Notice of Submission for Approval of Novel Food, Livestock Feed and Unconfined Environmental Release for Apple Genetically Engineered To Be Nonbrowning (GD743 and GS784) from Okanagan Specialty Fruits Inc.

April 15, 2012
Comment period closed: 2012-07-03

Background

The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) have received a submission from Okanagan Specialty Fruits Inc., seeking approval for unconfined environmental release for commercial planting purposes, livestock feed and food use for apple (Malus x domestica) events GD743 and GS784, which have been genetically engineered to be non-browning. The submission received is in accordance with CFIA guidelines for assessment of plants with novel traits (PNTs) for unconfined release, CFIA guidelines for assessment of novel feeds from plant sources, and HC guidelines for assessment of novel foods. To view information related to the environmental assessment of a PNT or a novel feed, please refer to the CFIA Web site. To view the information related to the health and safety assessment of a novel food, please refer to the HC Web site.

Summary of the Submission

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	The Biology document "The Biology of Cultivated Apple" is being prepared by the Plant Biotechnology and Risk Assessment Unit of the CFIA.
Description of the Modification	The PNT was developed through recombinant DNA technology. In order to assess the novel trait, the following was submitted: Rationale for development of non-browning apples Description of the transformation system Biology of polyphenol oxidase (PPO) Components of the transformation 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: Mendelian inheritance of the insert Clonal stability of the insert
Description of the Novel Trait	In order to characterize the trait, the following has been submitted: Characterization of the DNA insertion by PCR, Southern analysis and reverse primer PCR Quantification of polyphenol oxidase (PPO) suppression by enzyme assay Quantification of the effect of PPO suppression by controlled bruising experiments
Allergenicity/Toxicity Considerations	In order to assess allergenicity of the novel trait the following has been submitted: Analysis by NptII ELISA showing that NptII protein does not accumulate in mature apple fruit Rationale that no new proteins are expressed in GD743 and GS784 Comparison of the amino acid sequence of putative ORF to known allergens
Nutritional Evaluation of the Novel Plant	In order to assess the nutritional aspects of the novel plant the following has been submitted: The nutritional composition of the novel plant has been compared to an unmodified apple. The following have been considered: Proximate composition (e.g. ash, moisture, protein, fat, carbohydrates, calories and sugar profile) Dietary fibre Potassium Vitamin C Oxygen radical absorbance capacity (ORAC) Phenolics
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: Importance of apple, including production, cultivars, uses of apple, and apple nutrition Economic impact of browning and current methods for inhibition of browning Anticipated economic impact of GD743 and GS784 Gene flow and stewardship of GD743 and GS784 Agronomic and pest and disease data showing that GD743 and GS784 are equivalent to their untransformed parent cultivars

Comments will be received only via the Internet or by postal mail to CFIA or Health Canada. (See addresses below.)

For more information on this product, please contact:

Okanagan Specialty Fruits Inc.
PO Box 1533
Summerland, BC
250-404-0101

For more information on the regulatory system, please contact:

Animal Feed Division
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
1-800-442-2342
cfia.afp-paa.acia@inspection.gc.ca

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario
K1A 0L2
novelfoods-alimentsnouveaux@hc-sc.gc.ca

Plant Biosafety Office
Plant Health & Biosecurity Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
1-800-442-2342
pbo@inspection.gc.ca

The CFIA and HC, 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 HC of the Plant with Novel Trait(s) subject of the Notice of Submission and the CFIA and HC reserve all their rights under all the pertinent legislation that may be applicable. The CFIA and HC 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 HC 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 CFIA PPU 125. Information, including personal information, may be accessible or protected as required under the provisions of the Access to Information Act.