The Gene Technology Regulator is a statutory office holder responsible for administering the national regulatory system for gene technology. The Office of the Gene Technology Regulator (OGTR) has been established within the Australian Government Department of Health (the Department) to provide administrative support to the Regulator in the performance of her functions under the Gene Technology Act 2000.
PurposeIn accordance with subsection 8(1) of the FOI Act, this plan outlines how the Regulator, with the support of the staff of the OGTR, proposes to meet the IPS requirements. It outlines what information the Regulator proposes to publish, how the information will be published and the approach and mechanisms that the 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. The plan also aims to strengthen the existing openness and transparency of the national scheme by providing an additional platform for consultation and contribution by the public.
ObjectivesThe Regulator’s objectives in relation to the plan are to outline appropriate mechanisms and procedures to:
- effectively and efficiently manage its information holdings that are relevant to the IPS
- identify all information required to be published, including this plan, under the IPS and identify additional information that can appropriately be published as its ‘optional information’;
- ensure that the information published under the IPS is discoverable, searchable, understandable and reusable;
- regularly review information published under the IPS to ensure it remains complete, accurate and up-to-date;
- ensure that online content conforms with the Government’s Web Content Accessibility Guidelines (V2)
- develop a mechanism and procedures to measure the success of Health’s IPS
Implementing the Information Publication SchemeThe Regulator, supported by the OGTR senior executives, IPS coordinator and other senior OGTR officers, has prepared the IPS Entry. The information/documents required under IPS Entry are already available elsewhere on the OGTR website and the existing OGTR resources are allocated to establish and administer the Regulator’s IPS Entry. The Regulator has nominated a senior executive of OGTR (Executive Director, Regulatory Practice and Compliance) to manage the IPS Entry on a continuing basis.
The Regulator has well established practices and mechanisms for publishing and reviewing information on the OGTR website which will ensure timely publication and review of IPS entries for accuracy, currency and completeness. Additionally, information will be monitored and amended as required. However, confidential commercial information (declared under the Gene Technology Act 2000) and personal information (covered by the Privacy Act) are exempted from publication. As the Regulator is already providing free access to information published on the OGTR website, the information/documents under IPS Entry will also be made freely available to public.
FOI webpageThe FOI page on the OGTR website will be the main portal through which members of the public can obtain information on how to seek access to information under the FOI Act.
Disclosure LogThe disclosure log provides access to documents disclosed by OGTR pursuant to an FOI request by listing summary information such as title, date of release, including number of pages and descriptions of the types of documents released. The publication of this information is in accordance with section 11C 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 Executive Director, Branch Head and the Regulator.
Governance arrangementAustralia’s national regulatory scheme for gene technology was established by agreement between the Commonwealth and all State and Territory governments. The authority for the scheme comes from the Gene Technology Act 2000 and corresponding State law. The overarching responsibility for the scheme is held at Ministerial level by the Legislative Governance Forum on Gene Technology (LGFGT). The Assistant Minister for Health has portfolio responsibility within the Australian government. The role of the LGFGT is to provide policy input into implementing and operating the regulatory scheme. In addition the LGFGT provides advice to the Assistant Minister for Health on the appointment of the Regulator and appointment of members of the Gene Technology Committees (see below).
Functions of the Regulator/OGTRThe Gene Technology Act 2000 came into force on 21 June 2001 the object of which is 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 Gene Technology Act 2000 operates in conjunction with other regulatory schemes for food, agricultural and veterinary chemicals, biosecurity, industrial chemicals and therapeutics (APVMA, FSANZ, DAWR, NICNAS and TGA) to ensure an integrated approach that covers genetically modified organisms (GMOs) and GM products.
The OGTR has been established within the Australian Government Department of Health to provide administrative support to the Regulator in the performance of her 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 Raj Bhula, commenced as the Regulator on 18 July 2016. As a statutory office holder, she 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 her functions are provided above.
The Gene Technology Act 2000 also establishes two advisory committees to provide advice to the Regulator and the LGFGT:
- 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)
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 Annual Reports prepared by the Regulator.
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.
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 list of individuals and organisations that have subscribed to receive news from OGTR. Information received by subscribing to news from the OGTR includes:
- a notification when the OGTR has received an application to release a genetically modified organism (GMO) into the environment
- an invitation to comment on the consultation Risk Assessment and Risk Management Plan which is developed for each application to release a GMO into the environment notification that a licence to release a GMO into the environment has been issued
- invitation to comment on amendment Regulations following a technical review
- notification when there have been significant changes made to the gene technology legislation.
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 or 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.
Information required to be published
- Agency plan (subsection 8(2)(a)) – this document
- Structure of the Agency (subsection 8(2)(b)) - see above
- Functions of the Agency, including decision making powers that affect members of the public (subsection 8(2)(c))- see above
- Statutory appointments (subsection 8(2)(d)) - see above
- Annual reports and other responses to the Parliament (subsection 8(2)(e)) - see above
- Consultation arrangements (subsection 8(2)(f)) - see above
- Routinely requested information and disclosure log for information released in connection with FOI requests (subsection 8(2)(g)) and section 11C)
- Routinely provided information in response to requests and orders from the Parliament (subsection 8(2)(h)) (refer to the Departmental Records Listing Page)
- Contact details of OGTR for access to documents under FOI (subsection 8(2)(i)) - see above
- Operational information (subsection 8(2)(j)) - see below
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