University of Sydney Institutional Biosafety Committee

This form is to be completed by the Principal Investigator/Project Supervisor and MUST be
submitted by the Principal Investigator only.
1.Name of Principal Investigator/Project Supervisor:
2. Project title(s):
3. Type of project proposal:
□ Exempt Dealing
□ NLRD
□ DNIR
4. Is this application to replace an expiring University of Sydney NLRD?
□ Yes (Go to question 5)
□ No
(Go to Question 8)
5. Expiring project title/s:
6. Expiring NLRD approval number/s:
7. Please confirm that all work covered under your expiring NLRD(s) is
covered under this new application:
□ Yes
□
No (If No please explain your answer)
Please highlight any significant changes between this application and your
expiring application within the body of this application.
8. RIMS Project ID Code: (for projects that are part of a funded research grant )

For completion by IBC.
IBC Reference Number
Application form created on 7 May 2015
Approval Date
1
University of Sydney Institutional Biosafety
Committee – Notification of a Notifiable Low Risk
Dealing (NLRD) application form
Part 1:
Project Supervisor
Project supervisor’s name:
Position within the organisation:
Relevant qualifications:
Relevant experience:
Contact details of the Project Supervisor
Business telephone number:
Mobile telephone number:
E-mail address:
Business Postal address:
Part 2: About the dealings with the GMO or
GMOs
To answer the questions in this Part, please firstly remove any explanatory text (including this text)
and then insert your answer directly under the question.
Please note that you must not commence your project without written approval from the IBC.
Application form created on 7 May 2015
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2.A
What are the classes of people you wish to be authorised to undertake dealings with
the GMO(s)?
“Class of people” includes Research Fellows, senior scientists, research assistants, technical
officers, PhD students, Honours students, etc. You need to try and encompass as many
classes as you can foresee that might work on this project into the future. Amendments to
NLRDs are not permissible. If you are working with animals, you must include animal house
staff as a class of person. If you are likely to need to engage a transport provider to transport
the GMO anywhere within Australia you must include transport provider as a class of person.
2.B
Describe the training and experience of personnel involved in the dealing.
2.C
Briefly describe the project, including the purpose and aims of the proposed dealing.
Please take no more than half a page for this answer.
Part 3: Type of Notifiable Low Risk Dealing in
relation to Schedule 3 (Parts 1 and 2 ) of
the Gene Technology Regulations
Please place an X in 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;
Application form created on 7 May 2015
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(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:
(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 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;
(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:
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(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
(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
(B)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
Application form created on 7 May 2015
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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.
Part 4:
Description of the GMO
In this part, a description of the GMO(s) is required. This includes a description of all of the GMO(s)
to be generated and/or used during the proposed dealings, for example, bacteria used for subcloning
steps, tissue culture cell lines etc.
Use Table 1 at the end of the application form if using multiple GMOs.
Please replace any explanatory text with your answers.
4.A
What are the common and scientific names of the 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.
4.B
What vector(s) and methods are to be used for the 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.
4.Ci)
For projects involving the use of replication defective non-retroviral vectors (eg AAV)
are the vectors made using plasmids only or a combination of plasmids and an
adenoviral helper virus?
Not applicable
Plasmids only
Plasmids + helper virus
Is the helper virus also replication defective?
Yes
No
Application form created on 7 May 2015
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4.Cii)
For projects involving the use of replication defective retroviral vectors, are third
generation replication defective viral vectors used?
Not applicable
Yes
No – 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.
Your description should include details on the sensitivity of detection.
4.Ciii) For projects involving the use of a replication defective viral vector, is the vector able
to transduce human cells?
Not applicable
Yes
No - please provide evidence eg information from supplier or information
regarding the protein envelope.
4.D
What are the 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.
If you are planning to work with transgenic or knockout mice strains, please list the strains that
you currently wish to use. If it is likely that you may wish to add additional strains in the future
that you are not yet sure about please add a paragraph to the effect: “Additional mouse strains
may be required in the future. Any additional mouse strain will comply with the requirements
of Part 1, item 1.1 of Schedule 3 of the Gene Technology Regulations i.e. no advantage will
be conferred on the animal as a result of the genetic modification and the animal will not be
capable of secreting or producing an infectious agent as a result of the genetic modification. I
will notify the IBC of additional strains and await approval prior to obtaining the additional
strains”.
If you choose to add this, you will not be required to submit an entire new application if you
wish to change the transgenic or KO mice in the future from the one/s you have nominated in
this application (assuming the rest of the project remains the same). You will only be required
to notify the IBC by email that you intend to import/obtain a new mouse line.
4.E
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.
4.F
What are the organisms or tissues to be used in association with the GMO(s)?
Application form created on 7 May 2015
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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.
4.G
Containment Facilities
Provide details of all facilities to be used for this NLRD. Add extra rows if required. Please
ensure that this table is complete. If you do not know the OGTR Certification number, please
obtain the information from the OGTR sticker on the room door.
Facility
No.
Room Number and
Building Number
Facility Type (eg
animal house,
laboratory etc)
Physical
Containment
Level (eg PC1,
PC2)
OGTR
Certification
Number
1
2
3
4
Part 5: Additional information 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
5.A
Not 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.
5.B
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.
5.C
If plants are to be grown to seed, what procedures are in place to prevent accidental
release of seeds into drains?
5.D
If plants are to be grown to seed, what procedures are in place to prevent seeds
escaping onto the floor/ground and being walked out of the facility on shoes?
Part 6:
Risk assessment and management
Application form created on 7 May 2015
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In this Part please briefly describe, in no more than half a page, the risks the proposed dealings pose
to the health and safety of people and the environment
To answer the questions below, please firstly remove any explanatory text and then insert your
answer directly under the question.
6.A
What are the possible hazards and the likelihood and consequence of the hazards
occurring (ie 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 the facility/s. Include comparisons to the unmodified
organism.
Your answer also needs to consider the possible impact on the environment should there be
an accidental release. Include comparisons to the unmodified organism.
6.B
Do you propose to transport the GMO(s) outside a certified facility?
If you propose to transport the GMO(s) 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.G; from a laboratory to an autoclave or animal house; across corridors which are not
part of a certified facility, to storage facilities, to other organisations etc. It is not sufficient to
state that transport will be in accordance with the OGTR guidelines – you must be more
specific than this.
If you will be engaging a transport supplier to transport GMOs on your behalf, you will need to
provide the IBC with documentation from the transport provider that demonstrates their
employees are trained in the relevant aspects of the OGTR transport guidelines. The IBC will
then review this documentation and decide if they feel the documentation is adequate.
6.C
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 1 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/storageanddisp-3/$FILE/tsdguidelines.pdf).
6.D
How will the GMO(s) be disposed of?
This includes arrangements for disposing of liquid and solid waste from the dealings and for
disposing of the carcasses of all GMO animals or animals inoculated with GMO(s).
6.E
What are the steps will you take in the event of an unintentional release of the GMO(s)
outside the certified PC2 facility?
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.
Application form created on 7 May 2015
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Table 1 - Examples of responses to Part 4: The description of the GMO(s) – Please delete this example table and complete the blank table below
The “parent organism” means the organism(s) (or tissue derived from organisms) that you propose to genetically modify and “host” equates to “parent”.
4.A
Scientific name of
parent organism
4.B
Vector(s) and
method of transfer
4.D and 4.E
Identity and
function of gene(s)
and organism of
origin
4.F
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)
IGFII from Macropus
eugenii (Tammar
Wallaby)
none
a
Thale
cress
Arabidopsis thaliana
Non tumorigenic
disarmed Ti plasmid
via vacuum
infiltration.
GFP gene from
Aequorea victoria
none
Human cell
line
HER911
Transfection with
replication deficient
adenovirus
EGFR from Mus
musculus
none
Bacteria
Enterophathogenic
Escherichia coli
Standard nonconjugative cloning
vector pUC,
pBluescript by
electroporation
E. coli DNA
fragments
Mus musculus will
be injected with
modified bacteria
Yeast
Saccharomyces
cerevisiae
Standard yeast
expression vector
CDNA library from
Homo sapiens (to
investigate cell cycle
regulators- potential
oncogenes)
none
Common
name of
parent
organism
Application form created on 7 May 2015
NLRD
type
PC2
(a)-(m)
b
c
d
Exempt
10
Table 1 continued: The Table below can be used to enter your answers – add extra rows if required
Common
name of
parent
organism
4.A
Scientific name of
parent organism
4.B
Vector(s) and
method of transfer
(must include genus and
species name if
applicable)
Application form created on 7 May 2015
4.D and 4.E
Identity and
function of gene(s)
and organism of
origin
4.F
Organisms or tissues
to be used with the
GMO(s)
NLRD
type PC1
(a)-(c)
NLRD
type
PC2
(a)-(m)
11
Part 7: Signatures
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.
Project Supervisor
Signature: ________________________Date: ______________________________
Printed Name: _______________________________________________________
IBC Chair
Signature: ________________________Date: ______________________________
Printed Name: ________ Professor Anthony Weiss _________________________
Application form created on 7 May 2015
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