Department of Primary Industries Biotechnology Charter - 2011
Table of Contents
About this document
Key definitions
Biotechnology
Gene technology
Regulation of gene technology
Commonwealth Legislation
Victorian Legislation
DPI governance arrangements
Biotechnology in primary industries
The role of DPI in biotechnology
DPI biotechnology focus areas
DPI research and development facilities
Strategic policy documents
Victoria’s Technology Plan for the Future - Biotechnology
DPI’s Strategic Plan 2010-13 Interim
Conclusion
Glossary
Biological definitions
Governance definitions
About this document
This Biotechnology Charter sets out a framework through which the Department of Primary Industries (DPI) will responsibly use biotechnology research, development and extension in Victorian primary industries for the benefit of Victorian communities. These benefits will be realised through biotechnology opportunities developed and applied in partnership with Victorian primary industries.
This Charter defines the regulation of certain types of biotechnology research at the Commonwealth, State and Departmental levels and the role of DPI in biotechnology. The Charter also elaborates on the range of mechanisms that ensure the safe, responsible and legislated use of biotechnology within DPI with a demonstrable public benefit.
Key definitions
Biotechnology
Biotechnology describes a group of technologies that apply biological processes and techniques for the development of agricultural products, medicines, vaccines, food and other products and processes. Many of the principles and techniques involved in biotechnology have been practised for thousands of years, such as fermentation, in which microbes are used to produce food and beverage products such as beer, wine, cheese, bread and yoghurt.
Traditional animal and plant breeding techniques are a form of pre-industrial biotechnology. This involves ‘crossing’ or hybridising individual plants or animals to create a new generation with a mix of characteristics from both ‘parents’.
Today, biotechnology uses our knowledge of the role and function of genetic material and the genetic makeup of different organisms. It is an important technology that may be applied in many industries, including agriculture, forestry, fishing, food processing, energy and mining, chemicals, textiles and environmental management, pharmaceutical and health industries.
Biotechnology will continue to be an important driver of innovation and productivity and offers significant opportunity for economic, social and environmental gain.
Genomic selection for livestock improvement
DPI scientists have delivered breeding tools to the dairy industry based on genomic science. The breeding merit of bulls is now analysed and published for 41 important productivity and animal health traits through the Australian Dairy Herd Improvement Scheme (ADHIS), enabling farmers to make smarter breeding decisions to improve their herd. Genomics has many benefits including the ability to select younger superior bulls with more confidence to increase the rate of genetic gain. The April 2011 Australian Breeding Values (ABV) release by ADHIS to industry marked the first release of Genomic Breeding Values referred to as ABV(g)s. In this release genomics was introduced for the Holstein breed.
In addition to enhanced information for bull selection, dairy producers now have a cost-effective tool for genomic analysis of their cow herd. A DNA chip with 3000 gene markers can be used for parentage assignment and pedigree reconstruction. Better information and the ability to select the best genetics on both the maternal and paternal breeding line will accelerate genetic improvement and milk production.
Gene technology
Gene technology is a special application of biotechnology and is used by scientists to identify or modify the genetic information of cells of plants, animals and microorganisms. The term ‘genetically modified’ (GM) describes that altered organism and products derived from them. Genetic modification can give the altered organism a new function or ability - such as drought tolerance or increased nutrient levels - that may be much more difficult to achieve using other methods.
Improved forage grasses for livestock
The world’s first, elite, transgenic perennial ryegrass germplasm with stable, high-fructan and high-biomass traits has been developed by DPI scientists. The selection of elite transgenic events follows two years of field evaluation and identification of high-energy lines for varietal development. This represents a key milestone in the development of a high-value GM trait in the key forage grass for temperate pastoral agriculture worldwide and represents a foundation trait that can pave the way for GM forages for Australia’s grazing industries.
Regulation of gene technology
A nationally-adopted regulatory framework sets out stringent risk assessment procedures for all genetically modified organisms (GMOs). Under this framework, which was implemented through an Intergovernmental Gene Technology Agreement (IGTA), the Commonwealth Government is responsible for risks to health and safety of people and the environment and state and territory governments are responsible for risks to markets and trades (see Figure 1).
people and the environment
Responsibilty: Department of Health and Ageing
Legislation: Gene Technology Act 2000 (Cwlth), amended 2007
- Toxicity
- Allergenicity
- Carcinogenicity
- Pathogenicity
- Endocrine and reproductive effects
- Harm to protected species
- Harm to non-target organisms
- Effects on species diversity/genetic diversity
- Creation of new weeds, pests or pathogens
- Exacerbating the effects of weeds, pests or pathogens
- Disruption of biotic communities and ecosystems
- Disruption of rare and endangered or highly valued ecosystems
Responsibility: State and Territory governments
Legislation: Control of GM Crops Act 2004 (Vic.)
- Impact on domestic trade performance
- Impact on export trade performance
- Impact on the markets of non-GM crops
- Impact on the markets associated with other agricultural industries
- Costs and liability associated with coexistence of GM and non-GM markets
- Impact on our 'clean green' image
- Impact on growers' choice to grow GM-free crops
- Impact on Industry competitiveness
- Impact on Industry investment in research and development
Figure 1. Legislation governing gene technology and risk management in Australia.
Commonwealth Legislation
The Commonwealth Gene Technology Act 2000 establishes the role of the Office of the Gene Technology Regulator (OGTR), which is responsible for assessing and managing risks to human health and the environment from GMOs. The Gene Technology Act 2000 is the key component of the National Gene Technology Regulatory Scheme and was developed in consultation with all states and territories and provides for a cooperative national approach.
What does the Gene Technology Act 2000 do?
- Establishes a statutory officer, the Gene Technology Regulator, to administer and make decisions under the legislation;
- Establishes consultative committees with expertise in science, ethics and community issues from which the Regulator and the Gene Technology Legislative and Governance Forum (formerly the Gene Technology Ministerial Council) may request advice;
- Prohibits persons from dealing with GMOs unless the dealing is exempt, low risk, on the Register of GMOs, or licensed by the Regulator;
- Establishes a scheme to assess risks to human health and the environment associated with GMOs, including opportunities for extensive public input;
- Provides for monitoring and enforcement of the legislation;
- Creates a centralised, publicly available database of all GMOs and GM products approved in Australia; and
- Requires accredited organisations to either form their own Institutional Biosafety Committee or have access to another organisation’s committee.
More information is available at www.ogtr.gov.au
Victorian Legislation
Gene Technology Act 2001
The Victorian Gene Technology Act 2001 is the Victorian component of the National Gene Technology Regulatory Scheme. The Act establishes a regulatory framework and mirrors the Commonwealth Act. It recognises the Office of the Gene Technology Regulator as the independent statutory body maintaining the national gene technology regulatory framework on behalf of the State of Victoria.
Control of Genetically Modified Crops Act 2004
The Commonwealth Gene Technology Act 2000 enables State and Territory Governments to introduce legislation to protect markets and trade from the release of a GMO, if required. In Victoria, the Control of Genetically Modified Crops Act 2004 serves this purpose and provides for the creation of ‘orders’ under which the State of Victoria may be declared as an area where specified activities or dealings involving GM crops or related material may be controlled or prohibited for the purpose of protecting markets and trade. It also allows for the identity preservation of crops as either GM or non-GM for marketing purposes.
There are currently no orders in place under the Act.
DPI governance arrangements
DPI research and development projects involving GMOs are subject to stringent gene technology protocols and procedures. Through these protocols, DPI ensures its biotechnology program is consistent with and delivers government policy related to biotechnology. The protocols detail a range of procedures relating to the appropriate assessment and approval processes for gene technology projects.
DPI’s Gene Technology Steering Committee (GTSC) comprises senior managers from DPI, a representative from the Department of Business and Innovation and an independent external member. GTSC is also supported by other invited departmental representatives as required. The Committee provides assurance to the Secretary of DPI on the development of appropriate operational and risk management policies and procedures within DPI for gene technology research and its applications.
DPI has also established an Institutional Biosafety Committee in accordance with the Commonwealth Gene Technology Act 2000.
All gene technology research and development activities undertaken by DPI are reviewed by DPI’s IBCand the GTSC, and are undertaken according to legislation and strict codes of conduct.
Prior to implementing a research and development project, or entering into a contractual arrangement to undertake research and development involving GMOs, DPI assesses the economic, environmental and social benefits to the Victorian community. All project proposals must include a review of public benefit. This information is scrutinised by the Secretary prior to approving or declining a project.
Biotechnology in primary industries
Biotechnology offers significant benefits in several primary industry sectors, including agriculture, energy, minerals, petroleum, fishing and forestry. Some examples of the benefit of using biotechnology in primary industries include:
- Advances in the prevention, diagnosis and treatment of disease;
- Increased safety and quality of food, resulting in increased access to international markets and improved biosecurity risk management;
- Replacement of resource and energy-intensive processes with more sustainable and renewable energy sources;
- Productivity improvements through using gene technologies to develop disease-resistant crops, new crops, more sustainable farming practices and innovative high value agri-food products; and
- Improved industrial processes and materials, which will create new products, transform existing industries and open up new growth areas and opportunities.
The role of DPI in biotechnology
DPI employs around 1,100 scientists and technicians to help improve the performance of primary industries through the development and adoption of innovative new technologies and practices and by providing information and advice on the sustainable use of resources.
An important role of government is to fund those research and development projects that benefit society, but are unlikely to attract private sector investment at least in the early stages of the project. DPI conducts biotechnology research and development for the benefit of Victorian primary industries and communities to drive innovation in areas of primary industries where such research would not occur sufficiently if left entirely to the market. This research and development will be conducted within the legislative requirements previously outlined in this document (see ‘Regulation of gene technology’).
DPI biotechnology focus areas
DPI has an active interest in a range of agricultural biotechnology areas. These include traditional plant and animal breeding, genomics, proteomics, metabolomics, the use of molecular markers, molecular disease diagnostics, the development of vaccines, genetic modification and bioinformatics. Genetic and biochemical resources in native flora and fauna (biodiscovery) also have the potential to underpin modern biotechnology activities within DPI and to provide commercial opportunities through partnership with industry.
DPI research and development facilities
DPI manages world-class science and technology infrastructure that generates new knowledge and technologies to increase productivity, protect resources and reduce the environmental impact of primary industry production.
The Victorian AgriBiosciences Centre (VABC)
The VABC offers state-of-the-art research equipment to support innovation in agricultural biotechnology, efficient molecular breeding research and development programs and increased community awareness about the social, economic and environmental contribution of biotechnology research and development. Funded by DPI, La Trobe University and the Department of Business and Innovation, the VABC is helping improve the sustainable use of environmental resources for agriculture that, in turn, benefits Victorian, Australian and international communities.
The Centre for AgriBioscience (AgriBio)
The Centre for AgriBioscience (AgriBio) is a major new Victorian research and development facility for agricultural biosciences which is currently under construction. The centre, which is being built in partnership with La Trobe University and will be located on the University’s Bundoora campus, is expected to be fully operational in 2012.
AgriBio will further strengthen Victoria’s international reputation for plant, animal and microbial bioscience and bioprotection research and diagnostics. Research will focus on a range of areas, including climate change, drought tolerance, bioenergy efficiency and development of new generation crops and animals. Research will also be focused on enhancing rapid detection technologies and management systems for plant and animal pest and disease outbreaks.
Strategic policy documents
The Victorian Government sees biotechnology as one of the most transforming technologies of our time, with great potential to increase productivity growth, improve public health, and enhance environmental management. This commitment to biotechnology is underpinned by Victoria’s Technology Plan for the Future - Biotechnology and further supported within the Department under DPI’s Strategic Plan 2010 -13 (Interim).
Victoria’s Technology Plan for the Future - Biotechnology
The Government has developed a suite of technology strategies under Victoria’s Technology Plan for the Future, to capture economic, health and environmental benefits in Victoria by harnessing the power of biotechnology and its fellow enabling technologies, information and communication technology and small technologies.
The plan will help consolidate the strength of Victorian biotechnology as an important sector in its own right and promote biotechnology-enabled innovation in other industries to increase productivity growth across the economy. As such, the plan covers two action areas:
- Capability Development – support to develop the necessary talent pool, capitalise on Victoria’s world-class R&D base, and pursue international trade and investment opportunities; and
- Biotech-enabled innovation – focusing on demand-driven product development, uptake programs, demonstration projects and regulatory reform.
Milk Bioactives
DPI scientists at Bundoora have discovered a novel milk protein (RIPTAC) that has been shown to improve muscle function. Laboratory trials of RIPTAC have shown that it is effective in improving muscle growth and has potential as a treatment for metabolic syndrome and age-related muscle wasting. Ownership of intellectual property of RIPTAC is shared by DPI and Murray Goulburn Co-Op. It is currently in clinical development for humans, and may also benefit Australia's meat industries.
DPI’s Strategic Plan 2010-13 Interim
Victoria’s primary and energy industries produce food, fibre, energy, minerals and building materials that are essential to our health, wellbeing and quality of life. Primary and energy products make a large direct contribution to Victoria’s Gross State Product (GSP). For example, in 2009–10, Victoria’s agriculture, forestry and fishing industries contributed 2.3 per cent or $6.47 billion to GSP, or much more if agrifood is defined more broadly.
From food production and processing in the north, to fishing in the south, energy and native forestry in the east and grains and plantations in the west, the state’s primary industries underpin regional Victorian economies and provide a solid foundation for the wider economy and society. Victoria’s primary and energy industries will undergo major change over the next 20 years, driven by challenges and opportunities such as climate change, population growth, technological innovation and global competition.
DPI’s Strategic Plan 20010-13 (Interim) communicates DPI’s planned activities to our clients, stakeholders and staff, and identifies seven key outcomes for our accountability to the Victorian public:
- Businesses are innovative, productive and adaptive
- Markets are efficient, accessible and attractive for investment
- Natural resources are allocated and used efficiently and sustainably
- Supply chains are secure and emergencies effectively managed
- Public safety and animal welfare are ensured
Communities and industries are engaged, informed and capable - DPI delivers high performance
Biotechnology in DPI is directed by all seven outcomes.
Conclusion
The Victorian Government is committed to ensuring that Victoria is at the forefront of biotechnology discoveries, developments and breakthroughs and that these deliver sustainable, responsible and enduring benefits to the Victorian community.
The DPI Biotechnology Charter defines the regulation of certain types of biotechnology research at the Commonwealth, State and Departmental levels, the role of DPI in biotechnology and the strategic commitment to leverage the strength and reputation of our Victorian biotechnology sector. This ensures the safe, responsible and legislated use of biotechnology within DPI with a demonstrable public benefit.
Glossary
Biological definitions
Gene technology: the Gene Technology Act 2000 (Commonwealth)defines gene technology as any technique for the modification of genes or other genetic material, but not including sexual reproduction, homologous recombination or any other technique specified in the regulations for the purposes of the definition. Gene technology does not include cloning.
Genomics: the large-scale discovery of genes from animals, plants or micro-organisms. Once the position and function of a gene is known, it may be useful as a molecular marker, or be used in genetic modification or cloning research.
Metabolomics: the large-scale analysis of secondary metabolites produced by animals, plants and micro-organisms.
Molecular markers: molecular markers are pieces of DNA that are easily detectable and located near genes of interest. Selection of an animal or plant for breeding using this knowledge of its DNA profile is an important application of biotechnology.
Proteomics: the large-scale analysis of proteins and peptides synthesised by animals, plants and micro-organisms.
Traditional plant and animal breeding: the selection and development of lines showing desired characteristics for future use or commercial production. Traditional plant and animal breeding has been undertaken for thousands of years and the selection of appropriate lines of plants and animals still plays an important role in agriculture, horticulture, forestry and aquaculture.
Governance definitions
DPI Institutional Biosafety Committee (DPI IBC): The Institutional Biosafety Committee within DPI, responsible for the assessment, evaluation and oversight of all research and development involving gene technology, as required under the national gene technology regulatory scheme founded on the Gene Technology Act 2000 (Commonwealth).
DPI Gene Technology Steering Committee (GTSC): GTSC provides assurance to the Secretary of DPI on the development of appropriate operational and risk management policies and procedures within DPI for gene technology research and its applications.
Gene Technology Legislative and Governance Forum (previously the Gene Technology Ministerial Council): the Gene Technology Legislative and Governance Forum was established by the Intergovernmental Gene Technology Agreement 2001, to govern the activities of the Gene Technology Regulator. It includes one member from the Commonwealth and each State and Territory Government. Currently, it comprises Ministers from a range of portfolios, including health, agriculture and environment.
National gene technology regulatory scheme: the regulatory scheme based on the Gene Technology Act 2000 (Commonwealth) and complementary state legislation, the Gene Technology Act 2001 (Victoria), together with associated regulations and guidelines.
Office of the Gene Technology Regulator (OGTR): the Office of the Gene Technology Regulator established under the Gene Technology Act 2000 (Commonwealth) with responsibility for administration of the national gene technology regulatory scheme.
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