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 6 hexagons that centre around another hexagon.
The middle hexagon represents Gene Technology Regulator and the hexagons arranged around it are labelled as follows:
- Therapeutic Goods Administration (TGA)
- Food Standards Australia New Zealand (FSANZ)
- Australian Pesticides and Veterinary Medicines Authority (APVMA)
- Australian Industrial Chemicals Introductory Scheme (AICIS)
- Department of Agriculture, Fisheries and Forestry (DAFF)
- Department of Climate Change, Energy, the Environment and Water (DCCEEW)
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.
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
Department of Climate Change, Energy, the Environment and Water (DCCEEW)
The Department of Climate Change, Energy, the Environment and Water (DCCEEW) plays a role in the sound management of the risks posed by the release of the products of biotechnology into the Australian environment.
DCCEEW has two main responsibilities:
- Provision of advice to the Gene Technology Regulator
- Assessment of the environmental safety of biological products regulated as agricultural chemicals and veterinary medicines by the Australian Pesticides and Veterinary Medicines Authority (APVMA)
DCCEEWW also administers the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act). This Act regulates actions that are likely to have a significant impact on matters of national environmental significance. These provisions may be relevant to the release of a GMO, if it is determined that this action may have a significant impact on matters protected under the EPBC Act.
Department of Agriculture, Fisheries and Forestry
Dealings involving the intentional release of a GMO into the environment are illegal in Australia unless conducted pursuant to a licence from the Gene technology Regulator (the Regulator). This applies to both limited and controlled releases (eg field trials) and commercial scale releases. Before issuing such a licence, the Regulator must prepare a risk assessment and risk management plan (RARMP) that identifies any potential risks to the health and safety of people and the environment posed by gene technology, and the means of managing those risks.
For licence applications for environmental release of GMOs the Regulator must consult on the RARMP with States and Territories, other Australian Government agencies, relevant local councils and the public.
The Gene Technology Regulator consults with Department of Agriculture, Fisheries and Forestry (DAFF) through the Australian Quarantine and Inspection Service (AQIS) and Biosecurity Australia.
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’.
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.