Gene Technology Resources
General guidelines & policies
- DIR and DNIR evaluation process & flow chart
- Guidance on classification of contained dealings with viral vectors
- Explanatory information on guidelines for certification of physical containment facilities
- Guidance notes for the containment of exempt dealings
- Guide to physical containment levels and facility types
- NHMRC guidelines - generation, breeding, care & use of GMO & cloned animals for scientific purposes
- National framework - development of ethical principles in gene technology
- OGTR policy - licensing of plant GMOs where different genetic modifications are combined or ‘stacked’ by conventional breeding (DOC)
- OGTR risk analysis framework
- Schedules of the Gene Technology Regulations 2011
- Application for certification of a facility
- Application for declaration that specified information is confidential commercial information (CCI)
- DIR application forms
- DNIR application form
- IBC GMO dealing application form - exempt dealings & notifiable low risk dealings
- IBC facility coversheet - for facility certification applications
- Statement of suitability: DNIR project supervisor
- Training record form
Importing & exporting GMO's
The importation of live, viable GMOs, constitutes a dealing and thus is regulated under the Act.
Investigators should ensure that proposed importation of GMOs is included in their dealing approval to ensure that the import and transport of GMOs is authorised. Approval can be gained for additional/new import/transport requirements by seeking an amendment to your approval.
If importing GMOs, or viable organisms known to be mixed with any amount of a GM material, the importer is required to obtain appropriate approvals from the Department of Agriculture. To ensure the necessary approvals or authorisations are obtained prior to importation, the OGTR works with the Department. Investigators should also ensure that any other regulatory approvals that are required are also obtained.
When seeking a biosecurity import permit from the Department for GM seeds/grains or any other live viable GMOs, importers will be required to provide their licence number if DNIR, DIR, or NLRD identifier number and name of assessing IBC, as well as a declaration of the presence of a genetic modification and type of modification on the Department's import permit application.
As the Department and OGTR approvals must be gained before importing the GMOs into Australia, importers should take into account the time that both authorisations may take, and seek approvals well in advance of any proposed importation.
Note: if a species has not been imported previously, BioSecurity Australia undertakes a full assessment for potential biosecurity pest, weed and diseases risks associated with the introduced traits for that species and in such instances it may take longer for approvals to be granted.
To export GMOs, you need to ensure that you have the necessary OGTR authority to transport the GMOs and to supply GMOs to other organisations.
Ensure that transport and supply of GMOs is either included in your dealing or that you have requested an amendment to your dealing to permit this to occur. You should also notify the IBC of your intention to export GMOs.
You should also ensure that you have the relevant approvals from the Department of Agriculture and other Australian regulators (eg. approval from the Department of Defence, if your organisms are on the Defence & Strategic Goods list) and from the receiving country(ies).
University of Adelaide websites
Australia & New Zealand Standards (AS/NZS)
Access to the Australian Standards online via The University of Adelaide Library is governed by license agreements which restrict access to members of the Adelaide University community, for purposes of non-commercial research, education or personal use. Access is available from both within and outside the University network. The license permits only two concurrent users.
For further guidance on the comprehensive details of laboratory design & construction, biological safety, laboratory safety, and broader occupational health & safety issues, please refer to:
- AS/NZS 2982.1 - Laboratory Design & Construction Part 1: General Requirements
- AS/NZS 2243.3 - Safety in Laboratories Part 3: Microbiological Aspects and Containment Facilities
National Regulatory Scheme for genetically modified organisms
The nationally consistent legislative scheme for gene technology is comprised of the Commonwealth Gene Technology Act 2000 and Gene Technology Regulations 2001, and corresponding State and Territory legislation.
The Commonwealth Gene Technology legislation took effect on 21 June 2001 and consists of the following:
- The Gene Technology Act 2000 (current compilation)
- The Gene Technology Regulations 2001 (current compilation)
Further information regarding the national regulatory scheme and the corresponding legislation for the states and territories is available on OGTR legislation.
The corresponding South Australian Legislation is
South Australia Genetically Modified Crops Management Act 2004
Researchers who apply for an OGTR licence for dealings involving intentional release (DIR) of genetically modified (GM) plants into the environment under limited and controlled conditions need to be compliant with the South Australia Genetically Modified Crops Management Act 2004.
Pursuant to sections 5(1)(a)(ii) and 5A(1) of the above Act, areas of the State may be designated in which no genetically modified food crops may be cultivated.
Exemptions for certain activities may be permitted under the Act in order for field trials of GM food crops to occur in some areas.
Please contact the Research Compliance Officer (Gene Technology) for further information.
The organisation accredited in accordance with the Accreditation Guidelines issued by the Regulator.
The Gene Technology Act 2000. That is, Act No. 169 of 2000 as amended; the compilation prepared on 15 July 2011 taking into account amendments up to Act No. 58 of 2011.
Relates to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.
Includes every kind of organism in the animal kingdom, including non-vertebrates but not including human beings.
The Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
If a facility meets the containment requirements specified in guidelines issued by the Regulator, the Regulator may certify the facility to a specified containment level.
a. in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or
b. in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:
(i) potential gene products or potential functions of the gene or genomic region; and
(ii) the likely effect of the genetic modification on the gene products or functions.
For Schedule 2, has the meaning given in Part 3 of that Schedule: in relation to a toxin, means to specify the amino acid sequence of the toxin.
Confidential commercial information
Information declared by the Regulator to be confidential commercial information. A person may apply to the Regulator for a declaration that specified information is confidential commercial information for the purposes of the Act.
In relation to a facility, means the degree of physical confinement of GMOs provided by the facility, having regard to the design of the facility, the equipment located or installed in the facility and the procedures generally used within the facility.
In relation to restricting the dissemination or persistence of a GMO and its genetic material in the environment, and includes the following:
1. methods to restrict the dissemination or persistence of the GMO or its genetic material in the environment;
2. methods for disposal of the GMO or its genetic material;
3. data collection, including studies to be conducted about the GMO or its genetic material;
4. the geographic area in which the proposed dealings with the GMO or its genetic material may occur;
5. compliance, in relation to dealings with the GMO or its genetic material, with:
(i) a code of practice issued under section 24; or
(ii) a technical or procedural guideline issued under section 27.
Deal with, Dealings
In relation to a GMO, is defined in the Act to mean:
a. conduct experiments with the GMO;
b. make, develop, produce or manufacture the GMO;
c. breed the GMO;
d. propagate the GMO;
e. use the GMO in the course of manufacture of a thing that is not the GMO;
f. grow, raise or culture the GMO;
g. import the GMO;
h. transport the GMO;
i. dispose of the GMO.
And includes the possession, supply or use of the GMO, for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).
Emergency dealing determination
Provides a system, by legislative instrument, under which the Minister can make determinations relating to dealings with GMOs in emergencies.
Defined in the Act includes:
a. ecosystems and their constituent parts; and
b. natural and physical resources; and
c. the qualities and characteristics of locations, places and areas.
Ethics and Community Committee
The Gene Technology Ethics and Community Consultative Committee established on 1 January 2008, unless proclaimed earlier and which will replace the current Gene Technology Ethics Committee and the Gene Technology Community Consultative Committee.
The function of the Ethics and Community Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:
a. ethical issues relating to gene technology;
b. the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
c. the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons;
d. the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes;
e. community consultation in respect of the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment;
f. risk communication matters in relation to dealings that involve the intentional release of a GMO into the environment;
g. matters of general concern identified by the Regulator in relation to applications made under this Act;
h. matters of general concern in relation to GMOs.
A dealing specified by the Regulations to be an exempt dealing.
a. in Part 4 – an expert adviser appointed under subsection 102 (1) of the Act; and
b. in Part 5 – an expert adviser appointed under subsection 112 (1) of the Act.
Includes, but is not limited to, the following:
a. a building or part of a building;
c. an aviary;
d. a glasshouse;
e. an insectary;
f. an animal house;
g. an aquarium or tank.
Any technique for the modification of genes or other genetic material, but does not include:
a. sexual reproduction; or
b. homologous recombination; or
c. any other technique specified in the regulations for the purposes of this paragraph.
Gene Technology Community Consultative Committee (GTCCC)
The function of the Consultative Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:
a. matters of general concern identified by the Regulator in relation to applications made under this Act;
b. matters of general concern in relation to GMOs;
c. the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes.
Gene Technology Ethics Committee (GTEC)
The function of the Ethics Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:
a. ethical issues relating to gene technology;
b. the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
c. the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons.
Gene Technology Technical Advisory Committee (GTTAC)
The function of the Gene Technology Technical Advisory Committee is to provide scientific and technical advice, on the request of the Regulator or the Ministerial Council, on the following:
a. gene technology, GMOs and GM products;
b. applications made under the Act;
c. the biosafety aspects of gene technology;
d. the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products, and the content of such principles, guidelines and codes.
Genetically modified laboratory guinea pig
A laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.
Genetically modified laboratory mouse
A laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.
Genetically modified laboratory rabbit
A laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.
Genetically modified laboratory rat
A laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.
Genetically modified organism
a. an organism that has been modified by gene technology; or
b. an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
c. anything declared by the Regulations to be a genetically modified organism, or that belongs to a class of things declared by the Regulations to be genetically modified organisms;
but does not include:
a. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
b. an organism declared by the Regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the Regulations not to be genetically modified organisms.
A genetically modified organism.
A licence issued under the Act.
GMO Record and GM Product Dealings
The purpose of the Record is to maintain a comprehensive record of all dealings in Australia that involve GMOs or GM products.
The GMO Register established under the Act.
The Regulator may determine that certain dealings previously authorised by a licence be included on the GMO Register. If a dealing is included on the GMO Register, anyone may undertake the dealing, subject to any specified conditions.
means a thing (other than a GMO) derived or produced from a GMO.
A reference to a host/vector system mentioned in Schedule 2 Part 2 is a reference to any of the following:
a. a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;
b. a non‑vector system involving a host mentioned in column 2 of an item of the table;
c. a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.
An agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
Institutional Biosafety Committee (IBC)
A committee established as an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under the Act.
A person appointed by the Regulator under section 150 of the Act as an inspector.
In relation to a GMO into the environment, for the purposes of the Act, means a dealing with a GMO involves the intentional release of the GMO into the environment if the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment.
For the purposes of the Act, means known within the scientific community.
The holder of a GMO licence - generally the holder of a licence is an Accredited Organisation. A licence can cover dealings by persons other than the licence holder. The licence holder is required to inform such persons of any conditions of the licence that apply to them.
Limited and controlled release application
An application for a licence for a dealing involving intentional release of a GMO into the environment under Section 50A of the Act.
In relation to the release of a GMO that is proposed to be authorised by a licence, includes limits on any of the following:
a. the scope of the dealings with the GMO;
b. the scale of the dealings with the GMO;
c. the locations of the dealings with the GMO;
d. the duration of the dealings with the GMO;
e. the persons who are to be permitted to conduct the dealings with the GMO.
For Schedule 2, has the meaning given in Part 3 of that Schedule: means a plasmid that is not self-transmissible, and includes, but is not limited to, non-conjugative forms of the following plasmids:
a. bacterial artificial chromosomes (BACs);
c. P1 artificial chromosomes (PACs);
d. yeast artificial chromosomes (YACs).
Has the meaning given in Part 3 of Schedule 2.
Notifiable Low Risk Dealing (NLRD)
A dealing with a GMO is a notifiable low risk dealing if:
a. it is a dealing of a kind mentioned in Part 1 of Schedule 3 or Part 2 of Schedule 3;
b. is not also a dealing of a kind mentioned in Part 3 of Schedule 3; and
c. it does not involve an intentional release of the GMO into the environment.
Means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length.
The Office of the Gene Technology Regulator.
A genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
a. defects in DNA proofreading and repair;
b. defects in chromosome maintenance;
c. defects in cell cycle checkpoint mechanisms;
d. uncontrolled cell proliferation;
e. resistance to apoptosis;
f. cellular immortalisation.
Any biological entity that is:
a. viable; or
b. capable of reproduction; or
c. capable of transferring genetic material.
Out of session
For regulation 25, has the meaning given in subregulation 25 (4).
Packaging cell line
An animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.
In relation to an organism, means having the capacity to cause disease or abnormality.
A characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.
Person covered by a GMO licence
A person authorised by a GMO licence to deal with a GMO.
Physical containment level
Followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.
A DNA molecule capable of autonomous replication and stable extra-chromosomal maintenance in a host cell.
For the purposes of the Act includes the following:
a. a building;
b. a place (including an area of land);
c. a vehicle;
d. a vessel;
e. an aircraft;
f. a facility;
g. any part of premises (including premises referred to in paragraphs (a) to (f)).
The Record of GMO and GM Product Dealings.
The Gene Technology Regulations 2001. Statutory Rules 2001 No. 106 as amended made under the Gene Technology Act 2000. The compilation prepared on 1 September 2011 taking into account amendments up to SLI 2011 No. 73.
In relation to dealings with GMOs, means the prohibition of dealings with GMOs unless:
a. the person undertaking the dealing is authorised to do so by a GMO licence; or
b. the dealing is specified in an emergency dealing determination; or
c. the dealing is a notifiable low risk dealing; or
d. the dealing is an exempt dealing; or
e. the dealing is included in the GMO Register.
The Gene Technology Regulator.
Risk Assessment and Risk Management Plan (RARMP)
The risk assessment undertaken by the OGTR in relation to the dealings proposed to be authorised by a licence. The RARMP, which is an extensive process, takes into account any risks to the health and safety of people or risks to the environment and the means for managing any risks posed by the dealing, with regard to the matters prescribed by the Regulations.
The production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.
Includes a substance, and a thing in electronic or magnetic form.
A substance that is toxic to any vertebrate.
An organism producing toxin with an LD50 of less than 100 micrograms per kilogram.
in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.