June 13, 2024
Background
The Canadian Food Inspection Agency (CFIA) and Health Canada have received a submission from Bayer CropScience Inc. seeking an environmental safety approval and livestock feed and food use of a soybean line designated as MON 94637, which has been genetically modified for insect protection. MON 94637 offers soybean growers an additional choice for insect pest management, by providing crop protection against targeted lepidopteran insect pests. The submission received is in accordance with CFIA guidelines for assessment of plants with novel traits, novel feeds, and Health Canada guidelines for assessment of novel foods. To view information related to the assessment of a feed derived from a plant with novel trait, refer to CFIA's Guidelines for the assessment of novel feeds: Plant sources. To view information related to the health and safety assessment of novel foods, refer to Health Canada's Guidelines for the safety 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 the biology document BIO 2021-01: The Biology of Glycine max (L.) Merr. (Soybean)
Description of the modification
Soybean line MON 94637 was developed through 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 – Cry1A.2 and Cry1B.2
- 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 Cry1A.2 and Cry1B.2 genes (donor organism)
- Level of expression of the Cry1A.2 and Cry1B.2 proteins in leaf, silk, pollen, forage, root and grain tissue samples
- 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 organism to plants and other organisms
- History of safe use of the Cry genes
- 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 introduced trait
In order to characterize the DNA inserted in the plant, the following has been submitted:
- Information for all coding areas
- Information on promoters, terminators and other sequences flanking the inserted DNA: Next Generation Sequencing analysis, PCR analysis, and bioinformatics analysis of the Cry1A.2 and Cry1B.2 coding regions and flanking sequences
- Information on non-coding regions that have no known plant function and are not associated with expression of coding regions: DNA and bioinformatics analysis for known function
- Characterization of expressed Cry1A.2 and Cry1B.2 proteins in corn
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 corn. The following has been considered:
- Proximate composition (protein, fat, ash, carbohydrates)
- Composition of amino acids, fatty acids, carbohydrates, and minerals
- Antinutrients and Isoflavones
- Micro-nutritional elements (vitamins, etc)
- Endogenous allergens
Allergenicity and toxicity considerations
In order to assess allergenicity and toxicity of the novel protein, the following has been submitted:
- Acute toxicity study
- Digestibility of the Cry1A.2 and Cry1B.2 proteins
- Heat stability of the Cry1A.2 and Cry1B.2 proteins
- Analysis of the amino acid sequence similarity of the Cry1A.2 and Cry1B.2 proteins to known protein allergens or toxins through bioinformatics analysis
Evaluation of environmental impact
In order to assess the environmental impact of the novel plant, the following has been submitted or previously submitted, reviewed, and published:
- Examination for potential weediness
- Examination of phenotypic characteristics
- Examination of seed dormancy and germination
- Examination of the response to biotic and abiotic stressors
- Examination of plant pest potential
- Examination of non-target impacts of the PNT
For more information on this product, please contact:
Bayer CropScience Inc.
180 Kent Street, Suite 810
Ottawa ON K1P 0B6
(613) 234-5121
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 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.
Public communications
The CFIA and Health Canada are seeking feedback or comments on the notice of submission for MON 94637. 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 94637, 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 94637.
We invite you to send us your comments by email or mail before August 7, 2024.
Please send your comments to:
Canadian Food Inspection Agency
Plant Biosafety Office
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9