Governance Arrangements

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.
These provisions support an adequate and timely flow of information between the agencies to inform assessments and decisions. (Accordingly, where other agencies approve GM products, they seek advice from the Regulator and provide notification of their decisions to the Regulator for inclusion on the GMO Record.)

Australia's regulatory system for gene technology - how it works chart

Regulatory agencies in Australia with a role in regulating gene technology

GMO/GM productsAgencyPortfolioScopeRelevant legislation
GMO dealingsOffice of the Gene Technology RegulatorHealthThe 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 tissuesTherapeutic Goods Administration*HealthThe 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
FoodFood Standards Australia New Zealand*HealthFSANZ 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 chemicalsAustralian Pesticides and Veterinary Medicines Authority*AgricultureAPVMA 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 chemicalsAustralian Industrial Chemicals Introduction SchemeHealthAICIS 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*AgricultureDAWE 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
* Prescribed agencies in the Gene Technology Regulations that the Regulator must consult on applications for a dealing involving intentional release of a GMO into the environment.

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.

Content within this section