Regulators of Genetically Modified (GM) ProductsDefinition: A genetically modified product (GM product) means a thing (other than a GMO) derived or produced from a GMO (section 10 of the Act).
In Australia, GM products are regulated by a range of agencies with the appropriate expertise to assess any risks that may be associated with the GM product. In this way, duplication of regulatory oversight is, where at all possible, avoided.
For example: a recombinant protein such as insulin, that is used to treat diabetic patients to control blood sugar levels, is produced by GM bacteria and subsequently purified for clinical use. Production of the GM bacteria requires authorisation under the Gene Technology Act 2000. In addition:
- When manufactured for administration in humans (i.e. as a human therapeutic) it is also regulated by the Therapeutic Goods Administration.
- When manufactured for use in animals (i.e. as a veterinary medicine) it is also regulated by the Australian Pesticides and Veterinary Medicines Authority.
Please note, that as of 10 March 2016, the Gene Technology Regulator is no longer required under legislation to maintain a record of GM products authorised by other regulatory agencies.
|Regulatory agency||GM products regulated||Website|
|Food Standards Australia New Zealand||human foods||www.foodstandards.gov.au|
|Therapeutic Goods Administration||human therapeutics||www.tga.gov.au|
|Australian Industrial Chemicals Introduction Scheme||industrial chemicals||www.industrialchemicals.gov.au|
|Australian Pesticides and Veterinary Medicines Authority||agricultural chemicals and veterinary medicines||www.apvma.gov.au|
|Department of Agriculture and Water Resources||import and export||www.agriculture.gov.au|
Other relevant Australian websitesComLaw
Commonwealth Science and Industrial Research Organisation (CSIRO)
Department of Defence – Defence Export Controls
Department of the Environment and Energy
Legislative and Governance Forum on Gene Technology
Relevant overseas websitesU.S.A
U.S. Department of Agriculture
Animal and Plant Health Inspection Service, United States Department of Agriculture (USDA)
U.S. Food and Drug Administration
National Centre for Biotechnology - US Government
University Wisconsin-Madison Biotechnology Centre
Biotech and Biological Sciences Research Council, UK
National Centre for Biotechnology Education, Reading University, UK
New Zealand Biotechnology Association
Canadian Food Inspection Agency
Food and Agriculture Organisation of the United Nations (FAO)
Convention on Biological Diversity (CBD)
Organisation for Economic Cooperation and Development (OECD)
OECD Biosafety - Biotrack