Food safety and quality
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OECD Unique Identifier details

SYN-Ø53Ø7-1
Commodity: Corn / Maize
Traits: Coleoptera resistance
Australia
Name of product applicant: Syngenta Seeds Pty Ltd
Summary of application:
Insect-protected corn line 5307, a product of Syngenta Seeds Pty Ltd, is a genetically
modified (GM) corn that is protected from feeding damage caused by the larvae of a number of insect pest species. Protection is conferred by expression in the plant of a chimeric insecticidal protein derived from two naturally occurring crystal (Cry) proteins found in Bacillus thuringiensis (Bt), a common soil bacterium. The Cry proteins exert their effect by causing lysis of midgut epithelial cells, which leads to gut paralysis, cessation of feeding and eventual death of the insect larvae. The lysis of the epithelial cells is mediated by the binding of the activated Cry protein to specialised receptors on the cells of the insect midgut.
The gene introduced into corn line 5307, ecry3.1Ab, encodes a chimeric protein engineered from selected portions of the modified Cry3A (mCry3A) and Cry1Ab proteins. The chimeric eCry3.1Ab protein is insecticidally active against the larvae of Western corn rootworm (Diabrotica virgifera virgifera Le Conte), Northern corn rootworm (D. Longicornis barberi Smith and Lawrence) and Mexican corn rootworm (D. Virgifera zeae Krysan and Smith). These coleopteran species cause significant damage to corn crops grown in North American regions.
Corn line 5307 also contains the bacterial pmi gene, also known as manA, which is derived from Escherichia coli strain K-12. Expression of the PMI protein in plants allows growth on mannose as a carbon source. This was used as a selectable marker to assist with identification of transformed corn cells in the early stages of plant development.
Corn is not a major crop in Australia or New Zealand. Corn line 5307 is intended for use mainly in conventional plant breeding programs to generate agricultural products suitable for commercial cultivation in the United States and Canada, and is not intended for cultivation in Australia or New Zealand. If approved, food from this line may enter the Australian and New Zealand food supply as imported food products.
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Date of authorization: 26/04/2012
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 A1060 - Food derived from Insect-protected Corn Line 5307
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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)