Food safety and quality
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OECD Unique Identifier details

DAS-21Ø23-5xDAS-24236-5
Commodity: Cotton
Traits: Glufosinate tolerance,Lepidoptera resistance
Australia
Name of product applicant: Dow AgroSciences Australia Pty Ltd
Summary of application:
Cotton line MXB-13 has been genetically modified for protection against the cotton
bollworm (Heliothis zea), tobacco budworm (H. virescens) and pink bollworm (Pectinophora gossypiella), significant pests of cotton crops in Australia. Protection is conferred by the expression in the plant of bacterially derived protein toxins (Bt-δ-endotoxins) that are specific for these insects. Cotton line MXB-13 also contains two copies of a gene encoding resistance to the herbicide glufosinate ammonium.

Cotton line MXB-13 contains two insecticidal genes (cry1Ac and cry1F), derived from the common soil bacterium Bacillus thuringiensis (Bt). These genes express insecticidal proteins (Cry1Ac and Cry1F) that are toxic to specific lepidopteran caterpillar insects, including the major pests of cotton. The insecticidal genes were introduced separately into two cotton lines (MXB-7 and MXB-9) and these two traits were subsequently combined by crossing the two GM cotton lines using conventional breeding to produce cotton line MXB-13.

Using two B. thuringiensis derived insecticidal proteins, rather than one, in the same plant improves the spectrum of control, the seasonal efficacy and significantly reduces the chances of selecting insects resistant to the toxins. Bt formulations are widely used as biopesticides on a variety of cereal and vegetable crops grown organically or under conventional agricultural conditions.

In addition to the two cry genes, cotton line MXB-13 contains two copies of a selectable marker gene (pat) from the bacterium Streptomyces viridochromogenes, which produces an enzyme (phosphinothricin acetyltransferase, PAT) that detoxifies the herbicide glufosinate ammonium. PAT functions as a selectable marker in the initial laboratory stages of plant cell selection and thus cotton line MXB-13 is also tolerant to the herbicide glufosinate ammonium, however, this trait is not used in commercial production of cotton line MXB-13.

Cottonseed is processed into four major by-products: oil, meal, hulls and linters. Only the oil and the linters are used in food products in Australia and New Zealand. Cottonseed oil is used in a variety of food including cooking, salad and frying oils: mayonnaise, salad dressing, shortening, margarine and packaging oils. Cotton linters are used as a cellulose base in high fibre dietary products as well as viscosity enhancers in toothpaste, ice cream and salad dressing. Cottonseed meal is primarily used for stock food and is not currently sold for human consumption in Australia or New Zealand.

Cotton line MXB-13 is being developed for cultivation in Australia and the USA. Licences have been granted by the Office of the Gene Technology Regulator (OGTR) for field trials of this cotton (DIR 40/2003 and DIR 44/2003). None of the plants produced during the field trials will enter the human food chain. Cotton is not grown in New Zealand.

Food from cotton line MXB-13 may therefore enter the Australian and New Zealand food supply as imported food products or from cotton grown in Australia.
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Date of authorization: 28/04/2005
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 A518 - Food derived from Insect Protected cotton line MXB-13
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Authorization expiration date:
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.
Useful links
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)