246. Australia's gene technology regulatory system operates as part of an integrated legislative framework. Other agencies that also regulate GMOs or GM products include FSANZ, APVMA, Therapeutic Goods Administration, National Health and Medical Research Council, National Industrial Chemicals Notification and Assessment Scheme and AQIS. Dealings conducted under a licence issued by the Regulator may also be subject to regulation by one or more of these agencies13.
247. The Gene Technology Act 2000 requires the Regulator to consult these agencies during the assessment of DIR applications. The Gene Technology (Consequential Amendments) Act 2000 requires the agencies to consult the Regulator for the purpose of making certain decisions regarding their assessments of products that are, or contain a product from, a GMO.
FSANZ is responsible for human food safety assessment, including GM food. As the trial involves early stage research, the applicant does not intend any material from the GM sugarcane plants proposed for release to be used in human food. Accordingly, the applicant has not applied to FSANZ to evaluate the GM sugarcane plants. However, in the event of a commercial release, FSANZ approval would need to be obtained before materials from the GM sugarcane plants could be sold for human consumption.
248. No other approvals are required.
13More information on Australia's integrated regulatory framework for gene technology is contained in the Risk Analysis Framework available from the Office of the Gene Technology Regulator, free call 1800 181 030.