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Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety Approval for Commercial Planting Purposes of a Plant Genetically Modified For Insect Resistance from Monsanto Canada Inc.

Comment period closed: January 28, 2014

Background:

The CFIA and Health Canada have received a submission from Monsanto Canada Inc. seeking environmental safety approval for import purposes and livestock feed and food use of a soy line designated as MON 87751, which has been genetically modified for insect resistance. The submission received is in accordance with CFIA guidelines for assessment of plants with novel traits (PNTs) for unconfined release, CFIA guidelines for assessment of novel feeds from PNTs, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a plant with novel trait (PNT) or a novel feed derived from PNTs, please refer to the CFIA Web site. To view the information related to the health and safety assessment of a novel food, please refer to the Health Canada Web site.

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 CFIA's Regulatory Directive BIO 1996-10: The Biology of Glycine max (L.) Merr. (Soybean).

Description of the Modification

The PNT was developed through 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 Traits

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

Toxicity of the Novel Gene Products

The toxicity of the cry gene expression products on non-target species, humans and animals. The following have been previously submitted, reviewed,  and  published:

Nutritional Evaluation of the Novel Plant

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

Allergenicity/Toxicity Considerations

In order to assess allergenicity and toxicity of the novel proteins 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 has been submitted:

For each protein, non-target studies have been conducted on:

Insect studies are typically conducted on both larvae and adults

For more information on this product, please contact:

Monsanto Canada 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 their 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 required to provide a Notice of Submission. 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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