Determination 

### ofNonregulated Status for MON 87460 Corn (Zea mays L)

In response to petition 09-055-0I P from Monsanto Company (hereafterrefened to as Monsanto), the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has detem1ined that MON 87460 com and progeny derived from it are unlikely to pose plantpestrisks and is no longer to be considered regulated article underAPHIS' BiotechnologyRegulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). Since APHIS has detem1ined that MON 87460 corn is unlikelyto pose plant pestrisk, APHIS will approve the petition for nonregulated status ofMON 87460 corn. Therefore, APHIS approved pennits oracknowledged notifications that were previouslyrequired for environmental release, interstate movement, or importation under those regulations will no longerbe required for MON 87460 com and its progeny. Importation ofMON 87460 com 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 detelmination for MON 87460 com is based on APHIS' analyses offield and laboratory data submitted by Monsanto, references provided in the petition, peerreviewed pUblications, and otherrelevant infOlmation as described in the Plant Pest Risk Assessment (PPRA) for MON 87460 corn.

The Plant Pest Risk Assessment conducted on MON 87460 com concluded that it is unlikely to pose a plantpest lisk and should no longerbe subject to the plantpest provisions ofthe Plant Protection Act and 7 CFRpart 340 for the following reasons: (1) agronomic performance and disease and insect susceptibility ofMON 87460 comis similar to that ofits non-genetically engineered corn counterpaIi and/or othercorn cultivars grown in the U.S.; (2) the disarmedAgrobacterium transfom1ation vectorused
to introduce the genetic material into MON 87460 corn was eliminated and neither the transfonnation vector nor the introduced genetic material or gene products are known to

cause orpromote disease, damage orinjury to plants; (3) gene introgression from MON 87460 corn into wild relatives in the United States and its territories is unlikely and is not likely to increase the weediness potential ofany resulting progenynoradversely affect the genetic diversity ofrelated plants any more than would cultivation oftraditional or othercom vaIieties; (4) they exhibit no characteristics that would cause them to be weedier or more difficult to control as weeds than non-genetically engineered com or any other cultivated corn; (5) the gene products (cold shock protein B and neomycin phosphotransferase II protein) have no known toxicity and arc unlikely to pose anylisks
to non-target orbeneficial organisms (6) horizontal gene transfer is unlikely to occur between MON 87460 corn and organisms with which they cannot interbreed.

In addition to our finding thatMON 87460 corn is unlikely to pose a plantpestrisk, APHIS has completed a Final Environmental Assessment (EA) and Finding ofNo Significant Impact (FONSI) for this action and has detennined that a determination of nonregulated status for MON 87460 corn and its progeny would have no significant impacts, individualIy orcollectively, on the quality ofthe human environment and will



### 1haveno effecton federally listed threatened or endangered species, speciesproposed for listing, or their designated orproposed critical habitats (http://www.aphis.usda.gov/biotechnology/not reg.html). APHIS also concludcs in its PPRA that new varieties derived trom MON 87460 corn are unlikely to exhibit new plant pest properties that are substantially different from the ones observed for MON 87460
com, orthose observed for othercom varieties not considered regulated articles under 7 CFRpart 340.

Based on my full and completereview 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, thc FONSI, and my knowledge and experience as the Deputy Administrator ofAPHIS Biotechnology Regulatory Services, I have detemlined and decided that this determination ofnonregulated status for MON 87460 com is the most scientifically sound and appropriate regulatory decision.

Michael C. Gregoire Date DeputyAdministrator BiotechnologyRegulatory Services Animal and Plant Hea1th Inspection Service U.S. Department ofAgriculture

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