Gene Technology

What is Gene Technology?

Gene technology is defined as “any technique for the modification of genes or other genetic material, but does not include sexual reproduction or homologous recombination”. Organisms that have been modified by gene technology or have inherited particular modified traits from another organism, are known as genetically modified organisms (GMOs).

The Research Compliance Team within the Monash University Office of Research Ethics and Integrity (OREI) strives to help researchers understand and meet their obligations under the Gene Technology Legislative Scheme which regulates all dealings with GMOs in Australia.

In Australia, dealings with GMOs are regulated using a nationally consistent legislative scheme which is administered by the Office of the Gene Technology Regulator (OGTR). This legislative scheme consists of:
- the Gene Technology Act 2000 (the Act),
- the Gene Technology Regulations 2001 (the Regulations), and
- corresponding state and territory legislation.
The purpose of the gene technology legislative scheme is to “protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulation of dealings with genetically modiﬁed organisms.”
Organisations dealing with GMOs must be accredited with the OGTR and must have an Institutional Biosafety Committee (IBC), or access to an IBC. IBCs play an integral role in assisting compliance with Australia’s gene technology legislative scheme by assessing low-risk contained dealings that do not require case-by-case consideration by the OGTR, reviewing licence applications for higher risk dealings before the applications are sent to the OGTR, and the inspection and continual monitoring of OGTR-certified physical containment facilities.
Under the Gene Technology Act, a dealing, or to deal with, in relation to a GMO, means any of the following:
- 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 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 (1) to (9) above.
Dealings are divided into three main categories based on the level of risk to the health and safety of people and the environment.
- Exempt dealings are those that involve very well understood organisms and procedures for creating and studying GMOs. They have a very low level of inherent risk, and that risk can be easily reduced or managed. These dealings must be conducted within a facility that meets minimum containment requirements, speciﬁed as PC1 in the AS/NZS 2243.3, however, the facility does not need to be certiﬁed by the OGTR.
- Notifiable Low Risk Dealings (NLRDs) are considered to be of intermediate risk and are subdivided into three categories: PC1, PC2, PC3. The level of the dealing relates to the risk group classiﬁcation of the organisms being used (as described in AS/NZS 2243.3), and determines the containment requirements of the facility in which the dealing must be conducted.
- Licensed Dealings are considered to pose the highest level of risk. These dealings are subdivided into Dealings involving Intentional Release (DIR) and Dealings Not involving Intentional Release (DNIR). To conduct either a DNIR or DIR, a licence must be obtained from the OGTR and the dealings then be conducted in accordance with the specific conditions listed on the OGTR-issued licence.
Refer to the OGTR website for more information about the framework of legislation, regulations, policies and procedures that govern gene technology in Australia.

Monash University Institutional Biosafety Committee (MUIBC)

Institutional Biosafety Committees assess low-risk contained dealings that do not require case-by-case consideration by the OGTR, review licence applications for higher risk dealings before the applications are sent to the OGTR, and inspect and monitor OGTR-certified physical containment facilities.

The Monash University Institutional Biosafety Committee (MUIBC) is the nominated IBC for Monash University, the Hudson Institute of Medical Research, the Baker Heart and Diabetes Institute, and the Burnet Institute. The MUIBC also provides its services to other organisations when requested.

The MUIBC consists of researchers from various Departments in the university, facility/infrastructure managers, OHS consultants, and representatives from the Hudson, Baker and Burnet Institutes. Together, members of the IBC possess the technical and scientiﬁc expertise to advise on the risks associated with dealings with GMOs.

Gene Technology at Monash University

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