Notice of submission from Pioneer Hi-Bred Canada for novel food, livestock feed and environmental safety approval for commercial planting purposes of a plant genetically modified for herbicide tolerance and insect resistance

Background

The Canadian Food Inspection Agency (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 DP51291, which has been genetically modified to exhibit herbicide tolerance and 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

Corn line DP51291 was developed through the use of recombinant DNA technology. 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 genes, IPD072Aa, PAT and PMI
• Description of transformation, selection and breeding method

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:

• Mode of action of the IPD072Aa, PAT and PMI proteins
• Equivalence of the IPD072Aa, PAT and PMI proteins derived from DP51291 maize
• Levels of expression of IPD072Aa, PAT and PMI proteins in leaf, root, pollen, forage, and grain in DP51291 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 IPD072Aa, PAT and PMI proteins
• Heat lability of the IPD072Aa, PAT and PMI proteins
• Digestibility of the IPD072Aa, PAT and PMI proteins protein in simulated gastric fluid
• Acute oral toxicity evaluation of the IPD072Aa, PAT and PMI proteins

Nutritional evaluation of the novel plant

To assess nutritional aspects the nutritional composition of the novel plant has been compared to unmodified maize. The following have been considered:

• Estimate of dietary exposure to IPD072Aa, PAT and PMI proteins in grain from DP51291 maize
• Generation of tissue samples for nutrient composition analysis
• Determination of nutrient composition analyte concentrations
• Proximates, fiber, and minerals in DP51291 maize forage
• Proximates, fiber in DP51291 maize grain
• Fatty acids, minerals, vitamins, secondary metabolites and anti-nutrients in maize grain

Allergenicity considerations

To assess allergenicity of the expressed genetic components, the following have been submitted or previously submitted, reviewed, or published:

• in silico allergenicity evaluation of IPD072Aa, PAT and PMI in DP51291 maize

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 viability evaluation
• Evaluation of agronomic characteristics
• Field insect, disease, and abiotic stressor observations
• Weediness potential of DP51291 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

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 DP51291. If you have a scientific question or any information that would be of value to CFIA and Health Canada evaluators in the assessment of DP51291, 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 DP51291.

We invite you to send us your comments by email or mail before August 13, 2023.

Canadian Food Inspection Agency
Plant Biosafety Office
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9

Email: cfia.infobiotech-infobiotech.acia@inspection.gc.ca