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BIOSAFETY UNDER THE BIODIVERSITY CONVENTION

The Convention on Biological Diversity (CBD), which was negotiated under the auspices of the United Nations Environment Programme (UNEP), was adopted in May 1992 and was opened for signature at the Earth Summit in Brazil on 5 June 1992. It entered into force on 29 December 1993. As of 23 April 1997, 168 countries had become Parties to the Convention.

Article 19.4 of the Convention provides for Parties to consider the need for and modalities of a protocol, including advance informed agreement (AIA) in particular, to ensure the safe transfer, handling and use of living modified organisms derived from modern biotechnology that may have an adverse effect on biological diversity and its components.

The first Conference of the Parties to the CBD, which was held from 28 November - 9 December 1994, established an Open-ended Ad Hoc Group of Experts on Biosafety. This Group met in Madrid from 24-28 July 1995. According to the report of the meeting (UNEP/CBD/COP.2/7), most delegations favored the development of an international framework on biosafety under the Convention. The proposed elements of such a framework, as drafted in Madrid, are divided into two categories — those favored unanimously and those favored by a subset of delegates representing primarily developing countries. In the annex to the report, paragraph 18(a) lists the former elements, which include: all activities related to LMOs that may have adverse effects on biodiversity; transboundary movement of LMOs, including unintended movement; release of LMOs in centres of origin/genetic diversity; mechanisms for risk assessment and management (RAM); procedures for advance informed agreement; facilitated information exchange; capacity-building; and implementation and definition of terms. Paragraph 18(b) lists the latter elements, including: socio-economic considerations; liability and compensation; and financial issues.

In another meeting relevant to the biosafety process, the UNEP Panel of Experts on International Technical Guidelines for Biosafety met in Cairo, Egypt, from 11-14 December 1995 to adopt a set of international technical guidelines for biosafety (UNEP Guidelines). The UNEP Guidelines (UNEP/Global Consultations/Biosafety/4) are intended to provide a technical framework for risk management commensurate with risk assessment, without prejudice to the development of a biosafety protocol by the COP of the CBD.

At COP-2, which took place in Jakarta, Indonesia, from 6-17 November 1995, delegates met to consider the need for and modalities of a protocol on biosafety. From the outset it was clear that delegates intended to set in motion a negotiation process to develop a protocol on biosafety. While developed country delegations wanted to focus on “transboundary transfer of any LMO”, developing countries preferred a “protocol on biosafety in the field of the safe transfer, handling and use of LMOs.” The compromise language that was adopted by the COP calls for “a negotiation process 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 LMO that may have an adverse effect on biological diversity, setting out appropriate procedures for advance informed agreement.”

The decision also established an Open-ended Ad Hoc Working Group on Biosafety (BSWG) to meet to “elaborate, as a priority, the modalities and elements of a protocol based on appropriate elements from paragraph 18(a)” of the report of the Madrid meeting, and to “consider the inclusion of the elements from paragraph 18(b) as appropriate.” Other terms of reference for the BSWG (UNEP/CBD/BSWG/1/2) state that the Working Group shall: elaborate key terms and concepts; consider AIA procedures; identify relevant categories of LMOs; and develop a protocol whose effective functioning requires that Parties establish national measures and that takes into account the precautionary principle. The Working Group shall also: develop a protocol that provides for a review mechanism and seeks to minimize unnecessary negative impacts on biotechnology and does not hinder unduly access to and transfer of technology; take into account gaps in the existing legal framework; develop a protocol with a view to the largest possible number of ratifications; and use the best available scientific information.

BSWG-1, which was held in Aarhus, Denmark, from 22-26 July 1996, began the elaboration of a global protocol on safety in biotechnology. Although the meeting produced little in the way of written results, it represented a forum for defining issues and articulating positions characteristic of the pre-negotiation process. The meeting revealed several interesting dichotomies, including a fracture in the G-77/China bloc over elements to be included in the protocol, as well as strikingly divergent perspectives on biotechnology. Nonetheless, governments listed elements for a future protocol, agreed to hold two meetings in 1997 and outlined the information required to guide their future work.

By adopting decisions III/5 (additional guidelines to financial mechanisms) and III/20 (biosafety issues), COP-3 affirmed its support for a two-track approach through which the promotion of the application of the UNEP International Technical Guidelines for Safety in Biotechnology can contribute to the development and implementation of a protocol on biosafety, without prejudicing the development and conclusion of such a protocol, and endorsed recommendation II/5 of SBSTTA-2 with regard to capacity-building in biosafety.

An International Workshop to Follow-up on the UNEP International Technical Guidelines for Safety in Biotechnology was held in Buenos Aires on 31 October - 1 November 1996.

The nineteenth meeting of the UNEP Governing Council, held from 27 January – 7 February 1997 in Nairobi, adopted decision 19/16 on biosafety. The decision urges governments and subregional and regional organizations to promote the implementation of the Guidelines by designating focal points in countries to apply the Guidelines, and urges governments to promote safety in biotechnology by contributing relevant information to UNEP’s International Register on Biosafety. The Governing Council also requested the Executive Director to: continue to promote the implementation of the UNEP International Technical Guidelines for Safety in Biotechnology, particularly in developing countries; explore with other UN and international bodies the mutual sharing of information about organisms with novel traits; and organize within two years a second international workshop on the state of the art of the implementation of the Guidelines.

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