Canada
September 7, 2004
Canadian Food Inspection
Agency
Biotechnology Notices
of Submission Project
Wheat (ALS3),
which has been bred for herbicide tolerance
Notice of Submission for
Approval of Novel Food, Livestock Feed and Unconfined
Environmental Release for Herbicide Tolerant Wheat from
BASF
Canada
SOURCE:
http://www.inspection.gc.ca/english/plaveg/bio/subs/2004/20040907e.shtml
Introduction
The
CFIA
and Health Canada (HC)
have received a submission from
BASF
Canada seeking an approval for environmental release,
livestock feed, and food use for wheat designated as
ALS3,
which has been bred for herbicide tolerance. 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 assessment of a
novel feed, please refer to the
CFIA
Web site. To view the information related to the
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. |
|
Description of the host plant |
Please refer to
Regulatory Directive Dir1999-01: The Biology of
Triticum aestivum L.
(Wheat) at:
http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9901e.shtml |
|
Description of the Modification |
The
PNT
was developed through the plant breeding
technique of mutagenesis. In order to assess the
novel trait the following has been submitted:
-
Mutagenesis procedure
- Selection
process for imidazolinone herbicide
tolerance
-
Post-mutagenesis breeding history
|
|
Inheritance and Stability of the Introduced
Trait |
In
order to assess the inheritance and stability of
the trait the following has been submitted:
- Mendelian
Segregation of
ALS3 trait
-
Information on stability of homozygous
progeny
|
|
Description of the Novel Traits |
In
order to characterize the trait, the following
has been submitted:
-
Identification of
ALS3 acetohydroxy acid synthase as
modified trait
-
Confirmation of single codon change in
sequence of
ALS3
AHAS
- Expression
Level of
AHAS
- Product
feed-back inhibition of
AHAS
|
|
Toxicity/allergen-icity of the Trait |
In
order to assess toxicity/allergenicity of the
trait, on non-target species, humans and animals
the following has been submitted:
- Sequence
comparison of
ALS3
AHAS with the single amino acid
change to known protein toxins and allergens
-
Confirmation of protease and temperature
lability of
AHAS
|
|
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 wheat. The
following have been considered:
- Proximate
composition (e.g.
crude protein, crude fat and fibre)
Content of
protein, and amino acid profile
-
Composition of fatty acids
-
Composition of vitamins (B2, folate,
thiamine, niacin, pantothenic acid,
pyridoxine and vitamin E)
-
Composition of minerals (P,
Mg,
Zn,
Fe,
Cu,
Mn,
K)
-
Examination of antinutritionals
|
|
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:
- Potential
for
ALS3 wheat to become a weed
- Potential
for gene flow to wild relatives
- Potential
impacts on non-targets
- Agronomic
data, germination data confirming
ALS3 wheat is equivalent to other
wheat, with the exception of imidazolinone
tolerance
In addition,
herbicide tolerant crop management strategies
were submitted in the application. |
Comments will be
received only via the Internet or postal mail to
CFIA
or Health Canada. (See addresses below.)
BASF
Canada Inc.
345 Carlingview Drive
Toronto, Ontario
M9W 6N9
www.basf-canada.ca
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. |
|
