[ Office use only ]
IBC Application Number:
Application received:
Application approval date:
Notifiable Low Risk Dealing (NLRD)
Application Form
Use this form to apply to the Curtin University Institutional Biosafety Committee for permission to
carry out an NLRD.
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
NLRD
notifiable low risk dealing
OGTR
Office of the Gene Technology Regulator
PI
Principle Investigator
Identifying Information
The Notifying Organisation is Curtin University of Technology, Accreditation Number Accr-105.
The assessing 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.
Application type
Is this application for a new Dealing or a renewal of an old one?
(Give any relevant previous IBC Approval 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.
Applicant Information
The Principle Investigator (PI) of the Dealing being applied for must be a Curtin staff member, and
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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
Summary of previous experience performing
GM Dealings and working in OGTR-certified
facilities.
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 NLRD 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 and working in OGTR-certified
facilities.
Have you completed the Curtin GMO training?
The applicant may choose to name other researchers who will perform this Dealing, by copying and
pasting the table above.
4. The classes of people who will be performing this Dealing
Classes of person
Will they perform
the NLRD
(i.e. handle the
GMOs)?
(yes/no)
You may choose to name the
people who will initially be
involved in performing the
Dealing.
Have they
completed the
Curtin GMO
training?
(yes/no)
PI
DPI
Postdoctoral Research
Fellows
Research Assistants
Higher
Degree
by
Research students
Undergraduate students
Animal
Care
Technicians
Lab Technicians
5. Dealing Information
5.1 Dealing title
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5.2 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.
5.3 Please advise about the desired start date and the estimated end date of the work
6. Source of the GMO
6.1 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.
6.2 Will the GMO be imported under an AQIS permit and/or QWA Approval – if so, attach a copy
of the permit/approval.
7. Details about the GMO(s)
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.
7.1 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”.
7.2 If this organism produces spores then provide the spore size and normal method of transmission
(e.g. airborne, splash-mobilised, etc).
7.3 What vector(s) and methods are to be used to transfer the genetic material?
 Provide copies of references (or vector maps) for 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.
 Which species of cells can be transformed/transfected/transduced by the vector.
 Note any special or uncommon features.
7.4 Are the proposed host/vector systems listed as Exempt host/vector systems in the reference
material at the end of this form?
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7.5 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.
7.6 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.
7.7 If the GMO will then be placed inside or onto another organism, such as a mouse or plant, then
name it.
8. When the GMO is a whole plant or is to be used in conjunction with a whole plant
8.1 If the parent organism or GMO is a weed, or closely related to plants that are weeds, then
please identify this.
8.2 To what stage of development are the plants to be grown? Will the plant produce pollen or
seeds?
8.3 Indicate the type of growth medium (soil or soil substitute) to be used, and how it will be
subsequently sterilised or disposed of.
9. Risk assessment and management
9.1 Does the GMO, or the vector used to make the GMO, pose a threat to the health and safety of
the people handling the GMO?
What are the possible hazards from the proposed genetic modifications, and the likelihood and
consequence of the hazards occurring?
Note: GMOs and vectors that are made from organisms that are pathogenic to humans may be
hazardous.
9.2 If unintentionally released from containment, does the GMO, or the vector used to make the
GMO, pose a threat to the health and safety of people in the general population?
What are the possible hazards from the proposed genetic modifications, and the likelihood and
consequence of the hazards occurring?
Note: GMOs and vectors that are made from organisms that are pathogenic to humans may be
hazardous.
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9.3 If unintentionally released into the environment, does the GMO, or the vector used to make the
GMO, pose a threat to the health of organisms in the environment, or their position in the
ecosystem?
What are the possible hazards from the proposed genetic modifications, and the likelihood and
consequence of the hazards occurring?
Note: GMOS and vectors that are made from organisms that are pathogenic to animals, plants or
fungi may be hazardous. GMOs might outcompete non-GMOs in the environment.
9.4 Over and above the precautions that are outlined in the OGTR PC2 Procedures or Guidelines,
are there any other actions and precautions you will take to minimise risks posed by the proposed
dealing(s)?
9.5 In addition to those actions listed below, which are required, what (if any) are the 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 .
10. Kind of NLRD
Refer to the kinds of NLRDs listed in the reference material at the end of this form, and list the
category(s) of NLRD you will do.
11. Facility Information
Identify which OGTR-Certified facility or facilities you will perform the Dealing in. Note that use
of a facility is at the discretion of the Facility Manager.
Facility name
Facility type
B308 Rm 140-144
B305 L2 East Wing
B305 L2 West Wing
B300 animal facility
B300 Rm111-123
B300 Rm155
B300 Rm147-148
B300 PC3 lab
B126G Glasshouse
B126K Convirons
PC2 lab
PC2 lab
PC2 lab
PC2 animal facility
PC2 lab
PC2 lab
PC2 plant facility
PC3 lab
PC2 plant facility
PC2 lab (plant)
Certification
number
2405
3489
3490
2406
2407
3085
3086
2541
3370
future
Facility Manager
The NLRD will be
done here (yes/no)
TBA
Dr Rob Steuart
Dr Rob Steuart
Dr Beng Chua
Dr Beng Chua
Dr Beng Chua
Dr Beng Chua
Dr Beng Chua
Mr John Jackson
Mr John Jackson
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12. Storage outside the Certified facility
12.1 Identify the site(s) of any storage outside the Certified facility.
12.2 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.
13. Transport outside of a Certified facility
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.
14. Disposal of the GMO
14.1 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.
14.2 Which chemical disinfectant(s) will be used to disinfect surfaces that the GMO has been
handled over?
14.3 Below, write the procedure to decontaminate a spill of your GMO.
15. Confidential Commercial Information
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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The reference material below comes from the Gene Technology Regulations 2001. It includes
the table of Host/vector systems for exempt dealings, and the kinds of NLRDs.
Host/vector systems for exempt dealings
Item
1
Class
Host
Vector
Bacteria
Escherichia coli K12, E. coli B,
E. coli C or E. coli Nissle 1917
— any derivative that does not
contain:
(a) generalised transducing
phages; or
(b) genes able to complement
the conjugation defect in a
non-conjugative plasmid
1. Non-conjugative plasmids
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
2. Bacteriophage
(a)lambda
(b)
lambdoid
(c)Fd or F1 (eg M13)
3. None (non-vector systems)
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)
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
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)
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Item
2
3
Class
Fungi
Slime
moulds
Host
Vector
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. None (non-vector systems)
2. None (non-vector systems)
2. None (non-vector systems)
4
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
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)
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Item
Class
Host
Vector
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
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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Notifiable low risk dealings in relation to a GMO
(regulations 12 and 13)
Part 1
Notifiable low risk dealings suitable for at least physical
containment level 1
Note Because of subregulation 12 (1), a dealing mentioned in this Part is not a
notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.
1.1
Kinds of dealings suitable for at least physical containment level 1
The following kinds of notifiable low risk dealings must be undertaken, unless paragraph
13 (2) (c) or 13 (3) (b) applies, in facilities certified to at least physical containment level
1 and that are appropriate for the dealings:
(a) a dealing involving a genetically modified laboratory guinea pig, a genetically
modified laboratory mouse, a genetically modified laboratory rabbit or a genetically
modified laboratory rat, unless:
(i) an advantage is conferred on the animal by the genetic modification; or
(ii) the animal is capable of secreting or producing an infectious agent as a result of
the genetic modification;
(c) a dealing involving a replication defective vector derived from Human adenovirus or
Adeno associated virus in a host mentioned in item 4 of Part 2 of Schedule 2, if the
donor nucleic acid:
(i) cannot restore replication competence to the vector; and
(ii) does not:
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans.
Part 2
Notifiable low risk dealings suitable for at least physical
containment level 2 or 3
Note Because of subregulation 12 (1), a dealing mentioned in this Part is not a
notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.
2.1
Kinds of dealings suitable for at least physical containment level 2
The following kinds of notifiable low risk dealings must be undertaken, unless paragraph
13 (2) (c) or 13 (3) (b) applies, in facilities certified to at least physical containment level
2 and that are appropriate for the dealings:
(a) a dealing involving whole animals (including non-vertebrates) that:
(i) involves genetic modification of the genome of the oocyte or zygote or early
embryo by any means to produce a novel whole organism; and
(ii) does not involve any of the following:
(A) a genetically modified laboratory guinea pig;
(B) a genetically modified laboratory mouse;
(C) a genetically modified laboratory rabbit;
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(aa)
(b)
(c)
(d)
(D) a genetically modified laboratory rat;
(E) a genetically modified Caenorhabditis elegans;
a dealing involving a genetically modified laboratory guinea pig, a genetically
modified laboratory mouse, a genetically modified laboratory rabbit, a genetically
modified laboratory rat or a genetically modified Caenorhabditis elegans, if:
(i) the genetic modification confers an advantage on the animal; and
(ii) the animal is not capable of secreting or producing an infectious agent as a
result of the genetic modification;
a dealing involving a genetically modified plant;
a dealing involving a host/vector system not mentioned in paragraph 1.1 (c) or Part 2
of Schedule 2, if neither host nor vector has been implicated in, or has a history of
causing, disease in otherwise healthy:
(i) human beings; or
(ii) animals; or
(iii) plants; or
(iv) fungi;
a dealing involving a host and vector not mentioned as a host/vector system in Part 2
of Schedule 2, if:
(i) the host or vector has been implicated in, or has a history of causing, disease in
otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) the donor nucleic acid is characterised; and
(iii) the characterisation of the donor nucleic acid shows 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 (iii) if, 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.
(e) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the
donor nucleic acid:
(i) encodes a pathogenic determinant; or
(ii) is uncharacterised nucleic acid from an organism that has been implicated in,
or has a history of causing, disease in otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(f) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and
producing more than 25 litres of GMO culture in each vessel containing the resultant
culture, if:
(i) the dealing is undertaken in a facility that is certified by the Regulator as a
large scale facility; and
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(ii) the donor nucleic acid satisfies the conditions set out in subitem 4 (2) of Part 1
of Schedule 2;
(g) a dealing involving complementation of knocked-out genes, if the complementation
is unlikely to increase the capacity of the GMO to cause harm compared to the
capacity of the parent organism before the genes were knocked out;
Example
A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the
parent organism:
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
(h) 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 Schedule 2, if the donor nucleic
acid is derived from either:
(i) a pathogen; or
(ii) a toxin-producing organism;
(i) a dealing involving the introduction of a replication defective viral vector unable to
transduce human cells into a host not mentioned in Part 2 of Schedule 2, if the donor
nucleic acid cannot restore replication competence to the vector;
(j) a dealing involving the introduction of a replication defective non-retroviral vector
able to transduce human cells, other than a dealing mentioned in paragraph 1.1 (c),
into a host mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore
replication competence to the vector;
(k) a dealing involving the introduction of a replication defective non-retroviral vector
able to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the donor nucleic acid does not:
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans;
(l) a dealing involving the introduction of a replication defective retroviral vector able to
transduce human cells into a host mentioned in Part 2 of Schedule 2, if:
(i) all viral genes have been removed from the retroviral vector so that it cannot
replicate or assemble into a virion without these functions being supplied
in trans; and
(ii) viral genes needed for virion production in the packaging cell line are
expressed from independent, unlinked loci with minimal sequence overlap with
the vector to limit or prevent recombination; and
(iii) either:
(A) the retroviral vector includes a deletion in the Long Terminal Repeat
sequence of DNA that prevents transcription of genomic RNA
following integration into the host cell DNA; or
(B) the packaging cell line and packaging plasmids express only viral genes
gagpol, rev and an envelope protein gene, or a subset of these;
(m) a dealing involving the introduction of a replication defective retroviral vector able to
transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid does not:
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans; and
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(ii) all viral genes have been removed from the retroviral vector so that it cannot
replicate or assemble into a virion without these functions being supplied
in trans; and
(iii) viral genes needed for virion production in the packaging cell line are
expressed from independent, unlinked loci with minimal sequence overlap with
the vector to limit or prevent recombination; and
(iv) either:
(A) the retroviral vector includes a deletion in the Long Terminal Repeat
sequence of DNA that prevents transcription of genomic RNA
following integration into the host cell DNA; or
(B) the packaging cell line and packaging plasmids express only viral genes
gagpol, rev and an envelope protein gene, or a subset of these.
2.2
Kinds of dealings suitable for at least physical containment level 3
Any kind of dealing mentioned in this Part involving
a micro-organism that satisfies the criteria in
AS/NZS 2243.3:2010 for classification as Risk Group 3
must be undertaken, unless paragraph 13 (2) (c) or (3) (b) applies, in facilities that are:
(a) certified to at least physical containment level 3; and
(b) appropriate for the dealing.
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