Determination ofNonregulated Status ofMON 87769 Soybean (Glycine max) 

In response to petition 09-183-01 p from Monsanto Company (hereafter refened to as 

Monsanto), the Animal and Plant Health Inspection Service (APHIS) ofthe United States 

Depattment of Agriculture (USDA) has detennined that MON 87769 soybean and 

progeny derived from it are unlikely to pose plant pest risks and are no longer to be 

considered regulated articles under APHIS' Biotechnology Regulations (Title 7 of Code 

of Federal Regulations (CFR), part 340). Since APHIS has determined that MON 87769 

soybean is unlikely to a pose plant pest risk, APHIS will approve the petition for 

nomegulated stahts ofMON 87769 soybean. Therefore, APHIS approved pennits or 

acknowledged notifications that were previously required for environmental release, 

interstate movement, or importation under those regulations will no longer be required 

for MON 87769 soybean and its progeny. Importation ofMON 87769 soybean seeds and 

other propagative material would still be subject to APHIS foreign quarantine notices at 7 

CFR part 319 and the Federal Seed Act Regulations at 7 CFR part 201. 

This determination ofnonregulated status ofMON 87769 soybean is based on APHIS' 

analyses of field and laboratory data submitted by Monsanto, references provided in the 

petition, peer-reviewed publications, and other relevm1t infmn1ation as described in the 

Plant Pest Risk Assessment (PPRA) for MON 87769 soybean. 

The Plant Pest Risk Assessment conducted on MON 87769 soybean concluded that it is 

unlikely to pose a plant pest risk and should no longer be subject to the plant pest 

provisions ofthe Plant Protection Act and 7 CFR pmt 340 for the following reasons: (1) 

agronomic perfom1ance and disease and insect susceptibility ofMON 87769 soybean is 

similar to that of its non-genetically engineered soybean counterpart and/or other soybean 

cultivars grown in the U.S.; (2) the disarmed Agrobacterium transfonnation vector used 

to introduce the genetic mate1ial into MON 87769 soybean was eliminated and neither 

the transfonnation vector nor the introduced genetic material or gene products are known 

to cause or promote disease, dan1age or injury to plants; (3) gene introgression from 

MON 87769 soybean into wild relatives in the United States and its tenitmies is unlikely 

and is not likely to increase the weediness potential of any resulting progeny nor 

adversely affect the genetic diversity of related plants any more than would cultivation of 

traditional or other soybean varieties;· ( 4) they exhibit no chm·acteristics that would cause 

them to be weedier or more difficult to control as weeds than non-genetically engineered 

soybean or any other cultivated soybean; (5) the gene products (116 desaturase and t-15 

desaturase proteins) have no known toxicity and are unlikely to pose m1y risks to nontarget or beneficial organisms; (6) horizontal gene transfer is unlikely to occur between 

MON 87769 soybeat1 and organisms with which they cannot interbreed. 

In addition to our finding that MON 87769 soybean is unlikely to pose a plant pest risk, 

APHIS has completed a Final Environmental Assessment (EA) and Fiiiding ofNo 

Significant Impact (FONSI) for this action and has detennined that a detennination of 

nonregulated status ofMON 87769 soybean and its progeny would have no significant 

impacts, individually or collectively, on the quality of the human environment and will 

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have no effect on federally listed threatened or endangered species, species proposed for 

listing, or. their designated or proposed critical habitats 

(http:/Y\\rww.aphis.usda.gov/biotechnologv/not reg.html). APHIS also concludes in its 

PPRA that new varieties derived from MON 87769 soybean are unlikely to exhibit new 

plant pest properties that are substantially different from the ones observed for MON 

87769 soybean, or those observed for other soybean vmieties not considered regulated 

articles under 7 CFR part 340. 

Based on my full and complete review and consideration of all of the scientific and 

environmental data, analyses, information, and conclusions of the PPRA, the Final EA, 

the agency's Response to Public Comments received in reference to the Draft EA, the 

FONSI, and my knowledge and experience as the Deputy Administrator of APHIS 

Biotechnology Regulatory Services, I have determined and decided that this 

determination ofnomegulated status ofMON 87769 soybean is the most scientifically 

sound and approp1iate regulatory decision. 

Michael C. Gregoire 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

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