| Description of the host plant |
The Biology of Gossypium species
(Cotton) at:
http://www.aphis.usda.gov/brs/biology.html. Cotton is not grown in Canada. |
| 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
- 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 promoters and polyadenylation sequences
- 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 the CP4
EPSPS protein in cotton
- 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:
- Generational stability analysis through five 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 for all plant promoters: Southern analysis of the
CP4
EPSPS coding regions and their promoters
- DNA analysis for introns, enhancers, and polyadenylation sequences
of the plant expressible cassettes
- Analysis for other promoters and regions associated with bacteria
expressible cassettes and backbone regions of the vector outside of the
T-DNA region.
- Characterization of expressed
CP4
EPSPS protein in cotton
tissues
|
| Toxicity of the Novel Gene Products |
The toxicity of the
cp4
epsps gene on
nontarget species, humans and animals have been previously submitted,
reviewed, and published. Therefore, the following partial list of references
and data were provided in the submission.
- Decision Document DD97-21: Determination of the Safety of Cotton
Lines with Roundup Ready® Genes (Gossypium hirsutum L.).
- 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 Soybean (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
- Assessment of the in vitro digestive
fate of
CP4
EPSPS
synthase and purified E. coli produced
CP4
EPSPS protein.
- Bioinformatics analysis of the
CP4
EPSPS protein utilizing the
AD4, TOXIN5, and ALLPEPTIDES databases.
- Harrison, L., M. Bailey et al. 1996. The expressed protein in glyphosate tolerant soybean, 5-EPSPS from Agrobacterium sp.
Strain
CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice. Journal of Nutrition 126: 728-739.
- Petty, A.T., G.F. Hartnell et al. 2001. Performance of beef cattle
fed Roundup Ready Corn harvested as whole plant silage or grain. J. Anim.
Sci. 79(Suppl. 2):102. Abstract 321.
- Donkin, S.S., G.F. Hartnell et al. 2000. Effect of feeding Roundup
Ready Corn silage and grain on feed intake, milk production, and milk
composition in lactating dairy cattle. J. Dairy Sci. 83 (Suppl. 1): 273
Abstract 1144.
- Hammond, B. R.L. Fuchs et al. 1996. The feeding value of soybeans
fed to rats, chickens, catfish, and dairy cattle is not altered by
genetic incorporation of glyphosate tolerance. J. Nutr. 126: 717-727.
- Castillo, A.R., G.F. Hartnell et al. 2001. Effect of feeding
dairy cows with cottonseeds containing Bollgard and Roundup Ready genes
or control non-transgenic cottonseeds on feed intake, milk yield and
milk composition. J. Dairy Sci. 84(Suppl. 1) 413. Abstract 1713.
- Aalhus, J.L., M.E.R. Dugan, K.A. Lien, I.L. Larsen, F. Costello,
D.C. Roland, D.R. Best and R.D. Thacker. 2003. Effects of feeding
glyphosate-tolerant canola meal on swine growth, carcass composition and
meat quality. J. Anim. Sci. 81:3267.
- Stanford, K., J.L. Aalhus, M.E.R. Dugan, G.L. Wallins, R. Sharma,
T.A. McAllister. 2003. Effects of feeding transgenic canola on apparent
digestibility, growth performance and carcass characteristics of lambs.
Canadian J. Anim. Sci. 83(2):299-305.
|
| Nutritional Evaluation of the Novel Plant |
In order to assess nutritional aspects of the
novel plant products the following has been submitted:
- The nutritional composition of the novel plant products has been
compared to the appropriate negative segregant control. The following
have been considered:
-
Proximate composition (protein, fat, ash, carbohydrates)
- Composition of fiber, amino acids and minerals
- Composition comparison of fatty acid, vitamins and Gossypol
|
| Allergenicity/Toxicity Considerations |
In order to assess allergenicity of the novel
protein the following has been submitted:
- Comparison of the amino acid sequence similarity of
CP4
EPSPS protein to known allergen proteins bioinformatics analysis
- Digestive fate in vitro studies
|
| Evaluation of the Environmental Impact of the Novel Plant |
In order to assess the environmental impact of the novel plant
the previous approvals for cotton have been referenced. |
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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