COMMITTEE ON AGRICULTURE
Rome, 25-29 January 1999, Red Room
Item 7 of the Provisional Agenda
II. MAIN BIOTECHNOLOGY APPLICATIONS
III. PREVIOUS MAJOR WORK ON BIOTECHNOLOGY IN FAO
IV. ISSUES AND CONCERNS OF DEVELOPING COUNTRIES
1. Agriculture is expected to feed an increasing human population, forecast to reach 8 000 million by 2020, of whom 6 700 million will be in the developing countries. Although the rate of population growth is steadily decreasing, the increase in absolute numbers of people to be fed may be such that the carrying capacity of agricultural lands could soon be reached given current technology. New technologies, such as biotechnologies, if properly focused, offer a responsible way to enhance agricultural productivity for now and the future.
2. The 1992 Convention on Biological Diversity (CBD) defined biotechnology as "any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific uses." Biotechnology is here taken to cover the application of tissue culture, immunological techniques, molecular genetics and recombinant DNA techniques in all facets of agricultural production and agro-industry.
3. Biotechnology is a powerful tool in agricultural development with great potential - both positive and negative. Coupled with other technologies, biotechnology could provide new solutions for some of the old problems hindering sustainable rural development and achievement of food security. Biotechnology also offers unique opportunities to solve environmental problems, some of which derive from unsustainable agricultural and industrial practices. FAO recognizes the need to take a balanced and comprehensive approach to biotechnological development by considering its integration into various areas of the Organization's work programme. Since the scope for potential action is huge, while FAO resources are limited, it is important that close partnerships with other bodies be forged, including the CGIAR.
4. This paper provides an overview of biotechnology applications in agriculture and of FAO's previous work in biotechnology. Specific issues and concerns of biotechnology application are discussed, and tactics are suggested for applying the technologies in support of sustainable agricultural production and food security in developing countries, with an underlying emphasis on safety in use of biotechnology and its products. A proposal for an Organization-wide programme of work is submitted for COAG's advice, which is also sought on prioritization among biotechnology actions.
A. PLANT TISSUE CULTURE
5. Tissue culture is seen as a main technology for developing countries for the production of disease-free, high-quality planting material. In commercial applications, such as floriculture, it also generates much-needed employment, particularly for women.
6. Tissue culture includes micropropagation; embryo rescue; plant regeneration from callus and cell suspension; and protoplast, anther and microspore culture. These techniques are being used particularly for large-scale plant multiplication. Micropropagation has proved especially useful in producing high quality, disease-free planting material of a wide range of crops.
B. DNA TECHNOLOGY
7. DNA-based techniques include isolation, amplification, modification and recombination of DNA; genetic engineering to obtain Genetically Modified Organisms (GMOs); use of markers and probes in gene mapping and in functional and structural genomics; and unambiguous identification of genotypes through DNA fingerprinting.
8. Recombinant DNA techniques are used for the production of transgenic individuals, which involves isolation, cloning, recombination and reinsertion of genetic material by various techniques. Several transgenic cultivars of major food crops have been released incorporating genes for resistance to herbicides and insects. The area planted with transgenic crops went from 2.8 million ha in 1996 to 12.8 million ha in 1997.
9. Transgenesis offers many possibilities in micro-organisms with applications ranging from the production (through industrial processes and agro-processing) of recombinant vaccines and medicines such as insulin, growth hormones and interferon, to enzyme and special proteins productions. Recombinant vaccines have considerable application: not only can they be produced inexpensively but they also offer the advantages of safety and specificity, and allow the easy distinction between vaccinated and naturally infected animals. Modification of starter organisms presents opportunities for improved organoleptic properties and shelf life of milk and meat products as well as more predictable fermentation rates to facilitate mechanization. Organisms have been developed for bioremediation of land and water, for biological control and edaphic environment enhancement (e.g., modified mycorrhizal and rhizobial strains for better nutrient uptake). Work is underway to improve the rumen microbial digestive system through micro-organisms that enhance the accessibility and utilization of nutrients by the animal.
10. DNA-based molecular markers in various forms can be used to construct linkage maps of different species so as to locate particular genes. The mapped markers are used for speeding up selection in conventional breeding procedures. DNA fingerprinting uses molecular markers. Molecular markers, marker-assisted breeding and DNA fingerprinting are applicable to plants and animals but have greater potential in animal breeding in view of the value of individual animals, long breeding cycles and small offspring numbers.
11. Somatic cloning, based on the very recent demonstration of reversal of DNA quiescence allowing somatic cloning in sheep, offers new possibilities in animal improvement, conservation of animal genetic resources, and as a tool for more cost-effective research and training. The related techniques of embryo transfer, cryo-preservation of embryos and semen and artificial insemination are also widely used, with significant impact.
C. DIAGNOSTIC KITS
12. Although not exclusively DNA-based, diagnostic kits based on the products of biotechnology (monoclonal antibodies, recombinant antigens) are very important modern agricultural applications for identification of plant and animal pathogens, with economic implications for pathogen monitoring and control programmes. The possibility of standardization and quality control will prove critical in harmonizing and standardizing diagnostic assays on a global basis, with major implications for international livestock trade.
D. AGRO-INDUSTRIAL APPLICATIONS
13. Although biotechnology offers considerable potential for improvements in agro-industrial processing, particularly more environmentally friendly or energy efficient processes, there is relatively little ongoing work in this area in developing countries. There is untapped potential for increasing employment and adding value to agricultural products through agro-industry, through diversification and alternative utilization of raw materials (e.g., use of vegetable oils as biofuels).
14. FAO has been involved in biotechnology in order to help developing countries adopt useful methodologies and monitor developments in the area. As early as 1984 an FAO/IAEA Joint Division meeting discussed FAO's role in biotechnology, and since then numerous sectoral and general meetings have included specific aspects of biotechnology in the FAO context.
15. In 1991, the FAO Council endorsed a request from the Commission on Plant Genetic Resources - from 1995 the Commission on Genetic Resources for Food and Agri-culture (CGRFA) - that FAO draft a Code of Conduct for Biotechnology as It Affects the Conservation and Use of Plant Genetic Resources. A draft Code was prepared following a survey among 400 experts worldwide, and the Commission considered it in 1993. It includes sections on Biosafety, Intellectual Property Rights (IPRs), Substitution of Traditional Crops, and Development of Appropriate Biotechnologies for Developing Countries. Its aim is to minimize possible negative effects of biotechnology. Noting that CBD was considering the development of a biosafety protocol, the Commission recommended that FAO participate in this work in order to ensure that aspects of biosafety in relation to genetic resources for food and agriculture be appropriately covered. The biosafety and other environmental concerns component of the draft code were accordingly forwarded to the Executive Secretary of the Convention, at the request of the Commission, as an input to the proposed protocol. In 1995 the Commission considered a report on Recent International Developments of Relevance to the Draft Code of Conduct for Plant Biotechnology. Further work on the draft Code awaits the completion of the current negotiations for the revision of the International Undertaking on Plant Genetic Resources.
16. Other FAO involvement includes convening an FAO International Symposium on Plant Biotechnology in Luxembourg in 1989 jointly with the Technical Centre for Agricultural and Rural Cooperation (CTA); support for establishing plant tissue culture laboratories and training in related techniques in many countries; and establishing and providing the secretariat of REDBIO (Technical Cooperation and Network on Plant Biotechnology), a plant biotechnology network in Latin America involving more than 700 laboratories and regarded as one of the best organized and most useful biotechnology networks in the developing world.
17. A number of FAO publications - both meeting reports and technical bulletins - have addressed aspects of biotechnology, means of assisting member countries to acquire the technology, implications for agriculture sensu lato, and trade-related issues. Particular biotechnology-related issues have been considered by expert consultations and workshops such as: two Joint FAO/WHO Expert Consultations in 1990 and 1996 which addressed safety assessments of food derived from biotechnology and outlined procedures to be followed in establishing the quality and safety of such food. Biotechnology applicable to animal production and health has been considered by other expert consultations, while in 1997 there was a Joint FAO/Government of Italy Workshop on New Developments in Biotechnology and their implications for the Conservation of Farm Animal Genetic Resources - 1: Reversible DNA Quiescence and Somatic Cloning. Plant biotechnology was the subject of an expert consultation in 1993.
18. It is recognized that there are major differences among developing countries in relation to biotechnology and its application. Nonetheless, a generic approach is taken in this paper.
19. Sustainable food production is uncertain in many developing areas of the world because of their particular climatic, land and water limitations; thus, developing low-cost applications will be an important element in increasing food production and stability for rural poor. Biotechnology offers a potential solution for many problems affecting crops and livestock production in developing countries. National programmes should ensure that biotechnology benefits all sectors, including resource-poor rural populations, particularly in marginal areas where productivity increases will be more difficult to achieve. Biotechnology-derived solutions for biotic and abiotic stresses built into the genotype of plants could reduce use of agrochemicals and water, thus promoting sustainable yields. Durability of resistance to pests, as always, depends on natural evolution processes.
20. A number of issues are of special concern to members aiming at increasing their involvement in biotechnology and thus developing the agricultural sector, which is an integral element of rural development and overall national food security.
A. PRIORITY SETTING
21. Countries need to develop knowledge appropriate to their own situations and to decide if they need to use biotechnological approaches. Biotechnology expertise should complement existing technologies and be output-driven. Much biotechnology is more expensive than conventional research, so it should be used only to solve specific problems where it has comparative advantage. In many developing countries funding for research in agriculture is being reduced, and often research is being privatized with the consequence risk that it could be aimed mainly at resource rich farmers. Biotechnology research and policy should also address the needs of the poor who depend on agriculture for their livelihoods, particularly in marginal areas where productivity increases will be difficult to achieve.
22. In addition to technical considerations, priority setting should take into account national development policies, private sector interests and market possibilities. The diverse stakeholders should be involved in the formulation of national biotechnology strategies, policies and plans.
23. Agricultural problems are multidisciplinary in their nature and biotechnology in isolation is unlikely to solve them. Each country should decide how much of the technology should be developed nationally and how much imported and adapted. A good mix of the two can be synergistic, and reduce both the time and cost of developing products for the market.
B. INFRASTRUCTURE AND CAPACITY
24. Biotechnology research requires skilled staff, backed up by well-equipped laboratories with proper working conditions, a constant supply of good quality water, a reliable electricity supply, and organized institutional support including timely delivery of reagents and access to Internet and other international networks. A minimal technology base is required even to adapt technology tried and tested elsewhere to local ecological and production conditions and to meet national obligations for biosafety, release of GMOs and sale of products derived from them. In deciding to adopt biotechnology a country must be prepared therefore to commit itself to guaranteeing substantial ongoing financial support.
25. Biotechnology research does not finish with a laboratory product. To have useful results it must reach the end user. Biotechnology research needs strong and organized outreach services and suitable institutions and infrastructures to facilitate its application. A variety of institutions may be required, depending on the technology.
26. Biotechnology generates a large amount of data needing analysis and interpretation. Analysis software is available but requires adequate computer facilities. Access to informatics technology via Internet and existing databases is also needed to minimize duplication of effort, such as comparing DNA sequencing data.
27. For any research to be truly productive, there must be a critical mass of expertise, knowledge and facilities. Biotechnology is no exception. Individuals working in isolation are unlikely to produce either a process or a product.
C. INTELLECTUAL PROPERTY RIGHTS (IPRS)
28. With the establishment of the World Trade Organization (WTO) in 1995 all members are bound by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). TRIPS Article 27, on patentable subject matters, requires countries to grant patents for "inventions whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial applications."
29. Article 27.3(b) allows for the exclusion of diagnostic, therapeutic and surgical methods for animals and humans; and of plants and animals other than micro-organisms, but it obliges members to provide protection to plant varieties either by patents or by "an effective sui generis* system, or a combination thereof". The provisions of the subparagraph are to be reviewed in 1999.
30. Most processes and many products of biotechnology research are therefore patentable: "Patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology, and whether products are imported or produced locally." Following entry into force of the agreement in 1995, developed countries had a one-year transition period to allow the necessary legislative changes; developing countries have five years; and the least developed countries have eleven years, with the possibility of an extension.
31. Property rights regimes and laws were originally created with the intention of stimulating invention and, in exchange for disclosing inventions, they provide a temporary monopoly right over the patented matter. Most research to develop methods and procedures in biotechnology has been in industrialized countries, very often by private companies, and the results are patented. Hence, developing countries face a situation where they may have to pay to use a procedure or product.
32. IPRs are critical for growth of the biotechnology industry, and lack of patent protection in a country can limit access to the results of biotechnology originating elsewhere, blocking inward investment. The issues are complex, with implications for trade, technical investment and access to biotechnology outputs. Countries need to evaluate carefully their positions and, as appropriate, to introduce legislation, as foreseen in the WTO Agreement. In particular, they will need to evaluate the most appropriate form of protection to be given to plant varieties in the light of these implications.
D. BIOSAFETY, FOOD SAFETY AND THE ENVIRONMENT
33. Biosafety means the safe and environmentally sustainable use of all biological products and applications for human health, biodiversity and environmental sustainability in support of improved global food security.
34. Adequate biosafety regulations, risk assessment of biotechnology products, mechanisms and instruments for monitoring use and compliance are needed to ensure that there will be no harmful effects on the environment or for people. Potential environmental hazards from new products of biotechnology, mainly involving GMOs, have raised concerns that, in the absence of adequate legislation, companies may use developing countries as test sites for their products.
35. Some of the potential environmental risks concern plant pests. Gene escape from GMOs may result in increased weediness in sexually compatible wild species. The inclusion of novel genes for herbicide resistance in plants may increase the occurrence of weeds with resistance to certain agrochemicals. The inclusion of pest resistance in plants should be carefully evaluated for potential development of resistance in pests and possible side-effects on beneficial organisms. Were a GMO to be classified as a plant pest, it would fall within the ambit of the International Plant Protection Convention (IPPC).
36. Another worry about GMOs is the possible inadvertent production of toxins and allergens. The Codex Alimentarius Commission (CAC) was formed in 1962 to implement the Joint FAO/WHO Food Standards Programme, the purpose of which is "to protect the health of consumers and ensure fair practices in the food trade." Codex standards, guidelines and other recommendations are explicitly recognized under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and also qualify as "international standards" under the Agreement on Technical Barriers to Trade (TBT Agreement). The CAC is considering the development of a general standard which would apply basic food safety and food control disciplines to foods derived through biotechnology. The advice of prior FAO/WHO expert consultations in this area will be used as guidance for the conditions required for foods prepared through biotechnology. Foremost among these are considerations of potential allergenicity, possible gene transfer from GMOs, pathogenicity deriving from the organism used, nutritional considerations and labelling.
37. Since 1995 a CBD Biosafety Protocol has been under negotiation, touching particularly transboundary movement of living modified organisms. The protocol is expected to be adopted at an Extraordinary Conference of the Parties to the Convention in 1999.
38. Countries must be helped to develop appropriate legislation and to set up proper regulatory bodies for all aspects of biosafety. National legislation must be consistent with international instruments and reflect national positions.
E. BIODIVERSITY ISSUES
39. Biodiversity is the primary source of useful variation for use in breeding and biotechnology and an important component of sustainable agriculture; thus, without biodiversity biotechnology becomes academic. New gene transfer techniques have made it possible to transfer genes between species and even between kingdoms. Biotechnology can contribute to the conservation, characterization and utilization of biodiversity, thus increasing its usefulness.
40. Some techniques, like in vitro culture, are very helpful for maintenance of ex situ germplasm collections of plant species that have asexual propagation (bananas, onions, garlic) or polyploid species where fertility is often very low, and of species that are hard to keep as seeds or in field gene banks. Related techniques are also important for the preservation of animal biodiversity through cryopreservation of semen and embryos, coupled with embryo transfer and artificial insemination. However, they all presuppose the existence of an effective infrastructure.
41. Biotechnology may reduce genetic diversity indirectly by displacing landraces and their inherent diversity as farmers adopt genetically uniform varieties of plants and other organisms. At the same time it increases the potential to preserve and sustainably use diversity. In the case of endangered animal breeds, for example, cryopreservation and somatic cloning can strengthen traditional conservation strategies.
F. EXPORT SUBSTITUTION
42. Some products, such as food additives, flavours, food colouring, vegetable oils and fats, with a high export value for some developing countries, could be substituted by products with similar properties obtained through genetic modification (e.g., copra-quality oil from rapeseed) obtained by genetic modification of other crops or through in vitro techniques. Such products could alter the competitive position of traditional crops, affecting existing trade patterns and consequently the food security of many developing countries that rely on foreign exchange revenues generated from export of those crops.
G. ETHICAL ASPECTS
43. Biotechnology is more than just a scientific issue. It is capable of engendering disagreement and controversy, and highlighting moral and ethical concerns which are difficult to resolve. These concerns include or arise from uneasiness over the fact that biotechnology is seen by some to "interfere with the workings of nature and creation", and that it might involve risk-taking for commercial profit. However, in priority setting, all concerns must be clearly balanced, respecting ethical aspects but reflecting the actual and potential possibilities of increasing food supplies and alleviating hunger.
44. Many of the ethics-related issues are now being debated in the context of IPR legislation ("patents on life," etc.), but other issues remain unresolved. Since such issues are largely related to cultural background and to the level of public perception and awareness, decisions on the use of specific technologies should respect socio-economic realities.
45. Biotechnology is increasingly market and demand driven, and most of its products result from research and development investments by the private sector in developed countries. There is little point in developing a new technology if there is no market for the product. The same is valid for new varieties of plants and new breeds of animals, new vaccines and diagnostic kits. Market studies are fundamental in defining which ventures should be undertaken. Given that commercial considerations may not necessarily reflect social concerns and needs, there remains a pivotal role for public-sector research.
A. GENERAL CONSIDERATIONS
46. In many developing countries governments are establishing biotechnology research facilities. However, the type of research and its application vary considerably among countries, generally being far below the level of developed countries. Small-scale private sector investment in biotechnology has also begun in some developing countries; for example, a number of private laboratories are working on artificial insemination, embryo transfer in animals, and micro-propagation of plants to produce disease-free planting material.
47. Successful application of biotechnology is possible only when a broad research and knowledge base exists in biology, breeding, agronomy, physiology, pathology, biochemistry and genetics. Benefits offered by the new technologies cannot be realized without a continued commitment to conventional agricultural research. Biotechnology programmes, if they are to succeed, must be fully integrated into the existing research system without depriving other research of funding.
48. In line with its mandate and the three major areas of its programme: providing policy advice for issues related to food and agriculture; promoting information exchange; and rendering technical assistance to its members, and within available means and resources, FAO seeks to realise fully the positive impact of biotechnology and to minimize possible negative effects. It is proposed that FAO concentrate on the areas below, acting as facilitator in concert with appropriate entities. Currently, FAO's involvement does not reflect the growing importance of biotechnology. If FAO is to strengthen its involvement and respond to members' requests, budgetary adjustments and building its critical mass will be essential.
B. POLICY ADVICE
49. Components of policy advice include priority assignment, resource allocation, and regulatory legislation and international standards. Actions that can be undertaken by FAO within these main thrusts are proposed below.
50. Help developing members establish priorities for biotechnology within the broader context of agricultural research needs and policies. Help identify appropriate technologies for immediate use and provide guidance on their implementation, and on associated risks.
51. Through discussions in relevant bodies, and consultations, etc., help members to comprehend and address market needs and issues related to products derived through biotechnology.
52. Develop graphic-aided interactive decision-support procedures for managers. These kits should be constantly updated as knowledge expands.
53. Within FAO programmes, emphasize conventional animal and plant breeding technologies but also consider appropriate biotechnologies - when there is a clear advantage in their application.
54. Promote research and development, including appropriate biotechnology, on orphan crops and commodities, indigenous and minor livestock breeds, which are important in the ecosystems, agriculture and nutrition of local and tribal communities, but which lack major initiatives.
55. Advise and assist countries in preparing suitable biotechnology-related project proposals for donor funding.
Regulatory legislation and international standards
56. Through the Codex Alimentarius Commission and in collaboration with WHO and the International Office of Epizootics (OIE), help to devise and update standards for foods derived from biotechnology. Likewise collaborate with OIE and the IPPC to devise and update standards for the protection of animal and plant health, respectively.
57. Promote biosafety by helping countries devise suitable biosafety regulations.
C. PROMOTING INFORMATION EXCHANGE
58. Promoting information exchange is especially important in the rapidly changing area of biotechnology. Developing countries need to know what technologies are available, what they can be used for, how they can be applied, and what the cost-benefit implications are of using them. Maintaining awareness and brokering information, are important roles for FAO; several actions are proposed below.
59. Promote the use of cost-effective modern electronic information tools, building on networks having shared ownership of information, peer-reviewed interactive databases, topical E-mail conferences, etc.
60. Monitor developments and new technologies, assessing their usefulness and implications in developing countries, including for trade, and their biosafety in different environments and for intended uses.
61. Develop tools and methods for assessing the impact of biotechnology on agricultural production and associated socio-economic conditions.
D. TECHNICAL ASSISTANCE
62. Components of technical assistance include institutional collaboration and capacity building. Actions that can be undertaken by FAO in collaboration with other institutions with special expertise and the CGIAR are proposed below.
63. Help establish active research and development partnerships and linkages among biotechnology institutions and between countries, and emphasize closer cooperation between private and public sectors.
64. Promote, through networks and expert advice, the use of biotechnology in plant and animal husbandry, pest and disease detection and eradication, such as in support of the Emergency Prevention Systems for Transboundary Animal and Plant Pests and Diseases (EMPRES), vaccine development and investigations of genetic diversity.
65. Assist with other partners, in building member countries capacities in biotechnology and related issues through technical cooperation and training. In this context, FAO should concentrate on helping strengthen national capabilities in biotechnology research and application as an integral element of overall agricultural research, focusing on increasing and sustaining agricultural production, including marginal conditions. Training in biotechnology should have as its objective the resolution of actual constraints and the exploitation of real opportunities.
66. Promote seminars, meetings, visits, workshops, courses on the use of emerging technologies for technology transfer and access to biotechnology outputs.
67. Assist in capacity building in biosafety, including risk assessment, compliance monitoring and related issues, in accordance with international guidelines.
68. It is vital that developing countries are not left at the edge of development nor in a disadvantaged position. FAO, together with partners, should help members to optimize their capacity to develop, adapt and utilize biotechnology and its products to suit their needs and environment, and thus enhance global food security and improve living standards for all. Intrinsic to the application of biotechnology is knowledge, and knowledge builds upon information. Thus FAO must have the in-house capacity to identify and evaluate biotechnology advances and to determine their applicability for promoting enhanced, sustainable and socially equitable agriculture. Yet the spectrum of activities associated with biotechnology is so broad that no one organization can be competent in them all; effective partnerships are being established. FAO's comparative advantage in such partnerships lies in its intergovernmental status, its direct links with public and private entities in member countries, and its comprehensive experience in the agriculture sector. Although not yet effectively exploited in respect of biotechnology, this comparative advantage provides a basis for FAO to foster international information exchange via networks involving members' institutions, international bodies, academic centres, NGOs and the private sector.
69. A minimum requirement is that FAO maintain the capacity to meet its obligations and commitments at international level. COAG therefore may wish to recommend that the current biotechnology-associated activities and the related programmes should all continue, namely biosafety issues through Codex and others; biodiversity issues through CGRFA; trade implications through CCP; and phytosanitary implications through IPPC.
70. In the light of the rapid advances being made in biotechnology and the overarching imperative of ensuring sustainable food security and rural development, as declared in the World Food Summit Plan of Action, COAG may wish to request that a report be commissioned to assess the potential benefits in the short term (to 2010) of adapting relevant biotechnology applications to enhance food security, with emphasis on potential policy issues, including the sensitive area of ethics.
71. Biotechnology techniques and applications are similar across species and kingdoms. To reflect the inherent cross-sectoral nature of biotechnology in the context of FAO, COAG may also wish to consider the need for an Organization-wide coordinated programme of work on biotechnology, covering agriculture, fisheries and forestry, with a remit that includes monitoring relevant biotechnology advances and their implications, and identifying and promoting biotechnology opportunities in relevant facets of FAO's work. In such an instance, consideration would need to be given to budgetary allocations to enable coordination and promotion of cross-cutting work in biotechnology as a coherent programme to add value to otherwise isolated initiatives.
72. COAG may also wish to advise on the relative prioritization of the three action areas, namely, policy advice, information exchange and technical assistance to members within the context of the proposed Organization-wide programme, and in the light of likely available resources.