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

Comment period closed: January 28, 2014

Background:

The CFIA and Health Canada have received a submission from Monsanto Canada Inc. seeking environmental safety approval for import purposes and livestock feed and food use of a soy line designated as MON 87751, which has been genetically modified for insect 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 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 CFIA's Regulatory Directive BIO 1996-10: 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:

  • Characterization 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 insecticide resistance cry genes
  • Description of the promoters and terminators
  • Portion and size of the inserted sequence
  • Location, order and orientation in the vector
  • Function of the cry genes in the plant
  • Source of the cry genes (donor organism – bacteria)
  • Level of expression of Cry proteins in grain and forage
  • 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 vector
  • 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 plant promoters: e-Southern analysis of the cry coding regions and their promoters
  • DNA analysis for introns, terminators and enhancers of plant expressible cassettes
  • Analysis for other promoters and regions associated with bacteria expressible cassettes
  • Information on non-coding regions that have no known plant function and are not associated with expression of coding regions: DNA analysis for known function
  • Characterization of expressed Cry proteins in soy tissues

Toxicity of the Novel Gene Products

The toxicity of the cry gene expression products on non-target species, humans and animals. The following have been previously submitted, reviewed,  and  published:

  • Decision Document 2003-43: Determination of the Safety of Monsanto Canada Inc.'s Insect Resistant Corn (Zea mays L.) Line MON 863
  • Decision Document DD2003-45: Determination of the Safety of Monsanto's Insect Resistant Bollgard® II Cotton (Gossypium hirsutum L.)
  • Decision Document DD2006-57: Determination of the Safety of Monsanto Canada Inc.'s Glyphosate-Tolerant, Corn-Rootworm-Protected Corn (Zea mays L.) Event MON 88017
  • Decision Document DD2008-74: Determination of the Safety of Monsanto Canada Inc.'s Corn (Zea mays L.) Event MON 89034
  • Decision Document DD2010-81: Determination of the Safety of Monsanto Canada Inc.'s Soybean (Glycine max (L.) Merr.) Event MON 87701

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 soy. The following have been considered:
    • Proximate composition (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:

  • Comparison of the amino acid sequence similarity of Cry proteins expressed in MON 87751 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 reproductive features of the PNT
  • Examination of phenotypic characteristics of the PNT
  • Examination of pollen morphology and viability
  • Examination of seed dormancy and germination of the PNT
  • Examination of the response to biotic and abiotic stressors on the PNT
  • Examination of the PNT's potential to become a plant pest
  • Examination of gene flow from the PNT to wild relatives
  • Examination of non-target impacts of the PNT

For each protein, non-target studies have been conducted on:

  • 1 mammalian species
  • 2 avian species
  • 1 aquatic species
  • 2 species of soil decomposers
  • 4 beneficial insect species

Insect studies are typically conducted on both larvae and adults

For more information on this product, please contact:

Monsanto Canada Inc.
180 Kent Street, Suite 810
Ottawa ON
(613) 234-5121

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.

Date modified: