I. INTRODUCTION
1. Agenda 21, adopted at the United Nations Conference on Environment and Development (UNCED) held in Rio de Janeiro in June 1992, in its chapter 16 makes specific provision for the "Environmentally Sound Management of Biotechnology". In the introduction to that chapter it is recognized that, although biotechnology cannot provide solutions to all the fundamental problems of environment and development, it could nevertheless contribute substantially to sustainable development by improvements in food production and feed supply, health care and environmental protection.
2. Chapter 16 of Agenda 21 also recognizes that the community at large can only benefit maximally from biotechnology if it is developed and applied judiciously. It therefore seeks to ensure safety in biotechnology development, application, exchange and transfer through international agreement on principles to be applied on risk assessment and management.
3. The Convention on Biological Diversity also addresses the issue of safety in biotechnology in Articles 8(g) and 19, paragraphs 3 and 4. In Article 8(g) Parties to the Convention are called upon to establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse impacts on the conservation and sustainable use of biological diversity, while in Article 19(3) the Parties are called upon to consider the need for and modalities of a protocol for the safe transfer, handling and use of living modified organisms resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. Article 19 (4) states that each Party is obliged directly, or by requiring any natural or legal person under its jurisdiction providing the organisms referred to in paragraph 19 (3), to provide any available information about the use and safety regulations required by that Party in handling such organisms, as well as any available information on the potential adverse impact of the specific organisms concerned to the Party into which those organisms are to be introduced.
4. In its decision II/5, the second meeting of the Conference of the Parties to the Convention on Biological Diversity, held in Jakarta from 6-17 November 1995, while establishing an open-ended Ad Hoc Working Group to develop a protocol on biosafety, stressed the importance of urgent finalization of the UNEP International Technical Guidelines for Safety in Biotechnology and that these could contribute to the development and implementation of the protocol on without prejudice to its development or conclusion. Furthermore, the Conference of the Parties noted that such International Technical Guidelines may be used as an interim mechanism during the development of the protocol and to complement it after its conclusion for the purposes of facilitating the development of national capacities to assess and manage risks, establish adequate information systems and develop expert human resources in biotechnology.
5. The contribution that the adoption of safe procedures in biotechnology can make to the successful global development of the technology depends on the extent to which international information exchange, cooperation, harmonization, and agreement can be achieved.
6. The development of new techniques of genetic modification in the early 1970s prompted a thorough discussion on safety in biotechnology which resulted in a number of national and international recommendations, guidelines and legislation. By the mid-1980s, it was widely considered that recombinant DNA techniques could be considered as an extension of conventional genetic procedures and that organisms produced by this technology presented risks that were similar in kind to those posed by any other organism. But, while it was also recognized that the potential benefits of biotechnology were greater because of the new molecular techniques which allowed a greater diversity of genes to be introduced into organisms, the relative lack of experience with such organisms nevertheless indicated that it would be appropriate to develop the technology in a precautionary and judicious manner.
7. Modern biotechnology has now been developed and applied since the early 1970s under contained conditions, and since the mid-1980s for applications in the environment. As recognized by decision II/5 of the second meeting of the Conference of the Parties to the Convention on Biological Diversity, although considerable knowledge has accumulated, significant gaps in knowledge have been identified, specifically in the field of interaction between living modified organisms (LMOs) resulting from modern biotechnology and the environment, taking into account the relatively short period of experience with releases of such organisms, the relatively small number of species and traits used, and the lack of experience in the range of environments, specifically those in centres of origin and genetic diversity. Given the rapid development in the use of this technology and taking into account the knowledge and considerable experience gained with certain types and uses of modern biotechnology, international agreement on safety in biotechnology is now opportune.
8. The status and modalities of such international agreement have been the subject of international discussion. One of the issues under consideration then was whether such agreement should take the form of a legally binding instrument (such as a follow-up to Agenda 21 or a protocol to the Convention on Biological Diversity) or whether it should be voluntary in nature (such as a code of conduct, etc.). The Conference of the Parties to the Convention on Biological Diversity, at its second meeting in Jakarta, decided to establish an open-ended Ad Hoc Working Group to develop, in the field of the safe transfer, handling and use of living modified organisms, a protocol on biosafety, specifically focusing on transboundary movement, of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedure for advance informed agreement. The negotiation process may take several years to conclude the protocol. Furthermore, upon a binding agreement being adopted, a number of countries and intergovernmental, private-sector and other organizations will need technical guidance of the kind contained in these Guidelines to fulfill their commitments under such an international agreement. These technical Guidelines are intended to provide a common framework for safety in biotechnology at national, regional and international levels, without prejudice, but as a complement, to the development of a biosafety protocol. The Conference of Parties, therefore, stressed the urgent need for rapid finalization of the UNEP International Technical Guidelines for Safety in Biotechnology which may be used as an interim mechanism during the development and implementation of a protocol and to complement it after its conclusion (see paragraph 4 above).
9. The Guidelines have been developed on the basis of common elements and principles derived from relevant national, regional and international instruments, regulations and guidelines, and drawing upon experience already gained through their preparation and implementation. The sources taken into consideration are listed in Annex 1.
10. The Guidelines are based on the premise that adequate mechanisms for risk assessment and risk management and capacity-building through - among others the exchange of information and the use of these Guidelines at national, regional and international levels can contribute significantly to safety in biotechnology.
11. The Guidelines address the human health and environmental safety of all types of applications of biotechnology, from research and development to commercialization of biotechnological products containing or consisting of organisms with novel trait(s). They recognize that before such biotechnological products are placed on the market, they must comply with any specific product requirements, such as food safety, efficacy and quality, but these are not addressed in the Guidelines.
12. The Guidelines can be implemented by using existing structures and measures, or by introducing new ones.
13. To be credible, safety mechanisms need to be based on up-to-date knowledge.
14. Adequate safety mechanisms and international agreement on safety in biotechnology can contribute to the sustainable development of biotechnology and to the international trade in biotechnological products.
15. The adoption of guidelines does not in itself ensure safety. Rather, the guidelines propose mechanisms for evaluating biosafety, identifying measures to manage foreseeable risks and to facilitate processes such as monitoring, research and information exchange, all of which improve the safe application of biotechnology.
16. These technical Guidelines acknowledge the importance of assessing the socioeconomic and other impacts of new biotechnologies, but they do not address such issues, which are often considered within the particular national or regional context.
17. Complying with these Guidelines does not override obligations required under existing national, regional or international legal systems.