Australia
June 7, 2013

June 2013

Regulation of gene technology in Australia

All dealings with genetically modified organisms (GMOs) are regulated under the Gene Technology Act 20001.

The intentional release of a GMO into the Australian environment must be licensed by the Gene Technology Regulator (the Regulator), and can only be licensed if risks can be managed so as to protect the health and safety of people and the environment. The Australian regulatory scheme uses a science-based approach and robust risk analysis. The risk analysis methodology2 is based on key international standards and is widely respected internationally.

In making licensing decisions, the Regulator considers the latest available scientific information and expert advice. The Office of the Gene Technology Regulator (OGTR) also monitors the scientific and other literature for any new information relevant to GM crops, and assesses its potential to impact on existing licences.

Trade and marketing issues are not part of the Regulator’s consideration; these are matters for state and territory governments and industry.

GM wheat in Australia

There has been no commercial release of GM wheat in Australia, and no licence applications for the commercial release of GM wheat have been received.

Any food use would also require prior approval by Food Standards Australia New Zealand (FSANZ). FSANZ has not approved any GM wheat.
Since 2005, the Regulator has issued fourteen licences for small field trials of GM wheat. Eleven of these licences are still current (see table 1). Licences have only been issued after a risk assessment based on the latest accepted science and extensive public and expert consultation3.

These field trials relate to early stage research on GM wheat with traits such as salt tolerance, drought tolerance, altered starch content or improved nutrient use efficiency. Details of the locations of these trials are publically available on the OGTR website4.

Each field trial is limited in size and duration, ranging in size from 0.1 to 2.3 hectares per year for up to 5 years. The trials are subject to strict containment conditions to manage the potential for spread and persistence of the GM wheat and the introduced genes in the environment. The OGTR actively inspects trials for compliance with licence conditions. There have been no breaches of containment with any of these field trials.

GM wheat from these trials is not permitted to enter the commercial human food or animal feed supplies.

However, three licences held by CSIRO authorise animal nutritional studies (DIR 092, DIR 093 and DIR 111); two of these also authorise experimental human nutritional studies (DIR 093 and DIR 111). These studies are also subject to approval by animal- and human- ethics committees, and would use products made from GM wheat with altered grain composition aimed at improving nutritional properties such as glycemic index.

Table 1: Current Licences for limited and controlled release (field trial) of GM wheat

Licence No	Licence holder	Modified Trait	Issued	Field trial site status*
DIR 117	CSIRO	Altered grain composition & nutrient utilisation efficiency	March 2013	No site yet planted
DIR 112	CSIRO	Altered grain composition & nutrient utilisation efficiency	March 2012	1 in PHM
DIR 111	CSIRO	Altered grain composition, nutrient utilisation efficiency, disease resistance or stress tolerance	February 2012	2 in PHM
DIR 102	University of Adelaide	Abiotic stress tolerance	June 2010	5 in PHM
DIR 099	CSIRO	Altered grain composition & nutrient utilisation efficiency	June 2010	4 in PHM
DIR 094	CSIRO	Enhanced nutrient utilisation efficiency	July 2009	1 in PHM 2 signed off
DIR 093	CSIRO	Grain starch composition	June 2009	1 in PHM 2 signed off
DIR 092	CSIRO	Grain protein or carbohydrate composition	May 2009	1 in PHM 1 signed off
DIR 080 / 2007	Victorian Department of Primary Industries	Drought tolerance	June 2008	2 signed off
DIR 077 / 2007	The University of Adelaide	Enhanced tolerance to abiotic stressors, including soil boron and drought, and increased beta glucan levels	June 2008	1 signed off
DIR071 / 2006	Victorian Department of Primary Industries	Drought tolerance	June 2007	2 signed off

^*A field trial site may be: not planted (as at 7 June 2013, the licence holder had not planted any GM wheat under the licence); current (ie the GM crop is being grown and/or harvested); PHM = in post-harvest monitoring stage (ie the GM crop is no longer being grown but the licence holder is monitoring the site to ensure no GM plants remain); or signed off (ie the Regulator has determined that post-harvest monitoring is no longer required for a particular trial site).

Full details of licences issued by the Regulator can be found on the OGTR website.

 

¹ For more information, see the Fact Sheet Overview of the Gene Technology Regulatory System.

² For more information, see the Regulators’ Risk Analysis Framework

³ Information about these GM trials including risk assessments and licences is available on the OGTR website. Also see the Fact Sheet Application assessment process for dealings involving intentional release (DIR) of a GMO into the environment.

⁴ See the field trial site map page on the OGTR website.

Website: http://www.ogtr.gov.au

Published: June 7, 2013