UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON; D.C . . 20460 

February 12, 2015 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: EPA File Symbol 524-EUP-RNT: Application for an Experimental Use Permit to Test 

MON 87751 and Combined-Trait Insect-Protected Soybeans Section G Calculation 

PC Code: 

MRID: 

006532 (MON 87701); 006527 & 006532 (MON 87751) 

NONE 

Decision N2: 490839 

DP N2: 422734 

FROM: Kathleen Martin, Chemist, M.S.E.S. 

Microbial Pesticides Branch 

Biopesticides and Pollution Prevention Division 

THROUGH: Alan Reynolds, Team Leader 

Microbial Pesticides Branch 

Biopesticides and Pollution Prevention Division 

' 

TO: Kenneth Haymes, Regulatory Action Leader 

Microbial Pesticide Branch 

Biopesticides and Pollution Prevention Division 

Monsanto Company is testing MON 87751, a new plant-incorporated protectant technology for 

control of lepidopteran soybean pests. They are proposing to test one PIP combination 

(MON 87701 x MON 87751) planted on 3, 720 acres in 20 states plus the Commonwealth of Puerto 

Rico. The proposed experimental use is for two years. The attached Data Evaluation Record provides 

a description of Monsanto's proposed experimental program including the Section G calculations. 
Data Evaluation Record 

Reviewed by: Kathleen Martin, Chemist 

Secondary Review: Alan Reynolds, M.S. 

Study Type: Section G calculations for a new PIP Experimental Use Permit: 524-EUP-RNT. 

Test Guideline: Not applicable 

MRID: NA 

DP Barcode: 422734 

Test Material: MON 87751 and Combined-Trait Insect-Protected Soybeans 

Sponsor: Monsanto Company 

Testing Facility: NA 

Report Title: Revised Section G for the Application for an Experimental Use Permit to Test 

MON 87751 and Combined-Trait Insect-Protected Soybeans. Monsanto 

Submission ID SY259-14E1. No MRID. 

Authors: Debbie Mahadeo 

Submission Date: August 18,2014 

Conclusion: The Agency has reviewed the Section G calculations for Monsanto's proposed 

experimental program to test a new PIP technology. Both Monsanto's methodology 

and requested acreage are acceptable. 

Classification: Acceptable 

Good Lab 

Practice: Not applicable 

Monsanto Company is testing a new plant incorporated protectant (PIP) technology- MON 

87751 for control of lepidopteran soybean pests. The proposed experimental use is for one PIP 

combination (MON 87701 x MON 87751) planted on 3,720 acres in 20 states plus the Commonwealth 

of Puerto Rico. The proposed experimental use is for two years. 

Monsanto's approach to the Section G submission is slightly different from previous such 

submissions. Traditionally, EPA has required Monsanto to specify: the number of PIP, non-PIP, and 

border acres for each event combination by state; and, the total amount of PIP protein for each 

combination. To allow more flexibility in planning and implementing the investigation of MON 87751, 

Monsanto has submitted the Section G acreage data in a more general way. Monsanto is still 

specifying the acres by state and the PIP combination. What is different is that the proposed acres 

have been reported in aggregate (i.e., the number of acres they are requesting reflect PIP, non-PIP, 

and border acres) . . In addition, Monsanto has only provided the expected amount of PIP protein for the 

unregistered PIP (i.e., MON 87751). Previously, the amount of protein for both registered and 

unregistered combinations was provided. 

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 PIP, Non-PIP, and Border acres closer to planting. 

Monsanto's final report must provide the acre distribution for PIP, Non-PIP, and Border acres. 

DER-1 
UNIQUE PIP EVENTS and COMBINATIONS 

Monsanto is proposing to use one combined trait PIP (shown below) which is comprised of two 

single events: MON 87701 and MON 87751. MON 87701 has a single PIP protein (Cry1Ac); this event 

is registered. MON 87751 has two PIP proteins (Cry1A.105 and Cry2Ab2); this event is unregistered. 

Combined Trait PIP: MON 87701 x MON 87751 [Cry1Ac]1; [Cry1A.105, Cry2Ab2]2·3 

MON 87701: [Cry1Ac]; EPA Reg. NC? 524-594; and 

MON 87751: [Cry1A.105,Cry2Ab2]; Unregistered 

ACRES, AMOUNT OF PIP-CONTAINING SEED, AMOUNT OF PIP PROTEIN 

Total Acres. In total, Monsanto is requesting 3,720 acres over 2015 and 2016 as shown in 

Table 1. They intend to conduct their experimental program in 20 states in addition to the 

Commonwealth of Puerto Rico; the acres by state are tabulated in Table 2. Note that they 

reflect PIP, NON-PIP, and Border acres. 

T a bl e 1 0 vera II S ummary o fA cres f or 2015and2016 

2015 2016 Total 

1,846 1,874 3,720 

Amount of Soybean Seed (lb). In total, Monsanto expects to use 223,200 pounds of 

soybean seed. The amount of seed per state is provided in Table 2; see Equation 1 

for the calculation. 

Equation 1 Calculating Amount of Soybean Seed (lb) 

lb Soybean Seed = Acres x Planting Density, where 

Planting Density : 60 lb Soybean Seed 

Acre 

1Bacillus thuringiensis Cry1Ac and the genetic material necessary for its productiQn (PV-GMIR9) in soybean; PC Code 006532 

2Bacillus thuringiensis Cry1A.105 protein and the genetic material (Vector PV-GMIR1316) necessary 

for production in MON87751 soybean; PC Code 006614 

3 Bacillus thuringiensis Cry2Ab2 protein and the genetic material (Vector PV-GMIR1316) necessary 

for production in Mon 87751 soybean; PC Code 006615 

DER-2 
Amount of PIP Protein. Monsanto intends to use a single PIP combination under this 

EUP: MON 87701 x MON 87751 . MON 87701 has a single PIP protein- [Cry1Ac]. Because 

this event is registered, Monsanto has not provided the amount [Cry1Ac] protein. The 

amount of [Cry1A.105 and Cry2Ab2], the PIP events that comprise MON 87751 (unregistered PIP 

event), is shown in Table 2. The amount of protein (pounds and grams) was calculated using Equation 

2 

Equation 2 Calculating Amount of Protein (pounds and grams) 

Table 2 

AL: 

AR: 

GA: 

HI: 

IA: 

IL: 

IN: 

KS: 

LA: 

MD: 

MO: 

MS: 

NC: 

NE: 

OH: 

PA: 

SC: 

TN: 

TX: 

WI: 

PR: 

TOTAL 

lb Protein = Amount of Soybean Seed (lb) x % Al, where, 

% Active Ingredient is provided on the Confidential 

Statement of Formulation (CSF) and 1 lb=453.6 g. 

· Total Acres, Amount of Soybean Seed (lb) 

and Maximum Amount of PIP Protein (lb, g) 

Acres Amt Soybean Cry1A.105 Cry2Ab2 

Seed (lb) lb g lb g 

80 4,800 0.015 6.97 0.024 11.1 

403 24,180 0.077 35.1 0.123 55.9 

80 4,800 0.015 6.97 0.024 11.1 

214 12,840 0.041 18.6 0.065 29.7 

432 25,920 0.083 37.6 0.132 60.0 

384 23,040 0.074 33.4 0.118 53.3 

151 9,060 0.029 13.2 0.046 21 .0 

72 4,320 0.014 6.27 0.022 9.99 

80 4,800 0.015 6.97 0.024 11.1 

69 4,140 0.01°3 6.01 0.021 9.58 

72 4,320 0.014 6.27 0.022 9.99 

80 4,800 0.015 6.97 0.024 11.1 

324 19,440 0.062 28.2 0.099 45.0 

136 8,160 0.026 11.8 0.042 18.9 

72 4,320 0.014 6.27 0.022 9.99 

64 3,840 0.012 5.57 0.020 8.88 

80 4,800 0.015 6.97 0.024 11.1 

80 4,800 0.015 6.97 0.024 11.1 

106 6,360 0.020 9.23 0.032 14.7 

64 3,840 0.012 5.57 0.020 8.88 

677 40,620 0.130 59.0 0.207 94.0 

3,720 223,200 0.714 323.97 1.14 516.33 

DER-3 
DISCUSSION 

The Agency (the Office of Pesticide Programs Biopesticides and Pollution Prevention Division) 

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

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

Monsanto's calculations (see Table 2). The differences are slight and are attributable to rounding. 

EPA expects that Monsanto's modified approach to the acreage submission will allow them 

increased flexibility in the planning and implementation of their investigation of MON 87411 . 

In Monsanto's final report, the specific breakdown of acres per state, combination, and PIP, 

non-PIP, and border must be reported. 

REFERENCE 

Monsanto. 2014. Revised Section G for the Application for an Experimental Use Permit to Test MON 

87751 and Combined-Trait Insect-Protected Soybeans. Debbie Mahadeo, Regulatory Affairs Manager. 

Monsanto Company. Monsanto Submission ID SY259-14E1. August 18,2014. NO MRID. 

DER-4