August 19, 2024
Background
The Canadian Food Inspection Agency (CFIA) and Health Canada have received a submission from Syngenta Canada Inc. seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a maize line designated as MZIR260 which has been genetically modified to exhibit protection from targeted lepidopteran pests. 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 BIO2020-01: The Biology of Zea mays (L.) (Maize).
Description of the modification
Event MZIR260 corn was developed using techniques of modern molecular biology. To assess the modification process, the following has been submitted:
- Transformation method description and process
- Description of genetic elements used in the modification
- Description of the inserted gene, eCry1Gb.1Ig-03, and the selectable marker gene, pmi-15
- Description of transformation, selection and breeding methods
Inheritance and stability of the introduced trait
To assess the inheritance and stability of the genetic modification the following has been submitted:
- Mendelian inheritance of the novel traits
- Analysis of the stability of the novel traits over multiple generations
Description of the novel traits
To characterize the novel proteins produced in the plant, the following has been submitted herein or previously:
- Mode of action of the eCry1Gb.1Ig and pmi proteins
- Equivalence of the eCry1Gb.1Ig and pmi proteins derived from Event MZIR260 corn to microbially-produced versions
- Protein expression levels of PMI and eCry1Gb.1Ig in leaf, root, whole plant, pollen, forage, and kernels of Event MZIR260 corn
Absence of toxicity of the novel protein
To support the absence of toxicity of the expressed genetic components on non-target species, humans and animals, the following have been submitted herein or previously:
- Temperature effects on bioactivity of eCry1Gb.1Ig and pmi proteins
- Acute oral toxicity study of eCry1Gb.1Ig and pmi
- Homology assessment between eCry1Gb.1Ig and pmi and known or putative toxins
Allergenicity considerations
To assess allergenicity of the expressed genetic components the following have been submitted:
- Homology assessment of eCry1Gb.1Ig and pmi with known or putative allergens
- Digestibility of eCry1Gb.1Ig and pmi in simulated gastric fluid
Nutritional evaluation of the novel plant
To assess nutritional aspects the nutritional composition Event MZIR260 corn has been compared to non- transgenic lines and the following studies/information have been submitted:
- Estimate of dietary exposure to eCry1Gb.1Ig from Event MZIR260 corn
- Forage comparisons for:
- Proximates
- Fiber
- Minerals
- Grain comparisons for:
- Proximates
- Fiber
- Starch
- Minerals
- Vitamins
- Amino acids
- Fatty acids
- Secondary metabolites
- Antinutrients
- Forage comparisons for:
Evaluation of the environmental impact of the novel plant
To assess the environmental impact of the novel plant the following has been submitted:
- Germination and dormancy evaluations
- Evaluation of agronomic characteristics
- Degradation study for eCry1Gb.1Ig in soil
- Weediness potential of Event MZIR260 corn
- Evaluation on eCry1Gb.1Ig protein on non-target organisms:
- Wild bird
- Wild mammal
- Pollinators
- Arthropods
- Invertebrates
- Farmed fish
- Monarchs
For more information on this product, please contact:
Syngenta Canada Inc.
140 Research Lane, Research Park Guelph ON
N1G 4Z3
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 MZIR260. If you have a scientific question or any information that would be of value to CFIA and Health Canada evaluators in the assessment of MZIR260, 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 MZIR260.
We invite you to send us your comments by email or mail before October 18, 2024.
Please send your comments to:
Canadian Food Inspection Agency
Plant Biosafety Office
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9