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Publications archive - International Activities and Commitments

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Key departmental publications, e.g. annual reports, budget papers and program guidelines are available in our online archive.

Much of the material listed on these archived web pages has been superseded, or served a particular purpose at a particular time. It may contain references to activities or policies that have no current application. Many archived documents may link to web pages that have moved or no longer exist, or may refer to other documents that are no longer available.

Australia's report to the UNCSD - 1995

Implementation of Agenda 21
Department of the Environment, Sport and Territories, 1995
ISBN 0 6444 3152 0

Biotechnology

Chapter 16 of Agenda 21

Australia is continuing to develop and promote the environmentally sound management of biotechnology, with activities aimed at:

Biotechnology is one of the most powerful tools available for ecologically sustainable development and global food security, providing that its application is built on a rigorous and open system for assessing whether there is significant risk to health or the environment. Australia has put in place the essential elements necessary to manage the application of biotechnology, and is continuing to refine and develop these elements in accordance with Agenda 21.

Increasing the availability of food, feed and renewable raw materials

The Australian Government funds numerous research and development programs in Australia designed to increase the quality and efficiency of production of food, fodder, and renewable raw materials. Biotechnology projects include work on improving yields, improving quality, increasing post-harvest life, diagnosing and combating plant and animal disease, reducing pesticide use, moving to more environmentally friendly herbicides, expanding the capability to fix nitrogen, and improving food processing.

The 19 primary industries Research and Development Corporations and Councils support research, including biotechnology projects, aimed at improving the efficiency, quality and productivity of agricultural industries and their sustainable use of natural resources. In 1992-93, A$13.3 million was allocated by these organisations to gene technology projects.

The Commonwealth Scientific and Industrial Research Organisation (CSIRO) is recognised internationally for its contributions to research and development in agriculture, resources and the environment. Of the six CSIRO institutes, one concentrates on animal-based industries, one on plant-based industries, and a third on natural resources and the environment. Biotechnology is prominent in many CSIRO projects, and the organisation has made many major contributions. One example is the powerful 'gene shears ' technology, which shows promise in many areas, including combating plant, animal and human diseases.

Important research in renewable resource and agriculture related biotechnology is also undertaken at many universities and research institutes throughout Australia. State departments of agriculture play an important role in facilitating the utilisation and application of these technologies in agriculture and resource industries.

The Australian Centre for International Agricultural Research (ACIAR), established in 1982, aims to improve the well-being of people in developing countries and Australia, through collaborative research partnerships aimed at the development of sustainable agricultural systems and the design of appropriate natural resource management strategies. Among the achievements of ACIAR's research projects are: biological control, detection and management of serious pest and weed problems in Asia, Africa and the Pacific; development of more productive, disease-free lines of crops traditional in these regions, such as coconut, banana, sweet potato and cassava; successful aquaculture of giant clams; and improved techniques for measuring nitrogen-fixation by leguminous food, forage and tree crops. ACIAR provides funds to, inter alia, international agricultural research centres such as those of the Consultative Group on International Agricultural Research (CGIAR).

Australia is an active participant in the Food and Agriculture Organisation of the United Nations (FAO) and fully supports the high priority which the organisation gives to the environment and sustainable development in agriculture, forestry and fisheries in its work program, particularly the implementation of Agenda 21. Australia sees the FAO's contribution toward the promotion and development of biotechnologies as an important mechanism for increasing the global availability of food, feed and renewable raw materials.

Improving human health

Government support for health and medical research includes a substantial number of biotechnology projects, most of which are funded through the National Health and Medical Research Council (NH& MRC), the Cooperative Research Centre Program, or the Industry Research and Development Board. Australia continues to make a very prominent contribution in medical and health research, particularly in molecular genetics, haematology, immunology, virology, parasitology, otology, microsurgery, diagnostics, and reproductive physiology. Major advances have been made in areas as diverse as aiding patients' recovery from chemotherapy for cancer, and cochlear implants to provide artificial hearing for the deaf.

A specific program to help combat AIDS was instigated in 1987-88. It provided over A$12 million in 1993- 94 for research into diagnosis and treatment, identification of risk factors, and monitoring of its spread and its social impact. A$13 million has been allocated for 1994-95. The program includes a contribution, A$0.5 million in 1993-94, to WHO's Global Program on AIDS.

Australia supports research and training on international health through the World Health Organisation (WHO), the International Council for the Control of Iodine Deficiency Disorders, and the International Centre for Diarrhoeal Disease. Among the health initiatives by Australians in underdeveloped countries are important programs to combat blindness and chronic urinary infection in Africa.

CSL Limited has been designated as a key WHO Collaborating Centre for Influenza, and now operates as an international reference centre. A novel drug to combat influenza is being developed commercially by Biota Holdings Limited; this very promising drug has now been approved for clinical trials.

The Therapeutic Goods Administration (TGA), working with the Australian Drug Evaluation Committee and the pharmaceutical industry, seeks to ensure the quality and safety of available therapeutic drugs and devices.

The National Food Authority (NFA) develops and maintains national food standards and monitors the quality of food. Its objective is to facilitate the provision of a safe and wholesome food supply for the community and to promote national and international trade in food. The food standards are enforced as laws not by the NFA, but by the States and Territories.

Enhancing protection of the environment

The Australian Government supports many research and development projects involving biotechnology and the environment. Research organisations involved include:

Enhancing safety and developing international mechanisms for cooperation

The Genetic Manipulation Advisory Committee (GMAC) was established in 1987 to oversee the development and use of novel genetic manipulation techniques in Australia. A similar system had operated since 1976. GMAC assesses whether such work poses potential hazards to the community and the environment and, if so, recommends appropriate safety procedures and containment of organisms to researchers, commercial institutions and government regulatory bodies. Separate GMAC subcommittees consider proposals for contained work and for planned introduction of genetically modified organisms into an environment. GMAC also drafts and promulgates guidelines which specify procedures and containment levels.

An integral part of the GMAC system is a network of 82 Institutional Biosafety Committees (IBCs) in research institutes and companies throughout Australia. The IBCs monitor day-to-day genetic engineering work and ensure that GMAC's guidelines and specific advice are observed.

The voluntary guidelines for notification and assessment of genetic manipulation work have been very effective for 18 years but they have no legal force. Legislation is currently being developed which will set up a new statutory authority, whose framework and mode of operation are likely to approximate the existing system.

Approval processes for therapeutic goods are covered by the Therapeutic Goods Administration. The TGA can laboratory-test products, provide technical and specialist training, advise on the implementation of national drug policies, audit good manufacturing practice, and assist in the design and operations of pharmaceutical factories and production facilities.

The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) evaluates and registers agricultural and veterinary chemical products proposed for use in Australia. Evaluation encompasses toxicology, efficacy, public health issues, occupational health and safety, safety to non-target species, environmental quality, and agricultural concerns. The NRA specifies conditions under which a particular product may be used, and issues a clearance certificate and instructions for labelling. Where applicable, advice and assessment by other national and international authorities (eg World Health Organisation; Chemicals Safety Unit; Environmental Protection Agencies) is called upon.

The importation of living organisms and biological products is regulated by the Australian Quarantine and Inspection Service (AQIS). Quarantine Proclamations control the introduction into Australia of articles likely to introduce any disease or pest affecting humans, animals or plants. In the case of organisms for biological control, an administrative clearance is also necessary from State agricultural authorities, CSIRO and the Australian Nature Conservation Agency. When assessing import applications, AQIS works closely with the other relevant authorities and consultative bodies, including the Environment Protection Agency.

The National Residue Survey is a broad-based monitoring program for residues of agricultural and veterinary chemicals and for environmental contaminants in food commodities, such as meat, grains, eggs, honey, dairy products and fish.

The overall responsibility for regulatory policy governing gene technology rests with the Department of Industry, Science and Technology. However, the responsibility for biotechnology policy is widely dispersed among Commonwealth and State Government portfolios, particularly those responsible for health, agriculture and the environment.

International mechanisms for cooperation in safety

GMAC participates in the development of biosafety concepts and principles undertaken internationally by the OECD.

Australia is committed to the global harmonisation of therapeutic goods regulation. The TGA participates in the International Conference on Harmonisation series, and develops bilateral agreements to exchange regulatory information. Australia participates in the WHO Export Certification Scheme which ensures the standard of therapeutic drugs exported from Australia.

Establishing enabling mechanisms for the development and the environmentally sound application of biotechnology

Australia has already developed much of the capacity needed to address the objectives of Chapter 16.

The Australian system of plant variety protection ensures breeders' intellectual property rights to new plant varieties. A variety may be registered under the Plant Breeder's Rights system, and in addition the variety and its method of production may be patentable. All new varieties must be deposited and preserved in genetic resources centres, and must not be 'essentially derived from' existing or protected varieties. The system enables biotechnologists and traditional breeders to develop new varieties with confidence that their rights will be protected. This encourages the development of genetically diverse new varieties.

Australia's patent system is now fully consistent with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The availability of industrial property protection facilitates biotechnology trade, research and application. Australian patent law specifically recognises the problem inherent in describing inventions involving micro-organisms, by providing for deposits under the Budapest Treaty of 1977. The Australian Government Analytical Laboratories (AGAL) manages the Australian International Depositary Authority for deposition of micro-organisms for the purposes of patent procedure.

The Cooperative Research Centres (CRCs), launched in 1990, bring together research and other organisations into formal, long-term arrangements, to undertake cooperative programs of research and education. There are currently 61 CRCs, of which 22 have some involvement in biotechnology. All 22 are contributing to one or more of the first three objectives of Agenda 21 Chapter 16: increasing the availability of food, feed and renewable raw materials; improving human health; and enhancing protection of the environment.

The Australian Biological Resources Study (ABRS) documents the plants and animals of Australia by coordinating work aimed at the collecting, describing, classifying, and determining the distribution of Australia's biodiversity.

Biota collections in Australia include major collections of animals in the State Museums, of plants in the State Herbaria, and of various types of biota in many research and teaching organisations, including specialised collections such as the CSIRO's Australian National Insect Collection, collections of fungi, algae and bryophytes, and some 25 microbial culture collections.

The Australian National Genomic Information Service (ANGIS), established in 1991, assists research and development in molecular biology, genetic engineering and biotechnology through providing a databank of sequence data from nucleic acids and proteins.

Biotechnology-specific programs

The use of biotechnology is fostered through a wide range of measures to stimulate research and industry development generally. No separate statistical data are collected on biotechnology, since biotechnology is regarded as a set of technologies applicable to many sectors of activity.

Biotechnology research and development in Australia is carried out in a wide range of research organisations, universities, hospitals, government departments, and companies.

Public information and education activities in biotechnology

Australia is in the process of establishing a Gene Technology Information Unit, which will organise and support a network of groups working to increase public awareness and understanding of gene technology, providing such groups with a forum in which to share ideas materials and experiences. The Unit will also develop and supply high quality, objective and timely information on gene technology, both for schools and the general public and for 'expert' communicators trained by the Unit.

A successful activity aimed at informing the public and school children was the travelling exhibition on genetic engineering, 'Will Pigs Fly?', mounted by the CSIRO. The exhibition toured shopping centres and science museums throughout 1992 and 1993. The CSIRO also runs workshops introducing biotechnology techniques to the public. Permanent interactive displays have been set up at venues such as the National Science and Technology Centre in Canberra and SciTech in Perth. The Australian Biotechnology Association has published eleven information pamphlets on various biotechnology topics.

Information on GMAC activities is presented through its newsletter, quarterly public information sheets which outline planned release proposals, and the Commonwealth's Public Notices Gazette. The GMAC Annual Report also provides details of GMAC activities.

Public participation in decision- making on biotechnology

Regulatory bodies include public consultation phases within assessment procedures. GMAC, for example, publicly advertises proposals for planned release of genetically modified organisms, and also directly informs interested parties.

The membership of GMAC includes not only biosafety scientific experts, but also members from the wider community, with backgrounds in law, philosophy, and environmental issues. Institutional Biosafety Committees also include an independent member.

Building capacity in other countries

The Australian system of plant variety protection is appropriate for developing countries and, if adopted, will smooth the way for Australian companies to transfer technology and plant varieties to those countries by protecting the company's intellectual property there.

The International Union for the Protection of New Varieties of Plants (UPOV) has adopted an Australian proposal to develop DNA profiling to establish the identity of plants.

The current Australian system for notification and assessment of genetic manipulation work is viewed internationally as among the most effective regulatory systems in the world. Furthermore, the standard of biotechnology research is recognised as very high, and Australia has a long record of prominence in areas of biomedical and agricultural biotechnology. Other countries are benefiting by drawing upon Australia's research and regulatory experience. For example, the ASEAN-Australia Biotechnology Project, which ran from 1989 to 1993, strengthened the capability of the member countries in using biotechnology to maximise the value of important natural resources abundant in the ASEAN region. The Project provided salaries and equipment for R& D, and organised training courses for scientists and technicians of the ASEAN region. The Crawford Fund for International Agricultural Research has run several workshops to train scientists and others from the Asia-Pacific region in molecular biology techniques.

Australia's tertiary education system is open to and used by undergraduate and postgraduate students from many countries, and thereby provides a very effective mechanism to transfer know-how and technology (including biotechnology) to developing countries.

Australia's environment management industries have particular strengths in areas such as water and wastewater treatment, bioremediation of degraded sites, and monitoring equipment. Many firms are actively applying their expertise to problems in other countries.

Development assistance

A number of biotechnology-related activities have been supported through Australia's development cooperation program. For example, Australia is providing $6 million for a project titled the 'Eastern Islands Veterinary Management Project' in Indonesia. The project involves research on the various livestock diseases and capacity building of the Denpasar Disease Investigations Research Centre by equipping the laboratories and providing technical training.

The ASEAN-Australia Biotechnology Project was funded jointly by the six ASEAN nations (A$5.94 million) and Australia (A$5.94 million) as part of the ASEAN-Australia Economic Cooperation Program. The program was managed by Australian Biotechnological Resources Pty Ltd.

One of the major aims of the project was to capitalise on the knowledge of traditional herbalists in order to identify the active agents of indigenous plants and manufacture them in ASEAN. This project utilised the wide biological diversity of plants in the ASEAN region to explore possible alternatives to the current synthetic chemicals. The project included a component to train scientists and maintenance staff in aspects of the biotechnology industry. Also a manual, titled 'Biotechnology for Development: Principles and practice relevant to developing countries', was published and distributed.

Australia has signed and ratified the Biodiversity Convention which contains international obligations on biotechnology transfer, biosafety and conservation of biological resources. Part of Australia's contribution to the GEF is used to support activities under the Biodiversity Convention.

Case Studies

For further information contact:

Department of Industry, Science and Technology