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

glufosinate herbicides, hereinafter referred to as DAS-68416-4 soybean, and progeny derived 

from it, are not likely to pose a plant pest risk and are no longer to be considered regulated 

articles under APHIS's Biotechnology Regulations (Title 7 of the Code of Federal Regulations 

(CFR), part 340). Since APHIS has detem1ined that DAS-68416-4 soybean is unlikely to pose a 

plant pest risk, APHIS will approve the petition for nonregulated status ofDAS-68416-4 

soybean. Therefore, APHIS approved pennits or acknow !edged notifications that were 

previously required for environmental releases, interstate movement, or importation under these 

regulations will no longer be required for DAS-68416-4 soybean and its progeny. Importation of 

DAS-68416-4 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 Determination of nonregulated status for DAS-68416-4 soybean is based on APHIS' 

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

Assessment (PPRA) for DAS-68416-4 soybean. 

The Plant Pest Risk Assessment (PPRA) conducted on DAS-68416-4 soybean 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: 

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

expression of new genetic material, or from changes in metabolism in the DAS-68416-4 

soybean. 

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

atypical in the DAS-68416-4 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-68416-4 soybean is expected to be grown. Observed 

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

that the DAS-68416-4 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 and PAT) and agronomic and 

compositional data, exposure to and/or consumption of tl1e DAS-68416-4 soybean are 

unlikely to adversely impact nontarget organisms beneficial to agriculture. 
(5) The DAS-68416-4 soybean is not likely to increase the weed risk potential of other species 

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

introgression of inserted genes from the DAS-68416-4 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 and glufosinate herbicides. 

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

management. 

(7) Horizontal gene transfer ofthe new genetic material inserted into the DAS-68416-4 soybean 

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

disease, damage, injury or hann 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 68416-4 

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

observed for DAS 68416-4 soybean, or those observed in other soybean varieties not considered 

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

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

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

Determination of nonregulated status for the DAS-68416-4 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-68416-4 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 

nomegulated 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-68416-4 

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

observed for DAS-68416-4 soybean, or those observed for other soybean varieties not 

considered regulated articles under 7 CFR pmt 340, that would pose a plant pest risk. 

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

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

conclusions of the PPRA, tl1e EIS and its Record of Decision, and my lmowledge and 

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

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

Date: