Australia
July 13, 2010
Invitation to comment
CONSUlTATION rarmp for Licence APPLICATION dir 104 FROM bayer
Limited and Controlled Release of Genetically Modified (GM) Canola and Indian Mustard
Australia’s gene technology regulatory system is designed to protect the health and safety of people and the environment by identifying risks posed by, or as a result of, gene technology and managing those risks.
The Gene Technology Regulator is currently assessing Licence Application DIR 104 from Bayer CropScience Pty Ltd (Bayer) for a limited and controlled release of canola and Indian mustard lines genetically modified for herbicide tolerance and/or a hybrid breeding system.
The objectives of the trial are: to evaluate the agronomic performance of GM canola and Indian mustard lines under field conditions to allow selection of promising lines for future development; to increase seed stocks for future experiments; and to collect data to support potential future applications for commercial release. The trial is proposed to take place at up to 21 trial sites per year which will be located in 19 nominated LGAs in South Australia and Victoria. Each site will be a maximum of 6 ha with a total area of up to 126 ha planted annually over three years from January 2011 to February 2014. The GM canola and Indian mustard would not be used for human food or animal feed.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed release would pose negligible risk to human health and safety or to the environment. A range of licence conditions are proposed, including measures to restrict the release to the size, locations and duration requested by Bayer.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then form the basis of a decision on whether or not to issue the licence. The consultation RARMP and related documents can be obtained from the website <http://www.ogtr.gov.au> under ‘What’s New’ or by contacting the Office. Please quote application DIR 104 in any correspondence.
Submissions should be received by close of business on 24 August 2010.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
DIR 104 - Questions and Answers (PDF 15 KB)
DIR 104 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 75 KB)
DIR 104 - Consultation Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 83 KB)
DIR 104 - Full consultation Risk Assessment and Risk Management Plan (RARMP) for the limited and controlled release of canola and Indian mustard genetically modified for herbicide tolerance and/or a hybrid breeding system (PDF 609 KB)
DIR 104 - Licence Application Summary (PDF 69 KB)
Reference Material
Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (3rd Edition) 2009
The Biology of Brassica napus L. (canola)