Notice of submission from Bayer CropScience Inc. and KWS SAAT SE & Co. KGaA 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. and KWS SAAT SE & Co. KGaA seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a sugar beet line designated as KWS20-1, 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 further information from the developer.

Description of the host plant

Please refer to Biology Document BIO2023-01: The Biology of Beta vulgaris L. (Sugar Beet).

Description of the modification

Sugar beet line KWS20-1 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 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, pat and cp4 epsps
• 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, pat, and cp4 epsps genes (donor organisms)
• Level of expression of dicamba mono-oxygenase (DMO), phosphinothricin N-acetyltransferase (PAT) and 5‑enolpyruvylshikimate‑3‑phosphate synthase (CP4 EPSPS) in roots and tops
• 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 and cp4 epsps genes
• Detailed map of the vector

Inheritance and stability of the introduced trait

To assess the stability of the genetic modification the following has been submitted:

• Analysis of stability over multiple generations

To assess the inheritance of the genetic modification the following has been submitted:

• Analysis of segregation from one generation

Description of the novel traits

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, PAT and CP4 EPSPS proteins in sugar beet tissues

Absence of toxicity of the novel gene products

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

• Bioinformatics evaluation of the DMO, PAT and CP4 EPSPS proteins
• Heat stability of the DMO, PAT and CP4 EPSPS proteins
• Digestibility of the DMO, PAT and CP4 EPSPS proteins

Nutritional evaluation of the novel plant

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 soybean. The following have been considered:
  • Proximate composition (protein, fat, ash, carbohydrates)
  • Composition of amino acids and minerals
  • Crude fiber, pectin and root sucrose
  • Secondary metabolites

Allergenicity/toxicity considerations

To assess allergenicity and toxicity of the expressed genetic components the following has been submitted:

• Analysis of the amino acid sequence similarity of the DMO, PAT and CP4 EPSPS proteins to known protein allergens or toxins through bioinformatics analysis.

Evaluation of the environmental impact of the novel plant

To assess the environmental impact of the novel plant information addressing the following has been submitted:

• Potential of the PNT to become a weed of agriculture or be invasive of natural habitats
• Potential for gene flow to sexually compatible plants whose hybrid offspring may become more weedy or more invasive
• Potential of the PNT to become a plant pest
• Potential impact of the PNT or its gene products on non-target species, including humans
• Potential impact on biodiversity
• Herbicide tolerance management plan

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 KWS20-1. If you have a scientific question or any information that would be of value to CFIA and Health Canada evaluators in the assessment of KWS20-1, 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 KWS20-1.

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

Email: cfia.infobiotech-infobiotech.acia@inspection.gc.ca