| 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 - Cry1F
- 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
|
| Inheritance and Stability of the Introduced Trait |
In order to assess the inheritance and stability of the genetic
modification the following has been submitted:
- Mendelian Segregation of B.t. Cry1F Maize Line 6275
|
| 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 Cry1F 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 Cry1F protein in maize tissues
- Quantitative ELISA analysis of Cry1F and
PAT expression
levels in compositional analysis of maize inbred and hybrid lines
|
| 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. Cry1F with honeybee
- A dietary toxicity study of B.t. Cry1F with green lacewing
larvae
- A dietary toxicity study of B.t. Cry1F with ladybird beetle
- A dietary toxicity study of B.t. Cry1F with parasitic
hymenoptera
- Acute toxicity test of B.t. Cry1F with daphnia magna
- Acute toxicity test of B.t. Cry1F with earthworm
- Acute oral toxicity test of B.t. Cry1F with mice
- A dietary study of B.t. Cry1F with northern
bobwhite
- Toxicity study of Cry1Fprotein to larvae of monarch butterfly
|
| 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
|
| Allergenicity Considerations |
In order to assess allergenicity of the novel proteins the
following has been submitted:
- Comparison of the amino acid sequence similarity of Cry1F and PAT proteins to known
allergen proteins
|
| 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. Cry1F
maize
- Environmental fate of Cry1F 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 Cry1F corn
pollen
- Resistance management plan for the PNT with Cry1F protein
- Agronomic data
|
For more information on this product, please contact:
Dow AgroSciences Canada Inc.
201, 1144 29 Ave., N.E.
Calgary, Alberta
T2E 7P1
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.
|
