Many biotechnologies have been developed by people in most cultures. Some of them are thousands of years old, others are of very recent origin. New and modern biotechnologies developed over the last 30 to 40 years - such as tissue cultures, cell isolation, molecular diagnostics and genetic engineering - are powerful instruments that can be used for different purposes. Most of these biotechnologies are not controversial and can be used safely to increase food security. An important subset of modern biotechnologies is genetic engineering, or the manipulation of an organism's genetic endowment by introducing, rearranging or eliminating specific genes through modern molecular biology techniques. A genetically modified organism (GMO), otherwise referred to as a living modified organism (LMO) or transgenic organism, is understood to mean any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.
The Panel agreed that science and technology have provided great benefits in the past and are likely to do so in the future, as long as they are properly managed and applied. It noted in this connection that international human rights stipulate that everyone has the right to share in the benefits of scientific progress and its applications (Universal Declaration of Human Rights, Article 27).
Considering that classical plant, animal and fish breeding and modern biotechnologies comprise sets of tools that depend on naturally occurring genes as raw materials, the maintenance of biodiversity or genetic resources is a global concern of major importance to FAO.
The accelerating rate of developments within the field of modern biotechnology has given rise to an intense public debate, in which adversarial positions are often taken. Care should be taken to distinguish between different aspects of the debate. One set of concerns relates to the risks and uncertainties as well as the potential benefits that are directly associated with the biological consequences of the use of products generated by such technologies. Another set relates to the doubts, fears and hopes concerning the social and economic context in which these biotechnologies are introduced and used, and the consequences they may have for social and economic development. While the Panel was not in a position, during its first session, to examine all issues involved, it decided to proceed by following three main steps: i) indicating the risks, uncertainties and doubts involved; ii) reflecting on the potential benefits that the products of modern biotechnologies, including GMOs, may yield in the future; and iii) examining some of the conditions that would have to be fulfilled in order to ensure that the benefits, if any, are obtained by the most needy, in particular the developing countries and, within them, the poorer farmers and other vulnerable groups.
The Panel pointed out that biotechnology in its wide sense provides many alternatives to the production of GMOs and that such alternatives should be preferred where there are significant risks or uncertainties at present concerning the use of GMOs, particularly when the expected benefits of the latter are few. Preference should be given to the most appropriate technology.
While the impacts of most biotechnology products are relatively predictable, GMOs do present risks to human health and the environment and raise considerable uncertainties, in particular regarding their environmental impact. Here, the precautionary principle should be respected. When there are reasonable grounds for concern, even without complete scientific documentation, countries should be reluctant to introduce a GMO until more knowledge is available.3 With regard to developing countries, there is also a danger arising from the fact that field testing of GMOs is being undertaken in countries that still have little or no policy on GMO releases. GMOs need proper control and appropriate testing. They should not be released without risk analysis and the assurance of subsequent monitoring and risk management, or without accountability for possible harm arising from their use. The Panel underlined that a blanket endorsement should not be granted in the case of GMOs.
The risks to human health include the possible transfer of food allergenic compounds to products that did not previously contain them, and uncertainties as to other consequences. Regarding environmental issues, a fundamental concern is the protection of biodiversity. This is of general importance for future ecosystem equilibrium and is essential for poor farmers and local communities to be able to secure food and livelihoods for vulnerable groups. In turn, the conservation and development of biodiversity carried out by these communities - as part of a continuous adaptation to changing environmental conditions and human needs - is crucial for the sustainability of agriculture and the interests of future generations. The risk of losing this type of biodiversity management is becoming obvious where conventional agribusiness is expanding. If GMOs are developed and applied without consideration for biodiversity protection, particularly if they are developed exclusively for intensive monocultures, they will further undermine diversity-based agriculture.
The Panel expressed concern about the context in which GMOs are promoted. Many developing countries have two kinds of agriculture: one for subsistence and one for export. Because GMOs are likely to be used in the subsector that produces products only for export, local populations might not be able to buy the product. As an example, the introduction of high-technology and high-input monoculture cotton in Africa was mentioned, as this practice is of no benefit to small farmers who cannot afford the technology. The context in which this technology is being developed does not necessarily address the problems faced by food-insecure and vulnerable groups. In addition, poor countries might not benefit from GMOs as they currently exist, since a dependency on imported seeds could be created.
Modern biotechnologies, including the less sophisticated ones such as tissue culture technology, are currently being employed mainly to promote monocultures. For example, oil-palm clones are now spreading in parts of Latin America where various corporations employ this technique, thereby adversely affecting biodiversity. Conversely, tissue culture techniques could benefit biodiversity conservation and breeding programmes in several ways in developing countries (e.g. germplasm movement, collection and preservation).
Another risk is that, whatever their intended use, transferred genes may escape into weed relatives and wild relatives of cultivated plants, with potential negative effects on the fields and, especially, on the equilibrium of the local ecosystem. Special attention should be paid to the use of a given genetically modified crop in the area of origin, where most of the crop's wild relatives are present.
Developing countries face additional difficulties in assessing the risks of these technologies because the technological knowledge related to them often forms part of the exclusive intellectual property of corporations in developed countries.
The Panel discussed the ethical aspects of the Genetic Use Restriction Technologies (GURTs), which appear initially to have been designed to protect corporate property rights physically (by making harvested seeds infertile) where legal restrictions preventing farmers from planting harvested seeds may not work in practice. Following strong criticism, the corporations concerned have not commercialized GURTs, also called "terminator technologies", but they still hold patents and seek new ones, suggesting that they may still seek to market GURT products. The very nature of GURTs would render patents over seeds unnecessary. Moreover, while patents provide only a limited period of legal protection, GURTs could provide a perpetual form of physical protection. The Panel unanimously stated that the "terminator seeds" are generally unethical, as it is deemed unacceptable to market seeds whose offspring a farmer cannot use again because the seeds do not germinate. GURTs are not inherent in genetic engineering. While corporations are entitled to make profits, farmers should not be forced to become dependent on the supplier for new seeds every planting season.
There are situations where the assessment can be different, however. Where the concern is with possible outcrossing of crops, for example GMOs that could damage wild plant populations, GURTs might be justified. This may also apply elsewhere: when the primary concern is to prevent reproduction of farmed fish with wild populations, for example, then GURTs could be useful in protecting wild populations.
In relation to the issue of GURTs, the Panel expressed concern about potential risks of the inadvertent or unintended spread, through pollen, of gene complexes responsible for sterility traits; the possibility of the sale or exchange of non-viable seed for planting; and the potential negative impacts that the use of GMOs has on genetic diversity. It stressed the importance of farm-saved seed, particularly for resource-poor farmers, and the importance of farmers' selection and breeding for sustainable agriculture.
It was suggested that GMOs could be compared with nuclear technology in that such technology can be applied for peaceful purposes, although its risks have proved to be real and could be lethal for humankind and the biosphere. Every possible effort should be made to ensure that the risks are avoided.
The Panel recognized that there is considerable potential for food security and for developing countries in the use of appropriate biotechnologies, and that there is room for optimism. A distinction should be made between the production of GMOs and the other biotechnologies. Modern biotechnology, even without genetic engineering, makes it possible to breed plants and animals faster and in a more controlled way than before. In the case of GMOs, the Panel agreed that, rather than aiming at dramatic changes, progress in this field should be achieved through small, incremental developments, with the modification of single genes, possibly within the same or closely related species, for very specific improvements.
The Panel also stressed the need to work more with tropical and subtropical plant varieties and animal races. Biotechnologies should not be developed exclusively for major commercial crops and animals. In many cases, appropriate technologies could enhance promising but underutilized species to produce more and cheaper products and to improve local consumption. Appropriate efforts could enhance these traditional plants and increase their yields, market and processing value, thus making them more competitive and contributing to dietary diversity. The Panel noted that, should these crops and animals be more productive at a lower cost under marginal conditions, there would also be potential environmental benefits. Furthermore, in specific local conditions, there might be fewer risks than those associated with conventional intensification technology.
There is potential for maintaining, introducing and conserving crops and animal breeds from diverse cultures that may otherwise be diminishing. Certain biotechnologies could be used to protect and even develop biodiversity, particularly if they were applied to locally adapted and culturally valued crops and animals. Biotechnology offers the potential to enhance a range of crops and animals.
There may be potential for companies as well as public research institutions in developing countries to harness technology through strategic alliances with corporations in developed countries, while avoiding the exploitation of public research for the benefits of private corporations. With proper ethical commitments, corporations could help developing countries to use this technology.
It is too early to know what specific benefits GMOs can provide for developing countries, in particular for small-scale farmers and other vulnerable groups. Nevertheless, the Panel agreed that genetic engineering technologies are changing fast and, with this rapid development, the technology is likely to become less expensive. A possible consequence of this accelerated development is that, within 10 to 15 years, the technology could be out of the hands of large companies and be available to developing countries.
The Panel considered the particular example of molecular biology applied as a diagnostic tool in human health at a low cost in Central and South America. It also appreciated similar applications of DNA technology as a diagnostic tool in agricultural plant and animal pathology and in the production of vaccines, drugs and diagnostic kits for human health in Cuba. It likewise appreciated the results achieved through the sequencing of phytopathogen genomes and the sugar cane obtained in Brazil. However, a major problem is that, at present, the commercialization of biotechnology, including GMOs, is mainly pursued by major corporations which, understandably, seek to maximize profits. This is one of the reasons why the poorest and most vulnerable groups have not benefited from genetic engineering and are unlikely to do so unless important conditions are put in place. Part of the criticism directed against GMOs, while cast in terms of risk, flows from the fact that the benefits appear to be low or non-existent for poor farmers or poor consumers. It is necessary to look beyond the interests of corporations and the research institutions associated with them, and to bring into consideration the welfare of the poor, particularly in developing countries.
The fact that intellectual property rights (IPRs) include patents means that developing countries cannot easily gain access to technology. Mechanisms are required to facilitate developing countries' access to technology, including on preferential and/or concessionary terms. The Panel considered that there is an overuse of IPRs, which affects the production of food and the development of agriculture. It also considered that broad patents providing protection beyond the proven utility of a product discourage research and favour the development of monopolies.
The Panel held that IPR systems that restrict the use of naturally existing genetic material over a wide spectrum, from genes to organisms and species, should not be allowed. Access by international and national agricultural research institutions to basic enabling technologies and processes that are important for sustainable agriculture and food security should not be restricted through the use of patent systems.
The Panel expressed concern that existing IPR regulatory systems are effectively promoting varietal uniformity, as this quality is often explicitly required by the legal provisions of the system. The Panel also expressed concern that the unintended consequence of this is a progressive loss of agrobiodiversity.
The Panel appreciated the consensus that is forming among FAO Member Nations in the course of the revision of the International Undertaking on Plant Genetic Resources, which aims at a negotiated multilateral system for access to, and the sharing of benefits derived from the utilization of plant genetic resources, including provisions for the realization of Farmers' Rights as an incentive for the conservation and continuous development of agrobiodiversity.
It was impossible for the Panel, during this first brief session, to carry out the analysis necessary to make firm recommendations. More work needs to be done by the Panel. Nevertheless, some preliminary conclusions, based on the ethical perspective set out in the introduction to this report, are outlined below.
Science has benefited humanity in the past and can continue to do so in the future, provided there is a real concern for equity. The results of scientific research must be shared fairly. The assessment of the Panel is based on the ethical imperative to give priority attention to the impact and use of science for the poor, the hungry and the vulnerable, including small-scale farmers in the developing countries. Corporations are normally concerned with the interests of their shareholders, not the needs of the poor, the hungry or small-scale farmers. Those needs are more likely to be addressed by public, non-profit research, but the private sector should also be encouraged to address the ethical considerations mentioned in this report. A reference was made here to the efforts under way to draft a code of conduct for transnational corporations. FAO should be involved in this process in order to ensure that the concerns discussed by this Panel are taken into account. Reference was also made to the draft FAO Code of Conduct on Biotechnology as it relates to Genetic Resources for Food and Agriculture.
From the human rights perspective whereby everyone is entitled to benefit from the achievements of science and technology, the Panel noted with much concern that public research funding is being continually reduced, both at the national and the international level. At a time when new and powerful technologies are drastically increasing the efficiency of research, public funding for non-commercial research is essential in order to develop, transfer and utilize appropriate biotechnologies. It is also essential to ensure, through social science research, that such biotechnologies are harnessed to serve the interest of poor farmers, poor consumers and local communities, especially in developing countries - for example, by enhancing local, underutilized and sometimes marginal but promising crops and animals. The Panel is convinced that there is much room for research that can improve indigenous and other local crops and animals and thereby enhance dietary diversity and food security.
It is important to ensure that such research is multidisciplinary and covers the social and economic context and consequences of the introduction of such technologies as well as ways to remedy unintended, negative social consequences. The research should, at least in part, be explicitly and institutionally directed to the needs and benefits of poor farmers, herders, foresters and fishers. Participation by the intended beneficiaries should be sought where possible. Science should be open and scientists should be accountable regarding the aims and potential benefits or risks of their research output. Without broad, multidisciplinary and independent research and action to implement that research, the widening gap between the rich and the poor will become an inescapable trend.
The Panel underlined the advisability of conducting a comparative study of national regulations concerning biotechnology, including GMOs, exploring the possibility and desirability of harmonizing such regulations.
Information on the results of research in the public and private sectors should be disseminated and enter into the public domain as soon as possible. Developing countries need to be involved and to have access to technology so that they can harness its benefits. Biotechnologies can benefit the developing world if proper choices are made and if there is an ethical use of materials and a spirit of solidarity and cooperation. Worldwide cooperation should be pursued to ensure that the use of biotechnology meets everyone's needs. Developing countries should be enabled to make full use of biotechnology to increase agricultural productivity, while preserving diversity through the promotion of appropriate combinations of modern, traditional and local methods.
FAO should support developing countries in increasing research and development related to socially useful and environment-friendly biotechnologies, including - as appropriate - the possible development of certain GMOs. Consideration must be given to the potential benefits for food and nutrition security, and thereby for human health and well-being, on the one hand, and to the need to avoid risks to human health, social justice and the environment, on the other hand. Adequate safeguards must be put in place to ensure that all concerns are protected, including environmental concerns, while leaving options open for future generations.
FAO should support programmes designed to bring the benefits of biotechnology to small-scale farmers, especially in developing countries, while seeking to ensure that the aims and the effects of the use of such technologies serve to reduce hunger and malnutrition. Such programmes may also be directed towards the enhancement of farmers' varieties or landraces that are already well adapted to local growing conditions, thereby adding specific value of interest to farmers.
3 A comparable precautionary principle has been adopted by the European Commission.