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Message from the Regulator
This Strategic Plan both looks to the future and is informed by our current activities. It aims to provide a strategic picture of who we are and what we do, our values, our strategic objectives and the enabling strategies that will allow us to achieve these objectives. It addresses our primary purpose of protecting the health and safety of people and the environment by regulating genetically modified organisms.
In a changing environment this Strategic Plan will provide overarching guidance for our operational activities and business planning processes for 2013-2016. While there will be many influences on our operations over the next three years, some specific priorities for us will include ensuring the efficient and effective operation of the regulatory scheme, keeping pace with changes in gene technology and continuing to improve our communication and engagement.
I look forward to working with OGTR staff and our stakeholders as we deliver this Strategic Plan.
[Signed in Hard Copy and PDF versions.]
Dr Joe Smith
Office of the Gene Technology Regulator
To be a trusted and respected regulator of gene technology safeguarding the Australian people and the environment.
Dedicated to ensuring that genetically modified organisms are safely managed in Australia.
Who we are and what we do
Australia’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 (the Act) and corresponding State law which provide for the appointment of an independent decision maker, the Gene Technology Regulator. Overarching responsibility for the scheme is held at Ministerial level by the COAG1 Legislative and Governance Forum on Gene Technology. The Parliamentary Secretary for Health and Ageing has portfolio responsibility within government. The Regulator is supported by the Office of the Gene Technology Regulator (OGTR) within the Department of Health and Ageing. The Act operates in conjunction with other regulatory schemes for food, agricultural and veterinary chemicals, biosecurity and therapeutics (APVMA, FSANZ, DAFF and TGA2) to ensure an integrated approach that covers genetically modified organisms (GMOs) and GM products.
The focus of the Act is on protecting the health of people and the environment and does not include consideration of trade or marketing issues. The Act provides a variety of permissions that allow people to work with GMOs. The Regulator must decide, based on scientific evidence, whether or not to allow a GM crop to be planted or a GM vaccine to be released and what restrictions should be put in place to contain the GMO. Work with gene technology in laboratories and other contained facilities is also regulated. The Act has provisions for compliance and enforcement and work with GMOs is monitored by the Regulator to ensure compliance with requirements, including that appropriate containment is maintained, both for environmental releases and in laboratories.
Openness and transparency are cornerstones of the regulatory scheme. These principles are embedded in the legislation which requires the Regulator to consult widely before making a decision on environmental release of a GMO and also to publish the details of the decision, allow public access to documents and to keep a public record of approved GMOs. The performance of the scheme is reported to Parliament through quarterly and annual reports. OGTR also contributes to Outcome 1 (Population Health) of the Department of Health and Aging Portfolio Budget Statements and its performance and financial statements are part of the departmental annual report.
Professional, transparent, accountable, proactive, collaborative, responsive, respectful, inclusive, ethical.
The national regulatory scheme has been operating successfully since it began in 2001. However, gene technology remains a contentious area with a variety of strongly held and divergent views. Gene technology provides one approach in developing strategies to respond to global challenges such as food security, climate change and managing pests and diseases. It is an important tool for research in many fields of biology. It is also an area of rapid change as scientific knowledge advances. Since the scheme began, the complexity of activities conducted with GMOs has increased significantly. There are more crop types with a wider variety of introduced genes, different applications such as human and animal vaccines are being trialled, there are more multi-room, multi-purpose laboratory facilities, and large collaborations across different organisations are now common. Over the next three to five years the regulatory scheme will need to continue to adjust to such developments.
OGTR is also actively involved in wider government reforms including administrative reform, improving financial management, improving regulation, transparency, inclusiveness and accessibility (Ahead of the Game, CFAR, Gov 2.0 and WCAG 2.03).
During the period of this strategic plan, there are three key areas that will feature prominently in our operational activities. They are efficient and effective regulation, changes in gene technology and communication.
Efficient and effective regulation
Our key priority must be to continue to deliver efficient and effective regulation of gene technology. Against a background of increasing demand, we will maintain a focus on using our resources wisely, targeting priority areas, improving our performance through internal and external review, engaging with best practice regulatory authorities internationally, and streamlining our operations without compromising the protection of people and the environment. Major activities during the period of this Strategic Plan will include implementing the operational elements of the government response to the 2011 Review of the Act, preparing for the next review of the Act, optimising coordination within the national regulatory scheme and working towards greater domestic and international harmonisation. During this period, the government will be considering the feasibility of partial cost recovery for the regulatory scheme through the development of a cost recovery impact statement (CRIS). OGTR will provide input to the CRIS and implement the agreed policy position.
Changes in technology
Gene technology continues to develop both at the research level and in its application in a widening variety of areas. It is important for us not just to respond to such changes but to anticipate and prepare for them. The Review of the Act in 2011 highlighted the ongoing need for the regulatory scheme to provide appropriate oversight of new technologies and we will continue our work in this area. We will develop a science strategy that will guide us in building and maintaining contemporary knowledge and expertise and leverage through collaboration and engagement with relevant experts and other regulatory agencies. By staying abreast of scientific developments we can anticipate and prepare for changes in gene technology and its application.
As the internet puts information at people’s finger tips, citizen’s needs and expectations of government are increasing. In this environment, regulators are expected to be more communicative, more responsive, proactive in anticipating the public’s needs and ready to embrace new styles of communication tailored to individuals. We will be developing a communication strategy that does this, ensuring our mandate of openness and transparency is delivered according to 21st century expectations.
To deliver efficient and effective regulation that protects people and the environment, and encompasses regulatory decisions and activities (science, compliance, performance) that are evidence based, outcome focused, transparent, consistent and defensible.
To provide a safe, respectful and inclusive workplace that is productive and professionally rewarding.
To inform and engage effectively with our stakeholders so that they understand and respect our decisions.
To ensure our governance arrangements are robust, exemplify best practice and fulfil all legal obligations.
- Sound science
- Effective compliance
- Good governance
- Capable, qualified staff
- Clear communication
A high performing organisation that fulfils the requirements of the legislation, is respected as a regulator, can adapt to government imperatives, is responsive to stakeholders concerns, and anticipates change.
Regulatory decisions that are transparent, consistent, defensible and evidence based.
People that are skilled, productive and professional.
A cooperative and compliant regulated community that engages with the regulatory system.
1Council of Australian Governments.
2Australian Pesticides and Veterinary Medicines Authority; Food Standards Australia New Zealand; Department of Agriculture, Fisheries and Forestry; Therapeutic Goods Administration.
3Ahead of the Game, Blueprint for the Reform of Australian Government Administration; Commonwealth Financial Accountability Review; Government 2.0 the use of technology to encourage a more open, transparent and engaging form of government; Web Content Accessibility Guidelines.