Summary of the Submission Template (EXAMPLE)
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 Regulatory Directive 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 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 insect resistance gene - CryX
- Description of the marker gene - PAT
- Description of the promoters and terminators
- Portion and size of the inserted sequence
- Location, order and orientation in the vector
- Function of the CryX gene in the plant review of Bacillius
thuringiensis (B.t.)
- Source of the CryX gene (donor organism bacteria)
- 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:
- Medelian Segregation of B.t. CryX Maize Line 1111
- For infertile plants, data to demonstrate stability during vegetative
propagation
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Description of the Novel Traits |
In order to characterize the DNA inserted in the plant, the following has
been submitted:
- For all coding areas information on complete and partial copies
- Information plant promoters: Southern analysis of the CryX gene, the
PAT gene, 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 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 CryX protein in maize tissues
- Quantitative ELISA analysis of CryX and
PAT expression
levels in compositional analysis of maize inbred and hybrid lines
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Toxicity of the Novel Gene Products |
In order to assess toxicity of the novel genes on nontarget
species, humans and animals the following has been submitted:
- A dietary effect toxicity study of B.t. CryX with honeybee
- A dietary toxicity study of B.t. CryX with green lacewing
larvae
- A dietary toxicity study of B.t. CryX with ladybird beetle
- A dietary toxicity study of B.t. CryX with parasitic
hymenoptera
- Acute toxicity test of B.t. CryX with daphnia magna
- Acute toxicity test of B.t. CryX with earthworm
- Acute oral toxicity test of B.t. CryX with mice
- A dietary study of B.t. CryX with northern
bobwhite
- Toxicity study of CryX protein to larvae of monarch butterfly
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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 has been compared to
unmodified corn. The following have been considered:
- Proximate composition (e.g. ash, moisture
content, crude protein, crude fat, crude carbohydrate and fibre)
- Content of true protein, non-protein nitrogenous material (e.g. nucleic acids and aminoglycosides) and amino acid
profile
- Composition of total lipids
- Composition of the carbohydrate fraction
- Composition of vitamins
- Examination of antinutritionals
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Allergenicity Considerations |
In order to assess allergenicity of the novel proteins the
following has been submitted:
- Comparison of the amino acid sequence similarity of CryX and PAT proteins to known
allergen proteins
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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:
- Field survey of beneficial arthropods associated with B.t. CryX
maize
- Environmental fate of CryX protein in soil
- Examination for potential weediness of the PNT
- Examination of the PNT
to become a potential plant pest
- Examination of gene flow from the PNT to wild relatives
- Risk assessment for exposure of non-target organisms to CryX corn
pollen
- Resistance management plan for the PNT with CryX protein
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Comments will be received only via the Internet or postal
mail to CFIA or Health Canada. (See addresses below.)
Applicant Name
123 Growing Road
Ottawa, Ontario
(613) 555-5555
www.applicantname.com
For more information on the regulatory system, please contact:
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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