Food safety and quality
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OECD Unique Identifier details

MON-89249-2
Commodity: Canola / Oilseed rape / Rape Seed
Traits: Glyphosate tolerance
Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
The GT200 line of canola (Brassica napus) was developed through a specific genetic modification to be resistant to the activity of glyphosate herbicides. The novel variety was developed from the Westar canola variety by insertion of two genes, one of which is a bacterial derived version of the plant enzyme endogenous 5-enolypyruvylshikimate-3-phosphate synthase (EPSPS) and the other, a bacterial enzyme involved in the degradation of glyphosate. Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of aromatic amino acids such as tyrosine. This enzyme is present in all plants, bacteria and fungi, but not in animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified canola line permits farmers to use glyphosate-containing herbicides, such as Roundupâ, for weed control in the cultivation of canola.

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Date of authorization: 12/09/1997
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment:
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
Novel Feeds Decision (Supplement)
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
Country introduction:
Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods. The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.
Useful links
Relevant documents
Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

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Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Luc Bourbonniere, Section Head Novel Foods
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Canola
Trait 1 Added Protein: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS)
Source: Agrobacterium sp. strain CP4, Ochrobactrum anthropi strain LBAA
Intended Effect: Tolerance to the herbicide glyphosate
Trait 2 Added Protein: Glyphosate oxidoreductase (GOX)
Source: Ochrobactrum anthropi strain LBAA
Intended Effect: Tolerance to the herbicide glyphosate
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Date of authorization: 05/09/2002
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date:
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:
The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency