Notice of submission from Monsanto Canada ULC (now Bayer CropScience Inc.) for novel food, livestock feed and environmental safety approval for commercial planting purposes of a plant genetically modified for herbicide tolerance
December 15, 2020
The Canadian Food Inspection Agency (CFIA) and Health Canada have received a submission from Monsanto Canada ULC (now Bayer CropScience Inc.) seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a canola line designated as MON 94100, which has been genetically modified to exhibit herbicide tolerance. The submission received is in accordance with CFIA guidelines for assessment of plants with novel traits for unconfined release, CFIA guidelines for assessment of novel feeds from plants with novel traits, and Health Canada guidelines for assessment of novel foods.
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 BIO 2017-03: The Biology of Brassica napus L. (Canola/Rapeseed).
Description of the modification
Canola line MON 94100 was developed through the use of recombinant DNA technology. In order to assess the modification process, the following has been submitted:
- Characterization 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 – dmo
- Description of the promoters and terminators
- Portion and size of the inserted sequence
- Location, order and orientation in the vector
- Function of the genetic sequences in the plant
- Source of the dmo gene (donor organism)
- Level of expression of dicamba mono-oxygenase (DMO) protein in forage and grain
- Review of the absence of toxicity and pathogenic ability of the genetic components to plants and other organisms
- Review of the absence of toxicity and pathogenic ability of the donor organisms to plants and other organisms
- History of use of the dmo gene
- 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 trait
In order to characterize the DNA inserted in the plant, the following has been submitted:
- Information for all coding areas
- Information on plant promoters
- DNA analysis for introns, terminators and enhancers of plant expressible cassette
- 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
- Characterization of DMO protein in canola tissues
Absence of toxicity of the novel gene products
In order to assess the toxicity of the expressed genetic components on non-target species, humans, and animals, the following have been either submitted, or previously submitted, reviewed, or published:
- Analysis of the amino acid sequence similarity of the DMO protein to known protein toxins through bioinformatics analysis
- Heat stability of the DMO protein
- Digestibility of the DMO protein
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 canola. The following have been considered:
- Proximate composition (protein, fat, ash, carbohydrates)
- Composition of amino acids and minerals
- Micro-nutritional elements (vitamins)
- Anti-nutrients (glucosinates, phytic acid, sinapine, tannins)
In order to assess allergenicity of the expressed genetic components the following has been submitted:
- Analysis of the amino acid sequence similarity of the DMO protein to known protein allergens through bioinformatics analysis
Evaluation of the environmental impact of the novel plant
In order to assess the environmental impact of the novel plant the following have been previously submitted, reviewed, and published:
- Examination for potential weediness
- Examination of seed yield
- Examination of phenotypic characteristics
- Examination of seed dormancy and germination
- Examination of the response to biotic and abiotic stressors
- Examination of plant pest potential
The CFIA and Health Canada are seeking feedback or comments on the Notice of submission for MON 94100. If you have a scientific question or any information that would be of value to CFIA and Health Canada evaluators in the assessment of MON 94100, we encourage you to participate. Non-scientific input will also be evaluated and appropriate ways of addressing it will be explored.
Comments will not be responded to directly, unless CFIA requires more information. However, scientific questions or information you share will be forwarded to CFIA and Health Canada evaluators for consideration in the assessment. Non-scientific input will be evaluated and appropriate ways of addressing it will also be explored.
Additionally, subject to your consent, the CFIA will forward your comments to developers whose products are being assessed and may post them on the CFIA and Health Canada web sites. Developers will not be given your name or email, nor will any personal information be posted on the CFIA or Health Canada web site.
By way of submission, you acknowledge that Government of Canada officials and the developer may use your feedback in the assessment of MON 94100.
We invite you to send us your comments by email or mail before February 15, 2021.
Please send your comments to:
Canadian Food Inspection Agency
Plant Biosafety Office
59 Camelot Drive
You may also send your comments to the Canadian Food Inspection Agency via postal mail or email:
For more information on this product, please contact:
Bayer CropScience Inc.
180 Kent Street, Suite 810
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 Access to Information Act.
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