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Office of the Gene Technology Regulator December 2012 Questions & Answers on licence application DIR 117 for limited & controlled release of genetically modified (GM) wheat and barley What is this application for? The Commonwealth Scientific and Industrial Research Organisation is seeking approval to trial, under limited and controlled conditions, up to 138 lines of wheat that have been genetically modified for altered grain composition or enhanced nutrient utilisation efficiency, and 40 lines of barley that have been genetically modified for enhanced nutrient utilisation efficiency. The proposed field trial would take place at one site in the Shire of Narrabri, New South Wales, on a maximum area of 1.53 ha per year, between May 2013 and April 2016. What is the purpose of the trial? The primary purpose of the field trial is to assess the agronomic performance and grain composition of the GMOs under field conditions. The GM wheat and barley would not be permitted for use in human food or animal feed. How have the GM wheat and barley lines been modified? Some of the GM wheat lines contain part of a gene derived from wheat, which is expected to suppress the function of the corresponding endogenous gene in the GM plants, resulting in altered starch composition in grains. The remainder of the GM wheat lines, and all of the GM barley lines, contain a gene from barley that is expected to enhance nitrogen utilisation efficiency. In addition, most of the GM wheat and barley lines contain one of two selectable marker genes, derived from a common gut bacterium. These genes were used to select genetically modified plant cells and plants during initial development of the GM plants in the laboratory. What controls are proposed for this release? The Risk Assessment and Risk Management Plan (RARMP) for this application concludes that the proposed release poses negligible risks to people or the environment. However, a range of draft licence conditions would limit the size, location and duration of the release, as well as impose control measures to restrict the spread and persistence of the GMOs and the introduced genetic material. Control measures include conditions which provide for containment at the trial site, secure transport and storage of the GM plant materials, and post-harvest monitoring at the trial site to ensure all GMOs are destroyed. Full details of the draft licence conditions are set out in the RARMP, which is now available for comment. How can I comment on this application? You are invited to submit your comments on the consultation version of the RARMP that has been prepared for application DIR 117. The full consultation RARMP and the Summary are available on the ‘What’s New’ page of the OGTR website or via the Freecall number. Your advice would be appreciated on any risks to the health and safety of people or to the environment that may be posed by the proposed release. Please note that the consultation period closes on 8 February 2013 and written submissions are required by that date. What are the next steps in the evaluation process? Matters raised in submissions relating to the protection of people or the environment during the proposed release are taken into account in finalising the RARMP, which then forms the basis of the Regulator’s decision on whether or not to issue a licence. The Office of the Gene Technology Regulator Tel: 1800 181 030 Website: http://www.ogtr.gov.au