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Australian Office of the Gene Technology Regulator: Notification of Determination to place four GM carnation lines modified for flower colour on the GMO Register
Woden, ACT, Australia
November 29, 2006

Notification of Determination to place four GM carnation lines modified for flower colour on the GMO Register (Register 001/2004)

GMO Register
Application to include dealings with GM Carnations on the GMO Register

DETERMINATION ON APPLICATION REGISTER 001/2004 TO PLACE FOUR GM CARNATION LINES MODIFIED FOR FLOWER COLOUR ON THE GMO REGISTER

The Gene Technology Regulator (the Regulator) has made a determination in respect of application Register 001/2004 from Florigene Ltd (Florigene) to include dealings with four genetically modified (GM) carnation (Dianthus caryophyllus) lines on the GMO Register.

Under the Gene Technology Act 2000, and corresponding State and Territory legislation, dealings with genetically modified organisms (GMOs) that have been previously licensed may be placed on the GMO Register if (a) any risks posed by the dealing are minimal and (b) the Regulator is satisfied that the dealings are sufficiently safe to be undertaken by anyone without the need for a licence. This is the first entry on the GMO Register.

The carnation lines were modified by the insertion of genes that affect flower colour and have over 10 years of history of safe use. Following field trials by Florigene under limited and controlled conditions dating back to 1992, in September 1995 the four GM carnation lines were authorised for commercial release under the former voluntary system that was overseen by the Genetic Manipulation Advisory Committee (GMAC). The approved dealings included the Australia-wide propagation, growth, and distribution of GM plants and cut flowers. In June 2003, the Regulator issued a licence (DIR 030/2002) for the continued commercial release of the same GM lines. Neither the GMAC authorisation nor the DIR licence imposed conditions to limit the spread and persistence of the GMOs or their introduced genes and there have been no reports of adverse effects on people or the environment from the release.

The dealings that Florigene proposed for inclusion on the Register are the same as those currently authorised by DIR licence 030/2002. During 2005/6 the Regulator obtained additional data from the company, reviewed the latest scientific literature, and sought advice from the public, the Gene Technology Technical Advisory Committee, relevant Australian Government agencies, and State and Territory Governments on any risks to human health and
safety or the environment that may be posed by the dealings. No risks were identified in the Risk Assessments that were prepared for either DIR 030/2002 or Register 001/2004.

Under the Act, a determination to include dealings with a GMO on the GMO Register is a disallowable instrument. This determination will come into effect if and when the disallowance period for Parliamentary scrutiny has elapsed.

The Risk Assessment for Register 001/2004, documents relating to Licence DIR 030/2002, the revised ‘Biology and Ecology of Dianthus carophyllus L’, and Questions and Answers about the determination can be obtained on-line from the Office of the Gene Technology Regulator’s website or requested via the contacts detailed below.

Office of the Gene Technology Regulator MDP 54
PO Box 100
WODEN ACT 2606
Australia
Telephone: 1800 181 030
Facsimile: 02 6271 4202
http://www.ogtr.gov.au

Register 001/2004 Notification of Determination - posted 28 November 2006

Register 001/2004 Questions & Answers on placing dealings with GM Carnations on the GMO Register

Register 001/2004 Legislative instrument to include four GM Carnation lines on the GMO Register

Register 001/2004 Risk Assessment

DIR 30/2002 Licence and related documents (for these dealings with GM Carnation lines)

Reference material

Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (2nd Edition) 2005

The biology and ecology of carnation (Dianthus caryophyllus L.)

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