Notifiable Low Risk Dealing Application Form*
* if the dealing involves GM plants or GM micro-organisms that will be used in conjunction with plants then use the
Plant Research NLRD form instead of this form
Date Received
Office use only
IBC Reference Number
Office use only
Declaration
By submitting this application to The Australian National University Recombinant DNA Monitoring Committee
I/we declare the following:
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I /we accept responsibility for the conduct of the research detailed below in accordance
with the Gene Technology Act 2000 and Regulations 2001 and subsequent Amendments.
I/we will conduct this research project in accordance with the behavioural requirements
set out in the Guidelines for Certification of a Physical Containment Facility and the
Guidelines for Transport, Storage and Disposal of GMOs and ensure safe work practices
at all times.
I/we confirm that that all staff and students involved in this dealing have undertaken
training in Gene Technology Practices and Biological Safety and that training records are
retained within the laboratory.
I/we agree to maintain a register of all GMOs and records of all dealings.
I/we understand that ongoing IBC approval of this dealing is subject to meeting the IBC
annual reporting requirements.
I/we will inform the IBC of any proposed changes to the scope of the work described in
this application.
1
Title of Project
2
Is this notification to replace an existing NLRD(s)?
No
Yes
If yes, please provide the NLRD number(s) here:
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ANU Recombinant DNA Monitoring Committee
3
Dealing Information
3A
Project Supervisor
Project Supervisor’s name
including title
Visiting Fellow,
Postdoctoral Fellow
or term appointment?
No
If yes, dates of appointment:
Yes
Workplace Street Address
Workplace Telephone
Number
Mobile Telephone Number
Workplace Email Address
Relevant experience with
GMOs or more specifically
GMOs or parent organisms
of the kind listed in this
application.
3B
List of researchers (including the chief investigator) who will work on this project and are
authorised to undertake dealings with the GMO(s).
The Biological Safety and Gene Technology Practices courses are compulsory for all ANU researchers
listed (academic staff and students). Indicate the year these courses were last completed by each
researcher. Courses must be refreshed every 5 years (completion of exam only is sufficient for senior
researchers). If courses not yet completed, indicate when the researcher is registered for the courses.
Name
Biological Safety Course
Gene Technology Practices
completed
Course completed
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3C
Types of exempt dealings
Below are Exempt Dealings listed in the Gene Technology Regulations 2001 (amended 2011)
that are likely to be relevant to work with GM micro-organisms and/or GM animals. Double click
on the boxes that indicate the kinds of exempt dealings that will be used in this project.
N.B. The following categories exclude vectors carrying genes encoding toxins and pathogenic
determinants able to cause harm to humans or animals or an uncharacterized nucleic acid from
a toxin-producing organism or viral sequence (unless specific conditions are met).
Routine cloning in E. coli using non-conjugative plasmid vectors.
Routine cloning in yeast (Saccharomyces cerevisiae or Pichia pastoris) or a Baculovirus
expression vector system (Sf9 or Hi-5 insect cells) for the purposes of protein expression or
protein interaction studies.
Routine transformation of tissue cultures. Please describe the cell line, vector and genes.
Other. Please describe any other exempt dealings that will be used in this project.
3D
Briefly describe the project, including its purpose and aims, and the proposed use of
GMOs. Please include a brief description of all GMOs (including exempt GMOs) that will be used
in this dealing. Please take no more than one page for this answer.
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4
Description of the GMO(s)
In this part, a description is required of all non-exempt GMO(s) to be generated and/or used during the
proposed dealings.
4A
Do any of the following genetic modifications apply to this application?
Cloning of a gene encoding a toxin in a non-exempt host-vector system.
Expression of a toxin gene.
Cloning of an uncharacterised gene from a toxin-producing organism in a non-exempt host-vector
system
A genetic modification of a pathogen that provides an advantage, adds a new host or new mode of
transmission, or increases its virulence, pathogenicity of transmissibility compared to the
unmodified pathogen.
If so, do not complete this application, but contact the secretary of the ANU IBC for further
advice.
4B
Name(s) of the organism(s) being modified (e.g. animal, virus, bacterium)
4C
Vector(s) and methods used for transfer of genetic material.
4D
Modified trait(s) and gene(s) responsible (e.g. antibiotic resistance, attenuation, protein
expression, disease resistance). Do not include promoters or terminators.
Antibiotic resistance including resistance to Ampicillin, Chloramphenicol, Gentamicin, Kanamycin,
Neomycin and Tetracycline.
Reporter genes including DsRed and derivatives, GFP and derivatives, GUS (beta glucuronidase),
and luciferase.
Over-expression, inducible expression, attenuation or silencing of endogenous genes.
Attenuation (reduced ability to replicate and cause disease). Please elaborate.
Other. Please indicate the modified trait.
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4E
Non GM organisms or tissues (if any) to be used in association with the GMO(s) covered by
this dealing.
4F
GM organisms or tissues (if any) covered by another dealing (NLRD or DNIR) to be used in
association with the GMO(s) covered by this dealing?
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4G
Type of Dealing
Below are the kinds of Notifiable Low Risk Dealings that are listed in the Gene Technology Regulations
2001 (amended 1 September 2011). Click on the box(es) next to the statement(s) that best describes
the dealing(s) with the GMO(s).
Notifiable Low Risk Dealings that may be conducted in certified Physical Containment Level 1
facilities.
(a)
(c)
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;
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.
Notifiable Low Risk Dealings that may be conducted in certified Physical Containment Level 2
facilities.
(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;
(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 characterized; and
(iii) the characterization of the donor nucleic acid shows that it is unlikely to
increase the capacity of the host or vector to cause harm;
Example
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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 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
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:
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(m)
(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;
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.
5
Risk assessment and management
5A
Health and Safety of Staff: In the event of exposure, what are the risks to the staff performing
the proposed genetic modification(s) or handling the resulting GMO(s)? How will these risks be
controlled?
5B
Health and Safety of General Public: In the event of an unintentional release of GMO(s) to
the environment, what are the risks to the general public? How will these risks be controlled?
5C
Environment: In the event of an unintentional release of GMO(s) to the environment, what are
the risks to the environment? How will these risks be controlled?
5D
Please list the facility type (laboratory, animal house, etc.) and certification numbers for
all the facilities to be used in this dealing. If you are using facilities at other institutions
they should also be listed here. (Note: The ANU IBC cannot provide approval for work to be
conducted at a facility controlled by another IBC or by researchers at another institution. You
must have the approval of the other institution’s IBC before beginning work.)
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5E
What is the risk of backflow contamination of the water supply to each of the certified
facilities listed in Part 6D by the GMOs listed in Part 4? How will this risk be managed?
N.B. Backflow risk assessments and management procedures must be documented in your
facility manuals.
5F
Do you intend crossing GMOs expressing different transgenes to one another?
No
Yes
If yes, list the kinds of crosses proposed.
Exclude crosses required as part of the procedure to generate a GMO e.g. using the Cre/Lox
system to generate knockout mice, which should be listed in Part 4B.
Exclude crosses required for the maintenance of the GMO or crosses to non-GMOs. The
progeny of these crosses are considered the same as the original GMO.
Exclude crosses to GMOs expressing only selectable markers and/or commonly used reporter
genes e.g. GFP, luciferase, galactosidase, glucuronidase.
N.B. All crosses (including those excluded above) should be recorded and the crossing record
made available for inspection if required.
5G
Are the risks to health and safety of people, to the environment or of backflow
contamination predicted to be different for the progeny of any crosses listed in Part 6F
than the combined risks for the parent GMOs?
Not applicable
Not known
No
Yes
If yes, what are the altered risks?
N.B. Any additional actions and procedures required to manage altered risks must be listed in
Parts 5E and 5N.
N.B. If you discover the progeny have a different phenotype, and therefore different associated
risks than expected, you must discontinue any further experimental work with the progeny and
notify the Recombinant DNA Monitoring Committee to have your dealing re-evaluated.
5H
If relevant, please outline any training required for animal handling: training programs
administered by your laboratory/School or training provided by other facilities e.g. APF
Basic Mouse Handling. Note: A record of this training must be documented in your facility
manual.
5I
Will the dealing(s) involve the injection of GM micro-organisms into animals?
No
Yes
If yes, the training records in the laboratory must provide documentation that staff members
have attended a formal training course (e.g. an APF course in IP injections) OR a signed and
dated statement by the principal researcher that each staff member has been trained and
demonstrated competence with the injection methods used in this dealing.
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ANU Recombinant DNA Monitoring Committee
Please attach copies of relevant risk assessments and experimental protocols involving
injection of GM micro-organisms into animals to this application.
5J
Please explain how GMOs will be transported (e.g. transportation between facilities,
transportation of waste, transportation to storage facilities outside of a PC2 facility, or import or
export).
Your answer should provide details of transport. Please attach SOPs if appropriate.
N.B. All GMOs must be transported in accordance with the OGTR Guidelines for the Transport,
Storage and Disposal of GMOs. The answer to this question provides confirmation that you
have considered these requirements in the transport of GMOs for this project.
5K
Please list the proposed storage location(s) of non-exempt GMOs.
5L
How will the GMO(s) be disposed of? e.g. autoclaving, incineration or chemical
disinfection. If using chemical disinfection, please provide details of chemical
concentrations and procedures.
5M
What are the steps you will take in the event of an unintentional release of the GMO(s)?
5N
Are there any other actions or precautions you will take to minimise risks posed by the
proposed dealing(s) e.g. vaccinations?
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ANU Recombinant DNA Monitoring Committee
6
Signature
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.
I confirm that I have read and understood the relevant Acts, Regulations and Guidelines and also
confirm that as the Chief Investigator I will ensure all personnel working on the project are appropriately
trained and will comply with the relevant Acts, Regulations and Guidelines.
I will submit an annual review once every 12 months during the life of this project.
On completion of this project or termination of my employment, I will ensure that all GMOs covered by
this NLRD are destroyed or stored under an appropriate NLRD or transferred to another researcher with
an appropriate NLRD. I will complete a Dealing Expiry/Discontinuation report at the end of my research
or by the expiry date of my NLRD. I will ensure that the location of stored or transferred GMOs is
clearly documented in my report.
Project Supervisor
Signature: __________________________________ Date: ______________________
Printed Name:
Senior Manager Declaration: Required if the Project Manager is a Visiting Fellow, Post-doctoral
Fellow or Term Appointment.
As the Senior Manager responsible for the research activities of the project supervisor, I acknowledge
my responsibility to ensure that all GMOs covered by this NLRD are appropriately destroyed, stored or
transferred at the end of the project supervisor’s tenure. I will ensure that a Dealing
Expiry/Discontinuation report is completed for this project and that the location of all GMOs from this
project is clearly documented and communicated to the IBC.
Signature: __________________________________ Date: ______________________
Printed Name:
7
IBC Declaration
The IBC has evaluated this dealing and agrees that it is a NLRD as specified by Schedule 3 Part 1 or
Part 2 of the Gene Technology Regulations 2001 (Amended 2011).
Name of IBC
The Australian National University Recombinant DNA Monitoring Committee
Name of IBC Chair
Dr David Jones
Signature of IBC Chair
Date:
Submitting your form:
Please submit an electronic version of the completed form as an email attachment to the Secretary of the
University Recombinant DNA Monitoring Committee at rdna.officer@anu.edu.au
Please do not submit a signed hardcopy until requested to do so by the Secretary.
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ANU Recombinant DNA Monitoring Committee