Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety Approval for Commercial Planting Purposes of a Plant Genetically Modified For Increased Yield from Monsanto Canada Inc.

August 26, 2011
Comment period closed: 2011-12-27

Background:

The CFIA and Health Canada have received a submission from Monsanto Canada Inc. seeking an approval for environmental safety approval for commercial planting purposes and livestock feed and food use of a soybean line designated as MON 87712, which has been genetically modified for increased yield. 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 PNTs, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a plant with novel trait (PNT) or a novel feed derived from PNTs, 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 Health Canada 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 Health Canada may request further information from the developer.

Description of the host plant Please refer to Agriculture and Agri-Food Canada’s Regulatory Directive Dir. 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 regulatory gene – BBX32
  • Description of the promoter and terminator
  • Portion and size of the inserted sequence
  • Location, order and orientation in the vector
  • Function of the BBX32 gene in the plant
  • Source of the BBX32 gene (donor organism – bacteria)
  • Level of expression of BBX32 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 BBX32 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 BBX32 coding region and its promoter Southern analyses of other genetic elements that are incorporated into the soybean genome but are not expressed
  • Characterization of expressed BBX32 protein in soybean
Toxicity of the Novel Gene Products

The toxicity of the BBX32 protein on non-target species, humans and animals:

  • Bioinformatics Evaluation
  • Acute Toxicity Study
  • Digestibility of the Protein
  • Endogenous Allergenicity Study
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 (protein, fat, ash, carbohydrates)
    • Composition of amino acids, fatty acids, and minerals
    • Acid detergent fiber and neutral detergent fiber
    • Micro-nutritional elements (vitamins, etc) and anti-nutrients for soybean
Allergenicity/Toxicity Considerations

In order to assess allergenicity and toxicity of the novel proteins, the following has been submitted:

  • Comparison of the amino acid sequence similarity of BBX32 protein expressed in MON 87712 to known protein allergens or toxins through bioinformatics analysis
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:

  • Examination for potential weediness of the PNT
  • Examination of seed yield of the PNT
  • Examination of reproductive features of the PNT
  • Examination of phenotypic characteristics of the PNT
  • Examination of seed dormancy and germination of the PNT
  • Examination of the response to biotic and abiotic stressors on the PNT
  • Examination of the PNTs 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

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:

Monsanto Canada Inc.
180 Kent St. Suite 810
Ottawa, ON K1P 0B6
(613) 234-5121

For more information on the regulatory system, please contact:

Animal Feed Division
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
(613) 225-2342

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario
K1A 0L2
(613) 954-8921

Plant Biosafety Office
Plant Health & Biosecurity Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
(613) 225-2342

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.