Gene technology regulation in Australia
Australia's gene technology regulatory system came into force in June 2001 following the introduction of the Gene Technology Act 2000.
Under this Act, the Office of the Gene Technology Regulator (OGTR) was created within the Australian Government Department of Health and Ageing. The office supports the independent Gene Technology Regulator who administers the laws and makes decisions relating to gene technology research and development across Australia.
The Gene Technology Regulator is the primary regulator for any dealings or processes involving a GMO. A GMO is an organism that has been modified by gene technology; or that has inherited particular traits from an organism that has been modified by gene technology.
Genetically modified (GM) products are also regulated. A GM product is anything derived or produced from a GMO.
GM products are regulated by a number of authorities with specific areas of responsibility. If a GM product falls outside one of these areas it is regulated by the Gene Technology Regulator.
Medicines, medical devices, blood and tissues
The Therapeutic Goods Administration ensures the quality, safety and efficacy of medicines, medical devices, blood and tissues in Australia. This includes GM and GM-derived therapeutic products.
Food Standards Australia New Zealand (FSANZ) is responsible for setting the standards for the safety, content and labelling of food. FSANZ conduct a safety assessment on all genetically modified foods intended for sale in Australia and New Zealand.
The Gene Technology Regulator is the primary regulator for any dealings or processes involving a GMO.
Agricultural and veterinary chemicals
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is responsible for the registration, quality assurance and compliance of pesticides and veterinary medicines up to the point of sale. This includes regulation of agricultural chemicals produced in, or used on, GM crops.
The National Industrial Chemicals Notification and Assessment Scheme assesses new and existing industrial chemicals, including GM products, for their effects on human health and the environment.
Imported GM products
The Australian Quarantine and Inspection Service assesses GM products that are imported into Australia that may pose a pest or disease risk.
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