Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Soybean Genetically Modified for Herbicide Tolerant Traits (DAS-444Ø6-6 Soybean) from Dow AgroSciences Canada Inc.

September 21, 2011
Comment period closed: 2012-01-03

Background:

The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) have received a submission from Dow AgroSciences Canada Inc. seeking an approval for environmental release, livestock feed and food use for soybean designated as DAS-444Ø6-6 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 Health Canada guidelines for assessment of novel foods.

Summary of the Submission

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

Description of the host plant	Please refer to Biology Document BIO1996-10: The Biology of Glycine max (L.) Merr. (Soybean) Characterization of the recipient soybean line
Description of the Modification	DAS-444Ø6-6 was developed through recombinant DNA technology. In order to assess the modification process the following has been submitted: Description of Transformation Method Identity and Source of Genetic Material in pDAB8264 Analysis of the Insert and Its Genetic Elements
Inheritance and Stability of the Introduced Trait	In order to assess the inheritance and stability of the genetic modification the following has been submitted: Stability of the Insert Across Generations Segregation Analysis of DAS-444Ø6-6 Soybean Molecular Characterization of a Segregating Generation Segregation Analysis of Breeding Generations
Description of the Novel Traits	In order to characterize the DNA inserted in DAS-444Ø6-6, the following has been submitted: Identity of the AAD-12, 2mEPSPS and PAT protein Biochemical Characterization of the AAD-12, 2mEPSPS and PAT protein Expression of AAD-12, 2mEPSPS and PAT Protein in Plant Tissues
Toxicity and Allergenicity of the Novel Gene Products	In order to assess toxicity and allergenicity of the novel genes on non-target species, humans and animals the following has been submitted: Amino Acid Sequence Comparison to Known Toxins Acute Oral Toxicity Safety of Donor Organism Assessment of Allergenicity Potential Amino Acid Sequence Comparison to Known Allergens Heat Lability
Nutritional Evaluation of DAS-444Ø6-6	In order to assess nutritional aspects of DAS-444Ø6-6 the following has been submitted: Dietary Exposure Compositional Analyses of Soybean Forage Compositional Analyses of Soybean Grain Proximate and Fiber Analysis Mineral Analysis Amino Acid Analysis Fatty Acid Analysis Vitamin Analysis
Evaluation of the Environmental Impact of DAS-444Ø6-6	In order to assess the environmental impact of DAS-444Ø6-6 the following has been submitted: Ecological Observations Germination and Dormancy Field Efficacy of DAS-444Ø6-6 Weediness Potential of DAS-444Ø6-6Soybean Horizontal Gene Flow Assessment Potential Impact of the Introduction of Soybean Line DAS-444Ø6-6 on Agronomic Practices Potential Impact on Weed Control Practices Potential Impact on Volunteer Management Potential Impact on Non-Target Organisms and Endangered Species Stewardship of Herbicide Tolerant DAS-444Ø6-6 Soybean Herbicide Resistance Management Management of Volunteers Vertical Gene Flow Assessment (Introgression of the Trait into Related Species) Communication to Agricultural Chemical and Seed Customers Trait and Herbicide Field Testing Ag Chemical Labeling Training and Education of Sales Representatives and Agronomists Tracking Customer Satisfaction and Managing Issues Involvement in Industry Groups

Comments will be received only via the Internet or postal mail to CFIA or Health Canada. (See addresses below.)

For more information on this product, please contact:

Dow AgroSciences Canada Inc.
Suite 2100, 450-1st Street SW
Calgary, AB
T2P 5H1

For more information on the regulatory system, please contact:

The CFIA and Health Canada, 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 website does not in any way whatsoever constitute acceptance, approval or certification by the CFIA or Health Canada of the Plant with Novel Trait(s) subject of the Notice of Submission and the CFIA and Health Canada reserve all their rights under all the pertinent legislation that may be applicable. The CFIA and Health Canada 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 Health Canada 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 CFIA PPU 125. Information, including personal information, may be accessible or protected as required under the provisions of the Access to Information Act.