Notice of submission from Bayer CropScience Inc. for novel food, livestock feed and environmental safety approval for commercial planting purposes of a plant genetically modified for herbicide tolerance

Background

The Canadian Food Inspection Agency (CFIA) and Health Canada have received a submission from Bayer CropScience Inc. seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a soybean line designated as MON 94313, 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 and novel animal feeds, as well as 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 additional information from the developer.

Description of the host plant

Please refer to Biology Document BIO2021-01: The Biology of Glycine max (L.) Merr. (Soybean).

Description of the modification

Soybean line MON 94313 was developed through the use of recombinant DNA technology. 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 vector DNA
• Components of the vector
• Summary of all genetic components
• Description of the promoters and terminators
• Location, order and orientation in the vector
• Function of the genetic sequences in the plant
• Source of the dmo, pat, ft_t.1 and TDO genes (donor organisms)
• Detailed map of the vector

Inheritance and stability of the introduced trait

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

To characterize the DNA inserted in the plant, the following has been submitted:

• Description of the genetic material delivered to the plant
• Portion and size of the inserted sequences
• Description of the inserted genes – dmo, pat, ft_t.1 and TDO
• Information for all coding areas
• Information about 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
• Level of expression of dicamba mono-oxygenase (DMO), phosphinothricin N-acetyltransferase (PAT), fops and 2,4-D dioxygenase (FT_T.1) and triketone dioxygenase (TDO) proteins in forage and seeds
• Characterization of DMO, PAT, FT_T.1 and TDO proteins in soybean tissues

Absence of toxicity and allergenicity of the novel gene products

To address the absence of toxicity and allergenicity of the expressed genetic components on non-target species, including humans and animals, the following have been either submitted or previously submitted, reviewed, and published:

• 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, pat, ft_t.1 and TDO genes
• Analysis of the amino acid sequence similarity of the DMO, PAT, FT_T.1 and TDO proteins to known protein allergens or toxins through bioinformatics analysis
• Bioinformatics evaluation of the DMO, PAT, FT_T.1 and TDO proteins
• Heat stability of the DMO, PAT, FT_T.1 and TDO proteins
• Digestibility of the DMO, PAT, FT_T.1 and TDO proteins

Nutritional evaluation of the novel plant

To assess nutritional aspects of the novel plant, the nutritional composition of the novel soybean has been compared to unmodified soybean. The following have been considered:

• Proximate composition (protein, fat, ash, carbohydrates)
• Composition of amino acids and fatty acids
• Micro-nutritional elements (vitamins and minerals)
• Anti-nutrients and isoflavones (phytic acid, raffinose, soybean lectin, stachyose, trypsin inhibitor, daidzein and genistein)

Evaluation of the environmental impact of the novel plant

To assess the environmental impact of the novel soybean the following has been submitted or previously submitted, reviewed, and published:

• Examination of potential weediness
• Examination of potential impact on non-target organisms
• Examination of plant pest potential
• Examination of phenotypic characteristics
• Examination of seed dormancy and germination
• Examination of the response to biotic and abiotic stressors

For more information on this product, please contact:
Bayer CropScience Inc.
180 Kent Street, Suite 810
Ottawa ON
bcscanra@bayer.com

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.

Public communications

The CFIA and Health Canada are seeking feedback or comments on the Notice of submission for MON 94313. 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 94313, 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 submitting your comments, you acknowledge that Government of Canada officials and the developer may use your feedback in the assessment of MON 94313.

We invite you to send us your comments by email or mail before August 13, 2023.

Canadian Food Inspection Agency
Plant Biosafety Office
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9