### UNITED STATES ENVIRONMENTAL PROTECTION AGEN CY 

### WASH I NGTON ; D.C. 20460

February 2 , 2015 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM SUBJE CT :

FRO M : THROUGH : TO : 

### Second Amendment to EPA Reg . NQ 524-EUP-104 (MON 87411 Combined Trait Insect Control for Corn , Combinations Necessary for their Production and Controls). Section G Calculations . EPA Reg . N2 : 

### 524-EUP-104 PC Code : 006580 ; 006566 (for MON 87411 ) MRID : NONE Decision N2 : 

### 496549 DP N2 : 

### 425377 

### Kath l een Martin , Chemist , M.S.E.st . \t\· 

# "l\"'2.\\6 Microbial Products Branch Biopesticides and Pollution Prevention Division Alan Reynolds , Team Leader

# /.**~** 

# (JJ Microbial Products Branch 

# V

# ~ Biopesticides and Pollution Prevention Division Mike Mendelsohn , Regulatory Action Leader Microbial Products B ranch Biopesticides and Pollution Prevention Division Monsanto Company is testing MON 87411 , a new plant-incorporated protectant (P I P) technology . I n March 2013 EPA approved an experimenta l use permit 1 

### (EUP) for its testing ; the Agency amended this permit in February 2014 (U.S . EPA 2014a). Monsanto is now request i ng to amend the petiti on once more to: drop three states (Idaho , Kentucky , and Oklahoma); revise the acreage to 9 , 556 acres ; and , extend the EUP through February 28 , 2017.

1 

### EPA Reg . NQ 524-EUP-104

# Data Evaluation Record Reviewed by: Kathleen Martin , Chemist Secondary Review: Alan Reynolds , M.S .

# ~~up~ Section G calculations for an amended PIP Experimental Use Permit: 524-EU P-1 04 Test Guideline: Not applicable MRID: NA DP Barcode : 425377 Test Material: Comb inations of PIP events that are made up of one or more of the following indiv idual events : MON 89034 , TC 1507 , MIR 162 , MON 88017 , DAS-59122-7 and MON 87411 . Sponsor: Monsanto Company

Testing NA Facility:

Report Amended Appl ication for an Experimental Use Permit to Test MON 87411 , Combined Trait

Titl e : Insect Control Corn , Combinations Necessary for their Production , and Controls (EPA File Symboi524- EUP-104) . Giddings KS , Ph . D . and Lev is K, M . S . Monsanto Company. Monsanto Submission I D CR256-14E1 . October 10 , 2014 . 61 pp . NO MR ID . Amended Application fpr ap. Experirne ptal Use Permit to Test MON 87411, Combined Trait Insect Control Com , G,f> mbinaHoi'\S',t-.jecessary for their Production , and Controls EPA File Symboi524-EUP-104). Giddings KS,' Ph . D . and Levis K, M . S . Monsanto Company . Monsanto Submission ID CR256-14E2 . December 19 , 2014 . 64 pp . NO MRID . Authors: Giddings KS , Ph . D . and Levis K, M . S . Submission October 10 , 2014 Date: December 19 , 2014 EPA has reviewed Monsanto's revised approach for submitting proposed experimental Conclusion: acreage . Both the new methodology and the acreage requested are acceptable . Additionally , EPA has verified Monsanto 's calculations-the differences are slight and may be attributed to rounding . Classification: Acceptable Good Lab

Practice: Not applicable 

### Monsanto Company is testing a new plant incorporated protectant ( PIP) technology: MON 87411 , combined trait insect control corn, combinat ions necessary for their production and controls; MON 87411 contains a Dv49 double stranded RNA [d sRNA] suppression cassette . In March 2013 the Agency approved an experimenta l use permit (EUP) to test this new technology (EPA Reg . NQ 524-EUP-1 04) and i n February 2014 EPA approved an amendment (U . S. EPA 2014a) . Monsanto is now seeking to amend the permit for a second time to: drop three states (Idaho , Kentucky , and Oklahoma) bringing the total to 28 geographic locations2 

### (Monsanto 2014a , b) ; revise the acreage for a total of 9 ,556 acres ; and extend the EUP through February 28 , 2017. Table 1 provides an overall summary of the states, acreage , and PIP events among the original EUP (U . S . EPA 2013) and the two amendments (U.S. EPA 2014a , and this amendment).

2

### 27 states plus the Commonwealth of Puerto Rico . DER-1

### BACKGROUND The approach to this Monsanto Section G calculation is different from previous submissions . Traditionally , EPA has required Monsanto to specify the number of PIP , non-PIP , and border acres for each event combination under investigation along with the total amount of protein for each protein of the combination. I n addition , they were required to specify the states (including the Commonwealth of Puerto Rico) where the EUP planting would take place . To allow more flexibility in planning and implementing the investigation of MON 87411 , Monsanto has proposed to submit the Section G acreage data in a more general way . Monsanto still specifies the states and the combinations that may be used . What is different is that they have reported the total number of acres in aggregate (i.e ., the number of acres they are requesting includes PIP , non-PIP , and border acres) and only broke them down to the state level. Previously , Monsanto reported the number of acres per state and broke those acres down by combination and border & non-P I P acres. The advantage of this new approach is that Monsanto will be able to make their final dec is ion regarding how the acres will be parsed among the combinations and non-P I P & border acres closer to planting. Monsanto ' s final report must provide the specific combinations used and the acre distribution (which would include the number of acres for non-PIP and border) . UNIQUE PIP EVENTS and COMBINATIONS Monsanto is proposing to use seven PIP events which may be combined into 120 combinations . The seven PIP events with their corresponding registration status is provided in Table 2 ; except for MON 87411 , each of the individual events are registered . Table 3 and Table 4 list the potential P I P combinations that may be used under this EUP ; the breakout of unregistered and registered is : UNREGISTERED PIP COMBINATIONS : contains 

### 63 MON 87411 3 new combination of a previou sly 

### 40 registered event 

### S ubtot a l : 

### 103 REGISTERED PIP 

### 17 COMBINATIONS : G ran d Total : 120



### ACRES AND AMOUNT OF P I P-CONTAINING SEED and PROTEIN The distribution of acres among the 28 states for 2015 and 2016 is shown in Table 5; in summary , Monsanto is requesting a total of 9 , 556 acres . Table 5 also shows the amount of corn seed and the amount of MON 87411 protein (which includes Cry3Bb1 and DvSnf7dsRNA) expected to be used over the remainder of this EUP .

3 

### MON 87411 is an unregistered PIP event. DER-2

### TABLES Table 1 Key Study Parameters: Original vs . Amen ded EUP Original Amendments March 20 1 3 

### February 2014 

### Current P la n ti n g Feb 2013 Feb 2014 Feb 15 , 2015

Pe riod : to July 2014 to Feb 2016 to Feb 28 , 2017 Geog raphic 

### 23 3 1 28

Locat ions :

Al abama 

## " " Arkansas 

# " " " Californ i a 

## ., " " Colorado 

# " " 

## "

F:lorida 

## " " Georg ia 

## " 

## " "

Hawaii 

## " " "

Idaho 

## " 

## " Illinois 

## " " " Ind i ana 

## " " " Iowa 

## " " " Kansas 

## " " " Ke ntucky 

## " Lou i s i ana 

## " " Mich igan 

## " " " M inn esota 

## " " 

# " Mississipp i 

## " 

## " "

Missouri 

## " " 

## " Nebraska 

## " " 

# " North Carol i na 

## " " 

## "

North Dakota 

## ., " Ohio 

## " 

## ., " Okl ahoma 

## ., Pennsylvan ia 

## ., ., "

Puerto Rico 

## " 

## " " South Caro lin a 

## " " "

South Dakota 

## ., " 

## "

Tennessee 

## " " 

# " Texas 

# ., " Wash i ngton 

## " "

W i scons i n 

## " " 

## " Acres : Tota l 

### 20,893 46 , 522 

# -=l The values in '() PIP 1 7 ,740 (85%) 31 ,869 (68 .5%)

show %total Non PIP 1 ,782 (8 . 5%) 7 ,776 ( 16.7%) acres. Border

**1** (6 .6%) 6 ,877 ( 14 .7%) Individual Events : 

### 8 6 7 MON 89034 

## " " 

## " TC 1507 

## " " " MIR 162 

## " 

# ., " MON 8801 7 

## " " 

# ., MON 87410 

## ., MON 87411 

## ., ., ., DAS -59122 -7 

# ., " 

# ., 5307 

## ., MON 810 

## " # P I P Combinations: 

### 64 46 120 Unregiste red 

# I 13 29 103

Registered 51 1 7 17 

### DER-3

### T bl 2 a e 

### PIP Even san 

### d T 

## ot ra1 san

### d R 0 

### t 

## t' St t eg1s ra 1 on a us Event Trait(s) PC Code Registration Status MON 89034 Cry1A.105 and 006514 ; Registered Crv2Ab2 006515 MON87411 Cry38b1 and 006580 ; Unregistered DvSnf7dsRNA 006566 MON 88017 Cry3Bb1 006498 Registered

MON 810 Cry1Ab 006526 Registered TC 1507 Cry1F 006481 Registered MIR 162 Vip3Aa20 006599 Registered DAS-59122-7 Cry34Ab1 and 006490 ; Registered Crv35Ab1 006556 

### T bl 3

a e 

### P I P C b o 

## f s om 1na 1ons: 

# u 0 

### t d nreg1s ere PIP COMBINATION 

### U nregiste red : Contains MON 87411 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X TC1507 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X TC1507 

### X MIR162 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X TC1507 

### X MIR162 

### X DAS-59122-7 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X TC1507 

### X DAS -5 9122-7 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X MIR162 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X MIR162 

### X DAS-59122-7 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 

### X DAS-59122-7 MON 89034 

### X MON 87 411 

### X MON 88017 MON 89034 

### X MON 87411 

### X MON 88017 

### X MON 810 MON 89034 

### X MON 87411 

### X MON 88017 

### X TC 1507 MON 89034 

### X MON 87411 

### X MON 88017 

### X TC1507 

### X MIR162 MON 89034 

### X MON 87411 

### X MON 88017 

### X TC1507 

### X M I R162 

### X DAS-59122-7 MON 89034 

### X MON 87411 

### X MON 88017 

### X TC1507 

### X DAS-59122-7 MON 89034 

### X MON 87411 

### X MON 88017 

### X MIR162 MON 89034 

### X MON 87411 

### X MON 88017 

### X MIR162 

### X DAS - 59122 -7 MON 89034 

### X MON 87 411 

### X MON 88017 

### X OAS-59122-7 MON 89034 

### X MON 87 411 MON 89034 

### X MON 87411 

### X MON 810 MON 89034 

### X MON 87411 

### X MON 810 

### X TC1507 MON 89034 

### X MON 87411 

### X MON 810 

### X TC1507 

### X MIR162

0 

### MON 89034 

### X MON 87411 

### X MON 810 

### X TC1507 

### X MIR162 

### X OAS - 59122-7

MON 89034 

### X MON 87411 

### X MON 810 

### X TC1507 

### X DAS-59122 - 7 MON 89034 

### X MON 87411 

### X MON 810 

### X MIR162 DER-4

### PIP COMBINATION MON 89034 X MON 87411 X MON 810 X MIR162 X DAS-59122 -7 MON 89034 X MON 87411 X MON 810 X DAS-59122-7 MON 89034 X MON 87411 X TC1507 MON 89034 X MON 87411 X TC1507 X MIR162 MON 89034 X MON 87411 X TC1507 X MIR162 X DAS-59122 -7 MON 89034 X MON 87411 X TC1507 X DAS-59122-7 MON 89034 X MON 87411 X MIR162



# - MON 89034 X MON 87411 X MIR162 X DAS-59122-7 MON 89034 X MON 87411 X DAS-59122-7 MON 87411 X MON 88017 MON 87411 X MON 88017 X MON 810 MON 87411 X MON 88017 X MON 810 X TC1507 MON 87411 X MON 88017 X MON 810 X TC1507 X MIR162 MON 87411 X MON 88017 X MON 810 X TC1507 X MIR162 X DAS -59122 - 7 MON 87411 X MON 88017 X MON 810 X TC1507 X DAS-59122 - 7 I-- MON 8 7411 X MON 88017 X MON 810 X MIR162 MON 87411 X MON 88017 X MON 810 X MIR162 X OAS-59122- 7 MON 87411 X MON 88017 X MON 810 X OAS-59122-7 

# I MON 87411 X MON 88017 X TC1507 MON 87411 X MON 88017 X TC1507 X MIR162 MON 87411 X MON 88017 X TC1507 X MIR162 X DAS-59122-7 MON 87411 X MON 88017 X TC1507 X DAS-59122-7 MON 87411 X MON 88017 X MIR162 MON 87411 X MON 88017 X MIR162 X DAS-59122-7 MON 87411 X MON 88017 X DAS-59122-7 MON 87411 X MON 810 I-- MON 87411 X MON 810 X TC1507 1--- MON 87411 X MON 810 X TC1507 X MIR162 MON 87411 X MON 810 X TC1507 X MIR162 X DAS-59122-7 MON 87411 X MON 810 X TC1507 X DAS-59122-7 MON 87411 X MON 810 X MIR162 MON 87411 X MON 810 X MIR162 X OAS-59122-7 f--- MON 87411 X MON 810 X OAS -59122 - 7 MON 87411 X TC1507 MON 87411 X TC1507 X MIR162 MON 87411 X TC1507 X OAS-59122-7 MON 87411 X TC1507 X MIR162 X DAS -59122-7 MON 87411 X MIR162 MON 87411 X MIR162 X DAS-59122-7 

### DER-5

### PIP COMBINATION MON 87411 X DAS-59122-7 

### Unregistered : New Combination MON 89034 X MON 88017 X MON 810 MON 89034 X MON 88017 X MON 810 X TC1507 MON 89034 X MON 88017 X MON 810 X TC1507 X MIR162 MON 89034 X MON 88017 X MON 810 X TC1507 X MIR162 X DAS-59122-7 MON 89034 X MON 88017 X MON 810 X TC1507 X DAS-59122-7 MON 89034 X MON 88017 X MON 810 X MIR162 MON 89034 X MON 88017 X MON 810 X MIR162 X DAS-59122-7 MON 89034 X MON 88017 X MON 810 X DAS-59122-7 MON 89034 X MON 88017 X TC1507 X M IR 162 MON 89034 X MON 88017 X TC1507 X MIR162 X DAS-59122-7 MON 89034 X MON 88017 X MIR162 MON 89034 X MON 88017 X MIR162 X DAS-59122-7 MON 89034 X MON 810 MON 89034 X MON 810 X TC1507 MON 89034 X MON 810 X TC1507 X MIR162 MON 89034 X MON 810 X TC1507 X MIR162 X DAS-59122-7 MON 89034 X MON 810 X TC1507 X DAS -59122 - 7 MON 89034 X MON 810 X MIR162 MON 89034 X MON 810 X MIR162 X DAS-59122-7 MON 89034 X MON 810 X DAS-59122-7 MON 89034 X TC1507 X MIR162 MON 89034 X TC1507 X MIR162 X DAS-59122-7 MON 89034 X MIR162 MON 89034 X MIR162 X DAS - 59122-7 MON 88017 X MON 810 X TC1507 MON 88017 X MON 810 X TC1507 X MIR162 MON 88017 X MON 810 X TC1507 X MIR162 X DAS-59122-7 MON 88017 X MON 810 X TC1507 X DAS-59122-7 MON 88017 X MON 810 X MIR162 MON 88017 X MON 810 X MIR162 X DAS-59122 - 7 MON 88017 X MON 810 X DAS-59122-7 MON 88017 X TC1507 X MIR162 MON 88017 X TC1507 X MIR162 X DAS-59122-7 MON 88017 X MIR162 MON 88017 X MIR162 X DAS-59122-7 MON 810 X TC1507 X M IR 162 X DAS-59122-7 

### DER-6

### PIP COMBINATION MON 810 X MIR162



### - --- -- MON 810 X MIR162 X DAS-59122-7 TC1507 X MIR162 X DAS-59122-7 MIR162 X DAS-59122-7 

## Table 4 Registered P I Ps Combination: Re iste r ed 1 

### COMBINATION MON 89034 X MON 88017 (EPA Reg N!! 524-576) 

# I MON 89034 X MON 88017 X TC1507 (EPA Reg N2 524- 587) MON 89034 X MON 88017 X TC1507 X DAS-59122-7 (EPA Reg N2 524 -581) MON 89034 X MON 88017 X OAS-59122-7 (EPA Reg N2 524-589) MON 89034 X TC1507 (EPA Reg N2 524-585) MON 89034 X TC1507 X DAS-59122- 7 (EPA Reg N2 524-588) MON 89034 X OAS-59122-7 (EPA Reg N2 524-584) MON 88017 X MON 810 (EPA Reg N2 524 -552) MON 88017 X TC1507 (EPA Reg N2 524-583) MON 88017 X TC1507 X DAS-59122 -7 (EPA Reg N2 524- 590) MON 88017 X DAS -59122-7 ( EPA Reg N!! 524-586) MON 810 X TC1507 (EPA Reg N!! 29964-7) MON 810 X TC1507 X MIR162 (EPA Reg N2 29964-19) MON 810 X TC1507 X DAS-59122 -7 (EPA Reg N2 29964-8) MON 810 X DAS-59122-7 (EPA Reg N!! 29964-9) TC1507 X MIR162 ( EPA Reg N2 29964 -20) TC1507 X OAS -59122-7 (EPA Reg N2 29964-5)

**---- --------------------~**  1The listed EPA Reg . N9 is for just one product with t hat

combination (i. e ., not all reg istered products as listed) .



### DER-7

### EQUATIONS The following equations were used to calculate the amount of corn seed (lb) expected to be used in this EUP and the amount of PIP protein. The planting density and percent active ingredient (% 

### A I) were provided by Monsanto .

Table 

## 5 Equation 1

Equation 

## 2 Calculating Amount of Corn Seed (in pound s ) lb Corn Seed = Acres x Planting D en s ity, where PI 

## t . D . 60 lb Corn Seed



### an mg ens1ty =--A- c -r

e--



### Calculating Amount of Protein (in pound s and grams) lb Protein= Amount ofPotato (lb) x % AI, where, %Active Ingredient is provided on the Confidential Statement of Formulation (CSF) and llb::453.6 g.

Acres by State , Amount of Corn Seed (lb) , and Maximum Amount of MON 87411 

### {g , lb) that May Be Used Under this EUP Amount of PIP Protein Acres lb 

### Seed DvSnf7dsRNA Crv3Bb1 

## AL AR CA 

# co FL GA 

### I fH 

### lA 

### IL 

### IN

# " KS 

### LA M 

### I



### - MN MO MS NC 

# t 20 10 0 5 10 11 753 829 952 148 323 11 0 172 10 75 13 1,200 600



# -- 0 

## ·-- 300 600 660 45 , 180

## r49 , 740 57 , 120 8 , 880 19, 380

660

0 10 ,320

600 4 , 500 780 lb 

### grams lb 

### grams 2015 2.04E-06 9.25E-04 6 . 12 E-03 2 . 78 

# - 1.02E-06 4 .63E-04 3 .06E -03 1 . 39 0 0 0 0 5 . 10E-07 2 .31 E -04 1 . 53E -03 0 .694



### - 1 . 02E-06 4 .63E-04 3 . 06E-03 1 .39 1 . 12E-06 5 .09E-04 3 . 37E - 03 1 .53 7 .68E-05 3.48E-02 0 .230 105 8.46E-05 3 . 84E-02 0 .254 115 9 .71E-05 4.40E-02 0 .291 132 1 .51E-05 6 . 85E-03 4 .53E- 02 20 . 5

**~** 3 .29E-05 1.49E -02 9 . 88E - 02 44 . 8 1 . 12 E- 06 5 . 09E-04 l 3 . 37E - 03 1 .53 0 0 0 0 1 .75E-05 7 .96E-03 5 . 26E -02 23 .9 1.02E-06 4 .63E-04 3 .06E-03 1 . 39 7 .65E-06 3.47E-03 2 . 30E-02 10.4 1.33E-06 6.01 E -04 3 . 98E -03 1 .80 

### DER-8NO NE OH 

### PA PR 

## sc 

# so TN 

## T

X

I I WA



# w Tota



## Al AR CA 

# co Fl GA I H 

### lA 

### ll IN KS 

### LA M

### I MN MO M S N C NO NE O H 

### PA PR 

## sc 

# so TN 

## T

X WA



# w Tota

### I 

### I 

### Acres 16 !--- 333

8 1-- 3 605 10 6 88 31 150

5 4 ,597

108 100 12 50 100 1-- 401 903 446 246 122 265 101 100 100 40 244 105 1-- 13 241f10 5 507 100 !--- 6 103 216 305

**~** 10 4 ,959 !, I 

### lb Seed

960 19, 980

480 180 36 , 300

600 360 5 ,280 1 ,8 60 9,000

300 275,820

6,480 6 ,000 720 3 ,000 6 ,000 24 ,060 54 , 180 26 , 760 14 ,760 7,320 15 ,900 6,060 6 ,000 6 ,000 2,400 14,640 6 , 300

780 14,460

600 300 30 ,420 6 ,000 360 6 , 180 12 ,960 18 ,300

600 297,540 

### Amount of PIP Protein 

## I DvSnf7dsRNA Crv3Bb1 

# I lb grams lb grams 1.63E-06 7.40E-04 4 . 90E-03 2 .22 3.40E -05 1 .54E-02 0 . 102 46 .2 8.16E-07 3 .70E-04 2.45E-03 1 . 11 3.06E-07 1 .39E-04 9 . 18E-04 0.416 6 . 17E-05 2 .80E-02 0 . 185 

# _I_ 84 .0 1 .02E-06 4 . 63E-04 3 . 06E-03 1 .39 6 . 12E-07 2 .78 E -04 1 .84E-03 0 . 833 8.98E-06 4 .07E-03 2 .69E -02 12 . 2 3 . 16E-06 1.43E -03 9.49E -03 4 .30 1 . 53E-05 6.94E -03 4 . 59E-02 20.8 5.10E-07 2 .31E-04 1 .53E -03 0 .694 4 .69E-04 0.213 1.41 638 !.- 

# -- 2016



## - - 1 . 10E-05 5 .00E-03 3 .30E-02 15 .0 1 . 02E-05 4 .63E-03 3 .06E-02 13 .9



## - 1 .22E-06 5 . 55E-04 3 .67E-03 1 .67



# - - 5 . 10E-06 2 . 31 E-03 1 . 53E-02 6 .94



## - 1.02E-05 4 .63E-03 3 .06E -02 13 .9 4 .09E - 05 1 .86E-02 0 . 123 55 . 7



## -- f- ---- 9.21 E-05 4 . 18E -02 0 . 276 125 4 .55E-05 2 .06E-02 0 . 136 61 .9 2 .51 E-05 1 . 14E -02 7 . 53E-02 34 . 1 1 .24E-05 5 .64E -03 3 . 73E-02 16 .9 2 .70E-05 1 .23E -02 8 . 11E -02 36 .8 1.03E-05 4 .67E-03 3 .09E -02 14.0 1 .02E-05 4 .63E -03 3 .06E -02 13 . 9 1 .02E-05 4 .63E -03 3 .06E -02 13.

_ 9 4 .08E-06 1 . 85E-03 1 . 22E -02 5.55 2.49E-05 1 . 13E -02 7.47E -02 33 . 9 1 .07E-05 4 . 86E -03 3 . 21E -02 14. 6 1 .33E-06 6.01E -04 3 . 98E-03 1 .80 2.46E-05 1.12E-02 7 . 37E-02 33 . 5 1 .02E -06 4 .63E-04 3 . 06E-03 1 . 39 5 .10 E-07 2.31 E-04 1 .53E-03 0 .694 5 . 17E-05 2 .35E-02 0 . 155 70.4 1 .02E-05 4 .63E-03 3 .06E-02 13 .9 6 .1 2E - 07 2 .78 E-04 1 .84E - 03 0 .833 1 .05E-05 4 . 77E-03 3 . 15E -02 14 .3 2.20E - 05 9 .99E-03 6.61E -02 30 .0 3 . 11E-05 1.41E-02 9 . 33E-02 42 .3 1 .02E-06 4 .63E-04 3 .06E -03 1 .39 5.06E-04 0 .229 1 .52 

# I 688 

### DER-9A L AR CA 

# co FL GA 

### I H 

### lA IL 

### IN KS 

### LA M 

### I MN MO MS N C ND 

## N

E O H 

## P

A PR 

## sc s o T N 

## T

X WA

W I 

### Tota I 

### Acres

128 110 12 55 110 412 1 ,656 1 ,275 1,198 270 588 112 100 272 50 319 118 29 574 18 8 1 , 112 110 12 191 247 455 15 9 ,556 

### DISCUSSION lb Seed

7 ,680 6 ,600

720 3 , 300 6 ,600 . 24 , 720 99 , 360 76 , 500 71 ,880 16 ,200 35 ,280 6 , 720 6 ,000 16 ,320 3 ,000 19 , 140 7 , 080 1 , 740 34,440 1 , 080 480 66 ,720 6 ,600

720 11,460 14 ,820 27 , 300

900 573 , 360 

### Amount of PIP Protein DvSnf7dsRNA Crv3Bb1 lb grams lb grams

G RA ND T OTA L 1 . 31E -05 5 .92E - 03 3 .92E -02 17.8 1 . 12E -05 5 .09E-03 3 .37E -02 15 .3 1 . 22E -06 5 . 55E - 04 3 .67E-03 1 .67 5 .61 E-06 2 . 54E -03 1 .68E- 02 7 .63 1 . 12E-05 5 .09E-03 3 . 37E - 02 15.3 4 .20E-05 1 . 91E-02 0 . 126 57 . 2 1 . 69E-04 7 .66E-02 0 .507 230 1 .30E-04 5.90E-02 0 . 390 177 1 .22E-04 5 . 54E -02 0 . 367 166 2 .75E-05 1 .25E -02 8 .26E -02 37 . 5 6 .00E - 05 2 . 72E -02 0 . 180 81.6 1 . 14E-05 5 . 18E-03 3.43E-02 15.5 1 .02E-05 4 .63E-03 3 .06E-02 13.9 2 . 77E - 05 1.26E- 02 8 . 32E -02 37 .8 5 . 10E-06 2 .31 E -03 1 . 53E-02 6 . 94 3 . 25E -05 1.48E- 02 9 . 76E -02 44 . 3 1 . 20E-05 5.46E- 03 3 .61 E-02 16.4 2.96E -06 1 .34E -03 8 . 87E -03 4 . 03 5 . 85E -05 2 .66E-02 0 . 176 79 . 7 1 . 84E -06 8 .33E - 04 5 . 51 E -03 2 . 50 8.16E -07 3 .70E - 04 2.45 E- 03 1 . 11 1 . 13E-04 5.14E - 02 0 . 340 154 1: 12E -05 5.09E -03 3 .37E - 02 15. 3 1 .22E -06 5 . 55E -04 3 .67E-03 1 .67 1 .95E -05 8 . 84E-03 5 . 84E-02 26 . 5 2 .52E -05 1 . 14E -02 7 .56E - 02 34 . 3 4 .64E -05 2 . 11E -02 0 . 139 63 . 2 1 .53E -06 6 . 94E-04 4 . 59E -03 2 .08 9 .75E-04 0 .442 2 . 92 1 ,326



### The Agency (the Office of Pesticide Programs Biopest icides and Pollution Prevention Division ) has reviewed Monsanto' s revised approach for subm itti ng proposed experimenta l acreage. Both the new methodo l ogy and the acreage requested are acceptable. EPA has verified and agrees with Monsanto 's calculations (see Table 5) . T he d ifferences are slight and may be attributed to rounding . This is the first Monsanto EUP where the Section G calculations were ca l culated differently from past submissions. EPA expects that it wi ll allow Monsanto increased fl exib il ity i n the planning and imp l anting the i r investigation of M O N 87 411. I n Monsanto 's final report , the specific breakdown of acres per state , combination , and P I P , non - PIP , and border must be reported. DER-10

### REFERENCES Monsanto. 2014a. Amended Application for an Experimental Use Permit to Test MON 87411 , Combined Trait Insect Control Corn , Comb i nations Necessary for their P roduction , and Controls ( EPA F il e Symbol 524-EUP-104) . Gidd i ngs KS , Ph . D . and Levis K, M . S . Monsanto Company . Monsanto Submission ID CR256- 14E1 . October 10 , 20 1 4 . 61 pp . NO MRID. Monsanto . 2014b . Amended Application for an Experimental Use Permit to Test MON 87411 , Combined Tra it Insect Control Com , Combinations Necessary for their Production , and Controls ( EPA Fil e Symbol 524-EUP-104) . Gidd i ngs KS , Ph.D. and Levis K , M.S. Monsanto Company . Monsanto Submiss ion ID CR256-14E2. December 19 , 2014 . 64 pp. NO MRID . U.S. EPA. 2013. Me m orandum from Kathleen Martin to Shanaz Bacchus. Appl i cat ion for an Experimental Use Permit to Test MON 87410, MON 8741 Combined Tra it Insect Control for Corn ; EPA File Symbol 524-EUP-RNU . Sect ion G Calculations. Decision 

## N2 464546; DP 

## N2 405676. U . S . Envi ronmental Protection Agency Office of Pest icide Programs . B iopesti cides and Po ll ution Prevention Div i sion . February 11 , 2013 . U . S . EPA. 2014a . Letter from Steven Bradbury , Ph . D Di rector U.S. Env ironmental Protection Agency Office of Pesticide Programs to Mark G roth , Regu l atory Affa i rs Manager Monsanto Company . Corn Plant Incorporated Protectan ts with Mon 874 1 1 (containing a Dv49 double stranded RNA [dsRNA] suppress ion cassette) in combination with Bacillus thur i ngiensis 

### (Bt) Proteins (Cry 1 A.105 , Cry2Ab2 , Cry1F , V i p3Aa20 , Cry3Bb1 , and Cry34Ab1/Cry35Ab1) . EPA Experimental Use Permit 

## N2 524-EUP - 1 04 . Application Dated: October 3 , 2013 . Effective Dates : Upon Issuance to February 29 , 2016. February 18 , 2014 . U . S . EPA. 201.4b . Memorandum from Kathleen Martin to Shanaz Bacchus. Amendment to EPA Reg. 

## N2 524-EUP-104 (MON 87411 Combined Trait Insect Control f or Corn) . Section G Calcu lations. AMENDED (to correct a typograph ica l error) . Decis ion 

## N2 484130 ; DP 

## N2 416161. U . S. Environmental Protection Agency Office of Pesticide Programs . B i opestic ides and Pollution P revention Divis ion . February 25 , 2014.

DER-11