Determination of Nonregulated Status for MIR 162 Corn 

In response to petition 07-253-01p from Syngenta Biotechnology, Inc., the Animal and 

Plant Inspection Service (APHIS) ofthe United States Department ofAgriculture 

(USDA) has determined that event MIR 162 corn and its progeny are unlikely to pose a 

plant pest risk and are no longer to be considered regulated articles under APHIS' 

Biotechnology Regulations (7 Code of Federal Regulations (CFR) part 340). APHIS has 

no authority to continue to regulate a genetically engineered (GE) organism once APHIS 

reaches a determination that a GE organism regulated under 7 CFR part 340 regulations 

is unlikely to pose a plant pest risk. APHIS approved permits or acknowledged 

notifications that were previously required for environmental release, interstate 

movement, or importation ofMIR162 corn and its progeny are no longer required. 

Importation ofMIR162 seeds and other propagative material shall still be subject to 

APHIS Foreign Quarantine Notices at 7 CFR part 319 and Federal Seed Act Regulations 

at 7 CFR part 201. 

This determination for MIR162 corn is based on APHIS' analyses offield, greenhouse, 

and laboratory data submitted by Syngenta, of peer-reviewed publications and other 

relevant information as described in the Plant Pest Risk and Environmental Assessments, 

and of its response to public comments that indicated that MIR162 corn is unlikely to 

pose a plant pest risk. 

The Plant Pest Risk Assessment conducted on MIR162 corn 

(http://www.aphis.usda.govlbrs/not reg.html) concluded that it is no more a plant pest 

than conventional corn cultivars, it does not pose a plant pest risk and should be granted 

nonregulated status for the following reasons: (1) MIR 162 corn is similar to its 

conventionally-bred corn parents and other cultivated corn cultivars in its response to 

disease and insect susceptibility (except for the intended change for lepidopteran insect 

resistance in MIRI62); (2) The introgression of introduced genes from MIR162 corn into 

sexually-compatible wild relatives in the United States and its territories is extremely 

unlikely and is not likely to increase the weediness potential of any resulting progeny any 

more than what would be expected from the introgression between traditional or other 

specialty corn varieties and wild relatives; (3) MIR162 corn does not exhibit 

characteristics that would cause it to be weedier or make it a troublesome weed to control 

than the conventionally-bred parental corn lines or any other corn varieties currently 

under cultivation; (4) The introduced gene products have not exhibited any deleterious 

effects on non-target or beneficial organisms in the agro-ecosystem; and (5) Transfer of 

genetic information to organisms with which it cannot interbreed (horizontal gene 

transfer) is unlikely to occur. 

In addition to our finding that the cultivation ofMIR162 corn is unlikely to pose a plant 

pest risk, APHIS has completed an Environmental Assessment for this action and has 

determined that granting nonregulated status to MIR162 corn and its progeny would have 

no significant impact on the quality ofthe human environment and will 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.govlbrs/not reg.html). 

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APHIS also concludes that new varieties derived from MIRl62 com are unlikely to 

exhibit new plant pest properties that are substantially different from the ones observed 

for MIR162 com, or those observed for other com varieties not considered regulated 

articles under 7 CFR part 340. 

Michael Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department ofAgriculture 

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