Preliminary Determination 1 of Nonregulated Status for Dow AgroSciences LLC 81419

- 2 Insect

Resistant Soybean

In response to petition 12

- 272

- 01 p 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 DAS

81419

- 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) D isease and insect susceptibilities , agronomic performance, and compositional profiles of DAS

81419

- 2 soybean are similar to other soybean cultivars grown in the U.S.

, and are unlikely to alter

di sease and pest susceptibilities ;

(2) Ba sed on an evaluation of the gene products and testing of representative non

- target species, it has

been concluded that of 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) G ene introgression from event DAS

- 81419

- 2 soybean into wild relativ es 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 soy bean varieties;

(5) DAS

- 81419

- 2 soybean are similar to those of its parent line and other soybean cultiva rs grown in

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

(6) H orizontal 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

1 Determination is not effective until officially signed and posted.

1completed a n Environmental Assessment (EA) and preliminary Finding of No Significant Impact

( FONSI ) for this action and has determined that a determination of nonregulated status for DAS

- 81419

-

2 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 ). APHI S also concludes , based upon its PPR A

, that new varieties derived from DAS

- 81419

- 2

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

for DAS

- 81419

- 2 soybean

, or those observed for other soybean varieties not considered regulated

articles under 7 CFR part 340.

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

data, analyses, information, public input, and conclusions of the PPRA, t he EA

, the preliminary

FONSI, and my knowledge and experience as acting Deputy Administrator of APHIS Biotechnology

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

DAS

- 81419

- 2 soybean is the most scientifically sound and appropriate regulatory decision.

____________________________ _______________________ Michael J. Firko, Ph.D. Date

Deputy Administrator, Acting

Biotechnology Regulatory Services (BRS)

Animal and Plant Health Inspection Service (APHIS)

United States Department of Agriculture (USDA)

2