### Determination ofNonregulated Status for MIR 

### 162 Corn

In response to petition 07-253-01p from SyngentaBiotechnology, Inc., the Animal and Plant Inspection Service (APHIS) oftheUnited States Department ofAgriculture (USDA) has determined that event MIR 162 corn and its progeny are unlikely to pose a plantpestrisk and are no longer to be considered regulated articles under APHIS' BiotechnologyRegulations (7 Code ofFederal 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 CFRpart 340regulations is unlikely to pose aplantpest risk. APHIS approved permits or acknowledged notifications that were previously required for environmental release, interstate movement, orimportation ofMIR162 corn and its progeny are no longer required. Importation ofMIR162 seeds and otherpropagativematerial shall still be subject to APHIS Foreign Quarantine Notices at 7 CFRpart 319 and Federal Seed Act Regulations at 7 CFRpart 201.

This determination for MIR162 corn isbased on APHIS' analyses offield, greenhouse, and laboratory data submitted bySyngenta, ofpeer-reviewed publications and other relevant information as described in the Plant Pest Risk and Environmental Assessments, and ofits response to public comments that indicated that MIR162 corn is unlikely to pose aplant 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 plantpest than conventional corn cultivars, it does notpose aplantpestrisk and should begranted nonregulated status for the following reasons: (1) MIR162 corn is similarto its conventionally-bred corn parents and othercultivated corn cultivars in its response to disease and insect susceptibility (except for the intended change for lepidopteran insect resistance in MIRI62); (2) The introgression ofintroduced 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 ofany resulting progeny any
more than what would be expected from the introgressionbetween traditional or other specialty corn varieties and wild relatives; (3) MIR162 corn does not exhibit characteristics that would cause it to beweedier ormake 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 onnon-target orbeneficial 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 ourfinding that the cultivation ofMIR162 corn is unlikely to pose a plant pestrisk, APHIS has completed an Environmental Assessment for this action and has determined that granting nonregulated status to MIR162 corn and its progenywould have

no significant impact onthe quality ofthe human environment and will have no effect on federally listed threatened orendangered species, species proposed for listing, ortheir designated orproposed critical habitats (http://www.aphis.usda.govlbrs/not reg.html).

1APHIS also concludes that new varieties derived from MIRl62 com are unlikely to exhibit new plant pestproperties 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 BiotechnologyRegulatory Services Animal and Plant Health Inspection Service U.S. Department ofAgriculture

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