USDA announces deregulation of Dow’s GE soybean
Story Date: 4/24/2014

 

Source: USDA APHIS BIOTECHNOLOGY REGULATORY SERVICES, 4/21/14
 
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 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) Disease 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
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.

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