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May 2016 GM wheat field-trial approvals Regulating gene technology in Australia Making and working with genetically modified organisms (GMOs) in Australia is regulated through a nationally consistent legal scheme, including the Commonwealth Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state laws. 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 to protect the health and safety of people and the environment. The Australian regulatory scheme is science-based and uses robust risk analysis based on widely respected international standards. Before deciding to issue a licence, the Regulator conducts a comprehensive risk assessment—considering the latest available scientific information—and extensive public and expert consultation. The Office of the Gene Technology Regulator (OGTR) also monitors scientific and other literature for any new information relevant to GM crops, and assesses that information in relation to existing licences. Each state and territory can pass its own laws regarding trade and marketing of GMOs. GM wheat in Australia There has been no commercial release of GM wheat in Australia, and the OGTR has not received any licence applications for the commercial release of GM wheat. Since 2005, the Regulator has issued 18 licences for small field trials of GM wheat. Seven of these licences are still current (see Table 1). These field trials relate to early-stage research on GM wheat, modifying traits such as salt tolerance, drought tolerance, enhanced yield, altered grain composition, improved nutrient use efficiency or improved grain quality. You can see where the field trials are on the OGTR website. Each field trial is limited in its size (0.4–3 hectares per year) and duration (up to 5.5 years, i.e. six seasons). 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 to make sure they are compliant 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 commercial human food or animal feed supplies. However, three licences held by CSIRO authorised animal nutrition studies (DIR 092, DIR 093 and DIR 111); two of these also authorised experimental human nutrition studies (DIR 093 and DIR 111). These studies are also subject to approval by ethics committees who consider animal and human ethical issues. The studies used products made from GM wheat with altered grain composition that aim to improve nutritional properties such as glycemic index. The licences for DIR 092 and DIR 093 have been surrendered. Table 1: Current licences for limited and controlled releases (field trials) of GM wheat Licence No Licence holder Modified Trait Issued Field trial site status1 DIR 142 Vic DEDJTR Yield & abiotic stress tolerance April 2016 No site yet planted DIR 130 Murdoch University Improved grain quality March 2015 No site yet planted DIR 128 University of Adelaide Abiotic stress tolerance August 2014 8 sites: 5 site current, 3 in PHM DIR 122 Vic DEPI2 Enhanced yield stability October 2013 2 sites: 2 in PHM, DIR 117 CSIRO Altered grain composition and enhanced nutrientutilisation efficiency March 2013 No site yet planted DIR 111 CSIRO Altered grain composition, nutrient utilisation efficiency, disease resistance or abiotic stress tolerance February 2012 8 sites: 4 signed off, 4 in PHM DIR 102 University of Adelaide Abiotic stress tolerance June 2010 8 sites: 4 signed off, 4 in PHM3 1. A field trial site may be either: not planted: as at 31 May 2016, the licence holder had not planted any GM wheat under the licence current: the GM crop is being grown and/or harvested, in post-harvest monitoring (PHM): 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: the Regulator has determined that post-harvest monitoring is no longer required for a particular trial site. 2. Currently known as the Victorian Department of Economic Development, Jobs, Transport and resources (DEDJTR). 3. The DIR 102 licence covers trials for wheat and barley. Four sites under DIR 102 are planted to barley only.