ROYAL NORTH SHORE HOSPITAL
INSTITUTIONAL BIOSAFTEY COMMITTEE
Please note that this form has been temporarily amended to include the current
classifications for NLRD as per the current OGTR Regulations 2001 amended 2011.
Part 5 of this application is currently receiving review and does not fully reflect the current
Regulations.
Part 6 of this application has been amended to include the current Regulations and should
be used when classifying dealings listed within this application.
Notification of a
Notifiable Low Risk Dealing (NLRD)
Notifying Organisation Name:
____________________________________________________________
Accreditation Number*: ACCR _________________[ IBC use only ]
* If organisation is accredited by the Gene Technology Regulator
NLRD Project Title:
IBC use only
IBC Project Reference Number:
Is this notification accompanied by an application for a declaration that certain information be
treated as Confidential Commercial Information (CCI) ?
Yes
No
If the CCI is covered by previous CCI application(s), please provide the CCI application number(s)
here:
____________________________________________
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General Information
Notification of a notifiable low risk dealing (NLRD)
This notification is for a new NLRD under the Commonwealth Gene Technology Act 2000 (the Act) and
corresponding State law.
As stated in Regulation 13 of the Gene Technology Regulations 2001 (as amended with effect from 1
September 2011 by the Gene Technology Amendment Regulations 2011);
13 Requirements for undertaking notifiable low risk dealings
(1) A person may undertake a notifiable low risk dealing only if:
(a) a person or an accredited organisation has prepared and submitted a written proposal for an
Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing;
and
(b) the Institutional Biosafety Committee has assessed the dealing to be a notifiable low risk
dealing mentioned in Part 1 or 2 of Schedule 3;
Accuracy of information
Please answer all questions unless otherwise indicated in terminology understandable by a nonscientist. Please check that the information provided in this notification is true and accurate. The Act
provides for penalties to a person who knowingly gives information to the Regulator that is false or
misleading.
Confidentiality
If you wish to make an application for a declaration that specifies information is Confidential
Commercial Information (CCI) for the purposes of the Act, you must also complete the CCI application
form available at www.ogtr.gov.au and submit it at the same time as this notification.
Privacy
Any personal information is safeguarded by the Privacy Act 1988. This prevents the submitted
personal information from being used for purposes other than assessing the certification application, or
other circumstances specified by the Gene Technology Act 2000 (Commonwealth). In certain
circumstances information supplied as part of a notification may, according to their specific needs, be
given to the following:
 an officer or employee of the Department of Health and Ageing;
 an officer or employee of a State government agency or organisation;
 Courts, Tribunals and/or other Commonwealth agencies where it is an obligation under law to
provide it;
 law enforcement authorities; and
 the relevant Minister.
Authorisation
Please ensure that if you are completing this notification on behalf of the organisation, you hold the
proper authority to submit this application on behalf of the organisation.
Resubmission of amended form
If amendments have been requested by the IBSC committee, please provide a cover letter
outlining the amendments AND an amended version of the original IBC Application with all
changes to the protocol underlined and bolded.
For further information
Phone: 9926 4590 or E-mail: Research@nsccahs.health.nsw.gov.au
The completed notification can be lodged at the following address:
Research Office
Secretary, RNSH IBC
Research Office, Level 13 Kolling Building (6)
Royal North Shore Hospital
In addition, a pdf file of the completed form should be emailed to:
Research@nsccahs.health.nsw.gov.au
Please note: you should retain a copy of your completed notification for your own records.
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Part 1: Notification Contact Details
Details of the person the OGTR can contact regarding this notification (usually the
Project Supervisor)
Preferred first
name:
Surname:
Personal title:
(eg Ms/Mr/Dr)
Job title:
Phone number:
Fax number:
Mobile number:
E-mail
address:
Street number and name:
Town/City:
State:
Postcode:
Country:
Postal address:
(if different)
Details of the Institutional Biosafety Committee that has considered the
classification of this Notifiable Low Risk Dealing
Name of IBC:
Royal North Shore
Name of IBC Chairperson:
Anthony Ashton
Business telephone number:
9926 4500 (reception); 9926 4828 (office)
Facsimile number:
9926 5266
E-mail address:
anthony.ashton@sydney.edu.au
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Additional Project Personnel: Detail Personnel involved with this project including
name, qualifications, microbiological or other relevant PC2/GMO experience and
role in the project team (Delete or add personnel as required).
Additional Personnel 1
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and
PC2/GMO Experience
Relevant to the dealings
in this project
Additional Personnel 2
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and
PC2/GMO Experience
Relevant to the dealings
in this project
Additional Personnel 3
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and
PC2/GMO Experience
Relevant to the dealings
in this project
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Part 2:Description of the Dealings and GMO(s)
This table is intended to generate a concise, accurate record of all the GMOs to be generated or used and the purpose of the
proposed dealings. Part 5 provides example reference responses to the description of the GMOs. Part 6 provides information relating
to the completion of the column headed ‘NLRD Type’.
Name of Organisation
_______________________________________
Reference Number __________________________
1. Briefly describe the proposed dealing(s) and the purpose of conducting these dealing(s), in the space (box) below. The term 'dealings', in
relation to a genetically modified organism (GMO), is defined in the Gene Technology Act 2000 (the Act) as any of the purposes listed below:
a. conduct experiments with the GMO;
d. breed the GMO;
e.
b.
make, develop, produce or manufacture the GMO;
propagate the GMO;
f.
grow, raise or culture the GMO;
h. use the GMO in the manufacture of an object that is not the GMO itself;
i.
c.
g.
dispose of the GMO
import the GMO;
transport/storage of the GMO
NB: If tumour cells are being implanted into mice please outline how researchers will minimise the risk of “accidental transfer” to the researcher
during implantation and collection.
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2.
Please outline the management and disposal strategy for GMO waste. Please specify the strategies for solid waste, and liquid waste,
biological spills, bacterial broth, viral/plasmid vectors, animal carcasses, tumours, etc. as appropriate. Specify the decontamination agent,
final concentration (v/v% or w/v%) and contact time. [Please refer to OGTR guidelines and the Australian Laboratory Standard
AS/NZ2243(.3) for approved waste management options]
3.
For Users of (retroviral/adenoviral/lentiviral) vectors/delivery systems please provide details of the experience of project personnel with
such vectors and details of any additional training as per OGTR guidelines. As of 1 September 2011, the Gene Technology Regulator
amended the Commonwealth Gene Technology Regulations (2001) on dealings with viral vectors. The regulations now include criteria by
which IBCs assess whether the listed personnel have the appropriate training and experience to undertake the indicated dealings. [Please refer
to OGTR guidelines at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/viralvec-assessment2011-htm]
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Please provide details of the proposed dealings in the table below. [Please refer to Parts 5 & 6 for examples and details of NRLD
types]
COMMON NAME OF
PARENT ORGANISM
SCIENTIFIC NAME OF
PARENT ORGANISM
VECTOR(S) & METHOD OF TRANSFER
IDENTITY & FUNCTION OF NUCLEIC ACID &
ORGANISM OF ORIGIN
(include what is known regarding pathogenic or
oncogenic potential)
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If the work involves
animals indicate
ACEC approval No.
and expiry date
NLRD
TYPE
Part 3: Containment Facilities
Please provide information for all facilities to be used in connection with this NLRD
FACILITY NAME
eg. lab group/division
a.Please
FACILITY ADDRESS
TYPE
eg. room, level, building
eg.PC1a
PC2
OGTR ID
CERT
/
CERT
/
CERT
/
CERT
/
CERT
/
note that the RNS IBC have no certified PC1 laboratories
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EXPIRY DATE
Part 4: Declaration
Declaration of the organisation submitting this notification
This declaration must be signed by the CEO or another person with the authority to
sign on behalf of the organisation (laboratory).
PART A
 Please provide approval for use of the indicated laboratory in Part 3
Laboratory Representative/Head of Group
Printed
name:
Signature:
Job title:
Date:
PC2 Manager for the proposed laboratory
Printed
name:
Job title:
Signature:
Level ***; PC2 Floor Manager
Printed
name:
Job title:
Date:
Signature:
Level ***; PC2 Floor Manager
Date:
Kearn’s Facility Manager (as required)
Printed
name:
Giselle Bellamy
Signature:
Job title:
PC2 Manager, Kearn’s Facility
Date:
PART B
I DECLARE THAT:

I am duly authorised to sign this declaration;

The Institutional Biosafety Committee detailed in Part 1 of this form has
confirmed that the dealings listed in this notification are Notifiable Low Risk
Dealings;

Persons undertaking these dealings have been notified in writing that the
dealings are NLRDs; and

Personnel involved in the dealings have appropriate training and experience.
Organisation Representative
Printed
name:
Job title:
Karyn Joyner
Signature:
COO, Research
Date:
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Part 5: Examples of responses to Part 2 - Description of the GMO(s)
Note: “Parent Organism” means organism(s) (or tissue derived from organisms) that you propose to genetically modify. “Host” equates to “Parent”.
COMMON NAME OF
PARENT ORGANISM
Rat
SCIENTIFIC NAME OF
PARENT ORGANISM
VECTOR(S) & METHOD OF TRANSFER
IDENTITY & MODIFIED TRAIT/ FUNCTION OF
GENE(S) & ORGANISM OF ORIGIN
NLRD
TYPE
Rattus norvegicus
(list breed)
Transgene (type) microinjected into eggs
Overexpression of human metabolic
enzyme from transgene (description).
A
Human cultured
cells
Human cell line (list type)
Standard non-conjugative plasmid expression vector
transfected by lipofeection into cells
Expression of wild type and mutant
oncogenes isolated from Homo sapiens
B
Human cultured
cells
Human cell line (list type)
Transduction by replication defective human adenoviral
vector.
Expression of wild type and mutant
metabolic genes isolated from Homo
sapiens.
C
Danio rerio
Plasmid
microinjected into embryos.
Expression of green fluorescent protein
(GFP) from Aequorea victoria
(a)
Mus musculus
(list breed)
Bacterial artificial chromosomes (BACs) microinjected
into mouse embryos
Growth hormone from various Mus species
(a-1)
Arabidopsis thaliana
Non tumorigenic disarmed Ti plasmid via vacuum
infiltration.
Expression of pigment related genes from
Arabidopsis species.
(b)
Vibrio harveyi
Standard non-conjugative plasmid expression vector by
electroporation.
Expression of cell surface antigen
fragments from V. cholerae
(c)
Escherichia coli (pathogenic
strains)
Standard non-conjugative cloning vector pUC,
pBluescript by electroporation.
Expression of defective virulence genes
from E. coli
(d)
Human cell line (list type)
Replication defective human adenoviral vector.
Expression of wild type and mutant
oncogenes isolated from Homo sapiens.
(e)
Escherichia
Escherichia coli K12
Standard non-conjugative plasmids.
Expression of insulin gene from Homo
sapiens
(f)
Salmonella
Salmonella enterica
Conjugative plasmids.
Complementation of single virulence
related genes from S. enterica into knockout host
(g)
Escherichia
Escherichia coli K12
Non-conjugative plasmids by electroporation.
cDNA library from Clostridium toxin
producing species
(h)
Human cell line (HEK-293)
Transduction by replication defective 3rd generation
lentiviral vector
Expression of green fluorescent protein
from Aequorea victoria
(i)
Zebrafish
Mouse
Thale cress
Vibrio
Escherichia
Human cultured
cells
Human cultured
cells
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Part 6: NLRD Classification Guide
NLRD categories as from 1 September 2011 - posted 1 September 2011
The columns Schedule, Part and Kind of Dealing requires that you select one of the following
categories which best describes the dealing with the GMO(s) – as per Schedule 3 Part 1 of the
Gene Technology Regulations 2001 (as amended by the Gene Technology Amendment
Regulations September 2011).
Part 1 of Schedule 3 of the Regulations describes the types of dealings with GMOs that are
classified as NLRDs suitable for physical containment level 1.
Part 2 of Schedule 3 describes the types of dealings that are classified as NLRDs suitable for
physical containment levels 2 and 3.
This information can also be viewed on the OGTR website
Schedule 3 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;
*(b) N.B: Dealings formerly classified as Schedule 3 Part 1.1b “a dealing involving a
host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid
confers an oncogenic modification” now fall into the following categories (of the
2011 amended Regulations):Schedule 3, Part 2.1e (NLRD PC2 or PC3) *(b) is no
longer an available response
(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.
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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)
(B)
(C)
(D)
(E)
a genetically modified laboratory guinea pig;
a genetically modified laboratory mouse;
a genetically modified laboratory rabbit;
a genetically modified laboratory rat;
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 Caenorhabditis elegans, if:
(i)
(ii)
(b)
the genetic modification confers an advantage on the animal; and
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;
(c) 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;
(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:
(A)
(B)
(C)
(D)
human beings; or
animals; or
plants; or
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;
See example next page
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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)
(b)
(c)
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 otherwise healthy:
(A)
(B)
(C)
(D)
human beings; or
animals; or
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;
Example
A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the
parent organism:
(a)
(b)
(c)
provides an advantage; or
adds a potential host species or mode of transmission; or
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:
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(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the donor nucleic acid does not:
(A)
(B)
confer an oncogenic modification in humans; or
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)
(B)
confer an oncogenic modification in humans; or
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.
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)
(b)
certified to at least physical containment level 3; and
appropriate for the dealing.
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