INSTITUTIONAL BIOSAFETY COMMITTEE
GMO Notifiable Low Risk Dealing
(NLRD) Application Form
For questions about whether a dealing should be classified as an Exempt Dealing (ED), Notifiable Low Risk Dealing (NLRD)
or Dealing Not involving an Intentional Release (DNIR), please contact the relevant IBC directly, prior to completing forms
(Perkins: Kathy Davern [email protected], UWA: [email protected])
Submit the completed form to [email protected] or [email protected] Biosafety office at UWA accepts
sender’s email or e-signature as a way of authentication without ink signature.
OTHER CLEARANCES – If this section is incomplete your application will be returned.
Clearance Required
Yes
No
Approval period
Start/Finish
APPROVAL
NUMBER
Human Ethics
Animal Ethics
Carcinogen clearance
Radiation clearance
Dept of Agriculture
Any other State or Federal Permits
GTAS or other evidence of GM
training (please provide certificate or
badge)
General information about notifications of a Notifiable Low Risk Dealing
Notification of a notifiable low risk dealing
This notification is for an NLRD under the Gene Technology Act 2000 (Commonwealth) (the Act) and
corresponding State law.
According to the Act, to “deal with, in relation to a GMO, means the following:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
conduct experiments with the GMO;
make, develop, produce or manufacture the GMO;
breed the GMO;
propagate the GMO;
use the GMO in the course of manufacture of a thing that is not a GMO;
grow, raise or culture the GMO;
import the GMO;
and includes the possession, supply, use transport or disposal of the GMO for the purposes of, or in the
course of, a dealing mentioned in any of (a) to (g).”
Providing information to the Office of the Gene Technology Regulator (OGTR)
Accuracy of information
Please answer all questions unless otherwise indicated. Check carefully before you submit your
notification that all the information it contains is accurate.
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The Act provides for penalties to a person who gives information to the Regulator that they know to be
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 place it at the end of this application (after Part 8).
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 NLRD notification, or other
circumstances specified by the Gene Technology Act 2000 (Commonwealth). In certain circumstances
information supplied as part of a NLRD 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.
Information regarding notifications received by the OGTR will be published at
www.ogtr.gov.au/ogtr/gmorec/nlrd.htm. This is a public record and includes, for each notification, the
project title, organisation name and the kind of NLRD.
Abbreviations:
The Act
CCI
NLRD
DIR
DNIR
GMAC
GMO
IBC
OGTR
PC1, 2 etc
The Regulations
NLRD Form v1 2017
The Gene Technology Act 2000 (Commonwealth)
Confidential Commercial Information
Notifiable Low Risk Dealing
Dealings involving an Intentional Release of a GMO into the environment
Dealings NOT involving an Intentional Release of a GMO into the
environment
Genetic Manipulation Advisory Committee
Genetically modified organism
Institutional Biosafety Committee
Office of the Gene Technology Regulator
Physical Containment Level 1, 2 etc
The Gene Technology Regulations 2001 (Commonwealth)
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1. PROJECT TITLE:
☐ an initial application; or
☐ a renewal
Is this application?
Previous IBC identifier number(s) if it is a
renewal
2. PRINCIPAL INVESTIGATOR OR PROJECT SUPERVISOR
Name and Job title:
School or Centre or group:
Telephone no:
Mobile no:
Email:
Relevant experience
(experience handling GMOs
and/or working inside OGTRcertified facilities):
Proof of UWA GTAS and/or Yes ☐ Please indicate the year you did the course(s):
Biosafety training
No ☐ Please Log on to www.lms.uwa.edu.au to do the course(s)
Other Researchers including students:
List all personnel working on this NLRD and the positions they hold, with relevant GM experience.
Please note that proof of training in gene technology will be required, and the course is available online
via the UWA Biosafety website.
Name (incl. title):
Role /experience / proof of GTAS and or Biosafety training:
[Insert additional rows for additional investigators]
3. ABOUT THE DEALINGS WITH THE GMO(S):
3A. Expected date of commencement
3B. Expected date of completion (5 years maximum)
3C. Does this project utilise the genome editing tool Yes ☐ or No ☐
CRISPR/Cas9?
3D. Project Description
(including the purpose
and aims of the dealing)
Extracts from grant proposals are acceptable.
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4. DESCRIPTION OF GMO(S)
COMMON SCIENTIFIC NAME
NAME OF
OF PARENT
PARENT
ORGANISM
ORGANISM
VECTOR(S) AND METHOD OF
TRANSFER
EXEMPT IDENTITY AND FUNCTION OF GENE(S) AND
HOST/
ORGANISM OF ORIGIN
VECTOR
SYSTEM?
NLRD
TYPE* see
Appendix
1
e.g. Mouse
Mus musculus
No
PC1a
e.g. E. coli
Gal- SW102 E. coli
strain which is
unable to use
galactose as a
carbon source or
DH10B E. Coli
strain which is
allows for
kanamycin
selection
‘Knock out’ mice were generated by
recombination of the transgene conferring an
inactivating mutation of the gene of interest in
mouse embryonic stem cells
Homologous recombination into a
bacterial artificial chromosome (BAC)
expressing the mouse cytomegalovirus
MCMV genome
No
Balb/c Rag KO
These mice are mutated in the V(D)J recombination
activation gene RAG-1 thus they are unable to generate
mature B and T cells
Epitope tags inserted into the 3’ end of the
ie1 gene.
OVA - (chicken) marker T cell epitopes
and marker genes to assess immunity to
MCMV
HA - (Influenza A/PR/8/1934 (H1N1) -not
infectious in humans, however is
pathogenic in mice) marker T cell epitopes
and marker genes to assess immunity to
MCMV
HEL – (chicken) hen egg lysozyme T cell
epitope
Ealpha – (mouse) IE class II molecule
alpha chain T cell epitope
[Insert additional rows when necessary]
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PC2.1d
5. USE OF WHOLE PLANTS (GO TO 6 IF NOT APPLICABLE)
5A. Is the parent organism (that which is to be modified) a weed or closely related to plants
that are weeds?
5B. 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.
5C. 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.
6. RISK ASSESSMENT AND MANAGEMENT:
HEALTH AND SAFETY OF PEOPLE:
6A. What are the possible hazard(s) to people 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.
6B. What are the possible hazard(s) to people 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?
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This relates to the general population exposed to a GMO that is unintentionally released from containment. If appropriate, include
comparisons to the unmodified organism.
ENVIRONMENT:
6C. What are the possible hazard(s) to the environment 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 environment exposed to a GMO that is unintentionally released from containment. If appropriate, include
comparisons to the unmodified organism.
6D. Please provide information for all the facilities to be used:
Facility 1
Facility 2
Room Number
Facility 3
Building Name
Facility Type*
Physical Containment
Level (eg PC2)
OGTR Certification
Number**
Dates of
certification**
Facility contact
person (name and
email/ phone)
* Facility type = Laboratory, Animal House, Plant House or Other
** OGTR Certification number and dates of certification can be found on the OGTR sticker on the door of the facility.
6E. Do you propose to transport the GMO(s) outside a certified facility? IF YES, provide details.
Specify how the OGTR transport guidelines will be met (see:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/transport-guide-1 )
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 6D; from a laboratory to an autoclave or animal house; across
corridors which are not part of a certified facility, to storage facilities etc.
6F. How will the GMO(s) be disposed of?
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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). If a commercial waste disposal company is involved, name it. Also describe where, and for how long, the bins are stored before
being picked up by the disposal company.
6G. What are the steps you will take in the event of an unintentional release of the GMO(s)
outside the PC2 certified 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.
6H. Are there any other actions and precautions you will take to minimise risks posed by the
proposed dealing(s)?
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.
7. COMMERCIAL VALUE:
Does this research or its commercial outputs have actual or potential commercial value? Please
delete all rows that are not applicable to this research on the table below:
IP type
Potential Value
Range*
Extremely desirable / $10m+
commercially valuable
IP
Moderately desirable / $1m - $10m
commercially valuable
IP
Response
Storage in safe or equivalent with custom designed
access lists. Access limited in accordance with
specific grant conditions. Data encrypted.
Storage in safe or equivalent with custom designed
access lists. Safe/key access restricted to research
team and facilities. Data encrypted.
Low
level
desirability
commercial value
of $10,000 - $1m
or
Storage in lockable storage and/or secure
room. Key access restricted to research team and
facilities. Normal data protocols
Negligible
or
desirability
commercial value
nil <$10,000
or
No specific requirements. At discretion of research
team. Normal data protocols.
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m = million
Have you considered potential critical incident risks of the project and the minimum equipment
requirements
to
deal
with
those
risks?
Please
go
to
http://www.staff.uwa.edu.au/procedures/risk/management and indicate below that you have
considered risks and how to mitigate them
.Critical incident risk
Equipment requirements
8. DECLARATION
I declare that to the best of my knowledge, having made reasonable enquiries, 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 Name
Signature
Date
Head of School or Representative Name
Signature
Date
UWA policy deems this document as signed, if you send it attached to an email from your
UWA email address.
For example, the form can be filled out by the CI, emailed as an attachment to the Head of
School, and then the HOS Forward to the Biosafety office at [email protected] – this
method avoids the need for ink signatures, preserves the best available viewing and search
quality, saves paper and saves time.
If you are submitting this application to the Perkins’ IBC, once you have completed and signed this form,
email it to the IBC Office: [email protected]
APPENDIX 1: NLRD TYPE FOR Q4
To determine NLRD type, see the OGTR guidelines here:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/nlrdsSept2011-excerpt-htm
(Types of Dealings with GMOs classified as NLRDs: Excerpt from the Gene Technology Regulations
2001).
Physical Containment Level 1 (PC1) is outlined in Schedule 3, Part 1. NLRD type will be either PC1a
or PC1c, based on the definitions in these Regulations.
PC2 is outlined in Schedule 3, Part 2, Section 2.1. NLRD type will be PC2.1 (a) or (aa) or … or (m),
based on the definitions in these Regulations.
PC3 is outlined in Schedule 3, Part 2, Section 2.2.
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Details of the IBC that has considered the classification of this NLRD:
Name of the IBC:
Name of the IBC Chairperson:
Business phone number:
Email address:
Name of IBC Manager:
Business phone number:
Email address:
Street address:
Postal address:
UWA
Charlene Kahler
08 6457 2058
[email protected]
Caixia Li
08 6488 4701
[email protected]
35 Stirling Hwy, Crawley, WA 6009
M459, UWA, Research Integrity, Biosafety Office, 35 Stirling Hwy,
Crawley, WA 6009
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