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 PI P 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- 1UNIQUE 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 requ esting 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 bl 1



### a 

### e 0 veraII S fA ummary o f 2015and2016 cres or 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-2Amount 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 ofSoybean Seed (lb) x %

### Al, where, % Active Ingredient is provided on the Confidential Statement of Formulation (CS F) 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 1 1
. 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

### DISCUSS ION The Agency (the Office of Pesticide Programs Biopesticides and Pollution Prevention Division) has reviewed Monsanto's modified approach for subm itting proposed experimental acreage. Both the new approach and the acreage requested are acceptable. EPA has verified and agrees with Monsanto's calculations (see Tab le 2). The differences are slight and are attributable to round ing. EPA expects that Monsanto's modified approach to the acreage subm ission will allow them increased flexibil ity in the planning and implementation of the ir investigation of MON 87411
. In Monsanto's final report, the specific breakdown of acres per state , combination , and PI P, non- PIP , and border must be reported. REFERE NCE 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 Subm ission ID SY259- 14E1. August 18,20 1 4. NO MR I D.

DER-4