How the scheme works

Regulation of the National Gene Technology Scheme

We regulate the use of gene technology in Australia to protect the health and safety of people and the environment. Learn about the regulation of the scheme, how it’s governed, and the role that other agencies play in regulation.

National Gene Technology Scheme

The Gene Technology Act 2000 established a regulatory framework that:

  • protects the environment
  • provides an efficient and effective system for the application of gene technologies
  • operates in tandem with other Australian Government and state and territory government regulatory schemes relevant to genetically modified organisms (GMOs) and genetically modified (GM) products, such as those that regulate:
    • food
    • agricultural and veterinary chemicals
    • industrial chemicals
    • therapeutic goods for both humans and animals.

It outlines a system of:

  • scientific assessment
  • consultation processes
  • monitoring and review mechanisms
  • penalties for non-compliance.

Learn more about the legislation it’s based on.

Governance

The Gene Technology Act 2000, corresponding state and territory laws, and the intergovernmental Gene Technology Agreement together provide governance mechanisms to operate the scheme. The Act establishes the statutory office holder, the Gene Technology Regulator, to administer the Act and corresponding state and territory legislation.

Learn more about gene technology legislation.

State and territory governments take part in governing the scheme through the:

This diagram outlines:

  • how the scheme is governed
  • the groups that provide advice
  • who takes part in consultations.

The figure is a flow chart with 16 labelled boxes linked by lines.

The chart is one-directional and centres around a large hexagon representing the Gene Technology Regulator.

The labels are grouped into 3 categories by colour which represent governance, consultation and advice. 

Here the flow chart is described as a list that outlines the National Gene Technology Regulatory Scheme governance, advisory and consultation structures. 

  1. Intergovernmental Agreement (governance)
    1. lateral to Gene Technology Acts
    2. forward to Gene Technology Ministers Meeting
  2. Gene Technology Acts (governance)
    1. lateral to Intergovernmental Agreement
    2. forward to Gene Technology Ministers Meeting
  3. Gene Technology Ministers Meeting (governance)
    1. lateral to Gene Technology Standing Committee
    2. forward to Gene Technology Regulator
    3. forward to Gene Technology Technical Advisory Committee
    4. forward to Gene Technology Ethics and Community Consultative Committee 
  4. Gene Technology Standing Committee (governance)
    1. lateral to Gene Technology Ministers Meeting
  5. Gene Technology Technical Advisory Committee (GTTAC) (advice)
    1. lateral to Gene Technology Ethics and Community Consultative Committee
    2. lateral to Gene Technology Regulator
  6. Gene Technology Ethics and Community Consultative Committee (GTECCC) (advice)
    1. lateral to Gene Technology Technical Advisory Committee
    2. lateral to Gene Technology Regulator
  7. Gene Technology Regulator
    1. lateral to Gene Technology Ethics and Community Consultative Committee
    2. lateral to Gene Technology Technical Advisory Committee
    3. lateral to States and Territories
    4. lateral to Regulated Community
    5. lateral to Public
    6. forward to Environment Minister
    7. forward to Therapeutic Goods Administration
    8. forward to Food Standards Australia New Zealand
    9. forward to Australian Pesticides and Veterinary Medicines Authority
    10. forward to Australian Industrial Chemicals Introductory Scheme
    11. forward to Department of Agriculture, Water and the Environment
  8. States and territories (consultation)
    1. lateral to Gene Technology Regulator
  9. Regulated community (consultation)
    1. lateral to Gene Technology Regulator
  10. Public (consultation)
    1. lateral to Gene Technology Regulator
  11. Environment Minister (consultation)
  12. Therapeutic Goods Administration (consultation)
  13. Food Standards Australia New Zealand (consultation)
  14. Australian Pesticides and Veterinary Medicines Authority (consultation)
  15. Australian Industrial Chemicals Introductory Scheme (consultation)
  16. Agriculture, Water and the Environment (consultation)

Role of the regulator

When scientists use gene technology to create a GMO, the Gene Technology Regulator, assisted by staff in the Office of the Gene Technology Regulator (OGTR), regulates the use of that organism. They make sure it is safe and can be well managed to protect human health and the environment. They have been doing this for over 20 years.

The regulator:

  • administers licensing and other regulatory provisions
  • develops policy principles and guidelines for the Gene Technology Ministers’ Meeting (GTMM)
  • develops codes of practice
  • ensures compliance with the legislation
  • provides information and advice on gene technology matters to
    • the GTMM
    • other agencies
    • the public.

The OGTR maintains details of all GMOs and GM product approvals in Australia and publishes them on their website.

Learn more about the OGTR and how they support the Gene Technology Regulator to manage, and protect against, any risks posed by GMOs.

Visit the OGTR website

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