The Gene Technology Act 2000 and the Gene Technology Regulations 2001 and corresponding state and territory laws provide a nationally consistent system to regulate development and use of gene technology in Australia. The legislation establishes the Regulator as an independent statutory office holder to administer the national scheme. Under the intergovernmental Gene Technology Agreement, the states and territories have committed to maintaining corresponding legislation with the Commonwealth. The Regulator is charged with performing functions and exercising powers under the Gene Technology Act and corresponding legislation (see figure below).
While the Regulator must consider risks to human health and safety and the environment relating to dealings with GMOs, other agencies have responsibility for regulating GMOs or genetically modified (GM) products as part of a broader or different mandate. During development of the gene technology legislation, it was determined that the Regulator’s activities should form part of an integrated legislative framework that also includes a number of other regulatory authorities with complementary responsibilities and expertise. This arrangement both enhances coordinated decision-making and avoids duplication. The Gene Technology Act was accompanied by consequential amendments of the other relevant Acts relating to requirements for reciprocal request and provision of advice and exchange of information between the Regulator and other relevant regulatory agencies. These requirements include the following:
- the Regulator must consult Commonwealth regulatory agencies prescribed in the Regulations (see the table below) on all licence applications for dealings involving the intentional release of GMOs to the environment
- there are requirements for agencies1 regulating GM products2 to consult and/or notify the Regulator regarding applications for registration of products that are GM or contain GMOs.
Regulatory agencies in Australia with a role in regulating gene technology
|GMO/GM products||Agency||Portfolio||Scope||Relevant legislation|
|GMO dealings||Office of the Gene Technology Regulator||Health||The OGTR underpins the national scheme for regulating GMOs in Australia. It aims to protect human health and safety and the environment by identifying risks posed by or as a result of gene technology and managing those risks by regulating certain dealings with GMOs.||Gene Technology Act 2000|
|Medicines, medical devices, blood and tissues||Therapeutic Goods Administration*||Health||The TGA administers legislation that provides a national framework for regulating therapeutic products in Australia and ensures their quality, safety and efficacy.||Therapeutic Goods Act 1989|
|Food||Food Standards Australia New Zealand*||Health||FSANZ is responsible for the Australia New Zealand Food Standards Code, which prohibits use of food products produced using gene technology in Australia unless there is specific approval for sale of these foods following a safety assessment. The code also contains provisions for labelling GM foods.||Food Standards Australia New Zealand Act 1991|
|Agricultural and veterinary chemicals||Australian Pesticides and Veterinary Medicines Authority*||Agriculture||APVMA operates the national system that evaluates, registers and regulates all agricultural chemicals (including those that are, or are used on, GM crops) and veterinary therapeutic products. Assessments consider human and environmental safety, product efficacy (including insecticide and herbicide resistance management) and trade issues relating to residues.||Agricultural and Veterinary Chemicals (Code) Act 1994|
Agricultural and Veterinary Chemicals Administration Act 1994
|Industrial chemicals||Australian Industrial Chemicals Introduction Scheme||Health||AICIS provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effects of industrial chemicals.||Industrial Chemicals Act 2019|
|Quarantine||Department of Agriculture, Water and the Environment*||Agriculture||DAWE regulates importation into Australia of all animal, plant and biological products that may pose a quarantine pest and/or disease risk.||Quarantine Act 1908|
Imported Food Control Act 1992
1Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority, Australian Industrial Chemicals Introduction Scheme, Food Standards Australia New Zealand.
2A thing (other than a GMO) derived or produced from a GMO.