7.1 Australian approvals of GM wheat

7.1.1 Previous releases approved by the Genetic Manipulation Advisory Committee or the Regulator

84. There has been no release of these GM wheat lines in Australia. Dealings with the lines proposed for release have been undertaken in PC2 facilities under NLRDs 770/2003 and 2137/2006.

85. The Regulator has issued licences for the limited and controlled release of five other GM wheat lines: DIR 053/2004 was issued to Grain Biotech for GM salt tolerant wheat on an area of 0.45 ha in Western Australia; DIR 054/2004 was issued to CSIRO for GM wheat with altered starch content on 0.412 ha in the ACT; DIR 071/2006 was issued to Department of Primary Industries, Victoria for GM drought tolerant wheat on 0.315 ha in Victoria; DIR 077/2007 was issued to the University of Adelaide for GM wheat and barley with enhanced tolerance to abiotic stresses or increased beta glucan on 0.04 ha in South Australia; DIR 080/2007 was issued to Department of Primary Industries, Victoria for GM drought tolerant wheat on 0.225 ha in Victoria.

86. Under the former voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC), there have been five field trials of different types of GM wheat ranging in size from 325–1500 plants: PR65 (1996), PR66 (1996), PR102 (1998), PR102X (2000), and PR107 (1999).

87. There have been no reports of adverse effects on human health or the environment resulting from any of these releases.

7.1.2 Approvals by other Australian government agencies

88. The Regulator is responsible for assessing risks to the health and safety of people and the environment associated with the use of gene technology. Other government regulatory requirements may also have to be met in respect of release of GMOs, including those of the Australian Quarantine and Inspection Service (AQIS), Food Standards Australia New Zealand (FSANZ), and Australian Pesticides and Veterinary Medicines Authority (APVMA). This is discussed further in Chapter 3.

89. The applicant does not intend any material from the GM wheat lines proposed for release to be traded as human food. All genetically modified foods intended for sale in Australia must undergo a safety evaluation by FSANZ. Accordingly, the applicant is not required to apply to FSANZ for the evaluation of the GM wheat lines. However, FSANZ approval may need to be obtained before materials or products derived from the GM wheat lines could be sold for human consumption.

7.1.3 Consultation with other Australian regulatory councils

90. Products made from the GM wheat may be fed to rats and pigs in controlled laboratory experiments. The Australian Code of Practice for the Care and Use of Animals for Scientific Purposes provides guiding principles for researchers and institutions using animals in research. This code of practice is endorsed by the National Health and Medical Research Council (NHMRC), CSIRO, the Australian Research Council and the Australian Vice-Chancellors’ Committee, and is published by the NHMRC1. Under the code of practice, institutional Animal Ethics Committees advise on and monitor animal experiments, and ensure they comply with relevant Commonwealth, State or Territory animal welfare legislation. The applicant intends to seek approval for all animal experiments related to the current application from the Animal Ethics Committee of CSIRO Human Nutrition, which operates under the NHMRC guidelines.

7.2 International approvals of GM wheat

91. There have been no releases of these GM wheat lines internationally. However, there have been releases of other GM wheat plants. The traits which have been modified include novel protein production, disease resistance, altered grain properties and herbicide tolerance2.

1Available online at NHMRC website.

2http://www.aphis.usda.gov/brs/status/relday.html, http://gmoinfo.jrc.ec.europa.eu/ accessed 23 January 2009.