18 December 2002
INITIAL ASSESSMENT REPORT
DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: 29 January 2003
(See “Invitation for Public Submissions” for details)
Full Report [ pdf 224kb ]
An application has been received from Monsanto Australia Limited to amend theAustralia New Zealand Food Standards Code (the Food Standards Code) to approve food derived from genetically modified (GM) herbicide tolerant soybeans, called A2704-12 and A5547-127 soybeans. Standard 1.5.2 – Food Produced using Gene Technology requires that GM foods undergo a pre-market safety assessment before they may be sold in Australia and New Zealand.
This Initial Assessment report is not an assessment of the merits of the application but rather is an assessment of whether the application should be accepted for further consideration, according to criteria laid down in the Food Standards Australia New Zealand Act 1991 (the Act). It has been concluded that the application fulfils the requirements for Initial Assessment as prescribed in the Act. The application has therefore been accepted for further assessment.
The purpose of this report is to provide relevant information supplied by the applicant, to assist in identifying the affected parties and to outline the relevant issues necessary to complete assessment of the application, now that it has been accepted. The information needed to complete the assessment will include information received from public submissions.
There is currently no approval for the sale and use of food from A2704-12 and A5547-127 soybeans. If this application is successful, FSANZ will amend the Food Standards Code and insert a permission to use food from A2704-12 and A5547-127 soybeans in the Table to clause 2 of Standard 1.5.2.
A2704-12 and A5547-127 soybeans have been genetically modified for tolerance to glufosinate ammonium herbicides. Tolerance to the herbicides is achieved by expression in the plant of a bacterially derived enzyme that specifically inactivates the herbicide, thus allowing the plants to survive and grow following applications of the herbicide. A2704-12 and A5547-127 soybeans also contain a new gene encoding resistance to the antibiotics ampicillin and penicillin – this gene is not however active in the plant.
The glufosinate ammonium-tolerant soybeans have been developed for cultivation in the major soybean growing regions of the world and, at present, are not intended for cultivation in either Australia or New Zealand. Food derived from A2704-12 and A5547-127 soybeans may however still enter the food supply in Australia and New Zealand via imported products.
Public submissions are now invited on this Initial Assessment report. Comments are specifically requested on the scientific aspects of this application, in particular, information relevant to the safety assessment of food from A2704-12 and A5547-127 soybeans .
Full Report [ pdf 224kb ]