Gene technology legislation
National Gene Technology Scheme
Gene technology is any technique that modifies genes or any other genetic material to produce a genetically modified organism (GMO) such as a bacteria which may be used for the development of a new vaccine or medicine, or a food crop with inbuilt resistance to drought or a certain pest.
Gene technology is regulated via a nationally consistent legislative scheme. The scheme is made up of
- Commonwealth Gene Technology Act 2000
- Commonwealth Gene Technology Regulations 2001
- corresponding state and territory legislation.
The object of the gene technology legislation 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.
The Commonwealth Gene Technology Act 2000 and corresponding state and territory laws are administered by the Gene Technology Regulator (the Regulator), an independent statutory office holder who assesses the risks and issues licences for research and or commercial production of GMO’s.
More information about how gene technology is regulated, including a list of all approved GMO’s, can be found on the Office of the Gene Technology Regulator’s website.
The scheme is supported by the intergovernmental Gene Technology Agreement 2001 between the Australian Government and each state and territory.
All Australian jurisdictions contribute to developing the scheme, legislation and all amendments to the Commonwealth Gene Technology Act 2000 or Commonwealth Gene Technology Regulations 2001 are reviewed by each state and territories’ responsible Minister and undergo public consultation.
In South Australia, the South Australia Gene Technology Act 2001 and the South Australia Gene Technology Regulations 2017 mirrors (copies) the Commonwealth legislation, apart from some specific clauses.
The Minister for Health and Wellbeing has responsibility for the SA Gene Technology Act and Regulations.
Regulation of Genetically Modified Products
Genetically modified products are derived or produced from genetically modified organisms such as virus or bacteria. These products include food, medicines, agricultural and industrial chemicals. For example, a purified protein derived from a genetically modified bacteria for use in medicine or to produce an enzyme used for food production.
The process of using gene technology to develop a product such as food or medicine is monitored by the Gene Technology Regulator.
The final products developed using genetic modification techniques are regulated by other agencies, such as the:
- Therapeutic Goods Administration
- Food Standards Australia New Zealand
- Australian Pesticides and Veterinary Medicines Authority
- Australian Industrial Chemicals Introduction Scheme (AICIS), Department of Health
- BioSecurity, Department of Agriculture.
Each regulator undertakes its own safety evaluation of the products produced from GMO’s. Genetically modified products are only regulated by the Gene Technology Regulator if there is no existing product regulator.
Genetically Modified Food
Genetically modified food contains an ingredient which is produced using gene technology.
Food must be labelled as 'genetically modified' if the final food product:
- contains novel DNA and/or novel protein, or
- has altered characteristics.
Many highly processed foods such as vegetable oils are not required to be labelled as 'genetically modified' because the DNA and/or the protein that has been genetically modified is removed in the final product.
Standard 1.5.2 in the Australia New Zealand Food Standards Code sets out permissions and conditions for the sale and use of genetically modified food. These include labelling and other specific information requirements for foods produced using gene technology.
As part of the bi-national food regulation system, South Australia contributes to the assessment of these foods for safety and labelling issues.
Genetically Modified Crops
The South Australia Genetically Modified Crops Management Act 2004 provides for specific areas within South Australia for the following purposes:
- to cultivate a specified class of crop
- where specified class of crops cannot be cultivated
- where no genetically modified food crops may be cultivated
The Act also provides protections about controlling the spread of genetically modified plant material and provides powers to regulate the growing of genetically modified food crops.
Genetically modified food crops may be cultivated in South Australia, except on Kangaroo Island, providing the grower has successfully obtained a licence from the Regulator and abides by the conditions to control the spread of GM grains or pollen.
The Minister for Primary Industries and Regional Development has responsibility for the Genetically Modified Crops Management Act.