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

Comment period closed: January 23, 2015

Background:

The CFIA and Health Canada have received a submission from Monsanto Canada Inc. seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a maize line designated as MON 87419, which has been genetically modified to exhibit herbicide tolerance. 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 traits (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 Biology Document BIO 1994-11: The Biology of Zea mays (L.) (Maize).

Description of the Modification

Corn line MON 87419 was developed through the use of 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 inserted genes – dmo and pat
  • Description of the promoters and terminators
  • Portion and size of the inserted sequence
  • Location, order and orientation in the vector
  • Function of the genetic sequences in the plant
  • Source of the dmo and pat genes (donor organisms)
  • Level of expression of dicamba mono-oxygenase (DMO) protein and phosphinothricin N-acetyltransferase (PAT) protein in forage and grain
  • Review of the absence of toxicity and pathogenic ability of the genetic components to plants and other organisms
  • Review of the absence of toxicity and pathogenic ability of the donor organisms to plants and other organisms
  • History of use of the dmo and pat genes
  • 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: e-Southern analysis of dmo and pat coding regions and promoters
  • DNA analysis for introns, terminators and enhancers of plant expressible cassette
  • 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 DMO and PAT proteins in maize tissues

Absence of Toxicity of the Novel Gene Products

The absence of toxicity of the expressed genetic components on non-target species, humans and animals. The following have been either submitted or previously submitted, reviewed, and published:

  • Bioinformatics Evaluation of the DMO and PAT proteins
  • Acute toxicity study
  • Digestibility of the DMO and PAT proteins

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 maize. 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 expressed genetic components the following has been submitted:

  • Analysis of the amino acid sequence similarity of the DMO and PAT proteins 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
  • Examination of seed yield
  • Examination of phenotypic characteristics
  • Examination of seed dormancy and germination
  • Examination of the response to biotic and abiotic stressors
  • Examination of plant pest potential

For more information on this product, please contact:

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

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