GRAIN/CEAT Whereas by now most industrialised countries have adopted regulations concerning the safe handling and use of genetically engineered organisms, most developing countries still lack any regulations in this field. This imbalance is already stimulating companies to test their biotechnology products in the South, rather than in the North. Faced with many examples of such testing, there is a clear need for a binding regulatory mechanism to rule the testing, release and trade of genetically modified organisms (GMOs). This article draws from a position paper prepared for the Second Session of the Intergovernmental Committee for the Convention on Biological Diversity by the CEAT (European Coordination Friends of the Earth) Clearinghouse on Biotechnology and GRAIN. Since the mid 1980s most industrialised countries have in place certain regulations concerning the safe handling and use of genetically engineered organisms. Some, such as the US, simply adapted their regulatory framework by adjusting it to the special risks linked with the new recombinant DNA technologies. Others, like the European Union and most of its Member States like Denmark and France, established new laws covering the contained use as well as the deliberate release of genetically modified organisms. All the laws, regulations and guidelines which have been set up during the last 20 years in the field of genetic engineering are, though not identical, very similar in their scope, requirements and effects. In contrast to this regulatory situation in the developed countries, most developing countries still lack any binding regulations covering the safe handling and use of biotechnology. Biosafety regulation in most developing countries is still in its infancy. This is often due to the limited financial and technological capacities of the regulatory authorities in these countries. As a consequence, an increasing number of companies from the US and Europe prefer to conduct releases of GMOs in countries which have no regulations in place (see table) . Thus, as is the case with many other dangerous or risky substances and technologies, there is a regulatory imbalance between developing and developed countries (see box on page 11). And as we know from other issues, strict regulations in one country or certain parts of the world may have the effect that operators flee to the countries whose regulations are less strict or who have no regulations in place and/ or no capacity to control compliance with regulations. This regulatory vacuum and imbalance is one of the major argument used by many governments and NGOs for a biosafety protocol under the Convention on Biological Diversity (CBD). Risks of GMOs According to the well-known and widely accepted OECD Recombinant DNA Safety Considerations, the potential environmental impacts of agricultural and environmental applications of recombinant DNA (rDNA) organisms include: - direct but unanticipated effects of modified organisms on non-target species; - effects on the outcome of direct interactions among species; - alteration of indirect relationships between species; - influences on the biochemical processes that support all ecosystems; and - changes in the rate and direction of the evolutionary responses of species to each other and to their physical and chemical environments. In relation to transgenic plants a specific concern is that rDNA of transgenic plants may flow into wild relatives and thereby create a weed which may be difficult to control. Hybridisation might transfer new genes to wild plants and introduce traits like herbicide resistance or stress tolerance into existing weeds. A further concern is that transgenic plants themselves become weeds. Landraces, already threatened by replacement by more uniform crop varieties, may increasingly experience introgression of traits from dominating transgenic commercial varieties. A further potential danger of genetically modified plants is their production of toxic secondary metabolites or protein toxins. Concerns about genetically modified micro-organisms include the possibility that the genetic modification might affect their host range, affect their capacity to utilise substrates such as nitrogen or lignin, convert them into pathogens, and/or alter the balance between them and ecologically interrelated populations in the ecosystems. There might be economic risks as well. One of the earlier genetically engineered organisms was a bacteria designed to “eat” and degrade oilspills. While this might be a great tool to control environmental disasters, the concern of oil producing nations on what will happen if these bacteria “escape” into their oil-reserves, is understandable. It is obvious that the potential risks, in particular the possibility of gene flow, depend to a certain degree on the surrounding environment. Concerning gene flow from cultivated species to wild relatives, an important difference between the developing the developed world is that most crops originate from the developing world and many of their closest relatives can be found there as well. Thus, although risks of transgenic crops are generally the same no matter where they are grown, the level of risk associated with a particular crop will vary from country to country. The risks of the release of transgenic crops are potentially higher if more wild or domesticated crop relatives are present. At the moment, the countries with the highest level of risks have the lowest level of regulation. North-South biotechnology tourism In the past, developing countries have urged developed countries again and again not to allow export of chemicals which have been banned for use in the developed countries. But even this demand would not help in the case of transgenic organisms. While pesticides harm people and the environment everywhere, the harm that GMOs can cause depends on the country and its agroecological environment. The risks of releasing genetically engineered maize plants in Europe, for example, may differ considerably from the risks arising if the same maize plants are released in Mexico, the centre of origin of maize. Genetically engineered cold-tolerant potatoes may be approved for commercialisation in the United States if they are shown not to be noxious weeds and if there is no gene flow to wild relatives. By contrast, the presence of many local varieties and sexually compatible wild relatives of potato in Peru (a centre of diversity for potato) means that transgenes are more likely to move from the engineered crop to nearby relatives. Nonetheless it seems to be quite common for researchers and companies from developed countries to go South for field testing. “The most common form of biotechnology investment encountered in Africa”, stated Professor Chetsanga, Pro Vice Chancellor of Biochemistry at the University of Zimbabwe two years ago, “involves biotechnology enterprises in developed countries wanting to come to Africa tocarry out field trials of genetically engineered plants”. The table, which has been taken from the Proceedings of the African Regional Conference for International Cooperation on Safety in Biotechnology, which took place in October 1993 in Harare, lists up 35 releases of transgenic plants conducted between 1989 and 1992 by multinational companies in Latin America. Other reports state that during the last three to four years, over 60 field trials have been conducted in Latin America. For example, the US company Calgene tested its transgenic "Flavr Savr" tomato in Mexico and Chile before it was placed on the US market. Monsanto conducted field trials with genetically engineered soybean plants in Puerto Rico, Costa Rica, Argentina and Belize. Ciba Geigy released transgenic maize, canola and sugarbeet in Argentina. Calgene also conducted an experimental release of insecticide producing cotton plants in South Africa. As can be seen from the graph, most research and field tests in agricultural biotechnology do not deal with what could be considered the pressing problems of developing country agriculture — sustainability, external input reduction, increased access to food, etc. — but tend to concentrate on traits of significance for monocropped industrial production. Until today none of the countries mentioned in Table 1 nor any African country has adopted any binding regulations concerning the release of GMOs. Only some of them have some sort of safety guidelines which, however, are not binding. None of the countries ' authorities have possibilities to effectively control and monitor the releases. Even ardent supporters of biotechnology like Gabrielle J. Persley of the World Bank have described this situation as “less satisfactory” and serious concerns have been raised about the status of regulations in developing countries. A review of regulatory aspects in ten developing countries revealed that only two, the Philippines and India, had some sort of biosafety system in place. The box on the next page, which contrasts the experiences of Argentina and Belgium, offers an example of how the regulatory void in the South can lead to biotechnological colonialism, whereby the territories of developing countries are used to carry out field tests in conditions that would never be allowed in the North. The Need for a Biosafety Protocol The current regulatory imbalance serves no one, except perhaps those who are interested in quick and uncontrolled testing of GMOs. It endangers the human health and the environment in countries abused as testing fields. The UK Royal Commission on Environmental Pollution expressed this concern already in its 1989 Report on the Release of GMOs to the Environment: “If any country allows releases to be carried out without thorough scrutiny, control and monitoring there will be a consequent risk to the environment and to health in that country and more widely.” The recognition of the need for internationally harmonised safety regulations led to the inclusion of Art. 19 (3) in the Biodiversity Convention. According to this provision: The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. In order to facilitate the consideration of the need for and modalities of a biosafety protocol pursuant to Article 19 (3) the Executive Director of UNEP established in 1992 an Expert Panel which was requested to deliver a report on this issue. After reviewing existing international agreements and instruments on biosafety, the majority of the Panel members concluded that no effective international biosafety agreements exists as of yet, and agreed that the purpose of strengthened international cooperation in the field of biotechnology and biosafety is best served by the adoption of a legally binding instrument. During the last governmental meeting on the Convention, held last June in Nairobi, the discussion on the need for a protocol on biodiversity became one of the “hot” issues. A few developed country representatives, led by the US delegation, opposed any action that may lead to a protocol, assuming the industry position that any such action should be based on “sound scientific evidence” and not on what hardline biotechnologists consider “misrepresentations and distortions”. This position contrasted with concerns expressed by Third World country representatives and NGOs about ethical, socioeconomic, safety, and regulatory considerations. Fortunately, the vast majority of delegates, including an unanimous position from Group-77 and China, were of the view that immediate work on a protocol on biosafety should begin. The Conference of the Parties to the convention now has the responsibility and opportunity to take the international lead in creating a save environment for the handling of GMOs, including the following criteria: - that a Protocol on Biosafety under Article 19 (3) of the Convention be set up; - that such a Protocol should cover domestic handling and use of biotechnology as well as inter-state transfer of GMOs; - that such a Protocol should include an Advance Informed Agreement procedure which should apply to all transfers of GMOs; - that the Protocol should also deal with socio-economic impacts biotechnological products may have on developing as well as on industrialised countries; - that in order to ensure international recognition of the safety principles set out in the Protocol, States Party to the Protocol should ban import and export of GMOs or products containing or consisting of GMOs from or to States not Party to the Protocol. In the meantime, as requested by many NGOs and some governments, a moratorium should be declared on any further field testing of GMOs. Sources: Jos Bijman (1994): "Biosafety Regulation", Biotechnology and Development Monitor No. 18, pp. 14 - 15. Christopher J. Chetsanga (1992): "How Africa Can Mobilize International Financing for Biotechnology", Advance Technology Assessment System (ATAS) Issue 9 New York, pp. 102 - 106. Russ Hoyle (1994): "Unfortunately, the Biodiversity Treaty Is Dead", Bio/Technology, Vol.12, pp. 970-1. W.R. Jaffe (1993): "Implementation of Biosafety Regulations: The Experience in Latin America", in: African Regional Conference for International Cooperation on Safety in Biotechnology - Proceedings, pp. 150 - 158. John Komen and Gabrielle Persley (1993):"Agricultural Biotechnology in Developing Countries: A Cross-Country Review", ISNAR Research Report 2, The Hague. OECD (1986): Recombinant DNA Safety Considerations, Paris. Jane Rissler & Margaret Mellon (1993): Perils Amidst the Promise: Ecological Risks of Transgenic Crops in a Global Market, Cambridge MA. Royal Commission on Environmental Pollution, The Release of Genetically Engineered Organisms to the Environment - 13th Report, Cm. 720 July 1989. J.A. Southern/ D.I. Ferreira/ E.J. Morris (1993): " South Africa; Role and Control of Genetically Modified Organisms", in: African Regional Conference for International Cooperation on Safety in Biotechnology - Proceedings, pp. 120 - 126. UNEP/Bio.Div./Panels Inf.4: Report of Panel IV., 1993.