What is Gene Technology?
Gene technology refers to techniques and activities concerned with the expression of genes, selection of organisms based on genetic variation, artificial modification of genes, and transfer of genes to new host organisms.
Gene technology may create or involve genetically modified organisms (GMOs), and most techniques require approval from the Institutional Biosafety Committee (IBC) prior to commencement.
Gene technology in Australia is regulated by the Office of the Gene Technology Regulator (OGTR).
Sam Poynter, Biosafety and Biosecurity Officer
As per the Gene Technology Regulations 2001, a genetically modified organism (GMO) is:
- An organism that has had its genome modified by oligonucleotide-directed mutagenesis, or
- An organism modified by repair of single-strand or double-strand breaks of genomic DNA induced by a site-directed nuclease (SDN), if a nucleic acid template was added to guide homology-directed repair.
The following organisms are not classed as genetically modified organisms:
- A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species)
- A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.
- Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.
- An organism modified by repair of single strand or double strand breaks of genomic DNA induced by a site directed nuclease, if a nucleic acid template was not added to guide homology directed repair.
- Not in use
- An organism that results from an exchange of DNA if:
- the donor species is also the host species; and
- the vector DNA does not contain any heterologous DNA.
- An organism that results from an exchange of DNA between the donor species and the host species if:
- such exchange can occur by naturally occurring processes; and
- the donor species and the host species are micro organisms that:
- satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and
- are known to exchange nucleic acid by a natural physiological process; and
- the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.
- An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology.
- 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, if:
- the initial organism was not a genetically modified organism (because of the application of regulation 5); or
- all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.
- An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are no longer present.
- Agrobacterium radiobacter strain K1026.
- Pasteurella multocida strain PMP1.
|ABSANZ||Association of Biosafety for Australia and New Zealand.|
|Biohazard||A potential microbiological source of harm.|
|GMO||Genetically Modified Organism.|
|Hazardous Biological Material||Hazardous non-regulated biological agents categorised into a risk grouping according to AS2243.3. This may include organic toxins, bacteria, parasites, fungi, viruses, plant pathogens, invertebrates and aquatic organism pathogens capable of causing disease.|
|IBC||Institutional Biosafety Committee.|
|Licenced Dealing||A Dealing Not Involving Intentional Release (DNIR) or a Dealing Involving Intentional Release (DIR). DNIRs involve a higher level of risk than an NLRD, but do not permit intentional release of a GMO into the environment. DIRs pose a higher level of risk than an NLRD and involve intentional release of GMOs into the Australian environment. Licenced Dealings require direct scrutiny by the OGTR.|
|NLRD||Notifiable Low Risk Dealing. A dealing with a GMO which is not considered to pose risks that require direct scrutiny by the OGTR.|
|OGTR||Office of the Gene Technology Regulator.|
|TSD||Guidelines for the transport, storage and disposal of GMOs as enforced by the OGTR.|
The hazard and risk posed by different microorganisms varies greatly. This variation is reflected in the organisation of microorganisms into risk groups. The Physical Containment (PC) level describes the design of the laboratory or facility used when working with microorganisms. The PC level shall be at least the appropriate level to the risk group of the microorganism - ie. PC1 for RG1 microorganisms and PC2 for RG2.
All work done in a laboratory or facility of a specific PC level shall follow procedures and requirements prescribed for that level of PC as outlined in Section 5 of AS2243.3 Safety in Laboratories - Microbiological Safety and Containment.
Note: Activities involving genetically-modified organisms (GMOs) must be conducted in a PC facility which is certified by the Office of the Gene Technology Regulator (OGTR). For more details, refer to the Gene Technology website.
The University of Tasmania has several PC1 and PC2 facilities available for research activities. Contact the relevant facility manager or the Biosafety and Biosecurity Officer for more information.
Physical Containment Levels
Physical Containment Level 1 (PC1)
A PC1 laboratory or facility is suitable for work with microorganisms where the hazard levels are low, and where laboratory or facility personnel can be adequately protected by standard laboratory practice.
Physical Containment Level 2 (PC2)
A PC2 laboratory or facility with appropriate practices and infrastructure is appropriate for research involving material likely to contain Risk Group (RG) 2 microorganisms. If activities involving material which is likely to aerosolise, or with microorganisms transmissable by the respiratory route are performed, they must be done so in a biosafety cabinet (BSC).
Physical Containment Level 3 (PC3) and Level 4 (PC4)
PC3 and PC4 facilities provides additional building features and services to minimise the risk of infection or release appropriate to the use of RG3 and RG4 microorganisms.
Note: There are no certified PC3 or PC4 facilities in Tasmania.
Any work involving a GMO is called a dealing, and can involve any of the following activities:
- conduct experiments with the GMO;
- make, develop, produce or manufacture the GMO;
- breed the GMO;
- propagate the GMO;
- use the material in the course of manufacture of a thing that is not the GMO;
- grow, raise or culture the GMO;
- import the GMO;
- transport the GMO;
- 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 the paragraphs (1) to (9).
Dealings with GMOs must be approved by the University of Tasmania Institutional Biosafety Committee before commencement.
|Dealing Level||Definition||OGTR Licence Required||Containment Level Required|
|Exempt Dealing||Activities with GMOs that have been assessed over time as posing a very low risk (ie. contained research involving very well understood organisms and processes for creating and studying GMOs).||No – must be assessed by the University of Tasmania IBC.||Yes – PC1 or PC2|
|Notifiable Low Risk Dealing (NLRD)||Activities with GMOs undertaken in containment (ie. not released to the environment) that have been assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.||No – must be assessed by the University of Tasmania IBC and an annual report provided to the OGTR.||Yes – PC1 or PC2|
|Dealing Not Involving Intentional Release (DNIR)||Activities with GMOs of a higher risk than NLRDs which are undertaken in containment.||Yes, applications must be reviewed by the IBC and a risk assessment and management plan (RARMP) prepared prior to a licence decision by the OGTR.||Yes, usually PC2 or greater. Other conditions will apply.|
|Dealing Involving Intentional Release (DIR)||Activities with GMOs involving an intentional release into the Australian environment. The majority of DIR licences are for field trials or releases of plants, although GM vaccines also fall into the DIR category.||Yes, applications must be reviewed by the IBC, RARMP prepared, consultation on RARMP and licence decision by the OGTR.||Licence conditions apply (Note: agricultural DIRs are not currently permitted in Tasmania)|
Additionally, importing a GMO from interstate and overseas also requires compliance with biosecurity regulations. Visit the biosecurity page for information on how to obtain an Import Permit.
Dealings with GMOs classified as Exempt or NLRD do not require case-by-case assessment by the OGTR, and are instead reviewed and endorsed by the University of Tasmania Institutional Biosafety Committee (IBC).
Schedule 2 of the Regulations describes the types of dealings with GMOs that are classified as Exempt Dealings. The only legislative requirement for Exempt Dealings is that they must not involve and intentional release of a GMO into the Australian environment. The University of Tasmania IBC considers that Exempt Dealings should be conducted in a certified PC1 or PC2 laboratory to meet this requirement. Dealings which are classified as Exempt are listed on the application form, and this information can also be found on the OGTR website.
Schedule 3 of the Regulations describes the types of dealings with GMOs that are classified as NLRDs. This information is included on the application form, and can also be found on the OGTR website. These dealings must be conducted in a certified PC1 or PC2 laboratory.
DNIR and DIR applications should be discussed with the Biosafety and Biosecurity Officer or the IBC before preparing an application.
Please note that there are no PC3 or PC4 facilities in Tasmania, and as such work with Risk Group 3 or Risk Group 4 organisms at the University of Tasmania is strictly prohibited.
|IBC Application Form||Use for all applications to the IBC for Exempt and NLRD dealings with GMOs|
Looking for biosecurity (quarantine) forms? Visit the biosecurity page.
|Application Guide||A 'how to' guide for completing GMO dealing applications to the University of Tasmania IBC.|
|NLRD application process||A flowchart and timeline for University of Tasmania IBC review of NLRD applications.|
|Transport, Storage and Disposal Guidelines||The official OGTR transport, storage and disposal guidelines. This document contains regulatory information and should be reviewed by staff and students working with GMOs.|
|What is an Exempt Dealing?||Excerpt from Schedule 2 of the Gene Technology regulations covering the types of GMO dealings classified as Exempt.|
|What is an NLRD?||Excerpt from Schedule 3 of the Gene Technology regulations covering the types of GMO dealings classified as Notifiable Low Risk Dealings.|
|Gene Technology Regulations||The complete regulations pertaining to the use of GMOs and gene technology in Australia.|
|Classification of Viral Vectors||Flowchart guidance for establishing dealing classification for viral vector studies|
|Viral Vector Tables||Viral vector information arranged in tabular form|
|PC1 guidelines||Requirements for the certification and operation of Physical Containment Level 1 facilities|
|PC2 guidelines||Requirements for the certification and operation of Physical Containment Level 2 facilities|
As part of the development of an operations framework to guide biosafety and biosecurity at the University, the Biologicals Users Group (BUG) is an open-access forum which aims to cultivate an active and engaged community of staff and students who work with biological materials.
What do I get from participating in BUG?
BUG aims to provide members with a means to:
- Share experiences and resources
- Seek help for operational issues and solve problems
- Extend skills and knowledge
- Remain up-to-date on regulatory and legislative obligations
- Engage with the Institutional Biosafety Committee
This will be supplemented by a regular information bulletins, and opportunities for involvement in group events and training activities.
BUG is live!
BUG is a predominantly online forum, and maintains a presence through the Microsoft 365 platform, which includes Teams and Yammer pages for communications and a SharePoint site for distributing news, details of upcoming events, and relevant forms, information and training materials.
How do I join BUG?
Visit the BUG page on Microsoft Teams to join the conversation. Please share the page with your colleagues and students who may be interested!
Got any questions?
Please contact Sam Poynter (Biosafety and Biosecurity Officer) at email@example.com.
All work with GMOs at the University of Tasmania is overseen by the Institutional Biosafety Committee. To seek approval for an Exempt Dealing or Notifiable Low Risk Dealing (NLRD), please complete the application form and submit it to the Biosafety and Biosecurity Officer.
Guidance material to assist in the completion of the application form can be found here.
Research projects involving GMO plants also require authorisation from Biosecurity Tasmania. Contact the Biosafety and Biosecurity Officer for details on how to obtain authorisation.
Higher risk dealings (DIR or DNIR) require licencing from the OGTR, and commercial release of GMO material is currently prohibited in Tasmania. Contact the Biosafety and Biosecurity Officer for further information.
The IBC is the University of Tasmania Institutional Biosafety Committee. It is established as a requirement of authorisation from the Office of the Gene Technology Regulator (OGTR) to allow our researchers to work with GMOs.
Any work with GMOs at the University of Tasmania must be conducted in a certified Physical Containment (PC1 or PC2) laboratory. If you wish to have your facility certified, review the OGTR Certification Guidelines, then contact the Biosafety and Biosecurity Officer to arrange an audit.
Yes, genetically modified organisms (GMOs) may be imported to Tasmania, but additional conditions may be imposed, and permits will usually be required from the Department of Agriculture and Biosecurity Tasmania.
A dealing application to work with GMOs must be submitted to the University of Tasmania Institutional Biosafety Committee (IBC). It is recommended that the dealing application is submitted prior to applying for an import permit, as a Record of Assessment is usually required to support a permit application.
Tasmania maintains a moratorium on the commercial release of GMOs to the Tasmanian environment. This may impact your research proposal. Please contact the Biosafety and Biosecurity Officer for more information.
Notifiable Low Risk Dealings (NLRDs) are activities with GMOs undertaken in containment (i.e. not released into the environment) that have been assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.
Exempt dealings are a category of dealings with GMOs that have been assessed over time as posing a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). The only legislative requirement for exempt dealings is that they must not involve an intentional release of a GMO into the environment.
Details on what constitutes an Exempt Dealing or NLRD can be found in Schedules 2 and 3 of the Gene Technology Regulations 2001.
Dealing NOT involving an Intentional Release (DNIR) of genetically modified organisms (GMOs) into the environment are dealings with GMOs in contained facilities which do not meet the criteria for classification as Exempt Dealings or Notifiable Low Risk Dealings (NLRDs).
Dealings with a GMO licensed as a DNIR must not involve release into the environment.
These dealings must be licensed by the OGTR.
Schedule 3, Part 3, of the Gene Technology Regulations 2001 (the Regulations) describe DNIRs as higher risk dealings than Notifiable Low Risk Dealings (NLRD).
In general, DNIRs often involve work with GM pathogenic [disease-causing] organisms, or GMOs containing higher risk genes from pathogens or genes that:
- encode toxins or
- confer an oncogenic [cancer-causing] modification or immuno-modulatory [changing the immune system] effect.
Dealings involving an Intentional Release (DIR) of GMOs into the Australian environment are dealings with GMOs which take place outside of containment facilities.
The majority of DIR licences issued to date have been for experimental field trials (limited and controlled releases) or general/commercial releases of GM plants. A small number of DIR licences have also been issued for GM vaccines for human or veterinary use, either for trial (limited and controlled release) or general/commercial release. The release of GM animals would also require a DIR licence.
Commercial release of GMOs is not currently permitted in Tasmania.
Contact Sam Poynter (Biosafety and Biosecurity Officer) if you have any further questions.
The Institutional Biosafety Committee (IBC) is the University authoritative body regarding gene technology, biosecurity-regulated materials and biologically-hazardous materials.