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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