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Notice of Submission for Approval of Novel Food, Livestock Feed Use and Environmental Safety Approval for Seed Production Purposes of a Plant Genetically Modified For Herbicide Tolerance (MON 87427) from Monsanto Canada Inc.

January 07, 2011
Comment: 2011-06-18

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 corn line designated as MON 87427, which has been genetically modified for glyphosate 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 plant sources, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a plant with a novel trait or a novel feed, 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 the Canadian Food Inspection Agency’s Biology Document BIO1994-11: The Biology of Zea mays (L.) (Maize) http://www.inspection.gc.ca/english/
plaveg/bio/dir/dir9411e.shtml
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 herbicide tolerance gene – cp4 epsps
  • Description of the promoter and terminator
  • Portion and size of the inserted sequence
  • Location, order and orientation in the vector
  • Function of the cp4 epsps gene in the plant
  • Source of the cp4 epsps gene (donor organism – bacteria)
  • Level of expression of CP4 EPSPS protein in plant tissues, 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 cp4 epsps 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 cp4 epsps  coding region and its promoter; Southern analyses of other genetic elements that are incorporated into the corn genome but are not expressed
  • Characterization of expressed CP4 EPSPS protein in corn
Toxicity of the Novel Gene Products The toxicity of the CP4 EPSPS protein on pest and non-pest species, humans and animals. The following have been previously submitted, reviewed, and published:
  • Decision Document DD95-02: Determination of Environmental Safety of Monsanto Canada Inc.’s Roundup Ready® Herbicide-Tolerant Brassica napus Canola Line GT73
  • Decision Document DD95-05: Determination of Environmental Safety of Monsanto Canada Inc.’s Glyphosate Tolerant Corn (Glycine max L.) Line GTS 40-3-2
  • Decision Document 2002-35: Determination of Safety of Monsanto Canada Inc.’s Roundup Ready® Corn (Zea mays L.) Line 603
  • Decision Document 2005-53: Determination of Safety of Monsanto Canada Inc.’s Roundup Ready® Alfafla ( Medicago sativa L.) Events J101 and J163
  • Decision Document 2005-54: Determination of Safety of Monsanto Canada Inc.’s and KWS SAAT AG’s Roundup Ready® Sugar Beet (Beta vulgaris spp vulgaris L.) Event H7-1
  • Decision Document 2005-56: Determination of Safety of Monsanto Canada Inc.’s Roundup Ready® Flex Cotton (Gossypium hirsutum L.) Line MON 88913
  • Decision Document 2006-57: Determination of Safety of Monsanto Canada Inc.’s Glyphosate-Tolerant, Corn-Rootworm-Protected Corn (Zea mays L.) Event MON 88017
  • Decision Document 2007-67: Determination of the Safety of Monsanto Canada Inc.'s Soybean (Glycine max (L.) Merr.) Event MON 89788
  • Hammond, B. R.L. Fuchs et al. 1996. The feeding value of corns fed to rats, chickens, catfish, and dairy cattle is not altered by genetic incorporation of glyphosate tolerance. J. Nutr. 126: 717-727.
  • Harrison, L.,M. et al. 1996. The expressed protein in glyphosate-tolerant corn, 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice.  J. Nutr. 126:728-740.
  • McCann, M. et al. 2005. Glyphosate-tolerant corns remain compositionally equivalent to conventional corns (Glycine max L.) during three years of field testing. J. Ag. & Food Chem. 53(13): 5331-5335
  • Park, J. et al. 2001. Comparison of allergens in genetically modified corn with conventional corn. Yahak Hoeji. 45(3): 293-301
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 corn. 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 corn
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 cp4 epsps  protein expressed in MON 87427 to known protein allergens or toxins through bioinformatics analysis

The following has been previously submitted:

  • Analysis the amino acid sequence similarity of cp4 epsps  or protein expressed in other crops or products 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 PNT’s 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
  • Stewardship and mitigation plans

Comments will be received only via the Internet or by postal mail to CFIA or Health Canada. (See addresses below.)

For more information on this product, please contact:

Monsanto Canada Inc.
180 Kent Street, 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
Nepean, 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
Nepean, 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 Web site 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 Access to Information Act.


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