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Plants > Biotechnology / PNTs > Notices of Submission

Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Herbicide Tolerant Durum Wheat from BASF Canada

Date Posted: November 23, 2005

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To provide comments on this submission, please use the feedback form.

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 durum wheat (“wheat”) designated as ALS2, 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 HC 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	The Biology of Triticum turgidum spp. durum L. has been submitted.
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 the ALS2 trait Information on stability of homozygous progeny
Description of the Novel Trait	In order to characterize the trait, the following has been submitted: Identification of ALS2 acetohydroxy acid synthase as modified trait Confirmation of single codon change in sequence of ALS2 AHAS Expression Level of AHAS Product feed-back inhibition of AHAS
Toxicity/ allergenicity 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 ALS2 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 ALS2 wheat to become a weed Potential for gene flow to wild relatives Potential impacts on non-targets Agronomic data, germination data confirming ALS2 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.)

For more information on this product, please contact:

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.

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