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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 1 July 1996, 152 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 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.
MADRID MEETING: 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 (AIA); facilitated information exchange; capacity building; and implementation and definition of terms. Paragraph 18(b) lists the latter elements, including: socioeconomic considerations; liability and compensation; and financial issues.
UNEP GUIDELINES: 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 under the aegis of UNEP (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.
COP-2: At the second meeting of the Conference of the Parties to the CBD (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 Northern delegations wanted to focus on “transboundary transfer of any LMO”, Southern delegations 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 advanced 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 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;
- develop a protocol whose effective functioning requires that Parties establish national measures and that takes into account the precautionary principle;
- 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.