### UNITED

. S TATES ENVIRONME N TAL PROTE C TIO N AGE NCY 

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February 29
, 2016 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMO R ANDUM

S UBJE C T :

FROM :

THR O UGH :

T O : EPA File Symbol 62719-EUP-66 (MON 87411 Combined Trait I nsect Control for Corn). Section G Calculations. Amendment to Original Experimental Use Permit.
Decision 

### N2 : 511429 DP 

### N2 : 431097

Kathleen Martin
, Chemist

, M

. S.E.S

. 

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. Jllarfif\ 2 

# /

-zq j \ \)

Microbial Products Branch Biopesticides and Pollution Prevention Division

Alan Reynolds
, Team Leader 

# 1 1 

# 1)

M i crobial Products Branch

# ~ 1 L..- 

### Biopesticides and Pollution Prevention Division

Jeannine Kausch
, Regulatory Action Leader Microbial Products Branch Biopesticides and Pollution Prevention Division

BACKGROUND A N D ACTION REQUESTED

In December 2014
, EPA issued an Experimental Use Permit (EUP) to Dow AgroSciences LLC to test a new plant-incorporated protectant (P l P) technology: MON 87 411
, combined trait insect control

corn , combinations necessary for their production
, and controls

. The Agency authorized Dow to test 17 PIP combinations in 16 localities (15 states plus the Commonwealth of Puerto Rico) using a maximum of 9
, 038 acres (6,361 PIP and 2
, 707 nonPIP)

.

Dow is now requesting to amend the 2014 permit by adding five states
, increasing the number of PIP event combinations from 17 to 22
, and decreasing the number of acres from 9
, 038 to 5
, 844

acres {2

, 660 PIP and 3
, 194 nonPIP & border)

. The attached Data Evaluation Record provides a review of the amended Section G calculations.

## Data Evaluation Record



# ... , ...... ,**J/l~\\b** I I • 

### Primary Review : Kathleen Martin Chemist 

## ;f. rll)tnll 

## 4J:Jl'I ' Secondary Review : Alan Reynolds
, Team Leader

STUDY TYPE : Section G calculations for an Amendment to 62719-EUP-66

TEST GUIDELINE : Not applicable

MRID : none

DP BARCODE : 431097

TEST MATERIAL: PIP event combinations made up of one or more of the following individual events : MON 89034
, MON 88017
, TC1507

, DAS-59122-7

, and MON 87411

. SPONSOR: Dow AgroSciences

, LLC

TESTING FACILITY : Not applicable

REPORT TITLE :**Reque~t** 

### to**A~en~** 

### Experimental Use Perm it 62719-EUP-66 Corn Plant**lncqy~o~t~ciPro)ec t~** **n~~** 

### with Dvsnf7 dsRNA (A Double Stranded RNA Transcript Comprising a Dvsnf7 Inverted Repeat Sequence Derived from Diabrotica virgifera in Combination with Bacillus Thur ingiensis Cry Proteins (Cry1A.105

, Cry2Ab2

, Cry3Bb1

, Cry1 F

, and Cry 34/35 Ab1) with the Genetic Material Necessary for their Production In Corn

. Change Of Effective Dates And Revised Section G

. AUTHORS : Kavita Battla

, Dow AgroSciences LLC

SUBMISSION DATE : November 23
, 2015

CONCLUSION : Discrepancies were identified between EPA and Dow ' s calculations for the amount of Cry3Bb1 protein and amount of seed containing Cry1 F

. Therefore

, EPA has calculated the amount (weight) of the active ingredients using the methodology described in this review

. Regarding the number of

acres , EPA and Dow ' s calculations are in agreement.

GOOD LABORATORY Not applicable PRACTICE :
CLASSIFICATION : Acceptable

### 2 REVIEW OF SECTION G (experim ental protocol)

Dow is using two Protocols in thei r investigation. Protocol 1 (breeding) enables inbred and hybrid development along with observation nurseries while Protocol 2 (characterization) involves testing and collection of product characterization data including: phenotypic and agronomic observations; product efficacy and yield benefits; characterization, performance; and regulatory data.

In December 2014 (U.S. EPA 2014b), EPA issued Dow AgroSciences LLC an experimental use permit (EUP) to test a new plant-incorporated protectant (PIP) technology: MON 87411 containing a cassette (DvSnf7) that expresses a sequence matching that of Diabrotica virgifera (commonly known as corn rootworm). The expression of the DvSnf7 results in the formation of a double stranded RNA (dsRNA) transcript. The permit allowed Dow to plant 17 PIP event combinations on 9,038 acres (6,361 PIP and 2,707 nonPIP) across 16 localities (15 states plus the Commonwealth of Puerto Rico) over the period December 19, 2014 to March 23, 2016.

Dow is now asking the Agency to amend the 2014 permit to: extend the effective date through March 31, 2017; add five states (California, Georgia, North Carolina, Oklahoma, and South Carolina); use fewer acres (a decrease of 3,194), and add five PIP event combinations. Tables 1 and 2 provide comparative summaries between the original and amended EUP. Table 1 shows the difference between the states and total acres while Table 2 compares the PIP event combinations. Please note that a “breeding only” registration was approved for event MON87411 (EPA Reg. No 524-618) in 2015 (registered by Monsanto Company).

Table 1 . Comparing States and Acres: Original vs. Amended EUP Acres %Change Between Original and Amended EUP Under the Original EUP Under the Amended EUP AR: 48 270  82%  CA: 0 98 NA: New State  GA: 0 270 NA: New State HI: 618 365  41% IL: 812 545  33%
IN: 904 617  32%
IA: 894 564  37% KS: 96 98  2% MN: 815 338  59% MO: 88 98  10% NE: 745 345  54%  NC: 0 98 NA: New State

ND: 573 248  57% OH: 573 254  56%  OK: 0 98 NA: New State

PA: 48 98  51% PR: 775 360  54%  SC: 0 270 NA: New State

SD: 689 276  60% TX: 656 264  60% WI: 704 270  62% Total: 9,038 5,844  35% Note : 

###  = states being added to the EUP
The five new states account for about 15% of the amended acreage.

### 3 Table 2 . Comparing PIP Event Combinations: Original vs. Amended EUP

Original Amended Registered PIPs: MO N89034 

###  
MON88017 

###  
TC1507 

###  
MON87411 

###  
DAS-59122-7 

###  
TC1507 × DAS-59122-7 

###  
MON89034 × MON88017 

###  
MON89034 × TC1507 

###  
MON89034 × MON88017 × TC1507 

###  
MON89034 × MON88017 × DAS-59122-7 

###  
MON89034 × TC1507 × DAS-59122-7 

###  
MON89034 × MON88017 × TC1507 × DAS-59122-7 

###  
MON88017 × TC1507 NO 

### 
MON88017 × DAS-59122-7 NO 

### 
MON88017 × TC1507 × DAS-59122-7 NO 

### 

UnRegistered PIPs: TC1507 × MON87411 

###  

MON87411 × DAS-59122-7 

###  

MON89034 × MON87411 NO 

### 

MON89034 × TC1507 × MON87411 

###  

MON87411 × TC1507 × DAS-59122-7 

###  

MON89034 × MON87411 × DAS-59122-7 NO 

### 
MON89034 × MON87411 × TC1507 × DAS-59122-7 

###  

ACRES

Tables 3, 4, and 5 describe and characterize the proposed amendment acres. Table 3 is an overall summary, by state, of the PIP, nonPIP, and border acres. In total, the amendment will add 2,660 PIP acres, 1,312 nonPIP, and 1,872 border acres (total of 5,844). Table 4 provides a tabulation of the acres by state, protocol, and PIP (P1: Protocol 1—breeding and associated data and P2: Protocol 2—characterization; see U.S. EPA 2014a fo r a description of the protocols). Table 5 shows how the PIP acres are distributed between the two protocols.

### 4 Table 3 . Acres: Overall Summary of PIP, NonPIP, and Border Acres
PIP NonPIP Border Grand Total Registered UnRegistered Total PIP
AR: 78 42 120 50 100 270 CA: 20 8 28 50 20 98 GA: 78 42 120 50 100 270

HI: 111 84 195 130 40 365
IL: 152 93 245 90 210 545
IN: 173 112 285 106 226 617
IA: 168 104 272 86 206 564 KS: 20 8 28 50 20 98
MN: 101 67 168 60 110 338 MO: 20 8 28 50 20 98
NE: 111 64 175 60 110 345 NC: 20 8 28 50 20 98
ND: 68 30 98 50 100 248 OH: 68 36 104 50 100 254 OK: 20 8 28 50 20 98
PA: 20 8 28 50 20 98
PR: 155 75 230 80 50 360 SC: 78 42 120 50 100 270 SD: 80 46 126 50 100 276
TX: 76 38 114 50 100 264
WI: 78 42 120 50 100 270

Total: 1,695 965 2,660 1,312 1,872 5,844

% of Grand Total: 29.0% 16.5% 45.5% 22.5% 32.0% 100%5Table 4. Acres: Summary of Protocol 1 and Protocol 2 (P1 + P2) Acres by State and PIP(see Appendix for separate P1 and P2 tables)Registered PIPsUnRegistered PIPsGrandTotal

MON89034 MON88017 TC1507 MON87411 DAS-59122-7 TC1507 × DAS-59122-7 MON89034 × MON88017 MON89034 × TC1507 MON89034 × MON88017 × TC1507 MON89034 × MON88017 × DAS-59122-7 MON89034 × TC1507 × DAS-59122-7 MON89034 × MON88017 × TC1507 × DAS-59122-7 MON88017 × TC1507 MON88017 × DAS-59122-7 MON88017 × TC1507 × DAS-59122-7SubTotalRegistered TC1507 × MON87411 MON87411 × DAS-59122-7 MON89034 × MON87411 MON89034 × TC1507 × MON87411 MON87411 × TC1507 × DAS-59122-7 MON89034 × MON87411 × DAS-59122-7 MON89034 × MON87411 × TC1507 × DAS-59122-7SubTotalUnregisteredAR:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120CA:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828GA:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120HI:P1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 575 5 20 5 5 5 5 550125P2 3 1 1 1 4 3 11 1 2 1 2 3 1 1 136 1 28 1 1 1 1 13470P1+P2 8 6 6 6 9 8 16 6 7 6 7 8 6 6 6111 6 48 6 6 6 6 684195IA:P1 2 2 2 4 2 2 2 10 2 2 2 2 2 2 240 4 15 2 2 2 2 22969P2 8 6 8 20 8 8 12 8 6 8 6 8 6 8 8128 8 25 8 6 8 8 1275203P1+P2 10 8 10 24 10 10 14 18 8 10 8 10 8 10 10168 12 40 10 8 10 10 14104272IL:P1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 230 2 5 2 2 2 2 21747P2 6 6 6 20 6 8 12 8 6 8 6 8 6 8 8122 6 25 8 6 8 8 1576198P1+P2 8 8 8 22 8 10 14 10 8 10 8 10 8 10 10152 8 30 10 8 10 10 1793245IN:P1 2 2 2 4 2 2 2 10 2 2 2 2 2 2 240 4 15 2 2 2 2 22969P2 8 6 8 25 8 8 12 8 6 8 6 8 6 8 8133 8 35 8 6 8 8 1083216P1+P2 10 8 10 29 10 10 14 18 8 10 8 10 8 10 10173 12 50 10 8 10 10 121122856Registered PIPsUnRegistered PIPsGrandTotal

MON89034 MON88017 TC1507 MON87411 DAS-59122-7 TC1507 × DAS-59122-7 MON89034 × MON88017 MON89034 × TC1507 MON89034 × MON88017 × TC1507 MON89034 × MON88017 × DAS-59122-7 MON89034 × TC1507 × DAS-59122-7 MON89034 × MON88017 × TC1507 × DAS-59122-7 MON88017 × TC1507 MON88017 × DAS-59122-7 MON88017 × TC1507 × DAS-59122-7SubTotalRegistered TC1507 × MON87411 MON87411 × DAS-59122-7 MON89034 × MON87411 MON89034 × TC1507 × MON87411 MON87411 × TC1507 × DAS-59122-7 MON89034 × MON87411 × DAS-59122-7 MON89034 × MON87411 × TC1507 × DAS-59122-7SubTotalUnregisteredKS:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828MN:P1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 115 1 5 1 1 1 1 11126P2 4 4 4 10 4 6 12 6 4 6 4 6 4 6 686 6 20 6 4 6 6 856142P1+P2 5 5 5 11 5 7 13 7 5 7 5 7 5 7 7101 7 25 7 5 7 7 967168MO:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828NC:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828ND:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 468 4 4 4 4 4 4 63098P1+P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 468 4 4 4 4 4 4 63098NE:P1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 115 1 5 1 1 1 1 11126P2 6 4 6 12 6 6 10 6 4 6 4 6 4 6 1096 6 15 6 4 6 6 1053149P1+P2 7 5 7 13 7 7 11 7 5 7 5 7 5 7 11111 7 20 7 5 7 7 1164175OH:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 468 4 10 4 4 4 4 636104P1+P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 468 4 10 4 4 4 4 636104OK:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 28287Registered PIPsUnRegistered PIPsGrandTotal

MON89034 MON88017 TC1507 MON87411 DAS-59122-7 TC1507 × DAS-59122-7 MON89034 × MON88017 MON89034 × TC1507 MON89034 × MON88017 × TC1507 MON89034 × MON88017 × DAS-59122-7 MON89034 × TC1507 × DAS-59122-7 MON89034 × MON88017 × TC1507 × DAS-59122-7 MON88017 × TC1507 MON88017 × DAS-59122-7 MON88017 × TC1507 × DAS-59122-7SubTotalRegistered TC1507 × MON87411 MON87411 × DAS-59122-7 MON89034 × MON87411 MON89034 × TC1507 × MON87411 MON87411 × TC1507 × DAS-59122-7 MON89034 × MON87411 × DAS-59122-7 MON89034 × MON87411 × TC1507 × DAS-59122-7SubTotalUnregisteredPA:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828PR:P1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 575 5 5 5 5 5 5 535110P2 5 5 5 5 5 5 10 5 5 5 5 5 5 5 580 5 10 5 5 5 5 540120P1+P2 10 10 10 10 10 10 15 10 10 10 10 10 10 10 10155 10 15 10 10 10 10 1075230SC:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120SD:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 6 6 6 4 6 4 6 4 6 680 6 10 6 4 6 6 846126P1+P2 4 4 4 10 4 6 6 6 4 6 4 6 4 6 680 6 10 6 4 6 6 846126TX:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 6 4 6 10 6 6 4 6 4 4 4 4 4 4 476 4 10 4 4 4 4 838114P1+P2 6 4 6 10 6 6 4 6 4 4 4 4 4 4 476 4 10 4 4 4 4 838114WI:P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120Total:P1 18 18 18 22 18 18 18 34 18 18 18 18 18 18 18290 22 70 18 18 18 18 18182472P2 86 70 84 185 87 100 119 96 71 90 71 92 70 90 941,405 88 238 90 70 82 82 1337832,188P1+P2 104 88 102 207 105 118 137 130 89 108 89 110 88 108 1121,695 110 308 108 88 100 100 1519652,660

### 8 Table 5 . Acres: Distribu tion Between Experime ntal Protocols
P1 P2 P1+P2
Registered UnRegistered Subtotal Registered UnRegistered Subtotal Registered UnRegistered Subtotal

AR: 0 0 0 78 42 120 78 42 120
CA: 0 0 0 20 8 28 20 8 28
GA: 0 0 0 78 42 120 78 42 120

HI: 75 50 125 36 34 70 111 84 195
IL: 30 17 47 122 76 198 152 93 245
IN: 40 29 69 133 83 216 173 112 285
IA: 40 29 69 128 75 203 168 104 272
KS: 0 0 0 20 8 28 20 8 28
MN: 15 11 26 86 56 142 101 67 168
MO: 0 0 0 20 8 28 20 8 28
NE: 15 11 26 96 53 149 111 64 175
NC: 0 0 0 20 8 28 20 8 28
ND: 0 0 0 68 30 98 68 30 98
OH: 0 0 0 68 36 104 68 36 104
OK: 0 0 0 20 8 28 20 8 28
PA: 0 0 0 20 8 28 20 8 28
PR: 75 35 110 80 40 120 155 75 230
SC: 0 0 0 78 42 120 78 42 120
SD: 0 0 0 80 46 126 80 46 126
TX: 0 0 0 76 38 114 76 38 114
WI: 0 0 0 78 42 120 78 42 120
Total: 290 182 472 1,405 783 2,188 1,695 965 2,660

% Total Acres: 10.9 6.8 17.7 52.8 29.4 82.3 63.7 36.3 100

### 9 AMOUNT OF PIP PROT EIN BY STATE

Each PIP event combination may contain a si ng le PIP (e.g., MON88017) or multiple PIPs (e.g., MON88017 x TC1507); the single PIP events are:

MON89034: [Cry1A.105, Cry2Ab2] MON88017: [Cry 3Bb1] TC1507: [Cry1F] MON87411: [DvSnf7dsRNA, Cry3Bb1] DAS-59122-7: [Cry34Ab1, Cry35Ab1]

Note that the Cry 3Bb1 protein is found in MON88017 and MON87411. In calculating the amount of expected PIP protein (see Table 6), the, contribution from MON88017 and MON87411 are summed. The amount of PIP protein (in pounds) is calculated as follows:

1. Equation ܲܫܲ	݈ܾ 47 ൌ ݁݅݊ݐ݋ݎܲ ௕௟
஺ ݁݅݊ݐ݋ݎܲ	ܲܫܲ	݂݋	݊݋݅ݏݏ݁ݎ݌ݔܧ	%	 ൈ	 ݁݅݊ݐ݋ݎܲ	ܲܫܲ	ݕܾ	ݏ݁ݎܿܣ	݂݋	ݎܾ݉݁ݑܰ ൈ



### 47	l b /A	is	the	planting	density; the	%	expression	is	from	the	Confidential	Statement	of	Formulat ion

Table 6 provides the expected amount of PIP protein by state expressed in pounds (lb). A summary of this information in grams is provi ded below; Appendix III shows the amount (g) by state. The conversion factor for pounds to grams is 453.6 grams per pound.

Equation 2

. ݃	ܲܫܲ	ܲݐ݋ݎ݁݅݊ ൌ ݈ܾ	ݐ݋ݎ݌݁݅݊ 	ൈ ସହଷ.଺	௚
௟௕ 

### Cry1 A.1 05: 181 g

Cry2Ab2: 54.4 g Cry1F: 203 g DvSnf7dsRNA: 4.248E-04 g Cry34Ab1: 2,824 g Cry35 Ab1: 69.1 g

Cry3Bb1: 531 g

AMOUNT OF PIP-CONTAINING SEED BY STATE

The amount of PIP-containing seed is calculated as:

3 Equation

. 47 ൌ ܵ݁݁݀	ܲܫܲ	݂݋	ݐ݊ݑ݋݉ܣ ௕௟
஺ ݁݅݊ݐ݋ݎܲ	ܲܫܲ	ݕܾ	ݏ݁ݎܿܣ	݂݋	ݎܾ݉݁ݑܰ ൈ



### This information is provided in Table 7.

### 10 Table 6 . PIP Protein (lb) by State a



### Cry1A.105 Cry2Ab2 Cry1F DvSnf7 dsRNA Cry34Ab1 Cry35Ab1 Cry3Bb1

AR: 0.0184 0.00553 0.0216 4.155E-08 0.283 0.00692 0.0548
CA: 0.00428 0.00128 0.00522 7.990E-09 0.0619 0.00151 0.0109
GA: 0.0184 0.00553 0.0216 4.155E-08 0.283 0.00692 0.0548

HI: 0.0270 0.00809 0.0271 7.191E-08 0.512 0.0125 0.0863
IL: 0.0372 0.0112 0.0400 9.189E-08 0.588 0.0144 0.110
IN: 0.0388 0.0116 0.0431 1.127E-07 0.663 0.0162 0.117
IA: 0.0395 0.0118 0.0438 1.023E-07 0.627 0.0154 0.114
KS: 0.00428 0.00128 0.00522 7.990E-09 0.0619 0.00151 0.0109
MN: 0.0253 0.00760 0.0264 6.232E-08 0.411 0.0101 0.0781
MO: 0.00428 0.00128 0.00522 7.990E-09 0.0619 0.00151 0.0109
NE: 0.0260 0.00780 0.0292 6.152E-08 0.424 0.0104 0.0799
NC: 0.00428 0.00128 0.00522 7.990E-09 0.0619 0.00151 0.0109
ND: 0.0158 0.00474 0.0181 3.196E-08 0.203 0.00497 0.0434
OH: 0.0158 0.00474 0.0181 3.675E-08 0.230 0.00562 0.0450
OK: 0.00428 0.00128 0.00522 7.990E-09 0.0619 0.00151 0.0109
PA: 0.00428 0.00128 0.00522 7.990E-09 0.0619 0.00151 0.0109
PR: 0.0378 0.0114 0.0417 6.792E-08 0.508 0.0124 0.110
SC: 0.0184 0.00553 0.0216 4.155E-08 0.283 0.00692 0.0548
SD: 0.0197 0.00592 0.0223 4.474E-08 0.300 0.00735 0.0579
TX: 0.0171 0.00513 0.0202 3.835E-08 0.256 0.00627 0.0455
WI: 0.0184 0.00553 0.0216 4.155E-08 0.283 0.00692 0.0548
Total: 0.399 0.120 0.448 9.364E-07 6.22 0.152 1.17

a The amount of PIP protein is for all PIP acre s (i.e., those from Protocol 1 + Protocol 2)

### 11 Table 7 . PIP-Containing Seed (pounds) by Protein and Stat e Cry1A.105 Cry2Ab2 Cry1F DvSnf7 dsRNA Cry34Ab1 Cry3Bb1

EPA DOW EPA DOW EPA DOW EPA DOW EPA DOW EPA DOW EPA DOW
AR: 2,632 2,632 2,632 2,632 2,914 2,632 2,444 2,444 3,008 3,008 3,008 3,008 4,324 4,324
CA: 611 611 611 611 705 658 470 470 658 658 658 658 846 846
GA: 2,632 2,632 2,632 2,632 2,914 2,632 2,444 2,444 3,008 3,008 3,008 3,008 4,324 4,324

HI: 3,854 3,854 3,854 3,854 3,666 3,384 4,230 4,230 5,452 5,452 5,452 5,452 7,097 7,097
IL: 5,311 5,311 5,311 5,311 5,405 4,935 5,405 5,405 6,251 6,251 6,251 6,251 9,071 9,071
IN: 5,546 5,546 5,546 5,546 5,828 5,358 6,627 6,627 7,050 7,050 7,050 7,050 10,293 10,293
IA: 5,640 5,640 5,640 5,640 5,922 5,452 6,016 6,016 6,674 6,674 6,674 6,674 9,682 9,682
KS: 611 611 611 611 705 658 470 470 658 658 658 658 846 846
MN: 3,619 3,619 3,619 3,619 3,572 3,243 3,666 3,666 4,371 4,371 4,371 4,371 6,298 6,298
MO: 611 611 611 611 705 658 470 470 658 658 658 658 846 846
NE: 3,713 3,713 3,713 3,713 3,948 3,431 3,619 3,619 4,512 4,512 4,512 4,512 6,345 6,345
NC: 611 611 611 611 705 658 470 470 658 658 658 658 846 846
ND: 2,256 2,256 2,256 2,256 2,444 2,256 1,880 1,880 2,162 2,162 2,162 2,162 3,384 3,384
OH: 2,256 2,256 2,256 2,256 2,444 2,256 2,162 2,162 2,444 2,444 2,444 2,444 3,666 3,666
OK: 611 611 611 611 705 658 470 470 658 658 658 658 846 846
PA: 611 611 611 611 705 658 470 470 658 658 658 658 846 846
PR: 5,405 5,405 5,405 5,405 5,640 5,170 3,995 3,995 5,405 5,405 5,405 5,405 7,990 7,990
SC: 2,632 2,632 2,632 2,632 2,914 2,632 2,444 2,444 3,008 3,008 3,008 3,008 4,324 4,324
SD: 2,820 2,820 2,820 2,820 3,008 2,726 2,632 2,632 3,196 3,196 3,196 3,196 4,606 4,606
TX: 2,444 2,444 2,444 2,444 2,726 2,538 2,256 2,256 2,726 2,726 2,726 2,726 3,760 3,760
WI: 2,632 2,632 2,632 2,632 2,914 2,632 2,444 2,444 3,008 3,008 3,008 3,008 4,324 4,324
Total: 57,058 57,058 57,058 57,058 60,489 55,225 55,084 55,084 66,223 66,223 66,223 66,223 94,564 94,564



### BPPD COMMENTS:

Discrepancies were identified between EPA and Dow’s calculations for the amount of Cry3Bb1 protein and, the amount of seed containing Cry1F. Regarding the amount of PIP protein (Table 6), EPA and Dow’s calculations are generally in agr eement, except for Cry3Bb1 where the Agency’s values are about half tho se of Dow’s. A likely source of this discrepancy is the percent protein expression. Possibly, Dow used the same percent expression for both sources of Cry3Bb1. As noted above, Cry3Bb1 comes from two sources, each with it s own percent protein expression. With respect to the amount of seed containing Cry1F (Table 7), EPA’s calculated values were greater than Dow’s; the Agency does not have a suggestion for the source of the discrepancies. Because the Agency has a high degree of confidence in its calculations, it is recommended that its values for weight of the active ingredients (Table 6) and the weight of PIP-containing seed (Table 7) be used for the approval of this EUP. Regarding the number of acres, EPA and Dow’s calculations are in agreement.

For future Section G submissions, EPA would find it helpful if Dow would clearly state the assumptions it used in the calculation such as the source of the % protein expression (e.g., whole plant, seed, etc.). Such would allow the Agency to conduct its review in a more efficient manner. Cry35Ab1

### 12 REFER ENCES

Dow. 2015. Letter from Kavita Battla, Dow AgroSc iences LLC to Kimberly Nesci, U.S. Environmental Protection Agency Office of Pesticide Program Biopesticides and Pollution Prevention Division. Request to Amend Experimental Use Permit 62719-EUP-66 Corn Plant Incorporated Protectants with Dvsnf7 dsRNA (A Double Stranded RNA Transcript Comprising a Dvsnf7 Inverted Repeat Sequence Derived from Diabrotica virgifera in Combination with Bacillus Thuringiensis Cry Proteins (Cry1A.105, Cry2Ab2,Cry3Bb1, Cry1F, and Cry 34/35 Ab1) with t he Genetic Material Necessary for their Production In Corn. Change Of Effective Dates And Revised Section G. November 23,2015.

Dow. 2016a. Email from Stephanie Burton, Dow AgroSciences LLC to Kathleen Martin, U.S. Environmental Protection Agency. RE: Section G Calculations for EUP 62719-EUP-66 with attachment (2015_EUPext_Table8_revised.pdf). February 11, 2016 11:00 AM.

Dow. 2016b. Email from Stephanie Burton, Dow AgroSciences LLC to Kathleen Martin, U.S. Environmental Protection Agency. 62719-EUP-66 Revisions with attachment (2015_EUPext_Table7-8_rev2.pdf). February 17, 2016 4:14 PM.

U.S. EPA. 2014a. Memorandum from Kathleen Martin to Jeannine Kausch. EPA File Symbol 62719-EUP-AA (MON 87411 Combined Trait Insect Control for Corn). Section G Calculations. U.S. Environmental Protection Agency Office of Pesticide Program Biopesticides and Pollution Prevention Division. December 17, 2014.

U.S. EPA. 2014b. Letter from Jack Housenger, Director to Stephanie Burton, Regulatory Manager. Corn plant-incorporated protectants (PIPs) with MON 87411 (DvSnf7 dsRNA and BtCry3Bb1 protein), MON 89034 (BtCrylA.105 and Cry2Ab2 proteins), MO N 88017 (BtCry3Bbl protein), TC1507 (BtCrylF protein), and/or DAS-59122-7 (BtCry34Abl and Cry 35Ab1 proteins). EPA Experimental Use Permit No.: 62719-EUP-66. Decision No.: 491621. December 18, 2014.APPENDIX IAPPENDIX I.Acres by PIP and State: Protocol 1Registered PIPsUnRegistered PIPsGrandTotal

MON89034 MON88017 TC1507 MON87411 DAS-59122-7 TC1507 × DAS-59122-7 MON89034 × MON88017 MON89034 × TC1507 MON89034 × MON88017 × TC1507 MON89034 × MON88017 × DAS-59122-7 MON89034 × TC1507 × DAS-59122-7 MON89034 × MON88017 × TC1507 × DAS-59122-7 MON88017 × TC1507 MON88017 × DAS-59122-7 MON88017 × TC1507 × DAS-59122-7SubTotalRegistered TC1507 × MON87411 MON87411 × DAS-59122-7 MON89034 × MON87411 MON89034 × TC1507 × MON87411 MON87411 × TC1507 × DAS-59122-7 MON89034 × MON87411 × DAS-59122-7 MON89034 × MON87411 × TC1507 × DAS-59122-7SubTotalUnregisteredAR:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000CA:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000GA:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000HI:5 5 5 5 5 5 5 5 5 5 5 5 5 5 575 5 20 5 5 5 5 550125IA:2 2 2 4 2 2 2 10 2 2 2 2 2 2 240 4 15 2 2 2 2 22969IL:2 2 2 2 2 2 2 2 2 2 2 2 2 2 230 2 5 2 2 2 2 21747IN:2 2 2 4 2 2 2 10 2 2 2 2 2 2 240 4 15 2 2 2 2 22969KS:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000MN1 1 1 1 1 1 1 1 1 1 1 1 1 1 115 1 5 1 1 1 1 11126MO0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000NC:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000ND:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000NE:1 1 1 1 1 1 1 1 1 1 1 1 1 1 115 1 5 1 1 1 1 11126OH:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000OK:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000PA:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000PR:5 5 5 5 5 5 5 5 5 5 5 5 5 5 575 5 5 5 5 5 5 535110SC:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000SD:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000TX:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000WI:0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000Total:18 18 18 22 18 18 18 34 18 18 18 18 18 18 18290 22 70 18 18 18 18 18182472APPENDIX IIAPPENDIX II.Acres by PIP and State: Protocol 2Registered PIPsUnRegistered PIPsGrandTotal

MON89034 MON88017 TC1507 MON87411 DAS-59122-7 TC1507 × DAS-59122-7 MON89034 × MON88017 MON89034 × TC1507 MON89034 × MON88017 × TC1507 MON89034 × MON88017 × DAS-59122-7 MON89034 × TC1507 × DAS-59122-7 MON89034 × MON88017 × TC1507 × DAS-59122-7 MON88017 × TC1507 MON88017 × DAS-59122-7 MON88017 × TC1507 × DAS-59122-7SubTotalRegistered TC1507 × MON87411 MON87411 × DAS-59122-7 MON89034 × MON87411 MON89034 × TC1507 × MON87411 MON87411 × TC1507 × DAS-59122-7 MON89034 × MON87411 × DAS-59122-7 MON89034 × MON87411 × TC1507 × DAS-59122-7SubTotalUnregisteredAR:4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120CA:2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828GA:4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120HI:3 1 1 1 4 3 11 1 2 1 2 3 1 1 136 1 28 1 1 1 1 13470IA:8 6 8 20 8 8 12 8 6 8 6 8 6 8 8128 8 25 8 6 8 8 1275203IL:6 6 6 20 6 8 12 8 6 8 6 8 6 8 8122 6 25 8 6 8 8 1576198IN:8 6 8 25 8 8 12 8 6 8 6 8 6 8 8133 8 35 8 6 8 8 1083216KS:2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828MN:4 4 4 10 4 6 12 6 4 6 4 6 4 6 686 6 20 6 4 6 6 856142MO:2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828NC:2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828ND:4 4 4 10 4 4 4 6 4 4 4 4 4 4 468 4 4 4 4 4 4 63098NE:6 4 6 12 6 6 10 6 4 6 4 6 4 6 1096 6 15 6 4 6 6 1053149OH:4 4 4 10 4 4 4 6 4 4 4 4 4 4 468 4 10 4 4 4 4 636104OK:2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828PA:2 1 2 2 2 2 1 1 1 1 1 1 1 1 120 1 1 1 1 1 1 2828PR:5 5 5 5 5 5 10 5 5 5 5 5 5 5 580 5 10 5 5 5 5 540120SC:4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120SD:4 4 4 10 4 6 6 6 4 6 4 6 4 6 680 6 10 6 4 6 6 846126TX:6 4 6 10 6 6 4 6 4 4 4 4 4 4 476 4 10 4 4 4 4 838114WI:4 4 4 10 4 6 4 6 4 6 4 6 4 6 678 6 10 6 4 4 4 842120Total:86 70 84 185 87 100 119 96 71 90 71 92 70 90 941,405 88 238 90 70 82 82 1337832,188APPENDIX III 

### APPENDIX III . PIP Protein (g) by State a



### Cry1A.105 Cry2Ab2 Cry1F DvSnf7 dsRNA Cry34Ab1 Cry35Ab1 Cry3Bb1

AR 8.36 2.51 9.78 1.885E-05 128 3.14 24.9
CA 1.94 0.582 2.37 3.624E-06 28.1 0.686 4.92
GA 8.36 2.51 9.78 1.885E-05 128 3.14 24.9

HI 12.2 3.67 12.3 3.262E-05 232 5.69 39.2
IL 16.9 5.06 18.1 4.168E-05 267 6.52 50.1
IN 17.6 5.28 19.6 5.110E-05 301 7.36 53.1
IA 17.9 5.37 19.9 4.639E-05 285 6.96 51.6
KS 1.94 0.582 2.37 3.624E-06 28.1 0.686 4.92
MN 11.5 3.45 12.0 2.827E-05 186 4.56 35.4
MO 1.94 0.582 2.37 3.624E-06 28.1 0.686 4.92
NE 11.8 3.54 13.3 2.791E-05 192 4.71 36.2
NC 1.94 0.582 2.37 3.624E-06 28.1 0.686 4.92
ND 7.16 2.15 8.20 1.450E-05 92.2 2.26 19.7
OH 7.16 2.15 8.20 1.667E-05 104 2.55 20.4
OK 1.94 0.582 2.37 3.624E-06 28.1 0.686 4.92
PA 1.94 0.582 2.37 3.624E-06 28.1 0.686 4.92
PR 17.2 5.15 18.9 3.081E-05 230 5.64 49.8
SC 8.36 2.51 9.78 1.885E-05 128 3.14 24.9
SD 8.95 2.69 10.1 2.030E-05 136 3.33 26.3
TX 7.76 2.33 9.15 1.740E-05 116 2.84 20.6
WI 8.36 2.51 9.78 1.885E-05 128 3.14 24.9
Total: 181 54.4 203 4.248E-04 2,824 69.1 531

a The amount of PIP protein is for all PIP acre s (i.e., those from Protocol 1 + Protocol 2)