UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHI N GT O N , D . C . 204 60



### Ms. Stephanie Burton U.S. Regulatory Manager, Corn Dow AgroSciences LLC 9330 Zionsville Road Indianapolis , IN 46268-1054 

# DEC 1 8 2014 OFFICE OF CHEM I CAL SAFETY AND POLLUTION PREVENTION



### Re: Corn plant-incorporated protectants (PIPs) with MON 87411 (DvSnt7 dsRNA and Bt 

### Cry3Bb1 protein) , MON 89034 (Bt 

### CrylA.105 and Cry2Ab2 proteins) , MON 880 17 (Bt 

### Cry3Bb1 protein), TC1507 (Bt 

### Cry1F protein), and/or DAS-59122-7 (Bt 

### Cry34Ab1 and Cry35Abl proteins) EPA Experimental Use Permit No.: 

### 627 19-EUP-6 6 Decision No.: 

### 49162 1 Application Dated: 

### May 27, 20 14 Effective Dates: 

### Immediately through March 31, 2016 (includes planting and associated activities, e.g . , coll ect ion of field data, harvesting, and processing) Quantity Authorized: 

### 19.63 pounds (8,905 grams) of active ingredient (1.139, 0.3416, 1.961 x 10-6, 1.309, 14.07, 0.3443, and 2.428 pounds of Bt 

### Cry1A.105 protein, Bt 

### Cry2Ab2 protein, DvSnt7 dsRNA, Bt 

### Cry1F protein, Bt 

### Cry34Ab1 protein, Bt 

### Cry35Abl protein, and Bt 

### Cry3Bb 1 protein, respectively) in 1,113,853 pounds of seed Acres: 

### 9,038 acres, including PIP (unregistered= 2,454; registered = 3,907; total= 6,361), nonPIP (1 , 061), and border (1,616) acreage Dear Ms. Burton: On the basis of the information furnished by you, the U.S. Environmental Protection Agency (EPA) hereby issues the subject Experimental Use Permit (EUP) under section 5 of the Federal Insecticide , Fungicide, and Rodenticide Act (FIFRA) to test MON 87411 (DvSnt7 dsRNA and Bacillus thuringiensis (Bt) 

### Cry3Bbl protein) alone or in combination with the following plant-incorporated protectants (PIPs): MON 89034 (Bt 

### Cry1A.105 and Cry2Ab2 proteins), MON 88017 (Bt 

### Cry3Bbl protein), TC1507 (Bt 

### Cry I F protein) , and/or DAS-59122-7 (Bt 

### Cry3 4Abl and Cry35Ab1 proteins). This EUP is authorized only in the Commonwealth of Puerto Rico (PR) and in the States of Arkansas (AR), Hawaii (HI), Illinois (IL), Indiana (IN), Iowa (IA), Kansas (KS), Minnesota (MN), Mis sour i (MO), Nebraska (NE), North Dakota (ND), Ohio (OH), Pennsylvania (PA), South Dakota (SD), Texas (TX), and Wisconsin (WI) for inbred and hybrid development, nursery observations, and testing and collection ofproduct charact eriza tion data.

### EPA EUP No. 62719-EUP-66 Decision No. 491621 Shipment and/or use under this permit are subject to the provisions of 40 CFR Part 172. The Bt 

### proteins to be used in this EUP include CrylA.l05, Cry2Ab2, CrylF, Cry3Bbl, Cry34Abl, and Cry35Abl. The EPA previously determined the environmental and human health safety of these proteins and exempted them from the requirement of a tolerance as fo llows: 40 CFR 

### §§ 174 .502(a) (Bt 

### Cry1A.105 protein), 174.506 (Bt 

### Cry34Abl and Cry35Ab1 proteins), 1:74 . 5 18 (Bt 

### Cry3Bb1 protein), 174.519 (Bt 

### Cry2Ab2 protein), and 174.520 (Bt 

### Cry 1 F protein). The EPA has also established a permanent tolerance exemption for nucleic acids; this includes DvSnf7 dsRNA that is expressed in MON 87411 (40 CFR 

### § 174. 507) . The marker proteins phosphinothricin acetyltransferase (PAT), CP4 enolpyruvylshikimate-3- phosphate synthase (CP4 EPSPS), and phosphomannose isomerase (PMI) are also exempt from the requirement of a tolerance at 40 CFR 

### §§ 174.522, 174.523, and 174.527, respectively. 

### Harvested plant material from PIPs that have not yet been commercially registered must not be allowed to enter the food or feed supply. Prior to shipment and/or use of the subject com, you must consult with the pesticide regulatory officials and, if applicable, the biotechnology regulatory officials of the states 1 

### in which you will conduct your experimental program, and obtain a state permit or license if such is required. Issuance of this Federal permit does not negate the need for permission from individual states. Prior to initiating this experimental program in any state, you are required to notify the lead agency ofthe states in which you will conduct your experimental program of the specific testing program (when, where, how much, etc.). Failure to do so may result in revocation or modification of this EUP . You must comply with all requirements of the U.S. Department ofAgriculture's Animal and Plant He alth Inspection Service as they apply to the proposed testing. You must provide notice to the state pesticide regulatory agency at least 72 hours before you plant the experimental use PIPs. You must also provide a copy of this authorization letter, the stamped, accepted EUP label, and a non -confidential portion of the Section G Experimental Program to all cooperators, participants , and users prior to initial use of the experimenta l use PIPs in accordance with this EUP. The EPA will notify the relevant EPA Regions ofthe approval ofthis EUP by sending copies ofthis authorization letter to them. Conditions under which the EPA is issuing this EUP are as follows: 1. The acres, amount of pesticide, and amount of seed to be used shall not exceed the quantity authorized by this EUP. See Tables 1, 2, 3, 4,**and~** 

### for specific details. a e . T bl I S ummaryofth A e crea2e among on- 

### ' or er, an N PIP B d dPIP Acres State Unregistered Registered Total I Overall State I PIP PIP I PIP Non-PIP Border Total AR 12 24 36 10 2 48 HI 172 329 501 58 59 618 IL 206 330 536 98 178 812 I N 263 335 598 108 198 904 l A 268 335 603 103 188 894 KS 22 38 60 18 18 96
1 For the purpose of this Jetter, the terms "state ," " states, " and "state-by-state " includes the Commonwealth of Puerto Rico. 

### 2

### EPA EUP No. 62719-EUP-66 Deci sion No. 491621 State Unregistered 

### PIP MN 211 MO 19 NE 2 1 2 ND 143 OH 143 PA 12 PR 210 SD 196 TX 169 W I 196 TOTAL : 2,454 Registered l Total 

### PIP PIP 328 539 33 52 332 544 269 412 269 412 24 36 385 595 307 503 262 43 1 307 503 3,90 7 6,36 1 T b l 2

a e . Acr ea2e D .. b . b 1 s tn uhon etween 

### I PI P2 

### Non-PIP 98 18 83 68 68 10 80 78 80 83 1,06 1 Ex p e nm e n ta State Registered Unregistered Total Registered Un r egister ed Total 

### PI P2 AR 0 0 0 24 HI 124 60 184 205 I L 165 90 255 165 I N 165 90 255 170 lA 165 90 255 170 KS 0 0 0 38 MN 165 90 255 163 MO 0 0 0 33 

### NE 165 90 255 167 ND 165 90 255 104 OH 165 90 255 104 PA 0 0 0 24 P R 165 90 255 220 SD 165 90 255 142 TX 165 90 255 97 WI 165 90 255 142 Total : 1,939 1,050 2,989 1,968 Notes: P I = Protocol 1 (breedmg and assoc iated data) P2 = Pro t ocol 2 (characterization) 12 36 112 3 17 1 16 281 173 343 178 348 22 60 121 284 19 52 122 289 53 157 53 157 12 36 120 340 106 248 79 176 106 248 1,404 3,372



### 3 Overall State Border Total

178 815 18 88 1 18 745 93 573 93 573 2 48 100 775 108 689 145 656 118 704 1,6 16 9, 03 8 I P r otoco s TOTAL (Pl+P2) Registered Unregistered Total PI+P2 24 12 36 329 172 501 330 206 536 335 263 598 335 268 603 3 8 22 60 328 2 1 1 539 33 19 52 332 212 544 269 143 412 269 143 412 24 12 36 3 85 210 595 307 196 503 262 169 431 307 196 503 3 ,907 2,454 6,361E P A E U P No. 627 1 9-EU P -66

D ecis i on No. 49 1 62 1 **~--** -- - - - - ---- -- - --

r r . Registered

**P~** -,

I I

I I .... i STATE ":- **~**

.... :g

I ! z 0 - 0

a .... .. ..

**~**

C§

**~**

.... **~ ~** 

-

I

I I - .. I

**~**

.... 81 **~**
:g 00

z

z - **~** u z z

0

0 (.J 0 0

a

a .... 0 .... a a

AR 2 2 2 2 2 2 4

H I 26 26 26 26 27 27 5 9

I L 27 23 26 35 32 32 31

I N 26 23 26 35 32 32 3 4

lA 26 23 26 35 32 32 3 4

KS 2 2 2 4 4 4 4

M N 27 23 26 33 32 32 31

MO 2 2 2 5 3 3 4

N E 28 23 27 35 32 32 31

N D 23 23 23 2 5 24 24 31

OH 23 23 23 2 5 24 24 31

PA 2 2 2 2 2 2 4

PR 35 35 35 35 35 35 35

S D 27 23 26 30 29 29 3 1

T X 25 21 24 25 24 24 27

W I 27 23 26 · 30 29 2 9 3 1
Tota l: 328 297 322 382 363 3 6 3 422

N otes: PI = Prot ocol I (bree d i n g and assoc i a t e d d ata )

P 2 = Pro toco l 2 (cha r acterizat i o n ) ":-

I

.... **~**
:g

-
**~** 81 rh

.. "'
**~** .. 0 ........

.... 1 1a

C> i ..
**~**

.... :g

z z81

0

z 0 ou,

0 • 2 .... ac

..

.. ,.o ...... **~ ~·**  **~ ~**  ..

**~ ~~** 

I I!

00 z

Zc/) z zo

0

oc 0Ola

20 a a>< 2 2 2 2

3 1 27 27 2 7
29 32 31 32 32 32 31 32
32 32 31 32

4 4 4 4
29 32 31 32 3 3 3 3
29 32 31 32
24 24 24 24
24 24 24 24 2 2 2 2
35 35 35 35
26 29 28 29
21 24 23 24 26 29 28 29

3 49 363 355 363 -- - - - - -- -- - - --- -- i

Unregistered PIPs -

- - **·r-~**
":-

..

I ....

I :g

**~** ....

(

- - :g
(.J

81 - (.J
....

rh ....

":- .. "' .. I

**~**

- 0 - - - '

; ;:! .. ;:!

.... 00 .... I

:g

**~** 00

z z I

0 0 0 0 •

.... .... a

..

.. .. .. ......

I

- - - **~** .... **~· ~** 

**~**

- **~ ~**  **~ ~~** 

;:! I Q. **~** a:

'

0 **~** I cJ

00 00 00 00 z z z z z

zu, Iii

i ....

;::) 0 i 0 0 0 oc ::::» 0 0

II) a a a ::E ao II) .... ....

24

2 2 2 2 2 2 1 2 36 10 2 4 8 --

329 26 26 39 27 27 2 7 172 50 1 58 59 6 18

330 33 25 33 31 31 53 20 6 536 98 1 78 8 1 2

335 40 26 65 35 32 65 263 598 108 198 904

335 45 26 65 35 32 65 268 603 i03 188 894

38 4 2 4 4 4 4 22 60 18 18 96

328 38 25 33 3 1 31 53 211 539 98 i 78 815

33 5 2 3 3 3 3 1 9 52 18 18 88

332 39 25 33 31 3 1 53 212 544 83 11 8 745

269 24 23 24 24 24 24 143 412 68 93 573

269 24 23 24 24 24 24 143 4i2 68 93 573

24 2 2 2 2 2 2 12 36 1 0 2 48

385 35 35 35 35 35 35 210 595 80 100 775

307 35 25 30 28 28 50 i96 503 78 i08 689

262 30 23 25 23 23 4 5 169 431 80 145 656

307 35 25 30 2 8 28 50 1 96 503 83 118 704

3 , 907 417 3 1 5 4 4 7 363 357 555 2,454 6,36i 1

, 06 1 i,616 9,03 8

4

### EPA EUP No. 62719-EU P-66 Deci s ion No . 491621 T able 4. Total Pounds o f Seed Expected to be Used for Each Protein (for PI + P2 Acres Com bine

AR HI IL IN lA KS 1. State CrylA.lOS Cry2Ab2 DvSnf7 CrytF Cry34Abl Cry35Abl Cry3bl AR 940 940 564 1, 034 752 752 1,034 HI 13 ,066 13,066 8 ,084 14 ,2 88 10 , 669 10 ,6 69 14 , 570 IL 14, 006 14 ,006 9, 682 15 ,087 13 , 113 13 , 113 16, 638 IN 14, 993 14 , 993 12, 361 16,2 15 15,228 15 ,228 19 ,458 lA 14, 993 14, 993 12, 596 16, 215 15,228 15 ,22 8 19,693 KS 1, 598 1, 598 1 ,034 1, 692 1, 504 1 ,5 04 1; 880 MN 14 ,006 14 ,006 9,917 15 ,087 13 ,019 13 ,019 16,873 MO 1 ,269 1,269 89 3 1,3 63 1,222 1,222 1, 551 NE 14,053 14 ,053 9 , 964 15 , 134 13 , 113 13 , 11 3 16,920 ND 10,434 10,434 6 ,72 1 1 1, 5 15 9,071 9, 07 1 12,3 14 OH 10 ,43 4 10 ,434 6,721 11 , 515 9,071 9 ,07 1 12 , 3 14 PA 940 940 564 1,03 4 752 752 1 ,03 4 PR 14 , 805 14, 805 9 , 870 16,450 13 , 160 13,160 18 ,095 SD 13,0 19 13 ,019 9 , 212 14, 1 00 11,891 ll , 891 15 , 604 TX 11 , 092 1 1,092 7,943 12,079 10,0 II 10 ,0 1 1 13,301 WI 13,019 13 ,019 9 , 212 14, 100 11 , 891 1 1, 89 1 15,604 Total: 162,667 162 , 667 115 ,338 1 76 , 908 149,695 149 , 695 196,883 No tes: PI =Protoc o l I (breedmg and assoc1ated data) P2 = Protocol 2 (characteriza tion) CryiA.lOS Cry2Ab2 DvSnf7 CryiF Ib s : grams: lbs : g rams: 1bs: grams: lbs: g rams: lbs: grams: lbs: grams : 

### 5 Pounds and Gra Cry34Abt Cry35Abl Cry3bt

0 .07069 0.01344

32.06 6. 097 d)

### EPA EUP No. 62719-EUP-66 Decision No. 491621 CrylA.lOS DvSnfi Cry1F Cry34Abl Cry35Abl Cry3bl MN lbs: 0.09804 0 .02941 1.686 x 10·7 0.1116 MO lbs: NE lbs: grams: ND lbs: OH Jbs: PA lbs: PR lbs: SD lbs: TX lbs: WI lbs: TOTA L lbs: l.l39 0.3416 1.961 X 10· 6 1.309 grams: 516 . 5 154. 9 8. 894 X 1()· 4 593 . 8 Notes: PI =Protocol I (breeding and associated data) P2 = Protocol2 (characterization) 1 .224 0.02994 0.2076

14.07 0.3443 2.428 6,383 156.2 l,/01 

### 2. You will immediately notify the EPA of any findings from the experimental uses that have a bearing on safety (i.e., the EPA requires reporting of any adverse effects from the use of o r exposure to pesticides). You will also keep records of production, distribution, and performance, and make the records available on request to any authorized officer or employee ofthe EPA. 3. You must provide a final report to the EPA within 180 days of the expiration ofthe permit. The fmal report must include all ofthe items set forth in 40 CFR 

### § 172.8(b)(2) and report on the following information: • A state-by -state breakdown of actual acreage per protocol; 

### 6

### EPA EUP No. 62719-EUP-66 Decision No. 491621 • A state-by-state breakdown of actual locations per protocol; • Any changes to the stated program, including approved changes to study protocols; • A list of specific counties where studies took place. 4. Per 40 CFR 

### § 172.4(b )( 1 )(

v), you must provide to the EPA the name and street address of all cooperators as soon as available and prior to planting. You must record any changes to this information in an updated report and submit that report to the EPA prior to planting. 5. The label submitted in connection with this application is acceptable and must accompany all shipments of seed under this EUP subsequent to recei ving this approval. Labels must also be in 

### the possession of the user at the time of planting. 

### A stamped, accepted copy of the label is enclosed for your records. 6. This EUP is not a limited seed increase registration under section 3 of FIFRA , and plantings solely for commercial seed increase are prohibited. 7. 

### The PIP test plots under this permit must not be within Y-t 

### mile of endangered or threatened species in the Lepidoptera and Coleoptera insect orders (as listed by the U.S. Fish and Wildlife Service) or their Critical Habitats. You must provide the EPA with locations of test plots and an analysis of proximity of the test plots to endangered or threatened Lepidoptera and Coleoptera species and their designated Critical Habitats prior to planting. Should you have questions or concerns regarding the issuance ofthis permit, please contact Ms. Jeannine Kausch of the Biopesticides and Pollution Prevention Divi sion by email 

### (kauschjeannine@epa.gov) or by phone (703-347-8920).

irector Office of Pesticide Prog rams
Enclosures cc: Adrian Enache and Tracy Truesdale, EPA Region 2 (Puerto Rico) Fa tima El-Abdaoui, EPA Reg ion 3 (Pennsylvania) Terence Bonace and Seth Dibblee, EPA Region 5 (Illinois , Indiana , M innesota , Ohio, and Wisconsin) Eugene Thilsted , EPA Region 6 (Arkansas and Texas) Jamie Green , EPA Region 7 (Iowa, Kansas, Missouri, and Nebraska) Linda Himmelbauer, EPA Region 8 (North Dakota and South Dakota) Patti TenBrook, EPA Re gion 9 (Hawaii) 

### 7