UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Debbie Mahadeo, Regulatory Affairs Manager 

Monsanto Company 

800 North Lindbergh Blvd. 

St. Louis. MO 63167 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Plant- Incorporated Protectant Bacillus thuringiensis (B. I.) Cry2Ab2 and Cry! A. I 05 

insect control protein and the genetic material necessary for its production in MON 

8775 1 and the combined-trait insect protected soybean 

EPA Experimental Use Permit No. 524-EUP-1 07 

Application Dated: Apri l 23, 2015 

Effective Dates: From the stamped date through December 31 , 20 16 (includes planting and 

associated activities e.g., collection of field data, harvesting, processing). 

Quantity Authorized: 223,200 pounds of soybean seed containing 0.714 pound (Cry1A. 105) and 

1. 14 pound (Cry2Ab2). 

Acres: 3,720 acres in 20 states plus the Commonwealth of Puerto Rico. 

Dear Ms. Mahadeo: 

On the basis of the information furnished by the applicant and the annexed program, the U.S. 

Environmental Protection Agency (EPA) hereby issues the subj ect Experimental Use Permit (EUP) 

under section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act to test the Plant Incorporated 

Protectant (PIP) with Bacillus thuringiensis (B. I.) Cry2Ab2 and Cry I A.l 05 insect control protein and 

the genetic material necessary for its production in MON 8775 1 and the combined-trait insect protected 

soybean. The EUP is authorized only in the States of Alabama (AL), Arkansas (AR), Georgia (GA), 

Hawaii (HI), Illinois (IL), Indiana (IN), Iowa (IA), Kansas (KS), Louisiana (LA), Maryland (MD), 

Mississippi (MS), Missouri (MO), Nebraska (NE), North Carolina (NC), Ohio (OH), Pennsylvania (PA), 

South Carolina (SC), Tennessee (TN), Texas (TX), Wisconsin (WI), and the Commonwealth of Puerto 

Rico (PR). It allows breeding and observation nurseri es and product characterization for line selection 

trials, testing the efficacy and specificity of the trans genes, evaluation of phenotypic and agronomic 

performance and optimization, production of sampl e material for environmental risk assessment, and 

composition studies and to test the commercial viability of experimental PIP events, conduct field trials 

as needed to support regulatory submissions and assess appropriate IRM programs. 

Shipment and use under this permit are subject to the provisions of 40 CFR Part 172. The EPA reviewed 

the health and environmental safety of Bacillus lhuringiensis (B. I.) Cry I A. I 05 and Cry2Ab2 proteins 

and has determined that adverse effects are not expected to man and nontarget organisms, including 

federally listed threatened and endangered species, as a result of the experiments to be performed under 

this EUP. 
Any pesticide treatments (e.g., herbicides) of the plants under the EUP must have applicable 

registrations. The Section G review of this EUP is enclosed (US EP A/BPPD review from K. Martin to 

K. Haymes, Ph.D., 02112/15). 

Prior to shipment and/or use of the subject PIP soybeans, you must consult with the pesticide regulatory 

officials and, if applicable, the biotechnology regulatory officials of the States in which you will conduct 

yo ur experimental program, and obtain a State permit or license if such is required. Issuance of this 

Federal permit does not negate the need for permission from individual States. Prior to initiating this 

experimental program in any State, you are required to notify the lead Agency of the States in which you 

will conduct your experimental program of the specific testing program (when, where, how much, etc.). 

Failure to do so may result in revocation or modification of this EUP. You must comply with all 

requirements of the USDA/APHIS as they apply to the proposed testing. 

You must provide notice to the State pesticide regulatory agency at least 72 hours before you use the 

EUP. You must also provide a copy of this authorization letter and stamped label, as well as the nonconfidential portion of the Section G Experimental Program, to all cooperators, participants and users 

prior to the initial pesticide use made in accordance with the EUP. The EPA will notify the relevant EPA 

Regions of the approval of this EUP by sending copies of this approval letter to them. 

Conditions under which the EPA is issuing this EUP are as follows: 

I . The total acreage and amount of PIP Bacillus thuringiensis (B. I.) Cry I A.l 05 and Cry2Ab2 soybean seed 

to be used shall not exceed the quantity authorized by this EUP: 3,720 acres, including non-PIP and the 

border acreage of control or other non-transformed soybeans (see Table I). The table shows the amount 

of soybean seed and Cry proteins expected to be used in each state. The amount of soybean seed is 

calculated by multiplying the acres by the planting density (i.e., 60 lb/A). The maximum amount of 

Cry I A. l 05 and Cry2Ab2 proteins is the product of the amount of soybean seed and the protein percent 

expression (see US EPA/BPPD review from K. Martin to K. Haymes, 02112115).The an1ount (pounds) of 

soybean seed expected to be planted in the following 20 states plus the Commonwealth of Puerto Rico 

over the duration of the EUP shall not exceed the amount in Table 1. 

We note that the approach to acreage 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, you 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 87751 , while still 

meeting regulatory requirements, Monsanto has proposed acreage listing 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 while still meeting regulatory requirements. 

Monsanto's final report must provide the specific combinations used and the acre distribution (which 

would include the number of acres fo r non-PIP and border). 

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Table l : Total Acres, Amount of Soybean Seed (lb) and Maximum Amount of PIP Protein (lb, g) 

State Acres Amt Soybean CrvlA.lOS Co:2Ab2 

Seed (lb) lb g lb g 

AL: 80 4,800 0.015 6.97 0.024 11.1 

AR: 403 24,180 0.077 35. 1 0.1 23 55.9 

GA: 80 4,800 0.0 15 6.97 0.024 11.1 

HI: 2 14 12,840 0.041 18.6 0.065 29.7 

lA: 432 25,920 0.083 37.6 0.132 60.0 

IL: 384 23,040 0.074 33.4 0.1 18 53.3 

IN: 15 1 9,060 0.029 13.2 0.046 2 1.0 

KS: 72 4,320 0.0 14 6.27 0.022 9.99 

LA: 80 4,800 0.0 15 6.97 0.024 11.1 

MD: 69 4, 140 0.0 13 6.0 1 0.02 1 9.58 

MO: 72 4,320 0.014 6.27 0.022 9.99 

MS: 80 4,800 0.015 6.97 0.024 11.1 

NC: 324 19,440 0.062 28.2 0.099 45.0 

NE: 136 8,160 0.026 11.8 0.042 18.9 

OH: 72 4,320 0.0 14 6.27 0.022 9.99 

PA: 64 3,840 0.0 12 5.57 0.020 8.88 

SC: 80 4,800 0.0 15 6.97 0.024 11.1 

TN: 80 4,800 0.015 6.97 0.024 11.1 

TX: 106 6,360 0.020 9.23 0.032 14.7 

WI: 64 3,840 0.012 5.57 0.020 8.88 

PR: 677 40,620 0. 130 59.0 0.207 94.0 

TOTAL 3,720 223,200 0.7 14 323.97 1.1 4 516.33 

2. Monsanto Company will immediately notify the EPA of an y findings from the experimental uses 

that have a bearing on safety (i.e., EPA requires reporting of any adverse effects from the use of, 

or exposure to, the pesticide). Monsanto Company will also keep records of production, 

distribution and performance, and make the records available on request to any authorized officer 

or employee of the Environmental Protection Agency. 

3. Monsanto Company must provide a final report within 180 days of the expiration of the permit. 

The fina l report must include all ofthe items set forth in 40 CFR 172.8(b) and report on the 

following information: 

• A State-by-State breakdown of actual acreage per protocol; 

• A State-by-State breakdown of actua l locations per protocol; 

• Any changes to the stated program, including approved changes to study protocols; 

• A list of specific counties where studies took place. 

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4. Per 40 CFR l72.4(b)(v), Monsanto Company must provide the name(s) and street address(es) of 

all cooperators as soon as available and prior to planting. Monsanto Company must record any 

changes to this information in an updated report and submit that report prior to planting. 

5. The label submitted in connection with this application is acceptable and must accompany all 

shipments of soybean seed under this EUP subsequent to receiving this approval. Labels must 

also be in the possession of the user at the time of application. A stamped copy is enclosed fo r 

your records. 

6. This EUP is not a limited seed increase registration under section 3 of FIFRA, and plantings 

solely for commercial seed increase are prohibited. 

7. Monsanto Company must follow the containment procedures described in the Section G for the 

EUP. 

Should you have questions or concerns regarding the issuance of this permit, please contact Or. Kenneth 

Haymes, of the Biopesticides and Pollution Prevention Division, by email at haymes.kenneth@epa.gov 

or by phone (703) 347-0398. 

Enclosure (stamped label) 

Sincerely, 

Kimberly Nesci, Chief, Microbial Pesticides Branch 

Biopesticide and Pollution Prevention Division. 

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