Notice of Submission for Approval of Novel Food and Livestock Feed Use and Unconfined Environmental Release in Canada of a Plant Genetically Modified for Reduced Lignin from Monsanto Canada Inc. and Forage Genetics International LLC

Comment period closed: 2013-07-18

Background:

The Canadian Food Inspection Agency (CFIA) and Health Canada have received a submission from Monsanto Canada Inc. and Forage Genetics International LLC seeking approval for unconfined environmental release and livestock feed and food uses of an alfalfa line designated as KK179, which has been genetically modified for reduced lignin. 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 PNTs, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a plant with novel trait (PNT) or the assessment of a novel feed derived from PNTs, please refer to the CFIA website. To view the information related to the health and safety assessment of a novel food, please refer to the Health Canada website.

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 Biology Document Bio2005-02: The Biology of Medicago sativa L. (Alfalfa)

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
• Description of the genetic material delivered to the plant
• Components of the vector
• Summary of all genetic components
• Description of the inserted gene – Caffeoyl CoA 3-O-methyltransferase (CCOMT)
• 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
• Source of the CCOMT gene
• Review of the toxicity and pathogenic ability of the genetic components to plants and other organisms
• Review of the toxicity and pathogenic ability of the donor organisms to plants and other organisms
• History of use of RNA
• 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:

• Information for all coding areas
• Information on promoters: Southern analysis of the CCOMT coding regions and promoters
• DNA analysis for introns, terminators and enhancers of plant expressible cassettes.
• Information on non-coding regions that have no known plant function and are not associated with expression of coding regions: DNA analysis for known function

Allergenicity/Toxicity Considerations

In order to assess allergenicity and toxicity, the following has been submitted:

• Bioinformatics Evaluation of the insertion site and flanking sequences.

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 alfalfa. The following have been considered:
  • Proximate composition (protein, fat, ash, carbohydrates)
  • Composition of lignin, amino acids and minerals
  • Acid detergent fiber and neutral detergent fiber composition
  • Anti-nutrient analysis

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
• Examination of reproductive features of the PNT
• Examination of phenotypic characteristics 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's potential to become a plant pest

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:

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 their 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 required to provide a Notice of Submission. 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.