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THE CARTAGENA PROTOCOLON BIOSAFETY:A RECORD OF THE NEGOTIATIONS1


The designations employed and the presentation of material in this publication do not imply the expressionof any opinion whatsoever on the part of the Secretariat of the ong>Conventionong> on Biological Diversityconcerning the legal status of any country, territory, city or area or of its authorities, or concerning thedelimitation of its frontiers or boundaries.The views expressed in this publication are those of the authors and do not necessarily reflect those ofthe Secretariat of the ong>Conventionong> on Biological Diversity.This publication may be reproduced for educational or non-profit purposes without special permissionfrom the copyright holders, provong>idong>ed acknowledgement of the source is made. The Secretariat of theong>Conventionong> would appreciate receiving a copy of any publications that uses this document as a source.© Secretariat of the ong>Conventionong> on Biological DiversityISBN 92-807-2376-6For more information or additional copies, please contact:The Secretariat of the ong>Conventionong> on Biological DiversityWorld Trade Centre393 St. Jacques, Suite 300Montreal, Quebec, Canada H2Y 1N9Tel : + 1 (514) 288 2220Fax: + 1 (514) 288 6588E-mail: secretariat@biodiv.orgWebsite: http://www.biodiv.orgPHOTO CREDITSE. Purnomo/The Image Works (Woman drops rice)Chatree Wanasangtham/UNEP - Topham/Ponopresse (field Asia)Teuna Van Gyssel /UNEP - Topham/Ponopresse (rice field)J.Schytte/Still Pictures/Alpha Presse (tomatoes)M.Bond/Still Pictures/Alpha Presse (soja)J.Douillet/Bios/Alpha Presse (cereal)2


Article 38 Reservations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Article 39 Withdrawal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Article 40 Authentic Texts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Annex I Information Required in Notifications under Article 8, 10 and 13 . . . . . . . . . . . . . . . . . . . . 102Annex IIInformation Required Concerning Living Modified Organisms Intendedfor Direct Use as Food or Feed, or for Processing Under Article ong>11ong> . . . . . . . . . . . . . . . . . . . 105Annex III Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106APPENDIX I DELETED DRAFT ARTICLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>0Relationship with other international agreements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>0Jurisdictional Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>1Notification of Transit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>1Emergency Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>2Minimum national standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>3Non-discrimination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>4Subsequent Imports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>5Ratification, acceptance or approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>6Accession. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>7OTHER PROPOSALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>7Settlement of Disputes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>7Annex - LMOs that are not likely to have adverse effectson the conservation and sustainable use of biological diversity,taking into account risks to human health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>8Other Annexes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ong>11ong>8APPENDIX II NEGOTIATING SESSIONS AND GROUPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1ong>19ong>APPENDIX III EVOLUTION OF THE CONTENTS OF THE PROTOCOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121APPENDIX IV PROPOSALS FROM GOVERNMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128APPENDIX V LIST OF DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137APPENDIX VITERMS OF REFERENCE FOR THE OPEN-ENDED AD HOCWORKING GROUP (FROM COP DECISION II/5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1404


ABBREVIATIONSAIAAdvance informed agreementBCHong>Biosafetyong> ong>Clearingong> ong>Houseong>BSWGOpen-ended Ad Hoc Working Group on ong>Biosafetyong>BSWG-1 (BSWG-2…)First (second.. etc) meeting of the BSWGCBDong>Conventionong> on Biological DiversityCG-1 Contact Group 1CG-2 Contact Group 2CHMong>Clearingong>-house mechanism to promote and facilitate technical and scientific cooperation (Article 18,CBD)COPConference of the PartiesCOP1 (COP2…)First (second…etc) meeting of the COP (of the CBD)COP/MOPConference of the Parties serving as the meeting of the Parties to the ProtocolCNACompetent national authority (under Article ong>19ong>, ong>Biosafetyong> Protocol)ECEuropean CommunityEUEuropean UnionExCOPFirst extraordinary meeting of the COPIAEAInternational Atomic Energy AgencyICCPIntergovernmental Committee for the ong>Cartagenaong> Protocol on ong>Biosafetyong>ICJInternational Court of JusticeLMOLiving modified organismLMO-FFPLiving modified organism(s) intended for direct use as food or feed, or for processingMOPMeeting of the PartiesNFPNational focal point (under Article ong>19ong>, ong>Biosafetyong> Protocol)Resumed ExCOPResumed session of the first extraordinary meeting of the COPSWG-ISub-Working Group ISWG-IISub-Working Group IIDEFINITION OF TERMSAgenda 21 Agenda 21: Programme of Action for Sustainable Development (UNCED, ong>19ong>92)Compromise GroupNegotiating group formed at the ong>Cartagenaong> meeting, comprising Japan, Korea, Mexico, Norway andSwitzerland, later joined by Singapore and New ZealandCOP-MOPConference of the Parties to the ong>Conventionong> serving as the meeting of the Parties to the ProtocolLike-Minded GroupNegotiating group formed at the ong>Cartagenaong> meeting, comprising the G-77 countries and China, with theexception of Argentina, Chile and UruguayMadrong>idong> ReportThe report of the meeting of the Open-ended Ad Hoc Group of Experts on ong>Biosafetyong> (Madrong>idong>, 24-28 Julyong>19ong>95) (document UNEP/CBD/COP/2/7)Miami GroupNegotiating group comprising Argentina, Australia, Canada, Chile, Uruguay and the USARio Declaration Rio Declaration on Environment and Development (UNCED, ong>19ong>92)UNEP Technical Guong>idong>elines United Nations Environment Programme International Technical Guong>idong>elines on Safety in BiotechnologyVienna informal consultations Consultation meeting held by ExCOP Presong>idong>ent Juan Mayr, 15-ong>19ong> September ong>19ong>99, Vienna, prior to theresumed session of the ExCOP.5


FOREWORDThe adoption of the ong>Cartagenaong> Protocol on ong>Biosafetyong>, in the early hours of Saturday, 29 January 2000,marked the end of a four-year long negotiating process that had been often difficult and at timesappeared intractable. Three years on, the Protocol has now entered into force, and the commitments itcontains have become part of the ever-growing body of international environmental law. At the sametime, the work of the Intergovernmental Committee for the ong>Cartagenaong> Protocol on ong>Biosafetyong>, an interimbody established by the Conference of the Parties to undertake the preparations necessary for the firstmeeting of the Parties to the Protocol, has contributed significantly to further advancing the understandingon some of the key issues.As we look forward to the imminent operationalisation of the Protocol’s provisions, aiming to ensureadequate safety in the movement and use of living modified organisms resulting from modern biotechnologythat may have adverse effects on the conservation and sustainable use of biological diversity andhuman health, it seems an appropriate time to look back and reflect upon how the negotiating processdeveloped and how the final text emerged.The present volume serves as an excellent reference point in this respect. By reflecting the differing viewsduring the genesis of the Protocol and painstakingly charting the negotiation of indivong>idong>ual provisions,including draft articles not included in the final agreed text, The ong>Cartagenaong> Protocol on ong>Biosafetyong>: A Recordof the Negotiations provong>idong>es us with a history of the gestation and birth of the Protocol to help us understandwhy it took the final shape that it dong>idong>.The record has been meticulously compiled by the Foundation for International Environmental Law andDevelopment and will serve to inform those who dong>idong> not attend the negotiating sessions and refresh thememories of those who dong>idong>. I wish to extend my sincere thanks to the members of the FIELD team fortheir fruitful cooperation and the accuracy and attention to detail displayed in producing this valuabletool. I am confong>idong>ent that it will be of service to all those interested in the evolution and implementationof the Protocol.Hamdallah ZedanExecutive SecretaryMontreal, September 20036


I. INTRODUCTIONThis paper seeks to record the evolution of theong>Cartagenaong> Protocol on ong>Biosafetyong> to the ong>Conventionong>on Biological Diversity from the initial provisionin Article ong>19ong>(3) of the ong>Conventionong> itselfthrough to the final adoption of the text of theProtocol in January 2000.The paper aims to contribute to the institutionalmemory and to the historical record of the ong>Conventionong>on Biological Diversity. 1 It has beendeveloped by the Foundation for InternationalEnvironmental Law and Development (FIELD)at the request of the Executive Secretary of theSecretariat of the ong>Conventionong> on Biological Diversity(CBD). 2 Drafts of this paper were reviewed bythe CBD Secretariat and by a Steering Committeeestablished by the Executive Secretary 3 comprisinga number of indivong>idong>ual delegates who wereclosely involved in the negotiations. The contentsof the paper, however, remain the responsibilityof FIELD and do not necessarily reflect the viewsof the Secretariat of the ong>Conventionong> on BiologicalDiversity, or that of any of the reviewers, or of anyParty.This paper is structured as follows:The Background section provong>idong>es a brief overviewof the process undertaken in respect of Articleong>19ong>(3) of the ong>Conventionong>, including the work of theConference of the Parties at its first meeting, thework of the Open-ended Ad Hoc Working Groupon ong>Biosafetyong> (BSWG), and the two sessions of theExtraordinary Meeting of the Conference of theParties (ExCOP). It also provong>idong>es an overview of thestructure of the negotiations, including, for example,the Sub-Working Groups and Contact Groupsestablished by the BSWG, which are referred tothroughout the remainder of the document.At the heart of the paper, in Section III, is an article-by-articleanalysis of the development of theprovisions of the Protocol. The reader will need tobear in mind, however, that the elaboration of theProtocol was not a sequential process. Indeed, itwas a complex negotiating process with multiplesimultaneous and inter-linked strands, where theresolution of one issue would be contingent uponthe agreement on text under another in a sometimesbewildering set of interlocking dependenciesand trade-offs.Section III is based principally upon the officialdocumentation related to the negotiations, thatis, the reports of the meetings of the BSWG andthe ExCOP, pre-session documents including governmentsubmissions, and published reports ofconsultation meetings. These documents are allavailable on the website of the ong>Conventionong> on BiologicalDiversity at http://www.biodiv.org. In addition,in relation to some articles, reference is madeto the reports of the Earth Negotiations Bulletin. 4For clarification of the numbering of the articles ofthe Protocol over the course of the negotiations,the reader should refer to Appendix III. The analysisof the elaboration of each article in Section IIIdoes not necessarily make specific reference to allgovernment submissions made in respect of theprovision in question during the course of thenegotiations. However a full list of governmentsthat made submissions to each meeting of theBSWG is contained in Appendix IV.Appendix I traces the development and fate ofdraft articles of the Protocol that were proposedand discussed during the course of the negotiations,but that were deleted and are not includedin the final text of the Protocol.1For a set of personal recollections of some of those involved in the negotiations, see Christoph Bail, Robert Falkner and Helen Marquard (eds.), Theong>Cartagenaong> Protocol on ong>Biosafetyong>: Reconciling Trade in Biotechnology with Environment and Development? (London, Earthscan, 2002). For a detailedguong>idong>e to the provisions of the Protocol, see Ruth Mackenzie, Françoise Burhenne-Guilmin, , Antonio G.M. La Viña and Jacob Werksman, in cooperationwith Alfonso Ascencio, Julian Kinderlerer, Katharina Kummer and Richard Tapper, An Explanatory Guong>idong>e to the ong>Cartagenaong> Protocol on ong>Biosafetyong>, (IUCNEnvironmental Policy and Law Paper No. 46, 2003). The Secretariat and the United Nations Environment Programme have also produced a simplifiedguong>idong>e to the ong>Cartagenaong> Protocol on ong>Biosafetyong>, ong>Biosafetyong> and the Environment: An Introduction to the ong>Cartagenaong> Protocol on ong>Biosafetyong> (Belegarde, France,Sadag, SA, 2003), available at http://www.biodiv.org.2The FIELD team comprised Fernando Latorre, Ruth Mackenzie, Tony Gross, Elsa Tsioumani, and Catherine McLellan.3The Steering Committee comprised Mr. John Herity (Canada), Mr. Desmond Mahon (Canada), Mr. Cristian Samper (Colombia), Mr. Veit Koester(Denmark), Dr. Tewolde Berhan Gebre Egziabher (Ethiopia), Mr. Gabor Nechay (Hungary), Mr. François Pythoud (Switzerland), and Ms. Helen Marquard(UK).4These reports are available at http://www.iisd.ca.7


I. INTRODUCTIONAppendix II records the chronology of meetings,and also sets out the list of chairs and co-chairs ofthe various bodies established during the negotiations.Appendix III outlines the evolution of the structureof the Protocol. This Appendix is provong>idong>ed in orderto assist the reader, given that over the course ofthe negotiations the numbering of the articles ofthe Protocol was revised a number of times as theelaboration of the Protocol progressed.Appendix IV records the governments that submittedwritten proposals during the course of thenegotiations.Finally, Appendix V lists the extensive officialdocumentation related to the negotiation ofthe Protocol. This list does not include in-sessiondocuments.8


II. BACKGROUNDThe ong>Conventionong> on Biological DiversityArticle ong>19ong>(3) of the ong>Conventionong> provong>idong>es that:The Parties shall consong>idong>er the need forand modalities of a protocol setting outappropriate procedures, including, inparticular, advance informed agreement,in the field of the safe transfer, handlingand use of any living modified organismresulting from biotechnology that mayhave adverse effect on the conservationand sustainable use of biological diversity.This provision resulted from differing views duringthe negotiation of the ong>Conventionong>. Somecountries felt that the ong>Conventionong> should includea provision making mandatory the developmentof a future protocol on biosafety, whilst otherspreferred a provision requiring Parties to consong>idong>erthe need for a protocol. 5Resolution 2 of the Nairobi Final Act adopting theong>Conventionong> on Biological Diversity invited UNEPto consong>idong>er, inter alia, Article ong>19ong>(3) of the ong>Conventionong>.Consequently, Expert Panel IV established byUNEP consong>idong>ered the need for, possible elementsof and modalities of a protocol on biosafety. Thefinal report of the Panel was published in Aprilong>19ong>93. 6 However the report of Panel IV was notdirectly taken up and was not part of the formaldocumentation for the first meeting of the Conferenceof the Parties to the ong>Conventionong>.The Nairobi Final Act also established an IntergovernmentalCommittee on the ong>Conventionong> onBiological Diversity (ICCBD) to prepare for the firstmeeting of the Conference of the Parties of theong>Conventionong>. Article ong>19ong>(3) was taken up in WorkingGroup I of the ICCBD. 7 There was a generalagreement in the Working Group on the need foradequate and transparent safety and bordercontrol procedures to manage and control therisks associated with the use and release of LMOsresulting from modern biotechnology, to enablethe potential benefits of biotechnology to be maximised,and to gain wong>idong>espread public acceptance,especially in developing countries. 8 However, therewere different views on the need for and modalitiesof a protocol, and the report of the ICCBD reflectsthe different views expressed on this issue. 9 TheICCBD recommended that the issue of biosafetyshould be on the agenda of the first meeting of theConference of the Parties to the ong>Conventionong> to initiatethe process specified in Article ong>19ong>(3). 10The Conference of the PartiesThe first meeting of the Conference of the Partiesto the ong>Conventionong> (Nassau, Bahamas, Novemberong>19ong>94) decong>idong>ed, ong>11ong> as part of its medium-term programmeof work, to arrange two meetings in theinter-sessional period prior to its second meeting.The principal meeting was to comprise “an openendedad hoc group of experts nominated byGovernments without undue delay to consong>idong>er theneed for and modalities of a protocol setting outappropriate procedures, including, in particular,advance informed agreement, in the field of thesafe transfer, handling and use of any living modifiedorganism resulting from biotechnology thatmay have adverse effects on the conservation andsustainable use of biological diversity.” This groupwas to meet for a week during ong>19ong>95 and was to“consong>idong>er, as appropriate, existing knowledge,experience and legislation in the field of biosafety,including the views of the Parties, subregional,regional and international organisations, with aview to presenting a report for the consong>idong>erationof the second meeting of the Conference of theParties, so as to enable the Conference of the Partiesto reach an informed decision as to the needfor and modalities of a protocol”.In order to prepare for the work of the groupof experts, the COP requested the Secretariat toestablish:5Mackenzie et al (2003), p.2.6UNEP/Bio.Div./Panels/Inf.4, Report of Panel IV, Nairobi, 28 April ong>19ong>93.7See UNEP/CBD/IC/2/12, Note by the Interim Secretariat on consong>idong>eration of the need for and modalities of a protocol on biosafety.8UNEP/CBD/COP/1/4, Report of the Intergovernmental Committee on the ong>Conventionong> on Biological Diversity, para. 223.9Ibong>idong>., paras. 223-229.10Ibong>idong>., para 229.ong>11ong>Decision I/9, paras.3-89


II. BACKGROUNDa panel of 15 experts nominated by Governments,with an equitable geographicalrepresentation, in consultation with theBureau of the COP, assisted by UNIDO,UNEP, FAO and WHO, to prepare a backgrounddocument to be submitted tothe open-ended ad hoc group of expertsnominated by Governments based on aconsong>idong>eration, as appropriate, of existingknowledge and experience on risk assessmentand management, and guong>idong>elinesand/or legislation already prepared bythe Parties, other Governments and bynational and competent subregional,regional and international organisations. 12The meeting of the panel of experts took placein Cairo in May ong>19ong>95 and that of the Ad HocGroup of Experts in Madrong>idong> in July ong>19ong>95. TheMadrong>idong> meeting concluded that there was aneed for an international framework for safetyin biotechnology. 13 The Madrong>idong> report ong>idong>entifieda number of issues, which, it was agreed, shouldbe addressed within the international frameworkon biosafety, including a procedure for advanceinformed agreement. 14 Other issues were ong>idong>entifiedwhich, though not yet enjoying consensus,were supported by many delegations, includingsocio-economic consong>idong>erations, and liability andcompensation. 15 The large majority of delegationsfavoured the development, within the context ofthe international framework, of a protocol underthe CBD. 16The second meeting of the COP (Jakarta, Indonesia,November ong>19ong>95) consong>idong>ered the report ofthe Madrong>idong> meeting 17 and, after extensive negotiations,agreed to establish an Open-ended AdHoc Working Group on ong>Biosafetyong> under the COPto “seek solution to the […] concerns through anegotiation process to develop, in the field of thesafe transfer, handling and use of living modifiedorganisms, a protocol on biosafety, specificallyfocusing on transboundary movement, of anyliving modified organism resulting from modernbiotechnology that may have adverse effect onthe conservation and sustainable use of biologicaldiversity, setting out for consong>idong>eration, in particular,appropriate procedure for advance informedagreement.” 18The COP specified the terms of reference of theWorking Group in an annex to the decision (seeAppendix VI below). The Working Group was to“endeavour to complete its work in ong>19ong>98”. ong>19ong> DecisionII/5 also clarified that the subject of the protocolwas “living modified organisms resulting frommodern biotechnology,” a narrower category oforganisms than that referred to in Articles 8 (g)and ong>19ong> of the ong>Conventionong>, which use the term“living modified organisms resulting from biotechnology”.The Open-ended Ad Hoc WorkingGroup on ong>Biosafetyong>The Open-ended Ad Hoc Working Group (theBSWG) met six times between ong>19ong>96 and ong>19ong>99under the chairmanship of Mr. Veit Koester (Denmark).The first two meetings – BSWG-1 (Aarhus,July ong>19ong>96) and BSWG-2 (Montreal, May ong>19ong>97)– constituted a phase of ong>idong>entifying the elementsof the future protocol. Appendix III (Evolution ofthe contents of the Protocol) provong>idong>es the state ofprogress after both these meetings by listing the“Possible Contents of the Protocol on ong>Biosafetyong>”ong>idong>entified at BSWG-1 and the “Chairman’s Summaryof Elements Presented” contained in thereport of BSWG-2. 2012Id.13UEP/CBD/COP/2/7, Annex I, para. 6.14Ibong>idong>., para. 18(a)15Ibong>idong>., para. 18(b).16Ibong>idong>., para 20.17UNEP/CBD/COP/2/7.18Decision II/5ong>19ong>Decision II/5, Annex, para. 10.20See also, UNEP/CBD/ExCOP/1/3, paras. 29-30.10


II. BACKGROUNDAt BSWG-2, the first of a series of negotiatinggroups was established, a contact group ondefinitions. At BSWG-3 this group, which becameknown as Contact Group 1 (CG-1), had its mandateextended to deal also with annexes to the Protocol,and was supplemented by three other groups.Contact Group 2 (CG-2) was mandated to addressinstitutional matters and final clauses; Sub-WorkingGroup I (SWG-I) was charged with dealing withthe advance informed agreement procedure andrelated issues, including articles on risk assessmentand risk management; and Sub-Working Group II(SWG-II) dealt with a diverse range of remainingissues, including capacity-building, the clearinghouse and socio-economic consong>idong>erations. 21 Eachof these groups was co-chaired by one developedcountry Party and one developing country Partyrepresentative. The sub-working group and contactgroup structure was maintained until theearly phases of BSWG-6 in ong>Cartagenaong> (see below).At BSWG-5 another small group was charged withaddressing the issue of liability and redress; 22 andat BSWG-6 a Legal Drafting Group was formed toreview draft articles of the Protocol to ensure legalconsistency and wording in the text of the Protocol.23 The issues addressed by the Sub-WorkingGroups and Contact Groups were clearly closelylinked and, during the course of the negotiations,issues moved between the groups. Given theclose links between the tasks charged to ContactGroup 1 and Sub-Working Group I, it was decong>idong>edat BSWG-4 to make Contact Group 1 a sub-groupof Sub-Working Group I, reporting to it, in order toavoong>idong> duplication in the discussions and to ensurecoordination of work. 24 A table showing the varioussub-groups and contact groups, and their cochairs,is contained in Appendix II.At BSWG-3 (Montreal, October ong>19ong>97) the timepressures began to be felt. Article 28 of the ong>Conventionong>stipulates that the text of the proposedprotocol be communicated to the ContractingParties at least six months before the meeting toadopt such a protocol. As the Working Group hadbeen asked to complete its work in ong>19ong>98 and wasdue to meet for the fourth time in February ong>19ong>98,and as the COP itself was due to meet in May ong>19ong>98,there was the possibility of completing the negotiationsduring this period. However, to meet therequirements of Article 28 a text of the protocolwould need to be ready at the end of BSWG-3.Chair Koester argued that the term “text of a proposedprotocol” as contained in Article 28 couldbe defined as “a draft text of a protocol that allGovernments agree constitutes sufficient groundfor the completion of the negotiating processand the adoption of the protocol, meaning thatall options and elements should be contained inthe consolong>idong>ated draft in legal terms”. 25 On thisbasis BSWG-3 developed the ‘consolong>idong>ated textof draft articles’, which constituted the first structuredoutline of the future protocol and served asthe basis for future negotiations. It contained thetitle, a preamble, 43 articles and five annexes (seeAppendix III). (The title at this stage was simply“ong>Biosafetyong> Protocol”.) 26By BSWG-4 (Montreal, February ong>19ong>98), while theWorking Group entered the negotiating phase, 27it was clear that the protocol would not be readyfor adoption at the fourth meeting of the COP inMay ong>19ong>98. The COP accepted that the WorkingGroup would need more time and approved twofurther meetings of the Working Group – the first(BSWG-5) to be held in August ong>19ong>98 and the second(BSWG-6) in February ong>19ong>99. BSWG-6 would beimmediately followed by an extraordinary meetingof the COP (ExCOP) to adopt the text of theprotocol. 28For BSWG-5 (Montreal, August ong>19ong>98) the Secre-21See UNEP/CBD/BSWG/3/6, paras. 17-25.22This group was established by Contact Group 2. See UNEP/CBD/BSWG/5/3, para. 53. The group was retained at BSWG-6, see UNEP/CBD/ExCOP/1/2,para. 21.23UNEP/CBD/ExCOP/1/2, para. 18. In the earlier phases of the BSWG, a legal drafting function was also carried out by Contact Group 2. See UNEP/CBD/BSWG/5/3, para. ong>19ong>.24UNEP/CBD/BSWG/4/4, para. 17.25UNEP/CBD/BSWG/3/6, para.9826See UNEP/CBD/ExCOP/1/3, para. 31.27UNEP/CBD/ExCOP/1/3, para. 32.28Decision IV/3.ong>11ong>


II.BACKGROUNDtariat prepared a “revised consolong>idong>ated text of thedraft articles” (see Appendix III). At the end of themeeting, although agreed text on a number of thefinal clauses had been provisionally adopted, andthe Working Group had managed to focus furtherelements and articles to form the protocol, 29 fifteenof the substantive articles remained entirelyin square brackets.Disagreement on these key provisions persistedthroughout BSWG-6 (ong>Cartagenaong>, February ong>19ong>99),with further consultations taking place amongthe “Friends of the Chair”, a group of indivong>idong>ualsnominated by the regional groups to assist theChair of the BSWG. 30 However, with no resolutionof the outstanding issues, the Chair of the BSWGattempted to resolve the impasse by preparing a“clean text”, containing compromise wording onthe outstanding issues, to be transmitted by theWorking Group to the ExCOP. 31 This documentis frequently referred to in the remainder of thisdocument as the “Chair’s text” or “Chair’s proposedtext”. While many delegations expressed concernsabout aspects of this text, 32 in the absence of furtheragreement on its content it was agreed thatthe BSWG would forward this text with its reportto the ExCOP. 33The Extraordinary Meeting of theConference of the PartiesHowever, during the ExCOP, which immediatelyfollowed BSWG-6, Parties could not agree on theadoption of the Chair’s text, nor on any of theother proposals put forward by the various negotiatinggroups. The ExCOP was suspended. 34 However,before the suspension of the meeting, theExCOP agreed that the title of the Protocol, oncefinalised and adopted, would be the “ong>Cartagenaong>Protocol on ong>Biosafetyong>”. 35Following the suspension of the meeting, the Presong>idong>entof the ExCOP, Minister Juan Mayr (Colombia),embarked on a series of informal negotiationsinvolving the five distinct negotiating groups thathad emerged during the course of the ong>Cartagenaong>meetings: the Central and Eastern Europe Group,the Compromise Group, 36 the European Union,the Like-minded Group, 37 and the Miami Group. 38Informal negotiations took place in Montreal(1 July ong>19ong>99) 39 and in Vienna (15-ong>19ong> Septemberong>19ong>99). 40 It was during the latter meeting that MinisterMayr’s preferred arrangement of a hexagonalnegotiating table, seating the Chair and representativesof the five negotiating groups, with otherdelegations seated behind, became the locus ofthe discussions. These arrangements, which hadfirst been used in the later stages of the ExCOP inong>Cartagenaong>, became known as the “Vienna setting”,and were to be used again in the resumed sessionof the ExCOP in Montreal in January 2000.In December ong>19ong>99, Minister Mayr circulated hisdraft proposal for addressing the essential coreissues: the scope of the protocol (Article 4); applicationof the advance informed agreement procedure(Article 5) with regard to LMOs intended fordirect use as food or feed, or for processing (“com-29UNEP/CBD/ExCOP/1/3, para. 34.30UNEP/CBD/ExCOP/1/2, para. 22.31UNEP/CBD/BSWG/6/L.2. Corrected versions of this document were issued as UNEP/CBD/BSWG/6/L.2/Corr.1 and UNEP/CBD/BSWG/6/L.2/Rev.1, anda further version as revised by the Legal Drafting Group as UNEP/CBD/BSWG/6/L.2/Rev.2. The latter version was annexed to the report of the BSWG tothe Extraordinary Meeting of the Conference of the Parties, see UNEP/CBD/ExCOP/1/2, Annex.32UNEP/CBD/ExCOP/1/2, paras.41-45.33UNEP/CBD/ExCOP/1/2, para. 40 and Annex.34Decision EM-I/1, para.1.35Decision EM-I/1, para. 3.36Japan, Korea, Mexico, Norway and Switzerland, later joined by Singapore and New Zealand.37The G-77 and China (less the three members in the Miami Group).38Argentina, Australia, Canada, Chile, Uruguay and USA.39Informal consultation on the process to resume the ExCOP to adopt a protocol on ong>Biosafetyong>, 1 July ong>19ong>99, UNEP/CBD/ExCOP/1/INF/2.40Informal consultation on the process to resume the ExCOP to adopt a protocol on ong>Biosafetyong>, 15-ong>19ong> September ong>19ong>99, UNEP/CBD/ExCOP/1/INF/3.12


II. BACKGROUNDmodities”); and the relationship of the protocolwith other international agreements (Article 31). 41Further informal consultations took place in Montrealimmediately before the resumed sessionof the ExCOP. The informal consultations (22-23January 2000) and the resumed ExCOP (24-28January 2000) addressed the outstanding “core”issues – those ong>idong>entified in the Chairman’s nonpaper– as well as ong>idong>entification and documentation,and reference to the precautionary principle.Contact groups were established addressing,respectively, scope, commodities, and trade issues(including precaution), and one representativewas charged with coordinating consultations onother outstanding “non-core” issues. As notedabove, with the exception of formal plenary sessions,and negotiations in the contact groupsand in consultations, the resumed session of theExCOP was held in the Vienna Setting.With more than thirty Ministers taking part in thenegotiations, the final compromise was reachedon the core issues, and the text of the ong>Cartagenaong>Protocol on ong>Biosafetyong> was adopted at 4:50 a.m. on29 January 2000. 4241“Non-paper” dated 21 December ong>19ong>99, conveyed to all CBD National Focal Points and to the spokespersons of the five negotiating groups.42The final text of the Protocol was contained in document UNEP/CBD/ExCOP/1/L.5, submitted to the plenary of the ExCOP by the Legal DraftingGroup. One further amendment to Article 18(2)(a) was introduced orally by the Presong>idong>ent, on the basis of final consultations, prior to the adoption ofthe Protocol. See UNEP/CBD/ExCOP/1/3, paras. 90-92, The text of the Protocol is annexed to decision EM-I/3 adopted by the Conference of the Parties,Decision EM-I/3, para. 1.13


III. TEXT OF THE PROTOCOLPreambleThe Parties to this Protocol,Being Parties to the ong>Conventionong> on BiologicalDiversity, hereinafter referred toas “the ong>Conventionong>”,Recalling Article ong>19ong>, paragraphs 3 and 4,and Articles 8 (g) and 17 of the ong>Conventionong>,Recalling also decision II/5 of 17 Novemberong>19ong>95 of the Conference of the Partiesto the ong>Conventionong> to develop a Protocolon biosafety, specifically focusing ontransboundary movement of any livingmodified organism resulting from modernbiotechnology that may have adverseeffect on the conservation and sustainableuse of biological diversity, settingout for consong>idong>eration, in particular, appropriateprocedures for advance informedagreement,Reaffirming the precautionary approachcontained in Principle 15 of the Rio Declarationon Environment and Development,Aware of the rapong>idong> expansion of modernbiotechnology and the growing publicconcern over its potential adverse effectson biological diversity, taking also intoaccount risks to human health,Recognising that modern biotechnologyhas great potential for human well-beingif developed and used with adequatesafety measures for the environment andhuman health,Recognising also the crucial importance tohumankind of centres of origin and centresof genetic diversity,Taking into account the limited capabilitiesof many countries, particularly developingcountries, to cope with the nature andscale of known and potential risks associatedwith living modified organisms,Recognising that trade and environmentagreements should be mutually supportivewith a view to achieving sustainabledevelopment,Emphasising that this Protocol shall not beinterpreted as implying a change in therights and obligations of a Party under anyexisting international agreements,Understanding that the above recital isnot intended to subordinate this Protocolto other international agreements,Have agreed as follows:A number of countries prepared text or submittedviews on the preamble prior to BSWG-2. 43 The Africangroup in its draft preambular text introducedseveral elements that would be reflected in thefinal text. For example, it referred to Article 8(g) ofthe ong>Conventionong>, acknowledged the rapong>idong> expansionof biotechnology and growing public concernover potential adverse effects, acknowledgedthe limited capabilities of developing countries tocope with associated risks, and recalled the precautionaryprinciple. The precautionary principlewas referred to by Canada, the EU and, implicitlyby Norway. The EU also recalled decision II/5 ofCOP 5 (as dong>idong> Australia) and referred to Article ong>19ong>paragraphs 3 and 4 of the ong>Conventionong> (as dong>idong> theAfrican group and Norway). Norway noted theadvantages and potential of biotechnology butrecognised that significant gaps in knowledgehad been ong>idong>entified and, along with the Africangroup and the EU, pointed out the threat ofsignificant reduction or loss of biological diversity.The African group also referred to social andeconomic welfare. On the other hand, Switzerlandproposed that the Protocol should only deal withsafety issues complementary to existing internationalinstruments, in particular the WTO, and thatsocio-economic implications of biotechnology beaddressed in other frameworks. Both Switzerlandand the EU called for a flexible system to amendthe Protocol so that it could adapt to appropriatescientific and technical developments.BSWG-2, however, dong>idong> not discuss the preambleand it was agreed not to prepare any text at thatstage. 44At BSWG-3, the Working Group decong>idong>ed that theChair should prepare a draft preamble on the43UNEP/CBD/BSWG/2/2, pp. 2-7, contains the submissions of the African group, Australia, Canada, the EU, Norway, Switzerland and the US.44UNEP/CBD/BSWG/2/6, para. 166.14


III. TEXT OF THE PROTOCOLbasis of government submissions and elementssuggested by the Chairman himself, for consong>idong>erationat the following meeting. 45 The consolong>idong>atedtext at the end of BSWG-3 included three optionsreproducing in their entirety the submissions ofthe African group, the EU and Norway respectively.46Prior to BSWG-4, the US submitted further drafttext, the focus of which was to base the Protocolon scientific risk assessment whilst avoong>idong>ingunnecessary delays to bringing the benefits ofbiotechnology. 47 It also referred to Article 17 ofthe ong>Conventionong> (Exchange of Information).At BSWG-4, the preamble was discussed in CG-2and the draft text was reduced to a short anda long option. 48 The short option included textrecognising the value of modern biotechnologyand the limited capacity of some countries to dealwith its risks. The long version included the mainelements of the various proposals and referred tothe UNEP Technical Guong>idong>elines 49 and to Agenda21; the precautionary principle; significant gapsin scientific knowledge; capacity building; andadequate compensation for damages arisingfrom the handling and transfer of LMOs. It alsocalled for the avoong>idong>ance of unnecessary delays,in particular unwarranted administrative requirements,whilst acknowledging public concern overpotential adverse effects (including socio-economiceffects). As disagreement remained on thelevel of detail, the Contact Group decong>idong>ed to leavethe draft preamble open and subject to furtheramendment, pending finalisation of the entiretext of the Protocol. 50 In addition, there were anumber of important issues in relation to which ithad not yet been decong>idong>ed whether they should bethe subject of separate articles or instead includedin the preamble. These included: socio-economicconsong>idong>erations, capacity-building, public awarenessand participation, non-Parties, non-discrimination,and relationship with other conventions. 51At BSWG-5, Ambassador Ashe, Co-Chair of CG-2,reiterated the decision to defer any consong>idong>erationof the preamble until BSWG-6, when an overallgeneral framework of the Protocol would be inplace. 52During the first discussion of the preamble byCG-2 at BSWG-6, delegates agreed to insert languageon the importance of centres of originand of genetic diversity. 53 A footnote indicatingthat additional language could be added only ifagreed upon by other negotiating groups (includingthose consong>idong>ering the precautionary principle,socio-economic consong>idong>erations, and liability andredress) was also added. 54 Both the long andthe short options for the Preamble preparedat BSWG-4 were consong>idong>ered, and text from thelonger version was later added to the shorter. 55Although some delegates supported referenceto the precautionary principle, socio-economicconsong>idong>erations, and liability and redress, theyagreed to allow the sub-groups discussing thoseissues to decong>idong>e whether or not to include themin the preamble. The single version that was finallyagreed included the precautionary “approach” ascontained in the Rio Declaration, while omittingreferences to socio-economic consong>idong>erationsand liability. The Chair’s text 56 contained thislanguage, including references to: Articles 8(g),17 and ong>19ong> of the ong>Conventionong>; decision II/5 of theCOP; the precautionary approach; the expansionof biotechnology and growing public concern45UNEP/CBD/BSWG/3/6, para. 84.46Ibong>idong>., Annex I, see Preamble.47UNEP/CBD/BSWG/4/3, pp. 1-2.48UNEP/CBD/BSWG/4/4, para. 29; Annex III.49United Nations Environment Programme International Technical Guong>idong>elines on Safety in Biotechnology.50UNEP/CBD/BSWG/4/4, para. 29.51See now sections on Articles 26, 22, 23 and 24 below.52UNEP/CBD/BSWG/5/3, para. 52.53ENB Vol. 9 No. ong>11ong>2, p. 2.54Id.55ENB Vol. 9 No. ong>11ong>7.56UNEP/CBD/BSWG/6/L.2/Rev.1, see the Preamble.15


III. TEXT OF THE PROTOCOLover potential adverse effects on biodiversity andhuman health; the potential of biotechnologyfor human well-being; the importance of centresof origin and genetic diversity; and the limitedcapabilities of many countries to cope with risksassociated with LMOs.Ms. Kummer (Switzerland), Co-Chair of CG-2,reported the satisfactory conclusion of the workof the Group on the preamble during BSWG-6. 57However, a significant addition to the text wouldtake place at a later stage. Following the informalconsultations that took place in Montreal andVienna prior to the resumed ExCOP, Presong>idong>entMayr prepared a non-paper which suggesteddeleting the article on Relationship of the Protocolwith other International Agreements (thenArticle 31), and instead reflecting its content inthe preamble. 58 The non-paper proposed thatthe preamble should note that “there are otherinternational agreements relevant to sustainabledevelopment”, that “trade and environment agreementsshould be mutually supportive” and thatthe “Protocol and other international agreementsare of equal status”.There was further discussion on the core clusterof trade issues (Articles 31 and 22 (Non-discrimination))at the resumed ExCOP. Based onthe Presong>idong>ent’s non-paper, the contact group onArticles 31 and 22 proposed in a working paperthat those articles be deleted and their contentreflected in three preambular paragraphs. 59 Thegroup then sought to reach agreement on thesepreambular paragraphs. 60 Following further discussionsand high-level consultations, 61 the finaltext of the Protocol was submitted by the LegalDrafting Group to the plenary and was adoptedon 29 January 2000.57UNEP/CBD/ExCOP/1/2, para. 31.58Draft Chairman’s Proposal for Addressing the Essential Core Issues of the Scope of the Protocol (Article 4), Application of the Advance InformedAgreement (Article 5) with regard to Living Modified Organisms intended for Direct Use as Food or Feed or for Processing (“Commodities”) andRelationship of the Protocol with Other International Agreements (Article 31). Non-paper dated 21 December ong>19ong>99.59UNEP/CBD/ExCOP/1/3, para. 63.60Ibong>idong>., para. 85.61Ibong>idong>., para. 87.16


III. TEXT OF THE PROTOCOLReference to the precautionary principle emergedat BSWG-5, when the EC proposed its inclusion. 70Following negotiations in SWG-II, the result atthe end of BSWG-5 was a single bracketed text, 71with the references to the precautionary principle,‘products thereof’, risks to human health andsocio-economic imperatives still remaining to beresolved in Article 1, as well as in other parts of theProtocol. 72 Consensus was not reached on whetherthe Protocol would deal with LMO-relatedactivities other than transboundary movement,while references to animal health and sustainabledevelopment were removed.During BSWG-6, delegates in SWG-II were unableto make further progress. The issue was transferredto a Friends of the Chair group in BSWG-6.The final text 73 may be seen as a compromisebetween the opposing views. There are thus referencesto the precautionary ‘approach’ rather than‘principle’, linked to a reference to Principle 15 ofthe Rio Declaration, and to risks to human health.References to ‘products thereof’ and ‘socio-economicimperatives’ were removed. The text thenremained unaltered until it was adopted at theresumed ExCOP in January 2000.70UNEP/CBD/BSWG/5/2, p. 15.71UNEP/CBD/BSWG/5/3, Annex, see Article 1.72UNEP/CBD/BSWG/6/8, p. 14.73UNEP/CBD/ExCOP/1/2, p. 18.18


III. TEXT OF THE PROTOCOLArticle 2: General Provisions1. Each Party shall take necessary andappropriate legal, administrative andother measures to implement its obligationsunder this Protocol.2. The Parties shall ensure that the development,handling, transport, use, transferand release of any living modified organismsare undertaken in a manner thatprevents or reduces the risks to biologicaldiversity, taking also into account risks tohuman health.3. Nothing in this Protocol shall affect in anyway the sovereignty of States over their territorialsea established in accordance withinternational law, and the sovereign rightsand the jurisdiction which States have intheir exclusive economic zones and theircontinental shelves in accordance withinternational law, and the exercise by shipsand aircraft of all States of navigationalrights and freedoms as provong>idong>ed for in internationallaw and as reflected in relevantinternational instruments.4. Nothing in this Protocol shall be interpretedas restricting the right of a Party totake action that is more protective of theconservation and sustainable use of biologicaldiversity than that called for in thisProtocol, provong>idong>ed that such action is consistentwith the objective and the provisionsof this Protocol and is in accordancewith that Party’s other obligations underinternational law.5. The Parties are encouraged to take intoaccount, as appropriate, available expertise,instruments and work undertaken ininternational forums with competence inthe area of risks to human health.An article on general provisions was included insome, but not all, proposals on the possible contentsof the future Protocol, 74 and some writtensuggestions were submitted prior to BSWG-2. 75The submissions of the African region and Norwayincluded language on taking appropriate “legal,administrative and other measures to implementand enforce the provisions of this Protocol, includingmeasures to prevent and punish conduct incontravention of the Protocol.” These proposalsconstitute the origin of the first paragraph of thefinal text. The starting point of the article’s secondparagraph can be traced to the African region proposal,which however, went further by referencingrisks to human and animal health, biological diversity,the environment and socio-economic welfareof societies. 76 Finally, the African region text alsoincluded language on Parties imposing additionalrequirements that are consistent with the Protocoland in accordance with the rules of internationallaw, provong>idong>ing the basis for the fourth paragraphof the final text. BSWG-2 delegates held no discussionson this issue, but agreed to retain it andaddress it at a later stage. 77A number of delegations submitted text for consong>idong>erationat BSWG-3. 78 The EC’s proposal includedlanguage on the sovereignty of States over theirterritorial sea, drawn from Article 4.12 of the Baselong>Conventionong> on the Control of TransboundaryMovement of Hazardous Wastes and their Disposal.This provision remained unaltered in thefinal text. 79 By the end of the meeting, delegateshad agreed to consolong>idong>ate options submitted bythe African region, Australia, Brazil, Colombia, theEC, Norway, South Africa and Switzerland. 80 SWG-IIwas then requested to define elements or developlegal text.74UNEP/CBD/BSWG/1/4, Annex.75UNEP/CBD/BSWG/2/2, pp. 48-51, contains the submissions of the African region, Norway and Switzerland.76UNEP/CBD/BSWG/2/2, p. 43.77UNEP/CBD/BSWG/2/6, para. 176.78UNEP/CBD/BSWG/3/5 contains the submissions of the African region, Australia, Brazil, Colombia, EC, South Africa and Switzerland.79See Article 2(3).80UNEP/CBD/BSWG/3/6, para. 82, and Annex I, see Article 1bis.ong>19ong>


III. TEXT OF THE PROTOCOLMore submissions were received prior to BSWG-4, 81and Chair Koester consolong>idong>ated different optionsto facilitate negotiations. 82 With several delegationscalling for brevity, discussions resulted in theretention of four bracketed options, 83 includinga zero (no provision) option as suggested by theUS. 84Prior to BSWG-5, a number of governments submittedtheir views. 85 Debate in SWG-II focusedon the need for such a provision and the level ofdetail required. The outcome of the discussionsat BSWG-5 was a single bracketed option withparagraphs on: implementation measures; cooperationfor implementation; prohibition of LMOexports until an AIA is obtained; 86 prevention orreduction of risks to biological diversity; the sovereigntyof States over their territorial sea; and theright of a Party to take action that is more protectiveof biodiversity. 87The article on general provisions took its final formin the Chair’s proposed text 88 at BSWG-6. The fifthparagraph, on Parties taking into account availableexpertise in the area of risks to human health,was added as part of a compromise related to theinclusion of a reference to risks to human healthin the Protocol’s objective. Following revision bythe Legal Drafting Group, the title of the provisionwas changed to “General Provisions.” 89 Delegatesin the resumed ExCOP addressed the article’sfourth paragraph as part of the thematic clusterrelated to the relationship of the Protocol to otherinternational agreements, 90 and the second paragraphin the context of discussions under Article18 (Handling, Transport, Packaging and Identification).However, the language remained unalteredand only editorial corrections were made prior tothe article’s final adoption on 26 January 2000.81UNEP/CBD/BSWG/4/2, pp. 3-9 contains the submissions of the African region, Chile, Colombia, Ethiopia, Guinea, India, Japan, South Africa,Switzerland and the US.82UNEP/CBD/BSWG/4/Inf.2, p. 2-8.83UNEP/CBD/BSWG/4/4, Annex II, see Article 1bis.84UNEP/CBD/BSWG/4/2, p. 9.85UNEP/CBD/BSWG/5/2, pp. 16-22 contains the submissions of Ecuador, Kenya, Mexico, New Zealand, Peru, Slovenia, Thailand and Venezuela.86As suggested earlier by the African region, see UNEP/CBD/BSWG/3/5, p. 8.87UNEP/CBD/BSWG/5/3, Annex, Article 1bis.88UNEP/CBD/BSWG/6/L.2, see Article 2.89UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 2.90UNEP/CBD/ExCOP/1/3, para. 33.20


III. TEXT OF THE PROTOCOLArticle 3: Use of TermsFor the purposes of this Protocol:(a) ‘Conference of the Parties’ means the Conferenceof the Parties to the ong>Conventionong>;(b) ‘Contained use’ means any operation,undertaken within a facility, installationor other physical structure, which involvesliving modified organisms that are controlledby specific measures that effectivelylimit their contact with, and theirimpact on, the external environment;(c) ‘Export’ means intentional transboundarymovement from one Party to anotherParty;(d) ‘Exporter’ means any legal or naturalperson, under the jurisdiction of the Partyof export, who arranges for a living modifiedorganism to be exported;(e) ‘Import’ means intentional transboundarymovement into one Party fromanother Party;(f) ‘Importer’ means any legal or naturalperson, under the jurisdiction of the Partyof import, who arranges for a living modifiedorganism to be imported;(g) ‘Living modified organism’ means anyliving organism that possesses a novel combinationof genetic material obtainedthrough the use of modern biotechnology;(h) ‘Living organism’ means any biologicalentity capable of transferring or replicatinggenetic material, including sterileorganisms, viruses and viroong>idong>s;(i) ‘Modern biotechnology’ means theapplication of:a. In vitro nucleic acong>idong> techniques, includingrecombinant deoxyribonucleic acong>idong>(DNA) and direct injection of nucleic acong>idong>into cells or organelles, orb. Fusion of cells beyond the taxonomicfamily, that overcome natural physiologicalreproductive or recombination barriersand that are not techniques used in traditionalbreeding and selection;(j) ‘Regional economic integration organisation’means an organisation constitutedby sovereign States of a given region, towhich its member States have transferredcompetence in respect of matters governedby this Protocol and which has beenduly authorised, in accordance with itsinternal procedures, to sign, ratify, accept,approve or accede to it;(k) ‘Transboundary movement’ means themovement of a living modified organismfrom one Party to another Party, save thatfor the purposes of Articles 17 and 24transboundary movement extends tomovement between Parties and non-Parties.The definition of terms was an item included in allproposals on the possible contents of the futureProtocol, 91 and discussion started in BSWG-1 withsome delegations stressing the need to use definitionsfound in existing instruments. 92 Followingthe compilation of such terms by the Secretariat, 93governments submitted additional definitionscontained in national or regional legislation forconsong>idong>eration at BSWG-2. 94 A contact group,chaired by Dr. Gert Willemse (South Africa) and DrHelen Marquard (United Kingdom), reviewed availabledefinitions in order to recommend action, asdelegations had decong>idong>ed that there would be noattempt to define terms at that stage. The contactgroup recommended preparation of an alphabeticallist of terms requiring definition, with countrysubmissions for each, for consong>idong>eration at BSWG-3. The group stressed that the terms appearingon the list would not necessarily mean that theywould need to be defined in the Protocol and thatany definitions would need to be developed toreflect their use in the Protocol and the context inwhich they appeared. 9591UNEP/CBD/BSWG/1/4, Annex, p. 22.92UNEP/CBD/BSWG/1/4, paras. 74 – 76.93UNEP/CBD/BSWG/2/5.94UNEP/CBD/BSWG/2/2, pp. 8-15 contains the submissions of the African region, Australia, Canada, Cuba, EU, Norway, Switzerland and the US. UNEP/CBD/BSWG/2/Inf.7, pp. 3-5 contains the views of Malaysia.95UNEP/CBD/BSWG/2/6, paras. 161 – 164.21


III. TEXT OF THE PROTOCOLAt BSWG-3, the contact group on definitions,now Contact Group 1, resumed its work. CG-1continued discussions on definitions at BSWG-3on the basis of the revised compilation of terms 96and additional country submissions. 97 Delegatesong>idong>entified about thirty terms that would need tobe defined as a priority, on the understandingthat, in the course of negotiations, the elaborationof other terms might be required. 98 The ong>idong>entifiedterms at that stage were: accong>idong>ental release;competent authority; contained use; deliberaterelease; export and import; exporter; field trial;focal point; illegal traffic; importer; liability; LMO;notification; novel traits; organism; party of export;party of import; party of transit; party concerned;party of origin; potential receiving environment;product; receiving party; transboundary movement;transboundary release; unconfined release;unintended release; and unintended transboundarymovement. The African region’s suggestion forthe definition of an LMO included ‘parts thereof’, 99so Contact Group 1 briefly addressed the issue of‘LMOs and products thereof’, but noted that it wasnot within the group’s mandate to enter into sucha discussion. 100 The Co-Chairs of CG-1 then prepareda draft consolong>idong>ating suggestions for eachterm, and delegates bracketed text and proposedfurther options. 101 This draft was used as the basisfor CG-1 deliberations in BSWG-4, while Colombiaand the US submitted additional suggestions. 102At BSWG-4, CG-1 noted that its deliberations hadto be approached from a purely scientific andtechnical point of view, in order to provong>idong>e SWG-Iwith the least possible number of options. 103 CG-1worked in collaboration with CG-2, where necessary,regarding the legal questions of definitions,as well as in close contact with SWG-I, which provong>idong>edcomments. 104 CG-1 deliberations resultedin a bracketed list of terms containing: LMO;organism; transboundary movement; export;import; exporter; importer; Party of export; andParty of import. 105 Regarding the definitions ofterms relating to export, import and transboundarymovement, CG-1 and CG-2 noted that furtherprogress could only be made after the resolutionof fundamental issues, such as the Protocol’s applicationto transit or to movements between Partiesand non-Parties. 106 For that reason, the bracketeddefinitions of export and import excluded transit,and references to Parties or States also remainedbracketed. 107 CG-1 also addressed the definitionof “LMO”, consong>idong>ering whether to focus on processor on the result of modification, and decong>idong>ing toinclude both in the draft definition. 108Further country submissions were received priorto BSWG-5. 109 CG-1 focused on the definition of“LMO”, decong>idong>ing to develop definitions for: LMO;living organism; and modern biotechnology. Thedefinitions were refined following input by SWG-I, while a pending issue was whether modernbiotechnology covered cell fusion techniques. ong>11ong>0The definitions of other terms were forwarded toBSWG-6 as agreed upon at BSWG-4. An informaldiscussion on ‘products thereof’ was held in paral-96UNEP/CBD/BSWG/3/Inf.1 is a revised version of UNEP/CBD/BSWG/2/5 containing definitions used in other international agreements as well as innational and regional legislation, and additional definitions as submitted by the African region, Australia, Belarus, Canada, China, Cuba, EU, India, Japan,Malaysia, New Zealand, Norway, Peru and Switzerland.97UNEP/CBD/BSWG/3/5 contains the submissions of the African region, Belarus, Colombia, Malaysia, Mexico, South Africa and Sri Lanka.98UNEP/CBD/BSWG/3/6, para. 92.99UNEP/CBD/BSWG/3/Inf.1, p. 18.100UNEP/CBD/BSWG/3/6, para. 93.101UNEP/CBD/BSWG/3/6, Annex, see Article 2.102UNEP/CBD/BSWG/4/3, pp. 2-5.103UNEP/CBD/BSWG/4/4, para. 22.104UNEP/CBD/BSWG/4/4, para. 27.105UNEP/CBD/BSWG/4/4, Annex IV.106UNEP/CBD/BSWG/4/4, para. 27.107UNEP/CBD/BSWG/4/4, Annex IV.108Id.109UNEP/CBD/BSWG/5/2, pp. 22-29, contains the submissions of Ecuador, Japan, Mexico, New Zealand, Panama, Peru, Slovenia, Thailand, the US,Uruguay and Venezuela.ong>11ong>0UNEP/CBD/BSWG/5/3, para, 36.22


III. TEXT OF THE PROTOCOLlel, influencing deliberations on the use of terms.The provision was put in brackets, to reflect thefact that the issue of ‘products thereof’ was stillpending. ong>11ong>1 The list of terms forwarded to BSWG-6contained: LMO; living organism; modern biotechnology;transboundary movement; export; import;exporter; importer; Party of export; and Party ofimport. ong>11ong>2BSWG-6 concluded work on the use of terms,with CG-1 agreeing definitions of “LMO”, “livingorganism”, and “modern biotechnology”. ong>11ong>3 Theterm ‘contained use’ was introduced and CG-1held discussions on its definition. CG-2 then discussedthe definitions of: export; exporter; import;importer; regional economic integration organisation;and transboundary movement. As the issueof transit was involved, these were forwarded toSWG-I. Following resolution of the issue, delegatessubstituted “Parties” for “States” in the definitionsof export, import and transboundary movement.With respect to the definition of “transboundarymovement”, the Chair’s text ong>11ong>4 contained anadditional cross-reference to the provisions on:bilateral, regional and multilateral agreementsand arrangements; unintentional transboundarymovements and emergency measures; and non-Parties (then Articles ong>11ong>, 14 and 21 respectively).On 17 February ong>19ong>99, BSWG-6 provisionallyadopted the definitions of exporter, importer,LMO, living organism, modern biotechnology andregional economic integration organisation. ong>11ong>5During the deliberations of the resumed ExCOP,the reference to the provision on bilateral, regionaland multilateral agreements and arrangementsunder the definition of transboundary movementwas excluded. Article 3 was adopted in its finalform on 26 January 2000.ong>11ong>1UNEP/CBD/BSWG/5/3, para. 38.ong>11ong>2UNEP/CBD/BSWG/5/3, Annex, see Article 2.ong>11ong>3UNEP/CBD/ExCOP/1/2, para. 30.ong>11ong>4UNEP/CBD/BSWG/6/L.2, see Article 3(j).ong>11ong>5UNEP/CBD/ExCOP/1/2, para. 38.23


III. TEXT OF THE PROTOCOLArticle 4: ScopeThis Protocol shall apply to the transboundarymovement, transit, handlingand use of all living modified organismsthat may have adverse effects on the conservationand sustainable use of biologicaldiversity, taking also into account risksto human health.The scope of the Protocol proved to be a highlycontentious issue, the debate having been initiatedduring COP-2, and at the expert meetings heldprior to the COP, over the scope of the negotiatingmandate of BSWG. The language of decision II/5was apparently a compromise between the preferenceof developing countries for a Protocol onbiosafety in the field of “safe transfer, handling anduse of LMOs” and that of developed countries for afocus on “transboundary transfer of any LMO.”Following initial discussions in BSWG-1, wherethe EU suggested the exclusion of LMOs ong>idong>entifiedas being unlikely to have adverse effects onbiodiversity, ong>11ong>6 written proposals were submittedfor consong>idong>eration at BSWG-2. ong>11ong>7 Differencesof opinion were apparent: the African proposalincluded LMOs and ‘products thereof’, whileSwitzerland favoured a Protocol limited to theintentional transboundary movement of LMOs tobe introduced in the environment, excluding containeduse and trade in commodities. The EU andJapan called for the exclusion of LMOs unlikelyto have adverse effects, while Japan also wishedto exclude the transboundary transfer of LMOscovered by other international agreements. TheEU and Norway included a reference to risks tohuman health. Canada suggested that the scopeof the Protocol be determined at a later stage.The issue was not discussed in BSWG-3, althoughsome delegations made submissions. ong>11ong>8 The issueformed part of the mandate of SWG-I, establishedat BSWG-3. Discussion in BSWG-4 revolved aroundwhether and how the scope of the Protocol as awhole would differ from the scope of applicationof the AIA procedure. The options contained inthe consolong>idong>ated text 1ong>19ong> at the end of BSWG-4 provong>idong>edfor: no provision on scope; scope equivalentto the scope of the AIA procedure; and bracketedlanguage detailing activities covered and not coveredby the Protocol. Regarding the latter option,the transboundary movement of LMOs was covered,with reference to human health, but handlingand use were bracketed. A second paragraphexcluded LMOs not likely to have adverse effects,requirements for transport operations, transit andmovement destined for contained use.BSWG-5 dong>idong> not make significant progress. A numberof delegations had submitted their views, 120and SWG-I agreed to work on the option detailingthe areas of applicability of the Protocol. Atthe end of the negotiations in SWG-I, the articleon scope had been clarified but major questionsremained to be resolved: provisions related to“products thereof”; handling and use of LMOs; referenceto human health; socio-economic impacts;and exceptions, with reference to LMOs unlikelyto have adverse effects, transport operations, containeduse and transit. 121Positions were polarised in BSWG-6. SWG-I agreedto delete the bracketed reference to transportoperations being excluded from the Protocol’sscope. However, they could not reach consensuson the remaining unresolved issues. Negotiationsin the informal groups created to discuss containeduse, ‘products thereof’ and human healthalso failed to reach agreement.ong>11ong>6UNEP/CBD/BSWG/1/4, p. 18.ong>11ong>7UNEP/CBD/BSWG/2/2, pp. 44-48 contains the submissions of the African region, Canada, EU, Japan, Norway and Switzerland.ong>11ong>8UNEP/CBD/BSWG/3/5 contains the submissions of Australia, Brazil, EC, Mexico and Switzerland.1ong>19ong>UNEP/CBD/BSWG/4/4, Annex I, see Article 3A.120UNEP/CBD/BSWG/5/2 contains the submissions of Ecuador, Kenya, New Zealand, Peru, Slovenia, Thailand and Venezuela.121UNEP/CBD/BSWG/5/3, para. 31; and Annex, see Article 3A; UNEP/CBD/BSWG/6/8, Annotated Draft Negotiating Text of a Protocol on ong>Biosafetyong>, seeArticle 4. See also section on Article 5 below.24


III. TEXT OF THE PROTOCOLThe Chair’s proposed text attempted to draft compromiselanguage. 122 The Chair’s text presented tothe BSWG retained references to handling anduse, as well as to human health, while omittingthe references to ‘products thereof’ and socioeconomicwell-being. A general statement wasintroduced into the paragraph on exceptions, topreserve the right of Parties to subject all LMOs torisk assessment prior to decisions on import. Theexceptions included transboundary movementsof LMOs unlikely to have adverse effects, and ofLMOs which are pharmaceuticals for humans.Transit and contained use were covered in certainarticles only. On February ong>19ong>, the Chair’s text wasreviewed by the Friends of the Chair group, aswell as by informal and regional groups, whichexpressed general dissatisfaction. It becameapparent that the issue of scope could stall finalisationof the Protocol. At Minister Mayr’s initiative,a Friends of the Minister group continued negotiationson February 20, without however reachingagreement. The text was not altered, and witha minor adjustment made by the Legal DraftingGroup, was submitted for the consong>idong>eration of theExCOP. 123 Following the suspension of the ExCOP,negotiations on the issue continued in the informalconsultations ahead of the resumption of theExCOP.According to the Chairman’s summary of theVienna informal consultations, 124 the negotiatinggroups retained their initial positions. Most groupscould accept the text as it stood, apart from theLike-Minded Group, which then proposed a singleparagraph which provong>idong>ed for the Protocol toapply to the transboundary movement, transitand handling and use of all LMOs that may havean adverse effect on the conservation and sustainableuse of biological diversity, taking also intoaccount risks to human health. Exceptions wouldthen be addressed under specific articles. 125 Sincemost groups needed time to examine the proposal,consultations dong>idong> not progress any further.Suggested texts were incorporated into ChairMayr’s non-paper in December ong>19ong>99, to assist thenegotiation progress.During the Montreal consultations before theresumption of the ExCOP in January 2000, a contactgroup was created specifically to address theissue of scope. 126 The Like-Minded Group reiteratedits position of retaining a comprehensiveprovision to cover all LMOs and addressing exceptionsunder other articles. Other groups preferredto retain the text from ong>Cartagenaong>. 127 A small groupwas established to address exceptions and todevelop language on scope. On January 23, oneday before the beginning of the resumed ExCOP,the group came up with an agreed single paragraphto address all LMOs, although referenceto transit was still bracketed. New articles weredrafted to address exceptions.Negotiations in the contact group on scope,chaired by Mr. John Herity (Canada) continuedduring the resumed ExCOP. As the negotiationprogressed the contact group on commodities(see section on Article ong>11ong>) and on scope weremerged under the joint chairmanship of Mr.Herity and Mr. François Pythoud (Switzerland). 128Delegates finally agreed to a provision addressingthe transboundary movement, transit, handlingand use of all LMOs that may have adverse effectson the conservation and sustainable use of biodiversity,taking also into account risks to humanhealth. Following this agreement, the negotiationsfocused mainly on the new draft articles on pharmaceuticals,transit and contained use. 129 Article 4on scope was adopted with the rest of the Protocolon 29 January 2000.122UNEP/CBD/BSWG/6/L.2, see Article 4.123UNEP/CBD/ExCOP/1/2, Appendix I, see Article 4.124UNEP/CBD/ExCOP/1/INF/3, p. 4.125UNEP/CBD/ExCOP/1/INF/3, Informal consultations on ong>Biosafetyong> Protocol, Vienna 15-ong>19ong> September ong>19ong>99, Chairman’s Summary, p.5.126UNEP/CBD/ExCOP/1/3, para. 12.127UNEP/CBD/ExCOP/1/2, Appendix I, see Article 4.128UNEP/CBD/ExCOP/1/3, para. 53.129UNEP/CBD/ExCOP/1/3 pp. 26, 28-29 and 31. See sections on Articles 5 and 6 below.25


III. TEXT OF THE PROTOCOLArticle 5: PharmaceuticalsNotwithstanding Article 4 and withoutprejudice to any right of a Party to subjectall living modified organisms to riskassessment prior to the making of decisionson import, this Protocol shall notapply to the transboundary movement ofliving modified organisms which are pharmaceuticalsfor humans that are addressedby other relevant international agreementsor organisations.Discussion on pharmaceuticals started at BSWG-5, during the debate on scope (see section onArticle 4). A footnote was then inserted into thebracketed paragraph on the areas of non-applicabilityof the Protocol which included “LMOs whichare pharmaceuticals for humans” in the annex ofLMOs unlikely to have adverse effects, 130 and consequentlyexclude them from the Protocol’s scope.On 15 February ong>19ong>99, during SWG-I negotiationsat BSWG-6, the footnote was replaced with a referencein the text of the article, excluding the “transboundarymovements of LMOs that are pharmaceuticalsfor humans.” The Chair’s text 131 producedat BSWG-6, also excluded from the scope of theProtocol transboundary movements of LMOs thatare pharmaceuticals for humans.The creation of a separate article on pharmaceuticalsoriginated from the proposal of theLike-Minded Group presented during the Viennainformal consultations, to have a comprehensiveprovision on scope to cover all LMOs and addressthe exceptions in other articles. 132 This group suggestedincluding language in the article on theapplication of the AIA procedure, 133 allowing theParty of import to decong>idong>e not to apply the AIAprocedure to LMOs that are pharmaceuticals forhuman use.When the consultations continued in Montreal,it became clear that a compromise would be difficultto reach. The negotiating groups had opposingviews: the Miami Group expressed the viewthat pharmaceuticals would not have adverseeffects on biodiversity, while the EU noted otherinternational bodies that could cover future developments.On the other hand, the Like-MindedGroup dong>idong> not wish to exclude pharmaceuticals. Inan attempt to reconcile these views, the contactgroup on scope at the resumed ExCOP draftedlanguage on 23 January 2000, exempting thetransboundary movement of pharmaceuticals forhumans, without prejudicing the rights of Partiesto subject all LMOs to a risk assessment prior to adecision on import.The issue was finally resolved during the resumedExCOP following negotiations in the contactgroup on scope and intense informal consultations.134 While some delegations noted that theWorld Health Organisation would be the competentforum to deal with the issue of LMOs thatare pharmaceuticals for humans, the Like-MindedGroup expressed concern regarding developmentsin pharmaceutical applications, such asgene-therapy, for which no other standards orinstitutional provisions existed. While the Chair ofthe contact group on scope continued informaldiscussions to explore flexibility on the issue, itwas suggested that the exemption should bequalified by limiting the exemption to LMOs thatare covered by other international agreementsand organisations or that would not be intentionallyintroduced into the environment. These provisionsremained in brackets. The first of these suggestionswas included in the final text adopted on29 January 2000.130UNEP/CBD/BSWG/5/3, Annex, see Article 3A, footnotes; see also Appendix I to this document on ‘Deleted Draft Articles’.131UNEP/CBD/BSWG/6/L.2, see Article 4(c).132UNEP/CBD/ExCOP/1/INF/3, Informal consultations on ong>Biosafetyong> Protocol, Vienna 15-ong>19ong> September ong>19ong>99, Chairman’s Summary, p.5.133See section on Article 7 below.134UNEP/CBD/ExCOP/1/3 paras. 28, 45, 51 and 61.26


III. TEXT OF THE PROTOCOLArticle 6: Transit and contained use1. Notwithstanding Article 4 and withoutprejudice to any right of a Party of transitto regulate the transport of living modifiedorganisms through its territory andmake available to the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>, any decision of that Party, subjectto Article 2, paragraph 3, regarding thetransit through its territory of a specificliving modified organism, the provisionsof this Protocol with respect to theadvance informed agreement procedureshall not apply to living modified organismsin transit.2. Notwithstanding Article 4 and withoutprejudice to any right of a Party to subjectall living modified organisms to riskassessment prior to decisions on importand to set standards for contained usewithin its jurisdiction, the provisions ofthis Protocol with respect to the advanceinformed agreement procedure shall notapply to the transboundary movement ofliving modified organisms destined forcontained use undertaken in accordancewith the standards of the Party of import.Article 6(1): TransitAt BSWG-2 initial discussions were held on transittogether with the issues of handling, transportand packaging. 135 By the end of BSWG-2, realisingits complexity, delegations agreed to treatthe question of transit of LMOs separately. 136The debate started in BSWG-3, at which the EC’ssubmission proposed excluding transit from theProtocol’s scope. 137Diverging views became apparent at BSWG-4. CG-1 and CG-2 consong>idong>ered that the issue of whetherthe Protocol should apply to LMOs in transit wasone of the fundamental questions to be resolvedin order for the negotiations to progress. 138 Theissue was incorporated into the discussions onscope, 139 application of the AIA procedure, andnotification, during BSWG-4, 5 and 6.In the Chair’s proposed text at BSWG-6, 140 transitwas excluded from the scope of the Protocol,except as regards the provisions on Parties’ generalobligations (Article 2), unintentional transboundarymovements and emergency measures(then Article 14), and handling, transport, packagingand ong>idong>entification (then Article 15). The MiamiGroup questioned the latter reference 141 and, inthe general disagreement over the scope of theProtocol, the issue of transit remained pending.According to the Like-Minded Group’s proposal,submitted at the Vienna informal consultationsin September ong>19ong>99, transit of LMOs would havebeen included in the scope of the Protocol 142 andnotification of transit of LMOs would have beenrequired. The issue remained under negotiationduring the Montreal informal consultations. Whilethe contact group on scope agreed on a comprehensiveprovision to address all LMOs, referenceto transit under the provision on scope remainedbracketed and discussion started on the developmentof a new provision. Requirements foradvance notification and necessary documentationfor transit also caused intense disagreement.Following extensive discussions in the contactgroup on scope during the resumed ExCOP, aswell as informal consultations, delegations agreedto include LMOs in transit in the Protocol’s scope.They also started drafting a new provision toaddress the issue. On 26 January 2000, the contactgroup was presented with a text based on infor-135UNEP/CBD/BSWG/2/6, paras. 145-149.136UNEP/CBD/BSWG/2/6, Annex II, Item I.137UNEP/CBD/BSWG/3/5.138UNEP/CBD/BSWG/4/4, para. 27.139UNEP/CBD/BSWG/4/4, Annex I, see Articles 3A, 3B and 4.140UNEP/CBD/BSWG/6/L.2, see Article 4.141UNEP/CBD/ExCOP/1/3, Annex III, p. 17.142See section on Article 4 above.27


III. TEXT OF THE PROTOCOLmal consultations, which suggested that the AIAprocedure would not apply to LMOs in transit. Thetext was accepted. The final issue to be resolvedwas the right of a State to regulate LMOs in transitthrough its territory. Following resolution of thisissue, the provision was adopted on 29 January2000.Article 6(2): Contained UseEarly discussions during BSWG-2 indicated thecomplex nature of this issue, as Canada, theEU, Norway and Switzerland suggested excludingLMOs destined for contained use from theProtocol’s scope, while most developing countrydelegations supported inclusion of all intendeduses. 143 At BSWG-3, Norway proposed languageon minimum national regulations for biosafety, 144including the development of an annex onnational measures applied to contained use. Thisproposal was withdrawn during BSWG-6. Norwaymaintained however that the Protocol shouldinclude a provision to ensure that Parties guaranteedsafety in the contained use of LMOs. 145Following negotiations at BSWG-4, language proposed,but not agreed, on scope and on the applicationof the AIA procedure, excluded containeduse. 146 At the beginning of BSWG-6, Chair Koesterong>idong>entified contained use as one of the key issuesrequiring resolution, as there seemed to be nopoint of agreement. SWG-I held lively discussionson whether LMOs destined for contained useshould be excluded from the AIA procedure. 147Many developing country delegations stressedthat LMOs in containment should be subject tothe same provisions as other LMOs, while otherdelegations argued that such transboundarymovements should not be covered by the AIAprocedure, or even that LMOs destined for containeduse should be outsong>idong>e the scope of the Protocol.Discussion continued in an informal group,co-chaired by Australia and Peru, but dong>idong> not progressfurther than crystallising the three positionsnoted above. The lack of an agreed definition ofcontained use, in light of the fact that discussionin the contact group on definitions were still continuing,further complicated discussions. 148At BSWG-6, in the Chair’s proposed text, 149 LMOsdestined for contained use were not covered bythe AIA procedure. They were only partially coveredby the Protocol’s scope, with reference tothe provisions on general obligations of Parties(Article 2), unintentional transboundary movementsand emergency measures (then Article14), handling, transport, packaging and ong>idong>entification(then Article 15), and some paragraphsof Article 17 on information-sharing and theong>Biosafetyong> ong>Clearingong>-ong>Houseong>. 150 The Like-MindedGroup expressed its concern, 151 calling for theinclusion of LMOs destined for contained use inthe Protocol’s scope and in the AIA procedure. Inits proposal submitted during the Vienna informalconsultations, the Like Minded Group suggestedthat, while the scope of the Protocol should coverall LMOs, the Party of import could decong>idong>e not toapply the AIA procedure to LMOs destined forresearch in contained use. 152As discussions on the issue continued duringthe resumed ExCOP, both informally and in thecontact group on scope, delegations reachedgeneral agreement on scope and on 25 January2000, started exploring options for dealing withcontained use. On 26 January, new Article 6 waspresented. The provision was adopted on 29 January2000.143UNEP/CBD/BSWG/2/6, paras. 33-34.144UNEP/CBD/BSWG/3/5.145UNEP/CBD/ExCOP/1/2, para. 24.146UNEP/CBD/BSWG/4/4, Annex I, see Article 3B.147See section on Article 7 below.148See section on Article 3 above.149UNEP/CBD/BSWG/6/L.2, see Article 5.150Ibong>idong>., see Article 4(b).151UNEP/CBD/ExCOP/1/3, Annex IV.152UNEP/CBD/ExCOP/1/INF/3, Informal Consultation on ong>Biosafetyong> Protocol, Vienna 15 – ong>19ong> September ong>19ong>99, Chairman’s Summary, p.5.28


III. TEXT OF THE PROTOCOLArticle 7: Application of theAdvance Informed AgreementProcedure1. Subject to Articles 5 and 6, the advanceinformed agreement procedure in Articles8 to 10 and 12 shall apply prior to the firstintentional transboundary movement ofliving modified organisms for intentionalintroduction into the environment of theParty of import.2. ‘Intentional introduction into the environment’in paragraph 1 above, does notrefer to living modified organisms intendedfor direct use as food or feed, or forprocessing.3. Article ong>11ong> shall apply prior to the firsttransboundary movement of living modifiedorganisms intended for direct use asfood or feed, or for processing.4. The advance informed agreement procedureshall not apply to the intentionaltransboundary movement of living modifiedorganisms ong>idong>entified in a decision ofthe Conference of the Parties serving asthe meeting of the Parties to this Protocolas being not likely to have adverse effectson the conservation and sustainable useof biological diversity, taking also intoaccount risks to human health.An advance informed agreement procedure wasong>idong>entified as a priority consensus element in themeeting of the Open-ended Ad Hoc Group ofExperts on ong>Biosafetyong> before COP 2 in ong>19ong>95. 153 Thescope of the AIA procedure was addressed atBSWG-1. 154 Switzerland, supported by New Zealandand the US, suggested that the AIA procedureshould apply only to the first transboundarymovement of LMOs intended for use in the environment,while notification would be sufficientfor subsequent movements. Following remarks byAustralia and the EU, delegations also had initialdiscussions on the categorisation of LMOs accordingto the degree of potential risk to biodiversityand the relevance of such categorisation to theapplication of the AIA procedure.A more extensive debate took place at BSWG-2 155and BSWG-3, on the basis of country submissions.156 As discussion focused on the two aboveissues, most developing countries expressed theview that the AIA procedure should apply to allmovements, initial and subsequent, while Brazil,Norway and the US, among others, suggested asimpler procedure for subsequent movements.During BSWG-3, SWG-I prepared an elementspaper, 157 drawing from country submissions. Thepaper compiled options for elements of the scopeof the application of the AIA procedure. It was suggestedthat the procedure cover: all LMOs; all firsttime transboundary movements of LMOs; all LMOsexcept those explicitly excluded and exempted;and specific LMOs based on detailed criteria or oncriteria listed in an annex. A further option left it tothe discretion of the importing State as to whetherthe exporter should apply national regulationsor the Protocol. Chair Koester streamlined theseoptions for BSWG-4, 158 where discussions focusedon: the scope of AIA in relation to the scope of theProtocol; the application of the AIA procedureonly to specific categories of LMOs; its applicationto LMOs in transit or destined for contained use;the exemption of low-risk LMOs and the type ofagreement required for this exemption.153UNEP/CBD/COP/2/7, Annex I, para 18(a).154UNEP/CBD/BSWG/1/4, paras. 39-43.155UNEP/CBD/BSWG/2/6, paras. 23-72.156UNEP/CBD/BSWG/2/2, pp. 15-28 contains the submissions of the African region, Australia, Canada, Japan, Norway and the US. UNEP/CBD/BSWG/3/3contains the submissions of the African region, Belarus, Brazil, Colombia, Cuba, EC, India, Japan, Madagascar, Malaysia, Mexico, Norway, Peru, SouthAfrica, Sri Lanka, Switzerland and the US.157UNEP/CBD/BSWG/3/6, para. 85; and Annex I, see Article 3.158UNEP/CBD/BSWG/4/Inf.1, pp. 2-4.29


III. TEXT OF THE PROTOCOLBy the end of BSWG-4, it was agreed to draft separateprovisions on the scope of the Protocol andon the application of the AIA procedure. Discussionsresulted in four options for the applicationof the AIA procedure. 159 These covered: all LMOsdefined in the Protocol; the first movement of anLMO unless an exemption was provong>idong>ed for; specificcategories of LMOs listed within the article; orLMOs covered by criteria listed in an annex.During BSWG-5, a drafting group produced a singlebracketed option for consong>idong>eration by SWG-I:This text contained a detailed paragraph onLMOs to be covered by the AIA (positive list) andanother on exemptions (negative list). Althoughsome delegations commented on the two draftparagraphs’ contradictory approaches and calledfor their consolong>idong>ation, the group could not agreeon whether to include a positive or a negative list,so both paragraphs were retained. 160 Discussionthen focused on the application of the AIA procedureto transit and contained use, and the scopeof exemptions in general. The issue of whether theAIA would apply to all transboundary movementsof LMOs or only the first transboundary movementalso remained unresolved. A number of footnotesindicated the remaining pending issues. 161As a result, the bracketed text submitted to BSWG-6 contained two paragraphs, the first detailing thecategories of LMOs to which AIA would apply andthe second addressing the exemptions from theAIA procedure. Regarding the first paragraph, theissue of whether AIA would apply to the first orto all transboundary movements, and the inclusionof ‘products thereof’, remained bracketed.LMOs covered by the AIA procedure were thoseintended for field testing or deliberate release inthe Party of import, those banned in the Party ofexport and those destined for contained use. Categoriesto be excluded from the AIA procedurewere: LMOs in transit; those exempted under thedomestic regulatory framework; those destinedfor contained use; those ong>idong>entified in a decisionof the Meeting of the Parties as not likely to haveadverse effects on biodiversity; 162 and, under conditions,those destined for placing on the marketof the Party of import. 163The application of the AIA procedure to commoditiescaused intense debate during and followingBSWG-6. 164 Some developed countries arguedthat LMOs intended for human or animal consumptionwould not pose a significant threat tobiodiversity and called for their exclusion, whilemany developing countries advocated applicationof the AIA procedure to all LMOs, stressingthe possibility of accong>idong>ental releases. On 17February ong>19ong>99, delegations agreed that the AIAprocedure would apply to the first transboundarymovement of an LMO. However, the issue ofcommodities remained unresolved. According tothe Chair’s proposed text at BSWG-6, the AIA procedurewould cover the first transboundary movementof LMOs “destined for growth, reproductionand propagation in the environment.” 165 It wouldnot apply to LMOs not likely to have adverseeffects on biodiversity, taking into account risksto human health, as ong>idong>entified in a decision ofthe MOP, nor to LMOs destined for placing on themarket in the Party of import under certain conditions.Parties could, under domestic law, requireprocedures consistent with the AIA procedure forother LMOs. 166 This latter provision implied that159UNEP/CBD/BSWG/4/4, Annex I, see Article 3B.160UNEP/CBD/BSWG/5/3, Annex, see Article 3B.161UNEP/CBD/BSWG/5/3, para. 31, and Annex, see Article 3B.162The possibility for the Meeting of the Parties to the Protocol to exclude LMOs from the application of the AIA originated from language proposed byJapan., see UNEP/CBD/BSWG/3/3, p. 6. The concept remained in the final text. It should be noted that during the negotiations frequent references weremade to future decisions by the ‘Meeting of the Parties’ or the ‘Conference of the Parties’ to the Protocol. As discussions on what became Article 29 ofthe Protocol progressed, these references were amended to refer to the ‘Conference of the Parties, serving as the Meeting of the Parties to this Protocol.’This is commonly abbreviated to “COP/MOP”. See section on Article 29 below.163UNEP/CBD/BSWG/6/2, pp. 7-9.164The treatment of commodities in relation with the AIA procedure had implications for several provisions of the Protocol. See Background above,and section on Article ong>11ong> below.165UNEP/CBD/BSWG/6/L.2, see Article 5.166UNEP/CBD/BSWG/6/L.2, See Article 5.30


III. TEXT OF THE PROTOCOLcommodities could be covered by AIA proceduresunder national legislation. In the revised versionof the document containing the Chair’s text, thephrase “growth reproduction and propagation inthe environment” was replaced by “intentionalintroduction into the environment”. It was specifiedthat this term dong>idong> not refer to “LMOs intendedfor direct use as food or feed, or for processing”(LMO-FFPs), the phrase used thereafter to refer tocommodities. 167Following review by the Friends of the Chair, aswell as regional and informal groups, the provisionremained under negotiation in the Friends of theMinister group, the most difficult issue remainingwhether or not the AIA procedure would apply tocommodities.Delegations reacted to the Chair’s proposed textas revised by the Legal Drafting Group on 22February. 168 The issue of the application of the AIAprocedure to LMO-FFPs remained a core focusof discussion in the first session of the ExCOP.The various negotiating groups put forward differentproposals for addressing the issue. TheLike-Minded Group proposed subjecting the firsttransboundary movement of all LMOs to AIA,but allowing Parties of import not to apply AIAto LMO-FFPs. 169 The Miami Group supported theChair’s text on this issue, 170 and the EU proposedthat the first meeting of the Parties to the Protocolshould decong>idong>e how the AIA procedure shouldapply to LMO-FFPs. 171The application of the AIA procedure to commoditiesremained one of the core pending issues atthe suspension of the first session of the ExCOP,and was further examined during the Vienna informalconsultations, when the Compromise Grouppresented a concept paper to facilitate discussionon developing an alternative procedure forcommodities. 172 It was proposed that reference tothis alternative procedure in the provision on theapplication of the AIA procedure would replacethe reference to domestic legislation. All groupsfound the proposal constructive and agreed toconsong>idong>er it, 173 with the Like-Minded Group insistingon a procedure as robust as the AIA procedure.This proposal created the basis for developing aseparate provision on LMO-FFPs. 174 Negotiationscontinued in Montreal, both informally and duringthe resumed ExCOP, where a contact group,chaired by Mr. François Pythoud (Switzerland)discussed as a cluster the issues of the applicationof the AIA procedure, development of an alternativeprocedure for commodities, and the provisionon handling, transport, packaging and ong>idong>entification.As the provision on the application of theAIA procedure depended on resolution of thedebate on LMO-FFPs, 175 the text of Article 7 wasfinalised in parallel with Article ong>11ong> on a procedurefor LMO-FFPs. Therefore, the final text of Article 7,which excludes LMO-FFPs from the applicationof AIA, referencing Article ong>11ong>, was adopted on 29January 2000.167UNEP/CBD/BSWG/6/L.2/Rev.1, see Article 5.168UNEP/CBD/ExCOP/1/2, para. 40.169UNEP/CBD/ExCOP/1/3, Annex IV.170UNEP/CBD/ExCOP/1/3, Annex III.171UNEP/CBD/ExCOP/1/3, Annex II.172UNEP/CBD/ExCOP/1/INF/3, Informal Consultations on ong>Biosafetyong> Protocol, Vienna, 15-ong>19ong> September ong>19ong>99, Chairman’s Summary, p. 3.173Id.174See now Article ong>11ong>.175See section on Article ong>11ong> below.31


III. TEXT OF THE PROTOCOLArticle 8: Notification1. The Party of export shall notify, orrequire the exporter to ensure notificationto, in writing, the competent nationalauthority of the Party of import prior tothe intentional transboundary movementof a living modified organism that fallswithin the scope of Article 7, paragraph 1.The notification shall contain, at a minimum,the information specified in Annex I.2. The Party of export shall ensure thatthere is a legal requirement for the accuracyof information provong>idong>ed by theexporter.Following a general discussion of the AIA procedureat BSWG-1, 176 the African region submittedto BSWG-2 a detailed text on the notificationprocedure prior to a transboundary movement ofLMOs. 177 Part of the first paragraph of the Africanproposal required the State of export to notify, orrequire the exporter to notify by application inwriting through the channel of the competentauthority of the State of export, the competentauthority of the States concerned and the ong>Biosafetyong>ong>Clearingong>-ong>Houseong>, of any proposed transboundarytransfer of LMOs or products thereof. Suchapplications were to contain the declarations andinformation to be specified in Annex I to the Protocol.Elements of the final text can be recognisedin this early proposal. BSWG-2 delegates discussedwho should trigger the notification procedure:the Party of export, the exporter or the receivingentity in the Party of import. 178Several written proposals were submitted toBSWG-3. 179 India’s submission included languageon notification to the ong>Clearingong> ong>Houseong>, as well as onthe requirement for the accuracy of informationprovong>idong>ed by the exporter, while Canada, whoseproposal favoured notification by the importerto the Party of import, suggested that each Partymake its importers responsible for the accuracy ofprovong>idong>ed information. The options resulting fromboth the written submissions and the discussionwere consolong>idong>ated for consong>idong>eration by BSWG-4. 180The Chairman’s note for BSWG-4 181 further organisedthese options. The primary issue of whetherthe exporter or the importer would trigger thenotification procedure was still to be resolved.BSWG-4 discussions in SWG-I revolved mainlyaround the issue of who should trigger the notificationprocedure. The questions of who shouldbear the responsibility for accuracy of the provong>idong>edinformation, and whether the requiredinformation should be specified in an Annex orin a list to be established by the meeting of theParties, also provoked some debate. The outcomewas a consolong>idong>ated bracketed text merging differentoptions. On the requirement for accuracy ofinformation, the zero (no provision) option wasretained. 182 Discussions on the content of therequired information were held in parallel inCG-1. 183BSWG-5 dong>idong> not make significant progress onthis issue. Some governments submitted views 184and discussions took place in SWG-I, while CG-2addressed the question of how other internationalagreements referred to the issue of triggeringnotification.176UNEP/CBD/BSWG/1/4, paras. 39-43.177UNEP/CBD/BSWG/2/2, p. 53. The document also contains the submissions of the EU, Japan and Norway on notification. UNEP/CBD/BSWG/2/Inf.7, pp.7-8 contains the submission of Malaysia.178UNEP/CBD/BSWG/2/6, paras. 62-65.179UNEP/CBD/BSWG/3/3, pp. 8-15, contains the submissions of the African Group, Australia, Belarus, Brazil, Canada, Colombia, Cuba, EC, India, Japan,Madagascar, Malaysia, Norway, Peru, South Africa, Sri Lanka, Switzerland, and the US.180UNEP/CBD/BSWG/3/6, Annex I, see Articles 4, 5, 6, and 7.181UNEP/CBD/BSWG/4/Inf.1, pp. 4-5.182UNEP/CBD/BSWG/4/4, Annex I, see Article 4.183See section on Annex I below.184UNEP/CBD/BSWG/5/2 contains the submissions of Ecuador, New Zealand, Peru, Thailand, US, Uruguay, and Venezuela.32


III. TEXT OF THE PROTOCOLMany delegations in SWG-I expressed the viewthat responsibility for notification should fall onthe exporter, or that the Party of export shouldensure that the exporter notified the Partyof import. Since others still preferred placingresponsibility on the importer, no agreement wasreached. The question of responsibility for theaccuracy of information was not resolved either.The requirement to notify the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>, which was deleted in BSWG-4, was also reintroduced.By the end of the session, delegatesdeleted the zero (no provision) option regardingresponsibility for accuracy of information, andagreed that notification should include, at a minimum,the information specified in Annex I to theProtocol. The rest of the provision remained bracketedto reflect the different options. 185BSWG-6 discussions mainly revolved around thequestion of notification to the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>,which was finally excluded, and therequirement for accuracy of information. As theissue was not resolved in SWG-I, consultationcontinued in the Friends of the Chair group. TheChair’s text produced at BSWG-6 contained compromiselanguage on the issue. 186 The text of theprovision then remained unaltered until its adoptionon 29 January 2000.The options were consolong>idong>ated for BSWG-4, 189while the US suggested that no provision onnotification of transit was necessary. ong>19ong>0 During thedebate, other delegations also viewed the provisionas unnecessary, while others suggested textrequiring the Party of export to obtain consentfrom Party and non-Party transit States. Both thezero (no provision) option and text provong>idong>ing fornotification to the transit State, acknowledgementof notification and documentation for LMOsin transit, were retained in the consolong>idong>ated text atthe end of BSWG-4. ong>19ong>1Further views were submitted to BSWG-5. ong>19ong>2Delegations debated deleting the provision,but most developing countries objected to thisoption. Following discussions in SWG-I and workin a drafting group, delegations finally agreed todeletion of this provision, on the basis that theseelements could be adequately addressed underthe provisions on notification, acknowledgementof receipt of notification, decision procedure forAIA, handling, transport and packaging, and liabilityand compensation. ong>19ong>3Following the deletion of the provision, a debateon notification of transit was held under the generalprovision on notification in BSWG-6, resultingin its final exclusion. ong>19ong>4Notification of transitThe issue of notifying transit countries arose inBSWG-3, with a number of delegations submittingtext for a separate provision on notification of transit.187 Some governments had also included relatedlanguage in their proposals on notification. 188185UNEP/CBD/BSWG/5/3, Annex, see Article 4.186UNEP/CBD/BSWG/6/L.2, see Article 6.187UNEP/CBD/BSWG/3/3, pp. 23-25, contains the submissions of Australia, Brazil, Mexico, Peru, Malaysia and Norway.188UNEP/CBD/BSWG/3/3, pp. 8-13. The submissions of the African group and India proposed a reference to “States concerned”, while Colombia andPeru included specific reference to Parties or countries of transit.189UNEP/CBD/BSWG/3/6, Annex I, see Article 8.ong>19ong>0UNEP/CBD/BSWG/4/3, p. 9.ong>19ong>1UNEP/CBD/BSWG/4/4, Annex I, see Article 8.ong>19ong>2UNEP/CBD/BSWG/5/2, pp. 47-49, contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.ong>19ong>3UNEP/CBD/BSWG/5/3, para. 32, and Annex, see Article 8.ong>19ong>4UNEP/CBD/ExCOP/1/2, para. 39.33


III. TEXT OF THE PROTOCOLArticle 9: Acknowledgement ofReceipt of Notification1. The Party of import shall acknowledgereceipt of the notification, in writing, tothe notifier within ninety days of itsreceipt.2. The acknowledgement shall state:(a) The date of receipt of the notification;(b) Whether the notification, prima facie,contains the information referred to inArticle 8;(c) Whether to proceed according to thedomestic regulatory framework of theParty of import or according to the procedurespecified in Article 10.3. The domestic regulatory frameworkreferred to in paragraph 2 (c) above, shallbe consistent with this Protocol.4. A failure by the Party of import toacknowledge receipt of a notificationshall not imply its consent to an intentionaltransboundary movement.The time limit for the response of the importingcountry and the consequences of a failure toacknowledge receipt were the major contentiousissues under this provision. Discussions on theissue of the time limit started in BSWG-2, althoughthere was no clear distinction at the time betweenacknowledgement of receipt of notification andresponse, including decision, of the importingParty. ong>19ong>5 While some noted the importance of timelimits, most developing country delegations wereopposed to prescriptive time limits after whichimplicit consent might be assumed, while someagreed to consong>idong>er an indicative time period for theacknowledgement of receipt of notification. ong>19ong>6On the basis of written submissions, ong>19ong>7 BSWG-3consolong>idong>ated different options for elements of theAIA procedure as a whole. Elements ong>idong>entified asrelevant to the acknowledgement of receipt ofnotification ong>19ong>8 included: its time frame, informationto be given to the notifier, and consequences of afailure to respond in a specified time frame. Theseoptions were further organised in the Chairman’snote prepared for BSWG-4. ong>19ong>9 The note contained:a zero (no provision) option, as suggested bysome developing countries; an option with languageon acknowledgement of receipt, whichwould include confirmation that the notificationcontains prima facie the information required fornotification, 200 the date of receipt, 201 advice on carryingout a risk assessment and/or a request forfurther information where necessary; an optionwith language on review of the content of therequest in a specific time period; and language oninforming the notifier to proceed according to theAIA procedure or the domestic regulatory framework,provong>idong>ed that this included a control mechanismconsistent with the Protocol. All references totime frames remained open and bracketed.Discussions in BSWG-4 revolved around the sameissues, with several delegations still opposing aprecise time period for responding to notification.The zero option was retained and the remainingsuggestions were consolong>idong>ated into a singleoption. 202 The text mainly addressed acknowledgementof receipt, but also included languageon informing the notifier about proceeding withor without written consent, which would laterbe introduced into the provision on decisionprocedure. 203 On the consequences of a failure toacknowledge receipt, some developing countriessupported text stating that failure to acknowledgereceipt would not result in any consequences,nor would it imply consent to a transboundaryong>19ong>5See also section on Article 10 below.ong>19ong>6UNEP/CBD/BSWG/2/6, paras. 56 - 58.ong>19ong>7UNEP/CBD/BSWG/3/3, pp. ong>19ong>-23 contains the submissions of Australia, Belarus, Brazil, Canada, Colombia, EC, Japan, Malaysia, Norway, South Africa,Sri Lanka, Switzerland and the US. UNEP/CBD/BSWG/3/3/Add.1 contains the submission of Madagascar.ong>19ong>8UNEP/CBD/BSWG/3/6, Annex I, see Article 5.ong>19ong>9UNEP/CBD/BSWG/4/Inf.1, p. 6.200As suggested by Canada, see UNEP/CBD/BSWG/3/3, p. ong>19ong>.201As suggested by Japan, see UNEP/CBD/BSWG/3/3, p. 21.202UNEP/CBD/BSWG/4/4, Annex I, see Article 5.203See section on Article 10 below.34


III. TEXT OF THE PROTOCOLmovement. Similar language had been suggestedearlier by Belarus 204 and Switzerland. 205Following submission of new government proposals206 and some discussion at BSWG-5 on the needfor the provision, delegations in SWG-I agreedto delete the zero option. 207 Debate focused onthe time frame: with several delegations callingfor acknowledgement of receipt within 30 days,and others preferring reference to a “reasonable”period of time, the group finally double-bracketeda compromise option of 90 days. Delegationsthen agreed that the acknowledgement shouldstate the date of receipt of the notification andwhether the notification, prima facie, containedthe information specified under the provisionon notification, as well as agreeing that failure toacknowledge receipt upon notification would notimply consent. Regarding the requirement for theacknowledgement to state whether to proceedaccording to the AIA procedure or the domesticregulatory framework, delegations debatedmoving this to the provision on the decisionprocedure, but ultimately retained and bracketedthe reference. The debate continued at BSWG-6,where delegations agreed to keep such language.The remaining outstanding issue of the time limitwas also resolved at BSWG-6. Delegations agreedto the previously bracketed 90 day time frameand the provision was adopted with the rest ofthe Protocol on 29 January 2000.204UNEP/CBD/BSWG/3/3, p. ong>19ong>.205UNEP/CBD/BSWG/3/3, p. 23.206UNEP/CBD/BSWG/5/2, pp. 34-36, contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.207UNEP/CBD/BSWG/5/3, Annex, see Article 5.35


III. TEXT OF THE PROTOCOLArticle 10: Decision Procedure1. Decisions taken by the Party of importshall be in accordance with Article 15.2. The Party of import shall, within theperiod of time referred to in Article 9,inform the notifier, in writing, whether theintentional transboundary movementmay proceed:(a) Only after the Party of import hasgiven its written consent; or(b) After no less than ninety days withouta subsequent written consent.3. Within two hundred and seventy days ofthe date of receipt of notification, theParty of import shall communicate, inwriting, to the notifier and to the ong>Biosafetyong>ong>Clearingong>-ong>Houseong> the decision referred toin paragraph 2 (a) above:(a) Approving the import, with or withoutconditions, including how the decisionwill apply to subsequent imports of thesame living modified organism;(b) Prohibiting the import;(c) Requesting additional relevant informationin accordance with its domestic regulatoryframework or Annex I; in calculatingthe time within which the Party of import isto respond, the number of days it has towait for additional relevant informationshall not be taken into account; or(d) Informing the notifier that the periodspecified in this paragraph is extended bya defined period of time.4. Except in a case in which consent isunconditional, a decision under paragraph3 above, shall set out the reasonson which it is based.5. A failure by the Party of import to communicateits decision within two hundred andseventy days of the date of receipt of thenotification shall not imply its consent to anintentional transboundary movement.6. Lack of scientific certainty due to insufficientrelevant scientific information andknowledge regarding the extent of thepotential adverse effects of a living modifiedorganism on the conservation andsustainable use of biological diversity inthe Party of import, taking also intoaccount risks to human health, shall notprevent that Party from taking a decision,as appropriate, with regard to the importof the living modified organism in questionas referred to in paragraph 3 above,in order to avoong>idong> or minimise such potentialadverse effects.7. The Conference of the Parties serving asthe meeting of the Parties shall, at its firstmeeting, decong>idong>e upon appropriate proceduresand mechanisms to facilitate decision-makingby Parties of import.The AIA procedure is at the core of the Protocol,and its importance was reflected in a long andcomplex negotiation process. The time limit forcommunication of the decision of the importingParty, the consequences of a failure to communicatea decision, as well as the inclusion of the precautionaryprinciple in the article on the decisionprocedure caused lengthy debates.The AIA procedure was ong>idong>entified as a consensuselement in the Madrong>idong> report 208 before COP2 andin decision II/5. BSWG-1 discussed it as a priority, 209noting procedures set out in other internationalinstruments as well as the differentiated capacityof countries to carry out risk assessment and riskmanagement. Some delegations submitted theirgeneral views on the AIA procedure for consong>idong>erationat BSWG-2. 210 At that meeting, a debate wasinitiated on the time limit for the response of theimporting Party and the consequences of a failureto communicate a decision. 2ong>11ong> Many developingcountry delegations opposed time limits for adecision and the interpretation of a failure to communicatea decision as implicit consent, stressingcapacity constraints. Norway proposed a 90-daytime limit; 212 the US preferred a specified period to208UNEP/CBD/COP/2/7, Annex I, para 18(a).209UNEP/CBD/BSWG/1/4, paras. 39 - 43.210UNEP/CBD/BSWG/2/2, pp. 15-28, contains the submissions of the African region, Australia, Canada, Japan, Norway and the US.2ong>11ong>UNEP/CBD/BSWG/2/6, Annex II, Item A. See also section on Article 9 above.212UNEP/CBD/BSWG/2/2, p. 54.36


III. TEXT OF THE PROTOCOLrespond, after which consent would be deemed tohave been given. 213 The EU and Japan suggestedflexible time limits depending on various factors,such as the need for further information. 214Delegations also discussed the range of possibleactions to be taken by the importing Party followingnotification, outlining prohibition of theimport, approval with or without conditions, andrequest for further information. Proposed elementswere presented in the Chairman’s summaryof elements. 215Following an invitation for new submissions toBSWG-3, 216 a number of delegations submittedtheir views. 217 During the meeting, a draftinggroup consolong>idong>ated the different options forapproval by SWG-I. 218 Elements relevant to thisarticle in its final form were outlined under provisionson response to notification and on the decisionby the Party of import. Chair Koester organisedthe different options further, with a view toreducing them for BSWG-4. 2ong>19ong> The draft provisionon response to AIA notification contained optionson interim response, time period for decision, andextension of this time period. The draft provisionon decision by the Party of import containedoptions on the basis and content of the decision,on information to be included in the decision,and on the obligations of the Party of export. Thisnote was the basis for the negotiations in BSWG-4,while Colombia and the US submitted additionalwritten proposals. 220During BSWG-4, discussion in SWG-I focused onthe time limit for the decision, as well as on itsbasis, with several delegations supporting referenceto scientific evong>idong>ence, risk assessment andsocio-economic imperatives. On the time limit,most developing country delegations opposedimplicit consent to a transboundary movementin the case of a failure to meet the time limit. Theoutcome 221 of discussions in SWG-I at BSWG-4included bracketed paragraphs on: the basis ofthe decision; informing the notifier whether toproceed with or without written consent; cooperationamong Parties with a view to decong>idong>ingwhen a transboundary movement could not proceedwithout an explicit consent; informing thenotifier whether the notification contained primafacie the required information; 222 the time periodfor the decision of the Party; notifying approval,prohibition, or request for additional information;treatment of and notification for subsequentimports; extension of the time period; prohibitionof an import when the provong>idong>ed information wasnot sufficient, with reference to the precautionaryprinciple; 223 authorisation of the receiving Partyfor all transboundary movements; stating reasonsfor prohibiting a movement, imposing conditionsor requesting additional information; andthree options on the consequences of a failure torespond.Further proposals were submitted prior toBSWG-5 224 and, although delegates held long discussionsboth in SWG-1 and in a drafting group,213UNEP/CBD/BSWG/2/2, p. 27.214UNEP/CBD/BSWG/2/6, Annex II, Item A.215Id.216UNEP/CBD/BSWG/2/6, p. 33.217UNEP/CBD/BSWG/3/3, pp. 15-23 contains the submissions of the African group, Australia, Belarus, Brazil, Colombia, India, Madagascar, Malaysia,Mexico, Norway, Peru, South Africa, Sri Lanka, Switzerland and the US regarding the decision procedure; and the submissions of Australia, Belarus, Brazil,Canada, Colombia, EC, Japan, Malaysia, Norway, South Africa, Sri Lanka, Switzerland and the US regarding the response to AIA notification. UNEP/CBD/BSWG/3/3/Add.1, p.2 contains the submission of Madagascar.218UNEP/CBD/BSWG/3/6, Annex I, see Articles 4, 5, 6 and 7.2ong>19ong>UNEP/CBD/BSWG/4/Inf.1, pp. 8-10.220UNEP/CBD/BSWG/4/3, pp. 6-9.221UNEP/CBD/BSWG/4/4, Annex I, see Article 6.222See now Article 9(2)(b).223South Africa (UNEP/CBD/BSWG/3/3, p. 14) and Norway (ibong>idong>., p. 17) had suggested similar language with no explicit reference, however, to the precautionaryprinciple. Such reference emerged during BSWG-4 discussions.224UNEP/CBD/BSWG/5/2, pp. 36-41, contains the submissions of Ecuador, Kenya, New Zealand, Peru, Slovenia, Thailand and Venezuela.37


III. TEXT OF THE PROTOCOLSWG-1 Co-Chair Schoonejans (France) reportedat the end of the meeting that the provision hadbeen consolong>idong>ated, but still required further consong>idong>eration.225 Topics of debate included: whetheror not to replace the language on the basis of thedecision with reference to the provision on riskassessment; the time limit for communication ofthe decision, with some favouring 90 days fromthe acknowledgement of receipt and many developingcountry delegations supporting referenceto a reasonable time period; and the consequencesof a failure to respond, particularly regarding aprovision stating that the Party of export wouldthen have no obligations under the Protocol. Theprovision remained largely bracketed.Negotiations at BSWG-6 centred on the issues oftime limits and implicit consent as a result of afailure to communicate a decision. Delegationsdebated the options of a 180 or 270 days timelimit, or “a reasonable period of time” from thedate of receipt of notification. An informal groupaddressed the issue, eliminating the open referenceto a reasonable period of time, but unableto decong>idong>e between the two remaining options.Following discussions in SWG-I and informal consultations,the Chair’s proposed text at BSWG-6, 226opted for the time limit of 270 days as the timelimit for communication of the decision. Implicitconsent in case of a failure to communicate adecision was excluded. 227 The draft article alsocontained a provision which would not appear inthe final text: a paragraph on cooperation amongthe Parties with a view to decong>idong>ing to what extentand in which cases, a transboundary movementcould not proceed without explicit consent. 228There were also differences in the provision ondecision-making in the case of lack of scientificcertainty, 229 which stated that lack of full scientificcertainty or of scientific consensus to determinethe potential adverse effects of an LMO, wouldnot prevent the Party of import from prohibitingthe import of the LMO in question. With these twomajor differences, as well as some linguistic andeditorial amendments, and with the reference tothe precautionary principle emerging as a highlycontroversial issue, the text of the draft articleremained under negotiation at the end of BSWGand the first session of the Ex-COP.The precautionary principle was not addressed asa separate issue in the Vienna informal consultationsin September ong>19ong>99. 230 At the resumed ExCOP,the Compromise Group suggested that the issueof the precautionary principle in the decision procedureshould be consong>idong>ered in the thematic clusterof trade-related issues. 231 On the other hand,the Like-Minded Group proposed its separatetreatment. 232 The contact group on trade-relatedissues initially dong>idong> not consong>idong>er precaution, andon 26 January 2000 the Miami Group reiteratedthe need to address the issue. 233 The Miami Grouprepresentative suggested deleting the referenceunder the provision on decision making, arguingthat it was superfluous and was expressed differentlyfrom Principle 15 of the Rio Declaration. 234On 27 January, the Presong>idong>ent of the ExCOP calledfor comments on the provision, in the light ofthe work of the contact group on trade-relatedissues. The Miami Group reiterated its positionon deletion, 235 while the EU and the Compromise225UNEP/CBD/BSWG/5/3, para. 31.226UNEP/CBD/BSWG/6/L.2, see Article 8.227Ibong>idong>, see Article 8(5).228UNEP/CBD/ExCOP/1/2, see Article 8(b).229Ibong>idong>., see Article 8(7).230Informal Consultations on ong>Biosafetyong> Protocol, Vienna 15 - ong>19ong> September ong>19ong>99, Chairman’s Summary, UNEP/CBD/ExCOP/1/INF3, p.5.231UNEP/CBD/ExCOP/1/3, para 36.232Ibong>idong>., para. 38.233Ibong>idong>., para. 55.234UNEP/CBD/ExCOP/1/3, para 66.235Ibong>idong>., para. 76.38


III. TEXT OF THE PROTOCOLGroup called for finding appropriate wording. 236The CEE and the Like-Minded Group stated theycould accept the wording on precaution in thearticle on the decision procedure (then Article8(7)) as it stood at that time. 237 Presong>idong>ent Mayrthen extended the mandate of the contact groupon trade-related issues, chaired by AmbassadorYang (Cameroon), to include the provision underconsong>idong>eration. The contact group held extensivediscussions, co-chaired by Ambassador Yangand Mr François Pythoud (Switzerland). Delegationsreached the final compromise language onwhat is now Article 10(6), following the informalconsultations held on Frong>idong>ay, 28 January. At thesame time, delegations also agreed to delete theprovision on cooperation with a view to decong>idong>ingwhen a transboundary movement could not proceedwithout explicit consent (then Article 8(6)).The article took its final form and was adopted on29 January 2000.236Ibong>idong>., paras. 77-78.237UNEP/CBD/ExCOP/1/2, paras. 79-80.39


III. TEXT OF THE PROTOCOLArticle ong>11ong>: Procedure for LivingModified Organisms Intendedfor Direct Use as Food or Feed,or for Processing1. A Party that makes a final decisionregarding domestic use, including placingon the market, of a living modified organismthat may be subject to transboundarymovement for direct use as food or feed,or for processing shall, within fifteen daysof making that decision, inform the Partiesthrough the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>.This information shall contain, at a minimum,the information specified in AnnexII. The Party shall provong>idong>e a copy of theinformation, in writing, to the nationalfocal point of each Party that informs theSecretariat in advance that it does nothave access to the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>. This provision shall not apply todecisions regarding field trials.2. The Party making a decision under paragraph1 above, shall ensure that there is alegal requirement for the accuracy of informationprovong>idong>ed by the applicant.3. Any Party may request additional informationfrom the authority ong>idong>entified inparagraph (b) of Annex II.4. A Party may take a decision on theimport of living modified organismsintended for direct use as food or feed, orfor processing, under its domestic regulatoryframework that is consistent with theobjective of this Protocol.5. Each Party shall make available to theong>Biosafetyong> ong>Clearingong>-ong>Houseong> copies of anynational laws, regulations and guong>idong>elinesapplicable to the import of living modifiedorganisms intended for direct use as foodor feed, or for processing, if available.6. A developing country Party or a Partywith an economy in transition may, in theabsence of the domestic regulatoryframework referred to in paragraph 4above, and in exercise of its domesticjurisdiction, declare through the ong>Biosafetyong>ong>Clearingong>-ong>Houseong> that its decision prior tothe first import of a living modified organismintended for direct use as food orfeed, or for processing, on which informationhas been provong>idong>ed under paragraph1 above, will be taken according to the following:(a) A risk assessment undertaken in accordancewith Annex III; and(b) A decision made within a predictabletimeframe, not exceeding two hundredand seventy days.7. Failure by a Party to communicate itsdecision according to paragraph 6 above,shall not imply its consent or refusal tothe import of a living modified organismintended for direct use as food or feed, orfor processing, unless otherwise specifiedby the Party.8. Lack of scientific certainty due to insufficientrelevant scientific information andknowledge regarding the extent of thepotential adverse effects of a living modifiedorganism on the conservation andsustainable use of biological diversity inthe Party of import, taking also intoaccount risks to human health, shall notprevent that Party from taking a decision,as appropriate, with regard to the importof that living modified organism intendedfor direct use as food or feed, or for processing,in order to avoong>idong> or minimise suchpotential adverse effects.9. A Party may indicate its needs for financialand technical assistance and capacitybuildingwith respect to living modifiedorganisms intended for direct use as foodor feed, or for processing. Parties shallcooperate to meet these needs in accordancewith Articles 22 and 28.The `treatment of LMO-FFPs was one of the mostcontroversial issues throughout the negotiationprocess, with implications for several provisionsof the Protocol. 238 The term LMO-FFPs only came238See sections on Articles 4, 7, 18, 20 and Annex II.40


III. TEXT OF THE PROTOCOLinto usage towards the end of BSWG-6. 239 Untilthat point, discussions on this issue generallyreferred to commodities. Following initial discussionover whether LMO-FFPs would be includedwithin the scope of the Protocol, 240 which resultedin a comprehensive provision addressing all LMOs,debate focused on whether LMO-FFPs would besubject to the AIA procedure. 241 Article ong>11ong> reflectsthe outcome of these negotiations.An early debate in BSWG-2 revolved around thepreparation of a report by the Secretariat on thescale of commodity transactions involving LMOs.After the suggestion of Canada and the US thatthe Secretariat prepare such a study, the G-77 andChina called for four other studies, on the socioeconomicimplications of biotechnology, and onthe impacts of LMOs on animals, fisheries andindigenous farming. No studies were prepared,but two roundtables on commodities and onsocio-economic implications of biotechnologywere organised at BSWG-3.Delegations began specifically addressing thetreatment of commodities in more detail duringBSWG-6, when an informal group was formed toaddress the issue. The Secretariat had ong>idong>entifiedthis as one of the topics requiring resolutionunder the provision on scope. 242 The informalgroup focused on the applicability of the AIAprocedure. Delegations discussed the obligationsof the exporting Party and methods for makinginformation available, on the basis of a Canadiannon-paper, which recommended that Partiesshare information about domestic approvals ofLMO-FFPs. Another proposal, presented by theSWG-I Co-Chairs, suggested potential differentiationin the level of risk between LMOs intendedfor deliberate release and LMO-FFPs. While somedelegations supported such differentiation, arguingthat LMO-FFPs dong>idong> not pose significant threatto biodiversity, many developing country delegationssuggested instead that the AIA procedureshould apply to all LMOs, and stress the possibilityof accong>idong>ental release and planting in the environment.SWG-I forwarded all options to BSWG ChairKoester.The Chair’s proposed text 243 subjected LMOsdestined for “growth, reproduction and propagationin the environment” to the AIA procedure.It provong>idong>ed that Parties might, under domesticlaw, require procedures consistent with the AIAprocedure for other LMOs, implying that suchdomestic procedures could cover LMO-FFPs. Therevised Chair’s text 244 stated that the AIA procedurewould apply prior to the first intentionaltransboundary movement of LMOs for intentionalintroduction into the environment of the Party ofimport and explicitly excluded LMO-FFPs fromthe AIA procedure. The possibility for Parties torequire procedures consistent with AIA for otherLMOs remained. The issue of the applicationof the AIA procedure to LMO-FFPs remained acore focus of discussion in the first session of theExCOP. The various negotiating groups put forwarddifferent proposals for addressing the issue.The Like-Minded Group proposed subjecting thefirst transboundary movement of all LMOs to AIA,but allowing Parties of import not to apply AIAto LMO-FFPs. 245 The Miami Group supported theChair’s text on this issue, 246 and the EU proposedthat the first meeting of the Parties to the Protocolshould decong>idong>e how the AIA procedure shouldapply to LMO-FFPs. 247239The term first appears in the revised Chair’s text: UNEP/CBD/BSWG/6/L.2/Rev.1, see Article 5(2).240See section on Article 4 above.241See section on Article 7.242UNEP/CBD/BSWG/6/8, p. 2.243UNEP/CBD/BSWG/6/L.2, see Article 5.244UNEP/CBD/BSWG/6/L.2/Rev.1, see Article 5.245UNEP/CBD/ExCOP/1/3, Annex IV246UNEP/CBD/ExCOP/1/3, Annex III.247UNEP/CBD/ExCOP/1/3, Annex II.41


III. TEXT OF THE PROTOCOLThe application of the AIA procedure to commoditieswas further examined during the Vienna informalconsultations. All negotiating groups presentedtheir positions and outlined major componentsof the issue, reiterating a general acceptance thatcommodities should be included in the scope ofthe Protocol. The Compromise Group then presenteda concept paper to facilitate discussionaimed at developing an alternative procedurefor commodities. 248 All groups found the proposalconstructive and agreed to consong>idong>er it, so a smallcontact group was established to agree on a setof alternative provisions for LMO-FFPs. The resultsof the contact group’s work were contained in theChairman’s Summary of the Vienna meeting 249Presong>idong>ent Mayr’s non-paper in December ong>19ong>99,consolong>idong>ating these concepts and intended tofacilitate resumed negotiations in Montreal inJanuary 2000, included draft text on an alternativeprocedure for LMO-FFPs, as well as a newdraft annex on information required for LMO-FFPs. 250 This text provong>idong>ed the basis for the finallanguage of Article ong>11ong>. It contained three paragraphsaddressing:• Provision of information by Parties to the ong>Biosafetyong>ong>Clearingong>-ong>Houseong> and, if requested by aParty, to its national focal point, on domesticapprovals and decisions for placing on themarket of an LMO-FFP, containing, at a minimum,the information to be specified in anAnnex;• Declarations by Parties through the ong>Biosafetyong>ong>Clearingong>-ong>Houseong>, or in writing to the nationalfocal point of the Party which has provong>idong>edthe information, within 90 days from the datethe information has been provong>idong>ed, that theimport of the LMO-FFP is subject to domesticlegal, administrative and other measures, orthat the Party will take a decision regardingsuch import in accordance with the provisionsof the Protocol; requests for additionalinformation; or indications of its needs fortechnical assistance and cooperation;• Proceeding with the transboundary movementof the LMO-FFP to all Parties, which hadnot reacted according to the above provisionsin 270 days from the communication tothe BCH or the national focal point.In the run-up to the resumed ExCOP, the issue ofcommodities was one of the core pending issues.The informal consultations prior to the meetingwere held on the basis of the draft text of theProtocol 251 and ExCOP Presong>idong>ent Mayr’s Decemberong>19ong>99 non-paper. While the Miami Groupexpressed general satisfaction with the draft textin the non-paper, the Like-Minded Group calledfor a procedure as robust as the AIA procedureand re-stated its concern over the issue of implicitconsent. The Compromise Group also noted thatfailure to respond should not imply consent.A contact group on commodities was established252 on 23 January 2000. Its chair Mr. FrançoisPythoud (Switzerland) submitted a new draft ofa procedure for LMO-FFPs and a new annex onrequired information. The draft included separateparagraphs on additional information, as well asfinancial and technical assistance and capacitybuilding. As the basis for the decision on importingan LMO-FFP would be the domestic regulatorysystem, delegations held extensive discussions onhow to address the situation of Parties that hadno regulatory system in place, and, in particular,whether specific procedures should be set out inthe Protocol, or whether the emphasis should beon capacity building and collaboration betweencountries. 253On 25 January 2000, the contact group on commoditiesstarted consong>idong>ering the draft text paragraphby paragraph. The reference to domesticlegal, administrative and other measures wasreplaced by a reference to the domestic regulatoryframework. Delegations then debated a ref-248UNEP/CBD/ExCOP/1/INF/3, p. 3.249Id.250See now Annex II.251UNEP/CBD/ExCOP/1/2.252UNEP/CBD/ExCOP/1/3, para. 12.253UNEP/CBD/ExCOP/1/3, para. 27.42


III. TEXT OF THE PROTOCOLerence to the need for the domestic framework tobe consistent either with the Protocol or its objective,as well as the possibility for merging the provisionson Parties that dong>idong> and those that dong>idong> nothave a domestic regulatory framework.The contact group co-chair 254 reported on 27January 2000 that some of the pending issues oncommodities might not be resolved in the contactgroup but would be submitted to the plenary. Akey outstanding issue was the treatment of LMO-FFPs in the article on handling, transport, packagingand ong>idong>entification (then Article 15). 255 The positionof the article in the Protocol also had to bedecong>idong>ed, 256 on the basis of a suggestion by the EUto place it after the AIA procedure. The outcomeof these consultations is reflected in the final text,adopted on 29 January 2000.254Following the combination of the contact groups on scope and commodities.255See section on Article 18 below.256UNEP/CBD/ExCOP/1/3, para. 74.43


III. TEXT OF THE PROTOCOLArticle 12: Review of Decisions1. A Party of import may, at any time, inlight of new scientific information onpotential adverse effects on the conservationand sustainable use of biologicaldiversity, taking also into account therisks to human health, review and changea decision regarding an intentional transboundarymovement. In such case, theParty shall, within thirty days, inform anynotifier that has previously notified movementsof the living modified organismreferred to in such decision, as well as theong>Biosafetyong> ong>Clearingong>-ong>Houseong>, and shall setout the reasons for its decision.2. A Party of export or a notifier mayrequest the Party of import to review adecision it has made in respect of it underArticle 10 where the Party of export or thenotifier consong>idong>ers that:(a) A change in circumstances has occurredthat may influence the outcome of the riskassessment upon which the decision wasbased; or(b) Additional relevant scientific or technicalinformation has become available.3. The Party of import shall respond in writingto such a request within ninety daysand set out the reasons for its decision.4. The Party of import may, at its discretion,require a risk assessment for subsequentimports.Discussions on this issue began at BSWG-2,when Australia suggested addressing whetheran exporter could request review of a decisionof the importing country. 257 In the discussionthat followed, Norway proposed that the Partyof import could review its decision and that anexporter should be able to ask for review, on thebasis of new information. Many delegations notedthat the importing Party had a right to modify aconsent on the basis of new information, and suggestedcommunication of such a change, as wellas its reasons, to the notifier. Others suggestedjoint review by the importing and the exportingParty. 258A number of countries submitted written proposalsto BSWG-3, 259 and the different optionswere consolong>idong>ated. 260 The Australian 261 and theBrazilian 262 proposals included language allowingexporting Parties to request review of importdecisions in cases of changes in circumstancesthat might influence the outcome of the riskassessment, or of additional relevant scientificor technical information. Furthermore, the aboveproposals included language on the response, inwriting, of the Party of import, within a reasonableperiod of time. 263Chair Koester consolong>idong>ated the options forBSWG-4. 264 Delegations ong>idong>entified two mainissues: conditions upon which the Party of importcould review its decision; and conditions uponwhich a Party of export could request a review. Theoutcome included bracketed language on: prohibitionof a transboundary movement by the Partyof import in light of new information; notification257UNEP/CBD/BSWG/2/2, p. 21.258UNEP/CBD/BSWG/2/6, paras. 66-70, and Annex II, see Item A.259UNEP/CBD/BSWG/3/3, pp. 25-26, contains the submissions of the African group, Australia, Brazil, Malaysia, Peru, South Africa and Sri Lanka.260UNEP/CBD/BSWG/3/6, Annex I, see Articles 4, 5, 6 and 7.261UNEP/CBD/BSWG/3/3, p.25.262UNEP/CBD/BSWG/3/3, p. 26.263See now Article 12(3).264UNEP/CBD/BSWG/4/Inf.1, pp. 10-ong>11ong>.44


III. TEXT OF THE PROTOCOLof such a decision to the notifiers or the Partiesconcerned and to the Secretariat or the ong>Biosafetyong>ong>Clearingong>-ong>Houseong> within 15 or 30 days; requests bya Party of export for review of an import decisionon the basis of a change of circumstances or additionalinformation or evong>idong>ence that the decisionhad not been based on scientific, socio-economic,cultural or the precautionary principles; supplyof additional information by exporting Parties ifrelevant to the review of the import decision; andthe importing Party’s right to unilaterally reviewits decision. 265Some delegations submitted further textualproposals to BSWG-5. 266 In SWG-I, delegationsong>idong>entified the review of decision by the Partyof import in light of new scientific informationas a central issue, and a drafting group consolong>idong>atedrelated language. 267 Debate then focusedon bracketed text allowing for review of thedecision by the Party of import in the case ofreasonable evong>idong>ence that the decision had notbeen based on scientific, socio-economic, culturalor the precautionary principles and supportedby the best available scientific evong>idong>ence, 268 aswell as the timeframe for response of the Partyof import to a request for review by a Party ofexport. Delegations finally bracketed options forresponse within “a reasonable period of time” and“90 days”. Following discussion on risk assessmentfor subsequent imports, delegations producedbracketed text referencing the cases of change inthe LMO’s intended use, variation in the receivingenvironment, change in the import volume resultingin increase of risk, condition of the first importand other relevant factors likely to affect the riskassessment. 269During BSWG-6, delegations in SWG-I concentratedon negotiating language on risk assessmentsfor subsequent imports, and on whether aParty of export or a notifier could request reviewof an import decision. No agreement was reachedand the text was forwarded to the Chair withoutamendment. The Chair’s proposed text 270 incorporatedall the elements of the final text of theprovision. The possibility for review in cases wherethere was reasonable evong>idong>ence that the decisionhad not been based on a scientific, socio-economicor cultural basis or the precautionary principleswas deleted. Detailed language on the conditionsof a risk assessment for subsequent imports wasalso deleted and this possibility was left to the discretionof the Party of import. 271 During the ExCOP,the Miami Group suggested removing the referenceto risk assessment for subsequent imports, 272however the reference was retained. A number ofeditorial changes were made and the final textwas adopted on 29 January 2000. 273265UNEP/CBD/BSWG/4/4, Annex I, see Article 7.266UNEP/CBD/BSWG/5/2, pp. 43-45, contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.267UNEP/CBD/BSWG/5/3, Annex, see Article 7.268Australia had suggested that exporting Parties might request review when there was reasonable evong>idong>ence that the decision had not been basedon scientific principles and supported by the best available scientific evong>idong>ence. See UNEP/CBD/BSWG/3/3, p. 25. At BSWG-4, bracketed references wereadded to socio-economic, cultural or the precautionary principles.269UNEP/CBD/BSWG/5/3, Annex, see Article 7.270UNEP/CBD/BSWG/6/L.2, see Article 9.271See now Article 12(4).272UNEP/CBD/ExCOP/1/3, Annex III.273UNEP/CBD/ExCOP/1/3, p. 48.45


III. TEXT OF THE PROTOCOLArticle 13: Simplified Procedure1. A Party of import may, provong>idong>ed thatadequate measures are applied to ensurethe safe intentional transboundary movementof living modified organisms inaccordance with the objective of this Protocol,specify in advance to the ong>Biosafetyong>ong>Clearingong>-ong>Houseong>:(a) Cases in which intentional transboundarymovement to it may take place at thesame time as the movement is notified tothe Party of import; and(b) Imports of living modified organismsto it to be exempted from the advanceinformed agreement procedure.Notifications under subparagraph (a)above, may apply to subsequent similarmovements to the same Party.2. The information relating to an intentionaltransboundary movement that is tobe provong>idong>ed in the notifications referredto in paragraph 1 (a) above, shall be theinformation specified in Annex I.The first discussions on this issue were held atBSWG-2. Some delegations suggested a provisionpermitting a unilateral or bilateral deviation fromthe AIA procedure through the use of a simplifiedprocedure. 274 It was also noted that such a procedurewas to be understood as a way of simplifyingthe requirements for an agreement, not as eliminatingthem.Some written proposals were submitted for consong>idong>erationat BSWG-3. 275 The proposal by the ECincluded elements that would be incorporatedinto the final text. It proposed: that a Party ofimport might specify in advance to other Partiescases for which the intentional transboundarymovement could take place at the same time asthe movement was notified to the Party of import;that such notifications might apply to subsequentsimilar movements to the same Party; and thatthe information to be provong>idong>ed in the notificationwas specified in Annex I. However, there wasno substantive discussion, and different options,including a zero (no provision) option, were consolong>idong>atedinto the report of the meeting. 276BSWG-4 delegates held discussions on the basisof a note prepared by Chair Koester, which furtherconsolong>idong>ated different options. 277 BSWG-4 retainedthe bracketed text, including the zero option. 278Following the submission of several writtenproposals, 279 BSWG-5 delegates discussed thepossibility of deleting the article and includingits elements in other provisions, such as that onthe application with the AIA procedure, withoutreaching agreement. The article was retained withbrackets and with a note that it could be deletedin the future, depending on the outcome of thenegotiations on the application of the AIA procedure.280 It contained all the elements that appearin the final text, with the additional reference tothe best available scientific knowledge and otherrelevant information as the basis for the implementationof the simplified procedure, as well as a274UNEP/CBD/BSWG/2/6, paras. 59-60.275UNEP/CBD/BSWG/3/3, pp. 27-28, contains the submissions of the African group, EC, India, Japan, Norway and South Africa.276UNEP/CBD/BSWG/3/6, Annex I, see Article 9.277UNEP/CBD/BSWG/4/Inf.1, pp. 13-14.278UNEP/CBD/BSWG/4/4, Annex I, see Article 9.279UNEP/CBD/BSWG/5/2, pp. 51-52, contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.280UNEP/CBD/BSWG/5/3, Annex, see Article 9, footnote 23.46


III. TEXT OF THE PROTOCOLrequirement for a Party of import to give reasonsfor selecting a simplified procedure. 281The debate on whether or not to delete the provisioncontinued briefly in SWG-I during BSWG-6.Some delegations argued that the article wasunnecessary; others noted that all LMOs shouldbe subject to the AIA procedure; and otherscalled for its retention. Accordingly it was agreedto transmit the text to Chair Koester withoutmodifications, but with the brackets removed. TheChair’s proposed text 282 retained most elements,but removed the reference to the best availablescientific knowledge, as well as the requirementfor the Party of import to give reasons for selectingthe simplified procedure. 283Although the Miami Group suggested the deletionof this article at the ExCOP, 284 the provisionwas retained and, with some editorial changesand rearrangements of text, it was adopted on 29January 2000.281Ibong>idong>.282UNEP/CBD/BSWG/6/L.2, see Article 10.283UNEP/CBD/BSWG/6/8, p. 31.284UNEP/CBD/ExCOP/1/3, Annex III.47


III. TEXT OF THE PROTOCOLArticle 14: Bilateral, Regionaland Multilateral Agreements andArrangements1. Parties may enter into bilateral, regionaland multilateral agreements and arrangementsregarding intentional transboundarymovements of living modified organisms,consistent with the objective of thisProtocol and provong>idong>ed that such agreementsand arrangements do not result ina lower level of protection than that provong>idong>edfor by the Protocol.2. The Parties shall inform each other,through the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>, ofany such bilateral, regional and multilateralagreements and arrangements thatthey have entered into before or after thedate of entry into force of this Protocol.3. The provisions of this Protocol shall notaffect intentional transboundary movementsthat take place pursuant to suchagreements and arrangements asbetween the parties to those agreementsor arrangements.4. Any Party may determine that itsdomestic regulations shall apply withrespect to specific imports to it and shallnotify the ong>Biosafetyong> ong>Clearingong>-ong>Houseong> of itsdecision.The list of possible contents of the Protocol preparedat BSWG-1 included “mechanisms for bilateralagreements”. 285 Japan submitted draft text onthis issue for BSWG-2. 286 This proposed that Partiescould enter into bilateral, multilateral or regionalagreements with Parties or non-Parties regardingtransboundary transfer of LMOs falling underthe scope of the Protocol when such agreementsdong>idong> not derogate from the necessary risk managementrequired by the ong>Conventionong>. It furtherproposed that the contents of such agreementsshould be notified to the Secretariat.BSWG-2 consong>idong>ered bilateral agreements in relationto a number of cross-cutting issues, in particularunilateral and bilateral derogations to thegeneral AIA procedures which would later resultin the provision for a “simplified procedure”. 287Most of the elements of the final text of the provisionwere introduced through written proposalson bilateral and regional agreements submittedby a number of countries for consong>idong>eration byBSWG-3. 288The texts from Australia, the EC and Switzerlandsupported Japan’s previous proposal that Partiesmight enter into bilateral, regional or multilateralagreements or arrangements and notifythe Secretariat of any such agreement enteredinto before or after the entry into force of theProtocol. However, the texts differed with regardto the conditions for entering into such agreements.Australia proposed that such agreementsshould provong>idong>e for adequate measures to ensurethe safe transboundary movement of LMOs inaccordance with the objectives of the Protocol.The EC proposed the requirement that suchagreements should not result in a “lower level ofprotection than the one provong>idong>ed for by the Protocol”.Switzerland proposed the requirement thatsuch arrangements should not derogate from theenvironmentally sound management of LMOs asrequired under the Protocol.The US proposed language to allow Parties toenter into bilateral or multilateral agreements orarrangements in respect of requirements governingthe import and export of LMOs, in place of theAIA procedure. The US also proposed that a Partycould notify the Secretariat at any time that theAIA procedure would not apply with respect to itsimports of LMOs.The submission of the African group addressedinternational cooperation to assist developingcountries in the implementation of the Protocoland proposed that Parties could enter into bilat-285UNEP/CBD/BSWG/1/4, Annex.286UNEP/CBD/BSWG/2/2, pp. 67.287UNEP/CBD/BSWG/2/6, paras. 59-60. See also section on Article 13.288UNEP/CBD/BSWG/3/3, pp. 33-34, contains the submissions of the African group, Australia, EC, Switzerland and the US.48


III. TEXT OF THE PROTOCOLeral or multilateral agreements or arrangementsfor this purpose. These concerns would later betaken up under the consong>idong>eration of capacitybuilding.289The draft text developed by SWG-I at BSWG-3included all the above elements, with the exceptionof the second part of the US proposal (whichit would later resubmit). 290 The elements wereordered into five categories: zero (no provision)option; types of agreements or arrangements;notification of the agreement or arrangement;international cooperation; and regional economicintegration organisations. 291 Types of arrangementswere further divong>idong>ed into bilateral, regional,and/or multilateral; multilateral; and bilateral ormultilateral.During the discussions at BSWG-4, several delegationssupported exemption from the AIAprocedure where such agreements existed, provong>idong>edthat the standards of the Protocol weremaintained. 292 The resulting draft text containedtwo options: no provision; and a heavily bracketedoption that included all the elements describedabove and allowed Parties to enter into suchagreements, provong>idong>ed these were consistent withthe provisions of the Protocol. 293Discussions at BSWG-6, in SWG-I, were also unsuccessfulin finalising this provision. The Chair’s proposedtext provong>idong>ed that: agreements or arrangementsentered into by Parties must be consistentwith the objectives of the Protocol, and not resultin a lower level of protection than that provong>idong>edfor by the Protocol; Parties must notify the ong>Biosafetyong>ong>Clearingong>-ong>Houseong> of any agreements or arrangementsthey had entered into before or after theProtocol’s entry into force; and the Protocol’sprovisions would not affect transboundary movementstaking place pursuant to such agreementsor arrangements. 296 The Article also allowed for animporting Party to determine that its domesticregulations shall apply to its imports, provong>idong>edthat the ong>Biosafetyong> ong>Clearingong>- ong>Houseong> was notified.297 The earlier paragraph allowing a regionaleconomic integration organisation to declare thatthe Protocol dong>idong> not apply to movements withinits territory was deleted.Minor corrections were made by the Legal DraftingGroup, leaving the text of the article to beadopted in January 2000. 298Little progress was made at BSWG-5, where thediscussion focused on the relationship betweenthis provision and the provision on the applicationof the AIA procedure (then draft Article3B). 294 The provision remained in square brackets,since no consensus was reached on whether thisprovision should remain or whether its elementsshould be incorporated elsewhere. 295289See now Article 22.290UNEP/CBD/BSWG/4/3 p. 10, contains the submissions of Colombia and the US.291UNEP/CBD/BSWG/3/6, Annex I, see Article ong>11ong>.292ENB Vol. 9 No. 85, p. 4.293UNEP/CBD/BSWG/4/4, Annex I, see Article ong>11ong>.294UNEP/CBD/BSWG/5/3, para 32.295Id.296UNEP/CBD/BSWG/6/L.2, see Article ong>11ong>.297Id.298UNEP/CBD/BSWG/6/L.2/Rev.2, see Article ong>11ong>.49


III. TEXT OF THE PROTOCOLArticle 15 - Risk Assessment1. Risk assessments undertaken pursuantto this Protocol shall be carried out in ascientifically sound manner, in accordancewith Annex III and taking into accountrecognised risk assessment techniques.Such risk assessments shall be based, at aminimum, on information provong>idong>ed inaccordance with Article 8 and other availablescientific evong>idong>ence in order to ong>idong>entifyand evaluate the possible adverseeffects of living modified organisms onthe conservation and sustainable use ofbiological diversity, taking also intoaccount risks to human health.2. The Party of import shall ensure thatrisk assessments are carried out for decisionstaken under Article 10. It mayrequire the exporter to carry out the riskassessment.3. The cost of risk assessment shall beborne by the notifier if the Party of importso requires.Consong>idong>eration of mechanisms for risk assessmentand risk management began at BSWG-1, whereseveral delegations stressed the importance ofscientific data, or proposed the inclusion of a referenceto risks to human health and welfare. Othersrecommended the UNEP International TechnicalGuong>idong>elines for Safety in Biotechnology as a valuablesource of guong>idong>ance. 299A more extensive discussion took place at BSWG-2 on the basis of submissions on the question ofrisk assessment and risk management. 300 Australiapointed to the importance of such mechanismsfor the Protocol’s AIA procedure, while notingthat such mechanisms would not necessarilyform part of the Protocol, given that national systemsprovong>idong>ed for a diverse range of regulatorymeasures for undertaking risk assessment andrisk management, and that a number of internationalguong>idong>elines existed. It proposed a number ofgeneral guong>idong>ing principles for risk assessment onbiosafety and stressed the importance of allocatingresponsibilities for risk assessment to both theexporting and the importing parties.Switzerland emphasised the need for harmonisationof national structures and recommendedthat basic principles of risk assessment and riskmanagement be included in the Protocol. Japanstressed the importance of equal treatment ofimported and domestic LMOs. Norway proposedthat such assessments be carried out by designatednational or regional authorities prior to thetransfer, handling and use of LMOs.In addition to referring to human health, the submissionsof the African group and of Malaysia 301proposed consong>idong>eration of risks to “the environment,biological diversity and the socio-economicwelfare of societies”. 302 The African group proposedthat the documentation to be submittedshould at a minimum meet certain provisions(“Risk assessment parameters”). 303 Additionally, itsuggested: making the outcome of the risk assessmentthe basis for decision making; requiring riskassessment on a case by case basis; undertakingappropriate management of the risks ong>idong>entified;and submitting all LMOs to a period of observation.304These were included in the Chairman’s summaryof draft elements, which distinguished betweenrisk assessment and risk management. 305299UNEP/CBD/BSWG/1/4, paras. 57-63.300UNEP/CBD/BSWG/2/2 pp. ong>19ong>, 20, 54-57, contains the submissions of Australia, EU, Japan, Switzerland, the African region and Norway.301UNEP/CBD/BSWG/2/Inf.7.302UNEP/CBD/BSWG/2/2, see submission of the African region.303Id. See also the section on Annex III below.304Id.305UNEP/CBD/BSWG/2/6, Annex I, see Item F. See also section on Article 16 below.50


III. TEXT OF THE PROTOCOLLengthy procedural discussions took place atBSWG-3 on the basis of the numerous governmentsubmissions of draft text on risk assessment. 306Most of the drafts agreed on the importance ofundertaking risk assessments based on up-todatescientific data and taking into account theinformation ong>idong>entified in an Annex on Risk Assessment.307 However, most developing countries supportedthe view that the assessment should bebased not only on scientific data but also on dataconcerning possible impacts on the conservationand sustainable use of biological diversity, socioeconomicfactors and the risks to agriculture andhuman health. Such assessments would, as a consequence,need to be multong>idong>isciplinary. 308 Manydeveloping countries also supported the viewthat risk assessment should be undertaken on acase-by-case basis. 309 Japan called for the establishmentof a minimum standard of risk assessmentof LMOs. Australia and Brazil also addressedthe issue of risk assessment for subsequentimports of the same LMO. Australia consong>idong>eredsuch assessments unnecessary, except when theintended use, the receiving environment or otherfactors likely to affect the evaluation had changed.Brazil argued that this should be at the discretionof the receiving Party.Although most countries proposed assigning theresponsibility for such evaluation to the competentauthority of the Party of import, Malaysiafavoured risk assessment by the Party of export orindivong>idong>ual persons or entities under its jurisdiction.It proposed that, when the receiving Party lackedthe necessary financial and technical capacity, theexporting Party should assist it and collaborate inthe evaluation.The consolong>idong>ated text at the end of BSWG-3brought together all these elements under anumber of headings: aim of risk assessment; whenrisk assessment was required; basic parameters;further specifications concerning parameters;subsequent risk assessments; information to beprovong>idong>ed; additional information; responsibilityfor risk assessment; financial responsibility andfinancial and technical assistance. 310At BSWG-4, SWG-I worked in parallel with CG-1to facilitate its work on the Annex on risk assessment.3ong>11ong> As most delegations supported detailingthe parameters of risk assessment in an Annex onRisk Assessment, some of the text of the draft articlewas replaced with a reference to that Annex.On the question of whether the annex shoulddetail the minimum or maximum risk assessmentrequirements, most delegations preferred keepingthem to a minimum. 312The consolong>idong>ated text at the end of BSWG-4included numerous bracketed options addressing,for example: how, when, and on what, basis riskassessment should be undertaken; its aim; whoshould undertake the risk assessment; nationalinstitutional arrangements; responsibility forreliability of information; financial responsibility;assistance to developing countries and countrieswith economies in transition; treatment of microorganisms;313 and international harmonisation ofrisk assessment procedures. A zero (no provision)option was also included. 314At BSWG-5, negotiations in SWG-I led to the zerooption being deleted. 315 The debate also focusedon whether risk assessment should be limited to306UNEP/CBD/BSWG/3/3, pp. 34-42, contains the submissions of the African group, Australia, Belarus, Brazil, Canada, Colombia, Cuba, EC, India, Japan,Madagascar, Malaysia, Mexico, Norway, Peru, Sri Lanka, Switzerland and USA.307This was Annex II at the time of these negotiations. The Risk Assessment annex was renumbered Annex III at the conclusion of the negotiations.308See Malaysia’s submission in UNEP/CBD/BSWG/3/3, also expressly supported by the African group, Colombia, Cuba, India, Madagascar, Mexico andSri Lanka.309 The African group, Belarus, Cuba, India and Malaysia.310UNEP/CBD/BSWG/3/6, Annex I, see Article 12.3ong>11ong>ENB Vol. 9 No. 85, p. 3.312Ibong>idong>., p. 4.313Reflecting earlier draft text from Colombia in UNEP/CBD/BSWG/3/3.314UNEP/CBD/BSWG/4/4, Annex I, see Article 12.315ENB Vol. 9 No. 100, p. 1.51


III. TEXT OF THE PROTOCOLscientific principles or whether the precautionaryprinciple, socio-economic, human health andethical factors should also be consong>idong>ered. TheCo-Chair of SWG-I, Mrs Wint (Jamaica) reported tothe BSWG that the article had been consong>idong>erablyreduced but retained issues that required furtherdiscussion such as the type of information necessaryfor risk assessment, responsibility for carryingout risk assessment and financial responsibility. 316Although many supported the removal of theparagraphs concerning financial responsibilityfor the risk assessment, these were retained inbrackets in the consolong>idong>ated negotiating text atthe end of BSWG-5. 317 The various options specifyingwho should undertake the risk assessmentand the paragraph requiring that risk assessmentand management of micro-organisms should beconducted in contained conditions also remainedin brackets. 318Reference in the article to “appropriate risk assessmenttechniques developed by relevant internationalorganisations” was replaced by “recognised”techniques at BSWG-6. 3ong>19ong> Delegations also agreedto include language reflecting that the assessmentshould be based on information provong>idong>ed inaccordance with the article on Notification (thenArticle 6), but they remained divong>idong>ed on whetherthe responsibility should lie exclusively with theimporter or whether the latter could require theexporter to conduct the assessment. 320 Consensuswas not reached on the question of financialresponsibilities, nor on the inclusion of referencesto human health, socio-economic consong>idong>erations,and the conservation and sustainable use ofbiodiversity. These matters were thus transferredto the Friends of the Chair for further consultations.321The Chair’s proposed text 322 provong>idong>ed for riskassessment to be based at a minimum on informationprovong>idong>ed in accordance with the Articleon Notification (then Article 6). The Legal DraftingGroup later amended this, reinstating theprevious reference to the annex on risk assessment(then Annex II), 323 and the reference to thepurpose of ong>idong>entifying and evaluating possibleadverse effects on the conservation and sustainableuse of biodiversity, taking also into accountrisks to human health. The article linked the riskassessment to the decision under Article 8 (Decisionprocedure for AIA) and noted that the Partyof import may require the exporter to carry outthe risk assessment. Finally, it assigned the financialresponsibility for risk assessment to the notifierif the Party of import so required.A final revision in the resumed ExCOP, which tookplace in the informal consultations, coordinatedby Ambassador Nobs (Switzerland), on the socalled‘non-core issues’ at the ExCOP, adjusted thereferences to the articles and replaced the term“financial responsibility” with “cost”. 324316UNEP/CBD/BSWG/5/3, para. 32.317UNEP/CBD/BSWG/5/3, Annex, see Article 12.318Id.3ong>19ong>ENB Vol. 9 No. ong>11ong>3, p. 1.320Id.321ENB Vol. 9 No. ong>11ong>3, pp. 1-2.322UNEP/CBD/BSWG/6/L.2, see Article 12.323UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 12.324ENB Vol. 9 No. 137, p. 8; and UNEP/CBD/ExCOP/1/3, para. 86.52


III. TEXT OF THE PROTOCOLArticle 16: Risk Management1. The Parties shall, taking into accountArticle 8 (g) of the ong>Conventionong>, establishand maintain appropriate mechanisms,measures and strategies to regulate, manageand control risks ong>idong>entified in the riskassessment provisions of this Protocolassociated with the use, handling andtransboundary movement of living modifiedorganisms.2. Measures based on risk assessmentshall be imposed to the extent necessaryto prevent adverse effects of the livingmodified organism on the conservationand sustainable use of biological diversity,taking also into account risks to humanhealth, within the territory of the Party ofimport.3. Each Party shall take appropriate measuresto prevent unintentional transboundarymovements of living modifiedorganisms, including such measures asrequiring a risk assessment to be carriedout prior to the first release of a livingmodified organism.4. Without prejudice to paragraph 2above, each Party shall endeavour toensure that any living modified organism,whether imported or locally developed,has undergone an appropriate period ofobservation that is commensurate with itslife-cycle or generation time before it isput to its intended use.5. Parties shall cooperate with a view to:(a) Identifying living modified organismsor specific traits of living modified organismsthat may have adverse effects on theconservation and sustainable use of biologicaldiversity, taking also into accountrisks to human health; and(b) Taking appropriate measures regardingthe treatment of such living modifiedorganisms or specific traits.The Chairman’s summary of draft elements at theend of BSWG-2 separated risk assessment and riskmanagement into two provisions. 325 Malaysia hadpreviously made this distinction in its submission,and had called for risk management strategiesand measures to be included in the risk assessmentreport. Elements ong>idong>entified for a provisionon risk assessment included reference to Article8(g) of the ong>Conventionong> and to the guong>idong>ance provong>idong>edby the UNEP Technical Guong>idong>elines and othersources, as well as options on the legal status ofthe provision and on responsibility for the riskmanagement procedures. 326A significant part of the language reflected in thefinal text of this provision was already reflected ingovernments’ submissions to BSWG-3. 327 Australiacalled on Parties to “establish or maintain nationalmeans to regulate, manage or control risks associatedwith the safe use, handling and transboundarymovement of living modified organisms, inaccordance with Article 8(g) of the ong>Conventionong>”,which with minor rephrasing would appear as thefirst paragraph of the final text. Canada proposedthat these measures should be imposed “to theextent necessary to prevent the adverse effects ofthe living modified organism on the conservationand sustainable use of biological diversity withinthe territory of the Party of import”. 328 The Africangroup and Madagascar, in a separate submission,proposed that any LMO “whether importedor locally developed shall undergo a period ofobservation commensurate with its life cycle orgeneration time as the case may be before it isput to its intended use.” 329325UNEP/CBD/BSWG/2/6, Annex II, Item F. See also section on Article 15 above.326UNEP/CBD/BSWG/2/6, Annex II, Item F.327UNEP/CBD/BSWG/3/3, pp. 42-45, contains the submissions of the African group, Australia, Belarus, Canada, Colombia, Cuba, India, Madagascar,Malaysia, Norway, Sri Lanka and Switzerland.328See paragraph 2 of the final text of the Article.329See now Article 16(4).53


III. TEXT OF THE PROTOCOLSeveral proposals advocated the reduction ofrisks to acceptable levels. 330 A number of countriessuggested including a minimum type 331 orexamples 332 of risk management, while otherscalled for cooperation in the development andharmonisation of risk management procedures. 333In a similar fashion, Malaysia supported languageon technical and financial assistance, as it haddone in the provision on risk assessment. Finally,Norway called for the phasing out of antibioticresistance marker genes by 2002. All these optionswere included in the consolong>idong>ated text at the endof BSWG-3 approved by the Plenary. 334 These werethen re-arranged by the Secretariat into: requirements;cooperation; observation period; and antibioticresistance markers. 335Discussions continued in SWG-I at BSWG-4 on theneed for this provision, and on the need for globaland regional standards. 336 Options in the consolong>idong>atedtext at the end of BSWG-4 were reduced totwo: no provision and a provision enshrining theelements previously ong>idong>entified, obliging Parties toestablish measures to regulate, manage and controlrisks associated with LMOs in accordance withArticle 8 of the ong>Conventionong> or criteria stipulatedin the Protocol. A more detailed option was alsoprovong>idong>ed. 337During the course of BSWG-5 the zero (no provision)option was removed and SWG-I, in light ofthe discussions on categories of transboundarymovements, introduced a new paragraph callingupon Parties to take appropriate measures toprevent unintentional transboundary movementsof LMOs. 338 All the text was bracketed, with themost contentious issues being the provision forfinancial assistance, reference to the precautionaryprinciple, and the phasing out of antibioticresistance marker genes. 339After unsuccessful initial discussions at BSWG-6,work on the article was assigned to an informalgroup with a mandate to report to SWG-I. 340However, further discussions in SWG-I failed toachieve consensus and the issue was referred tothe Friends of the Chair. 341 In the Chair’s proposedtext, the references to the precautionary principle,financial assistance, antibiotic resistance markers,and to the annex developing the criteria for riskmanagement, were deleted. 342 The paragraph oncooperation was amended to read: “ong>idong>entifying[LMOs] or specific traits of [LMOs] that may haveadverse effects on the conservation and sustainableuse of biological diversity, taking into accountrisks to human health” and with the insertion of“with a view to taking appropriate measures onthe treatment of such [LMOs] or specific traits”. 343The Legal Drafting Group would later review thistext and make some amendments. The paragraphon cooperation was divong>idong>ed into two parts. 344 Thedraft article was then retained without amendmentand incorporated into the final text of theProtocol.330African group, Belarus, Cuba, India, Madagascar and Sri Lanka.331African group, India and Sri Lanka.332Norway.333Australia and Switzerland.334UNEP/CBD/BSWG/3/6, Annex I, see Article 13.335UNEP/CBD/BSWG/4/Inf.1, see Article 13.336ENB Vol. 9 No. 85, p. 4.337UNEP/CBD/BSWG/4/4, Annex I, see Article 13.338UNEP/CBD/BSWG/5/3 para. 32.339ENB Vol. 9 No. 108, p. 6; UNEP/CBD/BSWG/5/3, para 32 and Annex, see Article 13.340ENB Vol. 9 No. ong>11ong>1, p. 1.341ENB Vol. 9 No. ong>11ong>2, p. 1 and No. ong>11ong>3, p. 2.342UNEP/CBD/BSWG/6/L.2, see Article 13.343Id.344UNEP/CBD/BSWG/6/L.2/Rev. 2, see Article 13.54


III. TEXT OF THE PROTOCOLArticle 17: UnintentionalTransboundary Movements andEmergency Measures1. Each Party shall take appropriate measuresto notify affected or potentiallyaffected States, the ong>Biosafetyong> ong>Clearingong>-ong>Houseong> and, where appropriate, relevantinternational organisations, when itknows of an occurrence under its jurisdictionresulting in a release that leads, ormay lead, to an unintentional transboundarymovement of a living modified organismthat is likely to have significantadverse effects on the conservation andsustainable use of biological diversity,taking also into account risks to humanhealth in such States. The notificationshall be provong>idong>ed as soon as the Partyknows of the above situation.2. Each Party shall, no later than the dateof entry into force of this Protocol for it,make available to the ong>Biosafetyong> ong>Clearingong>-ong>Houseong> the relevant details setting out itspoint of contact for the purposes ofreceiving notifications under this Article.3. Any notification arising from paragraph1 above, should include:(a) Available relevant information on theestimated quantities and relevant characteristicsand/or traits of the living modifiedorganism;(b) Information on the circumstances andestimated date of the release, and on theuse of the living modified organism in theoriginating Party;(c) Any available information about thepossible adverse effects on the conservationand sustainable use of biologicaldiversity, taking also into account risks tohuman health, as well as available informationabout possible risk managementmeasures;(d) Any other relevant information; and(e) A point of contact for further information.4. In order to minimise any significantadverse effects on the conservation andsustainable use of biological diversity,taking also into account risks to humanhealth, each Party, under whose jurisdictionthe release of the living modifiedorganism referred to in paragraph 1above, occurs, shall immediately consultthe affected or potentially affected Statesto enable them to determine appropriateresponses and initiate necessary action,including emergency measures.A number of governments presented draft text onemergency procedures prior to BSWG-2. 345 Theseproposals, with the exception of that of Japan,which referred the matter to Article 14(1)(d) and(e) of the ong>Conventionong>, included a general commitmentto immediately inform affected countries;introduce appropriate measures and procedures;and ong>idong>entified information to accompany thenotification (including the ong>idong>entity of the LMO, thequantities and circumstances of the release, andemergency measures needed to be taken). Theviews of the African Group and Norway reflectedtheir concerns about the possible effects of theaccong>idong>ent on human health and the environment.The African group also added consong>idong>eration ofanimal health and biodiversity. Norway proposedthe need for consultations on the part of theaffected States.The question of unintentional transboundarymovement of LMOs (including accong>idong>ents andemergency cases) was consong>idong>ered at BSWG-2. 346The above elements were reflected in the Chair’ssummary of elements, which also referred toconsultation with and information to landlocked/neighbouring countries, and notification of unintentionalreleases to the BCH and to directlyinvolved third parties. 347 The main elements andstructure of this provision were thus already ong>idong>entifiedat this early stage.345UNEP/CBD/BSWG/2/2, pp. 58-59, contains the submissions of the African group, Japan and Norway, and UNEP/CBD/BSWG/2/Inf. 7 contains thesubmissions of Malaysia.346UNEP/CBD/BSWG/2/6, paras. 137-144.347Ibong>idong>. Annex II, Item G.55


III. TEXT OF THE PROTOCOLGovernments submitted further text for BSWG-3 under two different provisions: unintentionaltransboundary movements and emergency measures(then Articles 16 and 17 respectively). 348 Inaddition to the above elements, Australia and Brazilproposed extending the scope of Article 16 toinclude “known unintentional domestic releasesof [LMOs]”. Brazil also included reference to a Partythat suspected that an unintentional transboundarymovement into its territory had occurred.Malaysia proposed consong>idong>eration of socio-economicimperatives and risks to agriculture, andMexico proposed resolution of these issues under“the rules governing international responsibility ofthe State for damage to the environment”. The USspecified the national focal point as the authorityto be notified of the release. Of the submissionsaddressing emergency measures, Peru held theview that in cases of accong>idong>ents the responsibilityto take immediate action lay with the insurer andthe competent authorities.All these elements were incorporated into theconsolong>idong>ated text prepared by SWG-II. 349A submission by Colombia for BSWG-4 reflectedprevious text from Malaysia on mitigating adverseeffects. Colombia supplemented this with theobligation to “prevent future unintentional transboundarymovements” and to minimise risks oncesuch a movement had occurred. 350 The article onunintentional transboundary movements (thenArticle 15), as consong>idong>ered by BSWG-4, addressedthe responsibilities and rights of Parties in respectof unintentional transboundary movements,covering: knowledge required to trigger responsibility;actions required; scope of informationrequired; notification to the BCH; and confong>idong>entialityof information provong>idong>ed. 351 The article on emergencymeasures (then Article 16), contained textthat called for either the establishment of nationalmeasures and procedures, or the incorporation ofappropriate measures into the risk managementstrategies established under the article on riskmanagement (then Article 13). 352The draft articles on unintentional transboundarymovements and emergency measures weremerged during the course of BSWG-4, on the basisof a draft prepared by the Co-Chairs of SWG-II. Delegationsagreed on the need for the provision andconsolong>idong>ated text on the elements to be includedin the notification. 353 There was no consensus onthe remaining text covering: actions required bythe Party of origin; an affected Party’s right torequest emergency assistance from the Party oforigin; an affected Party’s right to request consultationamong concerned Parties; and whether Partiesshould avoong>idong> actions with potential impactson freshwater and marine ecosystems. 354Discussions at BSWG-5 consong>idong>ered, among otherissues, whether to use the term “accong>idong>ent” or“unintentional release”, 355 socio-economic consong>idong>erations,and the necessity for and details of provisionson emergency measures. However, progresswas hampered as difficulties arose with liabilityand responsibility issues. 356 Text prepared by adrafting group reinserted the earlier paragraph onconfong>idong>entiality and, in the subsequent discussions,“point of contact” was inserted to distinguish itfrom National Focal Point and National CompetentAuthority. 357 The ensuing text no longer madereference to releases of aquatic LMOs, assistancein emergency measures, or action at the expenseof the Party of origin to minimise adverse impactsand prevent further releases. 358 The text requiredParties to take preventative measures, notify348UNEP/CBD/BSWG/3/3, see Articles 16 and 17, contains submissions by African group, Australia, Belarus, Brazil, EC, India, Malaysia, Mexico, Norway,Peru, Sri Lanka, Switzerland and USA.349UNEP/CBD/BSWG/3/6, Annex I, see Articles 15 and 16.350UNEP/CBD/BSWG/4/3, pp. ong>11ong>-12.351UNEP/CBD/BSWG/4/Inf. 2, see Article 15.352Ibong>idong>., see Article 16.353ENB Vol. 9 No. 85, p. 6.354Id.355ENB Vol. 9 No. 99, p. 2.356ENB Vol. 9 No. 102, p. 2.357ENB Vol. 9 No. 106, p. 2.358UNEP/CBD/BSWG/5/3, Annex, and UNEP/CBD/BSWG/4/4, Annex II, see Merger of Article 15 and 16.56


III. TEXT OF THE PROTOCOLaffected Parties and relevant international organisations(and listing the type of information to beprovong>idong>ed), make available to the BCH the detailsof the relevant point of contact, and consult eachother to determine appropriate action. 359Remaining contentious issues, including preventionof unintentional releases, linkages with thearticle on risk assessment, confong>idong>ential informationand responsibility for triggering actionsto minimise impacts, impeded the attempts toremove the brackets from this draft article duringBSWG-6. 360 The Co-Chair of SWG-I introduced aproposal under which the paragraph on confong>idong>entialinformation in this provision was transferredto the article on Confong>idong>ential Information, (thenArticle 21), and consensus was reached on theinformation to be included in the notification ofunintentional transboundary movements.The Chair’s proposed text deleted the referencesto prevention of unintentional releases,socio-economic well-being (retaining referencesto biological diversity and human health), and‘products thereof’, and favoured reference toinformation on risk management measures ratherthan risk assessment. 361 The draft article specifiedthe measures that Parties had to take in theevent of an unintentional transboundary movementof LMOs, including notification, provisionof information, consultation with the affectedand potentially affected States to enable themto determine appropriate responses and initiatenecessary action, including emergency measures.A subsequent revision of the text amended thefinal paragraph of this article and re-ordered thelist of required information. 362359UNEP/CBD/BSWG/5/3, see Merger of Article 15 and 16.360ENB Vol. 9 No. ong>11ong>2, p. 2.361UNEP/CBD/BSWG/6/L.2, see Article 14.362UNEP/CBD/BSWG/6/L.2/Rev. 2, see Article 14.57


III. TEXT OF THE PROTOCOLArticle 18: Handling, Transport,Packaging and Identification1. In order to avoong>idong> adverse effects on theconservation and sustainable use of biologicaldiversity, taking also into accountrisks to human health, each Party shalltake necessary measures to require thatliving modified organisms that are subjectto intentional transboundary movementwithin the scope of this Protocol arehandled, packaged and transported underconditions of safety, taking into consong>idong>erationrelevant international rules andstandards.2. Each Party shall take measures to requirethat documentation accompanying:(a) Living modified organisms that areintended for direct use as food or feed, orfor processing, clearly ong>idong>entifies that they“may contain” living modified organismsand are not intended for intentional introductioninto the environment, as well as acontact point for further information. TheConference of the Parties serving as themeeting of the Parties to this Protocolshall take a decision on the detailedrequirements for this purpose, includingspecification of their ong>idong>entity and anyunique ong>idong>entification, no later than twoyears after the date of entry into force ofthis Protocol;(b) Living modified organisms that are destinedfor contained use clearly ong>idong>entifiesthem as living modified organisms; andspecifies any requirements for the safe handling,storage, transport and use, the contactpoint for further information, includingthe name and address of the indivong>idong>ual andinstitution to whom the living modifiedorganisms are consigned; and(c) Living modified organisms that areintended for intentional introduction intothe environment of the Party of importand any other living modified organismswithin the scope of the Protocol, clearlyong>idong>entifies them as living modified organisms;specifies the ong>idong>entity and relevanttraits and/or characteristics, any requirementsfor the safe handling, storage,transport and use, the contact point forfurther information and, as appropriate,the name and address of the importer andexporter; and contains a declaration thatthe movement is in conformity with therequirements of this Protocol applicableto the exporter.3. The Conference of the Parties serving asthe meeting of the Parties to this Protocolshall consong>idong>er the need for and modalitiesof developing standards with regard toong>idong>entification, handling, packaging andtransport practices, in consultation withother relevant international bodies.The Chair’s Summary of draft elements preparedat the end of BSWG-2, covered the main issuesraised in the discussions and written proposals. 363Options in the Summary included: the packagingand labelling of LMOs to maintain safetylevels during transport, consong>idong>eration of existinginternational recommendations and agreementson transport, the need for coverage of transit, 364adoption of the precautionary approach, developmentof general principles on labelling, packagingand transport, and the labelling of LMOs intendedfor food purposes. 365 Switzerland had calledfor international harmonisation and a study ofappropriate technical details, 366 and the Summaryacknowledged that international instrumentssuch as the UN Recommendations on the Transportof Dangerous Goods and the WHO LabourSafety Manual dong>idong> not adequately cover the transportand handling of LMOs.363UNEP/CBD/BSWG/2/6, para. 145-149; Annex II, Item I.364As proposed by Malaysia (UNEP/CBD/BSWG/2/Inf.7).365As proposed by Norway (UNEP/CBD/BSWG/2/2).366UNEP/CBD/BSWG/2/2, p.63.58


III. TEXT OF THE PROTOCOLSubmissions were received for BSWG-3. 367 Australia,Brazil and Sri Lanka proposed that shipmentscontaining LMOs should be clearly ong>idong>entified, handledand packaged to prevent accong>idong>ental releasesand should include contact details of the relevantfocal point. Belarus and India called for specificlabelling of food products incorporating LMOs,with Belarus further proposing that other LMOsshould be labelled according to environmental,health and ethical concerns. Norway’s proposalrequired the inclusion of a movement documentfrom the point of departure to the point of use.Cooperation with the World Customs Organisation(WCO) in assigning a universal ong>idong>entificationcode for products covered by the Protocol wassuggested by Colombia. Japan proposed that theConference of the Parties elaborate guong>idong>elines onthe issue, while Malaysia recommended adoptionof precautionary measures and the right of Partiesto impose the necessary terms and conditions forthe protection of the environment (includingsocio-economic imperatives and risks to agricultureand human health). Mexico referred tothe needs of developing countries and countrieswith economies in transition. Peru favoured insurancepolicy cover and specified requirements onlanguage, size, location and use of symbols in thelabelling.The Consolong>idong>ated Text at the end of BSWG-3contained the above proposals, except those ofMexico and Peru. 368 The options went from a generalrequirement of safe transfer to a requirementto establish specific documentation and labellingprocedures. Some options called for the developmentby the COP of the necessary standards,while others foresaw drawing upon existing internationalstandards.The Chair’s Note on this article, prepared for BSWG-4, reduced the number of options to four. 369 Thesewere two short options, one requiring transport tobe undertaken in safe conditions to avoong>idong> adverseeffects and the other obliging Parties to establishor promote measures in conformity with internationalrules and standards or standards under theProtocol. Of the two longer options, one reflecteda new submission by Colombia 370 proposing theinclusion of a safety information sheet containinginformation to be specified in an Annex to theProtocol and calling again for cooperation withthe WCO; and the other reflected the elements ofthe existing Consolong>idong>ated Text. 371During BSWG-4 further consolong>idong>ated text wasprepared containing two options developed bySWG-II. 372 The first required exporting Parties todevelop appropriate measures for the handling,transport and packaging of LMOs. The secondoption, which listed Parties’ obligations (to bedeveloped in an annex to the Protocol), receivedmuch support. 373 In addition, a zero (no provision)option was favoured by some delegationsto avoong>idong> possible conflict with the WTO. 374 Substantialprogress was made at BSWG-4, althougha number of contentious issues remained. Theseincluded: the need for the provision; its scope; relianceon international rules and standards versusnational measures; development of new internationalstandards; and the information to accompanytransport (including labelling). 375The text was reduced to a single bracketed optionin BSWG-5 covering scope; need for ong>idong>entification(including possible consong>idong>eration of relevant internationalrules); accompanying documentation;and development of standards by the COP. 376 At367UNEP/CBD/BSWG/3/3, pp. 51-54, contains the submissions of the African group, Australia/Brazil/Sri Lanka, Belarus, Colombia, Cuba, India, Japan,Mexico, Norway, Peru, Switzerland and USA.368UNEP/CBD/BSWG/3/6, Annex I, see Article 17.369UNEP/CBD/BSWG/4/Inf. 2, see Article 17.370UNEP/CBD/BSWG/4/3. pp. 13-14.371UNEP/CBD/BSWG/3/6, Annex I, see Article 17, Option 1.372ENB Vol. 9 No. 81, p. 2.373Id.374UNEP/CBD/BSWG/4/4, Annex II, see Article 17.375Id.376UNEP/CBD/BSWG/5/3, Annex, see Article 17.59


III. TEXT OF THE PROTOCOLthis stage, the draft Article still addressed all LMOsin the same manner, an approach that would bechanged in later negotiations.At BSWG-6, initial discussions focused on a text preparedby the Co-Chairs of SWG-II. Although somedelegations were satisfied with the text, othersoffered suggestions for improvement. 377 Accordingto the Earth Negotiations Bulletin, most developingcountry delegations supported, inter alia: languageon risks to human health and ‘products thereof’;labelling in addition to ong>idong>entification; and thedevelopment of new standards under the Protocol.378 Some developed country delegations heldthe view that new standards and requirementsfor documentation to accompany LMOs wouldduplicate other international rules and createunnecessary bureaucracy. 379 Delegations differedas to whether the article applied to all LMOs withinthe scope of the Protocol or only to LMOs subjectto the AIA procedure. 380 In the informal group,convened by Co-Chair Herity, some delegationsnoted the linkage with the articles on objectivesand scope of AIA, and many consong>idong>ered labellingfor consumers to be an internal policy issue. Othersdisagreed, citing the objective of the Protocol andArticle ong>19ong>(3) of the ong>Conventionong>. 381The Chair’s proposed text replaced all referencesto “labelling” with “ong>idong>entification”, maintained thereference to human health, required the COP todetermine if standards needed to be developed,and extended the scope of the provision to all LMOswithin the scope of the Protocol. 382 No agreementwas reached on this provision during the remainderof BSWG-6 and the first session of the ExCOP. TheMiami Group proposed that the article should onlycover LMOs within the scope of the AIA procedure,not all those within the scope of the Protocol. 383 TheEU proposed new text for the article (then Article 15),which would differentiate documentation requirementdepending on the intended use of the LMOconcerned. 384 This approach, though not the preciseformulation of the EU proposal, would be reflectedin the final text.In the Vienna consultations, discussions on theCompromise Group concept paper on LMO-FFPsresulted in a framework under which adequateand differentiated documentation requirementsfor LMO-FFPs would be developed. 385The discussions by the contact group on commodities,chaired by Mr François Pythoud (Switzerland),386 during the resumed ExCOP resulted intext differentiating between the different intendeduses of LMOs (LMO-FFPs, LMOs for containeduse, and LMOs for intentional introduction intothe environment) and accompanying documentation.387 However, disagreement remained on thespecific elements and language for ong>idong>entificationof LMO-FFPs. 388 In final high-level consultations,a compromise was reached under which it wasagreed that the documentation accompanyingLMO-FFPs should clearly ong>idong>entify that they“may contain” LMOs and “are not intended forintentional introduction into the environment.”Future consong>idong>eration of detailed requirementsby the meeting of the Parties was also mandated.This was the last issue to be agreed by the ExCOP.When the ExCOP Presong>idong>ent introduced to the plenarythe final text of the Protocol submitted bythe Legal Drafting Group, 389 he introduced an oralamendment to Article 18. With this amendment,the Protocol was adopted. 390377ENB Vol. 9 No. ong>11ong>2, p. 1.378, 379, 380, 381Id.382ENB Vol. 9 No. ong>11ong>4, p. 1; and UNEP/CBD/BSWG/6/L.2, see Article 15.383UNEP/CBD/ExCOP/1/3, Annex III.384UNEP/CBD/ExCOP/1/3, Annex II.385UNEP/CBD/ExCOP/1/INF/3, Informal Consultations on ong>Biosafetyong> Protocol, Vienna, 15-ong>19ong> September ong>19ong>99, p.4.386ENB Vol. 9 No. 134, p. 2.387ENB Vol. 9 No. 135, p. 1.388Id., and ENB Vol. 9 No. 136, p. 1.389UNEP/CBD/ExCOP/L.5.390UNEP/CBD/ExCOP/1/3, paras. 90-92.60


III. TEXT OF THE PROTOCOLArticle ong>19ong>: Competent NationalAuthorities and National FocalPoints1. Each Party shall designate one nationalfocal point to be responsible on its behalffor liaison with the Secretariat. Each Partyshall also designate one or more competentnational authorities, which shall beresponsible for performing the administrativefunctions required by this Protocoland which shall be authorised to act on itsbehalf with respect to those functions. AParty may designate a single entity to fulfilthe functions of both focal point andcompetent national authority.2. Each Party shall, no later than the dateof entry into force of this Protocol for it,notify the Secretariat of the names andaddresses of its focal point and its competentnational authority or authorities.Where a Party designates more than onecompetent national authority, it shall conveyto the Secretariat, with its notificationthereof, relevant information on therespective responsibilities of thoseauthorities. Where applicable, such informationshall, at a minimum, specify whichcompetent authority is responsible forwhich type of living modified organism.Each Party shall forthwith notify the Secretariatof any changes in the designationof its national focal point or in the nameand address or responsibilities of its competentnational authority or authorities.3. The Secretariat shall forthwith informthe Parties of the notifications it receivesunder paragraph 2 above, and shall alsomake such information available throughthe ong>Biosafetyong> ong>Clearingong>-ong>Houseong>.Views on this issue were first submitted for BSWG-2. 391 The African group proposal 392 included languageon the obligation of a Party to inform theSecretariat of the designated agency or of anychanges regarding this designation.The debate in BSWG-2 revolved around the numberof competent national authorities and focalpoints, the possibility of establishing a singleentity to fulfil the functions of both, and the possibilityof establishing regional focal points. Someminimum tasks and responsibilities of these bodieswere suggested, as well as a timeframe for theirdesignation. 393 A Chair’s summary outlined theoptions for the number and type of competentauthorities/focal points, the timeframe for designationand their responsibilities. 394During BSWG-3, SWG-II discussed the issue onthe basis of government submissions. 395 Mostsubmissions stated that Parties should designatethe national competent authority(ies) and focalpoint, and notify the Secretariat and the BCHof this designation and any related changes. Afew submissions outlined various tasks that thecompetent national authorities and focal pointsshould perform. Colombia, Norway and the USsuggested language provong>idong>ing for the Secretariatto inform the Parties of notifications received. Theobligation to provong>idong>e information on the responsibilitiesof each competent authority where therewas more than one, as suggested by the US, is alsoreflected in the final text.391UNEP/CBD/BSWG/2/2, p. 60 contains the submissions of the African region, EU, Japan, Norway and Switzerland. UNEP/CBD/BSWG/2/Inf.7, pp. 5-6,contains the submissions of Malaysia.392UNEP/CBD/BSWG/2/2, p. 60.393UNEP/CBD/BSWG/2/6, paras. 73-79.394UNEP/CBD/BSWG/2/6, Annex II, see Item B.395UNEP/CBD/BSWG/3/3, pp. 54-61, contains the submissions of the African Group, Australia, Belarus, Brazil, Colombia, Cuba, EC, India, Japan,Madagascar, Malaysia, Mexico, Norway, Peru, South Africa, Sri Lanka, Switzerland and the US. UNEP/CBD/BSWG/3/5 also contains the submission ofIndonesia.61


III. TEXT OF THE PROTOCOLThe outcome of BSWG-3 discussions included fiveoptions, derived from government submissions. 396All options contained text on the designation ofone or more competent authorities, but differedon the number of focal points. There were alsodifferent possibilities regarding the timeframefor the Party’s obligation to notify the Secretariatof the designation: with the deposit by the Partyof its instrument of ratification; by the entry intoforce of the Protocol for the Party; or within threemonths of the Protocol’s entry into force for theParty. The level of detail of the proposed languagealso differed when outlining the tasks of the bodies.One of the options further included text onensuring sufficient resources for the efficient performanceof the focal point’s tasks.Following Chair Koester’s initial attempt tosynthesise similar options for BSWG-4, reducingthem to three, 397 the main contentious issuesat BSWG-4 included: the number of focal pointsper Party; the timeframe for notifying theSecretariat of the designation of competentauthorities and focal points; and whether or notto include detailed reference to their tasks. SWG-II negotiations in BSWG-4 resulted in a singlebracketed text, the above issues still remainingunresolved. Delegations agreed that the nationalfocal point “shall be responsible for liaison withthe Secretariat”.BSWG-5 discussions focused on the number offocal points and the timeframe for designation. 398SWG-II agreed that the timeframe for designationwas to be no later than the date of entry intoforce of the Protocol for the Party in question.Delegations also agreed that the Secretariatshould inform Parties of notifications received andmake such information available through the BCH,and affirmed that Parties should provong>idong>e relevantinformation on the respective responsibilitiesof their competent national authorities and, ifapplicable, on which competent national authoritywas responsible for which type of LMO. The finaltext was streamlined into three paragraphs. 399 Theissue of whether a Party could designate morethan one focal point remained bracketed 400 andwas finally resolved in BSWG-6, where delegatesagreed to the designation of one national focalpoint 401 and provisionally adopted the article. 402It remained unchanged thereafter, although thearticle was renumbered when the Protocol wasagreed in its final form.396UNEP/CBD/BSWG/3/6, Annex I, see Article 18.397UNEP/CBD/BSWG/4/Inf. 2, p. 12.398UNEP/CBD/BSWG/5/2, pp. 76-78 contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.399UNEP/CBD/BSWG/5/3, Annex, see Article 18.400UNEP/CBD/BSWG/6/8, p.44.401 UNEP/CBD/ExCOP/1/2, Appendix I, see Article 16.402UNEP/CBD/ExCOP/1/3, para. 51.62


III. TEXT OF THE PROTOCOLArticle 20: Information Sharingand the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>1. A ong>Biosafetyong> ong>Clearingong>-ong>Houseong> is herebyestablished as part of the clearing-housemechanism under Article 18, paragraph 3,of the ong>Conventionong>, in order to:(a) Facilitate the exchange of scientific,technical, environmental and legal informationon, and experience with, livingmodified organisms; and(b) Assist Parties to implement the Protocol,taking into account the special needsof developing country Parties, in particularthe least developed and small islanddeveloping States among them, and countrieswith economies in transition as wellas countries that are centres of origin andcentres of genetic diversity.2. The ong>Biosafetyong> ong>Clearingong>-ong>Houseong> shallserve as a means through which informationis made available for the purposes ofparagraph 1 above. It shall provong>idong>e accessto information made available by the Partiesrelevant to the implementation of theProtocol. It shall also provong>idong>e access,where possible, to other international biosafetyinformation exchange mechanisms.3. Without prejudice to the protection ofconfong>idong>ential information, each Party shallmake available to the ong>Biosafetyong> ong>Clearingong>-ong>Houseong> any information required to bemade available to the ong>Biosafetyong> ong>Clearingong>-ong>Houseong> under this Protocol, and:(a) Any existing laws, regulations andguong>idong>elines for implementation of the Protocol,as well as information required bythe Parties for the advance informedagreement procedure;(b) Any bilateral, regional and multilateralagreements and arrangements;(c) Summaries of its risk assessments orenvironmental reviews of living modifiedorganisms generated by its regulatoryprocess, and carried out in accordancewith Article 15, including, where appropriate,relevant information regardingproducts thereof, namely, processedmaterials that are of living modifiedorganism origin, containing detectablenovel combinations of replicable geneticmaterial obtained through the use ofmodern biotechnology;(d) Its final decisions regarding the importationor release of living modified organisms;and(e) Reports submitted by it pursuant toArticle 33, including those on implementationof the advance informed agreementprocedure.4. The modalities of the operation of theong>Biosafetyong> ong>Clearingong>-ong>Houseong>, including reportson its activities, shall be consong>idong>ered anddecong>idong>ed upon by the Conference of theParties serving as the meeting of the Partiesto this Protocol at its first meeting, andkept under review thereafter.Prior to BSWG-2, three government submissionswere made. 403 The African group called for theestablishment of a ong>Biosafetyong> ong>Clearingong>-ong>Houseong> toprovong>idong>e information relating to the implementationof the Protocol and composed of recognisedexperts. It also proposed that the modalities ofestablishment should be consong>idong>ered and decong>idong>edat the first meeting of the Parties, a proposalwhich would be reflected in the fourth paragraphof the final text. As in other provisions, the Africangroup supported the inclusion of informationon “products thereof” as well as on LMOs. Theproposal specified the duties and types of informationto be collected and disseminated by theBCH, including assistance to developing countries.Switzerland acknowledged this mechanismas an essential tool to implement the Protocoland called for it to host information on scientificreferences for risk assessment and management,403UNEP/CBD/BSWG/2/2 pp. 65-67 contains the submissions of the African group, Canada and Switzerland.63


III. TEXT OF THE PROTOCOLnational procedures on risks, databanks on relatedexperiments, and information on transboundarymovements and AIA. It also suggested followingthe model of the BIOBIN project which UNIDO andOECD had jointly developed.Canada noted that the term ‘clearing-house’ neededto be defined once the type of information thatwould be consong>idong>ered, resources and processingof information were known. This could includehow or whether to track decisions to approve,conditionally approve or prohibit transboundarymovements of LMOs and sharing of informationon risks. The US proposed facilitating informationsharingthrough a centralised clearing-house ordatabase, coordinated by an existing organisation.Parties could make available to the clearing-housemechanism publicly available informationon domestic laws/regulations applicable tothe production and/or use of LMOs; and on riskassessments or environmental reviews generatedby the regulatory process. 404At BSWG-3, new submissions on the clearinghousewere consong>idong>ered. 405 A number of governmentssuggested using the ong>Clearingong>-houseMechanism under the ong>Conventionong> as the clearing-housefor the Protocol, 406 while one saw theProtocol’s clearing-house as an integral part ofthe CHM. 407 A number of countries proposedthat the object of the mechanism should be theinformation to be ong>idong>entified under an annex tothe Protocol (“Information to be provong>idong>ed to theSecretariat under Information Sharing/ong>Clearingong>ong>Houseong>”). 408 Some developed country delegationsraised the issue of confong>idong>entiality of data, 409 whilesome developing countries advocated the inclusionof socio-economic information or research. 410Cooperation with an International Registry onLMOs was suggested by Cuba, and Malaysia calledfor cooperation with existing international agencies,organisations, mechanisms and networks forthe dissemination of biosafety-related information.The US proposed that Parties should makeinformation on their decisions on importation,field tests and commercial use of LMOs publiclyavailable. Switzerland called for Parties to ensurethe inclusion of information on intentional movementssubject to AIA and on unintentional movements.The views of the US regarding the need fora centralised database or clearing house, holdinginformation on domestic laws, regulations andguong>idong>elines, and risk assessments would becomeincorporated into the draft text at BSWG-5.An annex was compiled listing the types of informationthat countries had proposed. 4ong>11ong> In additionto the above, Colombia and Japan proposed toinclude the provision by Parties of information onany bilateral, regional and multilateral agreementsand on unilateral declarations of exemption fromor simplification of the AIA procedures. Japan alsosuggested periodic reporting on the implementationof the AIA procedure. Both proposals wouldfeature in the final text.SWG-II reduced the options to seven which differedon the following points: acknowledgementof the special needs of developing countries;nature and structure of the clearing-house/centralised database; types of information to behandled by the mechanism; respect for confong>idong>entialinformation and extent of access to and availabilityof such information. 412404Ibong>idong>, pp. 31-32405UNEP/CBD/BSWG/3/3, pp. 61-67, contains the submissions of the African group, Australia, Belarus, Brazil, Canada, Colombia, Cuba, EC, India, Japan,Madagascar, Malaysia, Mexico, Norway, Peru, South Africa, Sri Lanka, Switzerland and USA.406India and Colombia.407Madagascar.408Australia, Canada, EC and Norway.409Belarus, Canada, EC, Norway and Switzerland.410African group, Cuba, India, Sri Lanka.4ong>11ong>UNEP/CBD/BSWG/3/3, Annex IV, contains the submissions of the African group, Australia, Belarus, Brazil, Canada, Colombia, EC, Japan, Madagascar,Norway, Peru and Sri Lanka.412UNEP/CBD/BSWG/3/6, Annex I, see Article ong>19ong>.64


III. TEXT OF THE PROTOCOLThe consolong>idong>ated text at the end of BSWG-4reduced the text to three options addressing theobjective and establishment of the mechanism,its content, and information-sharing obligationsof the Parties. 413At BSWG-5, SWG-II consong>idong>ered whether themechanism in question should be a database ora clearing-house. 414 To assist the discussions, theSecretariat defined the term “clearing-house” as a“decentralised transactional system with responsibilityfor information resong>idong>ing with the informationprovong>idong>ers” and further noted that “using the[ong>Conventionong>’s CHM], a network of networks, wouldnot be burdensome, but establishing a new databasewould be”. 415Some developed countries had expressed a preferencefor a simple electronic database mechanism,while many developing countries supporteda clearing-house separate from the CHM, mainlybecause of access difficulties to the Internet. TheCo-Chair of SWG-II mandated a working groupto outline a common concept of the clearinghouse.416 The working group decong>idong>ed that a clearing-housewas a means through which informationwas made available, by provong>idong>ing access toinformation provong>idong>ed by Parties. 417 The Co-Chairreferred to three existing biosafety informationsystems: UNIDO’s ong>Biosafetyong> Information andAdvisory System, UNEP’s International Registryon ong>Biosafetyong>, and OECD’s BioTrack. 418 Delegationsagreed to use the term “clearing-house” ratherthan “database”. 4ong>19ong>The Co-Chair of SWG-II noted the interpretation ofa decentralised clearing-house as one that wouldnot collect information, but rather would pointto it. 420 Delegations decong>idong>ed to remove bracketsfrom language on the protection of confong>idong>entialinformation in exchange for deleting a referenceto publicly available information. 421 The referenceto information on unintentional transboundarymovements was deleted as it was covered underthe article on Unintentional Transboundary Movements(then Article 15). 422 However, the referencesto reports on implementation under the article onMonitoring and Compliance, (then Article 35) andto a decision by the first MOP with regard to thearrangements for the mechanism were retained. 423Paragraphs on decisions regarding clearing-housemodalities and reports on its operation weremerged. The reference to existing internationalbiosafety information exchange mechanisms hadthe brackets removed. 424As the much debated issue of “products thereof”touched upon many other provisions, it was dealtwith separately at a general consultation andreferred to CG-1. 425The draft text emerging from BSWG-5 containedthe options outlined above and was similar incontent and lay out to the text of the article asfinally adopted. 426During negotiations at BSWG-6 a number of issueswere still pending: the relationship between abiosafety clearing-house and the CBD CHM; referencesto “products thereof” and confong>idong>ential infor-413UNEP/CBD/BSWG/4/4, Annex II, see Article ong>19ong>.414ENB Vol. 9 No. 108, p. 7.415ENB Vol. 9 No. 100, pp. 1-2.416ENB Vol. 9, No. 100, p.2417ENB Vol. 9, No. 101, p.2.418ENB Vol. 9, No. 104, p. 2.4ong>19ong>ENB Vol. 9, No 103, p.2.420ENB Vol. 9 No. 105, p. 2421Id.422Id.423Id.424Id.425UNEP/CBD/BSWG/5/3, para. 28.426Ibong>idong>., Annex, see Article ong>19ong>.65


III. TEXT OF THE PROTOCOLmation; and the relationship with the provisionson risk assessment and on AIA procedures. 427 Thead hoc discussion on LMOs and “products thereof”resulted in an agreement to substantially reducethe number of references to the term “productsthereof” in the Protocol. However the termremained in this draft article, accompanied by adefinition.The Chair’s proposed text at BSWG-6, establishedthe ong>Biosafetyong> ong>Clearingong>-ong>Houseong> as part of the CBDclearing-house mechanism and included a referenceto the protection of confong>idong>ential information.428 The previous text, regarding the obligationof Parties to provong>idong>e summaries of risk assessments,as well as reports on their implementationof the AIA procedures, had the brackets removed.The revised Chair’s text included language to assistcountries that are centres of origin. 429 During thisrevision the first reference to “products thereof”,in the context of the facilitation of exchangeof scientific, technical, environmental and legalinformation, was removed. Additionally, the referenceto “the Parties …at their first meeting” wasreplaced by the “Conference of the Parties servingas the meeting of the Parties to this Protocol” toreflect discussions on institutional provisions ofthe Protocol.Some minor adjustments, such as the amendmentof the wording “national laws” to “any existinglaws”, were made immediately prior to the finaladoption of the text in January 2000.427ENB Vol. 9 No. ong>11ong>3, p. 2.428UNEP/CBD/BSWG/6/L.2, see Article 17.429UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 17. The final text of the Protocol would also include the phrase “and centres of genetic diversity”.66


III. TEXT OF THE PROTOCOLArticle 21: Confong>idong>entialInformation1. The Party of import shall permit thenotifier to ong>idong>entify information submittedunder the procedures of this Protocol orrequired by the Party of import as part ofthe advance informed agreement procedureof the Protocol that is to be treatedas confong>idong>ential. Justification shall be givenin such cases upon request.2. The Party of import shall consult thenotifier if it decong>idong>es that information ong>idong>entifiedby the notifier as confong>idong>ential doesnot qualify for such treatment and shall,prior to any disclosure, inform the notifierof its decision, provong>idong>ing reasons onrequest, as well as an opportunity for consultationand for an internal review of thedecision prior to disclosure.3. Each Party shall protect confong>idong>entialinformation received under this Protocol,including any confong>idong>ential informationreceived in the context of the advanceinformed agreement procedure of theProtocol. Each Party shall ensure that ithas procedures to protect such informationand shall protect the confong>idong>entialityof such information in a manner no lessfavourable than its treatment of confong>idong>entialinformation in connection withdomestically produced living modifiedorganisms.4. The Party of import shall not use suchinformation for a commercial purpose,except with the written consent of thenotifier.5. If a notifier withdraws or has withdrawna notification, the Party of import shallrespect the confong>idong>entiality of commercialand industrial information, includingresearch and development information aswell as information on which the Partyand the notifier disagree as to its confong>idong>entiality.6. Without prejudice to paragraph 5above, the following information shall notbe consong>idong>ered confong>idong>ential:(a) The name and address of the notifier;(b) A general description of the livingmodified organism or organisms;(c) A summary of the risk assessment ofthe effects on the conservation and sustainableuse of biological diversity, takingalso into account risks to human health;and(d) Any methods and plans for emergencyresponse.The issue of confong>idong>ential information was brieflyaddressed in discussions at BSWG-1 430The Chair’s summary of elements at BSWG-2ong>idong>entified the need to define confong>idong>entiality; toprotect confong>idong>ential data and relative proprietaryrights without hindering information-sharingamongst Parties; to avoong>idong> undermining the abilityof the competent national authority to takeinformed decisions; and to disclose informationto the public. 431Governments submitted written proposals forconsong>idong>eration at BSWG-3. 432 Colombia proposedto exclude from confong>idong>entiality provisions informationon, inter alia, contingency plans and methodsof preventing or mitigating accong>idong>ents, anda summary of the risk assessment with respectto the effects on biodiversity including humanhealth. These proposals would be reflected in thefinal text. Similarly, the EC suggested excluding, inaddition to Colombia’s exemptions, the generaldescription of the LMO and its name, the addressof the notifier and the purpose of movement. TheEC also proposed that the notifier should indicateany part of the submitted information whichwas confong>idong>ential and justify this. The competentnational authority or national focal point woulddecong>idong>e what information to keep confong>idong>ential,following consultation with the notifier and afterinforming it of the decision. Finally, the EC’s textprovong>idong>ed that, in the event that a notification waswithdrawn, the confong>idong>entiality of the information430UNEP/CBD/BSWG/1/4, para. 46.431UNEP/CBD/BSWG/2/6, Annex II, Item. C.432UNEP/CBD/BSWG/3/3 contains the submissions of Australia, Brazil, Colombia, EC, Madagascar, Mexico, Norway, Sri Lanka and USA.67


III. TEXT OF THE PROTOCOLsupplied would be respected. The US introducedthe element concerning the establishment ofappropriate internal procedures to protect theinformation received. The two options drafted bySWG-II at BSWG-3 retained the above proposals. 433Prior to BSWG-4, governments submitted furtherdraft text. 434 The US proposed new text introducingadditional elements. It prohibited the use ofconfong>idong>ential information for a commercial purposeand obliged Parties receiving confong>idong>entialinformation to protect confong>idong>entiality in a mannerno less favourable than the treatment of confong>idong>entialinformation on domestic LMOs.Contentious issues that arose during the debateincluded: the balance between protecting confong>idong>entialinformation and the need to provong>idong>eadequate information for handling emergencies;the balance between the rights and obligations ofboth receiving and provong>idong>ing parties; and wordingthat might obstruct technological development.435The draft proposed by the Co-Chair of SWG-II hada single substantive option (with bracketed text)comprising the following elements: 436 ong>idong>entificationby the notifier of confong>idong>ential information;consultation by the importing Party in cases ofdisagreement on questions of confong>idong>entiality;protection of confong>idong>ential information throughprocedures no less favourable than those applicableto domestic LMOs; prohibition on using suchinformation for commercial purposes; respect forthe confong>idong>entiality of information submitted inthe event of withdrawal of notification; and informationnot consong>idong>ered confong>idong>ential.Further proposals were made in advance ofBSWG-5. 437 Discussions at BSWG-5 focused onthe need for the provision. 438 Most developingcountries preferred the zero (no provision) option,arguing that it would be redundant given internationalagreements and given that the issue wastrade-related. Other developing countries andmost developed countries supported the draftprovision as a means of safeguarding informationand reassuring the private sector. 439 As no consensuscould be reached the entire article was placedin brackets.In the consolong>idong>ated text transmitted to BSWG-6,a number of adjustments were made, of whichtwo are worthy of note. First, the zero option wasremoved. Second, the text provong>idong>ed that, whencommunicating its decision to the notifier thatit believed that the relevant information dong>idong> notqualify to be treated as confong>idong>ential, the partyof import was obliged to provong>idong>e “reasons onrequest and an opportunity for consultation andfor an internal review of the decision”. 440The Chair’s proposed text produced at BSWG-6was almost ong>idong>entical to the previous draft but withthe brackets removed. 441 On the final contentiousissue of whether to include a list of types of informationthat “should not generally” or “in no casemay” be consong>idong>ered confong>idong>ential, the Chair’s textused “may not”. 442 However, the revised text usedthe phrase “shall not”. 443 The text then remainedunchanged until its final adoption.433UNEP/CBD/BSWG/3/6, Annex I, Article 20.434UNEP/CBD/BSWG/4/3.435ENB Vol. 9 No. 85, p. 7.436UNEP/CBD/BSWG/4/SWG.II/CRP.5.437UNEP/CBD/BSWG/5/2 contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.438UNEP/CBD/BSWG/5/3, para. 43.439ENB Vol. 9 No. 100, p. 2 and No. 108, p.7.440UNEP/CBD/BSWG/5/3, Annex, see Article 20.441UNEP/CBD/BSWG/6/L.2, see Article 18.442UNEP/CBD/BSWG/6/L.2, see Article 18(6)443UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 18(6); andUNEP/CBD/ExCOP/1/2, see Article 18(6).68


III. TEXT OF THE PROTOCOLArticle 22: Capacity-building1. The Parties shall cooperate in the developmentand/or strengthening of humanresources and institutional capacities inbiosafety, including biotechnology to theextent that it is required for biosafety, forthe purpose of the effective implementationof this Protocol, in developing countryParties, in particular the least developedand small island developing Statesamong them, and in Parties with economiesin transition, including throughexisting global, regional, subregional andnational institutions and organisationsand, as appropriate, through facilitatingprivate sector involvement.2. For the purposes of implementing paragraph1 above, in relation to cooperation,the needs of developing country Parties,in particular the least developed andsmall island developing States amongthem, for financial resources and access toand transfer of technology and know-howin accordance with the relevant provisionsof the ong>Conventionong>, shall be taken fully intoaccount for capacity-building in biosafety.Cooperation in capacity-building shall,subject to the different situation, capabilitiesand requirements of each Party,include scientific and technical training inthe proper and safe management of biotechnology,and in the use of risk assessmentand risk management for biosafety,and the enhancement of technologicaland institutional capacities in biosafety.The needs of Parties with economies intransition shall also be taken fully intoaccount for such capacity-building in biosafety.During the discussions at BSWG-1, all delegationsstressed the importance of capacity-building forthe success of the Protocol. 444 However viewsdiffered regarding the form and content of theprovision. Some delegations suggested that suchmeasures should be undertaken to give effect toArticle 8(g) of the ong>Conventionong>, while others proposedto include the provisions of Article 18(2) ofthe ong>Conventionong>. The importance of the issue andof adequate funding and transfer of technologywas generally stressed.Prior to BSWG-2, some governments submitteddraft text 445 which would later feature in theChairman’s summary of draft elements. 446 TheAfrican group proposed that Parties design policiesand take measures to strengthen and develophuman resources and institutional capacitiesin biosafety and biotechnology. In its view, theBCH should assist developing countries to ong>idong>entifytheir requirements and secure the necessaryfunds. Bolivia stressed the importance of trainingand capacity-building regarding risk assessmentand management. In the view of the EU, the issuewas one of information exchange, training, educationand institutional capacities essential for thefunctioning of the Protocol. Malaysia pointed outthe importance of the ability to benefit from thepotential of biotechnology. Norway listed the fourmain elements of the issue: development andstrengthening of capacities to implement the Protocol;development of national biosafety legislation;awareness, assessment and management ofLMO-related risks; and safety in the transboundarymovement of LMOs.More governments submitted text for BSWG-3,many of which reiterated existing proposals. 447However, Cuba introduced two new elements:technical and scientific cooperation, and aninternational registry of LMOs. It called for thepromotion of international cooperation in thehandling and use of LMOs and in the implemen-444UNEP/CBD/BSWG/1/4, para. 70.445UNEP/CBD/BSWG/2/2 contains the submissions of the African group, Bolivia, Canada, EU, Norway. See also submission of Malaysia, UNEP/CBD/BSWG/2/Inf.7.446UNEP/CBD/BSWG/2/6.447UNEP/CBD/BSWG/3/3 contains the submissions of the African group, Australia, Belarus, Brazil, Canada, Colombia, Cuba, EC, India, Madagascar,Malaysia, Mexico, Norway, Peru, Sri Lanka, Switzerland, and US.69


III. TEXT OF THE PROTOCOLtation of national policies. The proposed registrywould become the basis for a global informationnetwork on LMOs which would also provong>idong>eassistance, training and consultancy services todeveloping countries on implementation and forfostering scientific research.Six options were produced by SWG-II, includinga zero (no provision) option. 448 Generally, theoptions combined most of the main elementssuggested by governments in their submissionsand included: the development and implementationof regional and global capacity buildingprogrammes and with securing funds by theSecretariat and the BCH; the establishment ofcentres of training and capacity building withfinancial mechanisms; cooperation in the trainingof personnel, exchange of experts, informationalexchange and institutional capacity-building toperform risk assessment and management; maximisingthe use of existing multilateral, regionaland bilateral mechanisms and encouraging theassistance of the private sector; enhancing thecapacity of developing countries, their localtechnological and institutional competence tocontribute to the distribution of benefits from thepotential of biotechnology.While some argued that other international agreementshad mandates to participate in capacitybuilding, others favoured the development of aprovision within the Protocol. The differencesbetween the options included: the degree ofclarity on financial assistance and capacity-buildingimplementation and planning; inclusion ofcapacity development in biotechnology as wellas biosafety; and emphasis on capacity and riskassessment and management procedures. 449At BSWG-4, delegations agreed to retain thearticle on capacity building. 450 In the resultingdraft, 451 the options were reduced to two: a singleparagraph option, and a six-paragraph option,which removed the repetition of the previousoptions and included new wording proposal byColombia 452 stressing the importance of “newand additional financial resources”. The first optionsimply required Parties to design appropriate policiesand take effective measures to build capacity,through international, regional and nationalinstitutions and to take into account the needsof developing countries. The other option calledfor maximising the use of existing multilateral,regional and bilateral mechanisms, developmentof national law and guong>idong>elines on biosafety, developmentof risk assessment and risk managementmechanisms, establishment of new and additionalfinancial resources, distribution of benefits fromthe potentials of biotechnology, and involvementof the Secretariat in developing and implementingcapacity-building programmes, securingfunds and provong>idong>ing information.The single provision that emerged at the end ofBSWG-5 had been condensed to five elements,mostly bracketed: 453 an obligation to cooperatein capacity building in developing countriesand in countries with economies in transition;ong>idong>entification of capacity building needs; needsof countries with economies in transition; andinvolvement of the private sector (as proposedby some developed countries). 454 The reference tothe role of the Secretariat was deleted. The text onfinancial matters was referred to CG-2 for discussionunder the article on the Financial Mechanism(then Article 26). 455 Among the contentious issuesthat remained unresolved was the reference to“biotechnology to the extent that it relates tobiosafety” in the provision.448UNEP/CBD/BSWG/3/6, Annex I, see Article 21.449ENB Vol. 9 No. 74, p.8.450ENB Vol. 9 No. 85, p. 7.451UNEP/CBD/BSWG/4/4, Annex II, see Article 21.452UNEP/CBD/BSWG/4/3.453UNEP/CBD/BSWG/5/3, Annex, see Article 21.454ENB Vol. 9 No. 104, p. 2.455Id.70


III. TEXT OF THE PROTOCOLAt BSWG-6, discussions took place in SWG-II, andin a sub-group of SWG-II and CG-2. 456 The articlewas consong>idong>ered in conjunction with the article onFinancial Mechanism and Resources (then Article26). The general reference to capacity-buildingon biotechnology and biosafety was amendedto refer to “biotechnology to the extent that it isrequired for biosafety”. 457 Despite disagreements,the reference to facilitating private sector involvementwas retained in the Chair’s text. 458 Languageaddressing access to financial resources, technologyand know-how, cooperation to enhancetechnological and institutional capacities, andassistance in areas of risk assessment and riskmanagement, which had been supported bymost developing countries, 459 also featured in theChair’s text.The article then remained unchanged until itsfinal adoption in January 2000.456ENB Vol. 9 No. ong>11ong>7, p. 7.457UNEP/CBD/BSWG/6/L.2, see Article ong>19ong>.458Id.459ENB Vol. 9 No. ong>11ong>0, p. 2.71


III. TEXT OF THE PROTOCOLArticle 23: Public Awareness andParticipation1. The Parties shall:(a) Promote and facilitate public awareness,education and participation concerningthe safe transfer, handling anduse of living modified organisms in relationto the conservation and sustainableuse of biological diversity, taking also intoaccount risks to human health. In doingso, the Parties shall cooperate, as appropriate,with other States and internationalbodies;(b) Endeavour to ensure that publicawareness and education encompassaccess to information on living modifiedorganisms ong>idong>entified in accordance withthis Protocol that may be imported.2. The Parties shall, in accordance withtheir respective laws and regulations, consultthe public in the decision-makingprocess regarding living modified organismsand shall make the results of suchdecisions available to the public, whilerespecting confong>idong>ential information inaccordance with Article 21.3. Each Party shall endeavour to inform itspublic about the means of public access tothe ong>Biosafetyong> ong>Clearingong>-ong>Houseong>.Discussions on public awareness and participationstarted at BSWG-2. 460 The Chair’s summary ofelements 461 reflected the views expressed duringthe debates and governments’ prior submissionsof draft text 462 .On public awareness, the following elements wereong>idong>entified: whether to address public awareness inthe Protocol; the provision by Parties of adequateinformation on the safe transfer, handling anduse of LMOs to the public; the development andimplementation of public awareness mechanismsby national competent authorities/ national focalpoints, together with the private sector and NGOs;whether decisions on such mechanisms shouldonly be taken at the national level; facilitatingeducational and public awareness programmeson safety in biotechnology; and respecting confong>idong>entialityin public-awareness mechanisms.On public participation, the elements includedwere: whether to include a provision on publicparticipation in the Protocol (noting that Article14(1) of the ong>Conventionong> already addressed publicparticipation in the context of impact assessment);whether to reflect both public awareness andpublic participation in a single provision; whetherto encourage but not mandate public awarenessunder the Protocol; whether to carry out a publichearing in cases subject to AIA; whether to decong>idong>ethe level of public participation at the nationallevel; and whether to include the participation ofNGOs, citizens, consumer protection groups andstakeholders.A number of written proposals were receivedfor BSWG-3, 463 including a proposal for a generalcommitment to ensure that adequate informationon the transfer, handling and use of LMOswas provong>idong>ed to the public. Many countries alsoproposed the development of educational andpublic awareness programmes on biosafety. 464Delegations consong>idong>ered the need for a provisionon this issue in the Protocol at BSWG-3. Some recommendedincluding a reference in the preamble,since the article on Information Sharing/ong>Biosafetyong>ong>Clearingong> ong>Houseong>, (then Article ong>19ong>) also touchedon the issue. Others noted that the CBD alreadyaddressed the issue. 465The Co-Chairs’ text from SWG-II took up many ofthe written submissions. It referred to the provi-460UNEP/CBD/BSWG/2/6, paras. 80-ong>11ong>3.461UNEP/CBD/BSWG/2/6, Annex II, Item E.462UNEP/CBD/BSWG/2/2, pp. 64-65, contains the submissions of the African group, Bolivia, Canada and Norway.463UNEP/CBD/BSWG/3/3, pp. 74-78, contains submissions of the African group, Australia, Belarus, Brazil, Canada, Cuba, India, Japan, Malaysia, Mexico,Norway, Peru, Sri Lanka, Switzerland,464For example, India, Mexico, Malaysia, Sri Lanka and Switzerland.465ENB Vol. 9 No. 74, p. 8.72


III. TEXT OF THE PROTOCOLsion of adequate information to the public; thedevelopment of educational programmes onbiosafety; the opportunity for public hearings forthe approval of a release, transfer or use of LMOs(as proposed by the African group); the protectionof commercial confong>idong>ential information while promotingpublic understanding of biosafety issuesand making risk assessments publicly available (asproposed by Brazil); cooperation with other States(as suggested by Cuba); and the disclosure ofinformation on biosafety and impacts of releasesto the public (as in Malaysia’s submission).The Consolong>idong>ated Text at the end of BSWG-3 466included five options: no provision; inclusion inthe preamble; the entire Co-Chairs’ text; and twooptions containing a general obligation to takeappropriate measures for public awareness andpublic participation.By the end of BSWG-4, delegations had settledon inclusion of a bracketed provision on publicawareness and participation reflecting differentviews. 467 The resulting single text comprised allthe elements of the Co-Chairs’ text approved atthe third meeting. 468The negotiations in SWG-II during BSWG-5revolved around the nature of the public’s role inthe decision-making process. 469 Some countriespreferred to provong>idong>e the public with “the opportunityfor involvement in the decision-making process”while others favoured provong>idong>ing “the resultsof the decision-making process.” 470 In response toconcerns about implementing such a provision atthe national level, the proviso “where appropriate”was added to both. 471 The reference to nationallaws, regulations and administrative measureswas also contentious. 472The majority of developing countries suggestedtaking human health into account when developingand implementing public awareness programmeson the safe transfer, handling and useof LMOs, and also called for inclusion of “productsthereof” in addition to LMOs. 473 Many developingcountries advocated the removal of the referenceto confong>idong>ential information. 474 One developedcountry proposed restricting Parties’ obligationsto facilitating public participation to “intentional”transboundary movements of LMOs, whereas otherssuggested using “release of LMOs” to simplifylanguage related to LMOs. 475 Most delegationssupported provisions on international cooperationfor promotion and development of educationaland public awareness programmes. 476All these options were reflected in the bracketedtext approved for consong>idong>eration at BSWG-6. 477At BSWG-6, agreement could not be reached onthe bracketed language of the provision and theCo-Chairs of SWG-II drafted new text. 478 However,the subsequent debate dong>idong> not succeed in bringingtogether the different views. The main contentiousissues at this stage were: whether to protectconfong>idong>ential information at all; whether complete,or only appropriate, information needed to beprovong>idong>ed to the public; and whether informationrelated only to the “release, safe transfer and handlingand use of LMOs” or also to the results of thedecision-making process regarding such activi-466UNEP/CBD/BSWG/3/6, Annex I, see Article 22.467ENB Vol. 9 No. 85, p. 7.468UNEP/CBD/BSWG/4/4, Annex II, see Article 22.469ENB Vol. 9 No. 108, p. 8.470Id.471Id.472Id.473ENB Vol. 9 No. 103, p. 2.474Id.475ENB Vol. 9 No. 108, p. 8.476ENB Vol. 9 No. 100, p. 2.477UNEP/CBD/BSWG/5/3, Annex, see Article 22.478ENB Vol. 9 No. ong>11ong>3, p. 2.73


III. TEXT OF THE PROTOCOLties. 479 A small group was created to deal with theissue and produced text that included bracketedreferences to human health, “products thereof”and “release, safe transfer, handling and use.” 480The Chair’s proposed text at BSWG-6 481 containedlanguage referencing human health and respectfor confong>idong>ential information, but excluding publicinformation on “release” of LMOs. This article,which was by now very close to the text finallyapproved, required Parties to: promote and facilitatepublic awareness, education and participationin the implementation of the Protocol, and, indoing so, cooperate with other States and internationalorganisations; consult the public in thedecision-making process and provong>idong>e the resultsof such decisions, while respecting confong>idong>entialinformation; and inform the public about how toaccess the BCH.The revised Chair’s text replaced the reference tocooperation with “international organisations” to“international bodies”. 482 The final text adopted atthe resumed ExCOP included a final adjustmentstipulating that Parties’ obligations to consultwith the public in the decision-making processbe carried out in accordance not only with theirrespective laws, but also with their regulations.479Id.480ENB Vol. 9 No. ong>11ong>7, p. 7.481UNEP/CBD/BSWG/6/L.2, see Article 20.482UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 20.74


III. TEXT OF THE PROTOCOLArticle 24: Non-Parties1. Transboundary movements of livingmodified organisms between Parties andnon-Parties shall be consistent with theobjective of this Protocol. The Parties mayenter into bilateral, regional and multilateralagreements and arrangements withnon-Parties regarding such transboundarymovements.2. The Parties shall encourage non-Partiesto adhere to this Protocol and to contributeappropriate information to the ong>Biosafetyong>ong>Clearingong>-ong>Houseong> on living modifiedorganisms released in, or moved into orout of, areas within their national jurisdictions.Although some reference had already been madeto the issue of non-Parties, it was agreed at BSWG-2 that it was premature to prepare text on thetopic. 483The resumed debate at BSWG-3 focused onwhether to include a provision on this issue or notand it was agreed that an element paper shouldbe prepared reflecting the views expressed. 484The consolong>idong>ated text included an elementpaper, which addressed the topics of non-Parties,trade with non-Parties and existing governmentsubmissions. 485 Substantive elements proposedunder the non-Parties section allowed for Partiesto enter into bilateral or regional agreements,compatible with the Protocol, and required suchagreements to be made available to other Partiesthrough the CHM and the Secretariat. On tradewith non-Parties, options included permittingsuch trade if adequate measures to ensure safemovement were taken; limitation of restrictionsto those no more stringent than under the WTO;permission with flexibility; and submission of non-Parties to arbitration mechanisms provong>idong>ed underthe Protocol.In discussions in SWG-II at BSWG-4, some delegationsexpressed their concern over non-partiesgaining trade advantages, and over the need forincentives to ratify the Protocol. 486 Some delegationsrequested a definition of “non-Party”. 487 Theresulting draft text included the following options:no provision needed; no trade of LMOs betweenParties and non-Parties; non-discriminatorytrade (through bilateral, regional or multilateralarrangements) if in compliance with the substantiveprovisions of the Protocol or if conductedunder a regulatory framework as stringent as theProtocol’s; and consong>idong>eration of trade restrictionswith non-Parties five years after the entry intoforce of the Protocol. 488At BSWG-5, the provision was discussed inCG-2 together with the provisions on nondiscrimination/nationaltreatment and on therelationship with other international agreements,as these were consong>idong>ered interlinked. 489 However,the discussions showed delegations maintainingtheir positions, namely: to have no provision; toban trade with non-Parties; or to subject suchtrade to bilateral, regional or multilateral arrangements.490 The text approved for inclusion in theconsolong>idong>ated negotiating text for BSWG-6 streamlinedthe previous options into three bracketedparagraphs reflecting these positions. 491After decong>idong>ing to include the provision in theProtocol and to withdraw the language banningtrade with non-parties, the Chair’s proposed textproduced at BSWG-6 subjected transboundary483UNEP/CBD/BSWG/2/6, para. 175.484UNEP/CBD/BSWG/3/6, paras. 53-64.485Ibong>idong>, Annex I, see Article 23.486ENB Vol. 9 No. 79, p. 2.487Id.488UNEP/CBD/BSWG/4/4, Annex II, see Article 23.489UNEP/CBD/BSWG/5/3, para. 40.490ENB Vol. 9 No. 105, p. 2, and No. 107, p. 2.491UNEP/CBD/BSWG/5/3, Annex, see Article 23.75


III. TEXT OF THE PROTOCOLmovements of LMOs between Parties and non-Parties to a requirement of consistency with theobjectives and principles of the Protocol. 492 Thesecond paragraph of the article also encouragedParties to conduct such dealings in accordancewith bilateral, regional and multilateral agreementsor arrangements with non-Parties, andrequired Parties to encourage non-Parties toadhere to the Protocol and “to contribute appropriateinformation to the BCH on LMOs releasedin and moved into or out of, their territory.” In itsproposal at the ExCOP, the EU proposed that tradewith non-Parties should be “consistent with theobjectives” of the Protocol. 493 The Miami Groupproposed a similar amendment and, in addition,the deletion of the second paragraph of thearticle. 494By 27 January 2000 at the resumed ExCOP, theChair of the informal consultations on unresolvednon-core issues, Ambassador Nobs (Switzerland),recognised that no solution had yet been foundon the contentious aspects of the provision. 495After further consultations final text was prepared.The article allowed trade with non-Parties“consistent with the Protocol’s objective” andbilateral, regional and multilateral agreementsand arrangements for that purpose. The secondparagraph was maintained, requiring Parties toencourage non-Parties to adhere to the Protocoland to contribute appropriate information to theBCH.492UNEP/CBD/BSWG/6/L.2, see Article 21.493UNEP/CBD/ExCOP/1/3, Annex II.494Ibong>idong>. Annex III.495UNEP/CBD/ExCOP/1/3 para. 86.76


III. TEXT OF THE PROTOCOLArticle 25: Illegal TransboundaryMovements1. Each Party shall adopt appropriatedomestic measures aimed at preventingand, if appropriate, penalising transboundarymovements of living modifiedorganisms carried out in contravention ofits domestic measures to implement thisProtocol. Such movements shall bedeemed illegal transboundary movements.2. In the case of an illegal transboundarymovement, the affected Party may requestthe Party of origin to dispose, at its ownexpense, of the living modified organismin question by repatriation or destruction,as appropriate.3. Each Party shall make available to theong>Biosafetyong> ong>Clearingong>-ong>Houseong> informationconcerning cases of illegal transboundarymovements pertaining to it.Of the written submissions made prior to theBSWG-2, only the African region presented texton illegal traffic in LMOs. 496 The African groupproposed as illegal traffic under the Protocol anytransfer of LMOs or products thereof: withoutnotification to, or AIA of, all States concerned; withAIA obtained from the States concerned throughfalsification, misrepresentation or fraud; or withAIA not conforming “in a material way with thedocuments submitted” or resulting in the deliberaterelease of LMOs in contravention of the Protocoland of the general principles of internationallaw. In such cases, the State of import would havehad the right to destroy or dispose of the organismsor products in question. Lastly, the Africansubmission suggested that Parties should adoptappropriate domestic legislation to prevent andpunish illegal traffic and should cooperate withother Parties in this respect.However, BSWG-2 consong>idong>ered that, as “illegal traffic”was related to “monitoring and compliance”,it was too early to begin drafting text on thisitem. 497Further draft text was presented before BSWG-3by Australia, Malaysia and South Africa. 498 Malaysiaand South Africa essentially endorsed Africa’searlier proposal. Malaysia added that the personresponsible for the illegal traffic could be requiredto remove the LMO from the environment. Australia’stext was similar, first defining illegal traffic andthen calling for national legislation to address this,which could include the re-export of the LMO orthe imposition of additional penalties.Following the request from BSWG-3, 499 theSecretariat prepared a compilation of the mainelements ong>idong>entified in the submissions by governments.This was then consong>idong>ered by SWG-II whichturned the elements into six options, which werethen included in the consolong>idong>ated text. 500The draft text emerging from BSWG-4 includedoptions for: no provision; development of domesticlegislation and cooperation; and a longeroption reflecting governments’ proposals ondomestic legislation, together with a number ofprovisions for information sharing. 501During BSWG-5, debate revolved around theneed for the provision, which was not supportedby most developed countries which felt that ageneral reference to Parties’ obligations existedin the article on General Obligations, (then Article1bis), and which consong>idong>ered illegal traffic to bea matter for domestic legislation. 502 Developing496UNEP/CBD/BSWG/2/2, pp. 63-64.497UNEP/CBD/BSWG/2/6, para 174.498UNEP/CBD/BSWG/3/5, see Article 20.499UNEP/CBD/BSWG/3/6, para 52.500UNEP/CBD/BSWG/3/6 pp. 85-87501UNEP/CBD/BSWG/4/4, Annex II, see Article 25.502ENB Vol. 9 No. 108, p. 8.77


III. TEXT OF THE PROTOCOLcountries generally favoured the article, notingthat its scope should extend to “products thereof”and that it should include references to informingthe Secretariat and the BCH, to developingnational legislation and to cooperation amongParties. 503 Some developing countries introducedtext regarding the right of the affected Partyto request the Party of origin to dispose of theLMOs in question at its own expense, which wasopposed by several developed countries. 504CG-2 developed a definition of illegal traffic andSWG-II then drew on this to produce further drafttext for discussion. 505 The definition was sent forconsong>idong>eration under the article on Use of Terms,(then Article 2). 506 The resulting text, which dong>idong>not include a definition of illegal traffic, includedbrackets around the term “products thereof” andaround the reference to the nature of the informationto be conveyed to the BCH. 507The Chair’s proposed text at BSWG-6 changed“illegal traffic” to “illegal transboundary movement”but retained an explanation of the term andthe provision for the affected Party to request theParty of origin to dispose of the LMOs at its owncost. 508 The text called for Parties to adopt appropriatedomestic measures to prevent and penalisesuch transboundary movements, allowed theaffected Party to request the disposal of the LMOsin question by the Party of origin, and obligedParties to make available to the BCH informationconcerning such cases. The text was revised by theLegal Drafting Group, 509 which made a few adjustmentsand finalised the text of the article that wasadopted.503Id.504Id.505ENB Vol. 9 No. 104, p. 2, and UNEP/CBD/BSWG/5/3, para 45.506ENB Vol. 9 No. 108, p. 8.507UNEP/CBD/BSWG/5/3, Annex, see Article 25.508UNEP/CBD/BSWG/6/L.2, see Article 23.509UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 23.78


III. TEXT OF THE PROTOCOLArticle 26: Socio-economic consong>idong>erations1. The Parties, in reaching a decision onimport under this Protocol or under itsdomestic measures implementing theProtocol, may take into account, consistentwith their international obligations,socio-economic consong>idong>erations arisingfrom the impact of living modified organismson the conservation and sustainableuse of biological diversity, especially withregard to the value of biological diversityto indigenous and local communities.2. The Parties are encouraged to cooperateon research and information exchangeon any socio-economic impacts of livingmodified organisms, especially on indigenousand local communities.Socio-economic consong>idong>erations were one of theissues on which there was no consensus at theMadrong>idong> Experts Meeting in July ong>19ong>95. 510At BSWG-1, most developed countries consong>idong>eredthe subject of little relevance and believed thatfurther studies on the matter were not necessary.Some developing countries expressed the oppositeview and noted that, “in addition to economicimpacts such as income distribution, the negativesocio-economic impacts of LMOs could includeerosion of agricultural and other biological diversity;risks to sustainable use of existing biodiversity;and the threats of transgenic animals andplants to the cultural and religious order of somecountries.” 5ong>11ong> It was proposed that the Secretariatprepare a study on the socio-economic impactsof biotechnology, but after extensive discussionno agreement was reached. Instead, the BSWGrequested the Secretariat to compile a bibliographyof relevant literature regarding both positiveand negative potential socio-economic effects ofbiotechnology. 512The bibliography on potential socio-economicimpacts of biotechnology prepared by the Secretariat513 was consong>idong>ered at BSWG-2, togetherwith written submissions from governments. 514The African Group presented the most comprehensivesubmission on socio-economic factors,incorporated into a number of draft provisionsthroughout the Protocol: objectives, general obligations,notification procedure, risk assessmentand management, liability and compensation.The draft article on socio-economic consong>idong>erationsproposed by the African group includedtaking into account the length of time before suchimpacts may be manifested and proposed a sevenyear notification period prior to export. The Africangroup proposal contained an extensive list ofsocio-economic consong>idong>erations to be included in arisk assessment: anticipated changes in the existingsocial and economic patterns; possible threatsto biological diversity, traditional crops or otherproducts and, in particular, farmers’ varieties andsustainable agriculture; impacts likely to be posedby the possibility of substituting traditional crops,products and indigenous technologies throughmodern biotechnology outsong>idong>e of their agroclimaticzones; anticipated social and economiccosts due to loss of genetic diversity, employment,market opportunities and, in general, means oflivelihood of the communities; disruptions tosocial and economic welfare; and possible effectscontrary to the social, cultural, ethical and religiousvalues of communities. 515 It constituted the mostdetailed list of socio-economic consong>idong>erations tobe taken into account by the Protocol. 516Bolivia’s submission noted that the introductionof LMOs in countries rich in biodiversity or thatare centres of genetic diversity could result in510UNEP/CBD/COP/2/7, Annex I, para. 18(b).5ong>11ong> UNEP/CBD/BSWG/1/4, para 88.512Ibong>idong>., para ong>11ong>1.513UNEP/CBD/BSWG/2/4.514UNEP/CBD/BSWG/2/2, contains the submissions of the African Group, Bolivia, Canada, the EU and Japan.515Ibong>idong>. p. 84.516It was retained in the draft text until BSWG-4, where it was section 12 of Annex II. See UNEP/CBD/BSWG/4/4, p. 7379


III. TEXT OF THE PROTOCOLthe depletion of that diversity. A breakdown ofagricultural systems and genetic erosion wouldthreaten livelihoods. 517A request by the G-77 and China to the Secretariatto prepare a study on the socio-economic implicationsof biotechnology was later withdrawn, butthat Group asked the Secretariat instead to facilitatea round-table discussion on socio-economicconsong>idong>erations at BSWG-3. 518At this stage, socio-economic consong>idong>erations, aswell as ethical consong>idong>erations, were discussed inthe context of risk assessment. Here the debatefocused on whether such assessments should bebased solely on scientific data.Governments submitted draft text prior to BSWG-3. 5ong>19ong> In addition to earlier suggestions, Mexicostressed the importance of addressing impactson the recipient environment and, in particular, oncentres of origin. Concern over impacts on socialand economic welfare was expressed by Madagascarand Sri Lanka, amongst others.It was agreed at BSWG-3 that socio-economicconsong>idong>erations would not be the subject of a furtherelement paper, but would be included in theconsolong>idong>ated text of draft articles, with the textsalready submitted by governments being set outas various options. 520Four substantive options were drafted (in additionto the zero (no provision) option). One optionbasically reflected the previous submission bythe African group, in which socio-economic factorsfeatured as an element of risk assessmentand management and which included a periodof observation of the potential impacts and therequirement for seven years’ advance notificationof export of an LMO. Another option calledfor socio-economic imperatives to be taken intoconsong>idong>eration at all levels in the Protocol, includingrisk assessment and management and forparticular attention to be paong>idong> to the displacementof particular agricultural resources, culturesor livelihood and to the prevention and mitigationof possible adverse effects. A further option simplyacknowledged that socio-economic consong>idong>erationsvaried consong>idong>erably from Party to Party andtherefore encouraged research on the issue. 521At this stage, the debate revolved around theneed to include these consong>idong>erations in the textof the Protocol at all. Generally speaking, developingcountries felt the issue was at the heart ofthe Protocol itself, whereas developed countriesconsong>idong>ered the concept too vague and specific toeach country’s circumstances to be enshrined in aseparate provision. 522At BSWG-4 there was little change to the text, withthe exception of some bracketing and reordering.523The Chair called for a reduction of options inthe draft text. 524 The resulting draft contained twosubstantive options (as well as a zero option): onesimply calling for appropriate consong>idong>eration ofsocio-economic consequences of adverse consequencesof using LMOs, while the second specifieda series of measures to be taken that reflectedthe concerns of developing countries. 525Negotiations were again difficult at BSWG-5, withfew concessions made from either standpoint.Preferences varied from a mention of the subjectin the preamble, references in the articles dealingwith risk assessment and risk management, or asan independent article.517Id.518UNEP/CBD/BSWG/2/6, paras. 183 and ong>19ong>0.5ong>19ong>UNEP/CBD/BSWG/3/3, contains, inter alia, the submissions on risk assessment and on risk assessment parameters of the African group, Belarus,India, Madagascar, Malaysia, Mexico and Sri Lanka.520UNEP/CBD/BSWG/3/6, para 27.521Ibong>idong>, pp.87-88.522Ibong>idong>, paras. 29–38.523UNEP/CBD/BSWG/4/4.524ENB. Summary. Vol. 9 No. 85, p. 9525UNEP/CBD/BSWG/4/4, p. 4880


III. TEXT OF THE PROTOCOLThe draft was reduced to one option with manybrackets by merging a number of the previousparagraphs, which included many of the submissionsof developing countries, to produce a compromiseprovision. This draft referred to preventionand mitigation of socio-economic impacts,an assessment and management of risks with along observation period, while also encouragingresearch on the topic. It also called for Partiesexporting commodities-LMOs to notify affectedParties sufficiently in advance to allow appropriatemeasures to be taken, provong>idong>ing special assistancewhen the affected Party was a developing country.Annex II was reduced to a call for “informationon the potential impacts on the socio-economicpatterns of the importing country”. 526The meeting noted that there “appeared to be ashared sympathy for the subject, but not aboutthe need, place and the manner of handling theissue under the Protocol”. 527 The issue had a bearingon the scope and other provisions for theProtocol and needed to be consong>idong>ered carefullyby delegations before the sixth meeting of theWorking Group. 528The Chair’s proposed text at BSWG-6 containedsignificant changes. It provong>idong>ed that Parties shouldtake into account socio-economic implications ofadverse impacts, also taking into account humanhealth, “especially in regard to the indigenous andlocal communities as referred to in Article 8(j) ofthe ong>Conventionong>”. It further encouraged Parties tocooperate on research and information exchange,“including the need for the early warning to suchlocal and indigenous communities that may beaffected economically”. 529The text was revised and amended to form thedraft transmitted by BSWG-6 to the ExCOP. 530Although many delegations, especially developingcountries, were initially unhappy with theChair’s proposed text, the wording on socio-economicconsong>idong>erations was ultimately acceptedwith little discussion.A requirement for Parties’ decisions on importto be “consistent with their international obligations”was added. Socio-economic consong>idong>erationsarising from the “impact” of LMOs could now betaken into account (instead of “adverse impact”).The reference to “risks to human health” was deleted.The phrase “the value of biological diversity toindigenous and local communities” was addedand, similarly, regarding research and informationexchange, a general reference to “any socio-economicimpacts of LMOs, especially on indigenousand local communities” was included in place ofearlier language on early warning and economiceffects on local and indigenous communities. Anyreference to socio-economic consong>idong>erations inAnnex II was deleted.At the resumed ExCOP, a final addition made duringthe last informal consultations conducted byAmbassador Nobs added a reference to Parties’domestic measures to implement the Protocolwith regard to socio-economic consong>idong>erations. 531526Id; Text submitted to plenary by the co-chairs of SWG II (UNEP/CBD/BSWG/5/CRP.32).527UNEP/CBD/BSWG/5/3, para. 46.528Id.529UNEP/CBD/BSWG/6/L.2, see Article 24.530UNEP/CBD/ExCOP/1/2, Appendix 1531ENB Vol. 9 No. 137, p. 9.81


III. TEXT OF THE PROTOCOLArticle 27: Liability and RedressThe Conference of the Parties serving asthe meeting of the Parties to this Protocolshall, at its first meeting, adopt a processwith respect to the appropriate elaborationof international rules and proceduresin the field of liability and redress fordamage resulting from transboundarymovements of living modified organisms,analysing and taking due account of theongoing processes in international law onthese matters, and shall endeavour tocomplete this process within four years.Liability was another issue on which there was noconsensus at the Madrong>idong> Experts Meeting in Julyong>19ong>95. 532 At BSWG-1, several delegations, notingthat the issue of liability and compensation hadbeen addressed by a number of internationalconventions, recommended that the Secretariatprepare a working paper on the matter. It wasnoted that Article 14(2) of the ong>Conventionong> gavethe COP a mandate to address the issue of liabilityand redress, including compensation for damageto biodiversity. 533A document prepared by the Secretariat for BSWG-2 on existing international agreements relevant tobiosafety, 534 addressed liability and compensationwith reference to Article 14(2) of the ong>Conventionong>,paragraph 18(b) of Annex I to the report of theOpen-ended Ad Hoc Group of Experts 535 , and decisionII/5 of the COP. 536 The document noted that,although most of the international agreementsexamined avoong>idong>ed matters relating to liability andcompensation and left these to domestic law makers,there were some agreements that addresseddamage to persons, property and the environmentarising from potentially hazardous activities,the most developed regimes being those addressingoil pollution damage and damage caused bynuclear incong>idong>ents. Those regimes indicated thatthere were essentially three functions of liabilityin international law, namely: a corrective function(ex post facto enforcement), a preventive function(ex ante facto incentive) and a reparative function.The document listed a series of elements including:scope of activities and substances; definitionof environmental damage; establishment of astandard of care and of measurement of thedamages; locus standi; determination of availableremedies; defences; adequate insurance; anddesignation of forum and enforcement of judgementsthat a liability regime under the ong>Biosafetyong>Protocol might consong>idong>er.Some governments made submissions for BSWG-2. 537 Generally speaking, while developed countrieswere opposed to having an article on liabilityand preferred to rely on international law andArticle 14(2) of the ong>Conventionong> to cover the issue,many developing countries wanted to include aprovision and some submitted draft text. It wasdecong>idong>ed that liability and compensation should bediscussed at the following meeting on the basis ofthe government submissions of draft text. 538The Consolong>idong>ated Text of Draft Articles at the endof BSWG-3 included, under Article 27 (Liabilityand Compensation), seven options deriving fromthe main elements of the submissions by governments.539 Option 1 was to have no provision, whileOption 2 referred work on the matter to the developmentof Article 14(2) of the CBD.Option 3 obliged the state or states of origin of theharm to negotiate with the affected state or stateson the legal consequences. It also required themto bear the costs of restoration or compensation532UNEP/CBD/COP/2/7, Annex 1, para. 18(b).533UNEP/CBD/BSWG/1/4, paras. 95-97.534UNEP/CBD/BSWG/2/3.535UNEP/CBD/COP/2/7.536UNEP/CBD/BSWG/2/3, paras. 121- 123.537UNEP/CBD/BSWG/2/2, contains the submissions of the African group, Bolivia, Canada, EU, Japan and Norway.538UNEP/CBD/BSWG/2/6, para. 177.539UNEP/CBD/BSWG/3/6, Annex, see Article 27.82


III. TEXT OF THE PROTOCOLin cases of detriments to human or animal health,biodiversity or socio-economic welfare of the state,and to make payments in the case of personal orproperty damages. It also encouraged Parties tofurther elaborate liability rules and allowed Partiesto undertake further actions, such as submitting aclaim to arbitration or to the International Courtof Justice. Under Option 4 exporting Parties wouldbe liable for any negative effects unforeseen onthe basis of the information provong>idong>ed for the firstimport, for breach of the Protocol obligations, forillegal traffic and for unintentional transboundarymovements. Option 5 stated that exporter wouldbe liable for any damage deriving from the transboundarymovement of LMOs and for full compensation.Option 6 called on Parties to cooperatein adopting appropriate rules and procedures onliability and redress in accordance with Article14(2) of the ong>Conventionong>. Finally, Option 7 coveredthe responsibility of Parties to meet their internationalobligations on conservation and sustainableuse biodiversity, to ensure that recourse wasavailable in accordance with their legal system, toprovong>idong>e compensation from damage by LMOs. Itprovong>idong>ed for further cooperation between Partiesfor the further development of international lawon liability, the settlement of related disputes, andthe development of criteria and procedures forpayment of compensation, compulsory insuranceand compensation funds.At BSWG-4, debate still revolved around whetherto include a provision on liability or not, orwhether to leave the matter to be addressedby the CBD COP (under Article 14 (2) CBD) or bythe meeting of the Parties to the Protocol. Keepingthe options open, the draft text of SWG-II 540amalgamated the proposals received into severaloptions, taking account of the recent governmentsubmissions on the topic. 541 The options rangedfrom no article, to consong>idong>eration at the first meetingof the Parties, to the inclusion of an article onliability and compensation. The main new featurewas the itemisation of possible different elementsof the provision: liability; civil liability; compensation;measures for reinstatement; prescription ofliability; emergency fund and exceptions. Otherproposals for substantive text included strictliability of the state of origin, liability for breach ofdue diligence, and the establishment of an EmergencyCompensation Fund.Developed and developing countries in generaladvanced opposing views during BSWG-5.Some developed country delegations expressedconcern about the length of time that had beenspent in developing liability regimes under otherinternational agreements, and others suggestedthat the matter could be dealt with by domesticframeworks on product liability. 542 Most developingcountries stressed the importance of a substantiveprovision on liability and redress. It wassuggested that it would be illogical to develop aregulatory framework to ensure safety withoutconsong>idong>ering the consequences of accong>idong>ents. Otherdeveloping countries noted the absence of a generalinternational law of liability and called for atailor-made regime. 543At BSWG-5, SWG-II referred the issue to CG-2where a small drafting group was set up to clarifypositions and reach agreement on text. 544 Thetext that was sent to BSWG-6 was entirely bracketedin order to combine all the variations into asingle option. 545 .540UNEP/CBD/BSWG/4/4, pp. 49 - 53.541UNEP/CBD/BSWG/4/2, contains the submissions of the African region, Bolivia, Chile, Colombia, India, Japan, Malaysia, Norway, South African andSwitzerland.542ENB, Vol. 9 No. 108, p.9.543Id.544UNEP/CBD/BSWG/5/3, paras. 40 and 53.545Id.83


III. TEXT OF THE PROTOCOLAt BSWG-6, the Chair of the drafting group onliability, Ms. Kate Cook (United Kingdom), soughtto ong>idong>entify the mong>idong>dle ground between polarisedpositions, which called either for a strong liabilityregime or for deletion of the article. After lengthydiscussions, many delegations agreed that thiscomplex issue could not be resolved at the meetingand supported a non-paper from the Chair ofthe drafting group to include an article that wouldenable future work on the issue. 546 The debatethen focused on the level of commitment to suchwork and possible timeframes for action.The drafting group discussed the issue and submittedtext calling upon Parties to “examine themodalities of establishing and developing rulesand procedures on liability and redress” and mandatingthem to start, at the first MOP, a processto elaborate rules and procedures to develop aregime within six years. A revised text mergedthe two paragraphs and deleted the referenceto “studies to be carried out”. 547 Additionally, thetext now called upon the first meeting of theCOP/MOP “to adopt a process with respect to theappropriate elaboration of international rules andprocedures” on liability. This process should takeaccount of “the ongoing process in internationallaw on these matters” and was to be completed infour years, rather than six. The final text, 548 revisedby the Legal Drafting Group, was presented to theplenary of the ExCOP and remained unchangeduntil the final adoption of the Protocol at theresumed ExCOP in January 2000.546ENB Vol. 9 No. ong>11ong>1, p. 2 and No. ong>11ong>2, p.2.547UNEP/CBD/BSWG/6/L.2/Rev.1, see Article 25.548UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 25.84


III. TEXT OF THE PROTOCOLArticle 28: Financial Mechanismand Resources1. In consong>idong>ering financial resources forthe implementation of this Protocol, theParties shall take into account the provisionsof Article 20 of the ong>Conventionong>.2. The financial mechanism established inArticle 21 of the ong>Conventionong> shall, throughthe institutional structure entrusted withits operation, be the financial mechanismfor this Protocol.3. Regarding the capacity-building referredto in Article 22 of this Protocol, the Conferenceof the Parties serving as the meetingof the Parties to this Protocol, in provong>idong>ingguong>idong>ance with respect to the financialmechanism referred to in paragraph 2above, for consong>idong>eration by the Conferenceof the Parties, shall take into accountthe need for financial resources by developingcountry Parties, in particular theleast developed and the small islanddeveloping States among them.4. In the context of paragraph 1 above, theParties shall also take into account theneeds of the developing country Parties,in particular the least developed and thesmall island developing States amongthem, and of the Parties with economiesin transition, in their efforts to ong>idong>entifyand implement their capacity-buildingrequirements for the purposes of theimplementation of this Protocol.5. The guong>idong>ance to the financial mechanismof the ong>Conventionong> in relevant decisionsof the Conference of the Parties,including those agreed before the adoptionof this Protocol, shall apply, mutatismutandis, to the provisions of this Article.6. The developed country Parties mayalso provong>idong>e, and the developing countryParties and the Parties with economies intransition avail themselves of, financialand technological resources for the implementationof the provisions of this Protocolthrough bilateral, regional and multilateralchannels.The issue of funding and other financial consong>idong>erationsrelating to implementation of the Protocolwas discussed at BSWG-1. 549 As with the issueof capacity-building, some delegations arguedthat appropriate financial mechanisms werealready established under other internationalagreements, while others favoured including aspecific provision within the Protocol, includingreference to Articles 20 and 21 of the ong>Conventionong>(Financial Resources and Financial Mechanism,respectively).Prior to BSWG-2, some governments presentedtheir views in writing. 550 The African group calledupon Parties to agree on a scale of contributionsto the budgets of the Secretariat and the BCH atthe first meeting of the Parties to the Protocol.It also proposed the establishment of a contingencyfund for cases of accong>idong>ents arising fromthe use, release and transfer of LMOs and voluntaryfunding mechanisms to cover the costs ofcapacity-building centres. Norway supported theong>idong>ea that financial resources for application of theProtocol should be in accordance with Article 20of the ong>Conventionong> (as the EU also suggested) andthe use of the ong>Conventionong>’s financial mechanismunder Article 21 (which Japan also proposed).It was agreed that the Secretariat should draftarticles on “financial issues” and “institutionalframework”, including different options if appropriate.551Further draft text was submitted to BSWG-3, underthe provisions on capacity-building, in whichdeveloping countries generally emphasised theimportance of a financial mechanism to ensuringand strengthening capacity-building. 552549UNEP/CBD/BSWG/1/4, paras. 98 – 100.550UNEP/CBD/BSWG/2/2, pp. 71-72 contains the submissions of the African region, EU, Japan and Norway.551UNEP/CBD/BSWG/2/6, para. 170552UNEP/CBD/BSWG/3/3, pp. 69-74, contains submissions of Canada, Colombia, Cuba, EU, India, Madagascar and Sri Lanka.85


III. TEXT OF THE PROTOCOLFollowing the request from BSWG-2, the Secretariatprepared two draft articles on financial resourcesand the financial mechanism. 553 Both took upmany of the elements of the previous governmentproposals, including the establishment of a fundingmechanism of a voluntary nature and a revolvingfund to assist in emergency situations.The draft article on financial resources obligeddeveloped country Parties to provong>idong>e new andadditional financial resources to enable developingcountry Parties to meet the costs of implementingmeasures taken under the Protocol. Italso encouraged developed country Parties toprovong>idong>e, and developing country Parties to availthemselves of, financial resources through bilateral,regional and other multilateral channels.Particular attention was to be paong>idong> to the specialneeds of least developed countries and smallisland states.Another draft article established a mechanism forthe provision of financial resources to developingcountry Parties, accountable to and operatingunder the authority of the Meeting of the Parties.The financial mechanism would constitute a trustfund. The Meeting of the Parties would determinethe policy, strategy and programme of accessto and utilisation of these resources. The draftalso encouraged Parties to strengthen existingfinancial institutions in order to provong>idong>e financialresources for the Protocol.The consolong>idong>ated text prepared by CG-2 at BSWG-3 included two options. 554 Both established theopportunity for developed countries to provong>idong>efinancial and technological resources to developingcountries. One specified that the financialmechanism and institutional structure referred toin Article 21 of the ong>Conventionong> would also servethe Protocol and would be accountable to andfunction under the authority of the Conferenceof the Parties.Both options were retained after BSWG-4,although a new paragraph was added to thelonger of the two options clarifying that the“guong>idong>ance to the financial mechanism of the ong>Conventionong>in relevant decisions of the Conference ofthe Parties … shall apply mutatis mutandis to theprovisions of this Article”. 555Progress was made during BSWG-5, where CG-2prepared a consolong>idong>ated text containing brackets.During the discussions, delegates deleteda paragraph that required developed countriesto provong>idong>e new and additional resources to thefinancial mechanism, as this would duplicateArticle 20 of the ong>Conventionong>. 556 Similarly, in orderto avoong>idong> repetition of Article 21 of the ong>Conventionong>,the paragraph detailing the financial mechanism’saccountability to the COP was removed. 557 Theconsolong>idong>ated text also included two new paragraphsalluding to the needs of developing countries,and in particular least developed countriesand small island states, for capacity-building forimplementation of the Protocol and for the developmentand implementation of programmes, particularlyon risk assessment and management. 558At BSWG-6, the draft article was provisionallyadopted at the second plenary session on 17 Februaryong>19ong>99. 559 The brackets in the first paragraph,linking financial resources under the Protocol toArticle 20 of the ong>Conventionong>, had been removed.The paragraph referring to capacity-building andimplementation had been retained, while thebracketed provision on risk assessment and riskmanagement was deleted. 560Two final adjustments were made, re-numberingthe reference to the number of the articleon capacity building in the third paragraph andchanging the references to small island states to“small island developing states”.553UNEP/CBD/BSWG/3/4, pp. 2-3.554UNEP/CBD/BSWG/3/6, pp.90 – 91.555UNEP/CBD/BSWG/4/4, pp.56 – 57.556ENB Vol. 9 No. 104, p. 2.557Id.558UNEP/CBD/BSWG/5/3, pp.43 -44.559UNEP/CBD/ExCOP/1/2, para. 38.560Id.86


III. TEXT OF THE PROTOCOLArticle 29: Conference of theParties serving as the Meeting ofthe Parties to this Protocol1. The Conference of the Parties shallserve as the meeting of the Parties to thisProtocol.2. Parties to the ong>Conventionong> that are notParties to this Protocol may participate asobservers in the proceedings of any meetingof the Conference of the Parties servingas the meeting of the Parties to thisProtocol. When the Conference of the Partiesserves as the meeting of the Parties tothis Protocol, decisions under this Protocolshall be taken only by those that areParties to it.3. When the Conference of the Partiesserves as the meeting of the Parties to thisProtocol, any member of the bureau of theConference of the Parties representing aParty to the ong>Conventionong> but, at that time,not a Party to this Protocol, shall be substitutedby a member to be elected by andfrom among the Parties to this Protocol.4. The Conference of the Parties serving asthe meeting of the Parties to this Protocolshall keep under regular review the implementationof this Protocol and shall make,within its mandate, the decisions necessaryto promote its effective implementation.It shall perform the functionsassigned to it by this Protocol and shall:(a) Make recommendations on any mattersnecessary for the implementation ofthis Protocol;(b) Establish such subsong>idong>iary bodies as aredeemed necessary for the implementationof this Protocol;(c) Seek and utilise, where appropriate,the services and cooperation of, and informationprovong>idong>ed by, competent internationalorganisations and intergovernmentaland non-governmental bodies;(d) Establish the form and the intervals fortransmitting the information to be submittedin accordance with Article 33 ofthis Protocol and consong>idong>er such informationas well as reports submitted by anysubsong>idong>iary body;(e) Consong>idong>er and adopt, as required,amendments to this Protocol and itsannexes, as well as any additional annexesto this Protocol, that are deemed necessaryfor the implementation of this Protocol;and(f) Exercise such other functions as may berequired for the implementation of thisProtocol.5. The rules of procedure of the Conferenceof the Parties and financial rules ofthe ong>Conventionong> shall be applied, mutatismutandis, under this Protocol, except asmay be otherwise decong>idong>ed by consensusby the Conference of the Parties servingas the meeting of the Parties to this Protocol.6. The first meeting of the Conference ofthe Parties serving as the meeting of theParties to this Protocol shall be convenedby the Secretariat in conjunction with thefirst meeting of the Conference of the Partiesthat is scheduled after the date of theentry into force of this Protocol. Subsequentordinary meetings of the Conferenceof the Parties serving as the meetingof the Parties to this Protocol shall be heldin conjunction with ordinary meetings ofthe Conference of the Parties, unless otherwisedecong>idong>ed by the Conference of theParties serving as the meeting of the Partiesto this Protocol.7. Extraordinary meetings of the Conferenceof the Parties serving as the meetingof the Parties to this Protocol shall be heldat such other times as may be deemednecessary by the Conference of the Partiesserving as the meeting of the Parties tothis Protocol, or at the written request ofany Party, provong>idong>ed that, within sixmonths of the request being communicatedto the Parties by the Secretariat, it issupported by at least one third of the Parties.8. The United Nations, its specialisedagencies and the International AtomicEnergy Agency, as well as any State memberthereof or observers thereto not party87


III. TEXT OF THE PROTOCOLto the ong>Conventionong>, may be represented asobservers at meetings of the Conferenceof the Parties serving as the meeting ofthe Parties to this Protocol. Any body oragency, whether national or international,governmental or non-governmental, thatis qualified in matters covered by this Protocoland that has informed the Secretariatof its wish to be represented at a meetingof the Conference of the Parties servingas a meeting of the Parties to thisProtocol as an observer, may be so admitted,unless at least one third of the Partiespresent object. Except as otherwise provong>idong>edin this Article, the admission andparticipation of observers shall be subjectto the rules of procedure, as referred to inparagraph 5 above.The African group, Australia, Cuba and the USA,submitted views on the Meeting/Conference ofthe Parties for consong>idong>eration at BSWG-2. 561 TheAfrican group proposed language on the first,subsequent and extraordinary meetings of theConference of the Parties, most of which wouldfind reflection in the final text of the provision. Itproposed to convene the first meeting of the Partiesnot later than one year after the date of entryinto force of the Protocol, in conjunction with ameeting of the Conference of the Parties to theong>Conventionong> if one was scheduled within the sameperiod. It also suggested that subsequent ordinarymeetings of the Parties should be held, unless theParties decong>idong>ed otherwise, in conjunction with themeetings of the Conference of the Parties to theong>Conventionong>. Finally, it proposed that extraordinarymeetings of the Parties should be held whendeemed necessary by a meeting of the Parties,or at the written request of any Party, when supportedby at least on third of the Parties within sixmonths of the request.Australia consong>idong>ered that the Conference of theParties to the ong>Conventionong> could serve concurrentlyas the meeting of the Parties to the Protocol andpointed out the possible confusion if the samename was kept. It also argued that the provisionsof Article 32(2) of the ong>Conventionong>, which stipulatethat decisions under any Protocol to the ong>Conventionong>shall be taken only by Parties to that Protocol,should apply.As requested by BSWG-2, the Secretariat prepareddraft text on institutional matters including a provisionon Meetings of the Parties. 562 The proposedtext from the African group on first, subsequentand extraordinary meetings was retained, togetherwith the issues it had ong>idong>entified to be addressedat the first meeting: rules of procedure, financialprovisions related to the financial mechanism; anddesignation of the Secretariat. The Secretariat textalso listed a number of functions of the Meetingof the Parties, and noted that the UN, its agenciesand the IAEA could participate in the sessions asobservers, as well as any other organisation meetingthe relevant criteria. In addition to a generalstatement that Parties might review the Protocoland its implementation, a list of functions of theMeeting of the Parties was proposed, includingobligations in respect of implementation, rules ofprocedure, budget, subsong>idong>iary bodies and amendmentof the Protocol or its annexes.However, the provision on the Conference of theParties developed by BSWG-3 on the basis of textintroduced by the Chair and followed by a fewalternatives, 563 took up few of the elements proposedby the Secretariat. This consolong>idong>ated textsimply established the Conference of the Partiesof the ong>Conventionong> as the Protocol’s supreme bodyand referred to the voting procedures under Article32(2) of the CBD, representation on the Bureauof the Conference of the Parties, and decisions tobe made at its first meeting. 564561UNEP/CBD/BSWG/2/2, pp. 36-39; UNEP/CBD/BSWG/2/Inf.6..562UNEP/CBD/BSWG/3/4, pp. 4-5.563UNEP/CBD/BSWG/3/6, p. 28.564Ibong>idong>., pp.125-126.88


III. TEXT OF THE PROTOCOLDuring BSWG-4 the discussion drew on precedentsin other international environmentalagreements, notably the Kyoto Protocol to theUN Framework ong>Conventionong> on Climate Change.This used the institutional device of the Conferenceof the Parties serving as the Meeting of theParties. 565 The draft article prepared by CG-2, andincorporated into the new consolong>idong>ated draft text,was largely derived from the earlier texts draftedby the Secretariat reflecting government submissions.566 Hence, Article 29 contained the previousparagraphs on the first meeting of the Parties (butwithout a timeframe), subsequent ordinary meetingsand extraordinary meetings. The text of thedraft prepared by the Secretariat on observerswas also incorporated, as well as earlier text onrepresentation on the Bureau and on review ofthe implementation of the Protocol. The articlenow clarified that the procedural and financialrules of the ong>Conventionong> would apply “mutatismutandis” to the Protocol, except as otherwisedecong>idong>ed by consensus, and listed a shorter numberof functions. Four of these functions had beenalready proposed by the Secretariat, namely, makingrecommendations on the implementation ofthe Protocol: establishing the necessary subsong>idong>iarybodies; consong>idong>ering and adopting proposalsfor amendment of the Protocol and annexes; andexercising any other functions required for theProtocol’s implementation. Two new functionswere added: to seek to utilise services, cooperationand information from international organisationsand bodies; and to establish the formand the intervals for transmitting information inreports and reports from subsong>idong>iary bodies. Thetext of the draft article was provisionally adoptedby BSWG-5 at its second plenary session on ong>19ong>August ong>19ong>98. 567This text remained unchanged until BSWG-6where it was provisionally adopted 568 and re-titled“Conference of the Parties serving as the Meetingof the Parties to the Protocol”. 569 It remainedunchanged until finally adopted at the resumedExCOP.565UNEP/CBD/BSWG/4/4, para. 23.566Ibong>idong>., p. 57-58.567UNEP/CBD/BSWG/5/3, para. 26.568UNEP/CBD/ExCOP/1/2, para. 38.569UNEP/CBD/ExCOP/1/2 p. 9. This change was also reflected in other provisions of the Protocol which had previously referred to “the Meeting of theParties”.89


III. TEXT OF THE PROTOCOLArticle 30: Subsong>idong>iary Bodies1. Any subsong>idong>iary body established by orunder the ong>Conventionong> may, upon a decisionby the Conference of the Parties servingas the meeting of the Parties to thisProtocol, serve the Protocol, in which casethe meeting of the Parties shall specifywhich functions that body shall exercise.2. Parties to the ong>Conventionong> that are notParties to this Protocol may participate asobservers in the proceedings of any meetingof any such subsong>idong>iary bodies. When asubsong>idong>iary body of the ong>Conventionong> servesas a subsong>idong>iary body to this Protocol, decisionsunder the Protocol shall be takenonly by the Parties to the Protocol.3. When a subsong>idong>iary body of the ong>Conventionong>exercises its functions with regard tomatters concerning this Protocol, anymember of the bureau of that subsong>idong>iarybody representing a Party to the ong>Conventionong>but, at that time, not a Party to theProtocol, shall be substituted by a memberto be elected by and from among theParties to the Protocol.Although the first draft text addressing subsong>idong>iarybodies was only prepared by the Secretariat forBSWG-3, Australia had already expressed its views inwriting before BSWG-2. It proposed that the Subsong>idong>iaryBody on Scientific Technical and TechnologicalAdvice (SBSTTA) of the ong>Conventionong> should provong>idong>esimilar services to the Protocol, if similar advice wasconsong>idong>ered necessary, and that non-Parties to theProtocol should be enabled to participate. 570Following BSWG-2, the Secretariat developeddraft text concerning institutional matters, whichprovong>idong>ed for the Meeting of the Parties to establishsuch subsong>idong>iary bodies as deemed necessaryfor the implementation of the Protocol and, at itsfirst session, to adopt rules of procedure for suchsubsong>idong>iary bodies. 571570UNEP/CBD/BSWG/2/2, p.38.571UNEP/CBD/BSWG/3/4, pp. 4-5.572ENB Vol. 9 No. 74, p. 9.573Id.574UNEP/CBD/BSWG/4/4, Annex III, see Article 30.At BSWG-3, the Contact Group on InstitutionalMatters and Final Clauses (CG-2) addressed theseissues and developed draft text including a provisionon subsong>idong>iary bodies. 572 The text was laterapproved by the plenary and incorporated intothe consolong>idong>ated text. 573 Elements included: theuse of the ong>Conventionong>’s subsong>idong>iary bodies andmechanisms as subsong>idong>iary bodies and mechanismsof the Protocol; and that decisions of thesubsong>idong>iary bodies while exercising their functionswere to be taken by the Parties to the Protocol.At BSWG-4, CG-2 consong>idong>ered precedents on institutionalmatters from other international environmentalagreements and prepared draft textthat, with the exception of minor amendments,was almost ong>idong>entical to the final text. 574 Article 30on subsong>idong>iary bodies called for subsong>idong>iary bodiesunder the ong>Conventionong> to serve the Protocol, subjectto a decision by the meeting of the Parties.The provision also provong>idong>ed for the participationof non-Parties to the Protocol that are Partiesto the CBD as observers in subsong>idong>iary bodies ofthe Protocol without the right to participate indecision-making. Finally, the article stated thatmembers of the Bureau of a subsong>idong>iary body tothe ong>Conventionong> representing a non-Party to theProtocol should be substituted by a memberrepresenting a Party to the Protocol when such abody operated under the Protocol.The provision was subsequently approved byCG-2 of BSWG-5. 575 The text of the draft article wasprovisionally adopted by BSWG-5 at its secondplenary session on 14 August ong>19ong>98. 576Following the review by the Legal Drafting Groupof the Chair’s text at BSWG-6, the reference, in thefirst paragraph, to the “meeting of the Parties” wasreplaced with “Conference of the Parties servingas the meeting of the Parties to this Protocol”(COPMOP), in accordance with the agreementreached on that article. 577 The article on subsong>idong>iarybodies was provisionally adopted at BSWG-6 578and remained unchanged until the final adoptionof the Protocol at the resumed ExCOP.575ENB Vol. 9 No. 100 p. 2.576UNEP/CBD/BSWG/5/3, para.26.577UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 28; see also section onArticle 29 above.578UNEP/CBD/ExCOP/1/2, para. 38.90


III. TEXT OF THE PROTOCOLArticle 31: Secretariat1. The Secretariat established by Article 24of the ong>Conventionong> shall serve as the secretariatto this Protocol.2. Article 24, paragraph 1, of the ong>Conventionong>on the functions of the Secretariat shallapply, mutatis mutandis, to this Protocol.3. To the extent that they are distinct, thecosts of the secretariat services for thisProtocol shall be met by the Parties hereto.The Conference of the Parties serving as themeeting of the Parties to this Protocol shall,at its first meeting, decong>idong>e on the necessarybudgetary arrangements to this end.Views on the secretariat of the Protocol were firstsubmitted to BSWG-2. 579 Although submissionsgenerally suggested that the administration of theProtocol should be undertaken by the Secretariatof the ong>Conventionong>, the African group proposed anumber of additional functions. These includedgiving the Secretariat the responsibility to: compileand disseminate, in collaboration with the BCH,information regarding any living modified organismsor products thereof; receive and convey informationfrom and to Parties on capacity building;assist Parties to ong>idong>entify cases of illegal traffic; andcooperate with Parties and relevant internationalorganisations in provong>idong>ing experts and equipmentfor the purpose of emergency assistance. In addition,Cuba proposed that the Secretariat encouragenon-Parties to participate as observers in the meetingsof the Parties and to act in conformity with theProtocol, as well as notify Parties of any request forscientific or technical cooperation in conformitywith an article of the Protocol on Technical andScientific Cooperation. 580The Secretariat prepared draft text for consong>idong>erationat BSWG-3, which referred to Art 24(2) of theong>Conventionong> and provong>idong>ed for the Secretariat ofthe ong>Conventionong> to serve as the Secretariat of the579UNEP/CBD/BSWG/2/2, pp. 36-39, contains the submissions of theAfrican region, Australia, EU, Japan and Norway on the Secretariat.580UNEP/CBD/BSWG/2/Inf.6.581UNEP/CBD/BSWG/3/4, pp. 5-6.582UNEP/CBD/BSWG/3/6, Annex I.583UNEP/CBD/BSWG/4/4, Annex III.Protocol. 581 A number of additional functions werealso listed, including those proposed by the Africangroup and functions equivalent to those of the Secretariatof the ong>Conventionong>, such as reporting to theMeeting of the Parties on work carried out.The Consolong>idong>ated Text of the article on the Secretariatresulting from the meetings of CG-2 atBSWG-3 referred to the costs of Secretariat servicesand proposed the establishment of a TrustFund, with the option that Parties meet the costsvoluntarily. 582At BSWG-4, CG-2 developed text that was almostong>idong>entical to the article as finally adopted. 583 Thefirst and second paragraphs established that theSecretariat of the ong>Conventionong> would serve as theSecretariat to the Protocol and that its functionswould apply “mutatis mutandis” to the Protocol. Thethird paragraph, in brackets, provong>idong>ed that the costsof the services of the Secretariat of the Protocolshould be met by the Parties to the Protocol, andthat the Conference of the Parties to the Protocol atits first meeting would decong>idong>e the related necessaryfinancial arrangements. No further reference to theproposed Trust Fund was made.At BSWG-5 two adjustments were made, replacing“Conference of the Parties” with “Meeting of theParties” and “financial arrangements” with “budgetaryarrangements”. 584 The bracketed text wasaccepted and the whole provision was agreed byCG-2. 585 The text of the draft article was provisionallyadopted by BSWG-5 at its second plenary sessionon ong>19ong> August ong>19ong>98. 586The revision by the Legal Drafting Group of theChair’s text at BSWG-6 changed “Meeting of theParties” to “Conference of the Parties serving asthe meeting of the Parties to this Protocol” 587 . Thearticle was provisionally adopted by BSWG-6 at itssecond plenary session on 17 th February ong>19ong>99, 588and remained unchanged until the final adoptionof the Protocol at the resumed ExCOP.584UNEP/CBD/BSWG/5/3, Annex.585ENB Vol. 9 No. 100, p. 2.586UNEP/CBD/BSWG/5/3, para. 26.587UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 29.588UNEP/CBD/ExCOP/1/2, para. 38.91


III. TEXT OF THE PROTOCOLArticle 32 - Relationship with theong>Conventionong>Except as otherwise provong>idong>ed in this Protocol,the provisions of the ong>Conventionong>relating to its Protocols shall apply to thisProtocol.Early proposals favoured the inclusion of a statementon the relationship between the Protocoland the ong>Conventionong> in the preamble (Australia), ina provision on jurisdictional scope (US), 589 or in aseparate provision (African group). 590However, the first draft for a provision on theissue was prepared during BSWG-3 by CG-2 oninstitutional matters and final clauses. 591 The Consolong>idong>atedText prepared at the end of that meetingincluded the same text of the article as wouldfinally be adopted. 592 The provision remainedunchanged during the subsequent negotiations,was provisionally adopted at BSWG-6, 593 andfinally adopted at the resumed ExCOP in January2000. 594589UNEP/CBD/BSWG/2/2, p. 4 and p. 31.590UNEP/CBD/BSWG/2/Inf.2.591UNEP/CBD/BSWG/3/6, see Article 33.592Id.593UNEP/CBD/ExCOP/1/2, para. 38.594UNEP/CBD/ExCOP/1/3.92


III. TEXT OF THE PROTOCOLArticle 33 – Monitoring andReportingEach Party shall monitor the implementationof its obligations under this Protocol,and shall, at intervals to be determined bythe Conference of the Parties serving asthe meeting of the Parties to this Protocol,report to the Conference of the Partiesserving as the meeting of the Parties tothis Protocol on measures that it hastaken to implement the Protocol.Although submissions for BSWG-2 on this issuewere compiled under the heading “Monitoringand Compliance”, only Canada proposed the inclusionof a new article to cover compliance. (Theissues of monitoring and compliance were subsequentlysplit into two different articles at BSWG-4,see further below). 595The African group called for Parties to reportannually to the Secretariat and to the BCH onthe implementation of the Protocol (including inparticular information on the status of the LMOsdeliberately released and on the operation of theAIA procedure), and to ensure that users monitoredactivities and products at regular intervalsand reported to the competent national authority.The EU noted the need for a cooperative andtransparent process based on good faith and fullparticipation. Norway proposed the establishmentof monitoring programmes on the use ofLMOs and distinguished monitoring during theresearch period from monitoring after an LMOhad been put on the market. It also noted thatcompliance procedures should be developed inaddition to dispute settlement procedures.BSWG-2, however, concluded that any draftingon the item was premature. 596 Hence in his summaryof “monitoring”, the Chair merely reflectedthe above elements, together with consong>idong>erationof Article 26 of the ong>Conventionong> and decision II/17,and of the problems of capacity-building and similarissues encountered during implementation. 597With regard to “compliance”, the main elementsong>idong>entified were the possibilities of establishing astanding or ad hoc body in charge of compliancereviews, obtaining formal findings of non-compliance,taking into account similar procedures ininternational legal instruments, and establishing acooperative and conciliatory advisory procedurewhere confong>idong>entiality was safeguarded. 598During BSWG-3, CG-2 prepared draft text on monitoringand compliance, which the BSWG agreedto incorporate into the consolong>idong>ated text, togetherwith the proposals of the African group. 599 Thus,the first two options prepared by CG-2 calledupon Parties “to determine at their first meetinghow to establish procedures and institutionalmechanisms for determining non-compliancewith the provisions of this Protocol and for thetreatment of Parties found in non-compliance”or to consong>idong>er whether to establish those procedures.The third option consisted of new textsubmitted by the African group requesting Parties“to introduce, implement and enforce nationalcompliance and monitoring systems”, taking intoaccount international standards and guong>idong>elines,and to provong>idong>e information on national monitoringand compliance systems, as well as informationon any significant incong>idong>ents of illegal trafficto the BCH. 600 The fourth option was the earlierproposal submitted by the African group.CG-2 agreed to split the article into two at BSWG-4: Monitoring and Reporting (then Article 35)and Compliance (then Article 35bis). 601 The first595UNEP/CBD/BSWG/2/2 p. 69-71 contains the submissions of the African group, Canada, EU and Norway. See also section on Article 34 below.596UNEP/CBD/BSWG/2/6, paras. 150-160.597Ibong>idong>. Annex II, Item H.598Id.599UNEP/CBD/BSWG/3/6 paras. 96 - 97.600UNEP/CBD/BSWG/3/5.601UNEP/CBD/BSWG/4/4, Annex III, see Articles 35 and 35 bis.93


III. TEXT OF THE PROTOCOLtwo options from the previous draft formed thebasis for Article 35bis, 602 while the remainingtwo options were integrated into the provisionon monitoring and reporting. The article onmonitoring and reporting thus required Partiesto monitor their implementation of the Protocol,to establish or maintain systems for that purpose,and to report to the meeting of the Parties onthese measures, at intervals to be determined bythe meeting of the Parties. 603 At this point, the textcontained the elements of the article that wouldfinally be adopted, albeit with minor changes.At BSWG-5, notwithstanding further submissions(notably that of the EC which advocated linkingthis article to the article on Decision Procedurefor AIA, (then Article 6) by encouraging Partiesto provong>idong>e assistance to Parties of import andproposing the establishment of a standing bodyof experts operating a monitoring and assistanceprocess), 604 the previous two paragraphs weremerged into one and language on establishingand maintaining mechanisms was deleted. 605 Thearticle was provisionally adopted at the secondplenary session at BSWG-5 on ong>19ong> August ong>19ong>98. 606References to the “meeting of the Parties” werereplaced by “the Conference of the Parties servingas the meeting of the Parties to this Protocol”once this matter was settled at BSWG-6, and thearticle was provisionally adopted. 607 The articlewas reviewed by the Legal Drafting Group, 608 andremained unchanged thereafter.602See now section on Article 34 below.603UNEP/CBD/BSWG/4/4, Annex III, see Article 35.604UNEP/CBD/BSWG/5/2 contains the submissions of EC, New Zealand, Peru, Slovenia, Thailand and Venezuela. See Article 35.605UNEP/CBD/BSWG/5/3, Annex, see Article 35.606UNEP/CBD/BSWG/5/3, para. 26.607UNEP/CBD/ExCOP/1/2, para. 38.608UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 32.94


III. TEXT OF THE PROTOCOLArticle 34: ComplianceThe Conference of the Parties serving asthe meeting of the Parties to this Protocolshall, at its first meeting, consong>idong>er andapprove cooperative procedures andinstitutional mechanisms to promotecompliance with the provisions of thisProtocol and to address cases of non-compliance.These procedures and mechanismsshall include provisions to offeradvice or assistance, where appropriate.They shall be separate from, and withoutprejudice to, the dispute settlement proceduresand mechanisms established byArticle 27 of the ong>Conventionong>.The issue of compliance was discussed andaddressed in an article together with the issue ofmonitoring until BSWG-4 where the items weresplit into two separate articles. 609 Three earlydrafts would constitute the core of this article:the options prepared by CG-2 at BSWG-3 wherebyParties would “determine at their first meetinghow to establish procedures and institutionalmechanisms for determining non-compliancewith the provisions of this Protocol and for thetreatment of Parties found in non-compliance” orconsong>idong>er whether to establish those procedures; 610the EC proposal for cooperation, advice and assistance;6ong>11ong> and the Norwegian submission proposinga distinction between dispute settlement andcompliance procedures. 612by CG-2 during BSWG-3, and included the possibilityof no provision. 613Following work on this provision by CG-2 atBSWG-5, language was developed which, in itself,was not the object of dispute and included theessence of the three elements of the final provision.614 However, the entire article was bracketedto reflect a lack of consensus on whether the provisionshould be included in the Protocol at all. 615At this stage Article 35bis required Parties toconsong>idong>er and approve, at their first meeting, proceduresand institutional mechanisms to promotecompliance with the Protocol and to addresscases of non-compliance. 616 This text also notedthat those procedures and mechanisms were tobe separate from, and without prejudice to, thedispute settlement procedure established underArticle 27 of the ong>Conventionong>. 617 Furthermore, theycould include provisions to offer advice or assistance,where appropriate. 618At BSWG-6, an amendment was introduced tothe text by CG-2 in order to reach a compromiseand allow the plenary to provisionally adopt thearticle. 6ong>19ong> Thus, the procedures to be establishedto promote compliance were qualified as “cooperative”,and with this, the brackets around thearticle were removed. 620 A final revision by theLegal Drafting Group replaced the reference tothe “meeting of the Parties” by “the Conference ofthe Parties serving as the meeting of the Parties tothis Protocol”. 621 The article remained unchangeduntil its final adoption by the resumed ExCOP.At BSWG-4, Article 35bis on compliance simplyreflected, in bracketed text, the options prepared609See section on Article 33above.610UNEP/CBD/BSWG/3/6, Annex I.6ong>11ong>UNEP/CBD/BSWG/2/2 p. 70.612Id.613UNEP/CBD/BSWG/4/4, Annex III, see Article 35 bis.614UNEP/CBD/BSWG/5/3, para. 55.615Id.616Ibong>idong>. Annex, see Article 35 bis.617Id.618Id.6ong>19ong>UNEP/CBD/ExCOP/1/2, para. 38.620ENB Vol. 9 No. ong>11ong>7, p. 9.621UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 33.95


III. TEXT OF THE PROTOCOLArticle 35: Assessment andReviewThe Conference of the Parties serving asthe meeting of the Parties to this Protocolshall undertake, five years after the entryinto force of this Protocol and at leastevery five years thereafter, an evaluationof the effectiveness of the Protocol,including an assessment of its proceduresand annexes.Japan and Norway submitted views on the issue of“review and adaptation” prior to BSWG-2. 622 Norwayproposed that the Protocol establish flexibleprocedures to allow adaptation to scientific andtechnical progress 623 , and Japan recalled paragraph5(c) of the annex to Decision II/5, which envisagedthe establishment of a review mechanism.The first draft text on the issue, together withother institutional matters and final clauses, wasprepared by the Secretariat for BSWG-3. 624 Twooptions envisaging amendments to the Protocolwere then developed. One was lengthy andincluded detailed language on procedures foramendment by the Secretariat and the Meetingof the Parties to the Protocol. This text was discussedby CG-2, 625 which prepared another draftin its place, later contained in the Consolong>idong>atedText at the end of BSWG-3. 626 (The supersededdraft would later re-appear in the discussions onthe article on the Conference of the Parties, whichwould include provisions for amending the Protocoland its annexes). 627 The draft had been proposedby Switzerland and was based on Article5 of the Montreal Protocol on Substances thatDeplete the Ozone Layer. 628 It called upon Partiesto assess the Protocol on the basis of availablescientific, environmental and technical informationat a certain date and at least every five yearsthereafter. It further specified that at least oneyear before each assessment, the Parties wouldconvene appropriate panel of experts, and thatthe panels would report their conclusions to otherParties within a year, through the Secretariat.Two more options were added at BSWG-4, includingthe removal of the provision and a shorterprovision calling for the regular evaluation of theeffectiveness of the Protocol, three years after theentry into force and at least every six years thereafter.629At BSWG-5, the article was consong>idong>ered by SWG-I,which agreed that the concept of the article wasin line with provisions set out under the CBD, andreduced the article to a short text with two sets ofsquare brackets. 630 References to “five” years and“at least every five years thereafter” were included,in brackets, in a text that largely reflected theshorter option from BSWG-4. 631 Text assigning theassessment to an expert panel was removed, butthe reference to an assessment of the proceduresand annexes was maintained. 632The bracketed text was accepted by SWG-I duringBSWG-6 633 and was provisionally adopted. 634The reference to the “meeting of the Parties” wasreplaced by “the Conference of the Parties servingas the meeting of the Parties to this Protocol”following revision by the Legal Drafting Group. 635The provision then remained unchanged untilfinal adoption at the resumed ExCOP.622UNEP/CBD/BSWG/2/2, p. 74.623A view also expressed by the EC (UNEP/CBD/BSWG/2/2, p. 42).624UNEP/CBD/BSWG/3/4, pp.10 – ong>11ong>.625ENB Vol. 9 No. 74, p. 9.626UNEP/CBD/BSWG/3/6, Annex I, see Article 36.627See section on Article 29 above.628UNEP/CBD/BSWG/3/5, see Article ong>19ong> of the Swiss submission.629UNEP/CBD/BSWG/4/4, Annex III, see Article 36.630UNEP/CBD/BSWG/5/3, para. 32.631Ibong>idong>, Annex, see Article 36.632Id.633ENB Vol. 9 No. ong>11ong>3, p. 1.634UNEP/CBD/ExCOP/1/2, para. 38.635UNEP/CBD/BSWG/6/L.2/Rev.2, see Article 34.96


III. TEXT OF THE PROTOCOLArticle 36: SignatureThis Protocol shall be open for signatureat the United Nations Office at Nairobi byStates and regional economic integrationorganisations from 15 to 26 May 2000,and at United Nations Headquarters inNew York from 5 June 2000 to 4 June2001.Dates (“24 May ong>19ong>99 to 23 May 2000”) were firstincluded in this provision in the Chair’s proposaltext at BSWG-6. 640 At the resumed ExCOP in Montrealthe final draft of the Protocol submitted bythe Legal Drafting Group revised the dates andprovong>idong>ed for signature in Nairobi during the fifthmeeting of the CBD COP, as well as at the UNHeadquarters. 641Only the African region submitted draft text onthis topic prior to BSWG-2. 636 It proposed whatwould become the final text (except for the dates,which were, of course, at that stage omitted).The text on final clauses for BSWG-3 prepared bythe Secretariat used this text, but referred to “any”regional economic integration organisation. 637The provision remained unchanged and it wasprovisionally adopted by BSWG-5 on ong>19ong> Augustong>19ong>98, 638 and then by the plenary of BSWG-6. 639636UNEP/CBD/BSWG/2/2, p. 74.637UNEP/CBD/BSWG/3/4, see Article K.1.638UNEP/CBD/BSWG/5/3, para. 26.639UNEP/CBD/ExCOP/1/2, para. 38.640UNEP/CBD/BSWG/6/L.2, see Article 35.641UNEP/CBD/ExCOP/1/L.5.97


III. TEXT OF THE PROTOCOLArticle 37: Entry into Force1. This Protocol shall enter into force onthe ninetieth day after the date of depositof the fiftieth instrument of ratification,acceptance, approval or accession byStates or regional economic integrationorganisations that are Parties to the ong>Conventionong>.2. This Protocol shall enter into force for aState or regional economic integrationorganisation that ratifies, accepts orapproves this Protocol or accedes theretoafter its entry into force pursuant to paragraph1 above, on the ninetieth day afterthe date on which that State or regionaleconomic integration organisation depositsits instrument of ratification, acceptance,approval or accession, or on thedate on which the ong>Conventionong> enters intoforce for that State or regional economicintegration organisation, whichever shallbe the later.3. For the purposes of paragraphs 1 and 2above, any instrument deposited by aregional economic integration organisationshall not be counted as additional tothose deposited by member States ofsuch organisation.The draft text on final clauses prepared by the Secretariatfor BSWG-3 merged both proposals (butomitted the number of instruments of ratification,acceptance, approval or accession that would berequired to trigger entry into force), and added athird paragraph to clarify that instruments depositedby regional economic integration organisationsshould not be counted as additional to thoseof each Member State of such organisation. 643At BSWG-4 the text was reviewed by CG-2, whichremoved the reference to Article 36 of the ong>Conventionong>and, regarding the entry into force of theProtocol for Parties, amended the last sentence torefer to the ong>Conventionong> instead of the Protocol.This reflected the requirement that Parties to theProtocol had to be Parties to the ong>Conventionong>. 644The text was provisionally approved at BSWG-5 645and at BSWG-6 646 but the number of ratificationsrequired (fifty) was first included in the subsequentChair’s proposed text. 647 A reference toregional economic integration organisations wasalso inserted in the first paragraph on the entryinto force of the Protocol. 648 This was later extendedby the Legal Drafting Group to the secondparagraph on entry into force of the Protocol for aState or a regional economic integration organisation.649 The article then remained unchanged untilits final adoption by the resumed ExCOP.Both the African group and Australia submitteddraft text before BSWG-2 on this subject. 642 TheAfrican proposal included a schedule for the entryinto force of the Protocol (ninety days after thedate of deposit of the sixteenth instrument ofratification, acceptance, approval or accession).Australia referred to Article 36 of the ong>Conventionong>,which sets out the provisions for the entry intoforce of the ong>Conventionong>, and for protocols to it.642UNEP/CBD/BSWG/2/2, p. 75, contains the submissions of the African region and Australia.643UNEP/CBD/BSWG/3/4, see Article K.4.644UNEP/CBD/BSWG/4/4, Annex III,see Article 40.645UNEP/CBD/BSWG/5/3, para. 26.646UNEP/CBD/ExCOP/1/2, para. 38.647UNEP/CBD/BSWG/6/L.2, see Article 36.648Id.649UNEP/CBD/BSWG/6/L.2/Rev. 2, see Article 36.98


III. TEXT OF THE PROTOCOLArticle 38: ReservationsNo reservations may be made to this Protocol.Only the African region presented text on “reservationsand declarations” for BSWG-2. 650 It proposedthat no reservations could be made to theProtocol and this language was retained in thefinal text of the Protocol.The draft text on final clauses prepared for BSWG-3 by the Secretariat employed the same text; 651however the Consolong>idong>ated Text, following discussionby CG-2, also included the option of not havingan article on this issue. 652At BSWG-5, the option for no provision wasreplaced by bracketing a single option. 653 Thebrackets were removed at BSWG-6 654 . The textremained unchanged until the adoption of thefinal draft of the Protocol at the resumed ExCOP.650UNEP/CBD/BSWG/2/2, pp. 75-76.651UNEP/CBD/BSWG/3/4, see Article K.5.652UNEP/CBD/BSWG/3/6, see Article 41.653UNEP/CBD/BSWG/5/3, Annex, see Article 41.654UNEP/CBD/BSWG/6/L.2, see Article 37.99


III. TEXT OF THE PROTOCOLArticle 39: Withdrawal1. At any time after two years from thedate on which this Protocol has enteredinto force for a Party, that Party may withdrawfrom the Protocol by giving writtennotification to the Depositary.2. Any such withdrawal shall take placeupon expiry of one year after the date ofits receipt by the Depositary, or on suchlater date as may be specified in the notificationof the withdrawal.The African group made the only submission onthis issue at BSWG-2. This submission, with theexception of the timeframes, was the same as thetext finally adopted. 655 The text stated that a Partycould withdraw from the Protocol by notifyingthe Depositary after two years from the date onwhich the Protocol had entered into force for thatParty. A second paragraph specified that the withdrawalwould become effective three years afterits receipt by the Depositary or at any other laterdate specified in the notification of withdrawal.Almost ong>idong>entical text was proposed by the Secretariat’sdraft on final clauses for BSWG-3, with theexception of the second timeframe being changedto “one year after the date of receipt” (as provong>idong>edin the final text), and the inclusion of a third paragraphprovong>idong>ing that any Party that withdrewfrom the Protocol would also be consong>idong>ered ashaving withdrawn from the ong>Conventionong>. 656The provision remained unchanged until BSWG-4,where it was revised by the CG-2 which removedthe third paragraph. 657The same text was provisionally adopted atBSWG-5 658 and at the second session of the plenaryat BSWG-6, 659 and was finally approved at theresumed ExCOP.655UNEP/CBD/BSWG/2/2, p. 76.656UNEP/CBD/BSWG/3/4, p.13.657UNEP/CBD/BSWG/4/4, Annex III, see Article 42.658UNEP/CBD/BSWG/5/3, para. 26.659UNEP/CBD/ExCOP/1/2, para. 38.100


III. TEXT OF THE PROTOCOLArticle 40: Authentic TextsThe original of this Protocol, of which theArabic, Chinese, English, French, Russianand Spanish texts are equally authentic,shall be deposited with the Secretary-General of the United Nations.Only the African group submitted text on thisissue prior to BSWG-2, 660 and this reflected thetext as finally approved. The Secretariat used thesame draft text in its document on final clausesprepared for BSWG-3. 661 The text was later agreedby CG-2 at BSWG-4, 662 and remained unchangeduntil its provisional adoption at BSWG-5 663 andat BSWG-6, 664 and final adoption at the resumedExCOP in Montreal on 29 January 2000.660UNEP/CBD/BSWG/2/2, pp. 76-77.661UNEP/CBD/BSWG/3/4, p.13.662ENB Vol. 9 No. 80, p. 2.663UNEP/CBD/BSWG/5/3, para. 26.664UNEP/CBD/ExCOP/1/2, para. 38.101


III. TEXT OF THE PROTOCOLAnnex I: Information Required inNotifications under Article 8, 10and 13102(a) Name, address and contact details ofthe exporter.(b) Name, address and contact details ofthe importer.(c) Name and ong>idong>entity of the living modifiedorganism, as well as the domesticclassification, if any, of the biosafety levelof the living modified organism in theState of export.(d) Intended date or dates of the transboundarymovement, if known.(e) Taxonomic status, common name,point of collection or acquisition, andcharacteristics of recipient organism orparental organisms related to biosafety.(f) Centres of origin and centres of geneticdiversity, if known, of the recipient organismand/or the parental organisms and adescription of the habitats where theorganisms may persist or proliferate.(g) Taxonomic status, common name,point of collection or acquisition, andcharacteristics of the donor organism ororganisms related to biosafety.(h) Description of the nucleic acong>idong> or themodification introduced, the techniqueused, and the resulting characteristics ofthe living modified organism.(i) Intended use of the living modifiedorganism or products thereof, namely,processed materials that are of livingmodified organism origin, containingdetectable novel combinations of replicablegenetic material obtained through theuse of modern biotechnology.(j) Quantity or volume of the living modifiedorganism to be transferred.(k) A previous and existing risk assessmentreport consistent with Annex III.(l) Suggested methods for the safe handling,storage, transport and use, includingpackaging, labelling, documentation,disposal and contingency procedures,where appropriate.(m) Regulatory status of the living modifiedorganism within the State of export(for example, whether it is prohibited inthe State of export, whether there areother restrictions, or whether it has beenapproved for general release) and, if theliving modified organism is banned in theState of export, the reason or reasons forthe ban.(n) Result and purpose of any notificationby the exporter to other States regardingthe living modified organism to be transferred.(o) A declaration that the above-mentionedinformation is factually correct.The African group proposed a comprehensive listof information required in notifications under theAdvance Informed Agreement (AIA) procedure forconsong>idong>eration by BSWG-2. 665 Many of the elementsof the final text were already included in this listand, taken together with the list of informationrelated to the LMO which the African regionincluded in its proposed Annex II on risk assessment,all the information referred to in this Annexhad been ong>idong>entified at this stage, with the exceptionof element (l). 666Many countries submitted draft text for BSWG-3 667 that, in most cases, was not as detailed as theAfrican proposal, but was in a similar vein. Cuba,however, put forward an extensive set of listscovering information relating to the LMO (classifiedby characteristics of the donor, recipientor parent organism, vector, modified organism);information relating to the conditions of releaseand the receiving environment; information relatingto the interactions between the LMOs andthe environment; and information on monitoring,control, waste treatment and emergencyresponse plans. 668 It also proposed an additionalannex covering information required in cases of665UNEP/CBD/BSWG/2/2, p. 77.666See section on Annex III below.667UNEP/CBD/BSWG/3/3, pp. 79-90, contains the submissions of the African region, Australia, Brazil, Canada, Colombia, Cuba, India, Norway, Peru,South Africa, Sri Lanka, Switzerland and the US.668Ibong>idong>. pp. 84-88.


III. TEXT OF THE PROTOCOLnotification for placing on the market. Colombiaalso specified information relating to the parentorganism, to include toxicity and allergenicity forhumans, mechanisms used by the organism tosurvive, and information pertaining to the hostorganism, to include methods of detecting itand its potential to affect ecosystem conditions.However, these types of information would belater transferred to the annex on risk assessmentunder which possible adverse effects were to beong>idong>entified and their likelihood evaluated. 669 The USsubmission proposed the qualification that suchassessments had to be “known and available”, languagewhich was retained until BSWG-6.The draft texts submitted by Norway, SouthAfrica and Switzerland introduced the elementsof contingency plans and information on experienceswith previous releases. Sri Lanka referredto risk management requirements. South Africaalso called for the observation of any differencesbetween the environment of the exporting countryand the environment of the release.The Contact Group on Definitions and Annexes(CG-1) established at BSWG-3, 670 having consong>idong>eredthe draft text in submissions and the issuesraised during the discussions, encapsulated themain elements in the Consolong>idong>ated Text. 671 Thistext referred to points (a)-(d), (h)-(m), and (o) ofthe final text. 672 The precise formulations however,differed. The list in the Consolong>idong>ated Text alsoenvisaged the inclusion of information relatingto insurance (as proposed by Africa, India and SriLanka), differences between the environment ofthe exporting country and the environment of therelease, contingency plans, requirements for riskmanagement, experiences with previous releases,contact details of person(s) responsible for planningand carrying out the release, and informationon the training of such personnel.At BSWG-4, CG-1 first reviewed and simplified thedraft Annex I, then referred it to SWG-I. 673 Duringthe discussion it was pointed out that some ofthe submissions were more detailed regardingrisk assessment. The need for an Annex II on riskassessment parameters was also discussed. 674The issue was sent back to CG-1, where drafts ofAnnex I and Annex II (risk assessment) were prepared.675 In order to facilitate the work on annexesat BSWG-5, CG-1 also prepared a list of annexesbased on those discussed at the meeting, annexesong>idong>entified in government submissions, and annexesreferred to in the text of articles discussed bythe sub-working groups at the meeting. 676Discussions in CG-1 addressed the uncertain legalstatus of the Annex and its level of detail, and itwas agreed to seek guong>idong>ance from SWG-I. 677 Delegationsdebated whether an AIA notificationshould include a risk assessment report in everycase, and whether such a risk assessment wouldbe undertaken according to the parameters listedin Annex II. 678 CG-1 also responded to concernsraised in SWG-I about “intended use of LMO”and “intended dates of transfer” where delegatesnoted that specific dates might not always beknown, and an exporter requesting AIA might nothave complete information about intended useof an LMO in the country of import. 679 The consolong>idong>atedtext listed categories of information tobe provong>idong>ed in an AIA notification, including thetaxonomic status of the recipient organism, methodsto ensure safe handling, a risk assessmentreport, intended dates of transfer, and intendeduse of the LMO. 680 Two footnotes were included toclarify and allow for further development of the669See section on Annex III below.670UNEP/CBD/BSWG/3/6, paras. 21-22.671 Ibong>idong>. paras. 92-95, see Annex I.672Id.673UNEP/CBD/BSWG/4/4, para. 22.674Ibong>idong>. paras. 22 and 28. See also ENB Vol. 9 No. 79, p. 1.675UNEP/CBD/BSWG/4/4, para. 28.676UNEP/CBD/BSWG/4/4, Annex V.677ENB Vol. 9 No. 85, p. 5.678Id.679Id.680UNEP/CBD/BSWG/4/4, see Annex I.103


III. TEXT OF THE PROTOCOLprovision: a first note retained the possibility ofre-consong>idong>ering the inclusion of information on theapplicable laws, procedures and guong>idong>elines of theState of export, as well as of available information,including purpose, about any notification to othergovernments on the import or development ofthe LMO. 681 Both of these would be included atBSWG-5. The second footnote simply noted thatresponsibility for declaring the factual correctnessof the information needed to be clarified. 682At BSWG-5 discussions of the annexes by CG-1began with the consong>idong>eration of the ong>19ong> annexesforwarded by BSWG-4. 683 Although the list wouldbe carried forward to BSWG-6, it was agreed thatthe Protocol should contain no more than fourannexes, of which Annexes I (Information requiredfor notification for AIA) and II (Risk Assessment)had strong support. 684In draft Annex I (Information), the number ofelements was increased from 12 to 15. 685 Thefootnotes were removed as the elements theyaddressed were inserted into the text. FollowingNorway’s proposal to include language onthe “regulatory status of the LMO” to addressthe issue of applicable laws referred to in theearlier footnote, this element was inserted. 686 Anew element concerning the “intended date ofthe transboundary movement, if known” wasalso included. 687 Finally, regarding the referenceto centres of origin, “a description of the habitatswhere the organism may persist or proliferate”was introduced in brackets, consistent withearlier proposals. 688 Other brackets that werekept at this stage referred to: “products thereof”,availability of risk assessments; and reference toeither “the exporter/importer or applicant/receivingcompany/institution/indivong>idong>ual”, respectively.Their removal was dependent upon discussionson issues and terminology in other groups. 689But, with the exception of these few brackets, thenumber and content of elements were those thatwould feature in the final text.Discussions continued at BSWG-6, where the Chairnoted that the heavy workload of the CG-1 precludedconsong>idong>eration of any annexes additional tothe two already contained in the draft negotiatingtext. 690 By the end of 16 February ong>19ong>99, discussionson Annex I had been completed 691 except forthe sub-paragraph on risk assessment, which wastransferred to the discussions on Annex II (RiskAssessment). 692 Annex I was completed the nextday when delegates agreed to text provong>idong>ing for“a previous and existing risk assessment reportconsistent with Annex II”. 693 Once the more generalpending issues were resolved, the Chair’s textincluded a single reference to “products thereof”in sub-paragraph (i) on intended use. 694 Annex Iwas then provisionally adopted by the BSWG. 695The remaining brackets had been removed inthis text, now ong>idong>entical to the final text exceptfor minor corrections made by the Legal DraftingGroup, 696 and Annex I was finally adopted at theresumed ExCOP. 697681Id.682Id.683UNEP/CBD/BSWG/5/3, paras. 36-37, and UNEP/CBD/BSWG/5/Inf.1.684Id.685UNEP/CBD/BSWG/5/3, see Annex I.686UNEP/CBD/BSWG/5/2, pp. 132-134, contains new submissions from New Zealand, Norway, Peru, Slovenia and Thailand.687Id. As New Zealand, Slovenia and Thailand proposed in their submissions.688UNEP/CBD/BSWG/3/3, see the submissions from Colombia, Cuba, Norway and South Africa.689UNEP/CBD/BSWG/5/3, para. 37.690UNEP/CBD/ExCOP/1/2, p. 7.691Ibong>idong>. p. 8.692ENB Vol. 9 No. ong>11ong>2, p. 2.693ENB Vol. 9 No. ong>11ong>3, p. 2.694UNEP/CBD/BSWG/6/L.2. See Annex I.695UNEP/CBD/ExCOP/1/3, para. 51.696UNEP/CBD/BSWG/6/L.2/Rev.2. See Annex I.697UNEP/CBD/ExCOP/1/3.104


III. TEXT OF THE PROTOCOLAnnex II: Information RequiredConcerning Living ModifiedOrganisms Intended for DirectUse as Food or Feed, or forProcessing Under Article ong>11ong>(a) The name and contact details of theapplicant for a decision for domestic use.(b) The name and contact details of theauthority responsible for the decision.(c) Name and ong>idong>entity of the living modifiedorganism.(d) Description of the gene modification,the technique used, and the resultingcharacteristics of the living modifiedorganism.(e) Any unique ong>idong>entification of the livingmodified organism.(f) Taxonomic status, common name, pointof collection or acquisition, and characteristicsof recipient organism or parentalorganisms related to biosafety.(g) Centres of origin and centres of geneticdiversity, if known, of the recipient organismand/or the parental organisms and adescription of the habitats where theorganisms may persist or proliferate.(h) Taxonomic status, common name,point of collection or acquisition, andcharacteristics of the donor organism ororganisms related to biosafety.(i) Approved uses of the living modifiedorganism.(j) A risk assessment report consistentwith Annex III.(k) Suggested methods for the safe handling,storage, transport and use, includingpackaging, labelling, documentation,disposal and contingency procedures,where appropriate.The development of an annex on informationrequirements for LMO-FFPs resulted from theagreement to develop an alternative procedurefor LMO-FFPs given their exclusion from the AIAprocedure. 698 An annex covering the informationto be provong>idong>ed under the new article on LMO-FFPs(then Article 9bis) was first proposed in Presong>idong>entMayr’s non-paper for the resumed ExCOP. 699 Thisproposal reduced the elements of Annex I (Informationrequired to obtain AIA) to six, 700 namely:name, address and contact details of developerand/or notifier; name, ong>idong>entity and domestic classificationof the biosafety level of the LMO (notin Annex I); description of the modification andresulting characteristics; centres of origin anddescription of habitats of proliferation; intendeduse; and risk assessment. 701Discussions at the resumed ExCOP were heldon the basis of the draft Protocol text and thePresong>idong>ent’s non-paper. The contact group on commoditiesat the resumed session of the ExCOPagreed to add several new elements to the listin this Annex, including, inter alia, unique ong>idong>entificationof LMOs and suggested methods for safehandling, storage and transport. 702 When this proposalwas further consong>idong>ered, contact group ChairPythoud reported a consensus on extending thedifferentiated approach to the accompanyingdocumentation. 703 Further elements from draftAnnex I were included: taxonomic status, andcharacteristics of recipient and donor organisms.In the final draft of the Protocol submitted by theLegal Drafting Group, the references to “intendeduses” was replaced by “approved uses” and thename and contact details were amended tobecome the “applicant for a decision on domesticuse” and the “authority responsible for the decision”.704 The Annex was then adopted as part of thefinal text of the Protocol as Annex II. This resultedin a renumbering of the remaining Annex on RiskAssessment, which became Annex III.698See sections on Article 7 and Article ong>11ong>.699Draft Chairman’s proposal for addressing the essential core issues of the scope of the Protocol of 21 December ong>19ong>99, see Annex 1B.700See section on Annex I above.701Id.702ENB Vol. 09 No. 132, p. 2.703ENB Vol. 09 No. 135, p. 2 and No. 136, p. 1.704UNEP/CBD/ExCOP/1/L.5, see Annex III.105


III. TEXT OF THE PROTOCOLAnnex III: Risk AssessmentObjective1. The objective of risk assessment, underthis Protocol, is to ong>idong>entify and evaluatethe potential adverse effects of livingmodified organisms on the conservationand sustainable use of biological diversityin the likely potential receiving environment,taking also into account risks tohuman health.Use of risk assessment2. Risk assessment is, inter alia, used bycompetent authorities to make informeddecisions regarding living modifiedorganisms.General principles3. Risk assessment should be carried outin a scientifically sound and transparentmanner, and can take into account expertadvice of, and guong>idong>elines developed by,relevant international organisations.4. Lack of scientific knowledge or scientificconsensus should not necessarily beinterpreted as indicating a particular levelof risk, an absence of risk, or an acceptablerisk.5. Risks associated with living modifiedorganisms or products thereof, namely,processed materials that are of livingmodified organism origin, containingdetectable novel combinations of replicablegenetic material obtained through theuse of modern biotechnology, should beconsong>idong>ered in the context of the risksposed by the non-modified recipients orparental organisms in the likely potentialreceiving environment.6. Risk assessment should be carried outon a case-by-case basis. The requiredinformation may vary in nature and levelof detail from case to case, depending onthe living modified organism concerned,its intended use and the likely potentialreceiving environment.Methodology7. The process of risk assessment may onthe one hand give rise to a need for furtherinformation about specific subjects,which may be ong>idong>entified and requestedduring the assessment process, while onthe other hand information on other subjectsmay not be relevant in some instances.8. To fulfil its objective, risk assessmententails, as appropriate, the followingsteps:(a) An ong>idong>entification of any novel genotypicand phenotypic characteristics associatedwith the living modified organismthat may have adverse effects on biologicaldiversity in the likely potential receivingenvironment, taking also into accountrisks to human health;(b) An evaluation of the likelihood of theseadverse effects being realised, taking intoaccount the level and kind of exposure ofthe likely potential receiving environmentto the living modified organism;(c) An evaluation of the consequencesshould these adverse effects be realised;(d) An estimation of the overall risk posedby the living modified organism based onthe evaluation of the likelihood and consequencesof the ong>idong>entified adverseeffects being realised;(e) A recommendation as to whether ornot the risks are acceptable or manageable,including, where necessary, ong>idong>entificationof strategies to manage these risks;and(f) Where there is uncertainty regardingthe level of risk, it may be addressed byrequesting further information on thespecific issues of concern or by implementingappropriate risk managementstrategies and/or monitoring the livingmodified organism in the receiving environment.Points to consong>idong>er9. Depending on the case, risk assessmenttakes into account the relevant technicaland scientific details regarding the characteristicsof the following subjects:(a) Recipient organism or parental organisms.The biological characteristics of therecipient organism or parental organisms,including information on taxonomic status,common name, origin, centres of ori-106


III. TEXT OF THE PROTOCOLgin and centres of genetic diversity, ifknown, and a description of the habitatwhere the organisms may persist or proliferate;(b) Donor organism or organisms. Taxonomicstatus and common name, source,and the relevant biological characteristicsof the donor organisms;(c) Vector. Characteristics of the vector,including its ong>idong>entity, if any, and its sourceor origin, and its host range;(d) Insert or inserts and/or characteristicsof modification. Genetic characteristics ofthe inserted nucleic acong>idong> and the functionit specifies, and/or characteristics of themodification introduced;(e) Living modified organism. Identity ofthe living modified organism, and the differencesbetween the biological characteristicsof the living modified organismand those of the recipient organism orparental organisms;(f) Detection and ong>idong>entification of the livingmodified organism. Suggested detectionand ong>idong>entification methods and theirspecificity, sensitivity and reliability;(g) Information relating to the intendeduse. Information relating to the intendeduse of the living modified organism,including new or changed use comparedto the recipient organism or parentalorganisms; and(h) Receiving environment. Informationon the location, geographical, climaticand ecological characteristics, includingrelevant information on biological diversityand centres of origin of the likelypotential receiving environment.The African group’s submission prior to BSWG-2 705included an annex on parameters for risk assessmentclassified according to: characteristics ofthe donor and recipient organisms, vectors, livingmodified organism, resuscitated organisms andgenes and fossil DNA, safety consong>idong>erations forhuman and animal health, environmental consong>idong>erations,and socio-economic consong>idong>erations.The submission also contained an annex on riskmanagement procedures. For the proposed articleon risk assessment, the African group proposedthat decisions on import should be based on riskassessments undertaken on a case by case basis,language that would later be reflected in thisannex. 706In its submission, Australia referred to Article 30of the ong>Conventionong> (Adoption and amendment ofannexes). Norway also submitted a comprehensiveproposal addressing: information related tothe LMO (similar to the African proposal); informationrelated to the intended use, sub-divong>idong>ed intoLMOs for contained use and those for deliberaterelease; and characteristics of the potential receivingenvironment.Further submissions were received prior to BSWG-3, the majority containing lists of specific informationrequirements. 707 The African group, Indiaand Norway proposed extensive listings of thecharacteristics of the different organisms involvedin the genetic modification. The African group andIndia also proposed information on the geneticstability of the organisms, the potential of theorganisms to transfer genes with other organisms,potential pathogenicity to humans and animals,and measures to counteract adverse impacts.Together with Sri Lanka, they also proposed takinginto account environmental and socio-economicconsong>idong>erations. Many of the submissions 708emphasised information on the characteristics ofthe vector, in contrast to the information requiredunder Annex I. 709 Malaysia referred to preliminary705UNEP/CBD/BSWG/2/2, pp. 78-97, contains the submissions of the African region, Australia and Norway.706Ibong>idong>., p. 56. See also section on Article 15 above.707UNEP/CBD/BSWG/3/3, pp. 92-103, contains the submissions of the African region, Australia, Belarus, Brazil, India, Malaysia, Norway, Peru and SriLanka.708The African region, Belarus, Brazil, India, Norway and Sri Lanka.709See section on Annex I above.107


III. TEXT OF THE PROTOCOLissues on methodology, advocating a multong>idong>isciplinaryapproach, and specifying the objectives ofthe risk assessment.CG-1, having agreed that an annex on riskassessment was necessary but without beginningdiscussions on its content, compiled thesesubmissions into the Consolong>idong>ated Text at BSWG-3, 710 by classifying them into general principlesand specific information requirements. These inturn were classified according to: characteristicsof donor and recipient or parental organisms;characteristics of the vector; characteristics of theLMOs; safety consong>idong>erations; environmental consong>idong>erations;release of LMOs for biological control;release experiment of LMO for bioremediation;and socio-economic consong>idong>erations. 7ong>11ong>The discussions during BSWG-4 addressed whethersome information requirements listed in draftannex I (Information required to obtain AIA) weremore appropriate for inclusion in draft annex II(Risk Assessment). 712 The repetition of informationin both annexes was also discussed. 713Working in parallel with the discussions on thearticle on Risk Assessment, (then Article 12) inSWG-I, CG-1 prepared a draft of annex II: a shortversion outlining a general approach and a longerversion containing a more detailed approach. Thisrecognised that, whichever approach was taken,no list of risk assessment parameters could fullyprovong>idong>e for all factors in all instances of risk assessment.714 It ong>idong>entified six risk assessment factors tobe consong>idong>ered and these, in essence, would constitutethe elements that feature in the final text asthe sequence of the risk assessment: ong>idong>entificationof hazardous characteristics of the LMO, the extentof the related consequences, the likelihood of thehazard, estimation of the risk posed, applicationof risk management strategies, and determinationof the overall risk of adverse effects. 715 A notewas also included to clarify that the informationrequired could vary from LMO to LMO dependingon the particular circumstances, which wouldalso appear in the final text (although differentlyphrased).Some countries submitted additional text prior toBSWG-5. 716 Australia proposed that the assessmenthad to be carried out in a scientifically sound andtransparent manner, taking into account scientificevong>idong>ence, expert technical and technologicaladvice, experience, and techniques developedby relevant international organisations. Norway,which advocated an annex on LMOs for containeduse, 717 proposed that the precautionary principleshould be taken into account in the containeduse of LMOs.While the discussions on the article on riskassessment continued to examine the need foran annex on principles and procedures for riskassessment, 718 CG-1 streamlined the draft annexII down to a framework specifying: the objective,use, general principles, and methodology ofrisk assessment (including the parameters to betaken into account). 7ong>19ong> The objective, in line withMalaysia’s earlier proposal, affirmed that the riskassessment aimed to ong>idong>entify and evaluate thepotential adverse effects of LMOs on biodiversity.Further references to human health and socio-710UNEP/CBD/BSWG/3/6, paras. 92 – 95.7ong>11ong>Ibong>idong>. See Annex II.712ENB Vol. 9 No. 78, p. 2.713ENB Vol. 9 No. 79, p. 2.714UNEP/CBD/BSWG/4/4, Annex IV, see Annex II (Revision).715Id.716UNEP/CBD/BSWG/5/2, pp. 135-144, contains submissions of Australia, New Zealand, Norway, Peru, Slovenia and Thailand.717See Appendix I below on Deleted Draft Articles: Annex III Contained Use.718ENB Vol. 9 No. 100, p. 1 and No. 104, p.1.7ong>19ong>UNEP/CBD/BSWG/5/3. Annex, see Annex II.108


III. TEXT OF THE PROTOCOLeconomic consong>idong>erations remained in brackets.The language on use was new and noted theuse of risk assessment by competent authoritiesin order to make informed decisions about thetransboundary movement of LMOs. The generalprinciples language acknowledged the precautionaryapproach as a guong>idong>ing principle of theassessment (in brackets), the uncertainty concerningthe level of risk when there is lack of scientificknowledge or consensus, and the risk associatedwith transboundary movements of LMOs or productsthereof. It noted that these should be consong>idong>eredin the context of using the non-modifiedrecipients or parental organisms in the receivingenvironments. Risk assessments should be carriedout on a case by case basis, and in a scientificallysound and transparent manner. 720 The section onmethodology contained the steps and parametersnoted above and included Australia’s reference toexpert advice and guong>idong>elines from internationalorganisations. 721 A footnote indicated that furtherdiscussion on the technical details was still pending.722organisms, vector, inserts/modification and donororganisms. 725 Information regarding safety consong>idong>erationsfor human health and socio-economicconsong>idong>erations depended on the resolution of discussionsby other sub-groups. 726 Similarly, the referencesto “products thereof” and the precautionaryapproach were dependent upon discussionsin other sub-groups. Following the resolution ofthese issues, the section on general principles inannex II of the Chair’s text could then contain areference to “products thereof” and an implicit referenceto the precautionary approach. 727 Annex II,together with Annex I, was then provisionallyadopted by the BSWG. 728The Legal Drafting Group at the resumed ExCOPlater reviewed this text and made minor editorialchanges. The annex was re-numbered and wasadopted as Annex III as part of the final text of theProtocol on 29 January 2000.At BSWG-6 agreement on the draft article on riskassessment was dependent upon a resolutionof the discussions on annex II. These took placein CG-1, which consong>idong>ered language on generalprinciples including reference to the precautionaryapproach and lack of scientific knowledge. 723Language on requesting additional informationor implementing appropriate risk managementtechniques to address uncertainties or increasedlevels of risk was inserted. 724 Delegates also discussedspecific technical and scientific detailsto be taken into account during risk assessment,including characteristics of recipient/parental720Id.721Id.722Id.723ENB Vol. 9 No. ong>11ong>2, p. 1.724Id.725Id.726ENB Vol. 9 No. ong>11ong>3, p. 2.727UNEP/BSWG/6/L.2/Rev.1, see Annex II.728UNEP/CBD/ExCOP/1/3, para. 51.109


III. TEXT OF THE PROTOCOLAPPENDIX I: DELETED DRAFTARTICLESRelationship with other internationalagreementsPrior to BSWG-2, a number of countries submittedviews on the relationship between the protocoland other international agreements. 729 Australiarecalled that the terms of reference of the BSWGstated that the protocol should “not overrong>idong>e orduplicate any other international legal instrumentin this area”, 730 and stressed that the protocol neednot derogate from WTO provisions. Similarly, theUS proposed specifying that “nothing in [theprotocol] shall affect the rights and obligationsof countries under [prior] agreements.” Norwayproposed an exemption in cases of “serious damageor threat to biological diversity”. The EU calledfor “consistency between the Protocol and theAgreements under the WTO” as well as with therelevant international obligations of the Parties,proposing to refer the issue as far as possible toArticle 22 of the ong>Conventionong>. At the same time theSecretariat prepared a background document onexisting international agreements on biosafety toprovong>idong>e the basis for negotiations, 731 which wassubsequently consong>idong>ered at BSWG-3. 732The Secretariat also prepared two options of drafttext for BSWG-3. 733 The first simply referred theissue to Article 22 of the ong>Conventionong>, while thesecond reflected the views expressed by Australiaand the US, but with the exemption proposedby Norway. A second paragraph required Partiesto “implement this Protocol with respect to themarine environment consistently with the rightsand obligations of States under the law of thesea”.The consolong>idong>ated text at the end of BSWG-3included both options, although it dropped thesecond paragraph of the second option. 734729UNEP/CBD/BSWG/2/2, pp. 32-35, contains the submissions ofAustralia, Canada, the European Union, Norway and United States.730Decision II/5, Annex, para. 4(b).731UNEP/CBD/BSWG/2/3.732UNEP/CBD/BSWG/3/Inf.2.733UNEP/CBD/BSWG/3/4, p. 8.734UNEP/CBD/BSWG/3/6, Annex I, see Article 34.735UNEP/CBD/BSWG/4/4, Annex III, see Article 34.At BSWG-4, CG-2 continued the preliminary discussionsand a third option was added to theconsolong>idong>ated draft text. 735 This provong>idong>ed that, inthe event of any inconsistency between the Protocoland the Agreement on Technical Barriers toTrade (TBT) and the Agreement on the Applicationof Sanitary and Phytosanitary Measures (SPS),the Protocol would “prevail to the extent of theinconsistency” and that Parties could “waive tothis extent their right to bring a complaint againstany other Party under [those] agreements”.Several further submissions were made prior toBSWG-5. 736 At BSWG-5, the issue was addressedby SWG-II in conjunction with draft articles onNon-Parties and Non-discrimination (then Articles23 and 24). 737 There was disagreement on therelationship between the proposed article on therelationship with other international agreements(then Article 34), and paragraph 5 of the articleon General obligations, (then Article 1bis) whichreferred to the jurisdiction, rights and obligationsof States under the law of the sea. 738The resulting consolong>idong>ated negotiating text at theend of BSWG-5 contained a single option. 739Consensus could not be reached during BSWG-6and the issue remained unresolved. Later, followingthe informal consultations, a non-paperby Presong>idong>ent Mayr proposed removing the draftarticle (then Article 31) and reflecting its intentinstead in the Preamble. 740 Agreement could notbe reached during the resumed ExCOP and thematter was finally resolved by informal negotiationson the last day of the negotiations, which ledto the insertion of new preambular provisions onthe relationship of the protocol with other internationalagreements, included in the final text ofthe Protocol. 741736UNEP/CBD/BSWG/5/2, see Article 34, contains the submissions ofEcuador, New Zealand, Peru, Slovenia, Thailand, Uruguay and Venezuela.737UNEP/CBD/BSWG/5/3, para. 40.738Ibong>idong>., para. 43.739UNEP/CBD/BSWG/5/3, Annex, see Article 34.740Draft Chairman’s Proposal, Non-paper dated 21 December ong>19ong>99. Seealso section on the Preamble in section III above.741See also section on Non-discrimination in this Appendix.ong>11ong>0


III. TEXT OF THE PROTOCOLJurisdictional ScopeA draft article on jurisdictional scope was preparedby the Secretariat for BSWG-3. 742 This proposalincluded two options for text:1. “Articles 4 of the ong>Conventionong> on BiologicalDiversity regarding Jurisdictional Scope shallapply to this Protocol.” or2. “Subject to the rights of other States, andexcept as otherwise expressly provong>idong>ed inthis Protocol, the provisions of this Protocolapply, in relation to each Contracting Party:(a) In the case of components of biologicaldiversity, in areas within the limits of itsnational jurisdiction; and(b) In the case of processes and activities,regardless of where their effects occur, carriedout under its jurisdiction or control, within thearea of its national jurisdiction or beyond thelimits of national jurisdiction.”The first option reflected a proposal submitted bythe EU prior to BSWG-2. 743The consolong>idong>ated text at the end of BSWG-3retained only the first option. 744At BSWG-4, CG-2 decong>idong>ed that this article wasredundant and could be deleted. 745 The recommendationwas reiterated at BSWG-5, and thedraft article (“Article 32 Jurisdictional Scope) wasdeleted. 746Notification of TransitA number of governments submitted draft textprior to BSWG-3. 747 Australia and Brazil proposedthat Parties could require notification in writingof “other Parties intent to transit an LMO throughtheir territory”. According to this proposal, suchParties would be required to provong>idong>e the BCHwith “details of the categories of LMOs for whichnotification is required” and “information to beprovong>idong>ed with the notification”. On receipt of thenotification, the Party would be required to adviseon relevant provisions for transit of the LMOs.Mexico proposed that transit required the issueby the country of transit of a permit to the exportingParty. The exporting Party should also assume“responsibility for any cases of accong>idong>ental releasein [the countries of transit]”. Malaysia proposed todefine transit as “the temporary stop-over of anLMO which is on a continuous journey to anotherdestination.” Norway proposed a detailed procedurewith timelines under which the country oftransit could “declare in writing whether a notificationis required for subsequent transit movementsof the same LMO.” Peru proposed that the“documentation provong>idong>ed for the transport ofLMOs must specify the care needed during theirtransit”.The Consolong>idong>ated Text at the end of BSWG-3included options for a draft article divong>idong>ed intofour sections: requirements; acknowledgement/response; treatment of goods in transit; andan option of no specific provision under thisarticle. 748At BSWG-4, the need for this article was consong>idong>eredby SWG-I. The resulting two optionscontained in the consolong>idong>ated text included anoption for no provision and an option requiringthe earlier proposed elements, i.e. the notificationbetween Parties of the intent to transit LMOs;acknowledgement of notification by the Stateof transit; notification by transit States regarding742UNEP/CBD/BSWG/3/4, p. 7.743UNEP/CBD/BSWG/2/2, p. 48.744UNEP/CBD/BSWG/3/6, Annex I, see Article 32.745UNEP/CBD/BSWG/4/4, para. 23.746UNEP/CBD/BSWG/5/3, Annex, p. 46747UNEP/CBD/BSWG/3/3, see Article 7, contains the submissions of Australia, Brazil, Malaysia, Mexico, Norway and Peru.748UNEP/CBD/BSWG/3/6, Annex I, see Article 8.ong>11ong>1


III. TEXT OF THE PROTOCOLtreatment of subsequent imports; and documentationspecifying the necessary care for the LMOswhile in transit. 749During BSWG-5, SWG-I recommended the deletionof the article on the grounds that its relevantelements were already covered in a number ofother articles. 750 The Working Group thereforeagreed to the deletion of draft Article 8 (Notificationof Transit). 751Emergency Measures 752Some governments presented draft text on emergencyprocedures prior to BSWG-2. 753 These proposals,with the exception of Japan which referred thematter to Article 14(1)(d) and (e) of the ong>Conventionong>,included a general commitment to immediatelyinform affected countries and to introduce appropriatemeasures and procedures; and ong>idong>entifiedinformation to accompany the notification (includingthe ong>idong>entity of the LMO, the quantities and circumstancesof the release, and emergency measuresneeded to be taken). The views of the African groupand Norway reflected their concerns about the possibleeffects of an accong>idong>ent on human health and theenvironment. The African group also added referencesto animal health and biodiversity and Norwayproposed the need for consultations on the part ofthe affected States.Further proposals were presented for BSWG-3under two separate headings: unintentionaltransboundary movements (then Article 16) andemergency measures (then Article 17). 754 Indiaendorsed the African group’s earlier text. Malaysiaemphasised the importance of emergency plansas part of risk management strategies under therelevant provision of the protocol and the needfor national measures that included contingencyplans and emergency measures. Peru held theview that in cases of accong>idong>ents the responsibilityto take immediate action lay with the insurer andthe competent authorities.All the proposed elements were contained in theconsolong>idong>ated text prepared by SWG-II. 755At BSWG-4, 756 the renumbered Article 16 on emergencymeasures contained text that called eitherfor the establishment of national measures andprocedures, or for the incorporation of appropriatemeasures into risk management strategiesrequired under draft article 13 (Risk Management).757 However, later in the meeting, the draftarticles on unintentional transboundary movementand on emergency measures were mergedon the basis of a draft prepared by the Co-Chairsof SWG-II. 758 These issues are now addressed inArticle 17 of the Protocol.749UNEP/CBD/BSWG/4/4, Annex I, see Article 8.750UNEP/CBD/BSWG/5/3, para. 32.751UNEP/CBD/BSWG/5/3, Annex, see Article 8. See also section on Article 6 in Section III above.752See also section on Article 17 in Section III above.753UNEP/CBD/BSWG/2/2, pp. 58-59, contains the submissions of Africa, Japan and Norway, and UNEP/CBD/BSWG/2/Inf. 7 contains the submission ofMalaysia.754UNEP/CBD/BSWG/3/3, p. 50, contains the submissions of the African group, India, Malaysia and Peru.755UNEP/CBD/BSWG/3/6, Annex I, see Articles 15 and 16.756Colombia had presented draft text in UNEP/CBD/BSWG/4/3, p. 13.757UNEP/CBD/BSWG/4/Inf.2, see Article 16.758UNEP/CBD/BSWG/4/SWG.II/CRP.1. See now section on Article 17 in Section III above.ong>11ong>2


III. TEXT OF THE PROTOCOLMinimum national standardsBy BSWG-3, a number of governments had submitteddraft text on minimum standards, 759 followingan earlier submission by Norway. 760 These proposalsgenerally agreed with Norway that each “Partyshall ensure that appropriate legal, institutionaland administrative frameworks with regard tothe safe transfer, handling and use of LMOs are inplace” and that “[t]he national regulations shall asa minimum fulfil the requirements set out in thisProtocol with regard to the safe transfer, handlingand use of LMOs”. Norway proposed that suchframeworks needed to be established “upon thedate of the entry into force of this Protocol for [theParty in particular].”During BSWG-5 views differed on whether toretain this article, delete it, or move it elsewhere,particularly to the draft article on general obligations(then Article 1bis). 764 At the fourth session ofthe plenary at BSWG-5, the Co-Chair of SWG-I, MrsWint (Jamaica), reported that SWG-I had agreedto delete the article if its substance was effectivelyaddressed in Article 1bis. 765At BSWG-6, SWG-II consong>idong>ered the draft for inclusionin Article 1bis. After its principal provisionswere incorporated into the draft Article 1bis (nowArticle 2 (General Provisions)), the Working Groupagreed to remove the draft Article 16 on minimumnational standards. 766Canada proposed a requirement for “domesticlaws [in so far as to] manage the risks ong>idong>entifiedunder [their] risk assessment procedures [in accordancewith the Protocol].” Language from the firsttwo elements would later be included in Article 2(General Provisions). The draft Consolong>idong>ated Textat the end of BSWG-3 included the Norwegianand Canadian proposals, as well as an option notto have any provision on this issue. 761Chair Koester prepared a note for BSWG-4based on the three earlier options. 762 This proposeda deadline of “two years after the date ofratification/accession”; the obligation to “cooperatein establishing at the international andregional level, procedures [for] risk assessment”;and that “Parties may impose more stringent orcomprehensive requirements based on scientificconsong>idong>erations”. At BSWG-4, SWG-I dealt withthis provision and the resulting text containedtwo options, a zero (no provision) option and anoption based on the Chair’s text but allowing theParties to impose more stringent requirementsbased on the precautionary principle. 763759UNEP/CBD/BSWG/3/3, see Article 15, p. 43, contains the submissions of the African group, Canada, Mexico, Norway and Peru.760UNEP/CBD/BSWG/2/2, p. 59.761UNEP/CBD/BSWG/3/6, Annex I, see Article 14, p. 68.762UNEP/CBD/BSWG/4/Inf.1, see Article 14.763UNEP/CBD/BSWG/4/4, Annex I, see Article 14.764Further submissions were made prior to BSWG-5. (UNEP/CBD/BSWG/5/2, pp. 61-63, contains the submissions of Ecuador, Kenya, New Zealand, Peru,Slovenia, Thailand and Venezuela.765UNEP/CBD/BSWG/5/3, para. 32.766UNEP/CBD/ExCOP/1/2, para. 39.ong>11ong>3


III. TEXT OF THE PROTOCOLNon-discriminationFollowing the discussion in plenary at BSWG-3 onnon-discrimination, it was decong>idong>ed to prepare anelement paper on non-discrimination by SWG-IIand include it in the Consolong>idong>ated Text. 767 Thirteenelements were included in the draft text encompassingviews ranging from acknowledging theexercise of sovereign rights by Parties in respectof non-discrimination to ensuring the Protocol’sconsistency with trade-related international treaties,and in particular, those under the WTO. 768A large number of submissions were made priorto BSWG-4. 769 Those from Argentina and Australiastressed that measures regulating the safe transfer,handling and use of LMOs should not “createunnecessary obstacles to, and or constitutemeans of arbitrary or unjustified discriminationor disguised restrictions on international trade”.Argentina also proposed that “Parties shall notdiscriminate between imported living modifiedorganisms and those produced locally and/orthose that have previously authorised to beimported from a third party”.Chile proposed that “Parties may restrict trade ofcertain living modified organisms while permittingothers”. Bolivia’s submission subjected theintroduction of an LMO into a country Party to theProtocol to compliance with the AIA procedure.The text from the US and Japan, following Argentinaand Australia, declared that the “importingParty shall ensure that its decisions and actionswith respect to the import of a living modifiedorganism are not more restrictive than withregard to the same living modified organism produceddomestically or imported from any othercountry.” Japan also proposed that “recipient ContractingParties may impose specific conditionswhen living modified organisms of foreign originare imported from non-Parties with which [thereis] no agreement or arrangement [as provong>idong>edunder the Protocol]”.Malaysia supported the receiving country Party’ssovereign right and prerogative to decong>idong>e on theissue and allowed that “any matter of nationalinterest such as social and ethical matters andsensitivities of the culture and religion prevailingin the receiving country” could be taken intoconsong>idong>eration. It also proposed that “[p]reviousdecisions by the receiving country Party... shallnot affect the right of the receiving country Partyto make its [own] decisions”.Elements from the proposals from Argentina, Australia,Japan and the USA were included in the twosubstantive options in the draft text prepared bySWG-II, together with the option to have no provisionon non-discrimination. 770Additional views were submitted prior to BSWG-5. 771 During BSWG-5, SWG-II discussed a draftarticle, “Non-discrimination/National Treatment”,following a proposal from Mexico 772 as part ofa cluster including draft articles on Non-Parties,(then Article 23), and on Relationship with OtherInternational Agreements, (then Article 34). Atthe heart of the discussion was the question ofthe extent to which the protocol would addresstrade issues and what role non-trade concernswould play. A drafting group worked on draftarticles on non-discrimination and on non-parties.The resulting consolong>idong>ated negotiating textat the end of BSWG-5 contained two paragraphsin brackets endorsing non-discrimination andprohibiting unnecessary obstacles/unjustifieddiscriminations/disguised restrictions to trade. 773767UNEP/CBD/BSWG/3/6, paras. 65-68.768Ibong>idong>., p. 85.769UNEP/CBD/BSWG/4/2, pp. 10-ong>11ong>, contains submissions of Argentina, Australia, Bolivia, Chile, Japan, Malaysia, Switzerland and USA.770UNEP/CBD/BSWG/4/4, Annex II, see Article 24.771UNEP/CBD/BSWG/5/2, pp. 97-98, contains the submissions of Ecuador, Mexico, New Zealand, Peru, Thailand, Uruguay and Venezuela.772Id.773UNEP/CBD/BSWG/5/3, Annex, see Article 24.ong>11ong>4


III. TEXT OF THE PROTOCOLAt BSWG-6, a Co-Chair (Canada) of the informalgroup on trade-related issues, reported to SWG-II that many delegates supported deleting theprovision, although one regional group wishedto retain it. 774 However, the issue remained unresolvedand the draft provision on non-discriminationin the Chair’s proposed text at BSWG-6 wasmodified slightly, although not in substance. 775The deletion of this article was proposed in Presong>idong>entMayr’s non-paper, 776 in view of the amendmentsto the preamble 777 and to the then Article 8,paragraph 4bis 778 (Decision procedure).At the resumed ExCOP, a contact group on articles31 (Relationship with other international agreements)and 22 (Non-discrimination) was established,chaired by Ambassador Yang (Cameroon),to examine the issues in the non-paper. AmbassadorYang would later report that the group’s proposal,set out in a working paper, also suggesteddeleting these articles and that their contentshould be reflected in three preambular paragraphs.779 Further consultations were held but noagreement was reached on the preambular textto replace those articles. 780 The outstanding issuesrelating to the preambular text were resolved inhigh-level consultations on the overall text of theProtocol. 781 Reference to non-discrimination wasnot included in the preamble when the final drafttext of the Protocol, as submitted by the LegalDrafting Group, was adopted.Subsequent ImportsA number of governments submitted draft texton subsequent imports of LMOs for consong>idong>erationat BSWG-3. 782 Australia proposed specifying thatnotification of subsequent imports of the sameLMO into the same importing Party should only berequired in writing: “where there may be a changein the intended use of the living modified organism;a variation in the receiving environment; orother factors likely to affect the risk assessmentor risk management”. However Brazil, togetherwith Mexico and Peru, proposed that notificationin writing should be required for all subsequentimports of the same LMO into the same importingParty. The EC suggested “a single notification”to cover similar or subsequent transboundarymovements to the same Party of import. Norwayproposed that a State of import could at any timedeclare that subsequent imports of a specific LMOinto its territory for specified uses or purposeswould be exempt from the AIA procedure. Switzerlandproposed that the national focal pointsof the importing party should be informed thirtydays in advance of any intended subsequenttransboundary movements and that, in cases ofno response, the exporter could proceed withsuch movements.The draft Consolong>idong>ated Text at the end of BSWG-3divong>idong>ed the proposals into three sections: notification(six options); application (two options); andregulation (one option). 783774ENB, Vol. 9 No. ong>11ong>2, p. 2.775UNEP/CBD/BSWG/3/6/L.2, see Article 22.776Draft Chairman’s Proposal, Non-paper dated. 21 December ong>19ong>99.777See sections on the Preamble in Section III above and on Relationship with Other International Agreements in this Appendix.778This new paragraph introduced by Presong>idong>ent Mayr was later removed. See also section on Article 10 in section III.779UNEP/CBD/ExCOP/1/3, para. 63.780Ibong>idong>., para. 85.781Ibong>idong>., paras. 87-91.782UNEP/CBD/BSWG/3/3, Article 10, contains the submissions of Australia, Brazil, European Community, Mexico, Norway, Peru and Switzerland.783UNEP/CBD/BSWG/3/6, Annex, Article 10.ong>11ong>5


III. TEXT OF THE PROTOCOLAt BSWG-4 the options, drawn mainly from thesubmissions of Australia, Brazil, EC and Norway,were narrowed down to five, including a zero (noprovision) option. 784However at BSWG-5, SWG-I decong>idong>ed to deletethe article on the grounds that its contents were“amply covered in the revised Article 6 [DecisionProcedure] para. 3 (a), as contained in UNEP/CBD/BSWG/5/SWG.I/CRP.3 as well as in Articles 9 [SimplifiedProcedure] and 12 [Risk Assessment], containedin working papers ong>11ong> and 4, respectively, ofSWG-I.” 785 The Article was provisionally deleteduntil BSWG-6, when final deletion of the draftArticle 10 (Subsequent Imports) was agreed. 786Ratification, acceptance or approvalThe Secretariat prepared a draft article on ratification,acceptance or approval for BSWG-3. 787 Thisstated that, in accordance with Article 34 of theong>Conventionong>, the Protocol would be subject toratification, acceptance or approval and that therelevant instrument would be deposited with theDepositary. Additional provisions regarding theparticular case of regional economic integrationorganisations were also envisaged, mirroring thetext of the ong>Conventionong>, in order to clarify that suchorganisations and their Member States could notexercise rights under the Protocol concurrently.However, during BSWG-4, CG-2 agreed that draftarticle 38 on ratification, acceptance and approvalwas redundant 788 and that it could be deleted. 789At BSWG-5, draft article 38 on ratification, acceptanceand approval was deleted. 790784UNEP/CBD/BSWG/4/4, Annex I, see Article 10.785UNEP/CBD/BSWG/5/3, para. 32; and Annex, see Article 10.786UNEP/CBD/ExCOP/1/2, para. 39.787UNEP/CBD/BSWG/3/4, p. 12.788See Article 34 of the ong>Conventionong>. See also section on Article 37 in section III above.789UNEP/CBD/BSWG/4/4, para. 23.790UNEP/CBD/BSWG/5/3, para. 27.ong>11ong>6


III. TEXT OF THE PROTOCOLAccessionThe Secretariat drafted text for BSWG-3 on thisissue, 791 which reproduced the relevant provisionsfrom the ong>Conventionong>. The draft read:1. In accordance with Article 35 of the ong>Conventionong>,this Protocol shall be open for accessionby States and by regional economic integrationorganisations from the date on whichthe ong>Conventionong> or the protocol concernedis closed for signature. The instruments ofaccession shall be deposited with the Depositary.2. In their instruments of accession, the organisationsreferred to in paragraph 1 above shalldeclare the extent of their competence withrespect to the matters governed by the Protocol.These organisations shall also inform theDepositary of any relevant modification in theextent of their competence.3. The provisions of Article [Ratification,] paragraph(b), shall apply to regional economicintegration organisations, which accede tothis Protocol.At BSWG-4, CG-2 agreed that Article 39 (Accession)was redundant 792 and could be deleted. 793BSWG-5 accepted this recommendation and, afterprovisionally 794 deleting this Article, it was thenfinally removed.OTHER PROPOSALSSettlement of DisputesA number of submissions were made on settlementof disputes prior to BSWG-2. 795 The Africangroup reproduced the text of Article 27 of theong>Conventionong> on Settlement of Disputes, while theEU invoked Article 27(5) CBD which states that“the provisions of this Article shall apply withrespect to any protocol except as otherwise provong>idong>edin the protocol concerned.” Bolivia calledfor an international arbitration mechanism underUNEP or another international organisation to bedecong>idong>ed by the ong>Conventionong>. Cuba also supportedarbitration but under the procedures set down inAnnex II of the ong>Conventionong>.The Secretariat prepared draft text for consong>idong>erationat BSWG-3 796 containing two options. Thefirst referred to Article 27 and Annex II of the ong>Conventionong>,while the second reproduced the textof Article 27. During the discussions at BSWG-3,it was agreed that the relevant provisions of theong>Conventionong> should apply and that the Protocolshould indicate in its article on Relationship withthe ong>Conventionong> (then article 33), by means of afootnote, that “[t]his provision potentially allowsfor the provisions of the ong>Conventionong> on, for example,settlement of disputes; amendment; adoptionand amendment of annexes; and right to vote toapply to the Protocol”. 797Draft Article 33 was reconsong>idong>ered at BSWG-4 andBSWG-5 in light of its relation to other pendingissues. Explicit reference to settlement of disputeswas finally removed at BSWG-6. 798791UNEP/CBD/BSWG/3/4, p. 12.792See Article 35 of the ong>Conventionong>. See also sections on Article 37 in section III above, and on Ratification, Acceptance or Approval in this Appendix.793UNEP/CBD/BSWG/4/4, para. 23.794UNEP/CBD/BSWG/5/3, para. 27.795UNEP/CBD/BSWG/2/2, pp. 40-41, contains the submissions of the African region, Australia, Bolivia, Canada and the EU. See also submission of Cubain UNEP/CBD/BSWG/2/Inf.6.796UNEP/CBD/BSWG/3/4, p. 9.797UNEP/CBD/BSWG/3/6, Annex I, see Article 33.798UNEP/CBD/BSWG/6/L.2, see Article 30.ong>11ong>7


III. TEXT OF THE PROTOCOLAnnex - LMOs that are not likely tohave adverse effects on the conservationand sustainable use of biologicaldiversity, taking into account risks tohuman healthFollowing a proposal from the EC before BSWG-3 799 to include an annex listing such LMOs, an“empty” annex was included in the Chair’s proposedtext at BSWG-6 800 but then removed duringthe second revision of the draft. 801Other AnnexesA number of other proposed annexes were ong>idong>entifiedin the Chair’s draft on content of certainarticles prepared for BSWG-3. These addressed:information required in order to obtain advanceinformed agreement; risk assessment parameters;risk management schemes; function of focalpoints/competent authorities; and information tobe provong>idong>ed to the Secretariat under informationsharing/clearing-house. 802 CG-1 recommendedthat these annexes be included in the consolong>idong>ateddraft, and a further list of proposed annexescontained in submissions was also provong>idong>ed. 803During BSWG-4, discussions continued on draftannexes I and II and on preparations for discussionson the remainder of the proposed annexesat the following meeting. However, at BSWG-5 thedecision was taken to limit the number of annexesto four. 804799UNEP/CBD/BSWG/3/5.800UNEP/CBD/BSWG/6/L.2, see Annex III.801UNEP/CBD/BSWG/6/L.2/Rev.2. For a more detailed account on this proposal see section on Article 4 in section III.802UNEP/CBD/BSWG/3/Inf.4.803UNEP/CBD/BSWG/3/6, para. 94.804UNEP/CBD/BSWG/5/3, para. 37. See also the sections on Annexes I, II and III in section III.ong>11ong>8


III. TEXT OF THE PROTOCOLAPPENDIX II: NEGOTIATING SESSIONS AND GROUPSOPEN-ENDED AD HOC WORKING GROUP ON BIOSAFETYFirst Meeting Aarhus, Chairman Mr. Veit Koester Denmark(BSWG-1) 22-26 July ong>19ong>96Second meeting Montreal, Chairman Mr. Veit Koester Denmark(BSWG-2) 12-16 May ong>19ong>97Third Meeting Montreal Chairman Mr. Veit Koester Denmark(BSWG-3) 13-17 October ong>19ong>97 Co-Chairs, Sub-Working Group I Dr. Eric Schoonejans FranceMrs. Sandra WintJamaicaCo-Chairs, Sub-Working Group II Ms. Hira Jhamtani IndonesiaMr. Davong>idong> GambleNew ZealandCo-Chairs, Contact Group 1 Mr. Gert Willemse South AfricaMr. Piet van der Meer NetherlandsCo-Chairs, Contact Group 2 Amb. John Ashe Antigua and BarbudaFourth meeting Montreal Chairman Mr. Veit Koester Denmark(BSWG-4) 5-13 February ong>19ong>98 Co-Chairs, Sub-Working Group I Dr. Eric Schoonejans FranceMrs. Sandra WintJamaicaCo-Chairs, Sub-Working Group II Ms. Amarjeet K. Ahuja IndiaMr. John HerityCanadaCo-Chairs, Contact Group 1 Mr. Gert Willemse South AfricaMr. Piet van der Meer NetherlandsCo-Chairs, Contact Group 2 Amb. John Ashe Antigua and BarbudaMs. Katharina Kummer SwitzerlandFifth meeting Montreal Chairman Mr. Veit Koester Denmark(BSWG-5) 17-28 August ong>19ong>98 Co-Chairs, Sub-Working Group I Dr. Eric Schoonejans FranceMrs. Sandra WintJamaicaCo-Chairs, Sub-Working Group II Ms. Amarjeet K. Ahuja IndiaMr. John HerityCanadaMr. Gert WillemseSouth AfricaCo-Chairs, Contact Group 1 Mr. Piet van der Meer NetherlandsAmb. John AsheAntigua and BarbudaCo-Chairs, Contact Group 2 Ms. Katharina Kummer SwitzerlandChair, Drafting Group on Liability and Redress Ms. Kate Cook United KingdomSixth meeting ong>Cartagenaong> Chairman Mr. Veit Koester Denmark(BSWG-6) 15-ong>19ong> February ong>19ong>99 Co-Chairs, Sub-Working Group I Dr. Eric Schoonejans FranceMrs. Sandra WintJamaicaCo-Chairs, Sub-Working Group II Mr. Rajen Habib Khwaja IndiaMr. John HerityCanadaCo-Chairs, Contact Group 1 Mr. Osama El-Tayeb EgyptMr. Piet van der Meer NetherlandsCo-Chairs, Contact Group 2 Amb. John Ashe Antigua and BarbudaMs. Katharina Kummer SwitzerlandChair, Legal Drafting Group Amb. Lynn Holowesko BahamasChair, Drafting Group on Liability and Redress Ms. Kate Cook United Kingdom1ong>19ong>


III. TEXT OF THE PROTOCOLCONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL DIVERSITYFirst extraordinary meeting ong>Cartagenaong> Presong>idong>ent Mr. Juan Mayr Maldonado, Colombia(ExCOP) 22-23 February ong>19ong>99Informal consultations Montreal, Presong>idong>ent Mr. Juan Mayr Maldonado, Colombia1 July ong>19ong>99Informal consultations Vienna, Presong>idong>ent Mr. Juan Mayr Maldonado, Colombia15-ong>19ong> September ong>19ong>99Informal Montreal Presong>idong>ent Mr Juan Mayr Maldonado ColombiaConsultations22-23 JanuaryFirst extraordinary meeting Montreal Presong>idong>ent Mr. Juan Mayr Maldonado, Colombia(Resumed ExCOP) 24-29 January 2000 Chair, Contact Group (commodities) Mr. François Pythoud SwitzerlandChair, Contact Group (scope) Mr. John Herity CanadaChair, Legal Drafting Group Amb. Lynn Holowesko BahamasChair, Contact Group (articles 31 and 22) Amb. Philémon Yang CameroonCo-ordinator, Consultations on non-core issues Amb. Beat Nobs Switzerland120


III. TEXT OF THE PROTOCOLAPPENDIX III: EVOLUTIONOF THE CONTENTS OF THEPROTOCOLBSWG-1During BSWG-1 (July ong>19ong>96) a contact group wasestablished to consolong>idong>ate proposals for the possiblestructure of the protocol into a single document,not necessarily the subject of consensus,including in a logical order all the elements putforward. 805 The working paper developed by thecontact group contained three sections: itemsincluded in all proposals, items included in somebut not all proposals, and terms proposed fordefinition. The working paper was submitted tothe final plenary and was included as the annexto the report of the meeting.Possible Contents of the Protocol on ong>Biosafetyong>A. Items included in all proposals:TitlePreambleUse of terms/DefinitionsAdvance informed agreementInformation sharingRelationship with other international agreementsInstitutional framework for the functioning of the ProtocolSettlement of disputesAmendmentFinal clausesB. Items included in some but not all proposals:ObjectivesScopeJurisdictional scopeGeneral obligationsCriteria to determine the use of AIAand/or notification proceduresNotification procedureConsong>idong>erations for risk assessment and risk managementMechanisms for risk assessmentMechanisms for risk managementEmergency proceduresMinimum national standards on biosafetyDesignation of competent authority and national focal pointCapacity buildingTransport and packaging requirementsfor the transfer of LMOsHandling, transport and transit requirements for LMOsTransboundary movement between partiesTransboundary movement from a partythrough States which are not partiesIllegal trafficDuty to re-importTechnical information networkPublic awarenessong>Clearingong>-houseMechanisms for bilateral agreementsLiability/Liability and compensationConsultations on liabilityMonitoring and complianceFinancial issuesSocio-economic consong>idong>erationsReview and adaptationSignatureAccessionRight to voteEntry into forceReservations and declarationsWithdrawalDepositoryAuthentic textsAnnexesAppendix I: Terms proposed for definition:Living Modified Organisms (LMOs)Transboundary movementTransferSafe transferCompetent authorityFamiliarityAdverse effectsContained useIntended/deliberate releaseUnintended releaseFocal pointRisk assessmentRisk managementModern biotechnologyAdvance Informed Agreement/Prior informed consent805UNEP/CBD/BSWG/1/4, paras. 101-102.121


III. TEXT OF THE PROTOCOLMinimum national standardsong>Biosafetyong>Limited field trialHandling of LMOsUse of LMOsCentres of originCentres of genetic diversityCompensationAccong>idong>ental releaseOpen environmentOpen field trialAccong>idong>ental(UNEP/CBD/BSWG/1/4)BSWG-2At BSWG-2 (May ong>19ong>97), the Chair, on the basis ofhis review of items which had been addressed bysubmissions of participants, tabled conferenceroom papers or aong>idong>e-mémoires raising specificquestions on which the views of the delegationswere sought. These views were compiled by theChair, and delegations were given an opportunityto add elements that had been proposed or tosuggest modifications. It was decong>idong>ed to annexthe revised Chair’s summary of draft elements tothe report of BSWG-2. It was agreed that theserevised summaries should not be treated as negotiateddocuments and that they in no way createda prescriptive framework for negotiations. 806Chairman’s Summary of Elements PresentedItem A: Procedures in the case of specific transfer ofLMOsTopic: Modalities of the Procedure(s)Elements: Notification; Information that may be required;Period of time; ReviewTopic: For which cases should the procedure(s) applyElements: No exceptions/deviations; Exceptions/deviations;Specific casesTopic: Simplified procedureTopic: ConsentItem B: Competent authority(s)/focal point(s)Topic: Modalities for competent authority(s)/focal point(s)Elements: Nomination; Time of designation; Responsibilitiesof CompetentAuthority(s)/Focal Point(s)Item C: Information-sharingGeneral; Between Parties; ong>Clearingong>-house; Confong>idong>entiality;Common formatItem D: Capacity-buildingItem E: Public awareness/public participationPublic awareness; Public participationItem F: Risk assessment and risk management (includingminimum national standards)Risk Assessment: Provisions; Responsibility; Legal status;Aim/basisRisk Management: Provisions; Legal status; Responsibility/trigger; BasisItem G: Unintentional transboundary movement ofLMOs (including accong>idong>ental and emergency cases)Item H: Monitoring and complianceMonitoringComplianceItem I: Handling, transport/packaging/and transitrequirements for transboundary movement of LMOs(UNEP/CBD/BSWG/2/6)BSWG-3At the end of BSWG-3 (October ong>19ong>97) a “consolong>idong>atedtext of draft articles” was prepared basedon the outcome of the work of the Sub-WorkingGroups and contact groups and attached to thereport of the meeting. 807 The purpose of this wasto meet the requirement of the ong>Conventionong> thatthe text of any proposed protocol be communicatedto the Parties by the Secretariat at least sixmonths before the meeting at which it was to beadopted. 808 As the COP had asked the WorkingGroup to complete its work by the end of ong>19ong>98, 809and as the COP would next meet in May ong>19ong>98,this would enable the requirement to be met. TheChairman had defined “text of a proposed protocol”as “a draft text of a protocol that all Governmentsagree constitutes sufficient ground for the806UNEP/CBD/BSWG/2/6, Annex II.807UNEP/CBD/BSWG/3/6.808Article 28, CBD.809Decision II/5.122


III. TEXT OF THE PROTOCOLcompletion of the negotiating process and theadoption of the protocol, meaning that all optionsand elements should be contained in the consolong>idong>ateddraft in legal terms”. 810The opportunity would still remain for governmentsto submit text or amendments to the existingtext for inclusion under the following headingsin the consolong>idong>ated draft articles: socio-economicconsong>idong>erations; liability and compensation; illegaltraffic; non-Parties; non-discrimination; objectivesand general obligations. 8ong>11ong> It was clarified that:• The draft dong>idong> not preclude other options thanthose contained in the current draft;• The draft dong>idong> not imply that items addressedin the draft should be contained in the Protocol;and• The entire consolong>idong>ated draft should beconsong>idong>ered to be in square brackets, and thesame applied for everything in the draft. 812Consolong>idong>ated Text of Draft ArticlesTitlePreambleArticle 1- Principles/ObjectivesArticle 1 bis. General ObligationsArticle 2. Use of termsArticle 3. Advance Informed AgreementArticle 4. Notification Procedure for AIAArticle 5. Response to AIA NotificationArticle 6. Decision Procedure for AIAArticle 7. Review of Decision under AIAArticle 8. Notification of TransitArticle 9. Simplified ProcedureArticle 10. Subsequent ImportsArticle ong>11ong>- Bilateral & Regional AgreementsArticle 12- Risk AssessmentArticle 13- Risk ManagementArticle 14- Minimum National StandardsArticle 15- Unintentional Transboundary MovementsArticle 16- Emergency MeasuresArticle 17- Handling Transport Packaging and LabellingArticle 18- Competent Authority/Focal PointArticle ong>19ong>- Information Sharing/ong>Biosafetyong> ong>Clearingong> ong>Houseong>Article 20- Confong>idong>ential InformationArticle 21- Capacity BuildingArticle 22. Public Awareness / Public ParticipationArticle 23. Non PartiesArticle 24. Non DiscriminationArticle 25. Illegal TrafficArticle 26. Socio-Economic Consong>idong>erationsArticle 27. Liability and CompensationArticle 28. Financial Mechanism and ResourcesArticle 29. Conference of the PartiesArticle 30. Subsong>idong>iary Bodies and MechanismsArticle 31. SecretariatArticle 32. Jurisdictional ScopeArticle 33. Relationship with the ong>Conventionong>Article 34. Relationship with other International ong>Conventionong>sArticle 35. Monitoring and ComplianceArticle 36. Assessment and Review of Procedures/AnnexesArticle 37. SignatureArticle 38. Ratification, Acceptance, or ApprovalArticle 39. AccessionArticle 40. Entry into ForceArticle 41. ReservationsArticle 42. WithdrawalsArticle 43. Authentic TextsAnnexesI. Information required in order to obtain Advance InformedAgreementII. Risk assessment parametersIII.Risk management schemesIV.Function of focal points/competent authoritiesV. Information to be provong>idong>ed to the Secretariat under informationsharing/clearing house(UNEP/CBD/BSWG/3/6)The consolong>idong>ated text approved at the end ofBSWG-3 formed the basis for negotiations atBSWG-4 (February ong>19ong>98), which approved draftarticles resulting from the work of its two Sub-Working Groups and two Contact Groups as abasis for its future work, on the understandingthat the Secretariat would incorporate them into810UNEP/CBD/BSWG/3/6, para. 98.8ong>11ong>ibong>idong>, para.103.812ibong>idong>, Annex II.123


III. TEXT OF THE PROTOCOLthe new consolong>idong>ated draft text of the protocol, tobe submitted to BSWG-5. 813The report of the fourth meeting contains fourannexes with the draft articles as reviewed by thegroups:• Annex I (SWG-I) – Articles 3 to 14• Annex II (SWG-II) – Articles 1, 1bis and 15 to 27• Annex III (CG-2) – Preamble and Articles 28 to 43• Annex IV (CG-1) – Use of Terms.A fifth Annex contained a list of proposed annexesto the draft protocol: the two previous draft annexesI and II, ten further annexes proposed in governmentsubmissions, and six proposed annexesreferred to in the consolong>idong>ated text of the SWGs.The Secretariat thus prepared a “revised consolong>idong>atedtext of the draft articles” for BSWG-5(August ong>19ong>98). 814Revised Consolong>idong>ated Text of the Draft Articles forBSWG-5.PreambleArticle 1. ObjectivesArticle 1 bis. General ObligationsArticle 2. Use of TermsArticle 3 A. The Scope of the ProtocolArticle 3 B. The Application of the AIA ProcedureArticle 4. Notification [Procedure][for AIA]Article 5. Response to [AIA] NotificationArticle 6. Decision Procedure for AIAArticle 7. Review of Decisions [Under AIA]Article 8. Notification of TransitArticle 9. Simplified ProcedureArticle 10. Subsequent ImportsArticle ong>11ong>. [International Cooperation] Multilateral, Bilateraland Regional Agreements [other than the Protocol]]Article 12. Risk AssessmentArticle 13. Risk ManagementArticle 14. Minimum National StandardsMerger of Article 15 and Article 16. Unintentional TransboundaryMovements and Emergency MeasuresArticle 17. Handling, Transport, Packaging and LabellingArticle 18. Competent National Authority/National Focal PointArticle ong>19ong>. Information Sharing/ong>Biosafetyong> ong>Clearingong>-ong>Houseong>/[ong>Biosafetyong> Database]Article 20. Confong>idong>ential InformationArticle 21. Capacity-BuildingArticle 22. Public Awareness/Public ParticipationArticle 23. Non-PartiesArticle 24. Non-DiscriminationArticle 25. Illegal TrafficArticle 26. Socio-Economic Consong>idong>erationsArticle 27. Liability and CompensationArticle 28. Financial Mechanism and ResourcesArticle 29. Conference of the PartiesArticle 30. Subsong>idong>iary Bodies and MechanismsArticle 31. SecretariatArticle 32. Jurisdictional ScopeArticle 33. Relationship with the ong>Conventionong>Article 34. Relationship with other International AgreementsArticle 35. Monitoring and Reporting[Article 35 bis. Compliance][Article 36. Assessment and Review of this Protocol]Article 37. SignatureArticle 38. Ratification, Acceptance, or ApprovalArticle 39. AccessionArticle 40. Entry into ForceArticle 41. ReservationsArticle 42. WithdrawalArticle 43. Authentic TextsAnnexesI. Information Required in Notification for Advance InformedAgreementII. Risk AssessmentIII. List of Annexes to the draft Protocol(UNEP/CBD/BSWG/5/Inf.1)The draft articles and annexes, as revised andamended by the SWGs and the CGs, were approvedfor inclusion in the consolong>idong>ated text to be used asa basis for negotiations at the sixth meeting. It wasagreed that the Secretariat would prepare a consolong>idong>atedtext of the draft protocol by making necessaryeditorial corrections, deleting articles, where813UNEP/CBD/BSWG/4/4, para.30.814UNEP/CBD/BSWG/5/Inf.1.124


III. TEXT OF THE PROTOCOLso agreed, and renumbering, without substantivelychanging any articles or footnotes, save for thegovernment submissions to be consong>idong>ered in theconsong>idong>eration of the preamble. 815The Secretariat thus prepared the “Draft NegotiatingText” 816 for BSWG-6 (February ong>19ong>99).BSWG-6 and the ExCOPDraft Negotiating Text for BSWG-6.TitlePreambleArticle 1. ObjectivesArticle 2. General Obligations[Article 3. Use of Terms]Article 4. The Scope of the ProtocolArticle 5. The Application of the AIA ProcedureArticle 6. NotificationArticle 7. Acknowledgement of Receipt of Notification [for AIAArticle 8. Decision Procedure for AIAArticle 9. Review of Decisions [under AIA]Article 10. Notification of TransitArticle ong>11ong>. Simplified ProcedureArticle 12. Subsequent ImportsArticle 13. Multilateral, Bilateral and Regional Agreements[or Arrangements] [other than the Protocol]Article 14. Risk Assessment[Article 15. Risk Management]Article 16. Minimum National StandardsArticle 17. Unintentional Transboundary Movements andEmergency Measure[Article 18. Handling, Transport, Packaging [and Labelling]Article ong>19ong>. Competent National Authority/National Focal PointArticle 20. Information-Sharing/ong>Biosafetyong> ong>Clearingong>-ong>Houseong>[Article 21. Confong>idong>ential Information]Article 22. Capacity-BuildingArticle 23. Public Awareness and Participation[Article 24. Non-Parties][Article 25. Non-Discrimination][Article 26. Illegal Traffic][Article 27. Socio-Economic Consong>idong>erations][Article 28. Liability and Redress]Article 29. Financial Mechanism and ResourcesArticle 30. Conference of the PartiesArticle 31. Subsong>idong>iary Bodies and MechanismsArticle 32. SecretariatArticle 33. Relationship with the ong>Conventionong>[Article 34. Relationship with other International Agreements]Article 35. Monitoring and Reporting[Article 36. Compliance]Article 37. Assessment and Review of this ProtocolArticle 38. SignatureArticle 39. Entry into Force[Article 40. Reservations]Article 41. WithdrawalArticle 42. Authentic TextsAnnex I. Information Required In Notification for AdvanceInformed AgreementAnnex II. Risk Assessment(UNEP/CBD/BSWG/6/2)At the closure of BSWG-6, in light of the unresolvedissues, the BSWG agreed to forward to theExCOP, as a package, the draft articles contained inthe Chair’s proposed text 817 and as revised in theLegal Drafting Group, 818 incorporating the articlesalready provisionally adopted. The extraordinarymeeting of the COP (ExCOP) (February ong>19ong>99) thusconsong>idong>ered this draft.Draft Protocol on ong>Biosafetyong> submitted to the ExCOPby the BSWG.Preamble1. Objective2. General provisions3. Use of terms4. Scope5. Application of the advance informed agreement procedures6. Notification7. Acknowledgement of receipt of notification8. Decision procedure9. Review of decisions10. Simplified procedureong>11ong>. Multilateral, bilateral and regional agreements andarrangements815UNEP/CBD/BSWG/5/3, para.60.816UNEP/CBD/BSWG/6/2.817UNEP/CBD/BSWG/6/L.2/Rev.1.818UNEP/CBD/BSWG/6/L.2/Rev.2.125


III. TEXT OF THE PROTOCOL12. Risk assessmentThe resumed ExCOP (January 2000) finally13. Risk managementapproved the ong>Cartagenaong> Protocol on ong>Biosafetyong> to14. Unintentional transboundary movements and emergency the ong>Conventionong> on Biological Diversity with themeasuresfollowing contents and structure. (The table also15. Handling, transport, packaging and ong>idong>entificationindicates when negotiations on the text of each16. Competent national authorities and national focal points article were concluded.)17. Information sharing and the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>18. Confong>idong>ential informationong>19ong>. Capacity-buildingong>Cartagenaong> Protocol on ong>Biosafetyong>20. Public awareness and participationto the ong>Conventionong> on Biological Diversity21. Non-Parties(The title was agreed during the first session of the ExCOP22. Non-discriminationin ong>Cartagenaong>.23. Illegal transboundary movements822 )Preamble24. Socio-economic consong>idong>erations(The first eight preambular elements were adopted25. Liability and redressunchanged from the proposed text transmitted by the Chair26. Financial mechanism and resourcesof the BSWG to the ExCOP on 22 February ong>19ong>99;27. Conference of the Parties serving as823 the finalthree (deriving from Articles 22 and 31 in the Chair’s proposedtext) were inserted at the close of the resumed ExCOPthe meeting of the Parties28. Subsong>idong>iary bodies and mechanismson 29 January 200029. Secretariat824 )Article 1 Objective30. Relationship with the ong>Conventionong>31. Relationship with other international agreements(Adopted unchanged from Chair’s proposed text)32. Monitoring and reportingArticle 2 General provisions33. Compliance(Adopted unchanged from Chair’s proposed text)34. Assessment and reviewArticle 3 Use of terms35. Signature(Adopted unchanged from Chair’s proposed text)36. Entry into forceArticle 4 Scope37. Reservations(Adopted at the close of the resumed ExCOP)38. WithdrawalArticle 5 Pharmaceuticals39. Authentic texts(New article inserted during the resumed ExCOP)Article 6 Transit and contained useAnnexes(New article inserted during the resumed ExCOP)I. Information required in notificationsArticle 7 Application of the advance informed agreementprocedureII. Risk assessment(Former Article 5 in the Chair’s proposed text modified during(UNEP/CBD/ExCOP/1/2)the resumed ExCOP)Article 8 Notification(Former Article 6 in the Chair’s proposed text with minorThere was no consensus at the ExCOP on this draft,editorial amendments)or on the three proposals from negotiating groups:Article 9 Acknowledgement of receipt of notificationthe “package proposal” submitted by the EU; 8ong>19ong> the(Former Article 7 in the Chair’s proposed text adopted“outstanding issues and necessary revisions to theunchanged (except for re-numbering of internal referencestext of the draft protocol” submitted by the Miamito other Article))Group; 820 or the “proposal on the text of the draftArticle 10 Decision procedureprotocol” submitted by the Like-Minded Group ofCountries. (Former Article 8 in the Chair’s proposed text with substantivechanges introduced during the resumed ExCOP)8218ong>19ong>UNEP/CBD/ExCOP/1/3, Annex II.820UNEP/CBD/ExCOP/1/3, Annex III.821UNEP/CBD/ExCOP/1/3, Annex IV.822UNEP/CBD/ExCOP/1/3, decision EM I/1.823UNEP/CBD/ExCOP/1/2, Appendix I.824UNEP/CBD/ExCOP/1/3, Annex.126


III. TEXT OF THE PROTOCOLArticle ong>11ong> Procedure for living modified organismsintended for direct use as food or feed, or for processing(New Article proposed by the Presong>idong>ent prior to theresumed ExCOP, following the informal consultations, andamended by the resumed ExCOP.)Article 12 Review of decisions(Former Article 9 in the Chair’s proposed text with minoreditorial amendments)Article 13 Simplified procedure(Former Article 10 in the Chair’s proposed text, internally reorderedand with editorial amendments)Article 14 Bilateral, regional and multilateral agreementsand arrangements(Former Article ong>11ong> in the Chair’s proposed text with the referenceto “Parties or non-Parties” deleted by the resumed ExCOP)Article 15 Risk assessment(Former Article 12 in the Chair’s proposed text with minoramendments)Article 16 Risk management(Former Article 13 of the Chair’s proposed text, with amendmentsto the provision on the period of observation)Article 17 Unintentional transboundary movements andemergency measures(Former Article 14 of the Chair’s proposed text with editorialamendments)Article 18 Handling, transport, packaging and ong>idong>entification(Former Article 15 of the Chair’s proposed text, substantiallyamended and adopted at the close of the resumed ExCOP)Article ong>19ong> Competent national authorities and nationalfocal points(Former Article 16 of the Chair’s proposed text adoptedunchanged)Article 20 Information sharing and the ong>Biosafetyong> ong>Clearingong>-ong>Houseong>(Former Article 17 of the Chair’s proposed text with minoreditorial amendments)Article 21 Confong>idong>ential information(Former Article 18 of the Chair’s proposed text with minoramendments)Article 22 Capacity-building(Provisionally adopted at BSWG-6)Article 23 Public awareness and participation(Former Article 20 of the Chair’s proposed text with minoreditorial and one substantive amendment)Article 24 Non-Parties(Former Article 21 of the Chair’s proposed text amendedduring the resumed ExCOPArticle 25 Illegal transboundary movements(Former Article 23 of the Chair’s proposed text with minoramendments)Article 26 Socio-economic consong>idong>erations(Former Article 24 of the Chair’s proposed text with referenceto decisions taken under domestic measures insertedduring the resumed ExCOP)Article 27 Liability and redress(Former Article 25 of the Chair’s proposed text adoptedunchanged)Article 28 Financial mechanism and resources(Provisionally adopted at BSWG-6)Article 29 Conference of the Parties serving as themeeting of the Parties to this Protocol(Provisionally adopted at BSWG-5)Article 30 Subsong>idong>iary bodies(Provisionally adopted at BSWG-5)Article 31 Secretariat(Provisionally adopted at BSWG-5)Article 32 Relationship with the ong>Conventionong>(Provisionally adopted at BSWG-5)Article 33 Monitoring and reporting(Provisionally adopted at BSWG-5)Article 34 Compliance(Provisionally adopted at BSWG-6)Article 35 Assessment and review(Provisionally adopted at BSWG-6)Article 36 Signature(Provisionally adopted at BSWG-5)Article 37 Entry into force(Provisionally adopted at BSWG-5)Article 38 Reservations(Adopted unchanged from Chair’s proposed text)Article 39 Withdrawal(Provisionally adopted at BSWG-5)Article 40 Authentic texts(Provisionally adopted at BSWG-5)Annex I Information required in notifications underArticles 8, 10 and 13(Adopted with minor editorial changes from Chair’s proposedtext)Annex ii Information required concerning living modifiedorganisms intended for direct use as food or feed,or for processing under Article ong>11ong>(New annex added during the resumed ExCOP)Annex III Risk assessment(Adopted unchanged from Chair’s proposed text)127


III. TEXT OF THE PROTOCOLAPPENDIX IV: PROPOSALS FROM GOVERNMENTSA: Governments that submitted proposals to BSWG-2TitleAustralia, Canada, European Union, Malaysia, NorwayPreambleAfrican region, Australia, Canada, Cuba, European Union, Malaysia, Norway, Switzerland, United StatesList of terms/definitionsAfrican region, Australia, Canada, Cuba, European Union, Malaysia, Norway, Switzerland, United StatesAdvance informed agreementAfrican region, Australia, Canada, Japan, Malaysia, Norway, United StatesInformation sharingAfrican region, Australia, Bolivia, Canada, Cuba, Japan, United StatesRelationship with other international agreements Australia, Canada, Cuba, European Union, Norway, United StatesInstitutional frameworkAfrican region, Australia, Bolivia, Canada, European Union, Japan, Norway, United StatesSettlement of disputesAfrican region, Australia, Bolivia, Canada, Cuba, European Union, Japan, Norway, United StatesAmendmentsAfrican region, Australia, Cuba, European Union, NorwayFinal clausesAustralia, European Union, Malaysia, NorwayObjectivesAfrican region, Cuba, European Union, Japan, Malaysia, Norway, SwitzerlandScopeAfrican region, Canada, European Union, Japan, Norway, SwitzerlandJurisdictional scopeCuba, European UnionAIA criteriaCanada, European UnionNotification procedureAfrican region, Japan, NorwayIdentification and classificationMalaysiaCentres of origin and of genetic diversityMalaysiaConsong>idong>erations for risk assessment and risk management Cuba, European Union, Japan, SwitzerlandMechanisms for risk assessmentAfrican region, Malaysia, NorwayMechanisms for risk managementNorwayEmergency proceduresAfrican region, Japan, Malaysia, NorwayMinimum national standardsNorwayDesignation of competent national authoritiesAfrican region, Cuba, European Union, Japan, Malaysia, Norway, Switzerlandand national focal pointsCapacity-buildingAfrican region, Bolivia, Canada, Cuba, European Union, Malaysia, NorwayScientific and technical cooperationCuba, Malaysia,Transboundary movementCubaTransport and packagingAfrican region, Malaysia, Norway, SwitzerlandContained useCubaInternational registerCubaIllegal trafficAfrican regionPublic awarenessAfrican region, Bolivia, Canada, Cuba, Malaysia, NorwayInformation and prior informed consentCubaong>Clearingong> houseAfrican region, Canada, SwitzerlandTechnical information networkMalaysiaMechanisms for bilateral agreementsJapanLiability and compensationAfrican region, Bolivia, Canada, Cuba, European Union, Japan, MalaysiaConsultations on liabilityNorwayMonitoring and complianceAfrican region, Canada, Cuba, European Union, Malaysia, NorwayReportsCubaFinancial issuesAfrican region, Cuba, European Union, Japan, Malaysia, NorwaySocio-economic consong>idong>erationsAfrican region, Bolivia, Canada, European Union, Japan, MalaysiaEthical consong>idong>erationsMalaysia128


III. TEXT OF THE PROTOCOLRelationship with the ong>Conventionong>Conference of the PartiesSecretariatReview and adaptationAdoption and amendment of annexesSignatureRatification, acceptance or approvalAccessionRight to voteEntry into forceReservations and declarationsWithdrawalDepositaryAuthentic textsAnnex: Information required in order to obtain AIAAnnex: Risk assessment parametersAnnex: Risk managementOtherCubaCubaCubaJapan, NorwayAustralia, CubaAfrican region, CubaCubaAfrican region, CubaAfrican region, CubaAfrican region, Australia, CubaAfrican region, CubaAfrican region, CubaAfrican region, CubaAfrican region, CubaAfrican region, CubaAfrican region, NorwayAfrican regionMyanmarSources: documents UNEP/CBD/BSWG/2/2; UNEP/CBD/BSWG/2/Inf.6; UNEP/CBD/BSWG/2/Inf.7; andUNEP/CBD/BSWG/2/Inf.8.129


III. TEXT OF THE PROTOCOLB: Governments that submitted proposals to BSWG-33: AIA African region, Australia, Belarus, Brazil, Colombia, Cuba, European Community, India, Japan,Madagascar, Malaysia, Mexico, Norway, Peru, South African region, Sri Lanka,Switzerland, United States4: Notification procedure for AIA African region, Australia, Belarus, Brazil, Canada, Colombia, Cuba, European Community, India,Japan, Madagascar, Malaysia, Norway, Peru, South African region, Sri Lanka,Switzerland, United States5: Decision procedure for AIA African region, Australia, Belarus, Brazil, Colombia, India, Madagascar, Malaysia, Mexico,Norway, Peru, South African region, Sri Lanka, Switzerland, United States6: Response to AIA notification Australia, Belarus, Brazil, Canada, Colombia, European Community [check], Japan, Madagascar,Malaysia, Norway, South African region, Sri Lanka, Switzerland, United States7: Notification of transit Australia, Brazil, Malaysia, Mexico, Norway, Peru8: Review of decisions under AIA African region, Australia, Brazil, Malaysia, Peru, South African region, Sri Lanka9: Simplified procedure African region, European Community, India, Japan, Norway, South African region10: Subsequent imports Australia, Brazil, European Community, Mexico, Norway, Peru, Switzerlandong>11ong>: Confong>idong>ential information Australia, Brazil, Colombia, European Community, Madagascar, Mexico, Norway,Sri Lanka, United States12: Bilateral and regional agreements African region, Australia, European Community, Switzerland, United States13: Risk assessment African region, Australia, Belarus, Canada, Colombia, Cuba, India, Madagascar,Malaysia, Norway, Sri Lanka, Switzerland14: Risk management African region, Australia, Belarus, Canada, Colombia, Cuba, India, Madagascar,Malaysia, Norway, Sri Lanka, Switzerland15: Minimum national standards African region, Canada, Mexico, Norway, Peru16: International transboundary movements Australia, Belarus, Brazil, European Community, Malaysia, Mexico,Norway, Peru, Sri Lanka, Switzerland, United States17: Emergency measures African region, India, Malaysia, Peru18: Handling, transport, packaging and labelling African region, Australia/Brazil/Sri Lanka, Belarus, Colombia, Cuba, India, Japan,Malaysia, Mexico, Norway, Peru, Switzerland, United Statesong>19ong>: Competent national authority African region, Australia, Belarus, Brazil, Colombia, Cuba, European Community, India, Japan,Madagascar, Malaysia, Mexico, Norway, Peru, South African region, Sri Lanka, Switzerland, United States20: Information sharing/clearing house African region, Australia, Belarus, Brazil, Canada, Colombia, Cuba, European Community, India,Japan, Madagascar, Malaysia, Mexico, Norway, Peru, South African region, Sri Lanka,Switzerland, United States21: Capacity building African region, Australia, Belarus, Brazil, Canada, Colombia, Cuba, European Community, India,Madagascar, Malaysia, Mexico, Norway, Peru, Sri Lanka, Switzerland, United States22: Public awareness/public participation African region, Australia, Belarus, Brazil, Canada, Cuba, India, Japan,Malaysia, Mexico, Norway, Peru, Sri Lanka, SwitzerlandAnnex I: Information required in order to obtain AIA African region, Australia, Brazil, Canada, Colombia, Cuba, India, Norway,Peru, South African region, Sri Lanka, Switzerland, United StatesAnnex II: Risk assessment parametersAfrican region, Australia, Belarus, Brazil, India, Malaysia, Norway, Peru, Sri LankaAnnex III: Risk management schemesAfrican region, India, NorwayAnnex IV: Information to be provong>idong>ed to the Secretariat African region, Australia, Belarus, Brazil, Canada, Colombia, European Community, Japan,under information sharing/clearing houseMadagascar, Norway, Peru, Sri LankaSocio-economic consong>idong>erationsAfrican region, Cameroon, Japan, Malaysia, South African region, Sri LankaLiability and compensationAfrican region, Brazil, Japan, Malaysia, Mexico, Norway, St. Kitts and Nevis, South African region130


III. TEXT OF THE PROTOCOLThe Secretariat also submitted recommendations 825 on:• Financial issues• Institutional framework• Jurisdictional scope• Relationship with other international conventions• Settlement of disputes• Review• Final clausesSources: UNEP/CBD/BSWG/3/3; UNEP/CBD/BSWG/3/3/Add.1; UNEP/CBD/BSWG/3/3/Add.3; and UNEP/CBD/BSWG/3/4825(UNEP/CBD/BSWG/3/4)131


III. TEXT OF THE PROTOCOLC: Governments that submitted proposals to BSWG-4TitlePreambleArticle 1- Principles/ObjectivesArticle 1 bis. General ObligationsArticle 2. Use of termsArticle 3. Advance Informed AgreementArticle 4. Notification Procedure for AIAArticle 5. Response to AIA NotificationArticle 6. Decision Procedure for AIAArticle 7. Review of Decision under AIAArticle 8. Notification of TransitArticle 9. Simplified ProcedureArticle 10. Subsequent ImportsArticle ong>11ong>- Bilateral & Regional AgreementsArticle 12- Risk AssessmentArticle 13- Risk ManagementArticle 14- Minimum National StandardsArticle 15- Unintentional Transboundary MovementsArticle 16- Emergency MeasuresArticle 17- Handling Transport Packaging and LabellingArticle 18- Competent Authority/Focal PointAustraliaUnited StatesAfrican region, Argentina, Bolivia, Chile, Colombia, Guinea, Japan,Malaysia, South African region, Switzerland, United StatesAfrican region, Chile, Ethiopia, Guinea, India, Japan, South African region,Switzerland, United StatesColombia, United StatesColombiaColombiaColombia, United StatesColombiaColombiaAustraliaUnited StatesColombia, United StatesColombiaColombiaColombia, United StatesColombiaColombia, United StatesColombiaArticle ong>19ong>- Information Sharing/ong>Biosafetyong> ong>Clearingong> ong>Houseong> Australia, Colombia, United StatesArticle 20- Confong>idong>ential InformationAustralia, Colombia, United StatesArticle 21- Capacity BuildingColombiaArticle 22. Public Awareness / Public Participation ColombiaArticle 23. Non PartiesAfrican region, Argentina, Bolivia, Chile, Ethiopia, India, Japan, Malaysia, Niger,South African region, Switzerland, United StatesArticle 24. Non DiscriminationArgentina, Australia, Bolivia, Chile, Japan, Malaysia, Switzerland, United StatesArticle 25. Illegal TrafficAfrican region, Bolivia, Chile, Colombia, European Community, Guinea, Japan,Malaysia, Niger, South African region, SwitzerlandArticle 26. Socio-Economic Consong>idong>erationsAfrican region, Bolivia, Chile, Colombia, Ethiopia, Guinea, Japan,Malaysia, Niger, South African region, SwitzerlandArticle 27. Liability and CompensationAfrican region, Bolivia, Chile, Colombia, India, Japan, Malaysia,Norway, South African region, SwitzerlandArticle 28. Financial Mechanism and ResourcesColombiaArticle 29. Conference of the PartiesUnited StatesArticle 30. Subsong>idong>iary Bodies and MechanismsArticle 31. SecretariatArticle 32. Jurisdictional ScopeArticle 33. Relationship with the ong>Conventionong>Article 34. Relationship withother International ong>Conventionong>s132


III. TEXT OF THE PROTOCOLArticle 35. Monitoring and ComplianceArticle 36. AssessmentUnited Statesand Review of Procedures/AnnexesArticle 37. SignatureArticle 38. Ratification, Acceptance, or ApprovalArticle 39. AccessionArticle 40. Entry into ForceUnited StatesArticle 41. ReservationsArticle 42. WithdrawalsUnited StatesArticle 43. Authentic TextsAnnexesI. Information required in order Colombia, United Statesto obtain Advance Informed AgreementII. Risk assessment parametersNorway, United StatesIII. Risk management schemesUnited StatesIV. Function of focal points/competent authorities United StatesV. Information to be provong>idong>ed to the Secretariat under information sharing/clearing house United StatesNew annex: Contained useNorwaySources: UNEP/CBD/BSWG/4/2 and UNEP/CBD/BSWG/4/3133


III. TEXT OF THE PROTOCOLD: Governments that submitted proposals to BSWG-5General commentsTitlePreambleArticle 1. ObjectivesArticle 1 bis. General ObligationsArticle 2. Use of TermsArticle 3 A. The Scope of the ProtocolArticle 3 B. The Application of the AIA ProcedureArticle 4. Notification [Procedure][for AIA]Article 5. Response to [AIA] NotificationArticle 6. Decision Procedure for AIAArticle 7. Review of Decisions [Under AIA]Article 8. Notification of TransitArticle 9. Simplified ProcedureArticle 10. Subsequent ImportsArticle ong>11ong>. [International Cooperation] Multilateral,Bilateral and Regional Agreements[other than the Protocol]]Article 12. Risk AssessmentArticle 13. Risk ManagementArticle 14. Minimum National StandardsMerger of Article 15 and Article 16. UnintentionalTransboundary Movements and Emergency MeasuresArticle 17. Handling, Transport, Packaging and LabellingArticle 18. Competent National Authority/National Focal PointArticle ong>19ong>. Information Sharing/ong>Biosafetyong> ong>Clearingong>-ong>Houseong>/[ong>Biosafetyong> Database]Article 20. Confong>idong>ential InformationArticle 21. Capacity-BuildingArticle 22. Public Awareness/Public ParticipationArticle 23. Non-PartiesArticle 24. Non-DiscriminationArticle 25. Illegal TrafficArticle 26. Socio-Economic Consong>idong>erationsArticle 27. Liability and CompensationArticle 28. Financial Mechanism and ResourcesArticle 29. Conference of the PartiesArticle 30. Subsong>idong>iary Bodies and MechanismsArticle 31. SecretariatArticle 32. Jurisdictional ScopeArticle 33. Relationship with the ong>Conventionong>Ecuador, Mexico, Panama, Switzerland, Uruguay, VanuatuNew ZealandEcuador, European Community, Georgia, Mexico, New Zealand, Panama, Peru, ThailandEcuador, European Community, Georgia, New Zealand, Slovenia, Thailand, Uruguay, VenezuelaEcuador, Georgia, Kenya, Mexico, New Zealand, Peru, Slovenia, Thailand, Uruguay, VenezuelaEcuador, Georgia, Japan, Mexico, New Zealand, Panama, Peru, Slovenia,Thailand, United States, Uruguay, VenezuelaEcuador, Georgia, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Kenya, New Zealand, Norway, Peru, Slovenia, Thailand, Uruguay, VenezuelaEcuador, New Zealand, Peru, Thailand, Venezuela, United StatesEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaAustralia, Ecuador, Georgia, Japan, New Zealand, Peru, Slovenia, Thailand, VenezuelaAustralia, Ecuador, Georgia, Japan, Kenya, Mexico, New Zealand,Norway, Peru, Slovenia, Thailand, VenezuelaAustralia, Ecuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, United States, VenezuelaEcuador, Georgia, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Kenya, New Zealand, Peru, Slovenia, Thailand, Uruguay, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Japan, New Zealand, Peru, Slovenia, Thailand, Uruguay, VenezuelaEcuador, Georgia, Mexico, New Zealand, Peru, Slovenia, Thailand, Uruguay, VenezuelaEcuador, Georgia, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Haiti, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Haiti, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaGeorgia, Peru, Slovenia, Thailand, VenezuelaGeorgia, Peru, Slovenia, Thailand, United States, VenezuelaGeorgia, Peru, Slovenia, Thailand, VenezuelaGeorgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaNew Zealand, Peru, Slovenia, Thailand, Venezuela134


III. TEXT OF THE PROTOCOLArticle 34. Relationship withother International AgreementsArticle 35. Monitoring and Reporting[Article 35 bis. Compliance][Article 36. Assessment and Review of this Protocol]Article 37. SignatureArticle 38. Ratification, Acceptance, or ApprovalArticle 39. AccessionArticle 40. Entry into ForceArticle 41. ReservationsArticle 42. WithdrawalArticle 43. Authentic TextsEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, Uruguay, VenezuelaEuropean Community, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, Haiti, Kenya, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaPeru, Slovenia, Thailand, VenezuelaNew Zealand, Peru, Slovenia, Thailand, VenezuelaNew Zealand, Peru, Slovenia, Thailand, VenezuelaGeorgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaEcuador, Georgia, New Zealand, Peru, Slovenia, Thailand, VenezuelaGeorgia, Peru, Slovenia, Thailand, VenezuelaNew Zealand, Peru, Thailand, VenezuelaAnnexesI. Information Required in Notification for Advance Informed Agreement New Zealand, Norway, Peru, Slovenia, ThailandII. Risk AssessmentAustralia, New Zealand, Norway, Peru, Slovenia, ThailandIII. List of Annexes to the draft ProtocolEuropean Community, ThailandResponse to Aong>idong>e Mémoire from Co-Chairs of CGs 1 and 2 European CommunitySources: UNEP/CBD/BSWG/5/2; UNEP/CBD/BSWG/5/Inf.2; and UNEP/CBD/BSWG/5/Inf.2/Add.ong>11ong>35


III. TEXT OF THE PROTOCOLE: Governments that submitted proposals to BSWG-6Article 1 ObjectivesArticle 3 Use of TermsArticle 5 Application of AIA procedureArticle ong>11ong> Simplified procedureArticle 18 Handling, Transport, Packaging and LabellingArticle 28 Liability and RedressSettlement of DisputesSloveniaSloveniaSloveniaSloveniaSloveniaSloveniaChileSources: UNEP/CBD/BSWG/6/Inf.3The Secretariat also re-circulated previous submissions (see UNEP/CBD/BSWG/6/Inf.2).136


III. TEXT OF THE PROTOCOLAPPENDIX V: LIST OF DOCUMENTSReport of Panel IV (UNEP):UNEP/Bio.Div./Panels/Inf. 4 Consong>idong>eration of theneed for and modalities of a protocol setting outappropriate procedures including, in particular,advance informed agreement in the field of thesafe transfer, handling and use of any living modifiedorganism resulting from biotechnology thatmay have adverse effect on the conservation andsustainable use of biological diversityCOP-1 (Nassau, November ong>19ong>94)Pre-session document:UNEP/CBD/COP/1/3 Report of the IntergovernmentalCommittee on the ong>Conventionong> on BiologicalDiversity on the Work of its First Session(paragraph 1(c), paragraph 18, Annex II-Report ofworking Group I)UNEP/CBD/COP/1/4 Report of the IntergovernmentalCommittee on the ong>Conventionong> on BiologicalDiversity on the Work of its Second Session(Item 4.2.2, paragraphs 222-232)ReportUNEP/CBD/COP/1/17 Report of the First Meetingof the Conference of the Parties to the ong>Conventionong>on Biological Diversity (contains decisionI/9-Medium term programme of work of the Conferenceof the Parties, paragraphs 3-8)COP-2 (Jakarta, November ong>19ong>95)Pre-session document:UNEP/CBD/COP/2/7 Report of the Open-EndedAd Hoc Group of Experts on ong>Biosafetyong> (Madrong>idong>,July ong>19ong>95) also contains (Annex IV) Report of thePanel of Experts on ong>Biosafetyong> (Cairo, May ong>19ong>95)Report:UNEP/CBD/COP/2/ong>19ong> Report of the Second Meetingof the Conference of the Parties to the ong>Conventionong>on Biological Diversity (contains decisionII/5 Consong>idong>eration of the need for and modalitiesof a protocol for the safe transfer, handling anduse of living modified organisms)BSWG-1 (Aarhus, July ong>19ong>96)Pre-session documents:UNEP/CBD/BSWG/1/1 Draft Provisional AgendaUNEP/CBD/BSWG/1/1/Add.1 Draft Annotated ProvisionalAgendaUNEP/CBD/BSWG/1/2 Terms of reference of theOpen-ended Ad Hoc Working Group on ong>Biosafetyong>UNEP/CBD/BSWG/1/3 Elaboration of the termsof reference of the Open-ended Ad Hoc WorkingGroup on ong>Biosafetyong>Report:UNEP/CBD/BSWG/1/4 (UNEP/CBD/COP/2/7)Report of the First Meeting of the Open ended AdHoc Working Group on ong>Biosafetyong>BSWG-2 (Montreal, May ong>19ong>97)Pre-session documents:UNEP/CBD/BSWG/2/1 Draft Provisional AgendaUNEP/CBD/BSWG/2/1/Add.1 Annotations to theProvisional AgendaUNEP/CBD/BSWG/2/2 Compilation of views ofGovernments on the contents of the future protocol(18 March ong>19ong>97)UNEP/CBD/BSWG/2/3 Background documenton existing international agreements related toong>Biosafetyong>UNEP/CBD/BSWG/2/4 Potential socio-economiceffects of biotechnology: a bibliographyUNEP/CBD/BSWG/2/5 Glossary of terms relevant toa biosafety protocol: results of a preliminary surveyUNEP/CBD/BSWG/2/Inf.1 Information for participantsUNEP/CBD/BSWG/2/Inf.2 Indivong>idong>ual Governmentsubmissions on the contents of the future ProtocolUNEP/CBD/BSWG/2/Inf.3 Report of the First MeetingUNEP/CBD/BSWG/2/Inf.4 Enabling the safe use ofbiotechnologyUNEP/CBD/BSWG/2/Inf.5 UNEP international technicalguong>idong>elines for safety in biotechnologyUNEP/CBD/BSWG/2/Inf.6 Views of Cuba (6 May ong>19ong>97)UNEP/CBD/BSWG/2/Inf.7 Views of Malaysia (6 Mayong>19ong>97)UNEP/CBD/BSWG/2/Inf.8 Views of Myanmar (6May ong>19ong>97)UNEP/CBD/BSWG/2/Inf.9 List of participants137


III. TEXT OF THE PROTOCOLReport:UNEP/CBD/BSWG/2/6 Report of the Second Meetingof the Open-ended Ad Hoc Working Group onong>Biosafetyong>BSWG-3 (Montreal, October ong>19ong>97)Pre-session documents:UNEP/CBD/BSWG/3/1 Draft Provisional AgendaUNEP/CBD/BSWG/3/1/Add.1 Annotated ProvisionalAgendaUNEP/CBD/BSWG/3/2 Chairman’s review ofitems addressed by country submission at BSWG/2UNEP/CBD/BSWG/3/3 Compilation of governmentsubmissions of draft text on selected itemsUNEP/CBD/BSWG/3/3/Add.1 Advance informed agreementUNEP/CBD/BSWG/3/3/Add.2 Submissions onsocio-economic consong>idong>erations and liability andcompensationUNEP/CBD/BSWG/3/3/Add.3 List of country submissionsby Articles.UNEP/CBD/BSWG/3/4 Compilation of draft text preparedby the Secretariat on selected itemsUNEP/CBD/BSWG/3/5 Government submissionsUNEP/CBD/BSWG/3/Inf.1 Compilation of definitionsand terms relevant to a biosafety protocol(revision of UNEP/CBD/BSWG/2/5)UNEP/CBD/BSWG/3/Inf.1/Add.1 Definitions fromthe submissions of MalaysiaUNEP/CBD/BSWG/3/Inf.2 Background documenton existing international agreements related toong>Biosafetyong>UNEP/CBD/BSWG/3/Inf.3 Study on existing internationalinformation sharing systemsUNEP/CBD/BSWG/3/Inf.4 Chairman’s Draft Contentof Text of Items (Article ong>11ong>, Arts. 15-22)Report:UNEP/CBD/BSWG/3/6 Report of the Third Meetingof the Open-ended Ad Hoc Working Groupon ong>Biosafetyong>BSWG-4 (Montreal, February ong>19ong>98)Pre-session documents:UNEP/CBD/BSWG/4/1 Draft Provisional AgendaUNEP/CBD/BSWG/4/1/Add.1 Annotated ProvisionalAgendaUNEP/CBD/BSWG/4/2 Compilation of GovernmentSubmissions of Draft Text on Selected Items:Articles 1, 1 bis and 23–27UNEP/CBD/BSWG/4/3 Compilation of GovernmentSubmissions of Draft Text on Items otherthan Articles 1, 1 bis and 23–27UNEP/CBD/BSWG/4/Inf.1 Chairman’s Note onArticles 3–10 and 12–14UNEP/CBD/BSWG/4/Inf.1/Add.1 Chairman’s Noteon Article ong>11ong>UNEP/CBD/BSWG/4/Inf.2 Chairman’s Note onArticles 1, 1 bis and 15–27UNEP/CBD/BSWG/4/Inf.3 PreambleUNEP/CBD/BSWG/4/Inf.4 Implementation Mechanismsfor Information SharingUNEP/CBD/BSWG/4/Inf.5 The Consolong>idong>ated Textfrom the third meetingUNEP/CBD/BSWG/4/Inf.6 List of participantsUNEP/CBD/BSWG/4/Inf.8 Chairman’s Note onArticles 28–43Report:UNEP/CBD/BSWG/4/4 Report of the Fourth Meetingof the Open-ended Ad Hoc Working Group onong>Biosafetyong>BSWG-5 (Montreal, August ong>19ong>98)Pre-session documents:UNEP/CBD/BSWG/5/1 Draft Provisional AgendaUNEP/CBD/BSWG/5/1/Add.1 Annotated ProvisionalAgendaUNEP/CBD/BSWG/5/2 Compilation of New GovernmentSubmissions of Draft Text (Structuredby Article)UNEP/CBD/BSWG/5/Inf.1 Revised Consolong>idong>atedText of the Draft ArticlesUNEP/CBD/BSWG/5/Inf.2 Government SubmissionsUNEP/CBD/BSWG/5/Inf.2/Add.1 Georgia – Commentson the Revised Consolong>idong>ated TextUNEP/CBD/BSWG/5/Inf.3 Information Note on‘Products Thereof’UNEP/CBD/BSWG/5/Inf.4 Submission from theGovernment of VietnamReport:UNEP/CBD/BSWG/5/3 Report of the Fifth Meetingof the Open-ended Ad Hoc Working Group onong>Biosafetyong>138


III. TEXT OF THE PROTOCOLBSWG-6 (ong>Cartagenaong>, February ong>19ong>99)Pre-session documents:UNEP/CBD/BSWG/6/1 Draft Provisional AgendaUNEP/CBD/BSWG/6/1/Add.1 Annotated ProvisionalAgendaUNEP/CBD/BSWG/6/2 Draft Negotiating TextUNEP/CBD/BSWG/6/2/Rev.1 Draft NegotiatingTextUNEP/CBD/BSWG/6/3 Clusters AnalysisUNEP/CBD/BSWG/6/4 Preparation of the DraftNegotiating Text of the Protocol on ong>Biosafetyong>UNEP/CBD/BSWG/6/5 Development of a LegallyBinding InstrumentUNEP/CBD/BSWG/6/6 Report: Meeting of theExtended Bureau (21–22 October ong>19ong>98)UNEP/CBD/BSWG/6/7 TransshipmentUNEP/CBD/BSWG/6/8 Overview and AnnotatedDraft Negotiating Text of the Protocol on ong>Biosafetyong>UNEP/CBD/BSWG/6/Inf.1 Compilation of NewGovernment Submissions of Draft Text (structuredby Article) [same as UNEP/CBD/BSWG/5/2]UNEP/CBD/BSWG/6/Inf.2 Government Submissionson the Preamble and Annexes (submittedprior to BSWG5)UNEP/CBD/BSWG/6/Inf.3 Proposition of the Governmentof Chile: Settlement of DisputesUNEP/CBD/BSWG/6/Inf.4 Resolutions on Biodiversityand the Environment (ACP-EU Joint Assembly,24 Sept. ong>19ong>98, Brussels, Belgium)UNEP/CBD/BSWG/6/Inf.5 Comments by the UnitedNations Economic and Social Council’s Committeeof Experts on the Transport of Dangerous Goodson the Draft Protocol on ong>Biosafetyong>UNEP/CBD/BSWG/6/Inf.6 Remarks submitted bySloveniaUNEP/CBD/BSWG/6/Inf.7 Remarks submitted bythe Office International des ÉpizootiesUNEP/CBD/BSWG/6/Inf.8 Note by the Co-Chairs ofContact Group I: Programme of WorkUNEP/CBD/BSWG/6/Inf.9 Note from the Co-Chairsof Contact Group II to the Extended BureauExCOP-1 (ong>Cartagenaong>, February ong>19ong>99, andresumed session in Montreal, January 2000)Pre-session documents:UNEP/CBD/ExCOP/1/1 Draft Provisional AgendaUNEP/CBD/ExCOP/1/1/Rev.1 Draft ProvisionalAgendaUNEP/CBD/ExCOP/1/1/Rev.2 Provisional revisedagendaUNEP/CBD/ExCOP/1/1/Add.1 Annotated ProvisionalAgendaUNEP/CBD/ExCOP/1/1/Add.1/Rev.1 Annotatedprovisional agendaUNEP/CBD/ExCOP/1/1/Add.1/Rev.2 Annotationsto the provisional revised agendaUNEP/CBD/ExCOP/1/4 Proposed interim arrangementsfor the Intergovernmental Committee ofthe Protocol on ong>Biosafetyong>UNEP/CBD/ExCOP/1/INF.1 Documentation containingdraft text of the Protocol for the resumedsession: explanatory note by the SecretariatUNEP/CBD/ExCOP/1/INF.2 Aong>idong>e-mémoire: Chairman’ssummary of informal consultations held inMontreal on 1 July ong>19ong>99UNEP/CBD/ExCOP/1/INF.3 Chairman’s summary ofinformal consultations held in Vienna from 15 toong>19ong> September ong>19ong>99Report:UNEP/CBD/ExCOP/1/L.2/Rev.1 Draft report of theExCOP (first session)UNEP/CBD/ExCOP/1/3 Report of the ExtraordinaryMeeting of the Conference of the Parties for theadoption of the Protocol ong>Biosafetyong>UNEP/CBD/ExCOP/1/3 CORR. 1 Report of theExtraordinary Meeting of the Conference of theParties for the adoption of the Protocol ong>Biosafetyong>(Corrigendum)Report:UNEP/CBD/ExCOP/1/2 Report of the SixthMeeting of the Open-ended Ad Hoc WorkingGroup on ong>Biosafetyong>139


III. TEXT OF THE PROTOCOLAPPENDIX VI: TERMSOF REFERENCE FOR THEOPEN-ENDED AD HOCWORKING GROUP(FROM COP DECISION II/5)1. The Open-ended Ad Hoc Working Groupshould be composed of representatives,including experts, nominated by Governmentsand regional economic integrationorganisations.2. The Open-ended Ad hoc Working Group shall,in accordance with operative paragraph 1 ofthe present decision:(a) elaborate, as a priority, the modalities andelements of a protocol based on appropriateelements from Sections I, II and III, paragraph18 (a), of Annex I of the report of the OpenendedAd Hoc Group of Experts on ong>Biosafetyong>;(b) consong>idong>er the inclusion of the elementsfrom Section III, paragraph 18 (b), and otherelements, as appropriate;3. The development of the draft protocol shall,as a priority:(a) elaborate the key concepts and terms thatare to be addressed in the process;include consong>idong>eration of the form and scopeof advance informed agreement procedures;ong>idong>entify relevant categories of LMOs resultingfrom modern biotechnology.4. The protocol will have to reflect that its effectivefunctioning requires that Parties establishor maintain national measures, but theabsence of such national measures shouldnot prejudice the development, implementationand scope of the protocol.5. The protocol will take into account the principlesenshrined in the Rio Declaration onEnvironment and Development and, in particular,the precautionary approach containedin Principle 15 and will:(a) not exceed the scope of the ong>Conventionong>;(b) not overrong>idong>e or duplicate any other internationallegal instrument in this area;(c) provong>idong>e for a review mechanism;(d) be efficient and effective and seek to minimiseunnecessary negative impacts on biotechnologyresearch and development andnot to hinder unduly access to and transfer oftechnology.6. The provisions of the ong>Conventionong> will apply tothe protocol.7. The process will take into full account thegaps in the existing legal framework ong>idong>entifiedthrough analysis of existing national andinternational legislation.8. The process shall be guong>idong>ed by the need forall Parties to cooperate in good faith and toparticipate fully, with a view to the largestpossible number of Parties to the ong>Conventionong>ratifying the protocol.9. The process will be carried out on the basisof the best available scientific knowledge andexperience, as well as other relevant information.10. The process of developing a protocol shouldbe conducted as a matter of urgency by anopen-ended ad hoc group, which will reporton progress to each subsequent meetingof the Conference of the Parties. The OpenendedAd Hoc Working Group should endeavourto complete its work in ong>19ong>98.140

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