Notice of submission from Monsanto Canada ULC for novel food, livestock feed and environmental safety approval for commercial planting purposes of a plant genetically modified for herbicide tolerance

January 25, 2019

Background

CFIA and Health Canada have received a submission from Monsanto Canada ULC seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a maize line designated as MON 87429, 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 BIO1994-11: The Biology of Zea mays (L.) (Maize).

Description of the modification

Corn line MON 87429 was developed through the use of 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 – dmo, pat, ft_t, 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, ft_t, and cp4 epsps genes (donor organisms)
• Level of expression of dicamba mono-oxygenase (DMO) protein, phosphinothricin N-acetyltransferase (PAT), a-ketoglutarate dependent dioxygenase (FT_T), and CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein in forage and grain
• 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,, ft_t, and cp4 epsps 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 novel traits

In order 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 cassettes
• 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, FT_T, and CP4 EPSPS proteins in maize tissues

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:

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

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

Allergenicity/toxicity considerations

In order 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, FT_T, and CP4 EPSPS proteins to known protein allergens or toxins through bioinformatics analysis

Evaluation of the environmental impact of novel plant

In order to assess the environmental impact of the novel plant the following has been submitted:

• Examination for potential weediness
• Examination of seed yield
• 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 ULC
180 Kent Street, Suite 810
Ottawa ON
613-234-5121

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 CFIA on its website does not in any way whatsoever constitute acceptance, approval or certification by CFIA or Health Canada of the Plant with Novel Trait(s) subject of the Notice of Submission and CFIA and Health Canada reserve all their rights under all the pertinent legislation that may be applicable. 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 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 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.