Food safety and quality
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OECD Unique Identifier details

SEM-ØCZW3-2
Commodity: Vegetable Marrow/ Squash
Traits: Cucumber mosaic virus resistance,Watermelon mosaic virus-2 resistance,Zucchini yellow mosaic virus resistance
Canada
Name of product applicant: Monsanto (Asgrow(USA))
Summary of application:
The yellow crookneck squash (Curcurbita pepo L.), line CZW-3, was developed through a specific genetic modification to be resistant to infection by three plant viruses WMV2, ZYMV and CMV. WMV2 and ZYMV are members of the potyvirus group and CMV is the type member of the cucumovirus group. The novel variety was developed by insertion of the coat protein (CP) encoding sequences from these three single-stranded RNA viruses. The introduced viral sequences do not result in the formation of any infectious particles, nor does their expression result in any disease pathology. The genetically modified squash exhibits the trait of resistance to infection and subsequent disease caused by these viruses through a process that is related to viral cross-protection.

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Date of authorization: 16/04/1998
Scope of authorization: Food
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 (food safety):
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
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Neil.Strand@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
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.

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 guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) 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.

Feed:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Neil Strand, Section Head of Novel Foods

United States of America
Name of product applicant: Seminis Vegetable Seeds, Inc.
Summary of application:

Squash
Trait 1 Added Protein or DNA: Cucumber mosaic virus (CMV) coat protein
Source: Cucumber mosaic virus (CMV)
Intended Effect: Resistance to cucumber mosaic virus
Trait 2 Added Protein or DNA: Zucchini yellow mosaic virus (ZYMV) coat protein
Source: Zucchini yellow mosaic virus
Intended Effect: Resistance to zucchini yellow mosaic virus
Trait 3 Added Protein or DNA: Watermelon mosaic virus 2 (WMV2) coat protein
Source: Watermelon mosaic virus 2
Intended Effect: Resistance to watermelon mosaic virus 2
Event Designation: CZW3

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Date of authorization: 10/07/1997
Scope of authorization: Food
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 (food safety):
Please consult the website links below.
Upload:
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
Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus; exemption from the requirement for a tolerance
Coat protein of cucumber mosaic virus; exemption from the requirement of a tolerance
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
cristina.soerensen@mag.gov.py
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
María Cristina Soerensen Gonzalez
Website:
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 21 492948
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: