Agency PlanThe Regulator has prepared an IPS plan that outlines how and what information the Regulator will publish, the approach and mechanisms that the Office of the Gene Technology Regulator (OGTR) has in place to assist the Regulator to proactively identify and disclose information to the public, as specified in sections 8(1), 8(2) and 8(4) of the FOI Act.
Structure of Office of the Gene Technology Regulator (OGTR)The OGTR organisation chart provides information on the OGTR structure and how it aligns with the functions of the Gene Technology Regulator (the Regulator) as set out in the Gene Technology Act 2000. The OGTR consists of two branches: Evaluation, and Regulatory Practice and Compliance. Each branch in turn includes several sections as shown in the organisation chart. The staff under each section have specialised sets of skills, expertise and experience to provide support to the Branch Heads and the Regulator.
Functions of the Regulator/OGTRThe Gene Technology Act 2000, which came into force on 21 June 2001, introduces a national scheme for the regulation of genetically modified organisms in Australia, in order to protect the health and safety of Australians and the Australian 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.
Section 27 of the Gene Technology Act 2000 sets out the functions of the Regulator.
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).
The GTMC was established by the Gene Technology Agreement 2001 between the Australian Government and the governments of all states. The Agreement also commits state governments to enacting corresponding state legislation. The role of the GTMC is to provide policy input into implementing and operating the regulatory scheme. In addition the GTMC provides advice to the Australian Government Minister for Health and Ageing on the appointment of the Regulator and appointment of members of the Gene Technology Committees (see below).
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The OGTR has been established within the Australian Government Department of Health and Ageing to provide administrative support to the Regulator in the performance of his functions under the Gene Technology Act 2000 and the corresponding State legislation.
The OGTR Strategic Plan and the Service Charter are available to public at: ‘About the OGTR’ page of the website.
Statutory appointmentsThe Gene Technology Act 2000 establishes a statutory position of the Gene Technology Regulator, Dr Joe Smith, commenced as the Regulator on 23 March 2009. As a statutory office holder, he is responsible for administering the national regulatory system for gene technology as set out in the Gene Technology Act 2000. The Regulator is an office holder appointed by the Governor-General only with the agreement of the majority of all jurisdictions. The details of his functions are provided above.
The Gene Technology Act 2000 also establishes two advisory committees to provide advice to the Regulator and the GTMC:
- 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 on matters of general concern to the community in relation to genetically modified organisms (GMOs)
Reporting to the ParliamentThe Regulator reports to the Parliament quarterly and annually about the operations of the OGTR.
Subsection 136A(1) of the Gene Technology Act 2000 (the Act) requires the Regulator to prepare and give to the responsible Minister after each quarter a report on the operations of the Regulator during that quarter. Its purpose is to inform the community of the Regulator’s roles and responsibilities and to provide a summary of achievements over the past quarter.
The Regulator’s Annual Report is prepared in accordance with section 136(1) of the Gene Technology Act 2000 and the guidelines approved by the Joint Committee of Public Accounts and Audit referred to in sections 63(2) and 70(2) of the Public Service Act 1999. The Annual Report details the operations of the Regulator against the performance indicators for the OGTR contained in Outcome 1, Population Health, of the Department of Health and Ageing Portfolio Budget Statements for the year.
Section 136(2) of the Gene Technology Act 2000 requires the Regulator to present these reports to each House of the Parliament. The following OGTR web page provides access to all the Quarterly and Annual Reports prepared by the Regulator.
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Consultation arrangementsTransparency is a feature of the decision-making by the Regulator. This includes extensive consultation with the general public, expert bodies, regulated organisations, other regulatory agencies and the states and territories on all licences for intentional release of genetically modified organisms (GMOs) into the environment, and on revision of guidelines and development of amended regulations.
Risk communication is integral to the processes of risk assessment and risk management and involves development of an interactive dialogue between the Regulator and stakeholders. The Regulator undertakes extensive consultation with a diverse range of expert groups (including the GTTAC, see the link above) and authorities and key stakeholders, including the public, before deciding whether or not to issue a licence. Differing values and perceptions of risk can influence the approach of stakeholders to particular issues. The Regulator can also seek advice on ethical and social issues raised by gene technology from the GTECCC (see the link above).
The Regulator endeavours to provide accessible information to interested parties on applications, licences, other dealings with GMOs, trial sites and the processes of risk assessment, risk management, monitoring and compliance activities undertaken by the OGTR. The Risk Analysis Framework is part of the Regulator’s commitment to clarity, transparency and accountability of decision-making processes and is supported by a risk communication charter. Risk communication establishes an interactive dialogue between the Regulator and stakeholders to provide open, transparent and consultative risk-based regulation of GMOs.
The OGTR maintains a client register, which is a list of individuals and organisations that have registered their interest in the regulation of gene technology. Members of client register receive notifications of new GMO applications and licences issued to release a GMO into the environment (Dealings involving Intentional Release, DIR), significant changes to the gene technology legislation, and an invitation to comment on risk assessment and risk management plans (RARMPs) developed for each application to release a GMO into the environment. Interested parties can register on the OGTR client register to receive notifications from the OGTR.
These notifications and invitations for comments are also placed on the OGTR website What’s New Page. As required by the Gene Technology Act 2000, the invitations to comment are advertised in national and relevant local/regional newspapers and in the Australian Government Gazette. The OGTR has also established a toll free number (1800 181 030) for any queries or request for additional information.
All the above arrangements aim to increase the transparency of the regulatory system and to increase participation in the consultation process.
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FOI requests and orders from Parliament
The OGTR will endeavour to place all information relating to FOI requests and any routinely provided information in response to requests and orders from the Parliament (subject to timeframe at Annex A of the Regulators’ IPS plan). The FOI disclosure log is provided at the link below:
FOI disclosure log
OGTR contact detailsThe OGTR contact details are provided on the home page of the website. Advice on how to obtain additional information, how to join the client register and provide feedback are also included in a separate page with a direct link from the contact page.
General operational informationGeneral operational information of the OGTR is available in the ‘About the OGTR’ page of the website and the quarterly and annual reports.
Other information to be published under the IPSConsistent with subsection 8(4) of the FOI Act, the Regulator already publishes a range of information as required by the gene technology legislation, as well as other information which goes beyond what is required. This is consistent with the pro-disclosure culture desired by the IPS.
The other information that is already published on the OGTR website includes:
- notifications and call for public comments
- application summaries, documents supporting decisions on licence applications
- operational policies
These information/documents will be assessed and modified where necessary to ensure that they meet the standards of the IPS (subject to timeframe at Annex A of the Regulator’s IPS plan).