Biotechnology Australia - Environment - Regulation of Research in Australia

Since 1975 Australia has had a voluntary system of controls over genetically modified organisms (GMOs). Australia was, in fact, one of the first countries in the world to set up a system that assesses the risks involved with dealing with GMOs, whether in the laboratory, through farming trials, or for general release.

The voluntary system revolves around an independent scientific committee. This committee assesses all work involving genetic manipulation to ensure that it does not pose unacceptable risks to the environment or to people.

The committee is currently called the Genetic Manipulation Advisory Committee (GMAC). The GMAC is a non-statutory advisory committee, which provides expert biosafety advice on the use of novel genetic manipulation techniques in Australia.

The need for regulation
While the GMAC has provided reliable scientific advice about the risks posed by gene technology, and how to manage those risks, the system is not backed up by legislation. This means there is no legally enforceable way to audit or monitor the use of gene technology or penalise breaches.

The Interim Office of the Gene Technology Regulator (IOGTR) was established as a branch of the Therapeutic Goods Administration within the Commonwealth Department of Health and Aged Care in May 1999.

The IOGTR has two primary functions:

to work with State and Territory Governments, other Commonwealth agencies, and non-government organisations to develop and implement a new national regulatory system for GMOs; and

pending the establishment of this new system, to provide support and direction to the current voluntary administrative arrangements for GMOs.

The Gene Technology Act 2000
Throughout 1999 and 2000 the States, Territories and the Commonwealth worked together with interested parties, to develop the Gene Technology Act 2000. The Act was passed by the Federal Government in December 2000. The legislation is the Commonwealth's component of a new national scheme for the regulation of GMOs, which will include legislation in every Australian State and Territory.

The Act is to take effect from 21 June 2001. Until 21 June 2001, GMAC will continue to provide advice on environmental and human risks associated with genetically modified organisms.

The objective of the Act 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. It does this by creating laws for certain dealings (or activities) with GMOs.

Details about the regulatory framework for gene technology in Australia (including information on the Act and Regulations) can be found at the IOGTR Internet site http://www.health.gov.au/tga/genetech.htm

A scientific, ethical and precautionary approach
The Gene Technology Act 2000 establishes three key advisory groups to assist the Gene Technology Regulator assess the biosafety of GMOs:

the Gene Technology Technical Advisory Committee (replacing GMAC) to advise on the science;

the Gene Technology Ethics Committee to advise on ethical matters; and

The Gene Technology Consultative Community Committee, to advise on community concerns regarding gene technology.

The object of the Act is also to be achieved through the application of the precautionary principle. The precautionary principle means that, where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

International arrangements
Working on international forums is one way Australia can encourage other countries to take up comprehensive arrangements to ensure the protection of people and the environment in the development of gene technology.

We need to ensure Australians and other nations act responsibly when exporting or transporting genetic material internationally. Likewise we need to ensure that people importing or transporting genetic material across Australian boundaries act appropriately. Through participation and agreement in an international treaty, countries can develop internationally consistent laws that bind each participating country to a common global approach to a global issue.

Convention on Biological Diversity
Australia is signatory to the Convention on Biological Diversity (CBD) and a member of the Intergovernmental Committee on the Cartagena Protocol on Biosafety. In response to the CBD, an international biosafety protocol is currently being negotiated through this committee. The protocol will govern the 'transboundary movement' (i.e. movement across international borders) of living modified organisms resulting from modern biotechnology, which may have an adverse effect on the conservation and sustainable use of biodiversity.

You can find evidence about the safety of genetically modified products around the world by examining the different regulatory arrangements around the world and the outcomes of other countries' research. While many countries are developing or have just established arrangements for regulating GMOs, some countries rely on self-regulation by industry and scientists. The Australian arrangements under the new Gene Technology Act 2000 set an international benchmark for managing the risks associated with GMOs.