Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Soybean Genetically Modified for Herbicide Tolerant Traits (DAS-68416-4 Soybean) from Dow AgroSciences Canada Inc.

February 19, 2010
Comment period closed: 2012-05-06

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-68416-4, 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.

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
Description of the Modification

DAS-68416-4 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 pDAB4468
  • Genetic Characterization of Event DAS-68416-4
  • 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-68416-4 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-68416-4, the following has been submitted:

  • Identity of the AAD-12 Protein
  • Biochemical Characterization of the AAD-12 Protein
  • Expression of AAD-12 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
  • Lack of Allergenicity and Toxicity of AAD-12
  • Safety of Donor Organism
  • Assessment of Allergenicity Potential
  • Amino Acid Sequence Comparison to Known Allergens
  • Heat Lability of AAD-12
  • Lability in Simulated Gastric Fluid
Nutritional Evaluation of DAS-68416-4

In order to assess nutritional aspects of DAS-68416-4 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
    • Isoflavones Analysis
    • Anti-Nutrient Analysis
Evaluation of the Environmental Impact of DAS-68416-4

In order to assess the environmental impact of DAS-68416-4 the following has been submitted:

  • Ecological Observations
  • Germination and Dormancy
  • Field Efficacy of AAD-12
  • Weediness Potential of 68416 Soybean
  • Horizontal Gene Flow Assessment
  • Potential Impact of the Introduction of Soybean Line 68416 on Agronomic Practices
  • Potential Impact on Cultivation and Management 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 68416 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