CHILDREN YOUTH AND WOMEN'S HEALTH SERVICE
Institutional Biosafety Committee
IBC reference No.
Exempt Dealing
Evaluation Report
The CYWHS Institutional Biosafety Committee (IBC) must be notified of and approve all work which falls
under the OTGR Guidelines (http://www.ogtr.gov.au/pubform/handbook) irrespective of whether the work is
exempt under Part 1 of Schedule 2 of the regulations. This form must be completed when Exempt Dealing
approval is required, along with an IBC Project Application and Evaluation Report form. A copy should be kept
by the investigator and the original plus 12 copies of all forms and attachments be forwarded to IBC Executive
Officer, Research Secretariat, Level 2, Samuel Way Building, Children Youth and Women's Health Service, 72
King William Rd, North Adelaide. Queries to tel: 8161 6390.
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Project Supervisor:
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Project Title
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Exemption category:

1.
Any dealing with gene-knockout mice (ie mice whose genetic modification involves deletion or
activation of a specific gene), if no advantage is conferred on the adult animal:
(a) by the deletion or inactivation of the gene concerned; or
(b) for mice that also carry a selectable marker gene–by the selectable marker gene

2.
any dealing with a whole animal, if:
(a) naked recombinant nucleic acid has been introduced into its somatic cells; and
(b) the introduced nucleic acid is incapable of giving rise to infectious agents

3.
any dealing with an animal into which genetically modified somatic cells have been introduced,
unless the cells:
(a) are capable of giving rise to recombinant infectious agents; or
(b) certain viral sequences that could recombine with, or be complemented by, genomes of
introduced superinfecting viruses

4.
any dealing involving a host/vector system mentioned in Part 2 of the Schedule and producing no
more than 10 litres of GMO culture, if:
(a ) the donor DNA:
(i) is not derived from micro-organisms capable of causing disease in human beings, other
animals, plants or fungi, or is fully characterised and will not increase the virulence or host
range of the host or vector; and
(ii) is not an oncogene; and
(iii) does not code for a toxin for vertebrates with an LD50 of less than 100 µg/kg; and
(iv) does not code for a toxin for vertebrates with an LD50 of 100 µg/kg or more, if the intention is
to express the toxin at high levels; and
(v) is not uncharacterised DNA from a micro-organism that produces toxins with an LD50 of 100
µg/kg or less; or
(b) the donor DNA includes a viral sequence or viral sequences, but:
(i) is missing at least 1 gene essential for viral multiplication that is not available in the cell into
which the DNA is introduced and that will not become available through subsequent breeding;
and
(ii) is incapable of complementing a defect in the host/vector system.

5.
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GMO (delete those that do not apply):
Any dealing involving shot-gun cloning of mammalian DNA in a host/vector system mentioned in
Part 2 of the Schedule.
Class of GMO
Algae
Animal
Bacteria
Fungi
Plant
Protozoa
Virus
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Details
Modified trait(s) and gene(s) responsible:
Class of modified trait
Virus resistance
Fungal resistance
Bacterial resistance
Disease resistance
Pest resistance
Herbicide resistance
Antibiotic resistance
Pesticide resistance
Abiotic stress resistance
Altered agronomic characteristics
Altered horticultural characteristics
Altered physical characteristics
Altered physiological characteristics
Altered pharmaceutical characteristics
Attenuation
Antigen expression
Protein expression
Growth factor expression
Altered bioscience characteristics
Altered bioremediation characteristics
Altered biocontrol characteristics
Reporter/marker gene expression
Immuno-modulatory protein expression
Other
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Facilities to be used (include containment level):
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Commencement date:
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Completion date:
Details
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IBC declaration:
The IBC has evaluated this dealing and agrees that it is an exempt dealing as specified by Schedule 2 of the
Gene Technology Regulations 2001.
Name of Accredited Organisation:
Children Youth and Women's Health Service
Name of IBC chair:
Signature of IBC chair:
last updated 12 October 2007
Date:
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