Australian Office of the Gene Technology Regulator issues licence for continued commercial release of GM carnation

June 18, 2003

DIR 030/2002 - Ongoing commercial release of colour modified carnations (replacement of deemed licence GR-2)

The Australian Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of application DIR 030/2002 from Florigene Ltd. The application requests approval to undertake commercial release of genetically modified (GM) carnation Australia-wide.

Four GM carnation lines have been modified (transformation events 123.2.38, 123.2.2, 11363, and 123.8.8) to produce purple, mauve, or blue flower colour. Each line also contains a selectable marker gene that confers tolerance to sulfonylurea herbicides and a range of other acetolactate synthase (ALS) inhibiting herbicides. It is intended that GM carnation be used solely as ornamental plants.

Since 1992 there have been a number of field trials and, since 1995, ongoing commercial release of colour modified carnation. These were authorised under the voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC). There have been no reports of adverse effects on human health or the environment resulting from any of these.

The decision to issue the licence was made after extensive consultation on the Risk Assessment and Risk Management Plan with the public, State and Territory governments, Commonwealth agencies, the Federal Environment Minister, the Gene Technology Technical Advisory Committee and the relevant local councils, as required by the Gene Technology Act 2000.

Issues relating to the health and safety of people and the protection of the environment raised during the consultation process on this application were considered in finalising the Risk Assessment and Risk Management Plan and in making a decision on whether to issue a licence.

As the risk assessment concluded that there no risks to human health and safety or to the environment that are different to those of conventional carnation, the licence has been issued with minimal oversight conditions. Complete and summary versions of the finalised Risk Assessment and Risk Management Plan and the licence conditions can be obtained on-line from the Office of the Gene Technology Regulator’s website or by telephoning the toll-free number, or by writing to the Office at the address below.

More at http://www.health.gov.au/ogtr/ir/dir030.htm

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