Notice of submission from Pioneer Hi-Bred Canada Company for novel food, livestock feed and environmental safety approval for commercial planting purposes of a plant genetically modified for herbicide tolerance and enhanced grain yield potential
June 6, 2019
The CFIA and Health Canada have received a submission from Pioneer Hi-Bred Canada Company seeking an environmental safety approval for commercial planting purposes and livestock feed and food use of a maize line designated as DP202216, which has been genetically modified to exhibit herbicide tolerance and enhanced grain yield potential. The DP202216 maize was genetically modified to increase and extend expression of the zmm28 gene relative to the native zmm28 gene expression. Both the introduced and native zmm28 genes encode the ZMM28 protein, a MADS-box transcription factor. The increased and extended expression of the ZMM28 protein results in enhanced grain yield potential. The DP202216 maize also contains the PAT (phosphinothricin acetyltransferase) protein, which confers tolerance to the herbicidal active ingredient glufosinate ammonium at current labeled rates. The PAT protein present in DP202216 maize is identical to the corresponding protein found in a number of approved events across several different crops that are currently in commercial use.
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 1994-11: The Biology of Zea mays (L.) (Maize).
Description of the modification
Corn line DP202216 was developed through the use of recombinant DNA technology. In order to assess the modification process, the following has been submitted:
- Rationale for development
- DP202216 maize yield efficacy
- Description of transformation, selection and breeding method
- Description of genetic elements used in the modification
- Safety of donor organisms
Inheritance and stability of the introduced trait
In order to assess the inheritance and stability of the genetic modification the following has been submitted:
- Mendelian inheritance of the T-DNA Insert
Description of the novel traits
In order to characterize the novel proteins produced in the plant, the following has been submitted:
- Equivalence of the introduced ZMM28 protein in DP202216 maize to the ZMM28 protein in conventional maize
- Mode of action of the ZMM28 protein
- Safety of the ZMM28 protein in DP202216 maize
- Equivalence of the PAT protein derived from DP202216 maize
- Mode of action of the PAT protein
- Expression of ZMM28 and PAT proteins in DP202216 maize
Absence of toxicity of the novel gene products
To support the absence of toxicity of the expressed genetic components on non-target species, humans and animals, the following have been submitted or previously submitted, reviewed, or published:
- in silico toxicity evaluation of the PAT protein
- Heat lability of the PAT protein
- Digestibility of the PAT protein in simulated gastric fluid
- Acute oral toxicity evaluation of the PAT protein
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:
- Estimate of dietary exposure to ZMM28 and PAT proteins in grain from DP202216 corn
- Generation of tissue samples for nutrient composition analysis
- Determination of nutrient composition analyte concentrations
- Proximates, fiber, and minerals in DP202216 maize forage
- Proximates, fiber in DP202216 maize grain
- Fatty acids, minerals, vitamins, secondary metabolites and anti-nutrients in maize grain
In order to assess allergenicity of the expressed genetic components the following has been submitted:
- in silico allergenicity evaluation of PAT protein in DP202216 maize
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:
- Germination and viability evaluation
- Evaluation of agronomic characteristics
- Field insect, disease, and abiotic stressor observations
- Weediness potential of DP202216 maize
- Agronomic performance and field observations conclusion
For more information on this product, please contact:
Pioneer Hi-Bred Canada Company
7398 Queen's Line,
Chatham, ON, N7M 5L1
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. 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.
Provision of the information requested on this form is voluntary. The personal information you include in an inquiry may be used to prepare a reply. The personal information is collected pursuant to the Canadian Food Inspection Agency Act. Such information may be used for statistical, evaluation and reporting purposes. The information may be shared with programs and activities of the Canadian Food Inspection Agency should your inquiry pertain to a specific program or activity of the agency.
The transmission of this information is not secure so sensitive personal information, such as your Social Insurance Number, should not be included in your message.
If after reading this statement, you prefer not to submit your inquiry via the Internet, you may send your comments to Canadian Food Inspection Agency via postal mail or email:
Canadian Food Inspection Agency
Plant Biosafety Office
59 Camelot Drive,
Report a problem or mistake on this page
- Date modified: