Food safety and quality
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OECD Unique Identifier details

DD-Ø26ØØ5-3
Commodity: Soyabean / Soybeans
Traits: Increased oleic acid content
Australia
Name of product applicant: Optimum Quality Grains LLC
Summary of application:
An application was received from Optimum Quality Grains LLC (a joint venture between DuPont and Pioneer Hi-Bred International, Inc) for theapproval of food from genetically modified (GM) soybean lines G94-1, G94-19 and G168.
The soybeans have been genetically modified to contain high levels of oleic acid, a
monounsaturated fatty acid. The GM soybeans are referred to as high oleic acid soybeans.
The high oleic acid trait was generated by the transfer of a second copy of a soybean fatty acid desaturase gene (GmFad 2-1) to a high yielding commercial variety of soybean. The fatty acid desaturase is responsible for the synthesis of linoleic acid, which is the major polyunsaturated fatty acid present in soybean oil. The presence of a second copy of the fatty acid desaturase gene causes a phenomenon known as “gene silencing” which results in both copies of the fatty acid desaturase gene being “switched off”, thus preventing linoleic acid from being synthesised and leading to the accumulation of oleic acid in the developing soybean seed.
Soybean oil has poor oxidative stability due to naturally high levels of polyunsaturated fatty acids (such as linoleic acid). High oleic acid soybean oil is considered to have superior properties to that of standard soybean oil because of its reduced levels of the oxidatively unstable polyunsaturated fatty acids. This means that high oleic acid soybean oil may be used for a number of food applications, including deep fat frying, without the need for additional processing, such as chemical hydrogenation. High oleic acid soybean oil is also considered to offer improved nutritional properties compared to conventional soybean oil or partially hydrogenated soybean oil because of the increased levels of monounsaturated fatty acids.
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Date of authorization: 07/12/2000
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.): OECD BioTrack Product Database
Summary of the safety assessment:
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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: Application A387 - Food dervied from high oleic acid soybean lines G94-1, G94-19 and G168
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Authorization expiration date: 20/01/2011
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Canada
Name of product applicant: DuPont Canada Inc.
Summary of application:
DuPont Agricultural Products has developed a transgenic soybean line which produces an oil with levels of oleic acid exceeding 80%, versus 23 % found in a typical conventional soybean oil. This soybean line, called high oleic soybeans, is homozygous for a GmFad 2-1 cDNA in the sense orientation under the control of a seed-specific promoter. The inserted GmFad 2-1 cDNA is causing a co-ordinate silencing of itself and the endogenous GmFad 2-1 gene.

In developing soybeans, the second double bond is added to oleic acid in the d-12 (omega-6) position by a d-12 desaturase, encoded by the GmFad 2-1 gene. A second Fad 2 gene (GmFad 2-2) is expressed in all tissues of the soybean plant. Silencing of the GmFad 2-1 in developing soybeans suppresses the addition of a second double bond to oleic acid, resulting in greatly increased oleic acid levels in the seed only.

The result is a more heat stable soybean oil which may be used in food applications such as frying without the need for chemical hydrogenation which converts polyunsaturated fatty acids like linolenic and linoleic acids to either trans or saturated fatty acids.

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Date of authorization: 02/10/2000
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
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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.
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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:
Luc Bourbonniere, Section Head Novel Foods
United States of America
Name of product applicant: DuPont Agricultural Products
Summary of application:
Soybean
Trait 1 Added Protein: GmFad2-1 gene to suppress endogenous GmFad2-1 gene, which encodes δ-12 desaturase
Source: Glycine max
Intended Effect: High oleic acid soybean oil
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Date of authorization: 14/03/1997
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.):
Summary of the safety assessment:
Please consult the FDA 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
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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.
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