UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON; D.C. 20460 

February 2, 2015 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: 

FROM: 

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 87 411) 

MRID: NONE 

Decision N2: 496549 

DP N2: 425377 

Kathleen Martin, Chemist, M.S.E.st .\t\· "l\ "'2.\\6 

Microbial Products Branch 

Biopesticides and Pollution Prevention Division 

Alan Reynolds, Team Leader /.~ (JJ Microbial 

Biopesticides 

Products 

and Pollution 

Branch 

Prevention 

V 

Division 

~ 

Mike Mendelsohn, Regulatory Action Leader 

Microbial Products Branch 

Biopesticides and Pollution Prevention Division 

Monsanto Company is testing MON 87 411 , a new plant-incorporated protectant (PIP) 

technology. In March 2013 EPA approved an experimental use permit1 (EUP) for its testing; the 

Agency amended this permit in February 2014 (U.S. EPA 2014a). Monsanto is now requesting to 

amend the petition 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. 

1EPA 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: Combinations of PIP events that are made up of one or more of the following individual 

events: MON 89034, TC 1507, MIR 162, MON 88017, DAS-59122-7 and MON 87411 . 

Sponsor: Monsanto Company 

Testing NA 

Facility: 

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

Title: Insect Control Corn, Combinations Necessary for their Production, and Controls (EPA File 

Symboi524-EUP-104). Giddings KS, Ph.D. and Levis K, M.S. Monsanto Company. 

Monsanto Submission ID CR256-14E1 . October 10, 2014. 61 pp. NO MRID. 

Amended Application fpr ap. Experirneptal 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 87 411 , combined trait insect control corn, combinations necessary for their production and 

controls; MON 87411 contains a Dv49 double stranded RNA [dsRNA] suppression cassette. 

In March 2013 the Agency approved an experimental use permit (EUP) to test this new technology 

(EPA Reg. NQ 524-EUP-1 04) and in 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). 

227 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. In 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-PIP acres. The advantage of this new approach is that Monsanto will be able to make their final 

decision regarding how the acres will be parsed among the combinations and non-PIP & 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 PIP 

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 previously 40 

registered event 

Subtotal: 103 

REGISTERED PIP 17 COMBINATIONS: 

Grand Total: 120 

ACRES AND AMOUNT OF PIP-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. 

3MON 87411 is an unregistered PIP event. 

DER-2 
TABLES 

Table 1 Key Study Parameters: Original vs. Amended EUP 

Original Amendments 

Mar

ch 20

13 February 2014 Current 

Pla

nti

ng Feb 2013 Feb 2014 Feb 15, 2015 

Pe

riod: to July 2014 to Feb 2016 to Feb 28, 2017 

Geog

raphic 23 

31 28 Locations: Alabama " " 

Arkansas " " " 

Californ

ia ., " " 

Colorado " " " F:lorida " " Georgia " " " Hawaii " " " 

Idaho " " Illinois " " " Indiana " " " Iowa " " " Kansas " " " Kentucky " 

Lou

i

s

iana " " 

Michigan " " " Minnesota " " " Mississippi " " " 

Missouri " " " Nebraska " " " North Carolina " " " North Dakota ., " 

Ohio " ., " Oklahoma ., 

Pennsylvania ., ., " 

Puerto 

Rico " " " South Carolina " " " South Dakota ., " " Tennessee " " " Texas ., " 

Wash

ington " " 

W

iscons

in " " " 

Acres : Total 20,893 46

,522 -=l The values in '() PIP 17,740 (85%) 31 ,869 (68.5%) 

sho

w%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

IP Combinations: 64 46 120 

Unregistered I 13 29 103 

Registered 51 

17 17 

DER-3 
T a e bl 2 PIP E ven san d T ot ra1 san d R 0 

eg1s t ra t' 1on St a t 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 a e bl 3 PIP s C om b1na o f 1ons: u 0 

nreg1s t ere d 

PIP COMBINATION 

Unregistered: Contains MON 87 411 

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-59122-7 

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 87 411 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 MIR162 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 87411 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 MIR162 

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 MIR162 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 PIPs Combination: Re istered1 

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) 

1

The listed EPA Reg. N9 is for just one product ----with --------------------~ that 

combination (i.e., not all registered 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 (% AI) were provided by Monsanto. 

Table 5 

Equation 1 

Equation 2 

Calculating Amount of Corn Seed (in pounds) 

lb Corn Seed = Acres x Planting Den sity, where 

PI t

. D . 60 lb Corn Seed 

an mg ens1ty =--A-c-re--

Calculating Amount of Protein (in pounds and grams) 

lb Protein= Amount of Potato (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 6.12E-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 

1.12E-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-8 
NO 

NE 

OH 

PA 

PR 

sc 

so 

TN 

TX 

I 

I 

WA 

w 

Tota 

Al 

AR 

CA 

co 

Fl 

GA 

H I 

lA 

ll 

IN 

KS 

LA 

M I 

MN 

MO 

MS 

NC 

NO 

NE 

OH 

PA 

PR 

sc 

so 

TN 

TX 

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 

241 

f10 

5 

507 

100 

!---

6 

103 

216 

305 ~ 

10 

4,959 

!, 

I 

lb Seed 

960 

19,980 

480 

180 

36,300 

600 

360 

5,280 

1,860 

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 

lb grams lb grams I 

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 2.78E-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 

5.10E-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 2.78E-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-9 
AL 

AR 

CA 

co 

FL 

GA 

H I 

lA 

IL 

IN 

KS 

LA 

M I 

MN 

MO 

MS 

NC 

ND 

NE 

OH 

PA 

PR 

sc 

so 

TN 

TX 

WA 

WI 

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 

GRAND TOTAL 

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 2.45E-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 Biopesticides and Pollution Prevention Division) 

has reviewed Monsanto's revised approach for submitting proposed experimental acreage. Both the 

new methodology and the acreage requested are acceptable. EPA has verified and agrees with 

Monsanto's calculations (see Table 5). The differences are slight and may be attributed to rounding. 

This is the first Monsanto EUP where the Section G calculations were calculated differently from 

past submissions. EPA expects that it will allow Monsanto increased flexibility in the planning and 

implanting their investigation of MON 87 411. In Monsanto's final report, the specific breakdown of 

acres per state, combination, and PIP, non-PIP, and border must be reported. 

DER-10 
REFERENCES 

Monsanto. 2014a. Amended Application for an Experimental Use Permit to Test MON 87 411 , 

Combined Trait Insect Control Corn, Combinations Necessary for their Production, and Controls 

(EPA File Symbol 524-EUP-104). Giddings KS, Ph.D. and Levis K, M.S. Monsanto Company. 

Monsanto Submission ID CR256-14E1 . October 10, 2014. 61 pp. NO MRID. 

Monsanto. 2014b. Amended Application for an Experimental Use Permit to Test MON 87411 , 

Combined Trait Insect Control Com, Combinations Necessary for their Production, and Controls 

(EPA File Symbol 524-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. 

U.S. EPA. 2013. Memorandum from Kathleen Martin to Shanaz Bacchus. Application for an 

Experimental Use Permit to Test MON 87410, MON 8741 Combined Trait Insect Control for Corn; 

EPA File Symbol 524-EUP-RNU. Section G Calculations. Decision N2 464546; DP N2 405676. 

U.S. Environmental Protection Agency Office of Pesticide Programs. Biopesticides and Pollution 

Prevention Division. February 11 , 2013. 

U.S. EPA. 2014a. Letter from Steven Bradbury, Ph.D Director U.S. Environmental Protection 

Agency Office of Pesticide Programs to Mark Groth, Regulatory Affairs Manager Monsanto Company. 

Corn Plant Incorporated Protectants with Mon 87411 (containing a Dv49 double stranded 

RNA [dsRNA] suppression cassette) in combination with Bacillus thuringiensis (Bt) Proteins 

(Cry1A.105, Cry2Ab2, Cry1F, Vip3Aa20, 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 for Corn). Section G 

Calculations. AMENDED (to correct a typographical error). Decision N2 484130; DP N2 416161. U.S. 

Environmental Protection Agency Office of Pesticide Programs. Biopesticides and Pollution Prevention 

Division. February 25, 2014. 

DER-11