Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Event 5307 Maize from Syngenta Seeds Canada Inc.

April 26, 2011
Comment period closed: 2011-09-03

Background:

The CFIA and Health Canada have received a submission from Syngenta Seeds Canada Inc. seeking an approval for unconfined environmental release for commercial planting purposes and livestock feed and food use of a Maize line designated as Event 5307, which has been genetically modified to resist Northern and Western Corn Rootworms. 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. To view information related to the environmental assessment of a PNT or 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

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 the Canadian Food Inspection Agency's Biology Document BIO1994-11: The Biology of Zea mays (L.) (Maize) http://www.inspection.gc.ca/english/ plaveg/bio/dir/dir9411e.shtml
Description of the Modification	The PNT 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 insect resistance gene - ecry3.1Ab Description of the selection gene - pmi Description of the promoter and terminator Portion and size of the inserted sequence Location, order and orientation in the vector Function of the ecry3.1Aband pmi gene in the plant Source of the ecry3.1Aband pmi gene Level of expression of eCry3.1Ab and PMI protein in plant tissues, forage and grain Review of the toxicity and pathogenic ability of the donor organisms to plants and other organisms History of use of the Bt-derived genes 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 Analysis of protein levels of multiple 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 on plant promoters: Southern analysis of the ecry3.1Ab  coding region and its promoter; Southern analyses of other genetic elements that are incorporated into the corn genome but are not expressed Characterization of expressed eCry3.1Ab protein in corn
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 corn. The following have been considered: Proximate composition (protein, fat, ash, carbohydrates) Composition of amino acids, fatty acids, and minerals Micro-nutritional elements (vitamins, etc.) and anti-nutrients for corn Analysis on digestibility Analysis on impact of heat on activity
Allergenicity/Toxicity Considerations	In order to assess allergenicity and toxicity of the novel proteins, the following has been submitted: Comparison of the amino acid sequence similarity of eCry3.1Ab protein expressed in Syngenta Eventa 5307 to known protein allergens or toxins through bioinformatics analysis Analysis of activity in mammalian system
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 for potential weediness of the PNT Agronomic Analysis of the PNT Examination of phenotypic characteristics of the PNT Examination of the PNT's potential to become a plant pest Examination of gene flow from the PNT to wild relatives based on literature Examination of plant pest and non-pest impacts of the PNT Examination of soil degradation Stewardship plans

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:

Syngenta Seeds Canada Inc.
15910 Medway Road, RR1
Arva, ON N0M 1C0
519-461-2003

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.