Griffith University Biosafety Committee
NLRD Project Application Form
(To be completed and submitted electronically) All explanatory text and examples are written in
orange italics.
Name of Organisation:
Griffith University
Name of IBC:
Griffith University Biosafety Committee
UBC NLRD Identifier:
This reference number will be advised upon receipt of application
Date of UBC approval:
(This section is to be completed by the UBC)
Click here to access the UBC website
SECTION 1.0: PROJECT INFORMATION:
Project Title:
Please categorise this application into one or more of the following fields:
Virology
Immunology
Microbiology
Cancer
Commencement Date:
You must not commence
your project without written
approval from the UBC. Your
proposed commencement date
should be either “as soon as
approved” or a date at least one
month after the date of submission.
Completion Date:
Note that the
completion date must not be
more than 5 years after the
date of assessment by the
UBC.
SECTION 2.0: PROJECT LEADER INFORMATION:
Project Supervisor:
Group (Health or Sciences):
School:
Research Centre:
Campus: (Nathan, Parklands,
Southport or Logan)
Business Hours Contact Number:
Email Address:
Relevant Experience:
Completion date of last Griffith
University Biosafety Training Session
What are the class of people
authorised to undertake dealings
associated with this project:
(e.g. Research fellow, senior scientist, research
assistant, technical officer, PhD student, Honours
student)
Name of Operations/Business Manager
to be informed of result:
Name(s) of staff and students working on
project
Outline the competencies of staff and students
(i.e. training and experience) and provide the completion
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date of last Griffith University Biosafety Training Session
SECTION 3.0: ABOUT THE PROPOSED DEALING(S):
Is this a storage application?
If yes, please provide a list of vectors and what genes are inserted into
which host that is being stored:
Do you propose to store GMOs outside a certified facility? If you propose to
store GMOs outside a certified facility, please provide details as to the
location of the storage unit, the type of containment, availability of a supply
of decontamination supplies, labelling, accounting requirements and
security. Please note that all arrangements must comply with Part of the
OGTR Guidelines for the Transport, Storage and Disposal of GMOs
Version 1.1
(http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/storageanddisp3/$FILE/tsd-guidelines.pdf).
Will the dealing involve a direct import of GMOs into Australia? If yes,
please provide brief details and if possible, the permit number
Briefly describe the project, including the purpose and aims of the proposed dealing. Please limit your answer to
half a page
(Y/N)
Is this a funded project or do you intent to apply for funding?
If yes, please list the funding bodies supporting the dealing or to which
submission is intended:
Funding status:
Approved
(Y/N)
Pending
(Y/N)
Submitted
(Y/N)
Planned
submission date
Please state the title of the project as it appears on your grant application:
Will the study be undertaken if the funding is not successful?
(Y/N)
Will this project involve the use of animals?
(Y/N)
If yes, has the project been submitted for approval to the Animal Ethics
Committee? If yes, please indicate the name of the title of the project as it
appears on your AEC application
(Y/N)
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Please provide your AEC reference number, date of approval and date of
expiry:
NOTE – If the project requires AEC approval work with GMOs cannot
be undertaken without first having obtained AEC approval. Please
contact the Animal Ethics Secretary if you require further information
about AEC approvals at animal-ethics@griffith.edu.au Tel: 07 373
56618
Ref:
(E.g. MSC/01/13/AEC)
Approval:
(E.g. 7/2/13)
Expiry:
(E.g. 7/2/16)
SECTION 4.0: TYPE OF NOTIFIABLE LOW RISK DEALING IN RELATION TO SCHEDULE 3 (PARTS 1 AND
2) OF THE GENE TECHNOLOGY REGULATIONS:
Please mark (X) the appropriate box(s)
Mark
item
with X
Part 1 – item 1.1
[Please note that any dealings classified in Part 1, must be undertaken in facilities certified to at least
physical containment level 1 by the OGTR].
(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 confer an oncogenic modification in humans and does not encode a protein with
immunomodulatory activity in humans.
Mark
item
with X
Part 2 – item 2.1
[Please note that any dealings classified in Part 2, must be undertaken in facilities certified to at least
physical containment level 2 by the OGTR].
(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;
(D) a genetically modified laboratory rat;
(E) a genetically modified Caenorhabditis elegans
(aa) 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 laboratory 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;
(b) a dealing involving a genetically modified plant;
(c) a dealing involving a host/vector system not mentioned as a host/vector system in Part 2 of Schedule
2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise
healthy human beings, animals, plants or fungi.
(d) a dealing involving a host and vector not mentioned as a host/vector system in Part 2 of Schedule 2,
if:
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(i) the host or vector has been implicated in, or has a history of causing, disease in otherwise
healthy human beings, animals, plants or fungi; and
(ii) the 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 (iii) if, in relation to the capacity of the host or vector
to cause harm, it provides an advantage; or adds a potential host species or mode of transmission; or
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 human beings, animals, plants or 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:
(ii) the donor nucleic acid satisfies the conditions set out in sub-item 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;
(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;
(i)
(j) a dealing involving the introduction of a replication defective non-retroviral vector able to transduce
human cells, other than a dealing mentioned in paragraph1.1 (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
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(iii) either:
(A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA
that prevents transcription of genomie 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 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
(C) encode a protein with immunomodulatory activity in humans; and
(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.
SECTION 5.0: DESCRIPTION OF THE GMO(S):
PLEASE NOTE THE FOLLOWING PRIOR TO COMPLETING YOUR APPLICATION:


ALL REFERENCES TO HOST CELLS, VECTORS, GENES OF INTEREST, TRANSFECTION SYSTEMS,
ETC SHOULD INCLUDE SOME EXPLANATION OF THEM.
PLEASE WRITE THE NAMES OF THE GENES AND/OR PROTEINS IN FULL THE FIRST TIME RATHER
THAN USING ACRONYMS.
Use table 1 on page 9 if using multiple GMOs
Common and Scientific name of parent
organism(s):
The “parent organism” means the organism (or tissue
derived from an organism) that you propose to genetically modify.
You must provide genus and species names. For viruses, you
must provide the family name.
Vector(s) and method of transfer of
genetic material:
Please provide copies of references (or vector maps) for
novel vectors or methods of transfer. Also include the name of
the company supplying any commercially obtained vectors.
Is the host/vector system listed as an
Exempt host/vector system in Schedule 2
Part 2 of the Gene Technology
Regulation?
(Y/N)
Does this project involve viral vectors?
(Y/N)
Replication ability of viral vector?
(Replication
defective,
replication
competent or N/A)
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If your project involves the use of a replication defective viral vector please provide
an explicit description of the assay you intend to perform to exclude the presence of
replication competent virus. Please provide a copy of the reference for your
intended assay.
Does the viral vector packaging system contain a self-inactivating component e.g.
SIN?
Your
description should
include details on
the sensitivity of
detection.
(Y/N)
Briefly describe the viral vector including
the packaging cell line and/or plasmids:
Identity and function of the gene(s) responsible for
the modified trait:
The primary interest here is in the gene or genes
under study and the function of these gene(s). Please
list this information if known.
Such functional details are not required about gene(s)
commonly used as markers, for selection and/or any
other routine procedures. However it is necessary to
identify generally which type of gene will be used. For
example, amp gene (ampicillin resistance), neo gene
(neomycin resistance), gfp gene (green fluorescent
protein) etc.
From what organism were the gene(s) responsible
for the modified trait(s) isolated?
In regards to gene(s) commonly used as
markers, for selection and/or any other routine
procedures, please indicate the plasmid from which
these gene(s) were derived.
What are the organisms or tissues to be used in
association with the GMO(s)?
Please list all the organisms you intend to use in
association with the GMO(s), for example, mice to be
inoculated or fed with the GMO(s). In this case ‘mouse’
must be listed here.
SECTION 6.0: ADDITIONAL INFOMRATION FOR A GMO THAT IS A WHOLE PLANT OR IS TO BE USED IN
CONJUNCTION WITH A WHOLE PLANT:
The following information is required if you propose to deal with a GMO that is a whole plant or is to be
used in conjunction with a whole plant.
Applicable?
(Y/N)
If Applicable, to what stage of development are the
plants to be grown?
This relates to the potential spread of the GMO,
for example, if the plant produces pollen or seed.
What will be used as the growing medium for the
plants?
Please indicate the type of medium (soil or soil
substitute) to be used and how it will be subsequently
sterilised or disposed of.
SECTION 7.0: ASSESSMENT AND RISK MANAGEMENT:
What are the possible hazard(s) and the likelihood
and consequence of the hazard(s) occurring (i.e.
the risk) from the proposed genetic
modification(s)?
This relates to the occupational health and
safety of people undertaking the dealings, for example,
laboratory staff working in labs. If appropriate, include
comparisons to the unmodified organism.
What are the possible hazard(s) and the likelihood
and consequence of the hazard(s) occurring (i.e.
the risk) from an unintentional release of the
GMO(s) into the environment?
This relates to the general population exposed to
a GMO that is unintentionally released from
containment. If appropriate, include comparisons to the
unmodified organism.
Provide details of disposal methods of GMOs:
This includes arrangements for disposing of liquid and solid waste from the dealings and for disposing of
the carcasses of all animals inoculated with GMO(s).
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Are the GMOs being transported between
facilities or off campus? If yes, please
indicate why it will be required and what
arrangements will be made. Transport
includes: between the facilities listed in
your answer to Part 4.H; from a laboratory
to an autoclave or animal house; across
corridors which are not part of a certified
facility, to storage facilities etc.
What are the steps you will take in the event of an unintentional release of the GMO(s):
Include here spills procedures for liquid spills and plans to deal with the escape of any animals to be used
during the proposed dealings.
Note that it is required in the Act that the Regulator must be notified if there has been an unintentional release of
the GMO from containment. Your answer must include a sentence indicating that any unintentional release of the
GMOs will be reported to the University’s Biosafety Officer who will notify the OGTR.
Are there any other actions or precautions you will take to minimise risks posed by the proposed
dealing(s)? (After hours contact details optional)
These refer to precautions that are over and above that outlined in PC2 procedures or guidelines. For
example, when using pathogenic organisms during the genetic modifications it may be required that, in addition to
working in a biological safety hood, gloves will also be required for all manipulations.
SECTION 8.0: FACILITIES USED:
(i)
Campus:
Building:
Are these facilities certified?
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
(ii)
Campus:
Has this Manager approved the
use of this facility?
Building:
Are these facilities certified?
(Y/N)
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
Has this Manager approved the
use of this facility?
(Y/N)
SECTION 8.0: FACILITIES USED:
(iii)
Campus:
Building:
Are these facilities certified?
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
Has this Manager approved the
use of this facility?
(Y/N)
SECTION 8.0: FACILITIES USED:
(iv)
Campus:
Are these facilities certified?
Building:
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
Has this Manager approved the
use of this facility?
(Y/N)
SECTION 8.0: FACILITIES USED:
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(v)
Campus:
Building:
Are these facilities certified?
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
Has this Manager approved the
use of this facility?
(Y/N)
SECTION 8.0: FACILITIES USED:
(vi)
Campus:
Building:
Are these facilities certified?
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
Has this Manager approved the
use of this facility?
(Y/N)
SECTION 8.0: FACILITIES USED:
(vii) Campus:
Building:
Are these facilities certified?
Room:
Containment Level:
Facility certification number:
Name of Facility Manager:
Has this Manager approved the
use of this facility?
(Y/N)
Please indicate if facility certification is
required: (Include specific rooms if additional rooms
are required)
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Table 1 - Examples of responses to Section 5: The description of the GMO(s)
The “parent organism” means the organism(s) (or tissue derived from organisms) that you propose to genetically modify and “host” equates to “parent”.
Common
name of
parent
organism
Scientific name of
parent organism
Vector(s) and
method of transfer
of genetic material
Exempt
Host/vector
system?
Identity and
function of gene(s)
and organism of
origin
Organisms or
tissues to be
used with the
GMO(s)
NLRD
type PC1
(a)-(c)
Mouse
Mus musculus
Bacterial artificial
chromosomes
(BACs)
microinjected into
mouse embryos
(knockout IGFII)
no
IGFII from Macropus
eugenii (Tammar
Wallaby)
none
a
Thale
cress
Arabidopsis thaliana
Non tumorigenic
disarmed Ti plasmid
via vacuum
infiltration.
no
GFP gene from
Aequorea victoria
none
Human cell
line
HER911
Transfections with
replication deficient
adenovirus
no
EGFR from Mus
musculus
none
Bacteria
Enterophathogenic
Escherichia coli
Standard nonconjugative cloning
vector pUC,
pBluescript by
electroporation
no
E. coli DNA
fragments
Mus musculus will
be injected with
modified bacteria
Yeast
Saccharomyces
cerevisiae
Standard yeast
expression vector
yes
CDNA library from
Homo sapiens (to
investigate cell cycle
regulators- potential
oncogenes)
none
NLRD
type
PC2
(a)-(m)
b
c
d
Exempt
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Table 1 continued: The Table below can be used to enter your answers – add extra rows if required
Common
name of
parent
organism
Scientific name of
parent organism
(must include genus and
species name if
applicable)
Vector(s) and
method of transfer
of genetic material
Exempt
Host/vector
system?
Identity and
function of gene(s)
and organism of
origin
Organisms or
tissues to be
used with the
GMO(s)
NLRD
type PC1
(a)-(c)
NLRD
type
PC2
(a)-(m)
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SECTION 9.0: STATEMENT OF COMPLIANCE:
I certify that the GMO dealings associated with this project will comply with conditions and requirements as
required by the OGTR and the Griffith University Biosafety Committee at all times.
I declare that to the best of my knowledge, having made reasonable inquiries, the information herein is true and
correct. I understand that providing misleading information to the OGTR, deliberately or otherwise, is an offence
under Commonwealth law. (electronic signature or email title accepted)
Signature of Project Supervisor:
Date:
Please email the completed NLRD Application Form to the Griffith University Biosafety Committee at
ubc@griffith.edu.au
School and Faculty Recommendation
Head of School/Centre Director
Date:
Or Dean
Date:
Comments (if applicable):
SECTION 10.0: UBC EVALUATION:
The UBC has evaluated this dealing and agrees that it is a notifiable low risk dealing as specified by Schedule 3 of
the Gene Technology Regulations 2001.
Name of IBC:
Griffith University Biosafety Committee
Name of UBC Chair:
Signature of UBC Chair:
Date:
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