Protocol and procedures involving genetically modified organisms
The Victorian Government recognises the potential future benefits from the use of biotechnology, including gene technology (In this document, gene technology refers to the process in which genetic material is inserted, deleted or modified using laboratory techniques to create animals or plants (genetically modified organisms or 'GMOs') that would be unlikely to arise from normal selective breeding programs) in agriculture, forestry, fisheries and environmental management in this State.
The Government is also committed to its policy of building the principles of ecologically sustainable development into the process of decision-making across the whole of Government.
Through this Protocol, the Department of Economic Development, Jobs, Transport, and Resources (DEDJTR), as the lead Victorian Government Departments involved in agriculture, forestry, fisheries and environmental research and development, will ensure that its biotechnology program is consistent with, and delivers Government policy related to biotechnology.
Ministerial direction on research and development involving genetically manipulated organisms
The Minister for Agriculture, the Minister for Environment and Conservation and the Minister for Energy and Resources, as the Ministers responsible for sustainable use and protection of Victoria's natural resources and environment, have released a Ministerial Direction to the DEDJTR for research and development projects involving genetically modified organisms.
The Ministerial Direction reflects the Government's commitment to ensuring that its biotechnology research and development projects, particularly those involving genetically modified organisms are;
- demonstrably in the public interest;
- compliant with all relevant Commonwealth and State regulations to protect the environment and public health; and
- transparent and publicly accountable.
The Ministerial Direction requires all DEDJTR research and development involving genetically modified organisms to include assessment of the public benefit to be gained from Government involvement in such research. Consideration of public benefit is to address all of the following:
- more efficient production, improved product quality, new products or increased choice for Victoria's domestic and export industries;
- contribution to the development of more ecologically sustainable agricultural systems;
- contribution to protection of the natural environment;
- building and securing public sector science capability that can be utilised for community benefits; or prudent management and protection of the State's intellectual property.
The Direction also requires that Government sponsored research and development within DEDJTR involving genetically modified organisms must not result in:
- limiting market choice to growers or consumers through creation of market monopolies;
- creating an unfair advantage to private or Government-owned companies;
- exclusive access to publicly owned facilities, technologies and germplasm; or
- adverse environmental impacts.
Assessment and approvals processes
Assessment of Public Benefit
Prior to implementing a research and development project (where the term 'project' is used, this may also include a group of projects within a program, as appropriate or entering into a contractual arrangement to undertake research and development involving genetically modified organisms) or entering into a contractual arrangement to undertake research and development involving genetically modified organisms, DEDJTR will assess whether the arrangement contributes significant economic, environmental and social benefits to the Victorian community as outlined in the Ministerial Direction.
All project proposals will include a review of "public benefit". This information will be used, by the Secretary, as a criterion for approving a project and will be reported in public notifications (see below).
Assessment of Public Health and Environmental Risks
Prior to implementing a research and development project involving genetically modified organisms, the proposal will be reviewed by a DEDJTR Institutional Biosafety Committee (IBC), who will assess potential risks to the environment and public health. The IBC will recommend environmental and public health safeguards based on a scientific risk assessment. Where there is uncertainty of the level of risk to the environment, the IBC will ensure the proposal stipulates the necessary precautions to be taken to minimise potential risk.
The IBC will assess the capacity of the project participants and parties to any proposed contracts to meet the regulatory and risk management requirements.
The project will not proceed if the capacity for compliance cannot be satisfactorily demonstrated. A compliance form must be signed by all parties additional to DEDJTR, involved in the project and is to be sighted by the Secretary (see below).
At an early stage, prior to detailed planning of a research and development project or advancing of formal contractual negotiations with other parties, the Secretary is to be advised of:
- the objectives and proposed public benefits anticipated from DEDJTR involvement in the research and development;
- environmental and public health risks associated with the research and development and a signed Compliance Form;
- proposed collaborative or contract arrangements;
- the basis of the proposed financial arrangement; and
- where the proposed arrangement constitutes the sale or exclusive licensing of the State's intellectual property, the proposed tender/expression of interest process.
At any time during the project development or contractual negotiations, the Secretary:
- may seek the advice of the Chief Scientists;
- may refer the proposed project or contract to the DEDJTR Audit Committee.
Recommendations of the DEDJTR Audit Committee, particularly in relation to liability and indemnity clauses in contractual arrangements, will be incorporated into the relevant project or project.
Final approval is required from the Secretary before any project is implemented or contract signed that involves research and development involving genetically modified organisms.
Protection of the environment and public health
Research and development involving genetically modified organisms will be undertaken in accordance with applicable laws, agreed codes of conduct and particular requirements that may be imposed by an IBC, the Office of the Gene Technology Regulator or other relevant regulatory agencies.
Operating procedures will be prepared for each research and development project that include environmental and public health safeguards based on a scientific risk assessment. The operating procedures will assign accountability and include mechanisms to ensure effective communication and implementation.
The relevant Institutional Biosafety Committee (IBC) will regularly audit compliance and report to the DEDJTR Audit Committee.
DEDJTR will ensure that details of its research and development activities involving genetically modified organisms are made publicly available on a regular and updated basis.
For every research and development project involving genetically modified organisms, DPI/DSE will also publish advice within 10 days of completion of contract arrangements (or project approval where no other parties are involved). Subject to essential restrictions on disclosure of commercial-in-confidence details, published advice will incorporate the following:
- the objectives and methodology of the project;
- its expected completion date;
- the expected public benefit;
- the parties involved in any business contract or collaborative arrangement;
- the nature and structure of any business arrangement between the parties;
- such other details about the project that are normally published by the Office of the Gene Technology Regulator, including the institutes and/or regions where the research and development will be undertaken.
Officers of DEDJTR undertaking research and trials involving genetically modified organisms will comply with the Department's Guidelines for the Ethical Conduct of Scientific Research and Provision of Scientific and Technical Advice.
Compliance with the Protocol
All research and development projects and contracts between DEDJTR and private and public organisations for research and development involving genetically modified organisms will be assessed by the Secretary, DEDJTR, for compliance with the Protocol.
A report on compliance will be included in the DEDJTR annual report.