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Description of the host plant |
A
Biology Document: The Biology of
Medicago sativa L. (Alfalfa) has been
submitted to the
CFIA by Monsanto Canada with their
application for unconfined environmental
release. The document is currently being
reviewed by external reviewers. When the review
process is complete, the biology document will
be posted on the
CFIA web site. |
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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 herbicide tolerance gene
–
-
cp4
epsps
-
Description of the promoters and terminators
- 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
expression of
cp4
epsps protein in forage
- 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 the To and dihomogenic Syn 1 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 region 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
cp4
epsps protein in alfalfa
tissues
|
|
Toxicity of the Novel Gene Products |
The
toxicity of the
cp4
epsps gene on nontarget species,
humans and animals has been previously
submitted, reviewed, and published. Therefore,
the following partial list of references were
provided in the submission.
- 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
- 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.
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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 alfalfa. The
following have been considered:
-
Proximate composition (protein, fat,
ash, carbohydrates)
-
Composition of lignin, amino acids and
minerals
- Acid
detergent fiber and neutral detergent
fiber
|
|
Allergenicity/Toxicity Considerations |
In
order to assess allergenicity of the novel
proteins the following has been previously
submitted:
- Comparison
of the amino acid sequence similarity of
cp4
epsps protein to known
allergen proteins bioinformatics analysis
|
|
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 feral alfalfa, examination for
potential weediness of the
PNT
-
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
-
Stewardship and Mitigation plan
|
Comments will be
received only via the Internet or postal mail to
CFIA
or Health Canada. (See addresses below.)
For more information on
this product, please contact:
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. |
