increased tolerance and resistance, respectively, to phenoxy auxin herbicides and 

aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitor ("fop") 

herbicides, hereinafter refeJTed to as DAS-40278-9 corn, and progeny derived from it, are not 

likely to pose a plant pest risk and are no longer to be considered regulated mticles under 

APHIS's Bioteclmology Regulations (Title 7 of the Code ofFederal Regulations (CFR), part 

340). Since APHIS has determined that DAS-40278-9 corn is unlikely to pose a plant pest risk, 

APHIS will approve the petition for nonregulated status of DAS-40278-9 corn. Therefore, 

APHIS approved permits or acknowledged notifications that were previously required for 

environmental releases, interstate movement, or importation under these regulations will no 

longer be required for DAS-40278-9 com and its progeny. Importation of DAS-40278-9 corn 

seeds and other propagative material will still be subject to APHIS foreign quarantine notices at 

7 CFR pmt 319 and Federal Seed Act regulations at 7 CFR part 201 and 7 CFR 361. 

This Detennination of nonregulated status for DAS-40278-9 corn is based on APHIS' analyses 

of field and laboratory data submitted by DAS, references provided in the petition, peerreviewed publications, and other relevant information as described in the Plant Pest Risk 

Assessment (PPRA) for DAS-40278-9 corn. 

The Plant Pest Risk Assessment (PPRA) conducted on DAS-40278-9 com concluded that it is 

unlikely to pose a plant pest risk and should no longer be subject to the regulations at 7 CFR part 

340 for the following reasons: 

(I) No plant pest risk was identified from the transfonnation process, the insertion and/or 

expression of new genetic material, or from changes in metabolism in the DAS-40278-9 

corn. 

(2) Disease and pest incidence and/or damage were not observed to be significantly increased or 

atypical in the DAS-40278-9 com and derived hybrids compared to their nontransgenic 

control counterparts or otl1er comparators in field trials conducted in growing regions 

representative of where the DAS-40278-9 com is expected to be grown. Observed agronomic 

traits also did not reveal any significant differences that would indirectly indicate that the 

DAS-40278-9 corn is more susceptible to pests or diseases. Therefore no plant pest effects 

are expected on these or other agricultural products. 

(3) Based on an evaluation of the gene product (AAD-1 protein) and agronomic and 

compositional data, exposure to and/or consumption of the DAS-40278-9 corn are unlikely to 

adversely impact nontarget organisms beneficial to agriculture. 
(5) The DAS

40278

9 com is not likely to increase the weed risk potential of other species with 

which it can interbreed in the U.S. or its territories. Gene flow, hybridization and/or 

introgression of inserted genes fi·om the DAS-40278-9 com to other sexually compatible 

relatives with which it can interbreed is not likely to occur. 

(6) Major changes in agricultural or cultivation practices associated with the adoption ofDAS40278-9 com are not expected with the exception of those associated with the use or the 

timing of application of certain phenoxy-auxin herbicides and ACCase inhibitor "fop" 

herbicides. These changes are not likely to increase plant diseases or pests or compromise 

their management. 

(7) Horizontal gene transfer of the new genetic material inserted into DAS-40278-9 com to other 

organisms is highly unlikely, and is not expected to lead directly or indirectly to disease, 

damage, injury or harm to plants, including the creation of new or more vimlent pests, 

pathogens, or parasitic plants. 

APHIS also concludes, based on the PPRA, that new varieties derived from DAS 40278-9 com 

are unlikely to exhibit new properties that are substantially different from the ones observed for 

DAS 40278-9 com, or those observed in otl1er com varieties not considered regulated articles 

under 7 CFS pati 340, tl1at would pose a plant pest risk. 

Prior to this Detennination of nonregulated status, APHIS completed a Final Environmental 

Impact Statement (FEIS) which explored the potential environmental impacts that a 

detennination of nonregulated status for the DAS-40278-9 com and its progeny would have on 

the quality of the human environment. The FEIS concluded, among other things, that a 

determination ofnonregulated status for DAS-40278-9 com (and its progeny) will have no effect 

on federally-listed threatened and endangered species, species proposed for listing, or their 

designated or proposed critical habitats. APHIS also concludes with its Determination of 

nonregulated status, based upon its PPRA, and informed by the completion of the FEIS and the 

Record of Decision that was issued for the FEIS, that new varieties derived from DAS-40278-9 

com are unlikely to exhibit new properties that are substantially different from the ones observed 

for DAS-40278-9 com, or those observed for other com varieties not considered regulated 

articles under 7 CFR part 340, that would pose a plant pest 1isk. 

Based on my full and complete review and consideration of all the scientific and environmental 

data, analyses, and inf01mation, the input from the public involvement process, and tl1e 

conclusions of the PPRA, the FEIS and its Record of Decision, and my knowledge and 

expeiience as the Deputy Administrator of APHIS Biotechnology Regulatory Services, I have 
Michael .f.Firko, Ph.D. Deputy Administrator Biotechnology Regulatmy Services 

Animal and Plant Healti1 Inspection Service 

U.S. Department, of Agriculture 

Date: c? / v· /;.;; ,)11) / u/ / L. I