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
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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.
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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
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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
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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
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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.
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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
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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
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Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunneys Pasture
Ottawa, Ontario
K1A 0L2
(613) 954-8921
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Plant Biosafety
Office
Plant Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario
K1A 0Y9
(613) 225-2342
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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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