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Plants > Biotechnology / PNTs > Notices of Submission 

Notice of Submission for Approval of Livestock Feed, Novel Food, and Environmental Safety for Genetically Improved Maize, Lysine Maize, Event LY038, from Monsanto Canada Inc.

Date Posted: September 14, 2004

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To provide comments on this submission, please use the feedback form.

Background:

The CFIA and Health Canada (HC) have received a submission from Monsanto Canada Inc. seeking livestock feed and food approval and environmental safety approval for maize, Event LY038, which has been genetically modified for elevated levels of free lysine in grain. These events are not intended for commercial planting or seed production purposes in Canada. 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, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a plant with novel trait (PNT)) or to the safety assessment of 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 to Biology Document Dir94-11: The Biology of Zea mays L. (Corn/Maize) at: http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9411e.shtml
Description of the Modification The PNT was developed using a biolistic transformation system. 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 lysine-insensitive dihydrodipicolinate synthase gene – cordapA
  • Description of the promoters and terminators
  • Portion and size of the inserted sequence
  • Location, order and orientation in the vector
  • Description of Cre recombination system to remove antibiotic resistance marker in plants
  • Function of the cordapA gene in the plant
  • Source of the cordapA gene (donor organism – bacteria)
  • Level of expression of cordapA protein in forage
  • Description of current commercial lysine production via fermentation of Corynebacterium glutamicum expressing cordapA
  • Review of the toxicity and pathogenic ability of the genetic component to plants and other organisms
  • Review of the toxicity and pathogenic ability of the donor organism 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 inheritance and genetic stability of the lysine trait through breeding and Southern blotting.
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 for all plant promoters: Southern analysis of the cordapA coding region and it’s promoter
  • DNA analysis for intron element, terminators and enhancers of plant expressible cassettes
  • cordapA cassette intactness
  • Confirmation of removal of antibiotic resistance marker
  • Information on noncoding regions that have no known plant function and are not associated with expression of coding regions: DNA analysis for known function
  • Characterization of expressed cordapA protein in maize tissues
Toxicity of the Novel Gene Products The toxicity of the cordapAgene was evaluated with the following studies:
  • Bioinformatics Analysis of the cordapA Protein Expressed in Event LY038 Utilizing multiple Databases.
  • An Acute Oral Toxicity 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 (forage and grain) 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
    • Metabolites in both Lysine anabolic and catabolic pathways
  • Comparison of Broiler Performance When Fed Diets Containing LY038, Negative Segregant Control, or Commercial Maize
Allergenicity Considerations In order to assess allergenicity of the novel proteins the following has been previously submitted:
  • Comparison of the amino acid sequence similarity of cordapA protein to known allergen proteins bioinformatics analysis
  • Assessment of the in vitro Digestibility in Simulated Gastric Fluid.
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 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 pollen morphology and viability of the PNT
  • Examination of the PNT to become a potential plant pest
  • Examination of gene flow from the PNT to wild relatives
  • Agronomic Stewardship

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

Monsanto Canada Inc.
130 Albert Street, Suite 1902
Ottawa ON, K1P 5G4

For more information on the regulatory system, please contact:

Feed Section
Animal Products 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 Products 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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