Preliminary Determination1 of Nonregulated Status for Syngenta and Bayer

double herbicide-tolerant SYHT0H2 soybean

In response to petition 12-215-01p from Syngenta Seeds, Inc. and Bayer CropSciences AG

(hereafter referred to as Syngenta and Bayer), the Animal and Plant Health Inspection Service 

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

and Bayer’s double herbicide-tolerant soybean (hereafter referred to as SYHT0H2 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 determined that SYHT0H2 soybean is unlikely 

to pose a plant pest risk, APHIS will approve the petition for nonregulated status of SYHT0H2 

soybean. Therefore, APHIS approved permits or acknowledged notifications that were 

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

regulations will no longer be required for SYHT0H2 soybean and its progeny. Importation of

SYHT0H2 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.

This determination for SYHT0H2 soybean is based on APHIS’ analyses of field and laboratory 

data submitted by Syngenta and Bayer, references provided in the petition, peer-reviewed

publications, and other relevant information as described in the Plant Pest Risk Assessment 

(PPRA) for SYHT0H2 soybean.

The Plant Pest Risk Assessment conducted on SYHT0H2 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:

(1) Disease and insect susceptibility, agronomic performance, and other observed characteristics 

(except for the intended changes) of SYHT0H2 soybean are similar to those of its nongenetically engineered soybean counterparts and/or 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 SYHT0H2 soybean is unlikely to adversely affect nontarget 

organisms beneficial to agriculture;

(3) Agronomic performance evaluations of SYHT0H2 soybean revealed no characteristics that 

would cause it to be weedier or more difficult to control as a weed than non-genetically 

engineered soybean or any other cultivated soybean;

(4) Gene introgression from SYHT0H2 soybean into wild relatives in the United States and its 

territories is not likely to increase the weediness potential of any resulting progeny, nor 

adversely affect the genetic diversity of related plants any more than would cultivation of 

traditional or other soybean varieties;

1 Determination is not effective until officially signed and published.

 
(5) SYHT0H2 soybean cultivation is similar to those of its parent line and other soybean

cultivars grown in the U.S., and therefore, there will be no change in agricultural and cultural 

practices;

(6) Horizontal gene transfer is unlikely to occur between SYHT0H2 soybeans and organisms 

with which they cannot interbreed.

In addition to our finding that SYHT0H2 soybean is not likely to pose a plant pest risk, APHIS 

has completed an Environmental Assessment (EA) and Finding of No Significant Impact 

(FONSI) for this action, and has determined that a determination of significant impacts, 

individually or collectively, on the quality of the human environment and 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, based upon its PPRA, that new 

varieties derived from SYHT0H2 soybean are unlikely to exhibit new properties that are 

substantially different from the ones observed for SYHT0H2 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, analysis, information, the input from the public involvement process, and conclusions of 

the PPRA, the EA, and the FONSI, and my knowledge and experience as the Deputy 

Administrator of APHIS Biotechnology Regulatory Services, I have determine and decided that 

this determination of non-regulated status for SYHT0H2 soybean is the most scientifically sound 

and appropriate regulatory decision.

____________________________

Michael J. Firko, Ph.D.

Deputy Administrator

Biotechnology Regulatory Services

Animal Plant Health Inspection Service

U.S. Department of Agriculture

Date: