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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

Background

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:

Inheritance and stability of the introduced trait

In order to assess the inheritance and stability of the genetic modification the following has been submitted:

Description of the novel trait

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

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:

Nutritional evaluation of the novel plant

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

Allergenicity considerations

In order to assess allergenicity of the expressed genetic components the following has been submitted:

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:

Public communications

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
Ottawa, Ontario
K1A 0Y9
Email: cfia.infobiotech-infobiotech.acia@canada.ca

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
Ottawa ON
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 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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