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Notice of
Submission for Approval of Livestock Feed, Novel Food, and
Environmental Safety for Genetically Improved Maize, Lysine
Maize, Event LY038,
from Monsanto Canada
Inc. |
Canada
September 14, 2004
Canadian Food Inspection
Agency
Biotechnology Notices
of Submission Project
Maize (Event LY038)
which has been genetically modified for elevated levels of free
lysine in grain
SOURCE:
http://www.inspection.gc.ca/english/plaveg/bio/subs/2004/20040914e.shtml
Background:
The
CFIA
and Health Canada (HC)
have received a submission from Monsanto Canada
Inc. seeking livestock
feed and food approval and environmental safety approval
for maize, Event
LY038, which has been genetically modified for
elevated levels of free lysine in grain. These events
are not intended for commercial planting or seed
production purposes in Canada. The submission received
is in accordance with
CFIA
guidelines for assessment of plants with novel traits (PNTs)
for unconfined release,
CFIA
guidelines for assessment of novel feeds, and HC
guidelines for assessment of novel foods. To view
information related to the environmental assessment of a
plant with novel trait (PNT))
or to the safety assessment of a
novel feed, please refer to the
CFIA
Web site. To view the information related to the health
and safety assessment of a novel food, please refer to
the
Health Canada Web site.
Summary of the
Submission Package
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. |
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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 |
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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
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Description of the transformation method
- Nature and
source of the carrier
DNA
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Description of the genetic material
delivered to the plant
- Components
of the vector
- Summary of
all genetic components
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Description of the lysine-insensitive
dihydrodipicolinate synthase gene –
cordapA
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Description of the promoters and terminators
- Portion
and size of the inserted sequence
- Location,
order and orientation in the vector
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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
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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:
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Information for all coding areas
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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
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Confirmation of removal of antibiotic
resistance marker
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Information on noncoding regions that have
no known plant function and are not
associated with expression of coding
regions:
DNA
analysis for known function
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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)
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Composition of amino acids and minerals
- Acid
detergent fiber and neutral detergent
fiber
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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
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Examination of reproductive features of the
PNT
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Examination of phenotypic characteristics of
the
PNT
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Examination of seed dormancy and germination
of the
PNT
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Examination of the response to biotic and
abiotic stressors on the
PNT
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Examination of pollen morphology and
viability of the
PNT
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Examination of the
PNT to become a potential plant
pest
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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 |
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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