Frequently asked questions about regulation and related information
- Who currently regulates GM products in Australia?
- What does the gene technology legislation do?
- Who administers the legislative framework?
- Who oversees the Gene Technology Regulator?
- Who advises the GTR?
- How does the Commonwealth Gene Technology Act 2000 affect the roles of other regulatory bodies?
- How does Victoria fit into the national framework?
- Who represents Victoria in the national scheme?
- Is Victoria establishing its own regulatory framework on biotechnology?
- Who is represented on the Senior Officers' Group (SOG)?
Who currently regulates GM products in Australia?
Biotechnology is currently regulated by a number of different bodies depending on the intended use of the Genetically Modified Organism (GMO) or Genetically Modified (GM) product.
These regulators include:
- Food Standards Australia New Zealand (FSANZ) - regulating food standards and labelling;
- Therapeutic Goods Administration (TGA) - regulating therapeutic goods and human gene therapy;
- Australian Pesticides and Veterinary Medicines Authority (APVMA) - regulating agricultural and veterinary chemicals;
- National Industrial Chemicals Notification and Assessment Scheme (NICNAS) - regulating industrial chemicals;
- Australian Quarantine and Inspection Service (AQIS) - regulating import and export of GM products and GMOs; and
- National Health and Medical Research Council (NHMRC) - overseeing research involving human gene therapy.
What does the gene technology legislation do?
The Commonwealth Gene Technology Act 2000 and the Victorian Gene Technology Act 2001 establishes a national framework to regulate gene technology and provides a framework to achieve coordination across Government.
Specifically, federal and state laws regulate gene technology through the formalisation of:
- A risk assessment process where possible hazards are identified and the likelihood of their occurrence assessed;
- A licensing framework for industry and institutions using biotechnology to develop products or in their research;
- The establishment of a Canberra based Office of Gene Technology Regulator to carry out those functions;
- The creation of a Ministerial Council for Gene Technology to develop policy principles to support the decisions of the Gene Technology Regulator; and
- The establishment of three independent national advisory committees with expertise in the science of gene technology, ethical matters and community concerns related to the use of gene technology.
Who administers the legislative framework?
The legislative framework is administered through the Office of the Gene Technology Regulator (OGTR). The Office also monitors and enforces the legislation. The Gene Technology Regulator receives licence applications from industry and institutions for the use of gene technology. Applications are assessed for the level of risk presented. The GTR determines whether or not to issue a licence to allow the proposed dealings and, if so, what conditions should be attached to the licence.
Who oversees the Gene Technology Regulator?
The Gene Technology Regulator (GTR) is accountable to the Commonwealth Parliament. The GTR tables quarterly reports to the Parliament on activities of the Office, including details of licence applications and the monitoring of licence holders.
Who advises the GTR?
The Ministerial Council for Gene Technology, comprising Ministers from the Commonwealth and each State and Territory, oversees the regulatory framework and provides advice to the GTR on policy principles to assist in decision-making.
In addition, three statutory committees provide advice to both the GTR and the Ministerial Council.
The advisory committees are:
- the Gene Technology Technical Advisory Committee that advises the Ministerial Council and the GTR on risk assessments for individual applications;
- the Gene Technology Ethics Committee that advises the Ministerial Council and the GTR on ethical matters arising in the regulatory framework; and
- the Gene Technology Community Consultative Committee that advises the Ministerial Council and the GTR on general community concerns.
How does the Commonwealth Gene Technology Act 2000 affect the roles of other regulatory bodies?
The legislation operates alongside existing regulatory systems for the regulation of food, therapeutic goods, agricultural and veterinary chemicals and industrial chemicals.
Existing regulators still regulate products and/or activities covered by existing legislation whether the products or activities are GM or not GM.
However, existing regulators are required to work closely with the Office of the Gene Technology Regulator (OGTR) to harmonise risk assessment on GMOs and GM products.
This working arrangement includes the sharing of databases and the requirement for existing regulators to take into account the advice of the GTR when considering applications for GMOs and GM products.
How does Victoria fit into the national framework?
The Victorian Government has enacted complementary State legislation mirroring the Commonwealth legislation under an Inter-Governmental Agreement on gene technology. The Victorian Gene Technology Act came into effect in December 2001.
Who represents Victoria in the national scheme?
The Victorian Minister for Health represents Victoria on the Gene Technology Ministerial Council.
A Biotechnology and Ethics Programme (BEP) located within the Public Health Group in the Victorian Department of Human Services, provides the central coordination role for the Victorian Government’s participation in the national regulatory framework for gene technology.
Is Victoria establishing its own regulatory framework on biotechnology?
The Victorian Government has established a State regulatory framework for biotechnology that sits within the national framework.
The State framework includes a high-level Senior Officers’ Group (SOG) and an independent ethics advisory committee. The Victorian Biotechnology Ethics Advisory Committee (VBEAC) and the Chair of the SOG report directly to the Minister for Health as Victoria’s lead Minister for biotechnology safety and ethics.
Who is represented on the Senior Officers' Group (SOG)?
The Director of Public Health (who is also the Victorian representative on the national Gene Technology Standing Committee) chairs the senior officers’ group. Its representation is drawn from the Departments of:
- Human Services
- Primary Industries
- Sustainability and Environment
- Justice
- Premier and Cabinet
- Innovation, Industry and Regional Development