Distr.

GENERAL

UNEP/CBD/BSWG/5/3

3 September 1998

ORIGINAL: ENGLISH

OPEN-ENDED AD HOC WORKING

GROUP ON BIOSAFETY

Fifth meeting

Montreal, 17-28 August 1998

REPORT OF THE FIFTH MEETING OF THE OPEN-ENDED

AD HOC WORKING GROUP ON BIOSAFETY

Introduction

The fifth meeting of the Open-ended Ad Hoc Working Group on Biosafety, established in accordance with decision II/5 of the Conference of the Parties to the Convention on Biological Diversity, was held in Montreal from 17 to 28 August 1998.

I. ORGANIZATIONAL MATTERS

A. Opening of the meeting

The meeting was opened by Mr. Veit Koester (Denmark), Chairman of the Open-ended Ad Hoc Working Group, at 10.15 a.m. on Monday, 17 August 1998. In his opening statement, Mr. Koester welcomed all participants, noted the progress achieved by the Working Group so far and drew attention to the tasks that remained. He highlighted the decision taken by the Conference of the Parties at its fourth meeting, held in Bratislava from 4 to 15 May 1998, to hold a sixth and final meeting of the Working Group, as well as an extraordinary session of the Conference of the Parties in order to adopt the protocol, in February 1999. Recalling the spirit of cooperation that had characterized the fourth meeting of the Working Group, he was confident that, if the Group continued to work in the same vein, the negotiations at the current meeting would also meet with success.

At the opening session of the meeting, the Working Group also heard statements from Mr. Hamdallah Zedan, Chief, Biodiversity Unit, United Nations Environment Programme (UNEP), Mr. Calestous Juma, Executive Secretary of the Convention on Biological Diversity, and from the representative of Colombia.

Mr. Juma welcomed all participants and recalled that, at its fourth meeting, the Conference of the Parties to the Convention had unanimously adopted the Working Group's recommendations and urged it to complete its work by the end of the year and, in any event, not later than February 1999. The urgency to finalize the protocol, however, should not be at the expense of the development of an effective instrument that would enjoy full international support, not only from Governments but also from the private sector, non-governmental organizations and, even more importantly, the public. The Secretariat had received an offer from the Government of Colombia to host the final meeting of the Working Group and the extraordinary meeting of the Conference of the Parties to adopt the protocol, and discussions on the details of those meetings would start soon between Colombia and UNEP. The text of the draft articles had been sent to all focal points, in line with the requirement of Article 28, paragraph 3, of the Convention. Expressing his gratitude for the generous financial contributions made by a number of States Parties and Governments in support of the meetings of the Group, he urged all to maintain the same spirit to enable the Secretariat to support the highest possible level of participation in the negotiations, particularly by representatives of developing countries and countries with economies in transition.

In conclusion, he announced that he had decided, for personal reasons, not to renew his contract when it expired at the end of October 1998. Expressing his gratitude to UNEP for giving him that unique opportunity, he said that he would leave with special memories of the hospitality and support he had received from Canada, Quebec and Montreal during the establishment of the permanent Secretariat of the Convention.

Mr. Hamdallah Zedan, Chief, Biodiversity Unit, UNEP, speaking on behalf of the Executive Director of UNEP, Dr. Klaus Töpfer, stressed the great importance that UNEP attached to the Working Group's negotiations and the need for the timely conclusion of a protocol on biosafety. He was glad to report that the 18 countries in developing regions assisted by the UNEP/Global Environment Facility (GEF) "Biosafety Enabling Activity Project" were now at different stages of preparation of their national biosafety frameworks and would report on the progress they had made at a workshop to be held during the current meeting. The formulation of the those frameworks within the context of the UNEP International Technical Guidelines for Safety in Biotechnology called for the involvement of a wide spectrum of stakeholders. In that respect, he announced that the American Seed Trade Association (ASTA) had offered to conduct a study tour of commercial field settings of transgenic crops in the United States for the national biosafety focal points of the participating countries. When the UNEP/GEF project was completed, the participating countries would be in a position to implement the UNEP Guidelines and the provisions of the biosafety protocol and other future biosafety and biotechology agreements in a more effective and comprehensive manner.

The representative of Colombia extended, on behalf of her Government, the official invitation to host the sixth meeting of the Open-ended Ad Hoc Working Group on Biosafety and the extraordinary session of the Conference of the Parties to adopt the Protocol in Colombia in February 1999.

B. Attendance

The meeting was attended by representatives of the following States and regional economic integration organizations: Albania, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Bahamas, Belarus, Belgium, Belize, Benin, Bhutan, Botswana, Brazil, Cambodia, Cameroon, Canada, Chile, China, Colombia, Comoros, Congo, Costa Rica, Cuba, Czech Republic, Democratic Republic of Congo, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, European Community, Finland, France, Germany, Ghana, Greece, Guinea, Guyana, Hungary, India, Indonesia, Iran (Islamic Republic of), Italy, Jamaica, Japan, Jordan, Kenya, Kiribati, Korea (Republic of), Kuwait, Lithuania, Madagascar, Malawi, Malaysia, Mali, Marshall Islands, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Rwanda, Saint Kitts and Nevis, Saint Lucia, Samoa, Seychelles, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Thailand, Togo, Turkey, Ukraine, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Venezuela, Viet Nam and Zambia.

The following United Nations bodies and specialized agencies were represented: Food and Agriculture Organization of the United Nations (FAO), Global Environment Facility (GEF), United Nations Environment Programme (UNEP), World Intellectual Property Organization (WIPO), World Trade Organization (WTO).

Representatives of the following intergovernmental organizations attended the meeting: Commonwealth Secretariat, Consultative Group on International Agricultural Research (CGIAR), Institut de l'énergie des pays avant en commun l'usage du français (IEPF).

The following non-governmental organizations were also represented: African Centre for Technology Studies (ACTS), Ag-West Biotech Inc., AgrEvo Belgium, Akin, American Bar Association, American Seed Trade Association, American Soybean Association, BioteCanada, Biotechnology Industry Organization, Canadian Broadcasting Corporation, Canadian Federation of Agriculture, Canadian Institute of Biotechnology, Cargill, Canadian Environmental Law Association (CELA), Centro de Biotecnologia "JOEL", International Centre for Tropical Agriculture (CIAT), Chapin, Chemical and Engineering News, Center for International Environmental Law (CIEL), Council for Responsible Genetics, DuPont Co., European Group for Ecological Action (ECOROPA), European Association for BioIndustries (EUROPABIO), International Seed Trade Federation/International Association of Plant Breeders for the Protection of Plant Varieties (FIS/ASSINSEL), Fleming et al., Forum Environment and Development Working Group on Biodiversity, Friends of the Earth International, Genetics Forum - UK, Green Industry Biotechnology Platform (GIBIP), Greenpeace International, Gump, Hauer & Feld, Healthy City Project - Westmount, Hoechst Schering AgrEvo GmbH, Hogan and Hartson, Illinois Corn Marketing Board, Institute for Agriculture and Trade Policy, International Chamber of Commerce, London School of Economics, McGill University, Merck Research Laboratories, Michigan State University - Agricultural Biotechnology Support Project (ABSP), Missouri Botanical Garden, Monsanto, Musée Canadien de la Nature, National Corn Growers Association, Nestlé, Novartis, O'Mara & Associates, Pasteur Mérieux Connaught, Pioneer Hi-Bred International, Rhone Poulenc Rorer, Inc., SNC-Lavalin, STOP, Strauss, The Edmonds Institute, Third World Network, TRONWELL, United States Grains Council, Université de Montréal, Université de Québec à Montréal (UQAM), Université du Québec à Trois Rivières, Université Senghor d'Alexandrie, U.S. Grains Council, Washington Biotechnology Action Council, World Conservation Union (IUCN), World Wide Fund for Nature (WWF), Yale University.

C. Confirmation and constitution of the Bureau

At the opening session of the meeting, the Chairman drew attention to paragraph 2 of decision IV/3 of the Conference of the Parties to the Convention on Biological Diversity, by which the Conference decided, inter alia:

"(a)	That the bureau of the Open-ended Ad Hoc Working Group on Biosafety shall be composed of representatives of Argentina, Bahamas, Denmark, Ethiopia, Hungary, India, Mauritania, New Zealand, Russian Federation and Sri Lanka;

(b)	That the members of the bureau shall remain in office, under the chairmanship of Mr. Veit Koester (Denmark) until the adoption of the Protocol on Biosafety."

Accordingly, the Open-ended Ad Hoc Working Group confirmed and constituted the Bureau on the basis of the nominations made at the fourth meeting of the Conference of Parties and those received thereafter by the Secretariat, as follows:

Mr. Veit Koester (Denmark) (Chairman)

Mr. Behren Gebre Egziabher Tewolde (Ethiopia)

Mr. Mohamed Mahmoud Ould el Gaouth (Mauritania)

Mr. Diego Malpede (Argentina)

Mrs. Lynn Holowesko (Bahamas)

Dr. Ervin Balázs (Hungary)

Dr. Alexander Golikov (Russian Federation) (Rapporteur)

Ms. Amarjeet K. Ahuja (India)

Mr. I.A.U.N. Gunatillake (Sri Lanka)

Mr. Darryl Dunn (New Zealand)

D. Adoption of the agenda

The Working Group adopted the following agenda on the basis of the provisional agenda that had been circulated under the symbol UNEP/CBD/BSWG/5/1:

1.	Opening of the meeting.

2.	Adoption of the agenda.

3.	Confirmation and constitution of the Bureau.

4.	Organization of work.

5.	Elaboration of a Protocol on Biosafety in accordance with decision II/5 of the Conference of the Parties to the Convention on Biological Diversity.

6.	Dates and venues of meetings of the Open-ended Ad Hoc Working Group on Biosafety for 1998/99.

7.	Adoption of the report.

8.	Closure of the meeting.

E. Documentation

The following documents were before the Working Group at the meeting: provisional agenda (UNEP/CBD/BSWG/5/1); annotated provisional agenda (UNEP/CBD/BSWG/5/1/Add.1); compilation of new government submissions of draft text (structured by article) (UNEP/CBD/BSWG/5/2); revised consolidated text of the draft articles (UNEP/CBD/BSWG/5/Inf.1); government submissions (UNEP/CBD/BSWG/5/Inf.2 and Add.1); and an information note on the term "products thereof" prepared by the Executive Secretary (UNEP/CBD/BSWG/5/Inf.3)

F. Organization of work

The Working Group decided that the organizational arrangements established for the fourth meeting would be maintained at its fifth meeting, namely to conduct the work of the meeting in two sub-working groups, two contact groups and in plenary.

Sub-Working Group I, co-chaired by Dr. Eric Schoonejans (France) and Mrs. Sandra Wint (Jamaica), would continue with the mandate on Articles 3-14. Sub-Working Group II, co-chaired by Mr. John Herity (Canada) and Ms. Amarjeet K. Ahuja (India), would continue with the mandate on Articles 1, 1 bis and 15-27.

Contact Group 1, under the authority of Sub-Working Group I, would continue to be co-chaired by Dr. Gert Willemse (South Africa) and Mr. Piet van der Meer (Netherlands). It would continue to provide to the Sub-Working Group draft definitions and annexes for discussion and adoption. On request, it would also provide definitions to Sub-Working Group II for its consideration.

Contact Group 2 would continue to be co-chaired by Mr. John Ashe (Antigua and Barbuda) and Ms. Katharina Kummer (Switzerland). It retained its broad mandate concerning articles on institutional and legal matters and final clauses (Preamble and Articles 28-43), as well as providing legal advice and definitions of a legal nature upon request by the sub-working groups. In addition, the Working Group agreed to extend its mandate to provide authority to the co-chairs to organize for legal drafting within the framework of Contact Group 2.

With regard to NGO participation in sub-working groups and contact groups, the Chairman reminded the Working Group of a decision reached by the Bureau, after extensive consultation and discussion at the fourth meeting of the Working Group, on how best to balance the need for appropriate negotiating conditions and for transparency. Outlining the major elements of that decision, he said that NGOs could participate as observers in the initial phase of the discussion of the sub-working groups and contact groups, but with no right to speak, except at the invitation of the co-chairs. NGOs would not participate in negotiations or drafting of sensitive discussions, as defined by the co-chairs. Any Party could at any time ask, through the co-chairs, that the meeting be restricted and that NGOs be requested to withdraw. NGOs could participate in plenary in the same way as they had done during the previous meetings of the Working Group. On the question of closed sessions, the Chairman emphasized that, while any delegation could submit a request to have a closed session, in the interests of, inter alia, inclusiveness such an approach should be utilized as prudently as possible.

II. ELABORATION OF A PROTOCOL ON BIOSAFETY IN ACCORDANCE WITH

DECISION II/5 OF THE CONFERENCE OF THE PARTIES TO THE

CONVENTION ON BIOLOGICAL DIVERSITY

At the 2nd plenary session, on 19 August 1998, the Working Group heard the interim reports of the Co-Chairs of Sub-Working Groups I and II and of Contact Groups 1 and 2.

Mrs. Wint (Jamaica), Co-Chair of Sub-Working Group I, said that the Group had discussed most of articles 4-8, 10, and 12-14. Working papers had been produced on articles 4 - 6 and were being prepared for articles 12-14, and discussions were ongoing on articles 7, 8 and 10. She congratulated the members of Sub-Working Group I on their positive spirit, and expressed confidence that they would be able to produce conference room papers on the articles within their remit by the end of the current week.

Mr. Herity (Canada), Co-Chair of Sub-Working Group II, said that the Sub-Working Group had already completed a first round of discussions on articles 15-27, as well as articles 1 and 1 bis. Working papers from the Co-Chairs on articles 15 and 16 combined and on article 18 had already been circulated within the Sub-Working Group and it was expected that texts on other articles within the purview of Sub-Working Group II would be distributed in the near future. He expressed satisfaction at the continued cooperative dialogue and approach within the Sub-Working Group and said that, in the light of the progress made, he anticipated that the Sub-Working Group would reach a successful conclusion.

Mr. Piet van der Meer (Netherlands), Co-Chair of Contact Group 1, said that the Contact Group had formulated 3 working definitions of the term "living modified organism (LMO)", which it had submitted to Sub-Working Group I for its consideration. Discussions in the Contact Group were currently centred on prioritization of the annexes.

Ms. Kummer (Switzerland), Co-Chair of Contact Group 2, reported on the progress made in the Contact Group's deliberations on articles 29-33, 35, 37-40, 42 and 43, for which draft proposals were available for adoption by plenary. Discussions were ongoing with regard to articles 28, 35 bis and 41. In addition, Contact Group 2 was ready to carry out a legal drafting function with regard to the proposals submitted to it by the other subgroups.

Also at its 2nd plenary session, the Working Group provisionally adopted the text of draft articles submitted by the Co-Chairs of Contact Group 2 on Conference of the Parties (UNEP/CBD/BSWG/5/L.10), subsidiary bodies and mechanisms (UNEP/CBD/BSWG/5/L.11), Secretariat (UNEP/CBD/BSWG/5/L.12), relationship with the Convention (UNEP/CBD/BSWG/5/L.3), monitoring and reporting (UNEP/CBD/BSWG/5/L.13), signature (UNEP/CBD/BSWG/5/L.4), entry into force (UNEP/CBD/BSWG/5/L.7), withdrawal (UNEP/CBD/BSWG/5/L.8) and authentic texts (UNEP/CBD/BSWG/5/L.9).

The Working Group also provisionally agreed to delete draft articles 32, 38 and 39 in the consolidated text, on, respectively, jurisdictional scope; ratification, acceptance and approval; and accession.

Also at its 2nd plenary session, the Working Group had an informal exchange of views on the term "products thereof", with a view to reaching a better understanding of the issues and the concerns of representatives and to identifying the approach to be followed on the subject by the Working Group. Following the informal exchange of views, the Working Group, recognizing the need for the discussion of definition of living modified organisms to be combined with the issue of "products thereof" and with the discussion of the related articles on use of terms, scope, risk assessment and risk management, decided that the various aspects should be discussed at the same time. Accordingly, it was agreed that Contact Group 1 should take up the issue within that framework and submit its conclusions for the consideration of Sub-Working Group I.

At the 4th plenary meeting, on 28 August 1998, the Working Group received reports on the conclusions of the work of the sub-working and contact groups, on the basis of the document UNEP/CBD/BSWG/5/L.1/Add.1, which contained those conclusions, arranged by article.

Mrs. Wint (Jamaica), Co-Chair of Sub-Working Group I, reported that since the 2nd plenary meeting the Group had continued its process of consolidation and succeeded in removing a great deal of options, square brackets, unnecessary text and duplication. During this meeting its mandate to consider Articles 3 A to 14 had been extended to consideration of Article 36 - Assessment and Review of this Protocol.

Dr. Schoonejans (France), Co-Chair of Sub-Working Group I, confirmed that the Group had reduced articles to single options, although retaining text in brackets, which would provide a good basis for finalization in Colombia. Articles had been discussed in three groups, namely scope and application of AIA (Articles 3 A, 3 B, 9 and 11), procedures (Articles 4, 5, 6, 7, 8 and 10) and risk assessment and management (Articles 12, 13 14 and 36). Article 3 A (The scope of the Protocol), had been greatly clarified but four questions remained for decision in Cartagena: the existence of provisions regarding "products thereof"; socio-economic impacts; possible exemption of some categories of LMOs; and the extent of provisions regarding handling and use of LMOs. Article 3 B (The application of the AIA procedure), had also been greatly clarified and footnotes indicated means by which remaining issues might be resolved. Three issues remained pending in Article 4 (Notification), namely responsibility and application of AIA procedures, transit and responsibility for information provided. Article 9 (Simplified procedures), might be deleted as its contents were covered in a number of other articles. The text of Article 5 (Acknowledgement of receipt of notification), would be finalized when discussion was completed in Cartagena on Article 3 B. Article 6 (Decision procedure for AIA) had been consolidated, but still required further consideration, particularly in relation to Article 12 and Annex 1. In the discussion on Articles 4, 5 and 6, the Group had benefitted from the participation of the Co-Chair of Contact Group 2 in clarifying the understanding of the concept. Article 7 (Review of decisions) had also been consolidated but required further discussion at the next meeting.

Mrs. Wint then reported that Articles 8 (Notification of transit) and 10 (Subsequent imports) should be deleted as their relevant elements were adequately covered in a number of other articles. Article 11 (Multilateral, bilateral and regional agreements), remained in square brackets because there had been no consensus on whether it should exist or whether its elements should be incorporated elsewhere. Discussion focused on its relationship with Article 3 B. Article 12 (Risk assessment), had been considerably reduced but retained issues that required further discussion such as the type of information necessary for risk assessment, responsibility for carrying out risk assessment and financial responsibility. Regarding Article 13 (Risk management), there had been no consensus on the elements addressed in paragraphs 2 to 9 and further discussions were required on consolidation regarding contained use and deliberate release, financial and technical assistance for risk management, banning or phasing out of certain categories of LMOs or products thereof, unintentional transboundary movements and phasing out of antibiotic-resistance marker genes in LMOs. The Group had agreed that Article 14 (Minimum national standards), could be deleted if its substance was effectively addressed in Article 1 bis. Article 36 (Assessment and review of this Protocol), had been reduced to a short text with two sets of square brackets, the Group agreeing that the concept of the article was in line with the provisions set out under the Convention on Biological Diversity.

On the proposal of one representative, the Working Group then agreed that a footnote be added to paragraph 1 of Article 3 B stating that Contact Group 2 would consider what constituted a "first" transboundary movement in relation to the novel status of a LMO in the receiving environment of a Party of import. This would also apply to the reference to first transboundary movement in Article 4, paragraph 1.

The Working Group then agreed to editorial suggestions that the last phrase of paragraph 2 (d) of Article 3 B should read "without prejudice to any decision made by the Party of import under Article 6, paragraph 3 (a)", and that reference should be made to the "Biosafety Clearing-house" in the penultimate line of paragraph 1 of Article 7.

The draft articles submitted by Sub-Working Group I, as revised and amended, were then approved for inclusion in the consolidated text to be used as the basis for negotiations at the sixth meeting of the Working Group. The text of the articles as so approved by the Working Group is contained in the annex to the present report.

Mr. Piet van der Meer (Netherlands), Co-Chair of Contact Group 1, reported that, under Article 2 (Use of terms), the Group had produced three working definitions, i.e., for "LMOs", "living organisms" and "modern biotechnology". Within the definition of "modern biotechnology", the term "cell fusion" had been placed in square brackets to reflect that further discussion was needed on the question of whether and to what extent cell-fusion techniques were covered by the term "modern biotechnology". In discussing those definitions, Sub-Working Group I had recognized that they were interrelated by cross-reference, and that changes in one definition may require changes in another. Mr. van der Meer also reported on the conclusions of the Contact Group regarding its discussion on the issue of "products thereof". He said that the Group had identified the following four possible categories of transboundary movement in relation to LMOs: (a) intentional transboundary movement of LMOs; (b) unintentional transboundary movement of LMOs (both these categories including propagules such as seeds, tubers and pollen); (c) intentional transboundary movements of processed products from LMOs (e.g., maize-gluten) containing dead modified organisms and/or non living components of LMOs such as DNA fragments (e.g., plasmids) or gene products (i.e., proteins); and (d) intentional transboundary movements of purified products from LMOs (e.g., insulin, enzymes, oil). The Contact Group had concluded that the first two categories fell under the scope of the Protocol and that the fourth did not. It had not yet reached a conclusion on whether or not and to what extent the products mentioned in the third category would be addressed under the Protocol. In discussing the latter issue, the possible effects of those products on human health were discussed, in particular possible direct effects, e.g., via food consumption, and indirect effects via impacts on biodiversity. The question was raised of the meaning and intent of the relevant language in the Convention and the Jakarta decision regarding those possible effects. The question was also raised of whether these safety aspects were or could be adequately addressed by other international instruments, for example the Codex Alimentarius. A possible basis for future discussion might be the proposal made by one representative, that "processed products from LMOs containing dead modified organisms and/or non-living components of LMOs such as DNA or gene products are addressed in the Protocol to the extent that there is a provision in the Protocol that relevant information on LMOs used for processing is made available through the clearing-house mechanism.

Mr. Willemse (South Africa), Co-Chair of Contact Group 1, reported that the Contact Group had discussed Annexes I and II of the Protocol guided by the instruction from the Co-Chairs of Sub-Working Group 1 and based on information contained in documents UNEP/CBD/BSWG/5/INF/1 and UNEP/CBD/BSWG/5/2. Both those documents should be carried forward to the next meeting for further consideration. Annex I (Information required in notification for Advance Informed agreement) still retained some square brackets whose removal was dependent upon discussions on issues and terminology in other groups. Annex II (Risk assessment) contained the basic objectives, principles and methodology of risk assessment and identified the essential component elements of risk assessment, which would be developed further at the next meeting. The Contact Group had considered the following detailed elements of the characteristics of recipient or parental organisms which should be included in the final document for the next meeting: (a) taxonomic status and common name of the organism; (b) pathogenicity, toxicity and allergenicity; (c) the natural habitat and the geographic origin of the organism, its distribution and its role in the habitat; (d) mechanisms by which the organism survives, multiplies and disseminates in the environment and its invasiveness; and (e) means for transfer of genetic material to other organisms. The Co-Chairs of the Sub-Working Group had also identified for possible development possible annexes on: (a) information for notification in cases of unintended transboundary transfer; (b) information for transit; and (c) contained use of LMOs. The Contact Group had decided that the possibility of including information for the first two of those annexes in Annex I should be investigated. The possible need for an annex on LMOs not to be included under the AIA had been identified as a matter for priority consideration. It had also been agreed that the protocol should contain no more than four annexes.

Following this presentation, one representative requested that square brackets be placed around Article 2 (Use of terms) to reflect that the issue of "products thereof" had not yet been fully resolved.

The draft article and annexes submitted by Contact Group 1, as revised and amended, were then approved for inclusion in the consolidated text to be used as the basis for negotiations at the sixth meeting of the Working Group. The text of the article and annexes as so approved by the Working Group is contained in the annex to the present report.

Ms. Ahuja (India), Co-Chair of Sub-Working Group II, speaking also on behalf of Mr. Herity (Canada), her fellow Co-Chair, reported on the work of the Sub-Working Group. She recalled that the Group had initially been given the task of dealing with Articles 1, 1 bis, and 15-27 and, to the extent possible, of reducing the text to single options. Following the preparation of the Co-Chairs' text on Article 27, dealing with liability and redress, and a discussion of the policy aspects in the plenary of the Group, the Article was transferred to Contact Group 2 for further work in order to consider the technical legal issues involved. At the same time, Article 34 (Relationship with other international agreements) was given to it by Contact Group 2, as it was interlinked with Articles 23 (Non-Parties) and 24 (Non-discrimination).

With the acceptance of the Sub-Working Group, and following an initial round of discussions by delegates, the Co-Chairs, in most cases, consolidated the initial text of each of the articles to create a new starting point for negotiations. The Group thereon adopted the strategy of further dealing with the articles in the plenary of Sub-Working Group I, constituting drafting groups wherever necessary, ensuring that no more than two meetings would take place at the same time. The text of the draft articles, which would form the basis of the discussions at the sixth meeting of the Working Group, was contained in document UNEP/CBD/BSWG/5/L.1/Add.1.

Having introduced a number of oral corrections to the text of the draft articles, Ms. Ahuja noted that, as far as the major issues were concerned, some more careful consideration was required as to who was responsible for notifying an unintentional release; who is responsible for taking action - the Party of origin, the recipient Party, the Party of export or the Party under whose jurisdiction the unintentional release occurred. Another major issue was whether or not labelling would be required under the Protocol, and whether there was a need for developing standards of handling, packaging and transfer of LMOs under the protocol.

There was still fundamental disagreement as to whether there was a need for a detailed reference to confidential information in the Protocol, given that the subject was already dealt with in other international instruments. A similar disagreement existed with respect to the saving clause under Article 34 dealing with the relationship with the other international agreements, and paragraph 5 of Article 1 bis, which referred to the jurisdiction, rights and obligations of States under the law of the sea.

Another set of issues requiring a solution related to non-Parties - whether trade should be allowed with non-Parties and, if so, under what conditions.

Furthermore, illegal traffic remained an unresolved issue, including what should be the responsibility of the Party of origin in relation to illegal traffic. A working definition of illegal traffic had been provided by Contact Group 2, which might need revision, depending upon the eventual definition of related terms. The final definition should, as appropriate, be included in the article on use of terms.

Another subject deserving mention was the socio-economic considerations. There had appeared to be a shared sympathy for the subject, but not about the need, place and the manner of handling the issue under the Protocol. Preferences varied from a mention of the subject in the preamble, to its reference in the articles dealing with risk assessment and risk management or as an independent article. The issue had a bearing on the scope and other provisions for the Protocol and needed to be considered carefully by delegations before the sixth meeting of the Working Group.

One representative proposed the addition of a footnote to Article 17, on handling, transport, packaging and labelling, to the effect that the specifications for documentation could be considered for inclusion in an annex on the AIA procedure. He subsequently withdrew the proposal but noted that the accompanying documentation and the AIA procedures were conceptually linked, and that relationship was an issue that could be further explored.

On the proposal of one representative, it was agreed that the consolidated text should retain the option of having an article on minimum national standards, which the Sub-Working Group had recommended should incorporated into Article 1 bis.

The Working Group also agreed to amend the text of draft articles 1, 17 and 21 on the basis of oral proposals made from the floor.

The draft articles submitted by Sub-Working Group II, as revised and amended, were then approved for inclusion in the consolidated text to be used as the basis for negotiations at the sixth meeting of the Working Group. The text of the articles as so approved by the Working Group is contained in the annex to the present report.

The Co-Chair of Contact Group 2, Mr. John Ashe (Antigua and Barbuda), speaking also on behalf of Ms. Katharina Kummer (Switzerland), reported on the results of the Group's deliberations on the remaining articles of the Protocol within its remit and made several corrections to typographical errors in the draft articles submitted by the group for approval.

Concerning issues that had been left outstanding until the sixth meeting of the Open-ended Working Group, he reiterated the Contact Group's decision to defer any consideration of the preamble to the Protocol until the final, sixth meeting of the Open-Ended Working Group, at which time an overall general framework of the protocol would be in place. Moreover, a number of government submissions concerning the preamble, which had been received before the deadline for such submissions, would also be taken into account at that time and should therefore be included in the consolidated text as additional options to be considered.

With regard to Article 27 (Liability and redress), which had been referred to Contact Group 2 following discussions in Sub-Working Group II, a decision had been taken to set up a small drafting group, chaired by Ms. Katherine Cook (United Kingdom). That group had prepared a consolidated draft text, incorporating all previously drafted options, and would pursue its work at the sixth meeting of the Working Group.

Concerning Article 28 (Financial mechanism and resources), the Contact Group had made progress and had drafted a consolidated text, which contained brackets and was thus to be the subject of further negotiation.

Following work on Articles 35 bis (Compliance) and 41 (Reservations), language had been drafted that, in itself, was not the object of dispute. However, the entire articles were bracketed to reflect a lack of consensus on whether such provisions should be included in the protocol at all.

In conclusion, the Co-Chair said that the Contact Group had also considered the need for a definition of the term "regional economic integration organization" and had agreed that the definition of that term contained in Article 2 of the Convention on Biological Diversity would provide a suitable definition of this term in the protocol. The Group agreed that that term would be included in Article 2 of the protocol when the Group considered the article in its capacity as legal drafting group.

On the proposal of one representative, the Working Group agreed to place paragraph 1 of Article 28 in square brackets, pending the outcome of negotiations on the existing brackets around paragraph 3 of that Article.

The draft articles submitted by Contact Group 2, as revised and amended, were then approved for inclusion in the consolidated text to be used as a basis for negotiations at the sixth meeting of the Working Group. The text of the articles as so approved by the Working Group is contained in the annex to the present report.

Following the consideration of the draft articles by the Working Group, the Chairman said that a suitable way would be found for dealing with the documentation required by Contact Group 1 in its discussions on the possible further annexes to the protocol.

The Chairman said that the Secretariat would prepare, by the end of September 1998, a consolidated text of the draft protocol for consideration by the Working Group at its sixth meeting. In that task, the Secretariat would make necessary editorial corrections, deleting articles, where so agreed, and renumbering, but without substantively changing any articles or footnotes, save for the government submissions to be considered in the consideration of the preamble by Contact Group 2. Sub-titles would be retained in order to indicate those articles that had been provisionally adopted and those that had been transmitted to the sixth meeting for further negotiation. In that context, he said, it was his hope that, at the sixth meeting, discussions would not be reopened on any unbracketed text in the draft protocol.

The Chairman highlighted the need for the Working Group to consider what recommendations needed to be made to the forthcoming extraordinary meeting of the Conference of the Parties. Decision IV/3 of the Conference of the Parties dealt with preparations for the first Meeting of the Parties and the interim arrangements for the Protocol, covering the period from the adoption of the Protocol until its entry into force, and also the period between its entry into force and the first Meeting of the Parties.

The Working Group needed to consider the elements of an enabling decision for the Protocol for the period up to the entry into force of the protocol and from the entry into force up to the first Meeting of the Parties. Such elements would include the establishment of an Intergovernmental Committee for the Biosafety Protocol (ICBP); election of a Chairman and a Bureau; adoption of a programme of work; an invitation to the Secretariat to convene ICBP meetings; and a supplementary budget. Moreover, the Conference of the Parties may also wish to consider the provisional application of the Protocol pending its entry into force; focal point(s); invitations to sign and ratify the Protocol; and invitations to other intergovernmental organizations to contribute to the work under the protocol and of the ICBP.

Following consultations within the extended Bureau, he said, the Secretariat would prepare, for submission to the sixth meeting of the Working Group, a document containing draft recommendations for interim arrangements during the periods identified.

In conclusion, the Chairman stated that it had been agreed that the sixth meeting of the Open-ended Working Group on Biosafety would commence in Cartagena, Colombia, on 14 February 1999, and the extraordinary meeting of the Conference of the Parties would be held at the same location on 22 and 23 February 1999. The sixth meeting of the Working Group would follow the same organizational set-up as at previous meetings, with two contact groups and two sub-working groups retaining the same Co-Chairs. In principle, the mandates would remain the same. However, some adjustments might be needed.

III. DATES AND VENUES OF MEETINGS OF THE OPEN-ENDED

AD HOC WORKING GROUP ON BIOSAFETY FOR 1998/99

At the 3rd plenary session, on 27 August 1998, the representative of Colombia, speaking as the Party that had offered to host the sixth meeting of the Open-ended Working Group and the extraordinary meeting of the Conference of the Parties in February 1999, said that the time was appropriate to highlight some of the positive results achieved by the Working Group. Many of the articles had been streamlined into a single option, allowing better identification of the unresolved issues which would be subjected to further, hopefully successful, negotiation in Colombia. The definition of LMOs should facilitate understanding of the scope of application of the protocol, and it was hoped that the new basic text for an article on liability and redress would facilitate future discussions.

However, as Colombia had one of the greatest levels of biodiversity, she wished to signal some concerns to the Working Group. Hitherto, scientific information on the effect of LMOs on biological diversity had been based on risks encountered in temperate regions with homogenous agricultural systems and its application to countries with wide diversity and highly diverse agricultural systems would clearly undermine the precautionary principle which underlay the Protocol. There was a marked tendency to require importing countries to assume far greater obligations and responsibilities than exporting countries, particularly regarding AIA procedures. Regarding the consolidation of lists of LMOs, she feared that at the current early stage such lists would be based on the commercial importance of a specific LMO, rather than on long experience with its impact on biological diversity. She said that she was concerned that the discussion on the liability and redress clause had been unduly delayed at the meeting, with the risk that it would not be resolved in Colombia. In conclusion, she said that Colombia, as host Government for the final meetings, wished to assure the Working Group of its spirit of conciliation and its commitment to bring to a happy conclusion the negotiation of a well-balanced protocol on biosafety which would complement the objectives of the Convention on Biological Diversity and the mandate given by the Conference of the Parties at its second meeting, namely to reduce the level of risk associated with transborder movement of LMOs through transparent and effective procedures.

IV. OTHER MATTERS

Statements by non-governmental organizations

At the 4th (closing) plenary session of the meeting, on 28 August 1998, the Working Group heard statements from the representative of the Third World Network, on behalf of the environment and development non-governmental organizations and a number of lawyers and scientists attending the meeting, and from the representative of Biotech Canada, on behalf of a broad consortium of international industry.

The representative of the Third World Network endorsed the statement made by the Executive Secretary at the opening session of the meeting that the completion of the protocol should not be at the expense of an effective and widely accepted agreement. She was very encouraged by the growing support of many delegations, from both developed and developing countries for the precautionary principle as a basis for the protocol and urged all delegations to adopt that principle as they proceeded to the sixth meeting of the Working Group. She was, however, also concerned by some disturbing trends in the negotiations, particularly at the current meeting. One such trend was that the protocol might become an extended form of a trade regime, with some concessions to safety. Trade issues were well dealt with in other agreements, and it was important for the protocol to be about safety and conservation and sustainable use of biological diversity. Developing countries were facing new products and technologies in the area of biotechnology, as potential consumers, farmers and civil society as a whole. That was one technology that for the first time could be assessed openly, and it was perhaps the last chance to complete a biosafety protocol. It was therefore essential to ensure that a strong protocol emerged from the final meeting of the Working Group. In conclusion, she reiterated the call for a global moratorium on commercial releases of LMOs and products thereof until such an international regime on safety was in place.

The representative of Biotech Canada said that industry supported the Convention on Biological Diversity and the objective of the protocol, namely, to ensure that transboundary movements of living modified organisms did not result in adverse impacts on the conservation and sustainable use of biological diversity. To achieve that objective, it was critical that energy and resources should be concentrated in areas where scientific considerations indicate significant potential for adverse impacts on biodiversity. Industry also supported capacity-building to achieve the goals of the protocol world-wide; it was involved in multiple activities to support capacity-building in developing nations and was in the process of identifying additional opportunities. Noting that the forthcoming six months would be crucial for the successful development of the protocol, he encouraged all delegations to consider the implications for both existing and future products. Biotechnology was an important tool for increasing the productivity of many traditional sectors and also supported the conservation and sustainable use of biodiversity. He expected that, in time, virtually every nation would choose to become both an exporter and importer of living modified organisms. In conclusion, he said that, as the dialogue on biosafety continued, industry would endeavour to provide information on technical issues, product development and trade, which were essential in the formulation of a practical and effective protocol.

Tribute to the outgoing Executive Secretary

At the 4th plenary session, on 28 August 1998, following statements by a number of representatives, the Working Group paid tribute to Mr. Calestous Juma, outgoing Executive Secretary of the Convention on Biological Diversity, who had decided not to renew his contract for personal reasons. The representative of Canada presented Mr. Juma with a gift as a token of esteem for his outstanding commitment to the work of the Convention during his tenure of office.

V. ADOPTION OF THE REPORT

The present report was adopted at the 3rd plenary session of the meeting, on 27 August 1998, on the basis of the draft report as contained in document UNEP/CBD/BSWG/5/L.1 and on the understanding that the Rapporteur would be entrusted with its finalization in the light the discussions during the remainder of the meeting.

VI. CLOSURE OF THE MEETING

Following the customary exchange of courtesies, the Chairman declared the fifth meeting of the Open-ended Ad Hoc Working Group closed at 3.50 p.m. on Friday, 28 August 1998.

Annex

CONCLUSIONS OF THE WORK OF THE SUB-WORKING AND CONTACT GROUPS,

ARRANGED BY ARTICLE

CONTENTS	Page

PREAMBLE

ARTICLE 1 - OBJECTIVES

ARTICLE 1 bis - GENERAL OBLIGATIONS

[ARTICLE 2 - USE OF TERMS]

ARTICLE 3 A - THE SCOPE OF THE PROTOCOL

ARTICLE 3 B - THE APPLICATION OF THE AIA PROCEDURE

ARTICLE 4 - NOTIFICATION

ARTICLE 5 - ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION [FOR AIA]

ARTICLE 6 - DECISION PROCEDURE FOR AIA

ARTICLE 7 - REVIEW OF DECISIONS [UNDER AIA]

ARTICLE 8 - NOTIFICATION OF TRANSIT

[ARTICLE 9 - SIMPLIFIED PROCEDURE]

ARTICLE 10 - SUBSEQUENT IMPORTS

[ARTICLE 11 - MULTILATERAL, BILATERAL AND REGIONAL AGREEMENTS

[OR ARRANGEMENTS] [OTHER THAN THE PROTOCOL]]

ARTICLE 12 - RISK ASSESSMENT

[ARTICLE 13 - RISK MANAGEMENT]

[ARTICLE 14 - MINIMUM NATIONAL STANDARDS]

MERGER OF ARTICLE 15 AND ARTICLE 16 - UNINTENTIONAL TRANSBOUNDARY MOVEMENTS

AND EMERGENCY MEASURES

[ARTICLE 17 - HANDLING, TRANSPORT, PACKAGING [AND LABELLING]]

ARTICLE 18 - COMPETENT NATIONAL AUTHORITY/NATIONAL FOCAL POINT

ARTICLE 19 - INFORMATION SHARING/BIOSAFETY CLEARING-HOUSE

[ARTICLE 20 - CONFIDENTIAL INFORMATION]

ARTICLE 21 - CAPACITY-BUILDING

ARTICLE 22 - PUBLIC AWARENESS AND PARTICIPATION

[ARTICLE 23 - NON-PARTIES]

[ARTICLE 24 - NON-DISCRIMINATION]

[ARTICLE 25 - ILLEGAL TRAFFIC]

[ARTICLE 26 - SOCIO-ECONOMIC CONSIDERATIONS]

[ARTICLE 27 - LIABILITY AND REDRESS]

ARTICLE 28 - FINANCIAL MECHANISM AND RESOURCES

ARTICLE 29 - CONFERENCE OF THE PARTIES

ARTICLE 30 - SUBSIDIARY BODIES AND MECHANISMS

ARTICLE 31 - SECRETARIAT

ARTICLE 32 - JURISDICTIONAL SCOPE

ARTICLE 33 - RELATIONSHIP WITH THE CONVENTION

[ARTICLE 34 - RELATIONSHIP WITH OTHER INTERNATIONAL AGREEMENTS]

ARTICLE 35 - MONITORING AND REPORTING

[ARTICLE 35 bis - COMPLIANCE]

ARTICLE 36 - ASSESSMENT AND REVIEW OF THIS PROTOCOL

ARTICLE 37 - SIGNATURE

ARTICLE 38 - RATIFICATION, ACCEPTANCE, OR APPROVAL

ARTICLE 39 - ACCESSION

ARTICLE 40 - ENTRY INTO FORCE

[ARTICLE 41 - RESERVATIONS]

ARTICLE 42 - WITHDRAWAL

ARTICLE 43 - AUTHENTIC TEXTS

Annexes

I.	INFORMATION REQUIRED IN NOTIFICATION FOR ADVANCE INFORMED AGREEMENT

II.	RISK ASSESSMENT

PREAMBLE

(Not considered by the Working Group at its fifth meeting)

Option 1

The Parties to this Protocol,

Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention",

Recalling Article 19, paragraphs 3 and 4, and Articles 8(g) and 17 of the Convention,

Recalling also decision II/5 of the Conference of the Parties to the Convention to develop a protocol on biosafety, specifically focusing on transboundary movement of any living modified organism (LMO) 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,

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,

Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms (LMOs),

Have agreed as follows:

Option 2

The Parties to this Protocol,

Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention",

Recalling Article 19, paragraphs 3 and 4, and Articles 8(g) and 17 of the Convention, and recognizing the linkages between them,

Recalling also decision II/5 of the Conference of the Parties to the Convention to develop a protocol on biosafety, specifically focusing on transboundary movement of any living modified organism (LMO) 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,

Reaffirming decision III/20 of the Conference of the Parties to the Convention and, in particular 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 and complement the implementation of this Protocol,

Noting the potential contribution of the United Nations Recommendations on the Transport of Dangerous Goods to the implementation of the Protocol,

Recalling the support of the international community for Agenda 21 adopted by the 1992 United Nations Conference on Environment and Development and, in particular Chapter 16, which provides for the "Environmentally Sound Management of Biotechnology", and which further seeks to ensure safety in biotechnology development, application, exchange and transfer through international agreement,

Recognizing that, while properly addressing the risks from living modified organisms (LMOs) resulting from modern biotechnology the Protocol should avoid causing unnecessary delays, including through the creation of unwarranted administrative requirements for the transboundary transfer of LMOs for contained use,

Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on human or animal health, biological diversity, the environment, and social and economic welfare,

Aware also of the benefit that biotechnology can bring for health agriculture and the environment and mindful that unnecessary negative impacts on biotechnology research and development and on access to and transfer of technology should be avoided.

Concerned that significant gaps in scientific knowledge remain, specifically with regard to the interaction between the environment and living modified organisms (LMOs) resulting from modern biotechnology,

Noting that, in accordance with the precautionary principle, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize risk where such a risk is posed by living modified organisms (LMOs) resulting from biotechnology,

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,

Determined to avoid and minimize the risks associated with the transfer, handling and use of living modified organisms (LMOs) through appropriate risk assessment and management techniques,

Recognizing the need to establish a minimum condition of safety and a procedure for the assessment and management of the potential risks arising from the development, use, release and transfer of living modified organisms (LMOs) and products thereof,

Recognizing that the socio-economic impacts of the introduction of LMOs and products thereof should be considered in risk assessment and management, taking particularly into account the needs and concerns of developing countries,

Affirming the need to provide adequate compensation for in the event of any damage caused by or arising from the handling, transfer and use of living modified organisms (LMOs),

Conscious of the need to promote and encourage public awareness of the safe use, handling and transfer of living modified organisms (LMOs) through the development and implementation of educational and public awareness programmes, and through public participation in risk assessment and management procedures,

Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms (LMOs),

Acknowledging the need for appropriate policies and measures to develop and strengthen human resources and institutional capacities in the safe handling, transfer and use of living modified organisms (LMOs), taking due account of the needs of developing countries,

Noting that the provisions of the Protocol should contribute to the field of biosafety, based on scientific risk assessment.

Have agreed as follows:

ARTICLE 1 - OBJECTIVES

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The objective of this Protocol is [[, in accordance with the precautionary principle,] to contribute to ensuring an adequate level of protection in the field of] [the safe, transfer, handling and use [in a transboundary context] [specifically focusing on]] [the safe] [transboundary movement] of living modified organisms [and products thereof] resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity [, taking also into account risks to human health [and socioeconomic imperatives]].

ARTICLE 1 bis - GENERAL OBLIGATIONS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Each Party shall take necessary and appropriate legal, administrative and other measures to implement [and enforce] its obligations under this Protocol.

[2.	Parties shall cooperate to facilitate the implementation of the provisions of this Protocol, and may involve interested organizations in implementation, as appropriate.]

[3.	Parties shall not allow the export of LMOs [or products thereof] until such time as they have obtained an advance informed agreement in writing from the State of import for the specific import, based on scientific risk assessment procedures.]

[4.	Parties shall ensure that the development, handling, transport, use, transfer and release of any LMOs [or products thereof] are undertaken in a manner that prevents or reduces the risks to biological diversity [, taking also into account human health].]

[5.	Nothing in this Protocol shall affect in any way the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their continental shelves in accordance with international law, and the exercise by ships and aircraft of all States of navigational rights and freedoms as provided for in international law and as reflected in relevant international instruments.]

6.	Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biodiversity than that called for in this Protocol, provided that such action is consistent with the [provisions] [objectives] of this Protocol [and is in accordance with its obligations under international law].

[ARTICLE 2 - USE OF TERMS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[LMO means any living organism containing a novel combination of genetic material obtained through the use of modern biotechnology.

Living organism means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.

Modern biotechnology means the application of in vitro nucleic acid techniques [and cell-fusion techniques] that overcome natural physiological reproductive or recombination barriers, other than traditional breeding and selection.]

(Not considered by the Working Group at its fifth meeting)

Transboundary movement

Transboundary movement [of an LMO ] means any movement [of an LMO] from [an area under the jurisdiction][the territory] of one Party[/State] to [an area under the jurisdiction][the territory] of another Party[/State].

Export

Export means the intentional movement [of an LMO] from [an area under the jurisdiction][the territory] of one Party[/State] into [an area under the jurisdiction][the territory] of another Party[/State][,but does not include transit through a third Party[/State]].

Import

Import means the intentional movement [of an LMO] into [an area under the jurisdiction][the territory] of one Party[/State] from [an area under the jurisdiction][the territory] of another Party[/State][,but does not include transit through a third Party[/State]].

Exporter

Exporter means any legal or natural person, under the jurisdiction of the Party[/State] of export, who [arranges][is responsible] for an LMO to be exported.

Importer

Importer means any legal or natural person, under the jurisdiction of the Party[/State] of import, who [arranges][is responsible] for an LMO to be imported.

Party of export

Party of export means a Party[/State] from which a [transboundary movement][export] [of an LMO] [is planned to be initiated or] is initiated.

Party of import

Party of import means a Party[/State] into which a [transboundary movement][import] [of an LMO] [is planned to be initiated or] is initiated.]

ARTICLE 3 A - THE SCOPE OF THE PROTOCOL

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[1.	This Protocol shall [, without prejudice to paragraph 2 below,] apply to the transboundary movement [, handling and use] of LMOs [or products thereof] [resulting from modern biotechnology] that may have an adverse effect on the conservation and sustainable use of biological diversity [and socio-economic well-being] [,taking also into account risks to human health].]

[2.	This Protocol shall not apply to:

[(a)	Transboundary movements of LMOs that are not likely to have adverse effects on the conservation and sustainable use of biological diversity, [taking also into account risks to human health,] as specified in Annex X;]

[(b)	Requirements for transport operations;]

[(c)	Transit of LMOs and transboundary movements destined for contained use, except as regards Articles 1 bis (General obligations) and 15 (Unintentional transboundary movements).]]

ARTICLE 3 B - THE APPLICATION OF THE AIA PROCEDURE

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	[All] [The first] [intentional] transboundary movements of [an] [all] [a specific] LMO[s] [or products thereof], [as defined in this Protocol] [for a specific use]:

[[(a) Intended for field testing in the Party of import;]

[(b) Intended for [first] deliberate [introduction] [release] in[to] the environment] [of the Party of import for growth or propagation];]

[(c) That has been banned in the Party of export;]

[(d) LMOs [exclusively] destined for [large scale production in] contained [use] [facilities]]]

shall be subject to [an] AIA.

[2.	The AIA procedure [shall] [may] not apply to [the transit of LMOs or to] the [intentional] transboundary movement of: ,

[(a) LMOs exempted under the domestic regulatory framework of the Party of import [or, in the absence of a specific regulatory framework, specified by the Party of import that the transboundary movement can take place at the same time as the movement is notified to the Party of import] ; or exempted pursuant to bilateral, multilateral or regional agreements [or arrangements]; where these are: [consistent with the objectives of this Protocol] [and obligations under international law] [and] [do not result in a lower level of protection than that provided for by the Protocol]; and communicated to the Secretariat and to all Parties [via the Biosafety Clearing-House];]

[(b) LMOs [exclusively] destined for [research in] contained [use] [facilities];]

[(c) LMOs identified in a decision by the Meeting of the Parties to the Protocol as not likely to have adverse effects on the conservation and sustainable use of biological diversity [taking also into account risks to human health];]

[(d) LMOs destined for placing on the market in the Party of import provided that the Party of import has previously granted an AIA for that specific purpose, without prejudice to any decision made by the Party of import under Article 6, para. 3 (a).]]

ARTICLE 4 - NOTIFICATION

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	The Party of [import] [export] [may] [shall] [notify] [or] require the [importer] [or] [the exporter] to notify in writing [the competent national authority of] the Party of import [and the Biosafety Clearing-House] [and, where applicable, [the designated national competent authority of] the Party of transit] prior to the [first] intentional transboundary movement of an LMO that falls under the scope of Article 3 B. The notification shall contain at a minimum the information specified in Annex I.

[2.	The Party of [export] [import] shall make its [exporter] [importer] legally responsible for the accuracy of information provided by the [exporter] [importer].]

ARTICLE 5 - ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION [FOR AIA]

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The Party of import shall acknowledge receipt of the notification, in writing, to the notifier within [[ninety]] days of receipt of notification.

The acknowledgment shall state:

The date of receipt of the notification;

Whether the notification, prima facie, contains the information specified in Article 4; [and]

[	Whether to proceed according to the domestic regulatory framework of the Party of import, provided that the framework is consistent with this Protocol or according to the procedures provided for in Article 6 of this Protocol.]

Failure to acknowledge receipt of notification by the Party of import will not imply consent for transboundary movement.

ARTICLE 6 - DECISION PROCEDURE FOR AIA

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Decisions taken by the Party of import shall be [based on risk assessment] [in accordance with Article 12] [made on the basis of scientific principles,] [, the precautionary principle] [of the adverse effect on the conservation and sustainable use of biological diversity], [taking also into account risks to human health] [and social, economic and cultural criteria].

[2.	The Party of import shall within the period of time referred to in Article 5 inform the notifier whether:

(a)	The intentional transboundary movement may proceed [after no less than ninety days] without a written consent; or

(b)	The intentional transboundary movement may proceed only after the Party of import has given its written consent.]

3.	Within [a reasonable period of time] [ninety] [one hundred and eighty] [days] from the acknowledgment of receipt of notification, the Party of import shall communicate its decision, in writing, to the notifier [and the Biosafety Clearing-House]:

(a)	Approving the import, with or without condition, including how the decision applies to subsequent imports of the same LMO;

(b)	Prohibiting the import; [or]

[(c)	[Requesting additional relevant information [in accordance with [its national legislation] [and] [or] Annexes I and II].] [When calculating the time for the Party of import to respond, the number of days for which the Party of import is waiting for additional relevant information shall not be taken into account]]; [or]

[(d)	Informing the notifier that the period specified in this paragraph is extended by [a defined period no longer than ninety days] [as much time as is necessary to assess the information it has received from the [notifier] so as to enable it to reach an informed decision.]]

4.	Decisions under paragraph 3 shall include the reasons for the decision [except in the case of unconditional approval.]

[5.	Lack of [sufficient information] [or] full scientific certainty or of scientific consensus to determine the potential adverse effects of an LMO shall not prevent the Party of import from prohibiting the import of the LMO in question.]

[6.	The Parties shall cooperate with a view to deciding, as soon as possible, to what extent in relation to the procedures, and in which cases, to be specified in an annex, a transboundary movement cannot proceed without an explicit consent.]

[7.	If the Party of import does not respond within the period specified under paragraph X [and it is not the case in which a movement shall not proceed without an explicit consent], [the exporter [may] [shall not] [should not] proceed with the transboundary movement] the Party of import shall be deemed to have [approved] [prohibited] import of the LMO concerned.]

[8.	The failure of the Party of import to communicate [its decision] [or] [substantial progress towards a decision] within [ninety] days after the acknowledgement of the receipt of notification [or, if there is no acknowledgement of receipt of notification within the period specified in Article 5,] shall not imply consent to the intentional transboundary movement of the LMO, but the Party of export shall have no [further] [consequent] obligation under [Articles X] with respect to that transboundary movement of the LMO.]

[9.	The Conference of the Parties shall at its first meeting decide upon appropriate procedures and mechanisms to facilitate the reaching of a decision by a Party of import.]

ARTICLE 7 - REVIEW OF DECISIONS [UNDER AIA]

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	A Party of import may at any time in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity [taking into account risks to human health] [and the precautionary principle], [unilaterally] review and change its decisions with regard to the transboundary movement of an LMO. In such a case, the Party must, within thirty days inform any notifier who has previously notified movements, [Parties concerned], and the Biosafety Clearing-House and give full details of the reasons for its decision.

[2.	A [[Party] [State] of export] [notifier] may request a Party of import to review a decision it has made in respect of it under Article 6 where the [[Party] [State] of export] [notifier] considers that:

(a)	A change in circumstances has occurred which may influence the outcome of the risk assessment upon which the decision was based;

(b)	Additional relevant scientific or technical information has become available; or

[(c)	There is reasonable evidence that the decision has not been based on scientific [socio-economic, cultural or the precautionary] principles and supported by the best available scientific evidence.]]

[3.	Parties of import shall respond to such requests in writing, within [a reasonable period of time] [ninety days], and provide full details on the basis for their decision.]

[4.	Risk assessment for subsequent imports of an LMO [or products thereof] into the same Party of import may [be taken at the discretion of the Party of import] [only be required if:

(a)	There is a change in the intended use of the LMO [or products thereof];

(b)	There is a variation in the receiving environment;

(c)	There is a change in the import volume of the LMO [or products thereof], where such a change were to increase the risk of adverse impacts on biological diversity through increased exposure into the receiving environment;

(d)	It is a condition of first import of the LMO [or products thereof] under Article 6; or

(e)	There are other relevant factors likely to affect the risk assessment or risk management of the LMO [or products thereof].]]

ARTICLE 8 - NOTIFICATION OF TRANSIT

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

Because the elements addressed in this article are covered in the following: Article 4, Article 5, Article 6, Article 17, and Article 27, this article should be deleted.

[ARTICLE 9 - SIMPLIFIED PROCEDURE

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	[Without prejudice to paragraph 5 of Article 6,] a Party of import may, [giving reasons,] [on the basis of the best available scientific knowledge and experience and any other relevant information] [provided that adequate measures are observed to ensure the safe transboundary movement of living modified organisms, in accordance with the objectives of this Protocol], specify in advance to the Biosafety Clearing-House:

[(a)	Cases for which transboundary movement can take place at the same time as the movement is notified to the Party of import. Such notifications may apply to subsequent similar movements to the same Party;]

[(b)	LMOs to be exempted from the AIA procedure.]

2.	The information relating to a transboundary movement that is to be provided in the notification referred to above is the information specified in Annex I.]

ARTICLE 10 - SUBSEQUENT IMPORTS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The contents of Article 10 are amply covered in the revised Article 6, para. 3 (a), as contained in UNEP/CBD/BSWG/5/SWG.I/CRP.3 as well as in Articles 9 and 12, contained in working papers 11 and 4, respectively, of Sub-Working Group I. For this reason, this article should be deleted.

[ARTICLE 11 - MULTILATERAL, BILATERAL AND REGIONAL AGREEMENTS

[OR ARRANGEMENTS] [OTHER THAN THE PROTOCOL]

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Parties may enter into bilateral, multilateral, or regional agreements [or arrangements] [with Parties] [or non-Parties] regarding [procedures or information exchange related to] transboundary movement of LMOs [and products thereof], [consistent with the objectives of this Protocol] [and obligations under international law] [and] [provided that such agreements [or arrangements] do not result in a lower level of protection than that provided for by the Protocol]. [Decisions taken under these agreements [and arrangements] shall be based on risk assessment, made on the basis of scientific principles.]

2.	Parties shall communicate to the Secretariat and to all Parties [via the Biosafety Clearing-House] any such bilateral, regional and multilateral agreements [or arrangements] entered into either before or after entry into force of this Protocol.

[3.	The provisions of this Protocol shall not affect transboundary movements that take place pursuant to such agreements and/or arrangements as between the Parties to that agreement or arrangement.]

[4.	Any Party may determine that its domestic regulations apply with respect to specific imports to it and shall notify the Secretariat and the Biosafety Clearing-House of its decision.]

[5.	A regional economic integration organization, which itself is a Contracting Party to the Protocol and has a specific legal framework for biosafety, may declare that the Protocol shall not apply to movements within its territory.]] /

ARTICLE 12 - RISK ASSESSMENT ,

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Risk assessment [under [Articles (X)] [AIA procedures] ] shall be undertaken [on a case-by-case basis] in a scientifically sound [and transparent] manner in accordance with Annex II [and taking into account appropriate risk assessment techniques developed by relevant international organizations] and be based [at a minimum] on information provided in accordance with Article 4, [the precautionary principle, socio-economic and cultural concerns and experience] [and other available scientific evidence] in order to identify and evaluate the possible adverse effects of LMOs [or products thereof] on [the environment of the Party of [import][transit] as regards] conservation and sustainable use of biological diversity, [taking into account the risks to [human health,] social, economic, cultural, ethical, agriculture, and animal health considerations]].

[2.	[The Party of import shall be responsible for ensuring that a risk assessment is carried out as necessary for a decision taken under Article 6.] [Risk assessment [shall] [may] [be required to] be undertaken by [[as the responsibility of the] [the competent authority of] [the Party of [import][export] ].] [The Party of import may [require] [ask] the exporter/Party of export to carry out the risk assessment.] ]

[3.	The financial responsibility for risk assessment shall rest with the [Party of [export][import][importer][exporter][notifier]].]

[4.	Parties shall ensure that risk-assessment and management processes of micro-organisms are conducted in contained conditions.]

[ARTICLE 13 - RISK MANAGEMENT

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	[[In accordance with] [To the extent required by] Article 8(g) of the Convention,] Parties [of import] shall establish and maintain appropriate mechanisms, measures and strategies to regulate and manage risks [[especially those] identified under the risk assessment provisions of the Protocol] associated with the [use, handling and] transboundary movement of LMOs [or products thereof].

[2.	Such measures shall adequately regulate both contained use and deliberate release. With regard to contained use of living modified organisms [or products thereof], each Party shall apply the measures set out in Annex X.]

[3.	Measures based on risk assessment [and in particular on sound and scientific information] [shall] [may] be imposed [to the extent necessary] to prevent adverse effects of the LMO [or products thereof] on the conservation and sustainable use of biological diversity [, [human health and socio-economic considerations] within the territory of the State of import]. [Lack of full scientific certainty or of scientific concern regarding the level of risk shall not be used as a reason for postponing measures to prevent harm.]]

[4.	[If the Party of import lacks the financial and technical capacity to do so,] the Party of export [shall offer technical and financial assistance and] [shall] [is encouraged to] collaborate with the Party of import [for risk management]. ]

[5.	The type of risk management to be employed shall be appropriate to the LMOs [or products thereof] and activity in question and such risk-management strategies and measures shall [be commensurate with] [correspond to the results of] the risk assessment]

[6.	[Each Party shall take appropriate measures to prevent unintentional [transboundary movements of LMOs], [including requiring [as appropriate] risk assessments to be carried out prior to the first release of an LMO]].

[7.	Without prejudice to paragraph x above, each Party, in order to ensure genomic and trait stability in the environment, shall ensure that any LMO [or products thereof], whether imported or locally developed, undergo a period of observation commensurate with its life-cycle or generation time as the case may be before it is put to its intended use.]

[8.	Parties shall cooperate with the view to ban or phase out LMOs [or products thereof] or specific traits of LMOs [or products thereof] that may have [global] adverse effects on the conservation and sustainable use of biological diversity [or human health.]

[9.	Parties shall require producers of LMOs [or products thereof] to phase out all antibiotic-resistance marker genes in LMOs by the year 2002.]]

[ARTICLE 14 - MINIMUM NATIONAL STANDARDS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The provisions of Article 14 have been sent verbatim, with the recommendation to Sub-Working Group II for inclusion in Article 1 bis. For this reason, this Article should be deleted.]

MERGER OF ARTICLE 15 AND ARTICLE 16 - UNINTENTIONAL

TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[1.	Each Party shall take appropriate measures to prevent unintentional transboundary movements of LMOs [and products thereof].]

2.	Each Party shall take appropriate measures to notify affected or potentially affected Parties and, where appropriate, relevant international organizations, when it knows of an [unforeseen] [unintentional] occurrence [within an area] under its jurisdiction resulting in a release which [leads to or presents a significant likelihood of] [may lead to] transboundary movement of LMOs [and products thereof] that [is likely to] [may] have [significant] adverse effects on the conservation and sustainable use of biological diversity [taking also into account human health] in such Parties. The notification shall be provided as soon as the Party knows of the above situation. The Party providing notification shall also make available to the Biosafety Clearing-House a summary of that notification.

[3.	Parties shall make available to the Biosafety Clearing-House [, through the Secretariat, as appropriate,] the relevant details of the point of contact, for the purposes of receiving notifications under this Article, no later than the date of entry into force of the Protocol for that Party.]

4.	Any notification arising from paragraph 2 above should include:

[(a)	Available relevant information on the estimated quantities and relevant characteristics/traits of the LMOs [and products thereof];]

[(b)	A point of contact for further information;]

[(c)	Information on the circumstances of the release, including the estimated date, as well as the use of the LMO in the originating Party;]

[(d)	Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity [taking also into account human health], as well as [available information about possible risk-management measures] [an assessment of the risks and methods for monitoring, control and mitigation or emergency measures, as appropriate];]

(e)	Any other relevant information.

[5.	Parties shall protect [, on the basis of national legislation,] the confidentiality of any information identified as confidential and provided under this Article.]

[6.	[Parties concerned] [Each Party, under whose jurisdiction the release of the LMO [and products thereof] referred to in paragraph 2 above originates,] shall immediately consult with [each other] [the affected Parties] to determine appropriate responses and initiate necessary action, including emergency measures, in order to minimize any negative impacts on the conservation and sustainable use of biological diversity [, taking also into account human health] [and socio-economic well being].]

[ARTICLE 17 - HANDLING, TRANSPORT, PACKAGING [AND LABELLING]

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Each Party [of export] shall [take] [promote] measures [as appropriate] to [ensure] [require] [provide] that LMOs [and products thereof] that are subject to intentional transboundary movement [within the scope of the Protocol] [under AIA] are:

(a)	[Clearly identified [labelled],] [as appropriate,] handled, packaged and transported under conditions of safety [[no less stringent than those applied within the territory of the Party of export,] from the point of export in the Party of export [to the point of import into the Party of import]], [taking into consideration relevant international rules and standards] [in accordance with standards under this Protocol] in order to avoid adverse effects on the conservation and sustainable use of biodiversity[, taking also into account risks to human health];

[(b)	Clearly identified in accompanying documentation [[or] [and] labelling] [specifying] [containing: a statement as to] the presence, identity and relevant traits/characteristics; the requirements for safe handling, storage, transport and use; the name and address of the importer and exporter [or] [and] [the contact point] for further information; and a declaration that the movement is in conformity with the requirements of this Protocol, except that the Party of import may indicate that these requirements will not apply as to imports to it.]

[2.	The Conference of the Parties shall [consider the need for, and the modalities of, further developing] [develop] standards with regard to [identification,] handling, packaging and transport practices [under the Protocol] [after] [taking into consideration the results of] consultations with other international organizations.]]

ARTICLE 18 - COMPETENT NATIONAL AUTHORITY/NATIONAL FOCAL POINT

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Each Party shall designate one [or more] national focal point[s] to be responsible for liaison with the Secretariat on behalf of that Party, and one or more competent national authorities that shall be responsible for performing the administrative functions required by this Protocol and be authorized to act on its behalf with respect to those functions. A Party may designate a single agency to fulfil both the functions of focal point and competent national authority.

2.	Each Party shall, no later than the date of entry into force of this Protocol for that Party, notify the name(s) and address(es) of its focal point[(s)] and competent national authority or authorities to the Secretariat. Where it designates more than one competent national authority, the Party shall convey to the Secretariat, with its notification, relevant information on the respective responsibilities of its competent national authorities to inform at a minimum, if applicable, a notifier which competent authority is responsible for which type of LMO. Each Party shall immediately notify the Secretariat of any changes in the designation of its national focal point[(s)] or in the name(s) and address(es) or responsibilities of its competent national authority or authorities.

3.	The Secretariat shall forthwith inform the Parties of notifications it receives under paragraph 2 above, and shall also make such information available through the Biosafety Clearing-House.

ARTICLE 19 - INFORMATION SHARING/BIOSAFETY CLEARING-HOUSE

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

A Biosafety Clearing-House is hereby established [as part of the clearing-house mechanism under Article 18, paragraph 3, of the Convention], in order to:

Facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, LMOs; and

Assist Parties to implement the Protocol,

taking into account the special needs of developing countries, countries with economies in transition and small island developing States.

The Biosafety Clearing-House shall serve as a means through which information is made available for the purposes of paragraph 1 and shall provide access to information made available by the Parties relevant to the implementation of the Protocol, as well as access, where possible, to existing international biosafety information exchange mechanisms.

Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House information required to be made available to it under this Protocol and:

National laws, guidelines and/or regulations adopted for the implementation of the Protocol, including information required by the Parties for the AIA procedures;

Any bilateral, regional and multilateral agreements [as well as unilateral declarations on the exemptions and/or the simplification of the AIA procedures];

[Summaries of its risk assessments or environmental reviews of LMOs generated by its regulatory process [, and carried out in accordance with Article 12, including, when appropriate, relevant information regarding products of LMOs, not defined as LMOs, that contain genetic material resulting from the modification];]

Its final decisions regarding the importation or release of LMOs [new to its environment], [including the time taken for decisions to be made regarding the importation of LMOs];

[Reports required under Article 35, including such reports on implementation of the AIA procedures.]

The modalities of the operation of the Biosafety Clearing-House, including reports on its activities, shall be considered and decided upon by the Parties to this Protocol at their first meeting, and kept under review thereafter.

[ARTICLE 20 - CONFIDENTIAL INFORMATION

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	The Party of import shall permit the notifier to identify information submitted under the procedures of this Protocol or required by the importing Party as part of the Protocol's Advanced Informed Agreement process that should be treated as confidential. Justification must be given in such cases upon request.

2.	The Party of import shall consult with the notifier if it believes that information identified by the notifier as confidential does not qualify for such treatment and shall inform the notifier of its decision providing reasons on request and an opportunity for consultation and for an internal review of the decision prior to disclosure.

3.	A Party shall protect confidential information [subject to national legislation], received under the Protocol, including any confidential information received in the context of the Protocol's Advanced Informed Agreement process. [Each Party shall ensure that it has procedures to protect such information [and shall protect the confidentiality of such information in a way no less favourable than its treatment of confidential information in connection with domestic LMOs].]

4.	A receiving Party may not use such information for a commercial purpose, except with the agreement of the notifier.

5.	If a notifier withdraws or has withdrawn a notification, a Party must respect the confidentiality of all information identified as confidential [, including information on which the competent authority and notifier disagree as to its confidentiality].

6.	Without prejudice to paragraph 5 of this Article, the following information [should not generally] [in no case may] be considered confidential:

(a)	The general description of the LMO or LMOs, the name and address of the notifier;

(b)	A summary of the risk assessment of effects on the conservation and sustainable use of biological diversity, [taking also into account human health]; and

(c)	Any methods and plans for emergency response.]

ARTICLE 21 - CAPACITY-BUILDING

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	The Parties shall cooperate [in] [to promote] the development and/or strengthening of human resources and institutional capacities [in biosafety, including biotechnology to the extent that it relates to biosafety] [for the purpose of the effective implementation of this Protocol] in developing country Parties, in particular the least developed and small island developing States amongst them, and in Parties with economies in transition, including through existing international, regional, subregional, national institutions and organizations.

[2.	The needs of developing country Parties, in particular the least developed and small island developing States amongst them, [and Parties with economies in transition] [for financial resources, [and technical and scientific assistance,] and access to and transfer of technology and know-how] shall be taken fully into account in capacity-building for biosafety [, in accordance with the relevant provisions of the Convention], including technical and scientific cooperation and assistance in training and exchange of experts. [The needs of Parties with economies in transition shall likewise be taken fully into consideration in capacity-building for biosafety.]

3.	Cooperation in capacity-building shall aim to enhance the technological and institutional capacities of developing country Parties, and Parties with economies in transition, in biosafety, [including] through training in science related to safety in the proper and safe [development and] management of biotechnology, and in the use of risk-assessment and risk-management techniques for biosafety.]

[4.	The needs of developing country Parties, in particular the least developed and small island developing States among them, and Parties with economies in transition in capacity-building for biosafety, including technical and scientific expertise and training related to the safe [development and] management of biotechnology and to the use of risk assessment and risk management techniques, shall be taken fully into account.]

[5.	Parties shall endeavour to facilitate private sector involvement in capacity-building activities under this Protocol.]

ARTICLE 22 - PUBLIC AWARENESS AND PARTICIPATION

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Parties shall promote and facilitate, as appropriate, public awareness and education on the safety in the transfer, handling and use of LMOs [and products thereof] in relation to the conservation and sustainable use of biological diversity [, taking into account human health]. In doing so, Parties shall cooperate, as appropriate, with other States and international organizations.

2.	Parties [shall] [are encouraged to] [, in accordance with their national laws, regulations and administrative measures] [and where appropriate,] provide the public [with the opportunity for involvement in the decision-making process concerning the [release] [safe transfer, handling and use] of LMOs [and products thereof] and] with [information regarding] [the results of] the decision-making process [concerning the [release] [safe transfer, handling and use] of LMOs [and products thereof]] [, whilst respecting confidential information] [subject to Article 20].

3.	Each Party shall endeavour to inform its public about the mode of public accessibility to the Biosafety Clearing-House.

[ARTICLE 23 - NON-PARTIES

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[1.	No Party shall export or import LMOs or products thereof to or from non-Parties.]

[1.	Parties shall [conduct their trade in LMOs with non-Parties on a basis consistent with the objectives] [not be restricted from trade in LMOs with non-Parties provided that such trade is carried out on the basis of the substantive provisions] of the Protocol. [Such trade could be the subject of bilateral, regional or multilateral agreements or arrangements with non-Parties [within Article 11], which should be made available through the Secretariat [and through the Biosafety Clearing-House].]]

2.	The Parties shall encourage non-Parties to adhere to this Protocol. The Parties shall encourage non-Parties to contribute appropriate information to the Biosafety Clearing-House on LMOs released in, and entering into trade to and from, their territory.]

[ARTICLE 24 - NON-DISCRIMINATION

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Parties shall ensure that measures to implement this Protocol, [including] [in particular in relation to] risk-assessment procedures, do not discriminate between or among foreign LMOs and LMOs of domestic origin.

2.	Parties shall also ensure that measures taken to implement this Protocol do not create unnecessary obstacles to, and/or constitute means of unjustified discrimination or disguised restrictions on, international trade.]

[ARTICLE 25 - ILLEGAL TRAFFIC

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

1.	Each Party shall adopt appropriate domestic measures aimed at preventing and penalizing illegal traffic of LMOs [and products thereof].

2.	[ Where illegal traffic has been established the affected Party may request the Party of origin to dispose of the LMOs in question by repatriation or destruction, as appropriate, and at its own cost/expense.]

3.	Each Party shall make available [appropriate] information concerning cases of illegal traffic [within that Party] to the Biosafety Clearing-House.]

[ARTICLE 26 - SOCIO-ECONOMIC CONSIDERATIONS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[1.	The Parties shall ensure that the socio-economic impacts of the introduction, transfer, handling or use of living modified organisms [and products thereof] on or within the [potential] Party of import and its environment, and strategies and measures to prevent or mitigate those impacts are appropriately considered during the [assessment and] management of risks, taking due account of [the long observation period that these socio-economic impacts may require to manifest] [such adverse consequences as genetic erosion and associated loss of income and dislocation of traditional farmers and farm products].]

2.	Parties shall encourage research on socio-economic considerations relating to the use, handling and transfer of LMOs and the exchange of the results of such research.

[3.	A Party that intends to produce, using a living modified organism, a hitherto imported commodity, shall notify the affected Party or the Party likely to be affected sufficiently in advance to enable the affected Party to undertake appropriate measures for conservation of potentially affected biological diversity. The Party substituting such import shall provide financial and technical assistance to the affected Party for undertaking these measures if the affected Party is a developing country.]]

[ARTICLE 27 - LIABILITY AND REDRESS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[1.	The Parties shall [at their first meeting] [as soon as practicable] [on the basis of studies to be carried out] [without prejudice to their existing domestic legal systems] [examine [whether and] how] [adopt appropriate measures] [to establish procedures for developing appropriate rules and procedures] [to establish and develop rules and procedures] [in the field of [strict] liability and redress] [including restoration and compensation for damages resulting from transboundary movements of LMOs to biological diversity].]

[2.	If harm, including transboundary harm, that proves detrimental to the environment, biological diversity, human or animal health or socio-economic welfare, arises as a consequence of living modified organisms or activities or products involving such organisms, the [operator in respect of production, handling, export and supply of those living modified organisms] [exporter] [Party of origin] shall be [strictly] liable for the harm, and the harm must be compensated. [If the [operator][exporter] is unable to [compensate] [discharge its obligations to redress,] the Party of origin shall be liable to [compensate to] the extent of the obligations not fulfilled by the [operator] [exporter].

3.	If harm, including transboundary harm, occurs that proves detrimental to the environment, biological diversity, human or animal health or socio-economic welfare, the [State of origin] [operator] [exporter] shall meet the costs of restoring as far as possible the conditions that existed prior to the occurrence of the harm. Parties shall establish an [Emergency Fund] [Compensation Fund] [insurance scheme] [financial security], to provide [redress] [compensation] as necessary in the event of harm arising from the transboundary movement of living modified organisms.

4.	Civil actions for compensation resulting from harm caused as a consequence of the transboundary movement, handling and use of LMOs [and products thereof] may only be brought within a Party at the courts of the place: (a) where the harmful event occurred; (b) where the damage was suffered; (c) in the Party where the defendant has his habitual residence.

5.	Parties shall, at their first meeting, initiate a process to further elaborate and adopt the details of the rules of liability and [redress] [compensation] [including] [and] the procedural rules [including the establishment of the [Emergency] [Compensation] Fund].]

[6.	Each [Party] [or] [Party of origin] shall be liable for [[appreciable and significant] harm to the biological diversity of another Party resulting from the transboundary movement of LMOs under this Protocol] [harm, including transboundary harm, that proves detrimental to the environment, biological diversity, human or animal health or socio-economic welfare, arising as a consequence of the transboundary movement of living modified organisms] [which] [if such harm] occurs as a consequence of an action or omission that can be attributed to that [Party] [State] [under the provisions established by this Protocol]; [as a consequence [of] a conduct that constitutes a breach of an international obligation of the State under the terms of this Protocol; if the [operator] [exporter] is unable to discharge its liability, the State or States of origin shall be liable to the extent of the breach of due diligence obligation of the State of origin].

7.	Each Party shall ensure that recourse is available in accordance with their legal systems for prompt and adequate compensation or other relief in respect of damage caused by the transboundary movement of living modified organisms by natural or juridical persons under their jurisdiction.] ]

ARTICLE 28 - FINANCIAL MECHANISM AND RESOURCES

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

[1.	In considering financial resources for the implementation of this Protocol, Parties shall take into account the provisions of Article 20 of the Convention.]

2.	The financial mechanism established in Article 21 of the Convention shall be the financial mechanism for this Protocol.

[3.	The financial mechanism referred to in paragraph 2 above, shall take into account the need for financial resources by developing country Parties, in particular the least developed and the small island States amongst them, for capacity-building and for the promotion and safe use of biotechnology and, upon request, for the capacity to develop and implement programmes, particularly in the areas of risk assessment and risk management.]

4.	In the context of paragraph 1 above, Parties shall also take into account the needs of the developing country Parties, in particular the least developed and the small island States amongst them, and of the Parties with economies in transition, in their efforts to identify and implement their capacity-building requirements for the purposes of the implementation of this Protocol.

5.	The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of this Article.

6.	The developed country Parties may also provide, and developing country Parties and Parties with economies in transition avail themselves of, financial and technological resources for the implementation of the provisions of this Protocol through bilateral, regional and multilateral channels.

ARTICLE 29 - CONFERENCE OF THE PARTIES

(Provisionally adopted)

1.	The Conference of the Parties to the Convention shall serve as the meeting of the Parties to this Protocol.

2.	Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, decisions under this Protocol shall be taken only by those that are Parties to it.

3.	When the Conference of the Parties serves as the meeting of the Parties to this Protocol, any member of the Bureau of the Conference of the Parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from amongst the Parties to this Protocol.

4.	The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decisions necessary to promote its effective implementation. It shall perform the functions assigned to it by this Protocol and shall:

(a)	Make recommendations on any matters necessary for the implementation of this Protocol;

(b)	Establish such subsidiary bodies as are deemed necessary for the implementation of this Protocol;

(c)	Seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies;

(d)	Establish the form and the intervals for transmitting the information to be submitted in accordance with Article 35 of this protocol and, as well, reports submitted by any subsidiary body;

(e)	Consider and adopt, as required, amendments to this Protocol and its annexes, as well as any additional annexes to this Protocol, that are determined necessary for the implementation of this Protocol; and

(f)	Exercise such other functions as may be required for the implementation of this Protocol.

5.	The rules of procedure of the Conference of the Parties and financial rules of the Convention shall be applied, mutatis mutandis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the Parties to this Protocol.

6.	The first meeting of the Conference of the Parties to the Convention serving as the meeting of the Parties to this Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the Parties that is scheduled after the date of the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held in conjunction with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting of the Parties to this Protocol.

7.	Extraordinary meetings of the Parties to this Protocol shall be held at such other times as may be deemed necessary by the meeting of the Parties to this Protocol, or at the written request of any Party, provided that, within six months of the request being communicated to the Parties by the Secretariat, it is supported by at least one third of the Parties.

8.	The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State member thereof or observers thereto not party to the Convention, may be represented as observers at meetings of the Parties to this Protocol. Any body or agency, whether national or international, governmental or non-governmental, which is qualified in matters covered by this Protocol and which has informed the Secretariat of its wish to be represented at a meeting of the Parties to this Protocol as an observer, may be so admitted, unless at least one third of the Parties present object. Except as otherwise provided in this Article, the admission and participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5 above.

ARTICLE 30 - SUBSIDIARY BODIES AND MECHANISMS

(Provisionally adopted)

1.	Any subsidiary body established by or under the Convention may, upon a decision by the meeting of the Parties, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise.

2.	Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of the Convention serves as a subsidiary body to this Protocol, decisions under this Protocol shall be taken only by the Parties to this Protocol.

3.	When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the Bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from amongst the Parties to this Protocol.

ARTICLE 31 - SECRETARIAT

(Provisionally adopted)

1.	The Secretariat established by Article 24 of the Convention shall serve as the secretariat to this Protocol.

2.	Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply, mutatis mutandis, to this Protocol.

3.	To the extent that these are distinct, the costs of the secretariat services for this Protocol shall be met by the Parties hereto. The Meeting of the Parties to this Protocol shall decide at its first meeting the necessary budgetary arrangements to this end.

ARTICLE 32 - JURISDICTIONAL SCOPE

(Deleted)

ARTICLE 33 - RELATIONSHIP WITH THE CONVENTION

(Provisionally adopted)

Except as otherwise provided in this Protocol, the provisions of the Convention relating to its protocols shall apply to this Protocol.

[ARTICLE 34 - RELATIONSHIP WITH OTHER INTERNATIONAL AGREEMENTS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The provisions of this Protocol shall not affect the rights and obligations of any Party to this Protocol deriving from any existing international agreement to which it is also a Party [, except where the exercise of those rights and obligations would cause serious damage or threat to biological diversity].]

ARTICLE 35 - MONITORING AND REPORTING

(Provisionally adopted)

Each Party shall monitor the implementation of its obligations under this Protocol, and shall, at intervals to be determined by the meeting of the Parties to this Protocol, report to the meeting of the Parties to this Protocol on measures taken to implement this Protocol.

[ARTICLE 35 bis - COMPLIANCE

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The Parties shall at their first meeting consider and approve procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance. Such procedures and mechanisms shall be separate from and without prejudice to the dispute-settlement procedure established under Article 27 of the Convention. They shall include provisions to offer advice or assistance, where appropriate.]

ARTICLE 36 - ASSESSMENT AND REVIEW OF THIS PROTOCOL

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

The Meeting of the Parties shall undertake, [five] years after the entry into force of this Protocol [and at least every five years thereafter], an evaluation of the effectiveness of this Protocol, including an assessment of the procedures and annexes.

ARTICLE 37 - SIGNATURE

(Provisionally adopted)

This proposal shall be open for signature at [ ] by all States and any regional economic integration organization from [ ] until [ ], and at the United Nations Headquarters in New York from [ ] to [ ].

ARTICLE 38 - RATIFICATION, ACCEPTANCE, OR APPROVAL

(Deleted)

ARTICLE 39 - ACCESSION

(Deleted)

ARTICLE 40 - ENTRY INTO FORCE

(Provisionally adopted)

1.	This Protocol shall enter into force on the ninetieth day after the date of the deposit of the [ ] instrument of ratification, acceptance, approval or accession.

2.	This Protocol shall enter into force for a Party that ratifies, accepts or approves this Protocol or accedes thereto after its entry into force pursuant to paragraph 1 above, on the ninetieth day after the date on which that Party deposits its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enters into force for that Party, whichever shall be the later.

3.	For the purposes of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization.

[ARTICLE 41 - RESERVATIONS

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

No reservations may be made to this Protocol.]

ARTICLE 42 - WITHDRAWAL

(Provisionally adopted)

1.	At any time after two years from the date on which this Protocol has entered into force for a Party, that Party may withdraw from the Protocol by giving written notifications to the Depositary.

2.	Any such withdrawal shall take place upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawal.

ARTICLE 43 - AUTHENTIC TEXTS

(Provisionally adopted)

The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.

Annex I

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

INFORMATION REQUIRED IN NOTIFICATION FOR ADVANCE INFORMED AGREEMENT

(a)	Name and identity [and domestic classification of biosafety level, if any, in the exporting country] of the LMO(s) [or products thereof].

(b)	Name, address and contact details of the [exporter] [applicant].

(c)	Name, address and contact details of the [importer] [receiving company/institution/individual].

(d)	Intended date[(s)] of the transboundary movement, if known.

(e) Taxonomic status, common name, point of collection or acquisition and characteristics of recipient or parental organism(s) related to biosafety.

(f)	Centre(s) of origin/genetic diversity, if known, of the recipient and/or parental organism(s). [A description of the habitats where the organism may persist or proliferate.]

(g)	Taxonomic status, common name, point of collection or acquisition and characteristics of donor organism(s) related to biosafety.

(h)	Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the LMO [or products thereof].

(i)	Intended use of the LMO [or products thereof].

(j)	Quantity or volume of LMOs [or products thereof] to be transferred.

(k)	[A [known and available] risk assessment report carried out in accordance with Annex II of the Protocol].

(l)	Suggested methods for [safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures] [where appropriate].

(m)	Regulatory status of the LMO [or product thereof] in question within the exporting state (e.g. whether it is prohibited in the state of export, whether there are other restrictions, or whether it has been approved for general release). If the LMO [or product thereof] is banned in the state of export, the reason(s) for such a ban.

(n)	[The result of any notification to other Governments by the [exporter] [applicant] regarding the LMO [or product thereof] and the purpose thereof.]

(o)	[Declaration] that the above-mentioned information is factually correct.

Annex II

(Approved for inclusion in the consolidated negotiating text

for the sixth meeting of the Working Group)

RISK ASSESSMENT

Objective

The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects [of the transboundary movement] [, handling and use ] of LMOs [ or products thereof] on the conservation and sustainable use of biological diversity in the [potential] receiving environment [, taking also into account the risk to human health] [and socio-economic considerations].

Use of risk assessment

The results of risk assessment are used by, inter alia, competent authorities with respect to informed decision making on transboundary movement [, handling and use] of LMOs [or products thereof].

General principles

[The guiding principle of risk assessment is the precautionary approach]. [Based on the precautionary approach,] risk assessment should be carried out in a scientifically sound and transparent manner.

Lack of scientific knowledge or consensus may contribute to uncertainty regarding the level of risk. [This should not be interpreted as indicating [a risk,] an absence of risk, or an acceptable risk].

Risks associated with the transboundary movement [,handling and use] of the LMO [or products thereof] should be considered in the context of the risks posed by using the non-modified recipients or parental organisms in the [potential] receiving environment.

Risk assessment should be carried out on a case-by-case basis. This means that the required information may vary from case to case, depending on the LMOs concerned, their [intended] use and the [potential] receiving environment.

Methodology

To fulfil its objective, risk assessment entails, as appropriate, the following steps:

1.	an identification of any characteristics associated with the [novel [base sequences of the genetic material] [compositions] [combinations]] of the LMO [or products thereof] that may have adverse effects on biological diversity in the [potential] receiving environment[, taking also into account the risk to human health][and socio-economic considerations];

2.	an evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the receiving environment to the LMO [or products thereof];

3.	an evaluation of the consequences should these adverse effects be realized;

4. an estimation of the overall risk posed by the LMO [or products thereof] based on the evaluation of the likelihood and consequences of the identified adverse effects; and

5.	a recommendation as to whether or not the risks are acceptable or manageable [, including, where necessary, identification of strategies to manage these risks and minimise the likelihood of adverse consequences].

[Risk assessment can take into account expert scientific and technical advice [and guidelines developed by relevant international organizations]].

Risk assessment may require more specific information about individual topics, which may be identified and requested during the assessment process, while other topics may not be relevant in some instances.

Depending on the case, risk assessment therefore takes into account the relevant technical and scientific details regarding:

[Characteristics of recipient or parental organism(s)]

The biological, physiological, genetic and ecological characteristics of the recipient/parental organism [related to biosafety] [necessary to conduct the risk assessment].

[Characteristics of donor organism(s)]

The characteristics of the donor organism(s) [necessary to conduct the risk assessment] [including, in particular, pathogenicity and toxicity].

[Characteristics of the vector]

The characteristics of the vector, including its sources and host ranges.

[Characteristics of the inserts]

Characteristics of the nucleic acid or modification introduced.

[Characteristics of the LMO [or products thereof]]

The known differences between the LMO [or products thereof] and its recipient/parental organism [or products thereof] in any biological, physiological, genetic or ecological characteristic.

[Information relating to intended use]

Information relating to the [intended] use of the LMO [or products thereof], including new or changed use compared to the unmodified recipient or parental organism.

[Receiving environment]

Information on the location, geographical, climatic and ecological characteristics of the [potential] receiving environment.

[Resuscitated organism]

[Characteristics of resuscitated organism(s) and gene(s) and fossil DNA sequences.]

[Safety considerations for human and animal health]

[Information on the impact of the LMO on human and animal health]

[Socio -economic considerations]

[Socio-economic considerations] [Information on the potential impacts on the socio-economical patterns of the importing country, especially on traditional practices and national programs on sustainable agriculture.]

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