The role of other agencies in the National Gene Technology Scheme

Learn about the role that other agencies play in the National Gene Technology Scheme.

Role of other agencies

The Gene Technology Regulator and the OGTR consult with the following agencies as needed. These agencies also consult with the Regulator, as required.

The figure shows 5 hexagons that centre around another hexagon.

The middle hexagon represents Gene Technology Regulator and the hexagons arranged around it are labelled as follows:

  1. Therapeutic Goods Administration
  2. Food Standards Australia New Zealand
  3. Australian Pesticides and Veterinary Medicines Authority
  4. Australian Industrial Chemicals Introductory Scheme
  5. Agriculture, Water and the Environment

Australian Industrial Chemicals Introduction Scheme (AICIS)

The AICIS protects Australians and our environment by:

  • assessing the risks of importing or introducing industrial chemicals
  • promoting their safe use.

They must consult with the Gene Technology Regulator when assessing:

  • an industrial chemical that is, or contains, a GM product
  • an application for a permit for an industrial chemical that is, or contains, a GM product.

Visit the AICIS website

Australian Pesticides and Veterinary Medicines Authority (APVMA)

The APVMA evaluates, registers and regulates all:

  • agricultural chemicals
  • veterinary therapeutic products

that are derived or produced from a GMO.

They must consult with the Gene Technology Regulator when deciding to:

  • approve an active constituent
  • register a chemical product for agricultural or veterinary use
  • approve a label
  • reassess any approvals or registrations
  • issue a permit for a GM product.

Visit the APVMA website

Department of Agriculture, Water and the Environment (DAWE)

The Department of Agriculture, Water and the Environment (DAWE) regulates the import and export of all animal, plant and biological products that may pose a quarantine pest or disease risk to our environment. This includes GM products and GMOs.

DAWE is also responsible for:

  • biosecurity
  • conducting environmental risk assessments of the products of biotechnology
  • providing advice to the OGTR on the environmental risks posed by GMOs.

Import applications must state:

Visit the DAWE website

Food Standards Australia New Zealand (FSANZ)

FSANZ regulates genetically modified foods. All GM foods and ingredients (such as GM proteins) must:

  • be assessed and approved as safe before they can be sold in Australia or New Zealand
  • be labelled with the words ‘genetically modified’.

Visit the FSANZ website

Therapeutic Goods Administration (TGA)

The TGA regulates the supply, import, export, manufacturing and advertising of therapeutic goods. It regulates human gene therapy, including clinical research and marketing of human gene therapy products. Their work is key to making sure the Australian community has access, within a reasonable time, to therapeutic advances.

When assessing a listing or registration of a therapeutic good that contains a GMO or GM product, the TGA must:

  • consult the Gene Technology Regulator for advice
  • take that advice into account when making their decision
  • let the regulator know their decision.

Visit the TGA website

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