Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Canola Genetically Modified for Glyphosate Tolerance (MON 88302) from Monsanto Canada Inc.

April 8, 2011
Comment period closed: 2011-08-21

Background:

The CFIA and Health Canada have received a submission from Monsanto Canada Inc. seeking an approval for environmental release, livestock feed and food use for canola designated as MON 88302, which has been genetically modified for glyphosate 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 from plant sources, and HC guidelines for assessment of novel foods.

Summary of the Submission

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 Biology Document BIO1994-09: The Biology of Brassica napus L. (Canola/Rapeseed) at: http://www.inspection.gc.ca/english/plaveg/ bio/dir/dir9409e.shtml
Description of the Modification	MON 88302 was developed through recombinant DNA technology. In order to assess the modification process the following has been submitted: Description 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 5-enolpyruvylshikimate-3-phosphate synthase protein 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 - Agrobacterium sp. Strain CP4) Level of expression of CP4-EPSPS protein in tissues 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 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: Analysis of stability over multiple generations
Description of the Novel Traits	In order to characterize the DNA inserted in MON 88302, the following has been submitted: Information on all coding regions Information plant promoters: Southern analysis of the cp4-epsps gene and its promoter ; Southern analyses of other genetic elements that are incorporated into the canola genome but not expressed Characterization of expressed CP4-EPSPS protein in canola tissues Analysis of CP4-EPSPS expression level and compositional analysis of canola lines
Toxicity of the Novel Gene Products	In order to assess toxicity of the novel genes on nontarget species, humans and animals the following has been submitted: Acute oral toxicity test of CP4-EPSPS protein with mice
Nutritional Evaluation of MON88302	In order to assess nutritional aspects of MON 88302 the following has been submitted: The nutritional composition of MON 88302 has been compared to unmodified canola. The following have been considered: Proximate composition (e.g. ash, carbohydrates, moisture, protein, and fat) Composition of amino acids, fatty acids and minerals Composition of vitamins and fibers Examination of antinutritionals
Allergenicity Considerations	In order to assess allergenicity of the novel proteins the following has been submitted: Comparison of the amino acid sequence similarity of CP4-EPSPS protein to known allergen proteins through bioinformatics analysis
Evaluation of the Environmental Impact of MON 88302	In order to assess the environmental impact of MON 88302 the following has been submitted: Examination of seed yield of the PNT Examination for potential weediness of the PNT Examination of reproductive features 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 the PNT to become a potential plant pest Examination of gene flow from the PNT to wild relatives Examination of plant pest and non-pest impacts of the PNT

Comments will be received only via the Internet or by postal mail to CFIA or Health Canada. (See addresses below.)

For more information on this product, please contact:

Monsanto Canada Inc.
180 Kent Street, Suite 810
Ottawa, ON K1P 0B6
613-234-5121

For more information on the regulatory system, please contact:

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 website 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 CFIA PPU 125. Information, including personal information, may be accessible or protected as required under the provisions of the Access to Information Act.