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About the Office of the Gene Technology Regulator (OGTR)
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The Office of the Gene Technology Regulator (OGTR)
The OGTR supports the Gene Technology Regulator (the Regulator), and is part of the Commonwealth Department of Health.
The OGTR is located in Canberra and comprises about 50 scientific, legal, policy, compliance and administrative staff. You can contact us here
You can also read the OGTR's Strategic Plan (2013 - 16) and Science Strategy (2013 - 18):
HTML 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)
HTML version of the Office of the Gene Technology Regulator Science Strategy 2013-2018
PDF version of the Office of the Gene Technology Regulator Science Strategy 2013-2018 (PDF 221 KB)
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The Gene Technology Act 2000
The Regulator regulates gene technology using a nationally consistent legislative scheme
The scheme is made up of the Commonwealth Gene Technology Act 2000
(the Act), the Gene Technology Regulations 2001
and corresponding state and territory legislation. All Australian jurisdictions contributed to developing the scheme and legislation.
The scheme is supported by the intergovernmental Gene Technology Agreement 2001
between the Australian Government and each state and territory.
The Act started on 21 June 2001. The object of the Act 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).
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, or other techniques that the Regulations specify are not gene technology.
The main features of the Act:
The Legislative and Governance Forum on Gene Technology (LGFGT; formerly the Gene Technology Ministerial Council
), 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.
Does the Act regulate GM products?
GM products are products that are derived or produced from a GMO but which are not alive; for example, a purified protein derived from a genetically modified bacteria.
GM products are not regulated under the Act unless there is no existing product regulator. The use of GM products is regulated by other agencies, such as the Therapeutic Goods Administration, Food Standards Australia New Zealand and the Australian Pesticides and Veterinary Medicines Authority.
The Regulator provides advice to other regulators on the GM aspects of such products.
The Regulator’s 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 Act sets out the functions of the Regulator to:
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- perform functions in relation to GMO licences as set out in the Act (Part 5), which outlines the licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs
- draft policy principles and policy guidelines, as requested by the LGFGT
- codes of practice
- issue technical and procedural guidelines in relation to GMOs
- provide information and advice to
- other regulatory agencies, about GMOs and GM products
- the public, about the regulation of GMOs
- the LGFGT about the
- operations of the Regulator and the Gene Technology Technical Advisory Committee
- effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments of relevant legislation
- undertake or commission research in relation to risk assessment and the biosafety of GMOs
- promote the harmonisation by regulatory agencies of risk assessments relating to GMOs and GM products
- monitor international practice in relation to the regulation of GMOs
- maintain links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia
- conduct other functions conferred by the Act, the Regulations or any other law, such as
- monitoring and enforcing the legislation
- reporting quarterly to the Minister and Federal Parliament.
The Gene Technology Regulator (the Regulator)
Dr Robyn Cleland is currently acting as Gene Technology Regulator until the appointment process for a new Regulator is completed. The Regulator is an independent statutory office holder or a head of public office. She is responsible for administering the national regulatory system for gene technology as set out in the Act. The OGTR staff are part of the Department of Health.
Dr Cleland has extensive experience in Australian Government regulatory agencies, including the OGTR, the Australian Pesticides and Veterinary Medicines Agency and most recently in Food Standards Australia New Zealand. Prior to joining the public service Dr Cleland held academic positions at the Australian National University and the University of Cambridge in the UK. She has worked in a number of roles at the OGTR, most recently as Assistant Secretary in the Regulatory Practice and Compliance Branch.
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Expectations and intent
The Parliamentary Secretary for Health gave the Regulator a 'Statement of Expectations' (PDF 64 KB)
about the role on 10 August 2009. The Regulator responded with a 'Statement of Intent' (PDF 69 KB)
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Australia’s regulatory system for gene technology—how it works
You can click the boxes below to go to each website.
If you cannot see the above image, you can use the PDF version of the flow chart of Australia’s regulatory system for gene technology PDF version (PDF 16 KB)
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How the legislation is used to regulate GMO dealings
The legislation regulates all dealings (for example: research, manufacture, production, transport, destruction, commercial release or import) with live and viable organisms that have been modified by gene technology.
This includes the progeny (or descendants) of GMOs which also share a genetically modified trait.
The legislation revolves around a system of, and process for, 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 (EDD).
Here is more information about different types of approvals:
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- Licences. All dealings with GMOs (that are not exempt, 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 and government agencies—and for intentional releases of GMOs into the environment, the public.
- Exempt dealings. Certain types of dealings with GMOs involve a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). Other than 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 may proceed if certain conditions are observed, such as specified dealings only being undertaken in certified contained facilities, overseen by Institutional Biosafety Committees 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.
- 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 safe enough that they can be undertaken by anyone, and that safety does not depend on oversight by a licence holder.
- Emergency Dealing Determination. The Minister may make an EDD authorising dealings with GMOs for a limited time in an emergency. The Minister must be satisfied that (a) there is an actual or imminent threat to people or the environment, (b) that the EDD would adequately address the threat and (c) that the risks posed are able to be managed to protect people and the environment. The Minister must receive advice from the Regulator about managing these risks.
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