A nationally consistent scheme
The Gene Technology Regulator regulates GMOs using a nationally consistent legislative scheme consisting of:
- the Gene Technology Act 2000 (the Act)
- the Gene Technology Regulations 2001 (the Regulations)
- corresponding state and territory legislation.
The scheme is supported by the intergovernmental Gene Technology Agreement 2001 between the Australian Government and each state and territory.
The Act’s aim is to protect the health and safety of people, and the environment, by:
- identifying risks posed by or as a result of gene technology
- managing those risks through regulating certain dealings with genetically modified organisms (GMOs).
The Act defines gene technology as any technique for the modification of genes or other genetic material. Gene technology does not include:
- sexual reproduction
- homologous recombination
- other techniques that the Regulations specify are not gene technology.
The main features of the Act:
- Prohibition of all dealings with GMOs unless authorised.
- Powers to allow monitoring and enforcement of the legislation.
- A process for assessing risk.
- Establishment of committees to provide expert advice.
- Appointment of a statutory officer (the Regulator) to make decisions under the legislation.
- Establishment of a centralised, publicly available database of all GMOs approved in Australia.
Sound science and rigorous risk analysis
Sound science and rigorous risk analysis are central to the regulatory activities undertaken by the Regulator. The staff of the Office of the Gene Technology Regulator (OGTR) support the Regulator by:
- providing scientific and technical advice
- conducting risk analyses.
The Regulator must also seek scientific and technical advice from the Gene Technology Technical Advisory Committee (GTTAC) for all risk assessment and risk management plans (RARMPs) for applications proposing intentional release of GMOs into the environment.
The advice from GTTAC and from other experts, agencies and authorities is a valuable contribution to regulatory science and risk analysis conducted by the OGTR.
Science forms the foundation for evidence-based regulatory decision making that protects people and the environment from the risks posed by gene technology.
The Science Strategy outlines how the OGTR maintains and enhances our scientific and risk analysis capabilities. It also ensures their effective application to meet current and future gene technology regulatory needs.
The strategy’s aim is for the OGTR to be recognised as leaders in regulatory science for gene technology. To achieve this, it focuses on 4 key areas:
- Maintaining and enhancing our scientific capacity.
- Effective application of science to regulatory activities.
- Collaboration, partnership and leadership.
- Stakeholder engagement and communication.
Risk analysis and assessment
The Act mandates the preparation of a risk assessment and risk management plan (RARMP) before issuing a licence. All RARMPs for applications proposing intentional release of GMOs into the environment are published in the GMO Record.
The Risk Analysis Framework provides guidance on how the Regulator, together with OGTR staff, implements risk analysis of GMOs in accordance with the Act and the Regulations. It explains the rationale and approach adopted by the Regulator in arriving at risk management measures and licence conditions.
The risk assessment reference documents address matters common to applications for dealings involving the intentional release of GMOs into the environment. The documents are regularly referred to in RARMPs.