Food safety and quality
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OECD Unique Identifier details

Commodity: Cotton
Traits: Bromoxynil tolerance,Kanamycin resistance
Name of product applicant: Aventis CropScience Pty Ltd and the Stoneville Pedigreed Seed Company
Summary of application:
Rhone Poulenc Rural Australia Pty Ltd (now trading as Aventis CropScience Pty Ltd after its merger with AgrEvo) and the Stoneville Pedigreed Seed Company (formerly owned by Monsanto Co.) have made a joint application to ANZFA to amend Standard A18 of the Australian Food Standards Code to include food derived from cotton which has been genetically modified to be tolerant to the oxynil family of herbicides comprising bromoxynil and ioxynil. The genetically modified cotton is known commercially either as OXY cotton or BXN cotton.

The oxynil family of herbicides act by inhibiting electron transport in photosystem II in
plants. Inhibition of electron transport causes superoxide production resulting in the
destruction of cell membranes and an inhibition of chlorophyll formation, leading to plant death. Tolerance to either bromoxynil (3,5-dibromo-4- hydorxybenzonitrile) or ioxynil (3,5-di-iodo-4-hydroxybenzonitrile) is achieved through expression in the plant of a bacterial nitrilase enzyme that hydrolyses the herbicide to aninactive, non-phytotoxic compound. The nitrilase is derived from the bacterium Klebsiella
pneumoniae subspecies ozaenae which is responsible for rapidly degrading bromoxynil in soil. The nitrilase enables the bacterium to utilise bromoxynil as a sole source of nitrogen.

The oxynil herbicides are primarily used on field corn, wheat and grain crops to control a variety of grasses and broadleaf weeds. Low concentrations of bromoxynil-containing
herbicides kill conventional cotton varieties. Therefore, current weed control practices in cotton involve either prophylactic pre-plant, pre-emergence herbicide application or postdirected herbicide sprays to avoid crop injury. The rationale for engineering cotton to be bromoxynil-tolerant is to enable bromoxynil-containing herbicides to be used for the postemergence control of dicotyledonous weeds in cotton crops.
The major human food products obtained from cotton are refined oil and linters. Cottonseed oil is a premium quality oil that may be used in a variety of foods including frying oil, mayonnaise, salad dressing, shortening, margarine and packing oil. Linters are short fibresremoved from the cottonseed during processing (delinting).

After extensive processing at alkaline pH and high temperatures, the linters may be used as high fibre dietary products, and thickeners in ice cream and salad dressings. The linters consist primarily of cellulose (>99%).

The BXN cotton lines currently in commercial production, or planned for future commercial release, are derived from transformation events 10222 (current lines) and 10211 (future lines). The currently available BXN cotton lines include BXN 47 and BXN 16. The first of these, BXN 47 cotton, was commercialised in 1997. Therefore, cottonseed oil derived from BXN cotton or processed products containing cottonseed oil or linters derived from BXNcotton may have been imported into Australia and New Zealand since that time.
Date of authorization: 09/05/2002
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:
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 A379 - Bromoxynil tolerant cotton Event10211 and 10222
Authorization expiration date:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
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) (