### Determination ofNonregulated Status for DP-32138-1 Corn

In response to petition 08-338-01p from Pioneer Hi-Bred International, the Animal and Plant Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has determined that DP-32138-1 com and progeny derived from it are unlikely to pose a plant pest risk and are no longer to be considered regulated articles under APHIS' Biotechnology Regulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). Since AP1IIS has determined that DP-32138-1 com is unlikely to pose a plantpest risk. APHIS will approve the petition tor nonregulated status ofDP-32138-1 com. Therefore, APHIS approved permits

oracknowledged notifications that were previouslyrequired for environmental release, interstate movement, orimportation ofDP-32138-1 corn and its progeny are no longer required. Importation ofDP-32138-1 seeds and otherpropagat1ve material will still be subject to APHIS foreign quarantine notices in 7 CFRpart 319 and Federal Seed Act regulations in 

### 7CFR part 201.

This determination for DP-32138-1 is based on APHIS' analysis oftield and laboratorydata submitted by Pioneer, references provided in the petition, peer-reviewedpublications, and otherrelevant information as described in the PlantPest Risk Assessment (PPRA) for DP32138-1 com. The Final Environmental Assessment (EA), the Finding ofNo Significant Impact (FONSI), and the Response to Public Comments on the Draft Environmental Assessment (EA) indicate and confirm that DP-32138-1 com is unlikely to pose a plantpest risk.

The Plant Pest Risk Assessment conducted on DP-32138-l comconcluded that it is unlikely
to pose a plant pestrisk and no longer subject to theplantpestprovisions ofthe Plant Protection Act and 7 CFR part 340 for the following reasons: (1) the disarmed Agrobacteriumplanttransformation vector used to introduce the genetic material into DP32138-1 com was eliminated and neither the transfoTI11ation vector northe introduced genetic material can cause or promote disease, damage or injury to plants; (2) it exhibits no characteristics that would cause it to be weedier ormore difficult to control as a weed than the non-genetically engineered corn hybrids evaluated or any othercultivated com; (3) gene introgression from DP-32138-l cominto wild relatives in the United States and its territories is extremely unlikely and is not likely to increase the weediness potential ofany resulting progenynor adversely affect the genetic diversity ofrelatedplants any more than would cultivation oftraditional or other specialty corn varieties; (4) agronomic performance, disease and insect susceptibility, and overall compositional profiles ofDP-32138-1 com are similar
to those ofits non-genetically engineered com counterparts and/or other corn cultivars grown in the U.S., andtherefore no direct orindirect plant pest effects on raw orprocessedplant commodities are expected; and (5) horizontal gene transfer is unlikely to occur between DP32138-1 com and organisms with which it cannot interbreed.

1In addition to ourfinding that DP-32138-1 corn is unlikely to pose a plant pest risk, APHIS has completed a Final EA and FONSI for this action and has determined that a determination ofnonregulated status ofDP-32138-1 corn and its progeny would have no significant impacts, individually orcollectively, on the quality ofthe human environment and will have no effect on federally listed threatened orendangered species, species proposed for listing, ortheirdesignated orproposedcritical habitats (http://www.aphis.usda.gov/brs/not reg.html). APHIS also concludes in its PPRA that new varieties derived from DP-32138-1 corn are unlikely to exhibit new plantpestproperties that

are substantially different from the ones observed for DP-32138-1 corn, orthose observed for other corn varieties not considered regulated articles under 7 CFR part340.

Based on my full and complete review 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, the FONSl, and myknowledge and experience as the Deputy Administrator ofAPHIS Biotechnology Regulatory Services, I have determined and decided that this determination ofnonregulated
status ofDP-32138-1 corn 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



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