Australia's Gene Technology Regulator stops the clock on two GM canola applications

November 8, 2002

The Commonwealth Gene Technology Regulator, Dr Sue Meek, announced today that she had decided to ‘stop the clock’ on two applications for the commercial release of genetically modified (GM) canola until more information becomes available.

Public consultation on the risk assessment and risk management plans for these applications was originally scheduled for mid November 2002. The ‘clock-stop’ means that this consultation will now be delayed until early next year and the final decisions on whether or not to issue licences (currently due in February/March 2003) will therefore also be delayed.

The two applications, from Monsanto and Bayer, contain references to a number of documents relating to technology stewardship and crop management. These documents are under development, in parallel with 'Guidelines for Supply Chain Management of GM Canola’ being prepared by the Gene Technology Grains Committee. The Committee comprises representation from across the grains industry, including producers, research institutions, technology providers, bulk handlers, food processors, and farmers’ associations "I have recently been advised that these documents will not now be finalised until early next year," Dr Meek said. "The crop management plans, technical manuals and their relationship to the overarching industry guidelines are all necessary for me to properly understand and assess any risks to human health and safety and the environment from potential commercial GM canola releases.

"Therefore, the preparation of the risk assessment and risk management plans for these applications has been put on hold until this documentation has been finalised and made available to my Office for analysis," Dr Meek said.

In August 2002 the Gene Technology Regulator notified the public of two new applications for the commercial release of genetically modified canola:

  • DIR 020/2002 - an application by Monsanto Australia Ltd for the commercial release of Roundup Ready® canola (Brassica napus), which is genetically modified to be tolerant to the herbicide glyphosate (the active ingredient of Roundup®), potentially in all current and future canola growing regions of Australia, including NSW, Queensland, Victoria, SA, WA, Tasmania and the ACT; and

  • DIR 021/2002 – an application by Aventis Cropscience Australia (now Bayer Crop Science Australia) for the commercial release of InVigor® canola (Brassica napus), which is genetically modified to incorporate a novel hybrid breeding system and tolerance to the herbicide glufosinate ammonium (the active ingredient in Liberty®), in potentially in all current and future canola growing regions of Australia, including NSW, Queensland, Victoria, SA, WA, Tasmania and the ACT.

"Due to the high level of public interest in GM canola, and the commercial release proposals in particular, in addition to the diverse range of expert groups and key stakeholders that are usually consulted on applications, I invited the public to advise me of any issues relating to risks to human health and safety and to the environment that may be posed by the proposed releases," Dr Meek said.

"The deadline for initial comment was in October 2002 to enable issues to be included in the risk assessment and risk management plans (RARMPs) for these applications. It was my intention then to release the RARMPs in mid November.

"All applications for intentional release of genetically modified organisms (GMOs) are required under legislation to be considered within 170 working days. This means that a decision was due by 10 February for DIR020 and 7 March for DIR021.

"However, I have decided to stop the clock to ensure that all relevant information will be available before moving to the next stage of evaluating these applications.

"The public will be notified when the risk assessment and risk management plans have been prepared and an extended consultation period of eight weeks is envisaged for feedback and input," Dr Meek said.

More information is available on the OGTR website: www.ogtr.gov.au.

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