Determination ofNonregulated Status for MON 87705 Soybean

In response to petition 09-201-01p from Monsanto Company (hereafterreferred to as Monsanto), the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has determined that MON 87705 soybean and progenyderived from it are unlikely to pose plant pestrisks and are no longer to be considered regulated articles under APHIS' BiotechnologyRegulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). Since APHIS has determined that MON 87705 soybean is unlikelyto pose a plant pest risk, APHIS will approve the petition for nonregulated status ofMON 87705 soybean. Therefore, APHIS approved permits or acknowledged notifications that were previously required for environmental release, interstate movement, orimportation underthoseregulations will no longerbe required for MON 87705 soybean and its progeny. Importation ofMON 87705 soybean seeds and other propagative material would still be subject to APHIS foreign quarantine notices at 7 CFRpart 319 and the Federal Seed Act regulations at 7 CFRpart 201.

This detennination for MON 87705 soybean is bascd on APHIS' analyses offield and laboratory data submittedbyMonsanto, references provided in the petition, peerreviewed pUblications, and otherrelevant information as desclibed in the Plant Pest Risk Assessment (PPRA) for MON 87705 soybean.

The Plant Pest Risk Assessment conducted on MON 87705 soybean concluded that it is unlikelyto pose a plantpest risk and should no longerbe subject to theplantpest provisions ofthe Plant Protection Act and 7 CFRpart 340 for the following reasons: (1) agronomic performance and disease and pest susceptibilityofMON 87705 soybean is similarto that ofits non-genetically engineered soybean counterparts andlor other soybean cultivars grown in the U.S.; (2) the new gene products are notknown to cause greater changes to the plant metabolism or seed composition (except for the intended changes inthe fatty acid profile than conventional soybean; (3) gene introgression from MON 87705 soybean into wild relatives in the United States and its territories is extremely unlikely and is not likelyto increase the weediness potential ofanyresulting progenynor adversely affect the genetic diversity ofrelated plants anymore than would cultivation oftraditional orother specialty soybean varieties; (4) they exhibit no characteristics that would cause them to be wcedier ormore diflicult to control as weeds than non-genetically engineered soybean orany other cultivated soybean; (5) horizontal gene transfer is unlikcly to occurbetween MON 87705 soybean and organisms with which they cannot interbreed.

In addition to our finding that MON 87705 soybean is unlikelyto pose a plantpest risk, APHIS has completed a Final Environmental Assessment (EA) and Finding ofNo Significant Impact (FONSn for this action and has determined that a detelmination of nonregulated status for MON 87705 soybean and its progenywould have no significant impacts, individually or collectively, on the quality ofthe human environment and will have no eifect on federally listed threatened or endangered species, species proposed for listing, ortheir designated orproposed critical habitats

1(http://wvvw.aphis.usda.f!ovbiotechnolof!vinotreg.html). APHIS also concludes in its PPRA that new varieties delived from MON 87705 soybean are unlikely to exhibit new plant pestproperties that are substantially different from the ones observed for MON 87705 soybean, or those observed for other soybean varieties not considered regulated articles under 7 CFRpart 340.

Based on my fiJII 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 Comments received in reference to the Draft EA, the FONS}, and myknO\v1edge and experience as the Deputy Administrator ofAPHIS Biotechnology Regulatory Services, I have detemlined and decided that this detell1inatiol1 ofnonregulated status for MON 87705 soybean is the most scientifically sound and appropriate regulatory decision.

Michael C. Gregoire Date Deputy Administrator Biotechnology Regulatory Services Animal and Plant Health Inspection Service US. Department ofAgriculture

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