International Transfer of GMOs The Need for a Biosafety Protocol Presented on the occasion of the 2nd Session of the Intergovernmental Committee on the Convention on Biological Diversity Nairobi, 20 June - 1 July 1994 by CEAT Clearinghouse on Biotechnology European Coordination Friends of the Earth & Genetic Resources Action International GRAIN Summary Whereas by now most industrialized 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. 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. These, and other, examples show that there is a clear need for a binding regulatory mechanism to rule the testing, release and trade of genetically modified organisms (GMOs). This paper, drawn up by the CEAT Clearinghouse on Biotechnology and Genetic Resources Action International is meant to provide a background for discussion. It discussed the risks of genetically modified organisms, the risks of an uncontrolled North-South transfer of such organisms, and the need for a legally binding biosafety protocol under the Convention on Biological Diversity. Recommendations CEAT Clearinghouse on Biotechnology and Genetic Resources Action International urge the governments present at the Second Intergovernmental Meeting on the Biodiversity Convention, to recommend to the Conference of the Parties: - 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 industrialized 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. Introduction Since the mid 1980s most industrialized countries have in place certain regulations concerning the safe handling and use of genetically engineered organisms. Some states like the US simply adapted their regulatory framework by adjusting it to the special risks linked with the new DNA recombinant 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. Thus, as is the case with many other dangerous or risky substances and technologies, there is a regulatory imbalance between developing and developed countries. 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. In order to avoid biotechnological tourism GRAIN and CEAT Clearinghouse on Biotechnology call for a Biosafety Protocol under the Convention on Biological Diversity, Article 19 (3). 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 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. Hybridization 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. Since landraces are threatened of being replaced by more uniform transgenic crop varieties, the genomes of landraces may increasingly experience introgression of traits from the dominating commercial varieties. A further potential danger of genetically modified plants is that the plants may produce a toxic secondary metabolite or protein toxin. Finally, plants engineered to contain virus particles can facilitate the creation of new viruses. This has been shown very recently by two US researchers who reported in the journal Science that pieces of virus that have been inserted through genetic engineering can combine with a newly introduced virus to make a new virus. The two researchers showed that this process occurred in 4 of 125 plants they tested, a rate of genetic recombination much higher than has been previously reported (Allison Greene 1994). 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. Their might be economic risks as well. One of the earlier genetically engineered organisms was a bacteria designed to "eat" and degrade oilspils. 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 (Visser 1993). 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 (Rissler & Mellon 1993). 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 agro-ecological 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 country of origin of maize. Mellon & Rissler give another example: Engineered cold-tolerant potatoes may be approved for commercialization 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 center of diversity for potato) means that transgenes are 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 to carry out field trials of genetically engineered plants"(Chetsanga, 1992). Table 1, which has been taken from the Proceedings of the African Regional Conference for International Cooperation on Safety in Biotechnology (Jaffe 1993), 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 (Bijman 1994). 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 (BXNTM) producing cotton plants in South Africa (Southern et al. 1993). 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 (World Bank) have described this situation as "less satisfactory" (Persley 1990) and serious concerns have been raised about the status of regulations in developing countries (Cohen et al. 1988). 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 who as a consequence are 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." (Royal Commission 1989) The recognition of the need for internationally harmonized 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. The report of Panel IV was adopted by the members of the panel at its third session held in Montréal, Canada, from 17 to 23 March 1993, (UNEP/Bio.Div./Panels/Inf.4) and was on the agenda of the first session of the ICCBD in Geneva. 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. The report gives a whole series of arguments for such a protocol. WHY A PROTOCOL? In favour of a Biosafety Protocol under the CBD the majority of Panel IV put forward inter alia the following arguments: The Convention on Biological Diversity The Parties to the negotiations of the Convention contemplated a protocol by including Article 19 (3). Follow-up to UNCED A protocol on biosafety could also be seen as a proper follow-up to the recommendations in Agenda 21 Chapter 16 D. At UNCED, Governments and NGOs called for a legally binding instrument on biosafety. Also, this will be in line with the Rio Principle 12 on international trade. New developments New development within the field of biotechnology are constantly occurring. Using the precautionary approach, the developing countries could be protected from being experimental grounds for these development. Existing legislation Legislation already exists in industrialized countries and is also needed in developing countries. International cooperation could be governed by a protocol, facilitate cooperation and avoid unilateral decisions. Common framework A protocol is more precise than guidelines and will help to provide a common framework and uniform requirements for the exchange of information. Importers and exporters A legally binding instrument will force importers and exporters to recognize their responsibilities in relation to biological diversity. Environmental concern A protocol is essential to protect the environment and address environmental concerns. Countries arguing that there is no risk in transfers have themselves had legally binding rules on biosafety for a long time and followed those rules. This could be a reason for the fact that no risks have been observed. Transboundary environmental effects Because of the ability of organisms to cross national boundaries, biotechnology may have a significant adverse transboundary effect. By harmonizing national regulations a protocol on biosafety should ensure that biotechnological activities carried out under the jurisdiction of a state do not cause damage to the environment of other states. Apart from recommending a protocol on biosafety, the majority of Panel IV recommended the establishment of an Advance Informed Agreement (AIA) procedure covering all international transfers of genetically engineered organisms destined to be released or to be used in large scale production in the country of import. The Panel's majority understood the AIA procedure as to be "substantially identical with the prior informed consent (PIC) procedure" as foreseen by the UNEP London Guidelines and the FAO Pesticides Code. PIC refers to the principle that international shipment of a chemical/ pesticide that is banned or severely restricted in order to protect human health or the environment should not proceed without the agreement, where such agreement exists, or contrary to the decision of the designated national authority in the importing country. The Panel proposed a detailed set of information to be given prior to the export to importing countries (See Annex IV of Report of Panel IV, UNEP/Bio.Div./Panels Inf.4). The requirements include information on the GMO, prior releases, safety regulations of the exporting country, potential risks and socio-economic implications. Panel VI went as far as it could. It is now up to the governments to turn these constructive recommendations into action. There are still a number of governments arguing that biosafety concerns are better dealt with in other fora. However, as we show in Box 2, the "other fora" either produced incomplete and voluntary guidelines, or have dropped their work in this area all together with the recommendation that those negotiating the Convention should take it up. It is high time they do so. The Convention is the Right Forum for the Issue of Biosafety While it is true that a number of international organisations have done work on the issue of biosafety, none of these initiatives have resulted in a comprehensive framework. Unfortunately they proposed only vague recommendations or codes of conduct and most of them did not address the issue of transfer at all. The UNIDO Secretariat proposed a Voluntary Code of Conduct for the Release of Organisms into the Environment. The Code which was finalised in July 1991 fails to address the issue of transfer of GMOs. Only the first version of the code, titled "Draft for a Voluntary International 'Code of Conduct' for Biosafety", included a short provision stating, that there should be no attempt to introduce into another country products that have been refused licence in their country of origin for clearly stated reasons. Even this half-hearted provision was kicked out when it came to the final version. In contrast to the UNIDO Code the preliminary draft Code of Conduct for Biotechnology drafted by the Commission on Plant Genetic Resources on request of the FAO Council (CPGR/93/9) includes more concrete safety regulations, including those relating to transfer. It also calls for an Advance Informed Agreement mechanism. However, it is unlikely that the Commission on Plant Genetic Resources will continue its work on this issue. At its last meeting (June 1993) the Commission recommended that, in order to avoid duplication and inconsistencies, the "biosafety and other environmental concerns component of the preliminary draft Code would constitute an input to the work of the IGC/ CBD on this matter"(FAO CL 103/16 June 1993). Thus, the governments meeting at FAO, explicitly left the matter to be dealt with in the context of the Convention, a task that should now be taken up by the same governments meeting on the Biodiversity Convention. References: * 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. * J.I. Cohen/ K. Jones/ D.L. Plucknett/ N.J. Smith (1988) Bio/Technology Vol. 6, p. 744. * Ann E. Greene & Richard F. Allison Greene (1994): Recombination Between Viral RNA and Transgenic Plant Transcripts, Science Vol. 263 pp. 1423 - 1426. * 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. * OECD (1986): Recombinant DNA Safety Considerations, Paris. * Gabrielle J. Persley (1990): Beyond Mendel's Garden: Biotechnology in the Service of World Agriculture, Biotechnology in Agriculture Series No. 1, Oxon (UK). * 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. * B. Visser (1993): Safety Considerations with Agricultural Applications: Specific Implications for African regional Centres of Diversity, in: African Regional Conference for International Cooperation on Safety in Biotechnology - Proceedings, pp. 31 - 43.