Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) is composed of people with expertise in the management of GMOs, safety, and includes a layperson and independent member. Their role is to assess, review and approve certain kinds of GM work, for example by advising on the identification and management of the risks associated with dealings with GMOs undertaken by the organisation, including the containment of GMOs and providing an interface with the OGTR. The IBC are also responsible for conducting inspection of OGTR-certified facilities to ensure that they meet with guidelines (e.g. PC2 labs).

Regulation of Genetically Modified Organisms in Australia

There is a national scheme for the regulation of genetically modified organisms (GMOs) in Australia. The aims of the scheme are to protect the health and safety of Australians and protect the environment, by identifying any risks of gene technology, and to manage those risks by regulating dealings with genetically modified organisms.

The Office of the Gene Technology Regulator (OGTR) oversees the regulation of genetically modified organisms in Australia, under the Gene Technology Act 2000. The legislation regulates all dealings (e.g. research, manufacture, production, commercial release and import) with live viable organisms that have been modified by techniques of gene technology, including the progeny (or descendants) of such GMOs which also share a genetically modified trait. The legislation will also regulate some GM products, but only where the products are not regulated by an existing agency. Further information can be obtained from the OGTR website: http://www.ogtr.gov.au

University of Ballarat IBC Terms of Reference

Terms of reference for the committee are available here.

Committee Members

A table listing the members of the committee is avaialable here.

Applications for undertaking dealings with GMOs

The legislation revolves around a system of prohibitions and approvals. Every dealing with a GMO will need to be licensed by the Regulator, unless the dealing is an exempt dealing, a notifiable low risk dealings (NLRD) or on the Register of GMOs.

Detailed and up-to-date information on the categories below can be found in the Handbook on the regulation of gene Technology in Australia:

1. Exempt dealings
   • Exempt dealings are those that pose little or no risk.
   • Exempt dealings must comply with definitions in the handbook.
   • Exempt Dealings do not require approval from the Institutional Biosafety Committee.
   • There will be no exemptions for any release of a GMO into the environment.
   • Exempt dealings must be conducted in accordance with Australian Standard AS/NZS 2243.3:2002 (Safety in laboratories: microbiology) for Physical Containment Level 1
   
   
2. Notifiable low risk dealings (NLRDs)
   • NLRDs are dealings with GMOs which are very low risk and which may proceed provided that certain conditions spelt out in the regulations are observed.
   • This will include requirements that the specified dealings be undertaken only in contained facilities (PC2).
   • NLRDs must comply with definitions in the handbook.
   • These must be submitted to the IBC for assessment. A record of all NLRDs will be kept.
   • Work may commence on the Dealing on approval by the IBC.
   • The GT Act does not allow dealings which involve the intentional release of a GMO into the environment to be prescribed as a NLRD.
   
   
3. Licences
   • All dealings with GMOs (that are not exempt or NLRDs) will need to be licensed by the Regulator.
   • There are two forms of licences - Dealings Not Involving Intentional Release (DNIR) and Dealings Involving an Intentional Release (DIR).
   • The licensing system will be based on rigorous scientific risk assessment and extensive consultation with expert advisory committees, Government agencies and the public for releases of GMOs into the environment.
   • These must be submitted to the IBC for assessment. The IBC then transmits the "Dealing" to the OGTR for approval.
   • Work must not commence on these dealings until a licence has been issued by the OGTR. Approval from the OGTR may take up to 90 working days.

Further Information and/or assistance

For further information on the University of Ballarat IBC, procedures, etc contact:

Dr Peter Aldred
Secretary, University of Ballarat IBC
Ph: 5327 9243
email: p.aldred@ballarat.edu.au

Further information on the OGTR and regulation of gene technology in Australia can be obtained from the OGTR.