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Determination of Nonregulated Status for Dow AgroSciences LLC 81419-2 Insect-Resistant

Soybean

In response to petition 12-272-01p from Dow AgroSciences LLC (DAS), the Animal and Plant Health

Inspection Service (APHIS) of the United States Department of Agriculture (USDA) has determined that

event DAS-81419-2 soybean and progeny derived from it are unlikely to pose plant pest risks and are

no longer to be considered regulated articles under APHIS' Biotechnology Regulations (Title 7 of Code

of Federal Regulations (CFR), part 340). Since APHIS has determined that DAS-81419-2 soybean is

unlikely to pose plant pest risks, APHIS will approve the petition for nonregulated status of DAS81419-2 soybean. Therefore, APHIS approved permits or acknowledged notifications that were

previously required for environmental release, importation, or interstate movement under those

regulations will no longer be required for event DAS-81419-2 soybean and its progeny. Importation of

DAS-81419-2 soybean seeds and other propagative material would still be subject to APHIS foreign

quarantine notices at 7 CFR part 319 and the Federal Seed Act regulations at 7 CFR part 201.

This determination for DAS-81419-2 is based on APHIS' analysis of field, greenhouse and laboratory

data submitted by Dow AgroSciences LLC, references provided in the petition, peer-reviewed

publications, and other relevant information as described in the Plant Pest Risk Assessment (PPRA) for

Dow AgroSciences LLC (DAS) event 81419-2 Insect-Resistant Soybean.

The Plant Pest Risk Assessment conducted on DAS-81419-2 soybean concluded that it is unlikely to pose

plant pest risks and should no longer be subject to the plant pest provisions of the Plant Protection Act and

7 CFR part 340 for the following reasons:

(1) Disease and insect susceptibilities, agronomic performance, and compositional profiles of DAS81419-2 soybean are similar to other soybean cultivars grown in the U.S., and are unlikely to alter

disease and pest susceptibilities;

(2) Based on an evaluation of the gene products and testing of representative non-target species, it has

been concluded that DAS-81419-2 soybean is unlikely to adversely affect nontarget organisms,

including those considered beneficial;

(3) Agronomic performance evaluations of DAS-81419-2 soybean revealed no characteristics that

would cause it to be weedier than the non-genetically engineered parent soybean line or any other

cultivated soybean;

(4) Gene introgression from event DAS-81419-2 soybean 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 genetic diversity of related plants any more than would

introgression from traditional soybean varieties;

(5) DAS-81419-2 soybean are similar to those of its parent line and other soybean cultivars grown in

the U.S., therefore, there will be no change in agricultural and cultural practices;

(6) Horizontal gene transfer is unlikely to occur between DAS-81419-2 soybean and organisms with

which it cannot interbreed.

In addition to our finding that event DAS-81419-2 is unlikely to pose a plant pest risk, APHIS has