BRIEFING NOTE ON THE INFORMAL CONSULTATIONS REGARDING THE RESUMED SESSION OF THE EXTRAORDINARY MEETING OF THE CONFERENCE OF THE PARTIES FOR THE ADOPTION OF THE PROTOCOL ON BIOSAFETY TO THE CONVENTION ON BIOLOGICAL DIVERSITY:

15-19 SEPTEMBER 1999

The Informal Consultations regarding the Resumed Session of the Extraordinary Meeting Of The Conference of the Parties (ExCOP) for the Adoption of the Protocol on Biosafety to the Convention on Biological Diversity met in Vienna, Austria, from Wednesday, 15 September to Sunday, 19 September 1999. Approximately 300 representatives from over 115 governments and 70 representatives from intergovernmental, nongovernmental and industry organizations attended. The first two days of the meeting were devoted to consultations within negotiating groups; the third day was for informal exchanges between groups; and the final two days were devoted to resolving differences between groups on pending core issues. This briefing note covers only the final two days of consultations. During the final two days of discussions, negotiating groups addressed the issues of commodities, the protocol's relationship with other international agreements, the protocol's scope and application of the advance informed agreement procedure. Negotiating groups agreed on a basic set of concepts for commodities and relations with other international agreements, while acknowledging that the central differences on those and other issues remain. The results will be forwarded as a President's Summary to the resumed session of the ExCOP, currently scheduled for 20-28 January 2000.

A BRIEF HISTORY OF THE BIOSAFETY PROTOCOL

The Convention on Biological Diversity (CBD), negotiated under UNEP's auspices, was adopted on 22 May 1992 and entered into force on 29 December 1993. Article 19.3 of the CBD provides for Parties to

consider the need for and modalities of a protocol setting out procedures in the field of the safe transfer, handling and use of living modified organisms (LMOs) that may have an adverse effect on biodiversity and its components. The first Conference of the Parties (COP-1) to the CBD, held in Nassau, the Bahamas, from 28 November - 9 December 1994, established an Open-ended Ad Hoc Group of Experts on Biosafety, which met in Madrid from 24-28 July 1995. This meeting's report (UNEP/CBD/COP.2/7) noted that most delegations favored the development of an international framework on biosafety under the CBD, and listed elements with unanimous and partial support. At COP-2 in Jakarta, Indonesia, in November 1995, delegates considered the need for and modalities of a protocol on biosafety, and adopted compromise language (Decision II/5) calling 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." COP-2 also established an Open-ended Ad Hoc Working Group on Biosafety (BSWG) to elaborate the protocol

based on elements from the Madrid report. The BSWG met six times between July 1996 and February 1999, where it developed draft text for a protocol on biosafety.

The sixth and final session of the BSWG, in Cartagena de Indias, Colombia held 14-22 February 1999, was followed by the first Extraordinary Meeting of the Conference of the Parties to the Convention on Biological Diversity, held from 22-23 February 1999. Despite ten days of intense negotiations, delegates were not able to agree on a protocol. The main areas of contention centered on trade issues, treatment of commodities and domestic vs. international regulatory regimes. The ExCOP adopted a decision to suspend the meeting and request the ExCOP President, Juan Mayr, Environment Minister of Colombia, and the COP-4 Bureau to decide when and where the session would resume. The COP Bureau met in Geneva on 25 May 1999, and agreed that a consultation with the major negotiating groups formed under the BSWG would take place around the Fourth meeting of the CBD's Subsidiary Body for Scientific, Technical and Technological Advice and the First Intersessional meeting on the Operations of the Convention, held in Montreal from 21-30 June 1999. On 1 July 1999, the spokespersons for the groups met with President Mayr. The major groups include: the Central and Eastern European countries; the Compromise Group (Japan, Mexico, Norway, South Korea and Switzerland); the European Union; the Like-minded Group (the majority of developing countries); and the Miami Group (Argentina, Australia, Canada, Chile, the United States and Uruguay). At the meeting the groups expressed their political will to finalize negotiations, and it was agreed to hold this series of informal consultations prior to resuming the ExCOP.

REPORT OF THE INFORMAL CONSULTATIONS

ExCOP President, Juan Mayr, opened the informal consultations among the five groups, expressing appreciation to Austria, Canada, the Central African Republic, Denmark, the European Community, Finland, France, Kenya, Namibia, Norway, Sweden and the United Kingdom for their financial support of the meeting. He reviewed the results of a consultation, held on 1 July 1999 in Montreal, with the spokespersons of all the major groups, where all expressed their commitment to successfully completing a protocol. He stated that the task at hand was to clarify positions and identify solutions, focusing only on areas of disagreement. The consultation would strive to develop mutually agreed concepts, not drafting text, for consideration by the resumed ExCOP.

He explained that the meeting's format would continue in the same format as the final discussions at the ExCOP in Cartagena, where each of the five groups designated two spokespersons. Designated spokespersons for the informal consultations included: Central and Eastern Europe (CEE) – Gábor Nechay (Hungary) and Andrey Ivanov (Russian Federation); the Compromise Group – Beat Nobs (Switzerland) and Peter Schei (Norway); European Union (EU) – Christoph Bail (European Community) and Carl Arne Hartman (Finland); the Like-minded Group – Tewolde Berhan Gebre Eghziabher (Ethiopia); and the Miami Group – Richard Ballhorn (Canada) and Ricardo Ernesto Lagorio (Argentina).

Hamdallah Zedan, Executive Secretary of the CBD, welcomed participants and thanked the United Nations Office of Vienna for hosting the meeting.

President Mayr then requested the spokespersons to provide a brief overview of their group discussions over the past three days. The EU noted the efforts made in Cartagena stating that time may have been insufficient or that conditions were not yet ready for compromise. He said that new ideas were being generated on including commodities in the protocol and the protocol's relation to other international agreements. The CEE stated that the final discussions in Cartagena revealed packages with clear flexibility, and that a fresh approach could be constructive. The Miami Group noted that discussion in Cartagena had moved from bracketing options to the actual issues, and mentioned commodities and documentation as issues for further work. The Compromise Group highlighted their efforts to develop tenable and equitable solutions and recalled the obligations for sustainable development agreed upon in Rio. The Like-minded Group noted its representation of the overwhelming majority of the world's population. He stressed the importance of commodities, both food and seed, for the survival of its peoples.

COMMODITIES: President Mayr raised commodities as the first agenda item, and asked the groups to present their position and any proposals. The EU noted that inclusion of commodities under the protocol was the most problematic issue, noting concerns of both exporting industries and developing countries. He stressed the importance of the links between commodities, risk assessment and the precautionary approach; information sharing; and the needs of importing countries. The Miami Group noted its inclusion of three developed and three developing countries and stressed an overall concern for harmonizing environmental protection with sustainable growth of agricultural economies. He stated the question is not zero-sum and that the negotiations need to develop a cooperative solution between environment and trade. The Compromise Group noted four primary concepts for addressing commodities within the protocol, including: information sharing and notification; identification as a means to monitor LMO movements; the right for a Party to make reasoned decisions on LMO imports; and respect for countries' differing capacities to respond to notifications and information. The CEE stated that commodities were the most important item on the agenda, noting a rise in public concern and the potential for segregating LMO and non-LMO commodities. He supported further work on the possibility of a simplified advanced informed agreement (AIA) procedure for commodities. The Like-minded Group stressed the central importance of applying the precautionary principle to commodities and the need for further precision on information and capacity-building. He stated that sustainable development in the national context needs to be compatible with the sustainable growth of other countries. Finally, he noted that a system differentiating between commodities and non-commercial LMOs might work, but legal obligations are necessary.

From such statements, President Mayr proposed four areas of agreement: the need to account for the concerns of importers and exporters, inclusion of commodities in the protocol, availability of information including notification, and needs-driven capacity-building for implementation. The Miami Group stated that commodities could be considered under the protocol, but the key question is how they relate to the AIA procedure. The Like-minded Group stated that the AIA procedure is the fundamental starting point for the agreement. The Compromise Group proposed including identification, as related to labeling, segregation of commodities and decisions by the importer. The Miami Group suggested using the term documentation, which the EU and CEE supported. The Like-minded Group noted that both documentation and identification are important, and the key to both is content. The Miami Group asked where the boundary between the AIA procedure and national regulatory systems lay.

President Mayr also solicited feedback on the importing Party's right to take, maintain and implement decisions on the movement of LMOs into its territory. The Like-minded Group stated that the right to take decisions is essential, especially regarding decisions outside the scope of AIA. He stressed that a robust AIA system and recognition by both importer and exporter is crucial for maintaining decisions, which may be challenged by other international agreements. The EU supported the right to take decisions with appropriate information, such as scientific risk assessments, and the possibility for reviewing decisions as delineated in Articles 8 (Decision Procedure), 9 (Review of decisions) and 10 (Simplified procedure). He stressed that there has been no dispute over the right to take decisions, although there has been no discussion on cooperation with the exporter to implement a decision. The Miami Group noted that Article 5 (Application of the AIA) includes the right to take a decision consistent with the AIA and based on scientific input. He noted that every country has the right to regulate, but the problem lies with adequate enforcement.

The Compromise Group affirmed the right to decide and noted the focus on applying the AIA procedure to commodities. He distributed a draft framework listing the general concepts of the existing AIA procedure in Articles 6 through 9 and possible alternative concepts for LMOs for food, feed and processing (LMO-FFPs). Under the alternative concepts for LMO-FFPs on Article 6 (Notification), Parties are obligated to notify the biosafety clearing-house and national focal points of domestic approval for large-scale releases of LMOs, including relevant information. On Article 7 (Acknowledgement of receipt of notification), Parties have the right to require additional information, indicate needs for assistance and cooperation and provide information on domestic legal or administrative measures related to the import of LMO-FFPs. On Article 8, the importing Party has the right to take a decision based on legitimate concerns, such as the precautionary approach and risk assessments. The proposal listed Article 9 (Review of decisions), but had not developed a corresponding concept for LMO-FFPs. The proposal also flagged two additional concepts for discussion on documentation requirements for LMO-FFPs and cooperation in capacity-building.

In response, the EU inquired about countries that have no approval systems for releases, the time-frame for acknowledgement of receipt and further detail on assistance and cooperation. The Miami Group asked about the time-frame for notification after approvals; the need to include a mechanism to ensure receipt of information; and the basis for decisions by the importing Party. He suggested adding the right to review decisions based on new scientific information, and addressing the capacity building issue under Article 19 (Capacity-building). Finally, he noted that such conceptual work on the AIA was provisional, as there are still issues to be resolved in those articles. The Like-minded Group stressed that such an alternative system should be as robust as the existing AIA system, and that gaps need to be closed when moving from general concepts to specific language. The CEE suggested changing language on large-scale releases under notification to reflect commercial activity of any scale.

Based on these suggestions, the Compromise Group re-drafted the proposal with participation by different groups, presented the results on the morning of Sunday, 19 September. New elements in the revised draft included: a time-frame for notification of domestic approval for commercial LMO releases; national mechanisms to respond to notifications and requests for information and assistance; a provision for the review of decisions; and a new element on illegal traffic. The CEE expressed its general support for the formulation. The Miami Group suggested further work on the time-frame for notification of approvals, specific information to be provided, delineation of responsibility for information provision and review of decisions based on new scientific information. He also expressed concern over basing an importer's decision on "legitimate concern," which should instead be risk assessments using sound science. He noted that a reference to a paragraph embodying the precautionary principle in Article 8 would be the first operationalization of it in an environmental agreement. Given the potential implications of such language, he stressed the need to maintain a provision maintaining consistency with rights and obligations under other existing international agreements.

The Like-minded Group supported the concern over cross-referencing articles that have not been finalized and presumed that the proposal was conditional on their successful conclusion. He also expressed concern that a reference to Article 23 (Illegal transboundary movements) might not be sufficient to address lost or unauthorized shipments, and noted that consideration of illegal traffic may require more proactive work by the Party of export. He affirmed the need to use the AIA as a departure point and asserted that the proposal for LMO-FFPs should provide a sufficient substitute. The EU suggested including a time-frame for providing information and assistance, as well as for responses and decisions. He noted the need to examine documentation requirements, and noted Article 23's current sufficiency regarding illegal traffic. The Compromise Group inquired about the operationalization of the precautionary approach in the World Trade Organization's (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS). The Miami Group responded that the SPS is not an environmental agreement, and that further discussion is needed on applying the precautionary approach in the environmental arena.

After a break, the Miami Group made a statement clarifying its overall position, which, inter alia: suggested that national regulatory frameworks are the only effective way to address the range of views on commodities; recognized the need for countries to take action to protect their environment; recognized the need for more information for national regulatory systems; noted that broad obligations cannot be undertaken regarding the movement of agricultural commodities; and recognized the need to clearly delineate the responsibilities of importing and exporting Parties, as well as commercial actors, in decision procedures for commodities. The EU supported the need to clarify the balance and responsibilities between the obligations of the protocol at the international level and the role of national legal systems. The Like-minded Group expressed concern that the Miami Group's position would not subject commodities to a full or equivalent AIA, and stressed that provision of information is not sufficient. He stated that seed for planting and seed for consumption have identical impacts, thereby requiring an AIA procedure for commodities.

A small working group reviewed the draft framework on governing transboundary movements of LMO-FFPs to address areas of conflict. The working group chair noted new revisions. The concept on notification specifies that a Party notify  the biosafety clearing-house and national focal points of domestic approvals for placing LMOs on the market within ten days, which should include relevant and accurate information. On acknowledgement of notification, Parties may require additional information, indicate needs for assistance and cooperation and refer to applicable domestic legal and administrative measures. The responsibility to reply in a timely fashion still needs to be clarified. On the decision-making rights of importing Parties, a Party of import may take a decision with respect to imports under the protocol based on concepts addressed in Article 8 (which remain to be determined). The chair noted that "under the protocol" was in conceptual brackets, given concern over countries that may not have regulatory decision-making processes in place. On review of decisions, Parties may review decisions in light of new scientific information addressed in Article 9. Finally, the paper notes three areas still to be discussed in the context of other articles, including: adequate and differentiated document requirements for LMO-FFPs as related to Article 15 (Handling, transport, packaging and identification); cooperation in capacity-building as related to Article 19; and illegal traffic and the need for cooperation as related to Article 23.

Noting the formulation's contingency on resolving the contents of Article 8, concern over the existing brackets and the need for more discussion, President Mayr closed the discussion.

RELATIONSHIP WITH OTHER AGREEMENTS: President Mayr asked the groups about their positions on Article 31 (Relationship with other international agreements) as related to the discussion on commodities and how their views have progressed since Cartagena. The Like-minded Group stated that it had not had enough time to develop a firm position. He noted that superiority or subordinancy of the protocol to other agreements could be detrimental, and stressed the need to find a middle ground where environmental protection is secured. The CEE stated that the current formulation of Article 31 undermines the protocol by subordinating it to other agreements, and that it should not be included in the operative section. He also suggested looking at how agreements on hazardous materials have addressed the issue. The Miami Group stressed the need to harmonize environment and trade agreements, noting that trade is tantamount to growth and sustainable development. He stated that the protocol needs a savings clause acknowledging rights and obligations under existing international agreements and that the protocol has to be consistent with such agreements without necessarily being inferior or superior. He stressed the need to prevent the introduction of artificial trade barriers to non-harmful LMOs, while also not allowing trade to harm the environment. The Compromise Group stressed that these negotiations should concentrate on environmental questions, as the WTO can take care of itself. He noted that the relevance of such protocols will arise at the WTO ministerial meeting in Seattle and that it is important that environmental conventions project their voice into the upcoming round of trade negotiations. The EU noted the need to define the rights and duties of importing countries in a manner consistent with other agreements and with no unjustifiable discrimination between imported and domestic LMOs. He stated that a conflict between an exporter and importer over a decision based on a risk assessment would most likely arise in the context of the WTO. He stressed that the importer needs to be able base the decision on the protocol's obligations, keeping in mind the WTO's exception for environmental issues.

In the ensuing discussion on concepts, groups debated the conceptual use of specific terms, including "consistency," "non-hierarchical relations" and "mutual supportiveness." The EU noted that maintaining consistency with other agreements establishes an implicit hierarchy.  The Like-minded Group noted the need for flexibility in breaking new ground in environmental protection, which the term consistency challenges. The Compromise Group supported consistency and mutual supportiveness, and the Miami Group supported consistency along with mutual supportiveness and a non-hierarchical structure. The discussion concluded with agreement on two general concepts: the main purpose of these negotiations is biosafety, and there are other relevant agreements for sustainable development with rights and obligations.

On Sunday, discussion on relations with other international agreements continued. The Like-minded Group again stressed the importance of not being constrained by being "consistent" with existing international law, given the need to address new problems. He stated that the protocol must relate to other instruments on an equal basis and that sectoral concerns must also be weighed equally. The Miami Group suggested that the article be addressed later, as other issues, such as the precautionary approach, socioeconomic considerations and commodities, require resolution before making a final decision on Article 31. The EU stated that Article 31 should be removed, and suggested that there was still some room for agreement on the discussion of concepts held the previous day. The Compromise Group stated that it did not have unified position, although its majority prefers removing the article. He stated that according to the Vienna Convention, if a savings clause is included in the protocol then previous agreements will prevail, whereas without it the more recent agreement prevails. He suggested that lawyers examine specific language to achieve a balance.

Delegates then resumed discussions on language relating the protocol with other agreements, debating the terms "mutually supportive," "compatible," "equally important," "consistent" and "of equal standing." A small working group convened and developed a list of agreed concepts, including: the main purpose of the protocol is biosafety; other international agreements related to sustainable development with rights and obligations are recognized; the protocol and other international agreements are of equal status; and trade and environment agreements and policies should be mutually supportive. After some debate and clarification of meanings, the groups agreed to the concepts on the understanding that they need to be translated into legal language, that they are without prejudice to the groups' views on Article 31 and that the list of concepts is not closed.

SCOPE OF THE PROTOCOL: On Sunday, President Mayr opened a discussion on Article 4 (Scope) by soliciting the groups' preliminary comments. The Miami Group, EU and CEE expressed support for the existing formulation in the ExCOP's draft report (UNEP/CBD/ExCOP/1/L.2/Rev.1). The EU noted that it reflects a delicate balance, and the Miami Group stated that commodities can be considered within protocol, but the question is how. The Compromise Group stated that although it does not have a unified position on all issues, it can basically accept the existing text. The Like-minded Group stated that the scope of the protocol should simply cover all LMOs and that exceptions listed in the existing formulation should be addressed under specific articles.

Later in the day, President Mayr re-opened discussion on Article 4 in combination with Article 5. The Like-minded Group presented a draft proposal on the articles, which shifts existing exceptions under Article 4 into Article 5. Thus, the scope under Article 4 applies to all LMOs. Concepts for Article 5 included: application of the AIA procedure to the first transboundary movement of an LMO; notification by Party of export or the exporter to the national authority of the Party of import prior to any movement; allowance for the Party of import to decide not to apply the AIA procedure to LMOs that are pharmaceuticals for human use or destined for research in contained use, which should be communicated to the biosafety clearing-house; and notification of transit of LMOs by the Party of export or exporter to the national authority of the Party of transit.

The Compromise Group and the EU noted that the need to further consider the proposal's implications on scope, exemptions and application of the AIA, as well as contained use and transit. The EU, Miami Group and Compromise Group noted their support for working with the existing text of Article 4. The Like-minded Group clarified that its reservations regarding Articles 4 and 5 had been expressed in Cartagena, as referenced in paragraph 52 of the draft report (UNEP/CBD/ExCOP/1/L.2/Rev.1), and that they should be revisited. The CEE noted modification of Article 4 and 5 might be acceptable, but that certain concepts in Article 5 should be further clarified.

President Mayr closed the discussion, noting that most groups needed more time to examine the concepts.

CLOSING: In closing the informal consultation, President Mayr posed three questions to the groups: do they have the political will to conclude a protocol; can the groups progress to the ExCOP to conclude the negotiations; and what are the groups' assessments of the progress made here and the key issues still to be addressed? All the groups re-confirmed their political will to conclude a protocol and their support for concluding negotiations at the resumed session of the ExCOP.

Regarding the third question, the Miami Group noted that there was movement at the conceptual level, although such concepts need to be translated into text. He cited the need to further develop conceptual agreement on commodities, as well as socioeconomic considerations and the precautionary approach. The CEE noted that progress on Article 31 was obscure and suggested that there be similar informal consultations prior to the ExCOP. The Compromise Group noted the need to develop a package of solutions and to galvanize political will, such as that shown in the final negotiations of the Kyoto Protocol. The Like-minded Group noted that progress was made, but questioned whether that progress was sufficient. The EU noted areas of progress on commodities and relations with other agreements, but stated that the most politically difficult questions have not been resolved. He cited these two issues along with the application of the precautionary approach as the most important questions remaining.

László Miklós, Minister of Environment of Slovakia and COP-4 President, reviewed a COP Bureau decision on the resumed ExCOP. It would be held in Montreal from 20 to 28 January 2000, and include two days of informal group meetings, one day of informal consultations between groups, one day for groups to communicate with their governments, two days for negotiations within the ExCOP and one or two days for a high-level session under the ExCOP. Miklós noted that the Bureau would convene again to finalize the details, taking into account comments from the final session.

This informal issue of the Earth Negotiations Bulletin (c) (enb@iisd.org) is written and edited by Stas Burgiel sb4997a@american.edu of the Earth Negotiations Bulletin Team. It was edited by Paola Bettelli pbettelli@iisd.org. The Managing Director is Langston "Kimo" Goree kimo@iisd.org. The Sustaining Donors of the Bulletin are The Netherlands Ministry of Foreign Affairs, the Government of Canada (through CIDA), the United States (through USAID), the Swiss Agency for Environment, Forests and Landscape, and the United Kingdom Department for International Development (DFID). General support for the Bulletin during 1999 is provided by the German Federal Ministry of Environment (BMU) and the German Federal Ministry of Development Cooperation (BMZ), the Government of Australia, the Danish Ministry of Foreign Affairs, the European Community (DG- XI), the Ministries of Environment and Foreign Affairs of Austria, the Ministries of Foreign Affairs and Environment of Norway, the Ministry of Foreign Affairs and Ministry of Environment of Finland, the Government of Sweden, the United Nations Development Programme (UNDP), the Global Environment Facility (GEF) and the Ministry for the Environment in Iceland. The Bulletin can be contacted by e-mail at (enb@iisd.org) and fax:+1-212-644-0206. IISD can be contacted at 161 Portage Avenue East, 6^th Floor, Winnipeg, Manitoba R3B 0Y4, Canada. The opinions expressed in the Earth Negotiations Bulletin are those of the authors and do not necessarily reflect the views of IISD and other funders. Excerpts from the Earth Negotiations Bulletin may be used in non-commercial publications only and only with appropriate academic citation.