(Office use only) IBC Application Number:
Application received:
Application approval date:
Exempt Dealing Declaration Form
Use this form to declare to the Curtin University Institutional Biosafety Committee the intention to
carry out an Exempt Dealing.
If you need assistance filling in this form then please contact the Biosafety Advisor, Dr Bernadette
Bradley on 9266 1383 or 0401 103 655 or bernadette.bradley@curtin.edu.au .
Abbreviations
GMO
genetically modified organism
IBC
Institutional Biosafety Committee
OGTR
Office of the Gene Technology Regulator
PI
Principle Investigator
Identifying Information
The Organisation is Curtin University of Technology, Accreditation Number Accr-105.
The IBC is the Curtin University Institutional Biosafety Committee. The Chair of the IBC is
Assoc/Prof David Groth. The Executive Officer of the IBC is Dr Bernadette Bradley.
1.
Declaration type
Is this declaration for a new Exempt Dealing or a renewal of an old one?
(Give any relevant previous IBC Numbers for renewals)
2.
Confidential Commercial Information (CCI)
If your Dealing needs to be covered by CCI then please indicate it below (yes/no). The CCI
information needs to be included in the final section of this Form, and it will be expurgated from the
IBC Records.
3.
Declarant Information
The Principle Investigator (PI) of the Dealing being declared must be a Curtin staff member, and
cannot be a postgraduate student. The PI is ultimately responsible for how the Dealing is
performed, who performs it, how they are trained, and stewardship of the GMOs.
3.1 PI title and full name
Position, Department and Faculty
Phone number(s)
Email address
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(Office use only) IBC Application Number:
Application received:
Application approval date:
Summary of previous experience performing
GM Dealings.
Have you completed the Curtin GMO training?
The PI must nominate a Deputy PI for the Dealing, who will assume stewardship of the GMOs and
the Exempt Dealing in the absence of the PI. The Deputy can be a staff member or a postgraduate
student.
3.2 DPI Title and full name
Position, Department and Faculty
Phone number(s)
Email address
Summary of previous experience performing
GM Dealings.
Have you completed the Curtin GMO training?
The declarant may choose to name other researchers who will perform this Dealing, by copying and
pasting the table above.
4. Dealing Information
4.1 Dealing title
4.2 Description of the Dealing
Please provide enough information, about the experimental work that you want to do involving
GMOs, that the IBC can envision the processes.
4.3 Please advise about the desired start date and the estimated end date of the work
5. Source of the GMO
5.1 Identify the source of the GMO – will it be purchased from a supplier, gifted from a colleague,
constructed during the Dealing, or other. Give details of any supplier or donor.
5.2 Will the GMO be imported under an AQIS permit and/or QWA Approval – if so, attach a copy
of the permit/approval.
6. Details about the GMO(s)
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(Office use only) IBC Application Number:
Application received:
Application approval date:
If you have different types of GMOs, and want to describe them separately, then you can copy and
paste the table below as many times as you need to.
6.1 What are the common and scientific names of the living organism that will be the GMO?
This is also referred to as the “parent organism” and the “host”.
6.2 If this organism produces spores then provide the spore size and normal method of transmission
(e.g. airborne, splash-mobilised, etc).
6.3 What vector(s) and methods are to be used to transfer the genetic material?
 Provide copies of references (or vector maps) for any novel vectors or methods of transfer.
 Include the name of the company supplying any commercially obtained vectors.
 State if plasmids are conjugative or non-conjugative.
 State which cell species the vectors can be transformed with.
 Note any special or uncommon features.
6.4 Are the proposed host/vector systems listed as Exempt host/vector systems in the reference
material at the end of this form?
6.5 Have either the host or the vector been implicated in, or have a history of causing, disease in
otherwise-healthy human beings, animals, plants or fungi? If so, then describe.
6.6 List all the types of modified DNA, genes and gene segments that have been introduced into the
host and will remain in the GMO after the modification.
 Include the associated reporter genes and selectable markers, promoters, fluorescent tags etc.
 Name the organism that each piece of DNA originally came from.
 Describe the original function of each sequence and anything the gene encoded, if known.
 Note if the gene will be expressed in the GMO, and what the gene product is expected to do to
the GMO.
6.7 If the GMO will then be placed inside or onto another organism, such as a mouse or plant, then
name it.
6.8 Referring to the reference material at the end of this form, which Item(s) of Exempt Dealing
will you be doing?
7. Facility Information
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(Office use only) IBC Application Number:
Application received:
Application approval date:
Identify all the facilities you will perform the Dealing in. (building and room numbers)
8. Storage
8.1 Identify the site(s) where any GMOs will be stored.
8.2 If you will be storing your GMO using methods that differ from those described in the
Guidelines for Transport, Storage and Disposal of GMOs, then describe the conditions by replacing
the text below. Leaving the text below indicates that you will comply with the Guidelines.
I will be storing my GMOs following the methods described in the OGTR Guidelines for Transport,
Storage and Disposal of GMOs.
9. Transport
If you will be transporting your GMO using methods that differ from those described in the
Guidelines for Transport, Storage and Disposal of GMOs, then describe the transport methods by
replacing the text below. Leaving the text below indicates that you will comply with the
Guidelines.
I will be transporting my GMOs following the methods described in the OGTR Guidelines for
Transport, Storage and Disposal of GMOs.
10. Disposal of the GMO
10.1 If you will be disposing of your GMO using methods that differ from those described in the
Guidelines for Transport, Storage and Disposal of GMOs, then describe the disposal methods by
replacing the text below. Leaving the text below indicates that you will comply with the
Guidelines.
I will be disposing of my GMOs following the methods described in the OGTR Guidelines for
Transport, Storage and Disposal of GMOs.
10.2 Which chemical disinfectant(s) will be used to decontaminate surfaces that the GMO is
handled over?
11. Release of the GMO
In addition to those actions listed below, which are required, what (if any) steps will you take in the
event of an unintentional release of the GMO(s)?
In the event of an unintentional release of GMOs from containment, I will notify the Manager of the
certified facility that housed the GMO, plus the Biosafety Advisor, Dr Bernadette Bradley as soon
as possible, by phone on 0401 103 655 and by email bernadette.bradley@curtin.edu.au .
12. Confidential Commercial Information
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(Office use only) IBC Application Number:
Application received:
Application approval date:
Include any CCI information below, or as an attachment to this form. It will be expurgated from the
IBC Minutes. Please also explain why the information is sensitive.
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(Office use only) IBC Application Number:
Application received:
Application approval date:
The reference material below comes from the Gene Technology Regulations 2001.
Exempt dealings
Item
Description of dealing
2
A dealing with a genetically modified Caenorhabditis elegans, unless:
(a) an advantage is conferred on the animal by the genetic modification; or
(b) as a result of the genetic modification, the animal is capable of secreting or producing an
infectious agent.
3
A dealing with an animal into which genetically modified somatic cells have been introduced,
if:
(a) the somatic cells are not capable of giving rise to infectious agents as a result of the
genetic modification; and
(b) the animal is not infected with a virus that is capable of recombining with the genetically
modified nucleic acid in the somatic cells.
3A
A dealing with an animal whose somatic cells have been genetically modified in vivo by a
replication defective viral vector, if:
(a) the in vivo modification occurred as part of a previous dealing; and
(b) the replication defective viral vector is no longer in the animal; and
(c) no germ line cells have been genetically modified; and
(d) the somatic cells cannot give rise to infectious agents as a result of the genetic
modification; and
(e) the animal is not infected with a virus that can recombine with the genetically modified
nucleic acid in the somatic cells of the animal.
4
(1)
Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of
this Schedule and producing no more than 25 litres of GMO culture in each vessel
containing the resultant culture.
(2) The donor nucleic acid:
(a) must meet either of the following requirements:
(i) it must not be derived from organisms implicated in, or with a history of causing,
disease in otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(ii) it must be characterised and the information derived from its characterisation show
that it is unlikely to increase the capacity of the host or vector to cause harm;
Example
Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that,
in relation to the capacity of the host or vector to cause harm, it:
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility; and
(b) must not code for a toxin with an LD50 of less than 100 g/kg; and
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(Office use only) IBC Application Number:
Item
Application received:
Application approval date:
Description of dealing
(c) must not code for a toxin with an LD50 of 100 g/kg or more, if the intention is to express
the toxin at high levels; and
(d) must not be uncharacterised nucleic acid from a toxin-producing organism; and
(e) must not include a viral sequence, unless the donor nucleic acid:
(i) is missing at least 1 gene essential for viral multiplication that:
(A) is not available in the cell into which the nucleic acid is introduced; and
(B) will not become available during the dealing; and
(ii) cannot restore replication competence to the vector.
5
A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector
system mentioned in item 1 of Part 2 of this Schedule, if the donor nucleic acid is not derived
from either:
(a) a pathogen; or
(b) a toxin-producing organism.
Host/vector systems for exempt dealings
Item
1
Class
Host
Bacteria
Escherichia coli K12, E. coli B, E. coli C or
1. Non-conjugative plasmids
E. coli Nissle 1917 — any derivative
2. Bacteriophage
that does not contain:
(a)lambda
(a) generalised transducing phages; or
(b)
lambdoid
(b) genes able to complement the
(c)
Fd
or
F1
(eg M13)
conjugation defect in a non-conjugative
plasmid
3. None (non-vector systems)
Bacillus — specified species — asporogenic
strains with a reversion frequency of less
than 10–7:
(a) B. amyloliquefaciens
(b) B. licheniformis
(c) B. pumilus
(d) B. subtilis
(e) B. thuringiensis
Pseudomonas putida — strain KT 2440
Vector
1. Non-conjugative plasmids
2. Plasmids and phages whose host
range does not include B. cereus,
B. anthracis or any other
pathogenic strain of Bacillus
3. None (non-vector systems)
1. Non-conjugative plasmids
including certified plasmids:
pKT 262, pKT 263, pKT 264
2. None (non-vector systems)
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(Office use only) IBC Application Number:
Item
2
3
Class
Fungi
Slime
moulds
Application received:
Application approval date:
Host
Vector
Streptomyces — specified species:
(a) S. aureofaciens
(b) S. coelicolor
(c) S. cyaneus
(d) S. griseus
(e) S. lividans
(f) S. parvulus
(g) S. rimosus
(h) S. venezuelae
1. Non-conjugative plasmids
Agrobacterium radiobacter
Agrobacterium rhizogenes — disarmed
strains
Agrobacterium tumefaciens — disarmed
strains
1. Non-tumorigenic disarmed Ti
plasmid vectors, or Ri plasmid
vectors
Lactobacillus
Lactococcus lactis
Oenococcus oeni syn. Leuconostoc oeni
Pediococcus
Photobacterium angustum
Pseudoalteromonas tunicata
Rhizobium (including the genus
Allorhizobium)
Sphingopyxis alaskensis syn. Sphingomonas
alaskensis
Streptococcus thermophilus
Synechococcus — specified strains:
(a) PCC 7002
(b) PCC 7942
(c) WH 8102
Synechocystis species — strain PCC 6803
Vibrio cholerae CVD103-HgR
1. Non-conjugative plasmids
Kluyveromyces lactis
Neurospora crassa — laboratory strains
Pichia pastoris
Saccharomyces cerevisiae
Schizosaccharomyces pombe
Trichoderma reesei
Yarrowia lipolytica
1. All vectors
Dictyostelium species
1. Dictyostelium shuttle vectors,
including those based on the
endogenous plasmids Ddp1 and
Ddp2
2. Certified plasmids: SCP2, SLP1,
SLP2, PIJ101 and derivatives
3. Actinophage phi C31 and
derivatives
4. None (non-vector systems)
2. None (non-vector systems)
2. None (non-vector systems)
2. None (non-vector systems)
2. None (non-vector systems)
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(Office use only) IBC Application Number:
Item
4
Application received:
Application approval date:
Class
Host
Vector
Tissue
culture
Any of the following if they cannot
spontaneously generate a whole animal:
(a) animal or human cell cultures
(including packaging cell lines);
(b) isolated cells, isolated tissues or
isolated organs, whether animal or
human;
(c) early non-human mammalian embryos
cultured in vitro
1. Non-conjugative plasmids
Either of the following if they are not
intended, and are not likely without human
intervention, to vegetatively propagate,
flower or regenerate into a whole plant:
(a) plant cell cultures;
(b) isolated plant tissues or organs
2. Non-viral vectors, or replication
defective viral vectors unable to
transduce human cells
3. Baculovirus (Autographa
californica nuclear polyhedrosis
virus), polyhedrin minus
4. None (non-vector systems)
1. Non-tumorigenic disarmed Ti
plasmid vectors, or Ri plasmid
vectors, in Agrobacterium
tumefaciens, Agrobacterium
radiobacter or Agrobacterium
rhizogenes
2. Non-pathogenic viral vectors
3. None (non-vector systems)
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