Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety for Commercial Planting Purposes of a Plant Genetically Modified Male Sterility and Herbicide Tolerance (MS 11) from Bayer Crop Science Inc.

Comment period closed: May 14, 2017

Background

The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) have received a submission from Bayer CropScience Inc. seeking an approval for unconfined environmental release (including for import purposes) and livestock feed and food use of Brassica napus (canola) designated as Event MS11, which has been genetically engineered for tolerance to glufosinate-ammonium herbicide and male sterility. 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 plant with novel trait or a novel feed derived from a plant source, please refer to the CFIA Web site. To view the information related to the assessment of a novel food, please refer 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

• The Biology of Brassica napus L. (Canola/Rapeseed) Biology Document BIO1994-09
• A Companion document to Directive 94-08 (Dir94-08) Assessment Criterial for Determining Environmental Safety of Plants with Novel Traits

Description of the Modification

The PNT was developed through recombinant DNA technology. In order to assess the modification process the following has been submitted:

• Transformation method
• Description of vector, detailed vector map, gene constructs
• Nature and source of the carrier DNA
• Description of the genetic material delivered to the plant
• Summary of all genetic compounds
• Description of the herbicide tolerance gene – bar gene; male sterility gene – barnase gene; restoration of fertility gene – barstar gene.
• Description of the promoters and terminators
• Portion and size of the inserted sequences
• Location, order and orientation in the vectors
• Source of the modified bar gene (donor organism – Streptomyces hygroscopicus); barnase and barstar genes (donor organism – Bacillus amyloliquefaciens)

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 of insert over multiple generations and in different genetic backgrounds
• Explanation of hybrid technology using the Male Sterile (MS) plant and the fertility restorer plant (RF) plant
• Mendelian segregation of the novel plant

Description of the Novel Traits

In order to characterize the DNA inserted in the plant, the following has been submitted:

• Function of the modified herbicide tolerance gene in the plant
• Information for all coding areas
• Information on plant promoters: Southern analysis of the modified barnase, barstar, and bar coding regions and their promoters
• DNA analysis for introns, terminators and enhancers of plant expressible cassettes
• Characterization of expressed modified Barnase, Barstar and modified Pat/bar proteins in canola plant tissue

Toxicity/Allergenicity of the Novel Gene Products

In order to assess toxicity and allergenicity of the novel gene products on nontarget species, humans and animals the following has been submitted:

• Comparison of the complete amino acid sequences of the modified Barnase, Barstar and Pat/bar proteins to known allergens and toxins
• Digestive fate in vitro studies
• Acute oral toxicity test of modified Barnase, Barstar and Pat/bar proteins with mice

Nutritional Evaluation of the Modified Plant

In order to assess nutritional aspects of the modified plant the following has been submitted:

• The nutritional composition of the novel plant (MS11) and MS11xRF3 have been compared to unmodified canola. The following have been considered:
  • Dietary exposure
  • Proximate composition (crude protein, crude fat, moisture, carbohydrates, ash and fibre)
  • Composition of amino acids, fatty acids, minerals, and vitamins
  • Anti-nutrients for canola (glucosinolates, phytic acid, sinapine, tannins)
  • A broiler chicken feeding study was submitted

More information about the approval of RF3 is available in the following decision document: DD1996-17: Determination of Environmental Safety of Plant Genetic Systems Inc.'s (PGS) Novel Hybridization System for Rapeseed (Brassica napus L.).

Evaluation of the Environmental Impact of the Modified Plant

In order to assess the environmental impact of the novel plant, the following were assessed:

• Agronomic performance to demonstrate substantial equivalence to other canola, with exception to herbicide tolerance. (Yield, plant phenotype, reproductive features, seed dormancy and germination, disease and pest characteristics)
• Potential to become a weed
• Gene flow from PNT to sexually compatible relatives
• Potential impact on non-target organisms
• Herbicide tolerance management plan

Additional Information

For more information on this product, please contact:

Bayer CropScience Inc.
#200, 160 Quarry Park Blvd., S.E.
Calgary, Alberta
T2C 3G3
403-723-7400
www.bayercropscience.ca

For more information on the regulatory system, please contact:

Feed Section
Animal Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, 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
Ottawa, 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.