ARCHIVED - Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety for Commercial Planting Purposes of a Plant Genetically Modified for Insect Resistant and Herbicide Tolerant Traits (MZIR098) from Syngenta Canada Inc.
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Comment period closed: January 23, 2016
The CFIA and Health Canada (HC) have received a submission from Syngenta Canada Inc. seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a corn line designated as MZIR098, which has been genetically modified for insect resistance and 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 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 from plant sources, 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.
Description of the host plant
Please refer the Canadian Food Inspection Agency's Biology Document BIO1994–11: The Biology of Zea mays (L.) (Maize)
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 inserted genes mCry3A, eCry3.1Ab and pat;
- Description of the promoters and terminators;
- Portion and size of the inserted sequence;
- Location, order and orientation in the vector;
- Function of the inserted gene in the plant;
- 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 the plant, the following has been submitted:
- Source of the genes (donor organism);
- Level of expression in forage and grain;
- Review of the absence of toxicity and pathogenic ability of the genetic components to plants and other organisms;
- Characterization of expressed genetic components in the corn tissue;
- History of use;
- Information on the coding regions;
- Information on plant promoters: Southern analysis of the genetic sequences and promoters;
- DNA analysis for introns, terminators and enhancers of plant expressible cassettes;
- Information on noncoding regions that have no known plant function and are not associated with expression of coding regions: DNA analysis for known function.
Nutritional Evaluation of the Novel Plant
In order to demonstrate the nutritional aspects of the novel plant are the same, 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 and minerals;
- Acid detergent fiber and neutral detergent fiber;
- Micro–nutritional elements (vitamins, etc.).
Absence of Allergenicity/Toxicity
In order to assess the absence of allergenicity and toxicity of the expressed genetic components, the following has been submitted or previously submitted, reviewed and published:
- Amino acid sequence comparison to known toxins;
- Assessment of allergenicity potential including bioinformatics evaluation and digestibility;
- Safety of donor organisms;
- History of use of these proteins and references to existing information on the safety:
- Decision Document DD2013–96: Determination of the Safety of Syngenta Canada Inc.'s Corn (Zea mays L.) Event 5307
- Decision Document DD2007–68: Determination of the Safety of Syngenta Seeds Inc.'s Corn (Zea mays L.) Event MIR604
- Decision Document DD1996–12: Determination of Environmental Safety of Northrup King Seeds' European Corn Borer (ECB) Resistant Corn (Zea mays L.)
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 or previously submitted:
- Agronomic analysis of the PNT;
- Examination of phenotypic characteristics of the PNT;
- Examination of seed dormancy and germination of the PNT;
- Examination for potential weediness of the PNT;
- Examination of seed yield of the PNT;
- Examination of pollen morphology and viability;
- Examination of the PNT's potential to become a plant pest;
- Examination of potential impact of the PNT on non–target organisms;
- Examination of plant pest and non–pest impacts of the PNT.
Comments will be received only via the Internet to CFIA or Health Canada.
For more information on this product, please contact:
Syngenta Canada Inc.
140 Research Lane
Guelph ON N1G 4Z3
1-87-SYNGENTA / 1-877-964-3682
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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