Determination of Nonregulated Status for MON 87460 Corn (Zea mays L) 

In response to petition 09-055-0 I P from Monsanto Company (hereafter refened to as 

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

Department of Agriculture (USDA) has detem1ined that MON 87460 com and progeny 

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

regulated article under APHIS' Biotechnology Regulations (Title 7 of Code of Federal 

Regulations (CFR), part 340). Since APHIS has detem1ined that MON 87460 corn is 

unlikely to pose plant pest risk, APHIS will approve the petition for nonregulated status 

ofMON 87460 corn. 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 87460 com and 

its progeny. Importation ofMON 87460 com 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 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 other relevant 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 plant pest lisk and should no longer be subject to the plant pest 

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

agronomic performance and disease and insect susceptibility of MON 87460 com is 

similar to that of its non-genetically engineered corn counterpaIi and/or other corn 

cultivars grown in the U.S.; (2) the disarmed Agrobacterium transfom1ation vector used 

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 or promote disease, damage or injury 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 progeny nor adversely affect 

the genetic diversity of related plants any more than would cultivation of traditional or 

other com 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 any lisks 

to non-target or beneficial 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 that MON 87460 corn is unlikely to pose a plant pest risk, 

APHIS has completed a Final Environmental Assessment (EA) and Finding of No 

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 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://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, or those observed for other com varieties not considered regulated articles under 7 

CFR part 340. 

Based on my full and complete review and consideration of all ofthe 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, thc 

FONSI, and my knowledge and experience as the Deputy Administrator ofAPHIS 

Biotechnology Regulatory Services, I have detemlined and decided that this 

determination of nonregulated status for MON 87460 com is the most scientifically 

sound and appropriate regulatory decision. 

Michael C. Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Hea1th Inspection Service 

U.S. Department of Agriculture 

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