A genetically modified (GM) cotton line, GHB119, has been developed which is protected against feeding damage by Lepidopteran insects, particularly cotton bollworm (Helicoverpa spp.), a major cotton pest in Australia, and tolerant to herbicides containing glufosinate ammonium.
Protection against feeding damage by Lepidopteran insects is achieved through expression in the plant of an insecticidal crystal protein, Cry2Ae, encoded by a modified cry2Ae gene derived from the soil bacterium Bacillus thuringiensis. Tolerance to glufosinate ammonium is achieved through expression of phosphinothricin acetyltransferase (PAT) encoded by the bar gene derived from another soil bacterium Streptomyces hygroscopicus. Both of these genes have been widely used for genetic modification of a number of crop species.
The main food products derived from cotton line GHB119 would be oil and linters.
Date of authorization:
Scope of authorization:
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.):
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
+61 2 6271 2266
+61 2 6271 2278
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.
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)