Notice of Submission for Approval of Novel Food, Livestock feed and Unconfined Environmental Release for Soybean Genetically Modified for Insect Resistance (DAS-81419-2) From Dow AgroSciences Canada inc.

Comment period closed: July 30, 2013

Background:

Dow AgroSciences Canada Inc. (DAS) has submitted to the Plant Biosafety Office and Animal Feed Division of the Canadian Food Inspection Agency and Health Canada a submission to approve DAS-81419-2 (genetically modified to be insect-resistant) for environmental release, livestock feed and food use and make a determination that this modified plant is safe. This submission is in accordance with Directive 94-08 (Dir94-08),“Assessment Criteria for  Determining Environmental Safety of Plants with Novel Traits”; Section 2.6 of Regulatory Guidance: Feed Registration Procedures and Labeling Standards; and Guidelines for the Safety 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 and Inheritance and Stability of the Introduced Trait

DAS-81419-2 was developed through recombinant DNA technology. In order to assess the modification process the following has been submitted:

  • Description of Transformation System
  • Selection of Comparators for DAS-81419-2 Soybean
  • Donor Genes and Regulatory Sequences: Identity and Source of Genetic Material in pDAB9582
  • Genetic Characterization
  • Analysis of the Insert and Its Genetic Elements
  • Absence of Plasmid Backbone Sequences
  • Stability of the Insert Across Generations
  • Segregation Analysis
Description of the Novel Traits

In order to characterize the DNA inserted in 81419-2, the following has been submitted:

  • Identity of the Cry1Ac and Cry1F Proteins
  • Cry1 Protein Mode of Action
  • Biochemical Characterization of the Cry1Ac and Cry1F Proteins
  • Expression of Cry1Ac and Cry1F Proteins in Plant Tissues
  • Identity of the PAT Protein
  • Mode of Action of PAT Protein
  • Biochemical Characterization of the PAT Protein
  • Expression of PAT Protein in Plant Tissues
  • Potential Novel Protein Expression
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 toxicity of Cry1Ac and Cry1F
  • Assessment of Allergenicity Potential
  • Safety of Donor Organisms
  • Endogenous Allergen Analysis of DAS-81419-2 Soybean
Nutritional Evaluation of DAS-81419-2

In order to assess nutritional aspects of DAS-81419-2 the following has been submitted:

  • Food and Feed Safety Assessments
  • Cry1Ac, Cry1F and PAT Human Dietary Risk Assessments
  • Cry1Ac, Cry1F and PAT Livestock Dietary Risk Assessments
  • Grain and Forage Composition, including:
    • Proximate, Fibre and Mineral Analysis of Forage and seed 
    • Amino Acid Analysis of seed
    • Fatty Acid Analysis of seed
    • Vitamin Analysis of seed
    • Bioactive Analysis of seed
Evaluation of the Environmental Impact of DAS-81419-2

In order to assess environmental impact of DAS-81419-2 the following has been submitted:

  • Agronomic Characteristics
  • Ecological Observations
  • Environmental Assessment and Impact of Agronomic Practices
  • Efficacy against Target Pests
  • Gene Flow Assessment
  • Potential Impact on Agronomic Practices
  • Potential Impact on Non-Target Organisms
  • Potential Impact on Threatened and Endangered Species
  • Detection
Stewardship of DAS-81419-2

To assess stewardship of DAS-81419-2 the following has been submitted:

  • Insect Resistance Management
  • Management Actions to Control Volunteers
  • Interactions with Expert Groups

Comments will be received only via the Internet or postal mail to CFIA or Health Canada.

For more information on this product, please contact:

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

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 their 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 required to provide a Notice of Submission. 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 Access to Information Act.

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