increased herbicide resistance to aryloxyalkanoate-based, including 2,4-D, pyridyl oxyacetate, 

glufosinate and glyphosate herbicides, hereafter referred to as DAS-44406-6 soybean, and 

progeny derived fi-om it, are not likely to pose a plant pest risk and are no longer to be considered 

regulated articles under APHIS's Bioteclmology Regulations (Title 7 oftl1e Code of Federal 

Regulations (CFR), part 340). Since APHIS has detetmined that DAS-44406-6 soybean is 

unlikely to pose a plant pest risk, APHIS will approve tl1e petition for nonregulated status of 

DAS-44406-6 soybean. Therefore, APHIS approved permits or aclmowledged notifications that 

were previously required for environmental releases, interstate movement, or importation under these regulations will no longer be required for DAS-44406-6 soybean and its progeny. 

Importation of DAS-44406-6 soybean seeds and other propagative material will still be subject 

to APHIS foreign quarantine notices at 7 CFR part 319 and Federal Seed Act regulations at 7 

CFR part 201 and 7 CFR part 361. 

This Detennination of nonregulated status for DAS-44406-6 soybean 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-44406-6 soybean. 

The Plant Pest Risk Assessment (PPRA) conducted on DAS-44406-6 soybean concluded that it 

is unlikely to pose a plant pest risk and should no longer be subject to 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-44406-6 

soybean. 

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

atypical in the DAS-44406-6 soybean and derived hybrids compared to their nontransgenic 

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

representative of where the DAS-44406-6 soybean is expected to be grown. Observed 

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

that the DAS-44406-6 soybean 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 products (AAD-12, PAT and 2mEPSPS) and agronomic 

and compositional data, exposure to and/or consumption of the DAS-44406-6 soybean are 

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

44406

6 soybean 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 from the DAS-44406-6 soybean 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 ofDAS68416-4 soybean are not expected with the exception of those associated with the use of the 

aryloxyalkanoate-based, including 2,4-D, pyridyl oxyacetate, glufosinate and glyphosate 

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 the DAS-44406-6 soybean 

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

disease, damage, injury or ham1 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 44406-6 

soybean are unlikely to exhibit new prope1iies that are substantially different from the ones 

observed for DAS 44406-6 soybean, or those observed in other soybean varieties not considered 

regulated articles under 7 C.F.R. Part 340, that would pose a plant pest risk. 

Prior to tl1is Determination of nonregulated status, APHIS completed a Final Enviromnental 

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

detemlination of nonregulated status for the DAS-44406-6 soybean 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-44406-6 soybean (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 Detennination of 

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

Record of Decision that was issued for the FEIS, that new varieties derived fi·om DAS-44406-6 

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

observed for DAS-44406-6 soybean, or those observed for other soybean varieties not considered regulated articles under 7 CFR part 340, that would pose a plant pest risk. 

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

data, analyses, and infonnation, the input from the public involvement process, and the 

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

experience as the Deputy Administrator of APHIS Biotechnology Regulatory Services, I have 
Deputy Administrator Bioteclmology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

Date: ?) 

I