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About the OGTR
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The Office of the Gene Technology Regulator (OGTR)
The OGTR supports the Gene Technology Regulator, and is part of the Commonwealth Department of Health and Ageing. The OGTR is located in Canberra and comprises some 50 scientific, legal, policy, compliance and administrative staff.
The Gene Technology Act 2000
The nationally consistent legislative scheme
for regulating gene technology is comprised of the Commonwealth Gene Technology Act 2000
, the Gene Technology Regulations 2001
and corresponding State and Territory legislation.
The scheme and legislation was developed in consultation with all Australian jurisdictions and the scheme is supported by the inter-governmental Gene Technology Agreement 2001
between the Australian Government and each State and Territory.
The Commonwealth Gene Technology Act 2000
took effect on 21 June 2001.
The object of the Gene Technology Act 2000 "is to protect the health and safety of people, and the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs)".
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The Act defines gene technology as any technique for the modification of genes or other genetic material, but does not include:
- sexual reproduction; or
- homologous recombination; or
- any other technique specified in the regulations.
The main features of the Act include:
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- Prohibition of anyone dealing with a GMO (eg. for research, manufacture, production, commercial release and import) unless the dealing is:
- Licensed by the Regulator for contained use or intentional release into the environment
- Notifiable Low Risk Dealing (NLRD) or exempt dealing eg. contained work which has been demonstrated to pose minimal risk to workers, the general public and the environment,
- on the Register of GMOs.
- Specified in an Emergency Dealing Determination
- Establishment of a statutory officer (the Gene Technology Regulator) to make decisions under the legislation;
- Establishment of the Gene Technology Technical Advisory Committee (GTTAC) and the Gene Technology Ethics and Community Consultative Committee (GTECCC). More information on the Gene Technology Advisory Committees is available on the OGTR Gene Technology Committees web page;
- Establishment of a process to assess risks to human health and the environment associated with various dealings with GMOs, including opportunities for public input;
- Extensive powers to allow monitoring and enforcement of the legislation; and
- A centralised, publicly available database of all GMOs and GM products approved in Australia (the Record of GMO and GM product dealings).
A Legislative and Governance Forum on Gene Technology
with representatives from the Commonwealth and every State and Territory has also been established to provide broad oversight of the implementation of the regulatory system.
GM products (i.e. products that are derived or produced from a GMO but which are not a GMO, for example a purified protein derived from a genetically modified bacteria) are not regulated under the Gene Technology Act 2000, unless there is no existing product regulator. The use of GM products is regulated by other regulatory agencies, such as the Therapeutic Goods Administration, Food Standards Australia New Zealand and the Australian Pesticides and Veterinary Medicines Authority. The Gene Technology Regulator provides advice to other regulators on the genetic modification aspects of such products.
The Gene Technology Regulator (the Regulator)
Dr Joe Smith commenced as Gene Technology Regulator on 23 March 2009. In this role, he is the statutory office holder responsible for administering the national regulatory system for gene technology as set out in the
Gene Technology Act 2000.
Dr Smith has an extensive and diverse background spanning some thirty years in both the public and private sector involving scientific research, services and regulation. He has over twenty years experience in senior government regulatory and related roles, including as Chief Executive of the Australian Pesticides and Veterinary Medicines Authority, Director of the Therapeutic Goods Administration Laboratories and as Australian Government Analyst. Dr Smith has been actively engaged in international standards setting activities through forums such as the OECD and FAO/WHO and in building cooperation with counterpart regulators in other countries.
He has a PhD in Chemistry and BSc (Hons), is a Fellow of the Royal Australian Chemical Institute and a Graduate of the Australian Institute of Company Directors.
Statement of Expectations and Intent
The Regulator was provided with a 'Statement of Expectations' (PDF 64 KB)
by the Parliamentary Secretary for Health.
The Regulator's response is contained in his 'Statement of Intent' (PDF 69 KB)
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Roles and functions
The Regulator is an office holder with significant independence - similar to the Auditor-General and the Tax Commissioner. The Regulator is appointed by the Governor-General only with the agreement of the majority of all jurisdictions.
Section 27 of the Gene Technology Act 2000
(the Act) sets out the functions of the Regulator as follows:
- to perform functions in relation to Genetically Modified Organism (GMO) licences as set out in Part 5 of the Act which outlines the licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs;
- to develop draft policy principles and policy guidelines, as requested by the Ministerial Council;
- to develop codes of practice;
- to issue technical and procedural guidelines in relation to GMOs;
- to provide information and advice to other regulatory agencies about GMOs and GM products;
- to provide information and advice to the public about the regulation of GMOs;
- to provide advice to the Ministerial Council about:
- the operations of the Regulator and the Gene Technology Technical Advisory Committee
- the effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments of relevant legislation.
- to undertake or commission research in relation to risk assessment and the biosafety of GMOs;
- to promote the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies;
- to monitor international practice in relation to the regulation of GMOs;
- to maintain links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia; and
- Such other functions as far as are conferred on the Regulator by the Act, the regulations or any other law.
Other functions include:
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- monitoring and enforcing the legislation; and
- Quarterly reporting to the Minister and Federal Parliament.
National Gene Technology Regulatory System flow chart
The interactive flow chart below contains links to relevant websites
PDF Printable version of National Gene Technology Regulatory System flow chart (PDF 207 KB)
The Office of the Gene Technology Regulator Strategic Plan 2013 - 2016HTML version of the Office of the Gene Technology Regulator Strategic Plan 2013 - 2016 (HTML)
PDF version of the Office of the Gene Technology Regulator Strategic Plan 2013 - 2016 (PDF 905 KB)
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- The legislation regulates all dealings (e.g. research, manufacture, production, transport, destruction, commercial release and import) with live viable organisms that have been modified by techniques of gene technology, including the progeny (or descendants) of such GMOs which also share a genetically modified trait.
- The legislation revolves around a system of prohibitions and approvals. Every dealing with a GMO needs to be licensed by the Regulator, unless the dealing is an exempt dealing, a Notifiable Low Risk Dealing (NLRD), on the GMO Register or specified in an Emergency Dealing Determination.
- Exempt Dealings - certain types of dealings with GMOs which involve a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). Other then listing in the Regulations, the only legislative requirement for exempt dealings is that they must not involve an intentional release of a GMO into the environment.
- Notifiable Low Risk Dealings - the regulations also set out categories of dealings with GMOs which are low risk and which may proceed provided that certain conditions spelt out in the regulations are observed. This includes requirements that the specified dealings be undertaken only in certified contained facilities, overseen by Institutional Biosafety Committees (IBCs) and notified annually to the Regulator. The conditions under which such dealings must be conducted are clearly set out in the regulations. An NLRD must not involve the intentional release of a GMO into the environment.
- Licences - all dealings with GMOs (that are not exempt or NLRDs or on the GMO Register) need to be licensed by the Regulator. The licensing system is based on rigorous scientific risk assessment and extensive consultation with expert advisory committees, Government agencies and, for intentional releases of GMOs into the environment, the public.
- GMO Register - dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time. Dealings will not be entered onto the Register until the Regulator is satisfied that the dealings are sufficiently safe that they can be undertaken by anyone, and that safety does not depend on oversight by a licence holder.
- Emergency Dealing Determination (EDD) - the Minister may make an EDD authorising dealings with GMOs for a limited period in an emergency. The Minister must be satisfied that there is an actual or imminent threat to people or the environment, that the EDD would adequately address the threat and that risks posed are able to be managed so as to protect people and the environment. The Minister must receive advice from the Regulator to management of risks.
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