. Consideration of the need for and modalities of a protocol for the safe transfer, handling and use of living modified organisms

CONSIDERATION OF THE NEED FOR AND MODALITIES OF A PROTOCOL FOR THE SAFE TRANSFER, HANDLING AND USE OF LIVING MODIFIED ORGANISMS

The Conference of the Parties,

Recalling Article 19, paragraph 3, of the Convention on Biological Diversity,

Recognizing the link between paragraphs 3 and 4 of Article 19,

Recognizing also the link between Articles 8(g) and 19, paragraph 3,

Recalling its decision I/9 made at its first meeting, held in Nassau, Bahamas, from 28 November to 9 December 1994,

Having considered the report and recommendations prepared for its second meeting by the Open-ended Ad Hoc Group of Experts on Biosafety, which met in Madrid from 24-28 July 1995,

Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health,

Recognizing also that, 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,

Noting that there is a need for further analysis of existing national, regional and international regulations and legally binding instruments of relevance to the impact of LMOs on the conservation and sustainable use of biological diversity,

Affirming that international action on biosafety should offer an efficient and effective framework for the development of international cooperation aimed at ensuring safety in biotechnology through effective risk assessment and risk management for the transfer, handling and use of any LMO resulting from modern biotechnology that may have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking into account the risks to human health, and taking also into account Articles 8(g) and 19, paragraph 4, of the Convention,

Considering that, although there are existing international agreements of relevance to the impact of LMOs resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, none of these specifically address the transboundary movements of such LMOs, and therefore there is an urgent need to give attention to this issue,

Taking into account that the large majority of delegations present at the meeting of the Open-ended Ad Hoc Group of Experts on Biosafety favoured the development, within the context of an international framework for safety in biotechnology, of a protocol on biosafety under the Convention on Biological Diversity,

Stressing the importance of the urgent finalization of the United Nations Environment Programme International Technical Guidelines on Safety in Biotechnology and that this could contribute to the development and implementation of a protocol on biosafety, but noting that this does not prejudice the development and conclusion of such a protocol,

Noting that guidelines on biosafety, including the proposed United Nations Environment Programme International Technical Guidelines on Safety in Biotechnology, may be used as an interim mechanism during the development of the protocol and to complement it after its completion, 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,

1. Decides to seek solution to the above-mentioned concerns through 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 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;

2. Decides to establish an Open-ended Ad Hoc Working Group under the Conference of the Parties which shall operate in accordance with the terms of reference in the annex to this decision;

3. Requests the Executive Secretary of the Convention to make the necessary arrangements for the Open-ended Ad Hoc Working Group to meet as soon as possible, at least once before the next meeting of the Conference of the Parties.

Annex to decision II/5

TERMS OF REFERENCE FOR THE OPEN-ENDED AD HOC WORKING GROUP

1. The Open-ended Ad Hoc Working Group should be composed of representatives, including experts, nominated by Governments and regional economic integration organizations.

2. The Open-ended Ad hoc Working Group shall, in accordance with operative paragraph 1 of the present decision:

(a) elaborate, as a priority, the modalities and elements of a protocol based on appropriate elements from Sections I, II and III, paragraph 18 (a), of Annex I of the report of the Open-ended Ad Hoc Group of Experts on Biosafety;

(b) consider the inclusion of the elements from Section III, paragraph 18 (b), and other elements, as appropriate;

3. The development of the draft protocol shall, as a priority:

(a) elaborate the key concepts and terms that are to be addressed in the process;

include consideration of the form and scope of advance informed agreement procedures;

identify relevant categories of LMOs resulting from modern biotechnology.

4. The protocol will have to reflect that its effective functioning requires that Parties establish or maintain national measures, but the absence of such national measures should not prejudice the development, implementation and scope of the protocol.

5. The protocol will take into account the principles enshrined in the Rio Declaration on Environment and Development and, in particular, the precautionary approach contained in Principle 15 and will:

(a) not exceed the scope of the Convention;

(b) not override or duplicate any other international legal instrument in this area;

(c) provide for a review mechanism;

(d) be efficient and effective and seek to minimize unnecessary negative impacts on biotechnology research and development and not to hinder unduly access to and transfer of technology.

6. The provisions of the Convention will apply to the protocol.

7. The process will take into full account the gaps in the existing legal framework identified through analysis of existing national and international legislation.

8. The process shall be guided by the need for all Parties to cooperate in good faith and to participate fully, with a view to the largest possible number of Parties to the Convention ratifying the protocol.

9. The process will be carried out on the basis of the best available scientific knowledge and experience, as well as other relevant information.

10. The process of developing a protocol should be conducted as a matter of urgency by an open-ended ad hoc group, which will report on progress to each subsequent meeting of the Conference of the Parties. The Open-ended Ad Hoc Working Group should endeavour to complete its work in 1998.