2009–10 has been another successful year for the OGTR. It has seen us achieve all of our regulatory objectives and advance a range of initiatives to strengthen further the performance of Australia’s national system for regulation of gene technology, which we administer under the Gene Technology Act 2000 and relevant state and territory legislation.
Given the continuing developments in the science and application of gene technology, it is critical that the regulatory system keeps pace with and maintains its ability to fulfil, as effectively and efficiently as possible, its legislated aim of protecting the health and safety of people and the environment. Reflecting this, the key strategic direction set down for the OGTR (Department of Health and Ageing Portfolio Budget Statements – PBS1) was to ensure that the regulatory system for gene technology continues to be responsive, efficient, effective and science-based. To achieve this, we:
- maintained a strong emphasis on sound science and robust risk analysis to support our regulatory decisions
- consulted widely with experts, the regulated community and the broader public
- engaged actively in national and international activities so our approaches continued to reflect current science and influence international best practice
- pursued an active program to monitor, facilitate and ensure compliance with regulatory requirements
- continued to review our requirements and processes, particularly through the current review of the Gene Technology Regulations 2001 to ensure optimal effectiveness and currency
- strengthened liaison with other Australian Government regulators to enhance coordinated decision-making and avoid regulatory duplication.
Pursuing these strategies, we achieved the deliverables and targets set down for us in the PBS, while strengthening our performance as an effective regulator. The OGTR made 100 per cent of the 794 decisions on applications for licences for dealings with GMOs and accreditation of organisations or certification of facilities within legislated timeframes.
The trend in recent years of increasing diversity in the nature of licence applications continued in 2009–10. Licence applications this year ranged from field trials of crops with traits such as drought and salt tolerance, and enhanced nutrient uptake and herbicide tolerance, to research involving GMOs to treat human diseases, research into human and animal pathogens, and development of vaccines against cancer and infectious diseases. Our risk analysis and approval activities were again very effectively complemented by monitoring and compliance programs to ensure licence holders were actually meeting regulatory requirements.
Exceeding our target, 53 per cent of field trials and 22 per cent of higher-level containment facilities were inspected, and all alleged compliance breaches were investigated within 10 working days. No significant risks to public health or the environment were identified.
Transparency a feature
Transparency was again a feature of our regulatory decision-making. Extensive consultation continued with the general public, expert bodies, regulated organisations, other regulatory agencies and the states and territories on all licences for intentional release of GMOs, and on revision of guidelines and development of amended regulations. An upgrade of the OGTR website mapping function, which provides a visual representation of the location of all licensed GMO field trial sites, was an important development in our public interface tools during 2009–10. The functionality of the mapping site was enhanced to allow improved search functions and better links to risk assessments and licences associated with each field trial.
Regulation keeping pace
We have focused on maintaining our awareness of scientific developments and regulatory practices, and ensuring our approach to regulation of GMOs reflected contemporary developments, our operational experience and feedback from stakeholders. In this vein, the updated OGTR Risk Analysis Framework, revised to reflect the latest developments in risk analysis methodology, was implemented throughout the year and revised Guidelines for the Certification of Physical Containment Level 3 Animal Facilities were issued as part of the ongoing review of guidelines to ensure they reflect current knowledge and best practice. A major review of the Gene Technology Regulations 2001 (the Regulations) was also progressed, following in-principle policy approval from the Gene Technology Ministerial Council. The review will be finalised in 2010–11, taking into account comments received from consultation undertaken during the year on the draft amendments.
Cooperation with other agencies
Australia’s national gene technology regulatory system operates as part of an integrated legislative framework that enhances coordinated decision making and avoids duplication. To this end, we have worked closely with colleagues in other agencies that also have a role in regulating GMOs or GM products, such as Food Standards Australia New Zealand, Australian Pesticides and Veterinary Medicines Authority, the Therapeutic Goods Administration, the National Industrial Chemicals Notification and Assessment Scheme, the Department of Agriculture, Fisheries and Forestry and the Department of the Environment, Water, Heritage and the Arts. More broadly, the Regulators Forum in which relevant agencies and the OGTR come together to optimise the effectiveness and integration of the overall regulatory system through sharing knowledge and combining expertise has progressed initiatives in important areas such as addressing future skills needs, emergency response management and stakeholder communication.
OGTR staff have participated actively in a range of local forums and been engaged in the international arena to receive feedback, raise awareness and help ensure our regulatory approaches were aligned with, and contributing to, best international practice, consistent with key legislated functions of the Gene Technology Regulator. In addition to strengthening bilateral cooperation with experts and counterpart regulators in Europe, North America, South America, New Zealand, Asia and South Africa, OGTR staff have made major contributions to the work of organisations such as the Organisation for Economic Co-operation and Development (OECD) Working Group on Harmonisation of Regulatory Oversight in Biotechnology and the United Nations Convention on Biological Diversity. The OGTR’s high international standing has been reflected in many ways throughout the year. We have been invited to lead the preparation of OECD consensus documents on the biology of sugarcane and eucalyptus, and been asked to give presentations or conduct GMO risk assessment training workshops to support development of regulatory systems in Malaysia, Thailand and Vietnam.
Underpinning every aspect of our performance has, of course, been the outstanding professionalism of OGTR staff, dedicated to ensuring we deliver a high quality, effective and transparent gene technology regulatory system. I thank them for their ongoing commitment to excellence, which we have endeavoured to support by providing a workplace that is encouraging and rewarding. Staff have been supported in maintaining their regulatory and scientific awareness through participation in relevant scientific conferences, our active internal training program on legal issues associated with regulation of GMOs and regular OGTR forums at which staff and invited experts present on topics of current interest.
The way ahead
As we enter our tenth year of operation, we will build on the achievements of the past year, being guided by the new OGTR Strategic Plan 2010–13 and the priorities articulated within it.
Through active and targeted engagement with national and international agencies and organisations, we will ensure the regulatory processes we use to deliver our legislative objectives remain contemporary, able to accommodate scientific advances and consistent with the best practices employed around the world. We will finish reviewing the Regulations and implement the revised Regulations, as well as providing input to the scheduled review of the national legislative framework for gene technology regulation.
Guided by examination of our existing consultation processes, we will seek to enhance our external communications to maintain a strong focus on stakeholder engagement and transparency in regulatory decision making. We will hold another Institutional Biosafety Committee Forum to update and seek feedback from our regulated community and, through both bilateral endeavours and activities such as the Regulators Forum, strengthen our interaction with other agencies with an interest in gene technology.
Informed by review of our operations, including the strategic review of administrative arrangements within the Health and Ageing Portfolio, we will ensure optimal use of our resources. Importantly, we will continue to strive to provide an environment that is both challenging and rewarding for our staff, so we can maintain the highest standards of gene technology regulation for Australia.
Dr Joe Smith
Gene Technology Regulator
13 September 2010
1The PBS describes strategic directions, major activities for the planned programs in terms of deliverables and key performance indicators and targets. For 2009–10, the OGTR contributed to Outcome 1 (Population Health) of the Health and Ageing PBS. OGTR performance against the PBS is reported in the Department's Annual Report, this Annual Report and Quarterly Reports to Parliament. In keeping with the national nature of the regulatory scheme, OGTR operations are also reported to the Gene Technology Ministerial Council (see Appendix 1).