OGTR | Regulatory system in Australia
Gene Technology Act 2000
The Regulator regulates gene technology using a nationally consistent legislative scheme. All Australian jurisdictions contributed to developing the scheme and legislation. The scheme is supported by the intergovernmental Gene Technology Agreement 2001 between the Australian Government and each state and territory.
The Act started on 21 June 2001. The object of the Act is to protect the health and safety of people, and the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).
The Act defines gene technology as any technique for the modification of genes or other genetic material.
Gene technology does not include sexual reproduction, homologous recombination, or other techniques that the Regulations specify are not gene technology.
The main features of the Act:
- prohibit anyone dealing with a GMO (for example: for research, manufacture, production, commercial release or import) unless the dealing is:
- licensed by the Regulator for contained use or intentional release into the environment
- a Notifiable Low Risk Dealing or exempt dealing (for example: contained work which has been demonstrated to pose minimal risk to workers, the general public and the environment)
- on the Register of GMOs
- specified in an Emergency Dealing Determination.
- establish a statutory officer (the Regulator) to make decisions under the legislation
- establish the Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee to provide expert advice
- establish a process to assess risks to human health and the environment associated with various dealings with GMOs, including opportunities for public input
- specify extensive powers to allow monitoring, compliance and enforcement of the legislation
- establish a centralised, publicly available database of all GMOs and GM products approved in Australia (the Record of GMO and GM product dealings).
The Legislative and Governance Forum on Gene Technology (LGFGT; formerly the Gene Technology Ministerial Council), with representatives from the Commonwealth and every state and territory, has also been established to provide broad oversight of the implementation of the regulatory system.
Does the Act regulate GM products?GM products are products that are derived or produced from a GMO but which are not alive; for example, a purified protein derived from a genetically modified bacteria.
GM products are not regulated under the Act unless there is no existing product regulator. The use of GM products is regulated by other agencies, such as the Therapeutic Goods Administration, Food Standards Australia New Zealand and the Australian Pesticides and Veterinary Medicines Authority.
The Regulator provides advice to other regulators on the GM aspects of such products.