### Determination ofNonregulated Status ofMON 87769 Soybean (Glycine max)

In response to petition 09-183-01p from Monsanto Company (hereafterrefened to as Monsanto), the Animal and PlantHealth Inspection Service (APHIS) ofthe United States Depattment ofAgriculture (USDA) has detennined that MON 87769 soybean and progeny derived from it are unlikely to poseplantpestrisks and are no longerto be consideredregulated articles under APHIS' BiotechnologyRegulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). Since APHIS has determined that MON 87769 soybean is unlikely to a poseplantpestrisk, APHIS will approve the petition for nomegulated stahts ofMON 87769 soybean. Therefore, APHIS approved pennits or acknowledgednotifications that werepreviouslyrequired for environmental release, interstate movement, or importationunder those regulations will no longer be required for MON 87769 soybean and its progeny. Importation ofMON 87769 soybean seeds and otherpropagative material would still be subject to APHIS foreign quarantine notices at 7 CFR part 319 and the Federal SeedActRegulations at 7 CFRpart 201.

This determination ofnonregulated status ofMON 87769 soybean is based onAPHIS' analyses offield and laboratory data submittedbyMonsanto, references provided in the petition, peer-reviewedpublications, and otherrelevm1t infmn1ation as described inthe Plant Pest Risk Assessment (PPRA) for MON 87769 soybean.

The PlantPest Risk Assessment conducted onMON 87769 soybean concluded that it is unlikely to pose a plantpest risk and should no longer be subject to the plant pest provisions ofthe Plant ProtectionAct and 7 CFR pmt 340 for the following reasons: (1) agronomic perfom1ance and disease and insect susceptibility ofMON 87769 soybean is similar to that ofits non-genetically engineered soybean counterpart and/or other soybean cultivars grown in the U.S.; (2) the disarmedAgrobacterium 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 wildrelatives in the United States and its tenitmies is unlikely and is not likely to increase the weediness potential ofany resulting progeny nor adversely affect the genetic diversity ofrelated plants anymore than would cultivation of traditional or other soybean varieties;·(4) they exhibit no chm·acteristics that would cause them to be weedier ormore 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 occurbetween MON 87769 soybeat1 and organisms with which they cannot interbreed.

In addition to our finding that MON 87769 soybean is unlikely to pose a plantpest 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 progenywould have no significant impacts, individually or collectively, on the quality ofthe 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 orproposed 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 exhibitnew plantpest properties that are substantially different from the ones observed for MON 87769 soybean, orthose observed for other soybean vmieties not consideredregulated articles under 7 CFRpart 340.

Based on my full and complete review and consideration ofall ofthe scientific and environmental data, analyses, information, and conclusions ofthe PPRA, the Final EA, the agency's Response to Public Commentsreceived in reference to the Draft EA, the FONSI, and myknowledge and experience as the Deputy Administrator ofAPHIS 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 DeputyAdministrator BiotechnologyRegulatory Services Animal and Plant Health Inspection Service U.S. Department ofAgriculture j


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