Notice of Submission for Approval of Novel Food and Livestock Feed Use for Cotton Genetically Modified for Insect Protection (MON 88702) from Monsanto Canada Inc.

Comment period closed: April 14, 2018

Background

The CFIA and Health Canada received a submission from Monsanto Canada Inc. seeking an approval for livestock feed and food use of a cotton line designated as MON 88702. MON 88702 offers cotton growers an additional choice for insect pest management, by providing crop protection against targeted hemipteran and thysanopteran insects including two species of tarnished plant bugs (Lygus hesperus, and Lygus lineolaris), cotton fleahopper (Pseudatomoscelis seriatus), and thrips (Frankliniella spp.) The submission received is in accordance with CFIA guidelines for assessment of 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, please refer to the CFIA Consensus Document on the Biology of Cotton (Gossypium spp.). To view the information related to the health and safety assessment of a novel foods, please refer to the Health Canada website.

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 Organization for Economic Co-operation and Development's Consensus Document on the Biology of Cotton (Gossypium spp.), published. 05-Dec-08. Cotton is not cultivated in Canada.

Description of the Modification

Cotton line MON 88702 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 gene – mCry51Aa2
• 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 mCry51Aa2 gene (donor organism)
• Level of expression of the mCry51Aa2 protein in leaf (two growth stages), root, pollen, and seed 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 use of the mCry51Aa2 gene and related 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 mCry51Aa2 coding region 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 mCry51Aa2 protein in cotton

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 cotton. The following has been considered:
  • Proximate composition (protein, total fat, ash, moisture)
  • Composition of amino acids, fatty acids, carbohydrates, and minerals
  • Acid detergent fiber and neutral detergent fiber and total dietary fiber
  • Micro-nutritional elements (vitamins, etc.)

Allergenicity/Toxicity Considerations

In order to assess allergenicity and toxicity of the novel protein, the following has been submitted:

• Acute toxicity study
• Digestibility of the mCry51Aa2 protein
• Heat stability of the mCry51Aa2 protein
• Analysis of the amino acid sequence similarity of the mCry51Aa2 protein to known protein allergens or toxins through bioinformatics analysis

Evaluation of Environmental Impact

In order to assess the environmental impact of MON 88702, the following has been submitted:

• 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

For more information on this product, please contact:

Monsanto Canada 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 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.