### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D

. C

. 20460



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

# MAR 0 4 

# 2016 O F F I CE OF CHEMI C AL SAFETY AND PO L LUTION PREVENTION



### Re: Experimental Use Permit Amendment and Extension for Com Plant-incorporated Protectants (PIPs) with MON 87411 (DvSnf7 

### dsRNA and Bacillus thuringiensis (Bt) 

### Cry3Bbl protein) , MON 89034 (Bt 

### CrylA.105 and Bt 

### Cry2Ab2 proteins) , MON 88017 (Bt 

### Cry3Bbl protein) , TC1507 (Bt 

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

### Cry34Abl and Bt 

### Cry35Abl proteins) EPA Experimental Use Permit No.: 62719-EUP-66 Decision No.: 511429 Application Dated: November 23, 2015 Effective Dates: Immediately through March 31, 2017 (includes planting and associated activities, e.g. , collection of field data, harvesting , and processing) Quantity Authorized: 8 .5 09 pounds (3,860 grams) of active ingredient (0.399, 0.120, 9.364 x 

## 10- 1
, 

### 0.448, 6

.22, 0.152, and 1.17 pounds ofBt 

### Cry 1A.I05 protein , Bt 

### Cry2Ab2 protein , DvSnf7 

### dsRNA , Bt 

### CrylF protein , Bt 

### Cry34Abl protein , Bt 

### Cry35Abl protein , and Bt 

### Cry3Bbl protein , respectively) in 456 ,699 pounds of seed Acres: 5 , 844 acres, including PIP (unregistered = 965; registered = 1 ,695; total= 2,660) , non-PIP (1 , 312), and border (1,872) acreage Dear Ms. Burton: On the basis of the information furnished by you, the U.S. Environmental Protection Agency (EPA) hereby amends and extends the subject Experimental Use Permit (EUP) under section 5 of the Federal Insecticide , Fungicide, and Rodenticide Act (FIFRA) to test MON 87411 (DvSnf7 

### dsRNA and Bacillus thuringiensis (Bt) 

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

### CrylA.105 and Bt 

### Cry2Ab2 proteins) , MON 88017 (Bt 

### Cry3Bbl protein) , TC1507 (Bt 

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

### Cry34Abl and Bt 

### Cry35Abl proteins)

. This EUP is authorized only in the Commonwealth of Puerto Rico (PR) and in the States of Arkansas (AR), California (CA), Georgia (GA), Hawaii (HI), Illinois (IL), Indiana (IN) , Iowa (IA), Kansa s (KS), Minneso ta (MN) , Missouri (MO) , Nebra ska (NE) , North Carolina (NC) , North Dakota (ND), Ohio (OH), Oklahoma (OK), Pennsylvania (PA) , South Carolina (SC) , South Dakota (SD) , Texas (TX), and Wisconsin (WI) for inbred and hybrid development , nursery observations, and testing and c ollection of product characterization data

.

### EPA EUP No. 62719-EUP-66 Decision No

. 511429 Shipment and/or u se under this permit are subject to the provision s of 40 CFR Part 172. The Bt 

### proteins to be use d in this EUP include C ry l A.105, Cry2Ab2, CrylF, Cry3Bbl , Cry34Abl , and Cry35Abl. The EPA prev iously determined the environmental and human health safety of thes e proteins and exempted them from the requirement of a tolerance as follows: 40 CFR §§ l 74.502(a) (Bt 

### CrylA.105 protein) , 174

. 504 (Bt 

### Cryl F protein) , 174

. 506 (Bt 

### Cry34Abl and Bt 

### Cry35Abl proteins) , 174.518 (Bt 

### Cry3Bbl protein), and l 74.5 l 9(a) (Bt 

### Cry2Ab2 protein). Jhe**~p** 

### AJws also estab li shed a permanent tolerance exemption for nucleic acids; this includes 

# n $ sn}7 dsRNA that is expressed in MON 87411 (40 CFR § 174.507). T he marker proteins phosphinothricin acety ltransferase (PAT) , CP4 enolpyruvy lshikimate

- 3

- phosphate synth ase (CP4 EPSPS), and phosphomannose isomerase (PMI) are also exempt from the requirement of a tolerance at 40 CFR §§ 174

. 522 and 174 .523, respectively. 

### Harvested plant material from PIPs that hav e not yet been commercially regi s t ered must not be allowed to enter the food or fe e d s upply. Prior to shipment and/or use of the subject com, yo u must consu lt with the pesticide regulatory officia ls and, if applicab le, the biotechnology regulatory official s of the states 1 

### in which yo u wi ll conduct your experimental program , and obtain a state permit or license if such is required. Amendment and extension 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 req ui red to notify the lead agency of the states in which you will conduct your experimenta l program of the specific testing program (when, where, how much , etc.)

. Fai lure to do so m ay result in revocation or modification of this EUP. You must comply with all requirements of the U .S. Department of Agric ulture's Animal and Plant Health Inspection Service as they apply to the proposed testing

. Yo u must provide notice to the state pesticide regulatory agency at least 72 hours before yo u plant the experimental u se 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 experimental use PIPs in accordance with this EUP

. The EPA wi ll notify the relevant EPA Regions of the approval of this EUP by sending copies of this auth orization l etter to them. Conditions under which the EPA is amending and extending this EUP are as follows:
I

. 

### The acres , amount of pesticide , and amount of seed to be u sed shall not exceed the quantit y authori ze d by this EUP. See Tab les 1 , 2, 3 , 4 , and 5 for specific d etails

. T bl 1 S

a e . f h A ummary o t
. e creae:e a m o ne: PLP N PLP d B d Pl 

### f 

## ' o n - , an or er a n me: s State Unregistered Registered Total PIP PIP PIP Non-PIP Border Overall State Total AR 

### 42 78 1 20 50 100 270 CA 

### 8 20 28 50 20 98 GA 

### 42 78 120 50 100 270 HI 

### 84 111 195 130 40 365 IL 

### 93 152 245 90 2 10 545 IN 

### 112 173 285 106 226 6 1 7

1 For the purpose of thi s l etter, the terms " s tate ," "states , " and " s tate-by- state " includ e the Co mm o nwealth of Puen o Ri co . 

### 2

### EPA EUP No. 62719-EUP-66 Decision No. 511429

State Unregistered Reg istered PIP PIP IA 

### 104 168 KS 

### 8 20 MN 

### 67 101 MO 

### 8 20 NE 

### 64 111 NC 

### 8 20 ND 

### 30 68 OH 

### 36 68 OK 

### 8 20 PA 

### 8 20 

### PR 75 155 SC 

### 42 78 SD 

### 46 80 TX 

### 38 76 WI 

### 42 78 TOTAL: 

### 965 1,695 T otal PIP Non-PIP Border Overall State Total 

### 272 86 206 564 28 50 20 98 168 60 110 338 2 8 50 20 98 175 60 110 345 28 50 20 98 98 50 100 248 104 50 100 254 28 50 20 98 28 50 20 98 230 80 50 360 120 50 100 270 126 50 100 276 114 50 100 264 120 50 100 270 2,660 1 ,312 1,872 5,844



### 3

### EPA EUP No. 627 1 9-EUP-66 Decision No. 511429 Table 2

. Acreae:e Distribution between Experimental Protocols (Pl and P2) Pl State Registered Unregistered Total Pl Reg istered AR 0 0 0 78 CA 0 0 0 20 GA 0 0 0 78 HI 75 50 1 25 36 IL 

### 30 17 47 122 IN 

### 40 29 69 133 IA 40 29 69 128 KS 0 0 0 20 MN 1 5 II 

### 26 86 MO 0 0 0 20 NE 15 II 

### 26 96 NC 0 0 0 20 ND 0 0 0 68 OH 0 0 0 68 OK 0 0 0 20 PA 0 0 0 20 PR 75 35 110 80 SC 0 0 0 78 SD 0 0 0 80 TX 

### 0 0 0 76 WI 

### 0 0 0 78 TOTAL: 

### 290 182 472 1,405 Notes: Pl = Protocol I 

### (breeding and as sociated data) P2 = Protocol 2 (characteri zation) P2 TOTAL (Pl+P2) Total Unregistered P2 Registered Unregistered 42 120 78 42 8 28 20 8 42 120 78 42 34 70 111 84 76 198 152 93 83 216 173 11 2 75 203 168 !04 8 28 20 8 56 142 IOI 

### 67 8 28 20 8 53 149 111 64 8 28 20 8 30 98 68 30 36 104 68 36 8 28 20 8 8 28 20 8 40 120 155 75 42 120 78 42 46 1 26 80 46 38 114 76 38 42 120 78 42 783 2,188 1,695 965



### 4 Total Pl+P2

120 28 120 195 245 285 272 28 168 28 175 28 98 104 28 28 230 120 126 114 120 2,660

### E PA EUP No. 62719

- EUP

- 66 Deci si on No

. 5114 29



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CA Pl 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I P2 2 I 2 2 2 2 I I I I I I I I I 2 0 I I I I I I 2 8 28 P l + P2 2 I 2 2 2 2 I I I I I I I I I 20 I I I I I I 2 8 2 8
GA P l 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 7 8 6 1 0 6 4 4 4 8 42 12 0 • P l + P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 1 0 6 4 4 4 8 42 12 0 

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P2 8 6 8 20 8 8 1 2 8 6 8 6 8 6 8 8 128 8 25 8 6 8 8 1 2 75 203 I Pl + P2 10 8 10 24 1 0 10 14 18 8 1 0 8 1 0 8 1 0 1 0 1 6 8 1 2 4 0 1 0 8 10 1 0 14 • 104 272 

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KS Pl 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I P2 2 I 2 2 2

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## MNP**I~** P2 4 P l +P2 5 I I I 6 4 6 6 5 11 I 26 4 5 4 1 0 I 4 12 6 6 6 4 4 13 7 5 7 7 7 1 5 I I 5 8 9 56 I 142 67 I 168 11 I 5 7 5 5 86 I 6 20 6 6 6 5 4 I OI I 7 25 7 7 7 7

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NC P l 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 P2 2 I 2 2 2 2 I I I I I I I I I 20 I I I I I I 2 8 28 P l + P2 2 I 2 2 2 2 I I I I I I I I I 20 I I I I I I 2 8 28
N D Pl 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I P2 4 4 4 I 0 4 4 4 6 4 4 4 4 4 4 4 68 4 4 4 4 4 4 6 3 0 98 I P l + P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 4 68 4 4 4 4 4 4 6 30 98

NE P l I I I I I I I I I I I I I I I 1 5 I 5 I I I I I 11 26 I P2 6 4 6 12 6 6 I 0 6 4 6 4 6 4 6 I 0 96 6 1 5 6 4 6 6 I 0 53 149 I Pl + P2 7 5 7 1 3 7 7 11 7 5 7 5 7 5 7 II 11 1 7 20 7 5 7 7 1 1 64 175
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SC Pl 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 P2 4 4 4 I O 4 6 4 6 4 6 4 6 4 6 6 78 6 I O 6 4 4 4 8 42 120 Pl + P2 4 4 4 1 0 4 6 4 6 4 6 4 6 4 6 6 78 6 1 0 6 4 4 4 8 42 I2 0
SD P I 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I P2 4 4 4 I 0 4 6 6 6 4 6 4 6 4 6 6 80 6 I 0 6 4 6 6 8 46 12 6 I P l +P2 4 4 4 10 4 6 6 6 4 6 4 6 4 6 6 80 6 10 6 4 6 6 8 46 12 6**TXP I~**  P216 P I + P2 1 6 0 0 4 6 4 6 

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### EPA EUP No. 62719-EUP-66 Decision No. 511429

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### EPA EU P No. 627 1 9

- EU P- 66 Decision No. 5 11 429

Table 4. Tot a l P ou nd s o 

## r s E eed xp ected t o b U db P

. /RN e se •Y r o t em A a nd S ( f Pl P 2 A t a te o r 

### + c re a2e State CrylA.105 Cry2Ab2 

### DvSnj7 Cry l F AR 2 , 632 2 , 632 2 ,444 2 , 9 1 4 CA 6 11 6 11 470 705 GA 2 , 632 2 , 63 2 2 ,444 2,9 1 4 HI 3 , 854 3 , 854 4,230 3,666 IL 5 , 3 11 5,3 11 5,405 5,405 IN 5 ,5 46 5 , 546 6,627 5 , 828 IA 5 , 640 5,640 6 , 0 16 5 , 922 K S 6 11 6 11 470 705 MN 3 , 6 19 3 , 619 3 , 666 3 , 572 MO 6 11 6 11 470 705 NE 3 , 7 1 3 3 ,713 3 ,6 19 3 , 948 NC 6 11 6 11 470 705 ND 2 ,256 2,256 1 , 880 2 ,444 OH 2,256 2,256 2, 162 2 ,444 OK 6 11 6 11 470 705 PA 6 11 6 11 470 705 PR 5,405 5 ,405 3 , 995 5 , 640 SC 2 , 632 2,632 2,444 2 , 9 14 SD 2 , 820 2,820 2,632 3 , 008 TX 2,444 2, 444 2 , 256 2,726 WI 2,632 2,63 2 2 ,444 2 , 9 14 TOTAL: 57 , 058 57,058 55 , 084 60 ,48 9

Notes: P 1 = Protoco l I (b reed ing and assoc iate d dat a) P2 = Protoco l 2 (c h arac ter izati on) Cry34Abl C r y3 5Abl Cry3bl 3,008 3 , 008 4 ,3 24 658 658 846 3 , 008 3 , 008 4,324 5 ,452 5,452 7 , 097 6 ,2 5 1 6,25 1 9 , 07 1 7,050 7 ,050 1 0 ,293 6,674 6 , 674 9 , 682

658 658 846 4 ,37 1 4 , 371 6 , 298

658 658 846 4 , 5 12 4 , 51 2 6,345

658 658 846 2, 162 2, 162 3,384 2,444 2,444 3 , 666

658 658 846 658 658 846 5,405 5 ,405 7,990 3 , 008 3,008 4,324 3 , 196 3, 196 4,606 2,726 2,726 3 , 760 3 , 008 3 , 008 4 , 324 66,223 66 , 223 94 , 564 Combined)

Tabl e 5. Total Pound s of Act ive Ingredi e nt to be Used b y Protein/RNA a nd Sta t e (for Pl 

### + P2 Acrea e Combined)

State CrylA.105 Cry2Ab2 CrylF 

### DvSuf7 Cry34A bl Cry35Abl Cry3Bbl

A R 0.018 4 0.00553 0 .02 16 4

. 1 55 x 10 ' 8 0 .283 0.00692 0.0548 CA 0.00428 0 .00 12 8 0.00522 7.990 x 10 · 9 0.06 19 0

.00 15 1 0.0109 GA 0

. 0 1 84 0.00553 0.02 16 4

. 1 55 x I 0 · 3 0.283 0

.0069 2 0.0548 HI 0.0270 0.0080 9 0.0271 7. 19 1 x 10 · 8 0.51 2 0

. 0 12 5 0.086 3 IL 0

.0372 0. 01 12 0.0400 9. 1 89 x 10 · 3 0 .588 0

. 0 144 0. 1 IO I N 0

. 0388 0

. 01 16 0.043 1 1.1 27 x 10 · 1 0.663 0.0 162 0. 1 17 I A 0.0395 0.0 1 1 8 0. 043 8 1 .023 x 10 · 7 0

. 627 0

. 0 154 0

. 11 4 K S 0. 004 28 0

. 00 12 8 0. 00522 7.990 x 1 0 ' 9 0

.061 9 0.00 1 51 0.0 10 9 MN 0.0253 0.00760 0.0264 6 .232 x 10 · 8 0.41 1 0.0 101 0

. 0781 MO 0.00428 0

. 00 128 0 .00522 7.990 x 10· 9 0 .0 6 19 0.00 1 5 1 0

. 0 109 

### 9

### EPA EUP No

. 62719

- EUP

- 66 Decision No. 51 1429

S t a te CrytA.105 Cry2Ab2 

### NE 0.0260 0.00780 

### NC 0.00428 0

. 00128 

### N

D 0.0158 0.00474 

### OH 0.0158 0.00474 

### OK 0.00428 0.00128 

### PA 0.00428 0.00128 

### PR 0

. 0378 0.0 11 4 

### SC 0.0184 0.00553 

### SD 0.0 197 0.00592 TX 0 .01 7 1 0.005 1 3 WI 0.0 1 84 0.00553 TOTAL: 0

. 399 0.120 

### CrylF
0.0292 0.00522 0.0 1 81 0.0 1 8 1 0.00522 0.00522 0.04 17 0.02 1 6 0.0223 0.0202 0.02 1 6 0.448 Notes: PI = Protocol I (b reeding and associated data ) P2 = Protoco l 2 (characterizatio n) 

### DvS11.f7 Cry34Abl Cry35Abl Cry3Bbl
6.152 x 10· 3 0.424 0.0104 0

. 0799 7.990 x 10 · 9 0.0619 0.00 151 0.0109 3.196 x I 

# o -s 0.203 0.00 497 0.0434 3.675x 10· 8 0.230 0.00562 0.0450 7.990 x 10· 9 0

. 06 19 0.00 151 0.0109 7.990 x 10 · 9 0.06 19 0.00 151 0.0109 6.792 x 10- s 0.508 0.0124 0.110 4.155 x 10· 8 0.283 0.00692 0.0548 4.474 x 10- s 0.300 0.00735 0.0579 3.835 x 10 -s 0.256 0

. 00627 0.0455 4.155 x 10· 8 0.283 0.00692 0

. 0548 9

. 364 x 10· 7 6 .22 0.152 1.17

Total amount of protein/RNA in grams (g) is as fo ll ow s: Cry I A. I 05, 181 g ; C r y2Ab2, 5 4.4 g ; Cry I F, 203 g; DvSnj7, 4 .24 8 x I 0 · 4 g ; Cry34Ab I , 2 , 822 g ; C r y35Ab I , 69. l g; and C r y3 Bb I , 53 1 g. 

### 2. You w ill imm e di a te ly n otify the EPA of any findings fr om the ex perimental use s that h ave a bearing o n safety ( i. e., the EPA requires reporting of any adverse effects from the use of or exposure t o pesticides)

. You wi ll a l so keep record s of production , distribut ion , and pe rformance , and m ake th e records avai la bl e on request to an y a uth o ri ze d offi

. cer or employee of the EPA.
3. 

### You mu st provide a fina l report t o the E PA w ithin 1 80 da ys of the exp ira ti o n of th e permit. The fina l repo 1 1 must include a ll of the items set fo rth in 40 CFR 

## § l 72.8(b)(2) and report on the fo ll owing in format i o n:

• A s t a te -b y - state breakd own of actual ac r eage per prot ocol ; • A state

- by

- state breakdown of ac tu al locatio n s p er p rotoco l ; • Any changes to the s ta ted program , inclu d in g ap pro ved change s to st u dy pro toco ls ; and • A l ist of s p ec ific cou nti es w here stu di es took p l ace. 4. 

### Per 40 CF R 

## § l 72.4(b)( l )(v), you must pro vi de to the EPA the name and street add ress of all cooperators as soon as ava il ab le and pri o r to planting. You must reco rd any changes to this in form a ti on in an updated report and s ubmit that re p ort to the EPA prio r to planting.
5. 

### The labe l s ubmitted in co nn ec tion w ith thi s ap plic a tion is acceptabl e and mu s t accompa n y all s hipment s of seed und e r this EUP s ub seq ue nt to receiving thi s approval. Labels mu st a lso be in the possession of the u ser 

### at the time of plantin g. A s tamped, accepted copy of the l abel is enclosed fo r yo ur records.

1 0

### EPA EUP No. 62719-EUP-66 Decision No

. 511429 6. This EUP is not a lim ited seed increase registration under section 3 of FIFRA , and pl a ntings solely for commercial seed increase are prohibited

. 7. 

### The PIP test plots under this permit mu s t not be within 

### 'l-4 mile of endangered or threatened species in the Lepidoptera and Coleoptera insect orders (as listed by the U.S. F ish 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 Co leo ptera species and their designated Critical Habita ts prior to planting. Should you ha ve que s tions or concerns regardin g the ame ndment and extension of thi s permit , please contact Jeannine Kausch of the Biopesticides and Pollution Prevention Di v ision by emai l 

### (kausch.jeannin e@ epa . gov) or by phone ( 703-347-8920).
Sincerely,

irector ftice of Pesticide Programs

Enclo s ures

cc : Adrian En ac he and Tracy Tru es d a le, EPA Regio n 2 (P u erto Rico) Fatima E l-Abd ao ui , E PA Reg ion 3 ( Penn sy lvania) Amber Davi s, E PA Reg ion 4 (Georgia , North Caro lina , and South Carolina) Seth D i bbl ee , EPA Region 

### 5 (Illinois, Ind iana , Minnesota , Ohio , and Wisconsin) Eugene T hil ste d , EPA Region 6 (Arkansas , Oklahoma , and Texas) Jamie Green , E PA Region 7 ( Iowa , Kan sa s, Mis so ur i, a nd Nebraska) J e nni fer Schuller, EPA Region 8 (North D akota and South Dakota) Patti TenBrook , EPA Region 9 (California a nd Hawaii) 

### 11