 4E -0 3 0. 5 61 60 2. E -+0 5 4. 50 E - 03 2.0 4 1 ,000 2, 500 , 000 7 . 50 E -02 3 4 .0 

## NA N A N A NA NA NA NA NA N

A N A N A N A 1 0 25 , 000 7 . 50 E -0 4 0. 3 4

0 2 5,000 1 . 50 E-04 0. 068 2 5, 000 1 . 50 E -0 4 0. 068 0 . 5 1 ,250 3. 75 E-0 5 0 .0 1 7 53 132 , 5 0

0 3. 9 8E

-0 3 1 .80 2.75 6, 8 75 .00 2. 06 E-0 4 0. 09 4 7.75 19,375 5 . 81E -04 0. 264 

## NA NA N A NA NA NA NA NA NA N A N A NA NA NA NA NA NA N A N A NA NA N A NA NA 6 15,000 4. 50 E-0 4 0 . 20 4 1 1 27 , 5 00 8 .25 E -0 4 0 . 374 2 5 , 000 1 . 50 E-0 4 0 . 068 55 1 3 7,500 4 . 13 E -03 1 . 87 95.75 2 39 , 375 7 . 1 8E-03 3. 26 128 5.25 3,213 , 125 9 .6 4 E

-02 4 3.7 - - 2n d 

### Amendment Total Over the D urat ion of the EUP Amt o f P I P P I P A mt o f P IP P I P P I P Po t ato Ma t e ri a l P I P Mater i a l A cres S eed ( lb ) A c res Pota t o l b A l gAI Seed ( l b ) l b A l g A I 1 0 25 ,000 7. 5 0E-0 4 0 . 34 0 

### 10 25 , 00 0 7.50 E -0 4 0 .3 4 0 50 125 ,0 0 0 3.75 E-03 1 . 70 5 0 125 , 00 0 3.75 E - 03 1 . 70 10 2 5,00 0 7. 50 E -0 4 0 . 3 4

0 1 0 25,000 7. 50 E -0 4 0.3 4 0 50 1 2 5,000 3 .75 E - 03 1 . 70 55 125,00 0 4. 13E -03 1 .87 1 0 25 ,000 7 . 50 E -0 4 0.3 4 0 1 0 2 5 ,000 7. 50 E-0 4 0.3 4 0 7 00 1 ,750 ,000 5 . 25 E -02 23.8 756 1 ,890 ,000 5. 67 E-02 25 . 7 1 0 2 5,000 7 . 5 0E -0 4 0 .3 4 0 10 2 5,000 7. 5 0 E

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

0 1 0 2 5,000 7 .5 0 E

-0 4 0 .34 0 10 25 ,000 7. 50E-0 4 0. 3 4

0 30 7 5,000 2 .2 5E

-0 3 1.0 2 30 7 5, 000 2.2 5E -03 1.02 600 1 , 500 ,000 4 .50 E-02 2 0 .4 669 .5 1 ,673,750 5.0 2E -02 22 .8 300 7 5

0,000 2 .25E -02 1 0 . 2 31 5 787,500 2.36 E -02 1 0 .7 50 125 ,0 00 3 .7 5E

-03 1 .70 5 0 125,000 3.75 E -03 1 . 70 50 1 25 ,000 3. 75E -03 1 .7 0 5 4 135,000 4.05 E -03 1. 8 4 130 3 2 5, 000 9 .75 E -03 4.42 1 4 9.5 373,750 1 . 1 2E -02 5 . 09 800 2,0 0 0, 000 6 .00 E -02 27.2 1 ,860 4 ,65 0 ,000 1 .40E -0 1 63.3 10 25 , 000 7.50 E -0 4 0. 3 40 

### 10 2 5,000 7.50 E -04 0.3 40 4 00 1,000 , 000 3.00 E -0 2 1 3.6 410 1 ,0 2 5,000 3.08 E - 02 1 3.9 5 0 125, 000 3.75E -03 1 .70 5 4 1 35,000 4.0 5E

-03 1 .8 4 4 00 1 ,000,000 3.00 E-02 1 3.6 4 53 . 5 1 , 1 33 ,750 3.4 0E -02 1 5 .4 30 7 5 ,000 2. 2 5E-03 1 . 0 2 4 0.5 1 01 , 2 5

0 3.04E-03 1 .3 8 10 2 5 ,000 7. 50 E-04 0 . 3 4

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

0

0 3.75 E -03 1 . 70 50 1 25 ,000 3.75 E -03 1 .70 7 00 1 ,750 ,00 0 5. 2 5E

- 02 2 3.8 700 1 ,7 5 0, 000 5. 25E -02 2 3. 8 1 3

0 32 5 ,000 9. 75 E - 03 4.42 1 4 7 367 , 5 00 1 . 10 E -02 5.00 600 1,500 ,000 4 .50 E -02 20.4 657 1 , 6 4

2,50 0 4.93E-0 2 2 2.4 5,200 1 3,000 ,000 3.90E-0 1 177 6 , 58 1 1 6,452 , 500 4 .9E - 01 2 24

### Table 5 Bv Prat 

## . I : A A 

### t of Potato - Seed ~ lb ) 

### dA t of PIP Protein { lb and

- 

# - Original Permit 1 51 

### Amendment 2n d 

### Amendment Total Over the Duration of the EUP P

ro tocol Am t of PIP Amt of PIP Amt of P I P A mt o f PIP P I P Ma teri a l PIP Ma terial PIP Ma terial PIP PIP Ma ter i al P I P P ot ato P I P Pota to P I P P ot ato Po ta to O ri g i n a l and 1 s1 2nd Ac re s Ac r es Acres Acres See d (l b ) l b Al gAI 

### -- S eed ( l b ) l b A l g A I 

### -- Se ed ( l b ) l b Al g Al 

# -- Seed ( lb ) l b Al g Al Amend ment Amend men t R

p i -vn t1 Lat e Blig ht Line Selection 5 . 5 13 ,750 4. 1 3 E

-0 4 0. 1 87 6 15 ,000 4.50 E -04 0 . 204 26.5 66 , 250 1. 99 E -0 3 0 . 9 0 1 R

p i-vn t1 Lat e Blight**~** R es e arch & Effica cy an d 0.75 1 ,875 . 00 5.63 E -0 5 0.026 0 .75 1, 875 5 .63 E -05 0.026 15 37 , 500 1 . 1 3 E

-03 0 .5 1 0 1 . 50 3 ,750 1 . 1 3 E

-0 4 0. 05 1 S

pe cificity Develo p men t Rpi-vnt 1 La te Blig ht 20 50 ,000 1 .50 E -03 0 .680 96 24 0,000 7 .2

0 E-03 3. 27 11 6.00 290,000 8.? 0 E

-03 3 .95 D

e monst r ation Agronom y A~ronomy R p ;.,m/1 

### t.,O Bl0 h~ Opt i mizatio n O ptimization 3. 5 8,750 .00 2 .6 3E -0 4 0. 11 9 3 .5 8 ,750 2.6 3 E

-04 0. 11 9 3 5 87,500 2. 63 E -03 1. 19 4 2.0 105,000 3. 15E-03 1.43 R p ;~11 

# c,• Blgh } Env ir onm en ta l R i s

k R ulato 66 165,000 4 .95 E -03 2. 25 1 , 1 79 2 ,947 ,500 8.84 E -02 40 . 1 5, 150 12 ,875 ,000 3 . 86 E -01 1 7 5. 20 6 ,3 95 1 5, 98 7, 5 00 4.80 E -01 2 17 . 56 A

ss e ssm ent a nd eg ry Composit i o n TOTAL 98 .75 239 ,375 7. 1 8E-03 3.26 1 ,285.25 3 ,213, 1 25 9 .6

2E -02 4 3.7 5, 2 00 1 3,000,000 3. 90 E -0 1 1 76 .90 6 ,581 1 6, 45 2,50 0 4.94E -0 1 223 .88



### DER- 7

### REFERENCES Simplot. 2014. E x perimental Program Submission for E x perimental Use Permit 8771 . Product: Potato Late Blight Resistance Gene ( also known as Rpi- v nt1) . 

### J . R. Simplot Company Plant Sciences . Boise , Idaho . January 20 , 2014 . 104 pp . MRID 493166-09. Simplot. 2015a . Modified Section G for E x perimental Use Permit 8917-EUP-E . Product: Potato Late Bl i ght Res i stance Gene (also known as Rpi-vnt1 ) . J . R. Simplot Company Plant Sciences . Boise , Idaho . January 27 , 2015 . 1 9 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 . Environmenta l Protection Agency . RE : ex tension of EUP 8917-EUP-2 . June 30 , 2015 . 31 pp . Simplot. 2015c . 2016 E x perimental Use Permit 8917-EUP-G , Section G: pSIM1678 (conta i ning Rpi-vnt1 ) Transformed Potato . E x perimental 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 gen e 

### that e x presses the VNT1 protein in Innate TM 2 . 0 branded potato varieties ) . Section G Acreage Calculations . MRID 493166-09 . DP 

## N2 : 418275 . Decision 

## N2 : 48597 7 . 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 e x presses the VNT1 protein in InnateTM 2.0 branded potato var i eties ). 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 .

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