UNITED.STATES ENVIRONMENTAL PROTECTION AGENCY 

:', : .. : '« · W~?HINGTON , D.C. 20460 '""' , 1 l • . ,f..-'t . 

February 29, 2016 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: 

FROM: 

THROUGH: 

TO: 

EPA File Symbol 62719-EUP-66 (MON 87411 Combined Trait Insect 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. ff. Jllarfif\ 2/-zq j \ \) 

Microbial Products Branch 

Biopesticides and Pollution Prevention Division 

Alan Reynolds, Team Leader 11 1) Microbial Products Branch ~ 1 L..-

Biopesticides and Pollution Prevention Division 

Jeannine Kausch, Regulatory Action Leader Microbial Products Branch 

Biopesticides and Pollution Prevention Division 

BACKGROUND AND ACTION REQUESTED 

In December 2014, EPA issued an Experimental Use Permit (EUP) to Dow AgroSciences LLC 

to test a new plant-incorporated protectant (Pl 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 I I • ... , ...... , J/l~\\b 

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 Permit 62719-EUP-66 Corn Plant 

lncqy~o~t~ciPro)ect~ n~~ 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 , 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 (experimental protocol) 

Dow is using two Protocols in their 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:

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 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 for 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 

Registered UnRegistered Total PIP Total 

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% 
Table 4. Acres: Summary of Protocol 1 and Protocol 2 (P1 + P2) Acres by State and PIP (see Appe

Registered PIPs UnRegistere

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-59122-7 

SubTotal 

Registered 

TC1507 × MON87411 

MON87411 × DAS-59122-7 

MON89034 × MON87411 

MON89034 × TC1507 × 

MON87411 

MON87411 × TC1507 × 

DAS591227 

AR: P1 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 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 

P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 

CA: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 

GA: P1 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 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 

HI: P1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 75 5 20 5 5 5 

P2 3 1 1 1 4 3 11 1 2 1 2 3 1 1 1 36 1 28 1 1 1 P1+P2 8 6 6 6 9 8 16 6 7 6 7 8 6 6 6 111 6 48 6 6 6 

IA: P1 2 2 2 4 2 2 2 10 2 2 2 2 2 2 2 40 4 15 2 2 2 

P2 8 6 8 20 8 8 12 8 6 8 6 8 6 8 8 128 8 25 8 6 8 P1+P2 10 8 10 24 10 10 14 18 8 10 8 10 8 10 10 168 12 40 10 8 10 

IL: P1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 30 2 5 2 2 2 

P2 6 6 6 20 6 8 12 8 6 8 6 8 6 8 8 122 6 25 8 6 8 P1+P2 8 8 8 22 8 10 14 10 8 10 8 10 8 10 10 152 8 30 10 8 10 

IN: P1 2 2 2 4 2 2 2 10 2 2 2 2 2 2 2 40 4 15 2 2 2 

P2 8 6 8 25 8 8 12 8 6 8 6 8 6 8 8 133 8 35 8 6 8 P1+P2 10 8 10 29 10 10 14 18 8 10 8 10 8 10 10 173 12 50 10 8 10 
Registered PIPs UnRegistere

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-59122-7 

SubTotal 

Registered 

TC1507 × MON87411 

MON87411 × DAS-59122-7 

MON89034 × MON87411 

MON89034 × TC1507 × 

MON87411 

MON87411 × TC1507 × 

DAS591227 

KS: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 

MN: P1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15 1 5 1 1 1 

P2 4 4 4 10 4 6 12 6 4 6 4 6 4 6 6 86 6 20 6 4 6 P1+P2 5 5 5 11 5 7 13 7 5 7 5 7 5 7 7 101 7 25 7 5 7 

MO: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 

NC: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 

ND: P1 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 10 4 4 4 6 4 4 4 4 4 4 4 68 4 4 4 4 4 P1+P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 4 68 4 4 4 4 4 

NE: P1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15 1 5 1 1 1 

P2 6 4 6 12 6 6 10 6 4 6 4 6 4 6 10 96 6 15 6 4 6 P1+P2 7 5 7 13 7 7 11 7 5 7 5 7 5 7 11 111 7 20 7 5 7 

OH: P1 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 10 4 4 4 6 4 4 4 4 4 4 4 68 4 10 4 4 4 P1+P2 4 4 4 10 4 4 4 6 4 4 4 4 4 4 4 68 4 10 4 4 4 

OK: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 
Registered PIPs UnRegistere

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-59122-7 

SubTotal 

Registered 

TC1507 × MON87411 

MON87411 × DAS-59122-7 

MON89034 × MON87411 

MON89034 × TC1507 × 

MON87411 

MON87411 × TC1507 × 

DAS591227 

PA: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 P1+P2 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 

PR: P1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 75 5 5 5 5 5 

P2 5 5 5 5 5 5 10 5 5 5 5 5 5 5 5 80 5 10 5 5 5 P1+P2 10 10 10 10 10 10 15 10 10 10 10 10 10 10 10 155 10 15 10 10 10 

SC: P1 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 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 

SD: P1 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 10 4 6 6 6 4 6 4 6 4 6 6 80 6 10 6 4 6 P1+P2 4 4 4 10 4 6 6 6 4 6 4 6 4 6 6 80 6 10 6 4 6 

TX: P1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

P2 6 4 6 10 6 6 4 6 4 4 4 4 4 4 4 76 4 10 4 4 4 P1+P2 6 4 6 10 6 6 4 6 4 4 4 4 4 4 4 76 4 10 4 4 4 

WI: P1 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 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 P1+P2 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 

Total: P1 18 18 18 22 18 18 18 34 18 18 18 18 18 18 18 290 22 70 18 18 18 

P2 86 70 84 185 87 100 119 96 71 90 71 92 70 90 94 1,405 88 238 90 70 82 

 P1+P2 104 88 102 207 105 118 137 130 89 108 89 110 88 108 112 1,695 110 308 108 88 100 
8 

 Table 5. Acres: Distribution Between Experimental 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 PROTEIN BY STATE 

Each PIP event combination may contain a single 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: 

௕௟ 	47 ൌ ݁݅݊ݐ݋ݎܲ	ܲܫܲ	݈ܾ 1. Equation

݁݅݊ݐ݋ݎܲ	ܲܫܲ	݂݋	݊݋݅ݏݏ݁ݎ݌ݔܧ	%	 ൈ	 ݁݅݊ݐ݋ݎܲ	ܲܫܲ	ݕܾ	ݏ݁ݎܿܣ	݂݋	ݎܾ݉݁ݑܰ ൈ஺ 	

47	lb/A	is	the	planting	density;	

the	%	expression	is	from	the	Confidential	Statement	of	Formulation	

Table 6 provides the expected amount of PIP protein by state expressed in pounds (lb). A 

summary of this information in grams is provided 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.଺	௚	

௟௕

Cry1A.105: 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: 

௕௟ 	47 ൌ ܵ݁݁݀	ܲܫܲ	݂݋	ݐ݊ݑ݋݉ܣ 3. Equation

݁݅݊ݐ݋ݎܲ	ܲܫܲ	ݕܾ	ݏ݁ݎܿܣ	݂݋	ݎܾ݉݁ݑܰ ൈ஺ 	

This information is provided in Table 7. 
10 

Table 6. PIP Protein (lb) by Statea

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 

aThe amount of PIP protein is for all PIP acres (i.e., those from Protocol 1 + Protocol 2)
11 

 Table 7. PIP-Containing Seed (pounds) by Protein and State 

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 agreement, except for Cry3Bb1 where the Agency’s 

values are about half those 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 its 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 

REFERENCES 

Dow. 2015. Letter from Kavita Battla, Dow AgroSciences 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 the 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), MON 88017 (BtCry3Bbl protein), TC1507 (BtCrylF 

protein), and/or DAS-59122-7 (BtCry34Abl and Cry35Ab1 proteins). EPA Experimental Use Permit 

No.: 62719-EUP-66. Decision No.: 491621. December 18, 2014. 
APPENDIX I. Acres by PIP and State: Protocol 1 

Registered PIPs UnRegistered PIP

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-59122-7 

SubTotal 

Registered 

TC1507 × MON87411 

MON87411 × DAS-59122-7 

MON89034 × MON87411 

MON89034 × TC1507 × 

MON87411 

MON87411 × TC1507 × 

DAS-59122-7 

MON89034 × MON87411 × 

DAS591227 

AR: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 CA: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

GA: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

HI: 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 75 5 20 5 5 5 5 IA: 2 2 2 4 2 2 2 10 2 2 2 2 2 2 2 40 4 15 2 2 2 2 

IL: 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 30 2 5 2 2 2 2 

IN: 2 2 2 4 2 2 2 10 2 2 2 2 2 2 2 40 4 15 2 2 2 2 

KS: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

MN 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15 1 5 1 1 1 1 

MO 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

NC: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ND: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

NE: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15 1 5 1 1 1 1 

OH: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 OK: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

PA: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 PR: 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 75 5 5 5 5 5 5 SC: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 SD: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

TX: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

WI: 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

Total: 18 18 18 22 18 18 18 34 18 18 18 18 18 18 18 290 22 70 18 18 18 18 
APPENDIX II. Acres by PIP and State: Protocol 2 

Registered PIPs UnRegistered PIP

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-59122-7 

SubTotal 

Registered 

TC1507 × MON87411 

MON87411 × DAS-59122-7 

MON89034 × MON87411 

MON89034 × TC1507 × 

MON87411 

MON87411 × TC1507 × 

DAS-59122-7 

MON89034 × MON87411 × 

DAS591227 

AR: 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 4 CA: 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 1 

GA: 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 4 

HI: 3 1 1 1 4 3 11 1 2 1 2 3 1 1 1 36 1 28 1 1 1 1 IA: 8 6 8 20 8 8 12 8 6 8 6 8 6 8 8 128 8 25 8 6 8 8 

IL: 6 6 6 20 6 8 12 8 6 8 6 8 6 8 8 122 6 25 8 6 8 8 

IN: 8 6 8 25 8 8 12 8 6 8 6 8 6 8 8 133 8 35 8 6 8 8 

KS: 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 1 

MN: 4 4 4 10 4 6 12 6 4 6 4 6 4 6 6 86 6 20 6 4 6 6 

MO: 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 1 

NC: 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 1 ND: 4 4 4 10 4 4 4 6 4 4 4 4 4 4 4 68 4 4 4 4 4 4 

NE: 6 4 6 12 6 6 10 6 4 6 4 6 4 6 10 96 6 15 6 4 6 6 

OH: 4 4 4 10 4 4 4 6 4 4 4 4 4 4 4 68 4 10 4 4 4 4 OK: 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 1 

PA: 2 1 2 2 2 2 1 1 1 1 1 1 1 1 1 20 1 1 1 1 1 1 PR: 5 5 5 5 5 5 10 5 5 5 5 5 5 5 5 80 5 10 5 5 5 5 SC: 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 4 SD: 4 4 4 10 4 6 6 6 4 6 4 6 4 6 6 80 6 10 6 4 6 6 

TX: 6 4 6 10 6 6 4 6 4 4 4 4 4 4 4 76 4 10 4 4 4 4 

WI: 4 4 4 10 4 6 4 6 4 6 4 6 4 6 6 78 6 10 6 4 4 4 

Total: 86 70 84 185 87 100 119 96 71 90 71 92 70 90 94 1,405 88 238 90 70 82 82 
APPENDIX III

 APPENDIX III. PIP Protein (g) by Statea

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

aThe amount of PIP protein is for all PIP acres (i.e., those from Protocol 1 + Protocol 2)