Why gene technology is regulated
There are a number of concerns in the community about gene technology. They particularly relate to potential risks to the environment and public health, including:
- higher risks of allergic reactions to genetically modified food
- unknown long-term consequences that we may not be able to reverse or fix once the GMO is widely used
- contamination of traditional or organic crops
- more agricultural chemicals used on genetically modified herbicide tolerant crops, possibly resulting in increased environmental damage
- crops so strong that they become weeds or pests
- GM animals escaping and becoming feral
- effects of insect-resistant crops on non-target insects, such as butterflies
- transfer of genes for herbicide tolerance from GM crops resulting in herbicide-resistant weeds.
A strong regulatory framework, that includes approval through licencing, allows those risks and concerns to be assessed and managed.
Who does what
While the Regulator must consider risks to human health and safety and the environment relating to dealings with GMOs, other agencies have responsibility for regulating GMOs or GM products as part of a broader or different mandate.
The Regulator is governed by the Gene Technology Ministers' Meeting (GTMM). The forum was established by the Intergovernmental Gene Technology Agreement. It is underpinned by the Gene Technology Act 2000 and supported by the Gene Technology Standing Committee.
The Regulator is advised by:
- the Gene Technology Technical Advisory Committee
- Gene Technology Ethics and Community Consultative Committee
The Regulator consults:
- other Commonwealth agencies prescribed in the Regulations
- state and territory governments
- the Environment Minister
- the public
- local councils.
Gene technology committees
The Gene Technology Act 2000 establishes 2 committees to provide advice to the Regulator and the GTMM.
The Gene Technology Technical Advisory Committee (GTTAC) provides expert scientific and technical advice.
The Gene Technology Ethics and Community Consultative Committee (GTECCC) provides advice on ethical issues and matters of general concern to the community relating to GMOs.
The Regulator must consult Commonwealth regulatory authorities and agencies prescribed in the Regulations on all licence applications for dealings involving the intentional release of GMOs to the environment.
|Regulatory agency||GM products regulated||Relevant legislation|
|human foods||Food Standards Australia New Zealand Act 1991|
|human therapeutics||Therapeutic Goods Act 1989|
|industrial chemicals||Industrial Chemicals Act 2019|
|agricultural chemicals and veterinary medicines||Agricultural and Veterinary Chemicals (Code) Act 1994
Agricultural and Veterinary Chemicals Administration Act 1994
|import and export||Quarantine Act 1908
Imported Food Control Act 1992
Authority and agencies regulating GM products are required to consult or notify the Regulator regarding applications for registration of products that are GM or contain GMOs.
State and territory legislation
The national regulatory system is underpinned by the Intergovernmental Gene Technology Agreement which:
- has been signed by all Australian jurisdictions
- sets out the understanding between governments of the nationally consistent regulatory system
- commits the states and territories to passing and maintaining corresponding laws.
The Regulator is charged with performing functions and exercising powers under the Gene Technology Act 2000 and corresponding legislation.
|Jurisdiction||Title of Act and Regulations|
Australian Capital Territory
|Gene Technology Act 2003
Gene Technology Regulations 2004
|New South Wales||Gene Technology (New South Wales) Act 2003|
|Northern Territory||Gene Technology (Northern Territory) Act 2004|
|Queensland||Gene Technology (Queensland) Act 2016|
|South Australia||Gene Technology Act 2001
Gene Technology Regulations 2002
|Tasmania||Gene Technology (Tasmania) Act 2012|
|Victoria||Gene Technology Act 2001
Gene Technology Regulations 2011
Regulatory Science Network
The OGTR is a member of the Regulatory Science Network. The network’s membership includes Australian Government agencies responsible for regulating chemical, biological or radiological agents:
- Department of Agriculture, Water and the Environment (DAWE)
- Australian Pesticides and Veterinary Medicines Authority (APVMA)
- Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)
- Food Standards Australia New Zealand (FSANZ)
- Australian Industrial Chemicals Introduction Scheme (AICIS)
- Office of Chemical Safety, Department of Health (OCS)
- Office of the Gene Technology Regulator (OGTR)
- SafeWork Australia
- Australian Safeguards and Non-proliferation Office
- Defence Export Controls (DEC)
- National Health and Medical Research Council (NHMRC).
The RSN allows member agencies to discuss regulatory scientific issues and improve interagency cooperation. The RSN’s objective is to improve the performance of the regulatory agencies by strengthening evidence-based decision-making by:
- providing an open forum where regulatory and technical issues can be discussed and solved
- promoting a consistent approach to evidence-based decision making
- providing cross-agency training and professional development opportunities
- enhancing and enabling cross-agency networking opportunities
- acting as a conduit for cross-agency liaison for regulatory and technical issues
- providing a platform to share information and upcoming key activities.
The RSN meets regularly and conducts at least one major science-focused activity each year. Other activities include:
- joint agency seminars
- interagency workshops
- conference presentations.