### Determination 

### ofNonregulated Status for Monsanto MON 87701 soybeans

In response to petition 09-082-01p from Monsanto Company, the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has determined that event MON 87701 soybean and progeny derived from it are unlikely to poseplant pest risks and are no longer to beconsidered regulated articles under APHIS' BiotechnologyRegulations (Title 7 ofCode ofFederal Regulations (CFR), part340). Since APHIS has determined thatMON 87701 soybeans are unlikely to poseplantpest risks, APHIS will approve thepetition for nonregulated status ofMON 87701 soybeans. Therefore, APHIS approved permits or acknowledged notifications that were previously required for environmental release, importation, or interstate movement underthose regulations will no longerbe required for event MON 87701 soybeans and its progeny. Importation ofMON 87701 soybeans seeds and otherpropagative 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 determination for MON 87701 is based on APHIS' analysis offield, greenhouse and laboratory data submitted byMonsanto, references provided in the petition, peer-reviewed publications, and otherrelevant information as described in the Plant Pest Risk Assessment (PPRA) for MON 87701.

The Plant Pest Risk Assessmentconducted onMON 87701 concluded that it is unlikely to pose plant pest risks and should no longerbe subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340 for the following reasons: (1) it exhibits no characteristics that would cause it to be weedierthan the non-geneticaUy engineered parent soybean line or any othercultivated soybeans; (2) gene introgression from event MON 87701 soybeans 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 genetic diversity ofrelated plants anymore than would introgression from traditional soybean varieties; (3) horizontal gene transfer is unlikely to occurbetween MON 87701 soybeans and organisms with which it cannotinterbreed; (4) disease and insect susceptibilities are similar to other soybean cultivars grown in the U.S. ; (5) it does
notpose a risk to non-target organisms, including beneficial organisms, and (6) compositional profiles ofMON 87701 soybeans are similar to those ofits parent line and other soybean cultivars grown in the U.S, therefore no direct orindirectplantpest effects

on raw orprocessed plant commodities are expected.

In addition to our finding that event MON 87701 is unlikely to pose a plantpest risk, APHIS has completed a Final Environmental Assessment (EA) and FONS! for this action and has determined that a determination ofnonregulated status for MON 87701 and its progeny would have no significant impacts, individually or collectively, on the quality of the human environment and will have no effecton federally listed threatened or endangered species, species proposed for listing, or their designated orproposed criticalhabitats (http://www.aphis.usda.govlbrsinotreg.htm!). APHJS also concludes in its PPRA that new varieties derived from MON 87701 are unlikely to exhibit new plant pest properties that are substantially different from the ones observed for MON 87701 soybeans, orthose observed for other soybean varieties not considered regulated articles under7 CFRpart 340.

Basedon my full and complete review and consideration ofall ofthe scientific and environmental data, analyses, information, and conclusions ofthe PPM,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 AdministratorofAPHIS Biotechnology Regulatory Services, I have determined and decided that this determination of nonregulated status ofMON 87701 soybeans is the most scientifically sound and appropriate regulatory decision.

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