Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety Approval for Commercial Planting Purposes of a Plant Genetically Modified for Herbicide Tolerant Traits (SYHT0H2) from Syngenta Canada Inc. and Bayer CropSciences Inc.

November 15, 2012
Comment period closed: 2013-02-05

The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) have received a submission from Syngenta Canada Inc. and Bayer CropSciences Inc. seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a soybean line designated as SYHT0H2, which has been genetically modified for herbicide resistance. The submission received is in accordance with CFIA guidelines for assessment of plants with novel traits (PNTs) for unconfined release, CFIA guidelines for assessment of novel feeds from plant sources, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a PNT or a novel feed from plant sources, please refer to the CFIA Web site. To view the information related to the health and safety assessment of a novel food, please refer to the HC Web site.

Summary of the Submission Package

Updated scientific information may be added to this submission by the developer at a later date, or CFIA and/or HC may request further information from the developer.

Description of the host plant	Please refer Agriculture and Agri-Food Canada's Regulatory Directive BIO1996-10; The Biology of Glycine max (L.) Merr. (Soybean).
Description of the Modification	The PNT was developed through recombinant DNA technology. In order to assess the modification process, the following has been submitted: Description of the transformation system/modification process Description of the transformation method Nature and source of the carrier DNA Description of the genetic material delivered to the plant Components of the vector Summary of all genetic components Description of the inserted genes avhppd-03 and pat Description of the promoters and terminators Portion and size of the inserted sequence Location, order and orientation in the vector Function of the inserted gene in the plant Source of the avhppd-03 and pat gene (donor organism) Level of expression of avhppd-03 and pat protein in forage and grain Review of the toxicity and pathogenic ability of the genetic components to plants and other organisms Review of the toxicity and pathogenic ability of the donor organisms to plants and other organisms History of use of the avhppd-03 and pat gene Detailed map of the vector
Inheritance and Stability of the Introduced Trait	In order to assess the inheritance and stability of the genetic modification, the following has been submitted: Analysis of stability over multiple generations
Description of the Novel Traits	In order to characterize the DNA inserted in the plant, the following has been submitted: Information for all coding areas Information on plant promoters: Southern analysis of the avhppd-03 and pat coding regions and promoters DNA analysis for introns, terminators and enhancers of plant expressible cassettes. Information on noncoding regions that have no known plant function and are not associated with expression of coding regions: DNA analysis for known function. Characterization of expressed avhppd-03 and pat protein in soybean
Nutritional Evaluation of the Novel Plant	In order to assess nutritional aspects of the novel plant, the following has been submitted: The nutritional composition of the novel plant has been compared to unmodified soybean. The following have been considered: Proximate composition (e.g. protein, fat, ash, carbohydrates) Composition of amino acids and minerals Acid detergent fiber and neutral detergent fiber Micro-nutritional elements (vitamins, etc)
Allergenicity/Toxicity Considerations	In order to assess allergenicity and toxicity of the novel proteins, the following has been submitted: Analysis of the amino acid sequence similarity of avhppd-03 and pat to known protein allergens or toxins through bioinformatics analysis Digestibility of the Protein
Evaluation of the Environmental Impact of the Novel Plant	In order to assess the environmental impact of the novel plant, the following has been submitted: Agronomic Analysis of the PNT Examination of phenotypic characteristics of the PNT Examination of seed dormancy and germination of the PNT Examination for potential weediness of the PNT Examination of seed yield of the PNT Examination of pollen morphology and viability Examination of the PNT's potential to become a plant pest Examination of gene flow from the PNT to wild relatives based on literature Examination of plant pest and non-pest impacts of the PNT Stewardship plans

Comments will be received only via the Internet to CFIA or HC.

For more information on this product, please contact:

Syngenta Canada Inc.
3151 Strandherd Dr.
PO BOX 45570
Ottawa ON K2J 0P9
613-440-6895

The CFIA and HC, including their employees, are not responsible for the content of this Notice of Submission as submitted by the Applicant. All Notices of Submission are the responsibility of the Applicant submitting them and the Applicant does so at its own risk. Submission of this Notice of Submission and its subsequent posting by the CFIA on its Web site does not in any way whatsoever constitute acceptance, approval or certification by the CFIA or HC of the Plant with Novel Trait(s) subject of the Notice of Submission and the CFIA and HC reserve all their rights under all the pertinent legislation that may be applicable. The CFIA and HC in no way whatsoever waives any of their rights under any of the legislation they enforce or administer by way of the CFIA posting this Notice of Submission.

The Applicant is not obliged to provide any information. The Applicant submits information that it chooses to submit. The information that the Applicant voluntarily provides on this Notice of Submission is collected by the CFIA and HC for the purpose of sharing information with the public. Personal Information will be protected under the provisions of the Privacy Act, and will be stored in Personal Information Bank CFIA PPU 125. Information, including personal information, may be accessible or protected as required under the provisions of the Access to Information Act.