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Issues and concerns in biotechnology with special reference to developing countries
The new biotechnologies are to be viewed as among the latest of the tools or means which advancing science has provided for the development of agriculture, forestry and fisheries. While they are already making significant contributions to pharmaceuticals, diagnostics and human health, the potential benefits are not being tapped adequately in agriculture and allied fields. In the developing countries, the overall use of modern biotechnology is rather limited.
The full value of products and technologies will only be realized when the necessary research and development infrastructures, guidelines and regulations, financing and public policies are in place. A technology will only succeed in an environment whose social and economic policies are prepared to support it. Furthermore, the products and technologies should be accessible to farmers, forests, fisherfolk and other bona fide users in both developed and developing countries. Moreover, the development gains accruing through the use of biotechnologies should be consistent with sustaining of the environment.
The recent trend of development and application of modern biotechnologies has raised certain socio-economic, institutional, environmental and political issues. Foremost among them are intellectual property protection, inadequate research and institutional support, biosafety and other environmental aspects, substitution of developing countries' exports, and social equity.
Intellectual property protection
The management of intellectual property has emerged as a major policy issue affecting the development, application and diffusion of biotechnologies. Intellectual Property Right (IPR) systems have been instituted in many, mostly developed, countries, to stipulate innovations which may contribute to improved productivity. These promote investment in research and development by, and secure rewards for, the private sector. They also provide an incentive to disclose details of the innovations.
Notwithstanding the positive effects of adoption of IPR in intensive production systems with high capital input, there are certain aspects of IPR which may hinder developing countries from reaping the full potential benefits of biotechnology. Transnational corporations have been increasing their control on biotechnology research and its fruits through the acquisition of companies, patents and licences. To improve that competitive edge in international markets, governments of industrialized countries are at the forefront of international efforts to reinforce the IPR systems. The developing countries are under pressure to adopt the IPR systems proposed by the industrialized countries in order to open markets for the protected products. In some countries which have adopted "foreign" IPR systems, the vast majority of patents are held by foreign companies and are seldom used to promote local research and production systems. On the other hand, patent incentives may be useful for the more advanced developing nations and for the application of privately derived technologies.
Most developing countries, especially the least developed ones, have more need to absorb and diffuse as widely as possible the new technologies for their development. They try to avoid the overpricing and monopolization that could occur through imposition of strict IPR systems. Some even consider that the current international patent regime works to their disadvantage and that they receive nothing in return for protecting inventions produced in the developed countries.
The patenting of life-forms is yet another sensitive issue and has complex ethical and legal implications, besides economic considerations, as discussed in a later section.
Thus, the role of IPR and the private sector will vary according to socio-economic settings and government policies. A system suitable for industrialized "seed-rich" countries may not necessarily be the most apt for "gene-rich" developing countries which are mostly comprised of resource-poor farmers and consumers. Each country should, therefore, develop its own policy on IPR and its support to the private sector according to its own national development needs and capabilities. In fact, several developing countries are reviewing their approaches to IPR systems and are trying to evolve and adapt patterns befitting their aspirations and opportunities.
The Plant Breeders' Rights (PBR) system evolved by the International Union for the Protection of New Varieties of Plants (UPOV) Convention, maintained the fundamental principle of unrestricted access to genetic resources. It also had provisions for "Breeders' Exemption" (breeders can use a protected variety for creating and commercializing a new variety) and "Farmers' Privilege" (farmers are permitted to multiply propagation material of a protected variety to be used for further crop growing on their own premises). However, the recently revised UPOV Convention (April 1991) has eliminated both "Exemption" and "Privilege". The extension of the industrial patent system to plant genetic resources, as stipulated in the new UPOV Convention, will interfere with FAO's proposed balance between PBR and "Farmers' Rights". The concept of "Farmers' Rights" was approved by all Member Nations of FAO in 1989 and is defined as "the rights arising from the past, present and future contributions of farmers in conserving, improving and making available plant genetic resources, particularly those in the centres of origin/diversity". If the patent system is applied universally to living matter, including plants and animals, and their genetic resources, then the principle of unrestricted access, as stipulated in the International Undertaking on Plant Genetic Resources, will be severely eroded.
Inadequate research and institutional support
As stated previously, research and technology development in biotechnology is expensive and requires highly trained personnel and comprehensive communication systems. The lack of expertise and research and development infrastructures, and the absence of appropriate policies, strategies, and priority-setting mechanisms, render most developing countries incapable of benefiting from the full potential of biotechnology. Other factors, such as the timely availability of credit, inputs and extension services, marketing and appropriate prices, are among the many economic conditions for the adoption of biotechnology, as for any new technology. A number of social and cultural conditions will also be relevant. Deficiencies in the involvement of the private sector in its links with the public sector, in policy-makers' awareness of technical possibilities, and in assessing the need for a biotechnological approach, the costs involved and the chances of success, aggravate the problems of the non-judicious use of biotechnology in most developing countries.
Advances in knowledge and applications of biotechnologies will continue and will probably accelerate in the most highly industrialized countries, who already have the lead in biotechnology development. Developing countries are therefore challenged to keep aware of the advances and to make their own appropriate contributions to developing technology. Although some laboratories in developing countries could make front-line research contributions, their priority needs would be:
The transition from research and development of technologies to commercial application is rather bumpy and inefficient in most developing countries. These countries should devote greater attention to applied research and technology transfer and should develop suitable personnel, infrastructures and institutions to facilitate technology application. For a workable transition to be made from the scientific effort to the market, a wide variety of capabilities and institutions have to be in place, and due attention should be paid to the development of biotechnological and engineering skills, market analysis and scale-up issues.
There are great differences in biotechnological capabilities among developing countries as well as between developed and developing countries. These differences will affect measures that the developing countries can take on their own and the extent and type of assistance they will find useful for the further development of biotechnology. Policies and measures that promote intercountry collaboration, based on the respective strengths and weaknesses of the cooperating countries, should be established and promoted in the spirit of technical cooperation among developing countries and also between developed and developing countries.
Biosafety and other environmental aspects
Another major issue affecting the role and application of biotechnology relates to the safety of Genetically Modified Organisms (GMOs) and the regulatory measures for research into and field testing and commercialization of GMOs. Fears have been expressed that uncontrolled release of GMOs might cause changes in ecological or genetic equilibria, with unforeseeable and perhaps deleterious consequences. This issue has been considered by several national and international bodies, including the US National Academy of Sciences, the US Congress Office of Technology Assessment, the European Commission, the Organization for Economic Cooperation and Development (OECD), the Australian Recombinant DNA Monitoring Committee, the UK Royal Commission on Environment Pollution and The United Nations Environment Programme (UNEP) and they generally believe that the technologies are safe. Studies by these organizations and others, and field tests carried out in the United States have concluded that careful design of transgenic organisms, along with proper planning and regulation of environmental releases, are sufficient to endure that GMOs will pose little or no risk to the environment.
It is increasingly appreciated that while biotechnology provides powerful new tools, they are generally used to generate products that fill essentially the same sorts of roles as those produced by more traditional methods. However, the potential power of biotechnology in creating diverse products is far-reaching and calls for greater preparedness to assess their acceptability from the point of view of biosafety. The efficacy and application of standards and regulatory measures for food and agricultural products, including food safety assessments and quarantine laws, should be examined in the context of new biotechnological products If necessary, suitable changes or strengthening measures should be brought about to render them effective both for encouraging the use of new products and for ensuring human welfare and health and environmental safety. A tiered system of responsibility for biosafety of products produced through biotechnology, at institutional and national levels, should be established.
It should also be appreciated that risks associated with the release of genetically engineered organisms cannot be reduced to zero. Biosafety aspects of genetically engineered biopesticides and other biochemicals should be assessed on the same lines as those of synthetic chemicals. Relatively greater risks may be involved if pathogenicity or weediness are implicated in release of GMOs. The risk of transferring herbicide resistance into weeds through the widespread cultivation of allied herbicide resistant transgenic crop plants should be analysed critically. The implications of releases should therefore be systematically investigated before the release is authorized, and steps should be taken to minimize potential problems.
The safety implications, if any, of applications of new biotechnologies to food production and processing should also be examined. Any safety assessment strategy should be based on considerations of the molecular, biological and chemical characteristics of the material at issue, and toxicological studies in animals. Facilities for adopting such an approach in most developing countries are inadequate. Action at the international level will be necessary to provide timely expert advice and technical assistance in this matter.
The biosafety aspects are primarily a matter for national decisions. The national governments and regional programmes should act to safeguard their own ecosystems, genetic resources and the health and well-being of their citizens from any possible risks associated with the release of GMOs and commercialization of genetically engineered food and other products. For this purpose, national governments should establish appropriate policies, laws, regulations and enforcement mechanisms for the control of potentially problematic introductions, either for testing, for export and import, or for releases on a commercial scale. Laws, regulations and guidelines on research, release, containment and monitoring of GMOs and on food safety assessment and their effective implementation are available and feasible in most industrialized countries. Generally, such measures do not exist in most developing countries because of insufficient scientific expertise and resources to assess the risks and implications adequately. However, national and international efforts are in progress to bridge this gap. International effort is further needed to develop, harmonize and implement procedures and standards based on sound and comprehensive scientific assessment, so that all countries may follow internationally agreed biosafety procedures and national decision-making processes.
Substitution of developing countries' exports
One of the potential negative impacts of biotechnology for developing countries is the speeding up of the process within industrialized countries of the substitution of products or high-value components of specific products originally derived from the produce of developing countries, thus depressing the limited opportunity for exports by the latter. Several significant agricultural exports of developing countries are already threatened. For instance, a number of companies in developed countries are now using biotechnology to produce a natural vanilla flavour in the laboratory - a process which could eliminate the need for traditional cultivation of the vanilla bean. This could result in the loss of over US$50 million in annual export earnings from Madagascar, jeopardizing the livelihood of some 70 000 small farmers.
Tissue culture production of certain components could displace their field production. For instance, biotechnology laboratories in Europe, the United States and Japan are standardizing techniques to substitute cocoa butter with cheaper vegetable oil, which could adversely affect the cocoa economy in several developing countries, especially in Africa. Other high-value, low-volume products such as pharmaceuticals, fragrances, flavourings and spices are also targets of biotechnology research. Efforts are being made to reduce the cost of production of these products under in vitro conditions in order to render the approach more competitive. There are no easy solutions to these problems. Certainly economic forces will dictate. One possible solution may be political, e.g. for production facilities to be located in nations whose economy will be affected rather than in the industrialized country that develops the process. Another solution is to reduce the cost of production in vivo by amplifying the genes responsible for production or amplifying the gene product through the incorporation of promoters in the plant genome.
Biotechnological advances in agricultural product processing have also led to the separation of plants from their specific characteristics, resulting in the substitution of one product for another. An instance of this is the increasing competition between sugar and starch producers. The production of alternative sweeteners has already adversely affected the sugar industries in major sugar-producing countries, threatening the livelihood of an estimated eight to ten million people in the developing countries by the loss of traditional sugar markets and a drop in world sugar prices. The development of High Fructose Corn Syrup (HFCS) from maize in the United States resulted in a drop in sugar exports from the Philippines to the United States from US$624 million in 1980 in US$246 million in 1984. Moreover, 500 000 people were rendered jobless because of this shift.
Social equity
Biotechnology, like any new technology, can be neutral, pro-rich or pro-poor, depending on the stage of its development and management, area of application and the socio-economic climate in which it operates. As regards research and generation of new techniques, biotechnological techniques are certainly high-cost and require highly trained personnel setting generally obtained in industrialized countries. Much of the research takes place in the private sector, which means that the marketability of the product and potential return on investment are crucial factors in deciding what research to undertake. Most of the new technologies, processes and products are, therefore, generally expected to be first available in industrialized countries and first applied to the commodities and priorities favoured by those countries. Furthermore, research and development goals of the private sector may diverge from those of the public sector. The gap should be narrowed, keeping in mind the interest of the people, especially the poorer sector who constitute the majority in developing countries.
The adoption of biotechnology-derived products/techniques intended for common use should ordinarily be scale-neutral. However, the time lag in availability and adoption of new technologies between developed and developing countries is likely to reduce the competitiveness of agriculture in the poorer countries, and of the poorer sectors within a country, at least in the short term, especially when more and more production surpluses will be competing in fewer markets. The share of industrialized countries in the world export of food products increased from about 45 percent in the early 1960s to about 68 percent in the early 1980s.
Another anticipated consequence of the application of biotechnology is an acceleration in the trend towards further industrialization of agriculture, for which many of the smaller and less developed countries are not sufficiently prepared. Even though biotechnologically modified varieties, breeds and microorganisms may be used with equal success in small- and large-scale agriculture, economies of scale in marketing and processing and ability to take risks and to invest favour adoption first and foremost by larger producers.
Biotechnology can positively be pro-poor. It may help to create new markets, both through the breeding of new industrial, medicinal and aromatic crops, and through changes in downstream processing. Given their richness in indigenous biodiversity, several developing countries, such as Brazil, China and India, which have biotechnological capabilities, should use the new technology for production of new high-value pharmaceutical and industrial products based on their local flora. The congenial agroecological settings and the availability of relatively cheap labour should be conducive to large-scale production of new high-value crops, especially medicinal and aromatic, enabling such countries to maintain comparative advantage in these commodities. The use of biotechnological techniques for the development of biofertilizers, biological management of pests, detection of pathogens and their biocontrol, etc., which are scale-neutral and labour-intensive, will be particularly suitable for resource-poor farmers. However, their transfer will require high-quality management, which requires complementary changes in training and extension activities. These technologies will also address non-tariff trade barriers arising because of pesticide residues in or pest infestation of traded food and other products, and would thus increase the access to particular export markets.
Ethical and legal aspects
Notwithstanding the high potentials of biotechnology for development, the genetic manipulation of crops and livestock using genes from unrelated organisms and the possible implications for biosafety and human health have raised ethical issues. In a widespread debate in both the industrialized and developing countries, many consider that patenting higher life forms and the genetic materials they contain is unacceptable for ethical, social and economic reasons. Most developing countries do not allow the patenting of plants, animals or their genetic component generally because of their importance in the food supply. Others, however, see the use of patents as one of the necessary mechanisms to stimulate technology development.
Differences in perspectives on the usefulness and exploitation of biotechnology emanate from the level of agricultural and economic development, the level of research and technology capability, the form and mechanics of transfer of technology, and the availability of appropriate regulations and the mode of their implementation. Several technical and legal problems related to biosafety and patenting of living organisms and their genetic materials remain unresolved. The definition of protected subject-matter as it applies to biological material is still evolving and is far from fixed, and in many countries a policy debate on this matter is under way. Specific legal provisions in the area of IPR for biological content are currently under consideration in various international fore such as the World Intellectual Property Organization (WIPO), General Agreement of Tariffs and Trade (GATT) and OECD. Specialized UN agencies and technical bodies, such as FAO and World Health Organization (WHO), are closely associated with, and involved in, such negotiations/debates to facilitate the formulation of socio-economically scientifically and ethically balanced decisions.
The system which is now emerging in some industrialized countries is one which will grant strict intellectual property protection to a wide array of biotechnological products. Great pressure is being and will continue to be exerted by these countries in a number of fore in order to assure that such protection is observed worldwide, although, at the Uruguay Round of the GATT negotiations, industrialized countries formally agreed that they did not expect developing countries "to make contributions which are inconsistent with their individual development, financial and trade needs". The system proposed by industrialized countries is designed to serve individual inventors in a formal research setting and to "protect" the "inventions" originating from their own economic systems. These laws do not take into account informal research and innovations or the indigenous knowledge and products of differing cultures, which have provided and will continue to provide invaluable information and materials for further innovations worldwide.
Member countries should carefully assess the implications of different rules regulating the development and use of biotechnology. Appropriate and workable legal frameworks on biotechnology-related matters should be formulated to ensure the balanced exploitation of new techniques and products. FAO, based on its experience on issues such as the safe and efficient use of pesticides and harmonization of quarantine principles and procedures, would be one of the intergovernmental bodies, such as WIPO and WHO, to assist Member Nations in formulating the necessary legal guidelines.
FAO considers that modern biotechnology is already making important contributions to and poses great potential and challenges for agriculture, forestry and fisheries development. The Organization recognizes that biotechnologies are a new group of powerful tools for research and ultimately for accelerating development and not an end in themselves. It perceives that modern biotechnologies should be used as adjuncts and not as substitutes to conventional technologies in solving problems, and that their application should be need- rather than technology-driven.
Successful development and application of biotechnology are possible only when a broad research and knowledge base in the biology, variation, breeding, agronomy, physiology, pathology, biochemistry and genetics of the manipulated organism exists. Benefits offered by the new technologies cannot be fulfilled without a continued commitment to basic research. Biotechnological programmes must be fully integrated into a research background and cannot be taken out of context if they are to succeed. With this background, FAO's strategy is to keep biotechnologies in a balanced perspective by undertaking activities within the framework of existing national research agendas and priorities through consultations, monitoring, and programme initiatives, rather than to support development of new independent programmes and structures around a set of technologies which, in fact, are tools to be used by diverse disciplines and programme areas.
Each country has a responsibility to formulate its own policies, priorities, strategies and programmes for harnessing biotechnology, and to weigh expected benefits, not only against possible negative effects but also against the risk of not exploiting the technology. Commensurate with these responsibilities, the countries must have the necessary infrastructures, financial support and expertise. A majority of the developing countries lack these prerequisites and will need assistance to strengthen their overall capabilities in biotechnological research and development in order to meet the potentials and challenges of the new technologies. On request, FAO can provide technical inputs to assist in planning, programming, priority setting and strategy formulation.
In line with its mandate and the three major areas of its programme, namely, providing information, providing a forum for international debate for issues related to food and agriculture, and rendering technical assistance to its Member Nations, FAO seeks, within its means and resources, to realize fully the positive impacts of biotechnologies and to minimize, if not completely eliminate, the negative effects. In this resolve, FAO's strategy is to concentrate on activities such as providing information, monitoring and advice, facilitating access to the new technologies, providing a forum for the review of trends, developing appropriate guidelines and codes to facilitate the environmentally sound and quotable harnessing of modern biotechnologies, assisting developing countries to identify biotechnology needs and priorities and to assess socio-economic impacts, and strengthening the overall biotechnological capabilities of the developing countries.
Monitoring and appraisal
FAO, in cooperation with concerned national and international institutions, through country-level and intercountry studies and consultations and seminars, will seek to assess the realistic potential of the new biotechnologies (short-term benefits must not be overstated) as well as their limitations for agricultural, forestry and fisheries production, with special reference to developing countries. The objectives of positive benefits include increased yields, stabilized production, improved ecological sustainability, better food quality and reduced losses. FAO, also through the work of the Commission on Plant Genetic Resources, shall monitor and define potential and real adverse effects of biotechnology and develop early warning systems to ward off possible negative effects. Longer-term activities would include assessment of the propensity of widespread uses of biotechnologies to modify established patterns of comparative advantages in food, agriculture, forestry and fisheries production and trade, and to displace traditional commodities, and the implications thereof. FAO will also monitor legal, socio-economic, and other policy aspects of biotechnological advances and alert Member Nations of the implications.
Information
It will be incumbent upon FAO to collect, consolidate, analyze and disseminate information on biotechnology in relation to food, agriculture, forestry and fisheries so that the Organization can assist Member Nations in evolving appropriate policies, strategies and management systems for rational exploitation of biotechnologies. Use will be made of AGRIS and CARIS (the FAO's information databases) and Member Nations will be assisted and encouraged to participate in information gathering and exchange. FAO will also assist in the development of international centres for the genomic databases of economically important organisms, and this information will be freely disseminated.
The participants in AGRIS and CARIS are conscious of the importance of biotechnology and already, at a general consultation in May 1990, have urged each other to make greater efforts to ensure complete coverage of the available information. However, because many disciplines are involved, biotechnology information tends to be widely dispersed in the scientific literature. Therefore, it is envisaged that AGRIS inputters could use new codes to flag relevant material and thus facilitate its extraction and presentation. Specialized products could then be issued in cooperation with other units of FAO for distribution to the global and regional networks. Such products could include printed bibliographies, similar to Animal biotechnology, specialized databases on diskettes or CD-ROM for use with personal computers, and alerting services directed to individuals and research groups.
AGRIS and CARIS are also exploring the possibilities of an electronic mail/bulletin board service which would enhance the speed at which critical information is delivered and provide an electronic conferencing capability for scientists in the various networks.
Increasing access to new technologies and products
In order to increase access of developing countries to biotechnological techniques, processes and products, including the protected ones, FAO will provide a natural forum to review and discuss the issue of free availability and other biotechnology access issues. Various FAO bodies such as the Committee on Agriculture, the Council, the Commission on Plant Genetic Resources and the Conference, will seek formulation of agreed norms, codes and procedures for the unhindered flow of information, technology and genetically engineered materials to all bona fide users, with due provisions for biosafety and environmental soundness. FAO would serve as an intermediary between the technology developers and the users to secure or acquire for developing countries the potential benefits arising from biotechnology research and its application. For this, FAO will act as an "honest broker" to match the needs of the developing countries and appropriate the proprietary technologies they require. The Organization will mobilize funding support from donors and development banks to implement the brokered proposals.
For some time, FAO has been debating the issue of free availability of genetic resources, including genetically engineered materials, to all bona fide users, particularly since 1983 when the Organization evolved a unique global system on plant genetic resources consisting of the International Undertaking, the Commission and the International Fund. In recent meetings of the FAO Commission on Plant Genetic Resources, and at the FAO Conference, the principle that plant genetic resources are a common heritage of the human race has been further clarified: it has been stressed that "free access" does not mean free of charge and it has been pointed out that the principle of a common heritage is not incompatible with national sovereignty. The discussions surrounding the recognition of Plant Breeders' Rights and Farmers' Rights, and the establishment of the International Fund for Plant Genetic Resources, have turned towards the need to establish a mechanism, or mechanisms, to reward breeders and to compensate farmers throughout the world - especially in developing countries - for having developed and preserved, over generations, the plant genetic resources that are now being utilized, and for making those resources available to today's breeders and scientists.
In FAO's view, an IPR system should be flexible enough to match the development goals, policies and socio-economic priorities of individual countries, and at the same time should be able to promote innovation and application of new technologies. Each country needs to weight the benefits and costs of IPRs in biotechnology, and frame its policies accordingly. If the national capability in genetic improvement and biotechnology research is negligible, the country will benefit little from establishing an IPR system generally used in industrialized countries. On the other hand, where the national capability is fairly developed and agriculture is market-oriented, a moderate system of the Plant Breeders' Rights (PBR), which would stimulate private sector investment, may prove appropriate. Developing countries should opt for a PBR system with provision for farmer plantback, especially where farmers cannot afford to buy seed each year or are not reached by a seed distribution system. Finally, member countries should ensure that no IPR system be established that would restrict access to and use of genetic resources, inhibit promotion of research and technology development and thereby adversely affect their vital socio-economic fabric. The important role that farmers had, and continue to have, in the development and maintenance of germplasm should be duly recognized. FAO is involved in preparing a code of conduct for biotechnology as it relates to conservation, exchange and use of genetic resources.
Strengthening national capabilities
Based on the needs and opportunities of individual developing countries, FAO will seek to strengthen national capabilities and to promote self-reliance for the generation and transfer of biotechnological techniques by supporting personnel development; enriching information collection, consolidation and dissemination; augmenting required research facilities; and assisting in the formulation of appropriate national policies and priorities.
Research and technology development. FAO has assisted several relatively well-positioned developing countries to assess their biotechnology requirements and prepare the way through institutional and human resources development for undertaking research and technology development with special emphasis on the integration of biotechnology. Assistance has been focused on biotechnology for crop improvement, or the production of vaccines and use of diagnostic, with involvement of the Joint FAO/International Atomic Engergy Agency (IAEA) Division (AGE), in livestock health and reproduction programmes. FAO's in-house capacity will be strengthened in order to meet the demands on the Organization in the field of biotechnology effectively.
Personnel. The present and future use of biotechnology depends, to a considerable extent, upon the availability of trained researchers, bioprocessing engineers and technicians. One of the major factors limiting the use of biotechnology in developing countries is the acute shortage of appropriately trained staff. FAO, through both its regular and the Field Programmes, should support developing countries in establishing functional applied biotechnology laboratories and in related training activities. The Joint FAD/IAEA Division (AGE) laboratory has a strong research-training component on biotechnologies and has been actively involved in staff training and basic research in this field. Fortunately, the techniques and methods have become more accessible through technological innovations such as the polymerase chain reaction and automated sequence analysis. Nonetheless, FAO should continue giving high priority to training scientists in developing countries.
Policy. In view of the fast pace of biotechnological development and the widening gap in the capabilities of developed and developing countries, the effort to narrow this gap will be further intensified by increasing the policy-formulation, priority-setting and programme-implementation capabilities of developing countries. In particular, FAO will reinforce its assistance to developing countries in analyzing the necessary and sufficient social and economic policies for the development, adaptation and implementation of appropriate technology.
Establishment of reference laboratories
FAO strongly advocates observation of all internationally established norms and requirements for bioengineered vaccines and other bioproducts based on the application of microbiological factors. The Organization will continue and further strengthen its programme on the establishment of collaborating laboratories that provide invaluable services, not only as reference for quality testing but also for training. For instance, arrangements are being made to test recombinant vaccines under the FAO umbrella. In addition to strengthening national institutes and supporting ongoing efforts in developing countries, FAO has established a Collaborating Centre for Biotechnology Transfer at the University of California, Davis. A counterpart Molecular Virology Unit for Biotechnology Transfer will be organized at the Pan-African Vaccine Centre in Addis Ababa, Ethiopia. The FAD/IAEA laboratory at Seibersdorf, Austria, will be strengthened to serve as an important reference centre for new biotechniques, genetically engineered organisms and resulting products.
Promotion of intercountry cooperation and networks
FAO will promote intercountry and interlaboratory cooperative research through the establishment of cooperative networks. Examples of such networks include the Asian Network for Biotechnology in Animal Production and Health; the Computer Assisted Analysis of Nucleic Acids and Protein Sequences (CANAPS) in Latin America and the Caribbean, and the Latin American Technical Cooperation Network on Plant Biotechnology. An Asian Network on Plant Biotechnology, and a Latin American Network on Animal Biotechnology, are currently being established. FAO is also sponsoring regional networks on the preparation and distribution of diagnostic probes/monoclonal antibodies for the rapid diagnosis of livestock and poultry diseases.
Based on their capabilities and willingness, certain laboratories in selected National Agricultural Research Services (NARS) will be strengthened to take the leadership role in specific areas. Results and products from these centres will be shared freely among all cooperators in the networks. FAO will work closely with selected biotechnological research and development centres both in developed and developing countries, and will seek their assistance in programme and project formulation, appraisal and evaluation.
Several expert consultations organized by FAO to prepare the ground for cooperation networks in animal production and health have recommended approaches and steps for FAO in this field. Regional expert consultations were held in the Asia-Pacific Region in 1990 and 1991 in order to establish a cooperation network on plant biotechnology. Through the 1991/92 André Meyer Fellowship on Forest Biotechnologies, the potential role of biotechnology, within well-founded tree improvement and breeding strategies, and in forestry in general, is being analyzed, with special reference to potential in developing countries.
FAO will stimulate development-related research in industrialized countries and help establish links with institutes in the developing countries. It will strive to influence at least the public sector institutions in developed countries to include in their biotechnology research agenda commodities and techniques of importance to developing countries. The Organization will encourage the strengthening of biotechnology capabilities at the IARCs, and work in concert with them in human resources development programmes and in cooperative research activities to strengthen the biotechnology capabilities of developing countries. FAO will keep abreast of opportunities for solving recalcitrant problems through the application of biotechnology, and will organize workshops/seminars to discuss methods and strategies for approaching such problems through cooperative research programmes.
Promotion of biosafety and environmentally friendly use
FAO will continue to cooperate with United Nations Industries Development Organization (UNIDO), UNEP and WHO in the establishment of codes and guidelines for biotechnology-related environmental and health risk assessment. The UNIDO/UNEP/WHO/FAO Working Group on Biosafety brought out a Voluntary Code of Conduct for the Release of Organisms into the Environment in 1991. The code sets out general principles, a framework and guidelines to be adopted at national, regional and international levels to facilitate the safe application of biotechnology. FAO will lead the establishment of "prior informed consent" and seek to further the use of relevant data to assist developing countries in elaborating pertinent policies and regulations.
FAO and WHO will jointly monitor the food safety aspects of foods prepared through biotechnology applications in accordance with established principles for the evaluation of food safety in general. While the 19th Session of the Codex Alimentarius Commission in 1991 had endorsed the opinion of the Joint FAD/WHO consultation on this subject in Geneva in 1990, that foods derived from "modern" biotechnologies were inherently not less safe than those derived from traditional biotechnologies, the issue of safety along with nutritional concerns had to be considered. The Consultation had recommended that FAO and WHO, in cooperation with other international organizations, should take the initiative in ensuring a harmonized approach on the part of the national governments to the safety assessment of foods produced by biotechnology. Based on scientific and technical advice by joint FAD/WHO committees and consultations, the various Codex Committees will discuss the issues concerned and help to reach international consensus on particular novel foods. For instance, the Codex Committee on Food Labelling is to provide guidance on how the fact that a food is derived from "modern" biotechnologies can be made known to consumers.
The Fourth Session of the FAO Commission on Plant Genetic Resources, in April 1991, resolved that FAO, in collaboration with other concerned organizations, should develop a Code that includes and promotes basic biosafety standards for the contained use and deliberate release of GMOs, and for their importation and exportation. The Code will include elements to minimize the negative potential of GMOs on genetic diversity. Work in this direction and on the lines suggested is already in progress.
Promotion of pro-poor features
Within the framework of overall strategies, FAO will seek to promote biotechnological research and development of commodities, often referred to as "orphan commodities", which are generally not researched by industrialized countries but which are of vital importance to most developing countries. It will strengthen national capabilities for biotechnological solutions of problems related to increased and sustained agricultural production under rainfed, saline and other marginal conditions, which are largely inhabited by resource-poor farmers and which are characterized by low and unstable productivity. FAO will also seek to strengthen national capabilities for exploiting in vitro culture techniques, biological nitrogen fixation, genetic resistance to pests and diseases, low-cost production, and increased employment opportunities. Furthermore, through expert consultations, information exchange and technical assistance, the Organization will promote the use of biotechnology for diversified and new uses of rich indigenous variability, especially those of industrial, medicinal and aromatic plants and small animals, and for developing new farming systems. These policy elements, if linked with appropriate action plans, should go a long way towards promoting equity coupled with sustained and environmentally sound economic development.
Links with other UN agencies and with NGOs
FAO has been collaborating with several UN and non-UN agencies/ systems in a number of activities related to biotechnology. For instance, it takes part in the UNEP-initiated effort to establish a Convention on Biodiversity and in the Biotechnology Working Group formed in that effort. FAO was a member of the Working Group on Biotechnology which was created in preparation for the 1992 UN Conference on Environment and Development (UNCED), and will continue to work with other UN Agencies in implementing the Action Plan on Biotechnology contained in UNCED Agenda 21. The Organization has been working with UNIDO, UNEP and WHO in developing a Code of Conduct for Biosafety, and in developing food safety standards. It will continue to work closely with WIPO and GATT in evolving appropriate intellectual property protection systems suitable for both developed and developing countries.
Addressing the issue of environmental safety in 1989 FAO, the International Office of Epizootics (OIE) and WHO jointly prepared the international requirements for vaccinia vector rinderpest vaccine. A joint FAD/WHO Consultation on Strategies for Assessing the Safety of Foods Produced by Biotechnology was organized in 1990. Other joint activities in this area are planned. The Joint FAD/IAEA Division operates a number of regional and interregional coordinated research programmes dealing with a variety of biotechnology applications in crop breeding and nutrition, animal production and health was held in 1991. FAO has also been collaborating with CGIAR in several biotechnology-related matters. For instance, it has been a member of the CGIAR Task Force on Biotechnology (BIOTASK) in discussing CGIAR-wide issues on biotechnology, including IPR and biosafety. FAO also organized a workshop for African biotechnologists in collaboration with IITA in 1990. FAO will interact with non-UN professional societies, such as the American Fisheries Society, that debate and develop review and position papers on biotechnology in their respective fields. FAO will continue to seek further active and effective international links in the field of biotechnology.