Office Use Only
IBC Ref. No. : …………...................
NOTIFIABLE LOW RISK DEALING
(NLRD) APPLICATION FORM
FLINDERS INSTITUTIONAL BIOSAFETY COMMITTEE
Use this form to apply for approval for a project involving gene technology (including GMOs) classified
as a Notifiable Low Risk Dealing (NLRD). Refer to Schedule 3 of the Gene Technology Regulations 2001
for information regarding NLRDs:
http://www.comlaw.gov.au/Details/F2011C00732/Html/Text#_Toc302474564
1) Chief Investigator’s Details
Name:
Contact details: Phone:
Email:
Discipline/Department/School:
Room no.:
Are you employed by Flinders University?
Yes
/ No
If no, who are you employed by, and what is your affiliation with Flinders University?
2) Contact person for this application (if not the Chief Investigator as listed above)
Name:
Contact details: Phone:
Email:
Discipline/Department/School:
Room no.:
3) Project Information
Project Title:
Is this project Commercial in Confidence (CIC)?
Yes
/ No
If yes, please provide an expurgated project title which will be included in the Annual Report to the
OGTR.
Expurgated Project Title (if CIC) :
Lay Summary: to be written in simple, understandable language
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 1 of 12
4) IBC Significance
Describe the IBC significance of the dealing to be undertaken in clear language. This
information will be supplied to the OGTR in the Annual Report. If Commercial in
Confidence, please include as an expurgated summary.
Consider the breadth and scope of all activities in relation to the dealings including any
importation, transport, storage or disposal of the GMO. Include the identity and source of donor
nucleic acid, including common and scientific names of the donor/parent organism(s), intended
use/purpose of the GMO(s) (e.g. cultured in vitro), genetic modification(s), method of genetic
modification and expected phenotype/trait/outcomes.
Refer to Section 10 of the Gene Technology Act 2000 for a definition of “deal with” in relation to
dealing with a GMO.
Importation Details:
Transportation Details:
Storage Details:
Disposal Details:
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 2 of 12
5) Genetically Modified Organism (GMO) Insert details where applicable
Class of GMO
Algae
Animal
Bacteria
Fungi
Plant
Protozoa
Virus
Human
Details
6) Modified Trait(s) and Gene(s) Responsible Insert details where applicable
Class of Modified Trait
Virus resistance
Fungal resistance
Bacterial resistance
Disease resistance
Pest resistance
Herbicide tolerance
Antibiotic resistance
Pesticide resistance
Abiotic stress resistance
Altered agronomic characteristics
Altered horticultural characteristics
Altered nutritional characteristics
Altered physical product characteristics
Altered physiological characteristics
Altered pharmaceutical characteristics
Attenuation
Antigen expression
Protein expression
Growth factor expression
Altered biosensor characteristics
Altered bioremediation characteristics
Altered biocontrol characteristics
Reporter marker gene expression
Immuno-modulatory protein expression
Other
Details
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 3 of 12
7) Description of the GMO(s) For examples of how to complete this section, see table
below
Common
Name of
Parent
Organism
Scientific
Name of
Parent
Organism
Vector(s) & Method of
Transfer
Exempt Host /
Vector
System?
Yes
/ No
Yes
/ No
Yes
/ No
Yes
/ No
Yes
/ No
Yes
/ No
Identity & Function of
Nucleic Acid and
Organism of Origin
NLRD
Type
(Must be
specific –
e.g. Part 1,
1.1, (a) (ii))
Examples of responses to above table - Description of the GMO(s)
Note: “parent organism” means organism(s) (or tissue derived from organism(s)) that you propose to
genetically modify. “Host” equates to “Parent”.
Common
Name of
Parent
Organism
Mouse
Scientific
Name of
Parent
Organism
Mus musculus
Human cultured
cells
Vector(s) & Method of
Transfer
Exempt Host /
Vector
System?
Standard non-conjugative
plasmid expression vector
microinjected into embryos
Yes
/ No
Human cell line
(HEK-293)
Replication defective human
adenoviral vector.
Yes
/ No
Zebrafish
Danio rerio
Plasmid : microinjected into
embryos
Yes
/ No
Mouse
Mus musculus
Yes
/ No
Thale cress
Arabidopsis
thaliana
Bacterial artificial
chromosomes (BACs)
microinjected into mouse
embryos
Non tumorigenic disarmed Ti
plasmid via vacuum infiltration
Yes
/ No
Vibrio
Vibrio harveyi
Yes
/ No
Escherichia
Escherichia coli
(pathogenic
strains)
Human cell line
(fibroblast cell
line)
Escherichia coli
K12
Standard non-conjugative
plasmid expression vector by
electroporation.
Standard non-conjugative
cloning vector pUC,
pBluescript by electroporation
Replication defective human
adenoviral vector
Yes
/ No
Yes
/ No
Standard non-conjugative
plasmids
Yes
(> 25L)
Human cultured
cells
Escherichia
Identity & Function of
Nucleic Acid and
Organism of Origin
NLRD
Type
Expression of neomycin
resistance gene and knockout of Vitamin D receptor
gene
Expression of green
fluorescent protein (GFP)
from Aequorea victoria
Expression of green
fluorescent protein (GFP)
from Aequorea victoria
Growth hormone from
various Mus species
1.1(a)
Expression of pigment
related genes from
Arabidopsis species.
Expression of cell surface
antigen fragments from V.
cholerae
Expression of defective
virulence genes from E.coli.
2.1(b)
Expression of wild type and
mutant oncogenes isolated
from Homo sapiens.
Expression of insulin gene
from Homo sapiens.
2.1( j )
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
1.1(c)
2.1(a)
2.1(aa)
2.1(c)
2.1(d)
2.1( f )
Page 4 of 12
8) Containment Facilities
List details of facilities where work is to be conducted.
Building/Facility Name & Room Number
PC Level (PC1/PC2)
OGTR Cert. ID#
9) Storage Information
Where will you store any GMOs associated with this project if different to (8) above?
Location
Building(s)
Room no(s)
(e.g. locked
freezer/fridge)
10) Access to Other Facilities
Please list any other common service facilities or equipment (e.g. Confocal Microscopy Suite,
Bioprocessing Facility) in which the microorganisms are likely to be handled and attach a signed
letter of approval or email from the Head of that section.
11) Department of Agriculture (formerly AQIS) Approval
Does this project require Dept. of Agriculture (formerly AQIS) approval
for importation? http://www.agriculture.gov.au/biosecurity
Yes
/ No
If yes, please provide the permit no.:
Please attach a copy of the permit with this application.
http://www.flinders.edu.au/mnhs/staff/safety-facilities/permits.cfm
12) Material Transfer Agreement (MTA)
Does this project require a Material Transfer Agreement (MTA)?
Yes
/ No
If yes, has the MTA been submitted?
Yes
/ No
If yes, has the MTA been finalised?
Yes
/ No
If yes, please attach a copy of the signed MTA - if pending, please forward once approved.
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 5 of 12
13) Animals
Yes
Does this project involve the use of animals?
If yes, have you received approval from the Animal Welfare
Committee?
Yes
/ No
/ No
/ Pending
If yes, please attach a copy of the signed approval, if pending, please forward once approved.
AWC Approval No.:
If no, please ensure that you submit an application to the Animal Welfare Committee.
http://www.flinders.edu.au/research/researcher-support/ethics/committees/animal/animal_home.cfm
14) Human Tissue
Does this project involve the use of human tissue?
If yes, have you received approval from the Southern Adelaide
Clinical Human Research Ethics Committee (SACHREC)?
Yes
Yes
/ No
/ No
/ Pending
If yes, please attach a copy of the signed approval, if pending, please forward once approved.
Ethics Approval No.:
If no, please ensure that you submit an application to the SA HREC.
http://www.flinders.sa.gov.au/research/pages/ethics/
15) Is this research part of a student’s post-graduate project?
Yes
/ No
If yes, who is the student’s supervisor? Name:
16) Training – Chief Investigator / Supervisor
Yes
/ No
Yes
I have attended a Flinders Biosafety Training Day within the last 3 years
Please give details of relevant experience with gene technology and/or GMOs:
/ No
I have read the Biosafety Manual
Signature :
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 6 of 12
Training – Other Personnel
Please ensure that all staff and students who will be working on this project fill in and sign the table
below (attach extra sheet if necessary)
Name
e.g. Robin Smith
Staff/
Student
Category*1
Have read
Biosafety
Manual
Research
staff
Yes
Have Received a Biosafety
Training Certificate
At Flinders
At another
institution
Yes/
If
Yes
If
If yes,
No
yes, /No yes,
where
year
year
Yes
2012 Yes 2005
Adel.
Uni
Signature
RSmith
*1Select
category from the following: research staff, research student (post-graduate),
undergraduate (including honours, placement and summer scholarship students).
NOTE: It is the supervisor’s responsibility to ensure that all students and staff involved in the
project attend the annual Biosafety Training Day and are familiar with the contents of the
Biosafety Manual:
http://www.flinders.edu.au/research/researcher-support/ebi/biosafety/about.cfm
17) Authorisation
As Head of the Discipline/School where this research is to be conducted, I acknowledge that
I am aware of this project.
Name:
Signature: ……………………………………..
As the Chief Investigator for this application, I acknowledge that the information provided
is correct.
Name:
Signature: ……………………………………..
Date:
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 7 of 12
STOP!
Have you attached the required supporting documentation?
Tick ✔
Attached Documentation
Risk Assessment Form(s)
Grant application including scientific background information (if applicable)
Material Transfer Agreement (MTA) (if required)
Animal Welfare Committee approval (if required)
Clinical Human Research Ethics Committee approval (if required)
Department of Agriculture (formerly AQIS) permit (if required)
** Please submit this application form, together with the Risk Assessment(s) and any other
required documentation to the IBC via email: ibcadmin@flinders.edu.au
Please retain a copy of your completed application for your own records.
Office Use Only:


Reviewer:
Does this project involve the use of animals? Yes
/ No
o If yes, a copy of the approved application must now be sent to the Animal House
Approved by Reviewer: Name:
Signature: …………………………………………..
Date:
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 8 of 12
TYPES OF DEALINGS WITH GMOs
CLASSIFIED AS NLRDs
Excerpt from Gene Technology Regulations 2001, effective 1st September 2011
http://www.comlaw.gov.au/Details/F2011C00732/Html/Text#_Toc302474564
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 with GMOs that are classified as NLRDs suitable for physical containment level 2 and 3.
These parts also refer to the host/vector systems described in Part 2 of Schedule 2 (host/vector
systems for exempt dealings). This list can be found on the OGTR website in “What dealings with
GMOs are classified as exempt dealings”:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/exemptdealclass-2
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;
(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.
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 9 of 12
TYPES OF DEALINGS WITH GMOs
CLASSIFIED AS NLRDs
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;
(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 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 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) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) the donor nucleic acid is characterised; and
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 10 of 12
TYPES OF DEALINGS WITH GMOs
CLASSIFIED AS NLRDs
(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
(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
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 11 of 12
TYPES OF DEALINGS WITH GMOs
CLASSIFIED AS NLRDs
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
(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.
Flinders IBC NLRD Dealing Application Form. Current as at April 2015.
Page 12 of 12