Determination of N onregulated Status for D P-32138-1 Corn 

In response to petition 08-338-01p from Pioneer Hi-Bred International, the Animal and Plant 

Inspection Service (APHIS) of the United States Department of Agriculture (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 of Federal Regulations (CFR), part 340). Since AP1IIS has 

determined that DP-32138-1 com is unlikely to pose a plant pest risk. APHIS will approve 

the petition tor nonregulated status ofDP-32138-1 com. Therefore, APHIS approved permits 

or acknowledged notifications that were previously required for environmental release, 

interstate movement, or importation of DP-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 CFR part 319 and Federal Seed Act 

regulations in 7 CFR part 201. 

This determination for DP-32138-1 is based on APHIS' analysis of tield and laboratory data 

submitted by Pioneer, references provided in the petition, peer-reviewed publications, and 

other relevant information as described in the Plant Pest Risk Assessment (PPRA) for DP32138-1 com. The Final Environmental Assessment (EA), the Finding of No 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 plant pest 

risk. 

The Plant Pest Risk Assessment conducted on DP-32138-l com concluded that it is unlikely 

to pose a plant pest risk and no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340 for the following reasons: (1) the disarmed 

Agrobacterium plant transformation vector used to introduce the genetic material into DP32138-1 com was eliminated and neither the transfoTI11ation vector nor the 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 or more difficult to control as a weed than 

the non-genetically engineered corn hybrids evaluated or any other cultivated com; (3) gene 

introgression from DP-32138-l com into 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 nor adversely affect the genetic diversity ofrelated plants any more than would 

cultivation of traditional or other specialty corn varieties; (4) agronomic performance, disease 

and insect susceptibility, and overall compositional profiles of DP-32138-1 com are similar 

to those of its non-genetically engineered com counterparts and/or other corn cultivars grown 

in the U.S., and therefore no direct or indirect plant pest effects on raw or processed plant 

commodities are expected; and (5) horizontal gene transfer is unlikely to occur between DP32138-1 com and organisms with which it cannot interbreed. 

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In addition to our finding 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 or collectively, on the quality of the 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.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 plant pest properties that 

are substantially different from the ones observed for DP-32138-1 corn, or those observed for 

other corn varieties not considered regulated articles under 7 CFR part340. 

Based on my full and complete review and consideration of all of the 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, the FONSl, 

and my knowledge and experience as the Deputy Administrator of APHIS Biotechnology 

Regulatory Services, I have determined and decided that this determination of nonregulated 

status of DP-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 of Agriculture 

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