THE CARTAGENA PROTOCOL
ON BIOSAFETY:
A RECORD
OF THE NEGOTIATIONS
Secretariat of the
Convention on
Biological Diversity
1
THE CARTAGENA PROTOCOL
ON BIOSAFETY:
A RECORD OF THE NEGOTIATIONS
2 The designations employed and the presentation of material in this publication do not imply the expres-sion
of any opinion whatsoever on the part of the Secretariat of the Convention on Biological Diversity
concerning the legal status of any country, territory, city or area or of its authorities, or concerning the
delimitation of its frontiers or boundaries.
The views expressed in this publication are those of the authors and do not necessarily reflect those of
the Secretariat of the Convention on Biological Diversity.
This publication may be reproduced for educational or non- profit purposes without special permission
from the copyright holders, provided acknowledgement of the source is made. The Secretariat of the
Convention would appreciate receiving a copy of any publications that uses this document as a source.
© Secretariat of the Convention on Biological Diversity
ISBN 92- 807- 2376- 6
For more information or additional copies, please contact:
The Secretariat of the Convention on Biological Diversity
World Trade Centre
393 St. Jacques, Suite 300
Montreal, Quebec, Canada H2Y 1N9
Tel : + 1 ( 514) 288 2220
Fax: + 1 ( 514) 288 6588
E- mail: secretariat@ biodiv. org
Website: http:// www. biodiv. org
PHOTO CREDITS
E. 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)
3
TABLE OF CONTENTS
ABBREVIATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
II. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
III. TEXT OF THE PROTOCOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Article 1 Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Article 2 General Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Article 3 Use of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Article 4 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Article 5 Pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Article 6 Transit and contained use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Article 6( 1) Transit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Article 6( 2) Contained Use.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Article 7 Application of the Advance Informed Agreement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 29
Article 8 Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Article 9 Acknowledgement of Receipt of Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Article 10 Decision Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Article 11 Procedure for Living Modified Organisms Intended
for Direct Use as Food or Feed, or for Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Article 12 Review of Decisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Article 13 Simplified Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Article 14 Bilateral, Regional and Multilateral Agreements and Arrangements . . . . . . . . . . . . . . . . . . . 48
Article 15 Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Article 16 Risk Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Article 17 Unintentional Transboundary Movements and Emergency Measures . . . . . . . . . . . . . . . . . 55
Article 18 Handling, Transport, Packaging and Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Article 19 Competent National Authorities and National Focal Points . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Article 20 Information Sharing and the Biosafety Clearing- House . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Article 21 Confidential Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Article 22 Capacity- building . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Article 23 Public Awareness and Participation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Article 24 Non- Parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Article 25 Illegal Transboundary Movements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Article 26 Socio- economic considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Article 27 Liability and Redress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Article 28 Financial Mechanism and Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Article 29 Conference of the Parties serving as the Meeting of the Parties to this Protocol . . . . . . . 87
Article 30 Subsidiary Bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Article 31 Secretariat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Article 32 Relationship with the Convention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Article 33 Monitoring and Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Article 34 Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Article 35 Assessment and Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Article 36 Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Article 37 Entry into Force . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
4 Article 38 Reservations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Article 39 Withdrawal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Article 40 Authentic Texts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Annex I Information Required in Notifications under Article 8, 10 and 13 . . . . . . . . . . . . . . . . . . . . 102
Annex II Information Required Concerning Living Modified Organisms Intended
for Direct Use as Food or Feed, or for Processing Under Article 11 . . . . . . . . . . . . . . . . . . . 105
Annex III Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
APPENDIX I DELETED DRAFT ARTICLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Relationship with other international agreements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Jurisdictional Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Notification of Transit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Emergency Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Minimum national standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Non- discrimination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Subsequent Imports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Ratification, acceptance or approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Accession. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
OTHER PROPOSALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Settlement of Disputes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Annex - LMOs that are not likely to have adverse effects
on the conservation and sustainable use of biological diversity,
taking into account risks to human health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Other Annexes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
APPENDIX II NEGOTIATING SESSIONS AND GROUPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
APPENDIX III EVOLUTION OF THE CONTENTS OF THE PROTOCOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
APPENDIX IV PROPOSALS FROM GOVERNMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
APPENDIX V LIST OF DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
APPENDIX VI TERMS OF REFERENCE FOR THE OPEN- ENDED AD HOC
WORKING GROUP ( FROM COP DECISION II/ 5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
5
ABBREVIATIONS
AIA Advance informed agreement
BCH Biosafety Clearing House
BSWG Open- ended Ad Hoc Working Group on Biosafety
BSWG- 1 ( BSWG- 2…) First ( second.. etc) meeting of the BSWG
CBD Convention on Biological Diversity
CG- 1 Contact Group 1
CG- 2 Contact Group 2
CHM Clearing- house mechanism to promote and facilitate technical and scientific cooperation ( Article 18, CBD)
COP Conference of the Parties
COP1 ( COP2…) First ( second… etc) meeting of the COP ( of the CBD)
COP/ MOP Conference of the Parties serving as the meeting of the Parties to the Protocol
CNA Competent national authority ( under Article 19, Biosafety Protocol)
EC European Community
EU European Union
ExCOP First extraordinary meeting of the COP
IAEA International Atomic Energy Agency
ICCP Intergovernmental Committee for the Cartagena Protocol on Biosafety
ICJ International Court of Justice
LMO Living modified organism
LMO- FFP Living modified organism( s) intended for direct use as food or feed, or for processing
MOP Meeting of the Parties
NFP National focal point ( under Article 19, Biosafety Protocol)
Resumed ExCOP Resumed session of the first extraordinary meeting of the COP
SWG- I Sub- Working Group I
SWG- II Sub- Working Group II
DEFINITION OF TERMS
Agenda 21 Agenda 21: Programme of Action for Sustainable Development ( UNCED, 1992)
Compromise Group Negotiating group formed at the Cartagena meeting, comprising Japan, Korea, Mexico, Norway and
Switzerland, later joined by Singapore and New Zealand
COP- MOP Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol
Like- Minded Group Negotiating group formed at the Cartagena meeting, comprising the G- 77 countries and China, with the
exception of Argentina, Chile and Uruguay
Madrid Report The report of the meeting of the Open- ended Ad Hoc Group of Experts on Biosafety ( Madrid, 24- 28 July
1995) ( document UNEP/ CBD/ COP/ 2/ 7)
Miami Group Negotiating group comprising Argentina, Australia, Canada, Chile, Uruguay and the USA
Rio Declaration Rio Declaration on Environment and Development ( UNCED, 1992)
UNEP Technical Guidelines United Nations Environment Programme International Technical Guidelines on Safety in Biotechnology
Vienna informal consultations Consultation meeting held by ExCOP President Juan Mayr, 15- 19 September 1999, Vienna, prior to the
resumed session of the ExCOP.
6 The adoption of the Cartagena Protocol on Biosafety, 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 times
appeared intractable. Three years on, the Protocol has now entered into force, and the commitments it
contains have become part of the ever- growing body of international environmental law. At the same
time, the work of the Intergovernmental Committee for the Cartagena Protocol on Biosafety, an interim
body established by the Conference of the Parties to undertake the preparations necessary for the first
meeting of the Parties to the Protocol, has contributed significantly to further advancing the understand-ing
on some of the key issues.
As we look forward to the imminent operationalisation of the Protocol’s provisions, aiming to ensure
adequate safety in the movement and use of living modified organisms resulting from modern biotech-nology
that may have adverse effects on the conservation and sustainable use of biological diversity and
human health, it seems an appropriate time to look back and reflect upon how the negotiating process
developed and how the final text emerged.
The present volume serves as an excellent reference point in this respect. By reflecting the differing views
during the genesis of the Protocol and painstakingly charting the negotiation of individual provisions,
including draft articles not included in the final agreed text, The Cartagena Protocol on Biosafety: A Record
of the Negotiations provides us with a history of the gestation and birth of the Protocol to help us under-stand
why it took the final shape that it did.
The record has been meticulously compiled by the Foundation for International Environmental Law and
Development and will serve to inform those who did not attend the negotiating sessions and refresh the
memories of those who did. I wish to extend my sincere thanks to the members of the FIELD team for
their fruitful cooperation and the accuracy and attention to detail displayed in producing this valuable
tool. I am confident that it will be of service to all those interested in the evolution and implementation
of the Protocol.
Hamdallah Zedan
Executive Secretary
Montreal, September 2003
FOREWORD
7
This paper seeks to record the evolution of the
Cartagena Protocol on Biosafety to the Conven-tion
on Biological Diversity from the initial pro-vision
in Article 19( 3) of the Convention itself
through to the final adoption of the text of the
Protocol in January 2000.
The paper aims to contribute to the institutional
memory and to the historical record of the Con-vention
on Biological Diversity. 1 It has been
developed by the Foundation for International
Environmental Law and Development ( FIELD)
at the request of the Executive Secretary of the
Secretariat of the Convention on Biological Diver-sity
( CBD). 2 Drafts of this paper were reviewed by
the CBD Secretariat and by a Steering Committee
established by the Executive Secretary3 compris-ing
a number of individual delegates who were
closely involved in the negotiations. The contents
of the paper, however, remain the responsibility
of FIELD and do not necessarily reflect the views
of the Secretariat of the Convention on Biological
Diversity, or that of any of the reviewers, or of any
Party.
This paper is structured as follows:
The Background section provides a brief overview
of the process undertaken in respect of Article
19( 3) of the Convention, including the work of the
Conference of the Parties at its first meeting, the
work of the Open- ended Ad Hoc Working Group
on Biosafety ( BSWG), and the two sessions of the
Extraordinary Meeting of the Conference of the
Parties ( ExCOP). It also provides an overview of the
structure of the negotiations, including, for exam-ple,
the Sub- Working Groups and Contact Groups
established by the BSWG, which are referred to
throughout the remainder of the document.
At the heart of the paper, in Section III, is an arti-cle-
by- article analysis of the development of the
provisions of the Protocol. The reader will need to
bear in mind, however, that the elaboration of the
Protocol was not a sequential process. Indeed, it
was a complex negotiating process with multiple
simultaneous and inter- linked strands, where the
resolution of one issue would be contingent upon
the agreement on text under another in a some-times
bewildering set of interlocking dependen-cies
and trade- offs.
Section III is based principally upon the official
documentation related to the negotiations, that
is, the reports of the meetings of the BSWG and
the ExCOP, pre- session documents including gov-ernment
submissions, and published reports of
consultation meetings. These documents are all
available on the website of the Convention on Bio-logical
Diversity at http:// www. biodiv. org. In addi-tion,
in relation to some articles, reference is made
to the reports of the Earth Negotiations Bulletin. 4
For clarification of the numbering of the articles of
the Protocol over the course of the negotiations,
the reader should refer to Appendix III. The analy-sis
of the elaboration of each article in Section III
does not necessarily make specific reference to all
government submissions made in respect of the
provision in question during the course of the
negotiations. However a full list of governments
that made submissions to each meeting of the
BSWG is contained in Appendix IV.
Appendix I traces the development and fate of
draft articles of the Protocol that were proposed
and discussed during the course of the negotia-tions,
but that were deleted and are not included
in the final text of the Protocol.
I. INTRODUCTION
1 For a set of personal recollections of some of those involved in the negotiations, see Christoph Bail, Robert Falkner and Helen Marquard ( eds.), The
Cartagena Protocol on Biosafety: Reconciling Trade in Biotechnology with Environment and Development? ( London, Earthscan, 2002). For a detailed
guide to the provisions of the Protocol, see Ruth Mackenzie, Françoise Burhenne- Guilmin, , Antonio G. M. La Viña and Jacob Werksman, in cooperation
with Alfonso Ascencio, Julian Kinderlerer, Katharina Kummer and Richard Tapper, An Explanatory Guide to the Cartagena Protocol on Biosafety, ( IUCN
Environmental Policy and Law Paper No. 46, 2003). The Secretariat and the United Nations Environment Programme have also produced a simplified
guide to the Cartagena Protocol on Biosafety, Biosafety and the Environment: An Introduction to the Cartagena Protocol on Biosafety ( Belegarde, France,
Sadag, SA, 2003), available at http:// www. biodiv. org.
2 The FIELD team comprised Fernando Latorre, Ruth Mackenzie, Tony Gross, Elsa Tsioumani, and Catherine McLellan.
3 The 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).
4 These reports are available at http:// www. iisd. ca.
8 Appendix II records the chronology of meetings,
and also sets out the list of chairs and co- chairs of
the various bodies established during the nego-tiations.
Appendix III outlines the evolution of the structure
of the Protocol. This Appendix is provided in order
to assist the reader, given that over the course of
the negotiations the numbering of the articles of
the Protocol was revised a number of times as the
elaboration of the Protocol progressed.
Appendix IV records the governments that sub-mitted
written proposals during the course of the
negotiations.
Finally, Appendix V lists the extensive official
documentation related to the negotiation of
the Protocol. This list does not include in- session
documents.
I. INTRODUCTION
9
The Convention on Biological Diversity
Article 19( 3) of the Convention provides that:
The Parties shall consider the need for
and modalities of a protocol setting out
appropriate procedures, including, in
particular, advance informed agreement,
in the field of the safe transfer, handling
and use of any living modified organism
resulting from biotechnology that may
have adverse effect on the conservation
and sustainable use of biological diversity.
This provision resulted from differing views dur-ing
the negotiation of the Convention. Some
countries felt that the Convention should include
a provision making mandatory the development
of a future protocol on biosafety, whilst others
preferred a provision requiring Parties to consider
the need for a protocol. 5
Resolution 2 of the Nairobi Final Act adopting the
Convention on Biological Diversity invited UNEP
to consider, inter alia, Article 19( 3) of the Conven-tion.
Consequently, Expert Panel IV established by
UNEP considered the need for, possible elements
of and modalities of a protocol on biosafety. The
final report of the Panel was published in April
1993.6 However the report of Panel IV was not
directly taken up and was not part of the formal
documentation for the first meeting of the Confer-ence
of the Parties to the Convention.
The Nairobi Final Act also established an Inter-governmental
Committee on the Convention on
Biological Diversity ( ICCBD) to prepare for the first
meeting of the Conference of the Parties of the
Convention. Article 19( 3) was taken up in Work-ing
Group I of the ICCBD. 7 There was a general
agreement in the Working Group on the need for
adequate and transparent safety and border
control procedures to manage and control the
risks associated with the use and release of LMOs
resulting from modern biotechnology, to enable
the potential benefits of biotechnology to be maxi-mised,
and to gain widespread public acceptance,
especially in developing countries. 8 However, there
were different views on the need for and modalities
of a protocol, and the report of the ICCBD reflects
the different views expressed on this issue. 9 The
ICCBD recommended that the issue of biosafety
should be on the agenda of the first meeting of the
Conference of the Parties to the Convention to initi-ate
the process specified in Article 19( 3). 10
The Conference of the Parties
The first meeting of the Conference of the Parties
to the Convention ( Nassau, Bahamas, November
1994) decided, 11 as part of its medium- term pro-gramme
of work, to arrange two meetings in the
inter- sessional period prior to its second meeting.
The principal meeting was to comprise “ an open-ended
ad hoc group of experts nominated by
Governments without undue delay to consider the
need for and modalities of a protocol setting out
appropriate procedures, including, in particular,
advance informed agreement, in the field of the
safe transfer, handling and use of any living modi-fied
organism resulting from biotechnology that
may have adverse effects on the conservation and
sustainable use of biological diversity.” This group
was to meet for a week during 1995 and was to
“ consider, as appropriate, existing knowledge,
experience and legislation in the field of biosafety,
including the views of the Parties, subregional,
regional and international organisations, with a
view to presenting a report for the consideration
of the second meeting of the Conference of the
Parties, so as to enable the Conference of the Par-ties
to reach an informed decision as to the need
for and modalities of a protocol”.
In order to prepare for the work of the group
of experts, the COP requested the Secretariat to
establish:
II. BACKGROUND
5 Mackenzie et al ( 2003), p. 2.
6 UNEP/ Bio. Div./ Panels/ Inf. 4, Report of Panel IV, Nairobi, 28 April 1993.
7 See UNEP/ CBD/ IC/ 2/ 12, Note by the Interim Secretariat on consideration of the need for and modalities of a protocol on biosafety.
8 UNEP/ CBD/ COP/ 1/ 4, Report of the Intergovernmental Committee on the Convention on Biological Diversity, para. 223.
9 Ibid., paras. 223- 229.
10 Ibid., para 229.
11 Decision I/ 9, paras. 3- 8
10 a panel of 15 experts nominated by Gov-ernments,
with an equitable geographical
representation, in consultation with the
Bureau of the COP, assisted by UNIDO,
UNEP, FAO and WHO, to prepare a back-ground
document to be submitted to
the open- ended ad hoc group of experts
nominated by Governments based on a
consideration, as appropriate, of existing
knowledge and experience on risk assess-ment
and management, and guidelines
and/ or legislation already prepared by
the Parties, other Governments and by
national and competent subregional,
regional and international organisations. 12
The meeting of the panel of experts took place
in Cairo in May 1995 and that of the Ad Hoc
Group of Experts in Madrid in July 1995. The
Madrid meeting concluded that there was a
need for an international framework for safety
in biotechnology. 13 The Madrid report identified
a number of issues, which, it was agreed, should
be addressed within the international framework
on biosafety, including a procedure for advance
informed agreement. 14 Other issues were identi-fied
which, though not yet enjoying consensus,
were supported by many delegations, including
socio- economic considerations, and liability and
compensation. 15 The large majority of delegations
favoured the development, within the context of
the international framework, of a protocol under
the CBD. 16
The second meeting of the COP ( Jakarta, Indo-nesia,
November 1995) considered the report of
the Madrid meeting17 and, after extensive nego-tiations,
agreed to establish an Open- ended Ad
Hoc Working Group on Biosafety under the COP
to “ seek solution to the […] concerns through a
negotiation process to develop, in the field of the
safe transfer, handling and use of living modified
organisms, a protocol on biosafety, specifically
focusing on transboundary movement, of any
living modified organism resulting from modern
biotechnology that may have adverse effect on
the conservation and sustainable use of biological
diversity, setting out for consideration, in particu-lar,
appropriate procedure for advance informed
agreement.” 18
The COP specified the terms of reference of the
Working Group in an annex to the decision ( see
Appendix VI below). The Working Group was to
“ endeavour to complete its work in 1998”. 19 Deci-sion
II/ 5 also clarified that the subject of the proto-col
was “ living modified organisms resulting from
modern biotechnology,” a narrower category of
organisms than that referred to in Articles 8 ( g)
and 19 of the Convention, which use the term
“ living modified organisms resulting from bio-technology”.
The Open- ended Ad Hoc Working
Group on Biosafety
The Open- ended Ad Hoc Working Group ( the
BSWG) met six times between 1996 and 1999
under the chairmanship of Mr. Veit Koester ( Den-mark).
The first two meetings – BSWG- 1 ( Aarhus,
July 1996) and BSWG- 2 ( Montreal, May 1997)
– constituted a phase of identifying the elements
of the future protocol. Appendix III ( Evolution of
the contents of the Protocol) provides the state of
progress after both these meetings by listing the
“ Possible Contents of the Protocol on Biosafety”
identified at BSWG- 1 and the “ Chairman’s Sum-mary
of Elements Presented” contained in the
report of BSWG- 2.20
12 Id.
13 UEP/ CBD/ COP/ 2/ 7, Annex I, para. 6.
14 Ibid., para. 18( a)
15 Ibid., para. 18( b).
16 Ibid., para 20.
17 UNEP/ CBD/ COP/ 2/ 7.
18 Decision II/ 5
19 Decision II/ 5, Annex, para. 10.
20 See also, UNEP/ CBD/ ExCOP/ 1/ 3, paras. 29- 30.
II. BACKGROUND
11
At BSWG- 2, the first of a series of negotiating
groups was established, a contact group on
definitions. At BSWG- 3 this group, which became
known as Contact Group 1 ( CG- 1), had its mandate
extended to deal also with annexes to the Proto-col,
and was supplemented by three other groups.
Contact Group 2 ( CG- 2) was mandated to address
institutional matters and final clauses; Sub- Work-ing
Group I ( SWG- I) was charged with dealing with
the advance informed agreement procedure and
related issues, including articles on risk assessment
and risk management; and Sub- Working Group II
( SWG- II) dealt with a diverse range of remaining
issues, including capacity- building, the clearing
house and socio- economic considerations. 21 Each
of these groups was co- chaired by one developed
country Party and one developing country Party
representative. The sub- working group and con-tact
group structure was maintained until the
early phases of BSWG- 6 in Cartagena ( see below).
At BSWG- 5 another small group was charged with
addressing the issue of liability and redress; 22 and
at BSWG- 6 a Legal Drafting Group was formed to
review draft articles of the Protocol to ensure legal
consistency and wording in the text of the Proto-col.
23 The issues addressed by the Sub- Working
Groups and Contact Groups were clearly closely
linked and, during the course of the negotiations,
issues moved between the groups. Given the
close links between the tasks charged to Contact
Group 1 and Sub- Working Group I, it was decided
at BSWG- 4 to make Contact Group 1 a sub- group
of Sub- Working Group I, reporting to it, in order to
avoid duplication in the discussions and to ensure
coordination of work. 24 A table showing the vari-ous
sub- groups and contact groups, and their co-chairs,
is contained in Appendix II.
At BSWG- 3 ( Montreal, October 1997) the time
pressures began to be felt. Article 28 of the Con-vention
stipulates that the text of the proposed
protocol be communicated to the Contracting
Parties at least six months before the meeting to
adopt such a protocol. As the Working Group had
been asked to complete its work in 1998 and was
due to meet for the fourth time in February 1998,
and as the COP itself was due to meet in May 1998,
there was the possibility of completing the nego-tiations
during this period. However, to meet the
requirements of Article 28 a text of the protocol
would need to be ready at the end of BSWG- 3.
Chair Koester argued that the term “ text of a pro-posed
protocol” as contained in Article 28 could
be defined as “ a draft text of a protocol that all
Governments agree constitutes sufficient ground
for the completion of the negotiating process
and the adoption of the protocol, meaning that
all options and elements should be contained in
the consolidated draft in legal terms”. 25 On this
basis BSWG- 3 developed the ‘ consolidated text
of draft articles’, which constituted the first struc-tured
outline of the future protocol and served as
the basis for future negotiations. It contained the
title, a preamble, 43 articles and five annexes ( see
Appendix III). ( The title at this stage was simply
“ Biosafety Protocol”.) 26
By BSWG- 4 ( Montreal, February 1998), while the
Working Group entered the negotiating phase, 27
it was clear that the protocol would not be ready
for adoption at the fourth meeting of the COP in
May 1998. The COP accepted that the Working
Group would need more time and approved two
further meetings of the Working Group – the first
( BSWG- 5) to be held in August 1998 and the sec-ond
( BSWG- 6) in February 1999. BSWG- 6 would be
immediately followed by an extraordinary meet-ing
of the COP ( ExCOP) to adopt the text of the
protocol. 28
For BSWG- 5 ( Montreal, August 1998) the Secre-
21 See UNEP/ CBD/ BSWG/ 3/ 6, paras. 17- 25.
22 This 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.
23 UNEP/ 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. 19.
24 UNEP/ CBD/ BSWG/ 4/ 4, para. 17.
25 UNEP/ CBD/ BSWG/ 3/ 6, para. 98
26 See UNEP/ CBD/ ExCOP/ 1/ 3, para. 31.
27 UNEP/ CBD/ ExCOP/ 1/ 3, para. 32.
28 Decision IV/ 3.
II. BACKGROUND
12 tariat prepared a “ revised consolidated text of the
draft articles” ( see Appendix III). At the end of the
meeting, although agreed text on a number of the
final clauses had been provisionally adopted, and
the Working Group had managed to focus further
elements and articles to form the protocol, 29 fif-teen
of the substantive articles remained entirely
in square brackets.
Disagreement on these key provisions persisted
throughout BSWG- 6 ( Cartagena, February 1999),
with further consultations taking place among
the “ Friends of the Chair”, a group of individuals
nominated by the regional groups to assist the
Chair of the BSWG. 30 However, with no resolution
of the outstanding issues, the Chair of the BSWG
attempted to resolve the impasse by preparing a
“ clean text”, containing compromise wording on
the outstanding issues, to be transmitted by the
Working Group to the ExCOP. 31 This document
is frequently referred to in the remainder of this
document as the “ Chair’s text” or “ Chair’s proposed
text”. While many delegations expressed concerns
about aspects of this text, 32 in the absence of fur-ther
agreement on its content it was agreed that
the BSWG would forward this text with its report
to the ExCOP. 33
The Extraordinary Meeting of the
Conference of the Parties
However, during the ExCOP, which immediately
followed BSWG- 6, Parties could not agree on the
adoption of the Chair’s text, nor on any of the
other proposals put forward by the various nego-tiating
groups. The ExCOP was suspended. 34 How-ever,
before the suspension of the meeting, the
ExCOP agreed that the title of the Protocol, once
finalised and adopted, would be the “ Cartagena
Protocol on Biosafety”. 35
Following the suspension of the meeting, the Pres-ident
of the ExCOP, Minister Juan Mayr ( Colombia),
embarked on a series of informal negotiations
involving the five distinct negotiating groups that
had emerged during the course of the Cartagena
meetings: the Central and Eastern Europe Group,
the Compromise Group, 36 the European Union,
the Like- minded Group, 37 and the Miami Group. 38
Informal negotiations took place in Montreal
( 1 July 1999) 39 and in Vienna ( 15- 19 September
1999). 40 It was during the latter meeting that Min-ister
Mayr’s preferred arrangement of a hexagonal
negotiating table, seating the Chair and represen-tatives
of the five negotiating groups, with other
delegations seated behind, became the locus of
the discussions. These arrangements, which had
first been used in the later stages of the ExCOP in
Cartagena, became known as the “ Vienna setting”,
and were to be used again in the resumed session
of the ExCOP in Montreal in January 2000.
In December 1999, Minister Mayr circulated his
draft proposal for addressing the essential core
issues: the scope of the protocol ( Article 4); appli-cation
of the advance informed agreement proce-dure
( Article 5) with regard to LMOs intended for
direct use as food or feed, or for processing (“ com-
II. BACKGROUND
29 UNEP/ CBD/ ExCOP/ 1/ 3, para. 34.
30 UNEP/ CBD/ ExCOP/ 1/ 2, para. 22.
31 UNEP/ 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, and
a 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 to
the Extraordinary Meeting of the Conference of the Parties, see UNEP/ CBD/ ExCOP/ 1/ 2, Annex.
32 UNEP/ CBD/ ExCOP/ 1/ 2, paras. 41- 45.
33 UNEP/ CBD/ ExCOP/ 1/ 2, para. 40 and Annex.
34 Decision EM- I/ 1, para. 1.
35 Decision EM- I/ 1, para. 3.
36 Japan, Korea, Mexico, Norway and Switzerland, later joined by Singapore and New Zealand.
37 The G- 77 and China ( less the three members in the Miami Group).
38 Argentina, Australia, Canada, Chile, Uruguay and USA.
39 Informal consultation on the process to resume the ExCOP to adopt a protocol on Biosafety, 1 July 1999, UNEP/ CBD/ ExCOP/ 1/ INF/ 2.
40 Informal consultation on the process to resume the ExCOP to adopt a protocol on Biosafety, 15- 19 September 1999, UNEP/ CBD/ ExCOP/ 1/ INF/ 3.
13
modities”); and the relationship of the protocol
with other international agreements ( Article 31). 41
Further informal consultations took place in Mon-treal
immediately before the resumed session
of the ExCOP. The informal consultations ( 22- 23
January 2000) and the resumed ExCOP ( 24- 28
January 2000) addressed the outstanding “ core”
issues – those identified in the Chairman’s non-paper
– as well as identification and documenta-tion,
and reference to the precautionary principle.
Contact groups were established addressing,
respectively, scope, commodities, and trade issues
( including precaution), and one representative
was charged with coordinating consultations on
other outstanding “ non- core” issues. As noted
above, with the exception of formal plenary ses-sions,
and negotiations in the contact groups
and in consultations, the resumed session of the
ExCOP was held in the Vienna Setting.
With more than thirty Ministers taking part in the
negotiations, the final compromise was reached
on the core issues, and the text of the Cartagena
Protocol on Biosafety was adopted at 4: 50 a. m. on
29 January 2000.42
41 “ Non- paper” dated 21 December 1999, conveyed to all CBD National Focal Points and to the spokespersons of the five negotiating groups.
42 The 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 Drafting
Group. One further amendment to Article 18( 2)( a) was introduced orally by the President, on the basis of final consultations, prior to the adoption of
the 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.
II. BACKGROUND
14 Preamble
The Parties to this Protocol,
Being Parties to the Convention on Bio-logical
Diversity, hereinafter referred to
as “ the Convention”,
Recalling Article 19, paragraphs 3 and 4,
and Articles 8 ( g) and 17 of the Conven-tion,
Recalling also decision II/ 5 of 17 Novem-ber
1995 of the Conference of the Parties
to the Convention to develop a Protocol
on biosafety, specifically focusing on
transboundary movement of any living
modified organism resulting from mod-ern
biotechnology that may have adverse
effect on the conservation and sustain-able
use of biological diversity, setting
out for consideration, in particular, appro-priate
procedures for advance informed
agreement,
Reaffirming the precautionary approach
contained in Principle 15 of the Rio Decla-ration
on Environment and Development,
Aware of the rapid expansion of modern
biotechnology and the growing public
concern over its potential adverse effects
on biological diversity, taking also into
account risks to human health,
Recognising that modern biotechnology
has great potential for human well- being
if developed and used with adequate
safety measures for the environment and
human health,
Recognising also the crucial importance to
humankind of centres of origin and cen-tres
of genetic diversity,
Taking into account the limited capabilities
of many countries, particularly developing
countries, to cope with the nature and
scale of known and potential risks associ-ated
with living modified organisms,
Recognising that trade and environment
agreements should be mutually support-ive
with a view to achieving sustainable
development,
Emphasising that this Protocol shall not be
interpreted as implying a change in the
rights and obligations of a Party under any
existing international agreements,
Understanding that the above recital is
not intended to subordinate this Protocol
to other international agreements,
Have agreed as follows:
A number of countries prepared text or submitted
views on the preamble prior to BSWG- 2.43 The Afri-can
group in its draft preambular text introduced
several elements that would be reflected in the
final text. For example, it referred to Article 8( g) of
the Convention, acknowledged the rapid expan-sion
of biotechnology and growing public con-cern
over potential adverse effects, acknowledged
the limited capabilities of developing countries to
cope with associated risks, and recalled the pre-cautionary
principle. The precautionary principle
was referred to by Canada, the EU and, implicitly
by Norway. The EU also recalled decision II/ 5 of
COP 5 ( as did Australia) and referred to Article 19
paragraphs 3 and 4 of the Convention ( as did the
African group and Norway). Norway noted the
advantages and potential of biotechnology but
recognised that significant gaps in knowledge
had been identified and, along with the African
group and the EU, pointed out the threat of
significant reduction or loss of biological diver-sity.
The African group also referred to social and
economic welfare. On the other hand, Switzerland
proposed that the Protocol should only deal with
safety issues complementary to existing interna-tional
instruments, in particular the WTO, and that
socio- economic implications of biotechnology be
addressed in other frameworks. Both Switzerland
and the EU called for a flexible system to amend
the Protocol so that it could adapt to appropriate
scientific and technical developments.
BSWG- 2, however, did not discuss the preamble
and it was agreed not to prepare any text at that
stage. 44
At BSWG- 3, the Working Group decided that the
Chair should prepare a draft preamble on the
III. TEXT OF THE PROTOCOL
43 UNEP/ CBD/ BSWG/ 2/ 2, pp. 2- 7, contains the submissions of the African group, Australia, Canada, the EU, Norway, Switzerland and the US.
44 UNEP/ CBD/ BSWG/ 2/ 6, para. 166.
15
III. TEXT OF THE PROTOCOL
basis of government submissions and elements
suggested by the Chairman himself, for consider-ation
at the following meeting. 45 The consolidated
text at the end of BSWG- 3 included three options
reproducing in their entirety the submissions of
the African group, the EU and Norway respec-tively.
46
Prior to BSWG- 4, the US submitted further draft
text, the focus of which was to base the Proto-col
on scientific risk assessment whilst avoiding
unnecessary delays to bringing the benefits of
biotechnology. 47 It also referred to Article 17 of
the Convention ( Exchange of Information).
At BSWG- 4, the preamble was discussed in CG- 2
and the draft text was reduced to a short and
a long option. 48 The short option included text
recognising the value of modern biotechnology
and the limited capacity of some countries to deal
with its risks. The long version included the main
elements of the various proposals and referred to
the UNEP Technical Guidelines49 and to Agenda
21; the precautionary principle; significant gaps
in scientific knowledge; capacity building; and
adequate compensation for damages arising
from the handling and transfer of LMOs. It also
called for the avoidance of unnecessary delays,
in particular unwarranted administrative require-ments,
whilst acknowledging public concern over
potential adverse effects ( including socio- eco-nomic
effects). As disagreement remained on the
level of detail, the Contact Group decided to leave
the draft preamble open and subject to further
amendment, pending finalisation of the entire
text of the Protocol. 50 In addition, there were a
number of important issues in relation to which it
had not yet been decided whether they should be
the subject of separate articles or instead included
in the preamble. These included: socio- economic
considerations, capacity- building, public aware-ness
and participation, non- Parties, non- discrimi-nation,
and relationship with other conventions. 51
At BSWG- 5, Ambassador Ashe, Co- Chair of CG- 2,
reiterated the decision to defer any consideration
of the preamble until BSWG- 6, when an overall
general framework of the Protocol would be in
place. 52
During the first discussion of the preamble by
CG- 2 at BSWG- 6, delegates agreed to insert lan-guage
on the importance of centres of origin
and of genetic diversity. 53 A footnote indicating
that additional language could be added only if
agreed upon by other negotiating groups ( includ-ing
those considering the precautionary principle,
socio- economic considerations, and liability and
redress) was also added. 54 Both the long and
the short options for the Preamble prepared
at BSWG- 4 were considered, and text from the
longer version was later added to the shorter. 55
Although some delegates supported reference
to the precautionary principle, socio- economic
considerations, and liability and redress, they
agreed to allow the sub- groups discussing those
issues to decide whether or not to include them
in the preamble. The single version that was finally
agreed included the precautionary “ approach” as
contained in the Rio Declaration, while omitting
references to socio- economic considerations
and liability. The Chair’s text56 contained this
language, including references to: Articles 8( g),
17 and 19 of the Convention; decision II/ 5 of the
COP; the precautionary approach; the expansion
of biotechnology and growing public concern
45 UNEP/ CBD/ BSWG/ 3/ 6, para. 84.
46 Ibid., Annex I, see Preamble.
47 UNEP/ CBD/ BSWG/ 4/ 3, pp. 1- 2.
48 UNEP/ CBD/ BSWG/ 4/ 4, para. 29; Annex III.
49 United Nations Environment Programme International Technical Guidelines on Safety in Biotechnology.
50 UNEP/ CBD/ BSWG/ 4/ 4, para. 29.
51 See now sections on Articles 26, 22, 23 and 24 below.
52 UNEP/ CBD/ BSWG/ 5/ 3, para. 52.
53 ENB Vol. 9 No. 112, p. 2.
54 Id.
55 ENB Vol. 9 No. 117.
56 UNEP/ CBD/ BSWG/ 6/ L. 2/ Rev. 1, see the Preamble.
16
III. TEXT OF THE PROTOCOL
over potential adverse effects on biodiversity and
human health; the potential of biotechnology
for human well- being; the importance of centres
of origin and genetic diversity; and the limited
capabilities of many countries to cope with risks
associated with LMOs.
Ms. Kummer ( Switzerland), Co- Chair of CG- 2,
reported the satisfactory conclusion of the work
of the Group on the preamble during BSWG- 6.57
However, a significant addition to the text would
take place at a later stage. Following the informal
consultations that took place in Montreal and
Vienna prior to the resumed ExCOP, President
Mayr prepared a non- paper which suggested
deleting the article on Relationship of the Pro-tocol
with other International Agreements ( then
Article 31), and instead reflecting its content in
the preamble. 58 The non- paper proposed that
the preamble should note that “ there are other
international agreements relevant to sustainable
development”, that “ trade and environment agree-ments
should be mutually supportive” and that
the “ Protocol and other international agreements
are of equal status”.
There was further discussion on the core cluster
of trade issues ( Articles 31 and 22 ( Non- dis-crimination))
at the resumed ExCOP. Based on
the President’s non- paper, the contact group on
Articles 31 and 22 proposed in a working paper
that those articles be deleted and their content
reflected in three preambular paragraphs. 59 The
group then sought to reach agreement on these
preambular paragraphs. 60 Following further dis-cussions
and high- level consultations, 61 the final
text of the Protocol was submitted by the Legal
Drafting Group to the plenary and was adopted
on 29 January 2000.
57 UNEP/ CBD/ ExCOP/ 1/ 2, para. 31.
58 Draft Chairman’s Proposal for Addressing the Essential Core Issues of the Scope of the Protocol ( Article 4), Application of the Advance Informed
Agreement ( Article 5) with regard to Living Modified Organisms intended for Direct Use as Food or Feed or for Processing (“ Commodities”) and
Relationship of the Protocol with Other International Agreements ( Article 31). Non- paper dated 21 December 1999.
59 UNEP/ CBD/ ExCOP/ 1/ 3, para. 63.
60 Ibid., para. 85.
61 Ibid., para. 87.
17
III. TEXT OF THE PROTOCOL
Article 1: Objective
In accordance with the precautionary
approach contained in Principle 15 of the
Rio Declaration on Environment and
Development, the objective of this Proto-col
is to contribute to ensuring an ade-quate
level of protection in the field of the
safe transfer, handling and use of living
modified organisms resulting from mod-ern
biotechnology that may have adverse
effects on the conservation and sustain-able
use of biological diversity, taking
also into account risks to human health,
and specifically focusing on transboundary
movements.
The first exploratory discussions on the Protocol’s
objective took place at BSWG- 2, with a number of
delegations submitting written proposals. 62 The
EU suggested language reflecting Decision II/ 5,
which included many of the elements appearing
in the final text, namely ensuring an adequate
level of protection from LMOs resulting from
modern biotechnology that may have adverse
effect on the conservation and sustainable use of
biodiversity, specifically focusing on transbound-ary
movement. Norway introduced the term of
safe transfer, handling and use of LMOs, while
Malaysia made reference to risks to human health,
to agriculture and to socio- economic welfare.
The African region proposal called for a broader
objective to encompass safeguarding human and
animal health, the environment, biodiversity and
the socio- economic welfare of societies from the
potential risks of LMOs and products thereof. The
negotiations revealed a lack of consensus and the
issue remained to be revisited at BSWG- 3.
BSWG- 3 delegates considered government sub-missions63
and debated references to human
health, socio- economic conditions and ‘ products
thereof’. 64 SWG- II worked on reducing the num-ber
of alternatives and developing a framework
for the drafting of the article. The framework65
referred to the need for the Protocol to contain a
separate article on objectives, which should: be
broad, reflect the language from Decision II/ 5; and
cover all the issues required to protect biodiversity,
the environment and human health. References to
animal health and social well- being were brack-eted.
Developing a draft bracketed article did not
prove possible, so eight options incorporated gov-ernment
submissions. 66 Most texts included refer-ence
to human health, with the exception of that
of Australia, while animal health was referred to in
the African region and South African proposals,
and ‘ products thereof’ in the African and Brazilian
proposals. The African and Malaysian proposals
also included socio- economic imperatives. The
Norwegian and South African texts referred to the
principle of sustainable development.
A number of delegations submitted text prior to
BSWG- 4,67 and the Chairman’s note prepared for
BSWG- 468 synthesised divergent views into six
options. At BSWG- 4, negotiations in SWG- II did not
make significant progress. The main contentious
issues included references to: impacts on human
and/ or animal health, and on socio- economic
welfare, and references to capacity building, 69 to
the principle of sustainable development, and to
‘ products thereof’.
62 UNEP/ CBD/ BSWG/ 2/ 2, pp. 43- 44, contains the submissions of the African group, EU, Japan, Norway and Switzerland. The submissions of Cuba and
Malaysia are contained in UNEP/ CBD/ BSWG/ 2/ Inf. 6 and Inf. 7 respectively.
63 UNEP/ CBD/ BSWG/ 3/ 5.
64 UNEP/ CBD/ BSWG/ 3/ 6, paras. 69- 73.
65 UNEP/ CBD/ BSWG/ 3/ 6, p. 32.
66 Ibid., Annex I, see Article 1. The options reflected the submissions of the African region, Australia, Brazil, EC, Malaysia, Norway, South Africa and
Switzerland.
67 UNEP/ CBD/ BSWG/ 4/ 2 contains the submissions of the African region, Argentina, Bolivia, Chile, Colombia, Guinea, Japan, Malaysia, South Africa,
Switzerland and the US.
68 UNEP/ CBD/ BSWG/ 4/ Inf. 2, p. 2.
69 As suggested by Colombia, see UNEP/ CBD/ BSWG/ 4/ 2, p. 2.
18
III. TEXT OF THE PROTOCOL
Reference to the precautionary principle emerged
at BSWG- 5, when the EC proposed its inclusion. 70
Following negotiations in SWG- II, the result at
the end of BSWG- 5 was a single bracketed text, 71
with the references to the precautionary prin-ciple,
‘ products thereof’, risks to human health and
socio- economic imperatives still remaining to be
resolved in Article 1, as well as in other parts of the
Protocol. 72 Consensus was not reached on wheth-er
the Protocol would deal with LMO- related
activities other than transboundary movement,
while references to animal health and sustainable
development were removed.
During BSWG- 6, delegates in SWG- II were unable
to make further progress. The issue was trans-ferred
to a Friends of the Chair group in BSWG- 6.
The final text73 may be seen as a compromise
between the opposing views. There are thus refer-ences
to the precautionary ‘ approach’ rather than
‘ principle’, linked to a reference to Principle 15 of
the Rio Declaration, and to risks to human health.
References to ‘ products thereof’ and ‘ socio- eco-nomic
imperatives’ were removed. The text then
remained unaltered until it was adopted at the
resumed ExCOP in January 2000.
70 UNEP/ CBD/ BSWG/ 5/ 2, p. 15.
71 UNEP/ CBD/ BSWG/ 5/ 3, Annex, see Article 1.
72 UNEP/ CBD/ BSWG/ 6/ 8, p. 14.
73 UNEP/ CBD/ ExCOP/ 1/ 2, p. 18.
19
III. TEXT OF THE PROTOCOL
Article 2: General Provisions
1. Each Party shall take necessary and
appropriate legal, administrative and
other measures to implement its obliga-tions
under this Protocol.
2. The Parties shall ensure that the devel-opment,
handling, transport, use, transfer
and release of any living modified organ-isms
are undertaken in a manner that
prevents or reduces the risks to biological
diversity, taking also into account risks to
human health.
3. Nothing in this Protocol shall affect in any
way the sovereignty of States over their ter-ritorial
sea established in accordance with
international law, and the sovereign rights
and the jurisdiction which States have in
their exclusive economic zones and their
continental shelves in accordance with
international law, and the exercise by ships
and aircraft of all States of navigational
rights and freedoms as provided for in inter-national
law and as reflected in relevant
international instruments.
4. Nothing in this Protocol shall be inter-preted
as restricting the right of a Party to
take action that is more protective of the
conservation and sustainable use of bio-logical
diversity than that called for in this
Protocol, provided that such action is con-sistent
with the objective and the provi-sions
of this Protocol and is in accordance
with that Party’s other obligations under
international law.
5. The Parties are encouraged to take into
account, as appropriate, available exper-tise,
instruments and work undertaken in
international forums with competence in
the area of risks to human health.
An article on general provisions was included in
some, but not all, proposals on the possible con-tents
of the future Protocol, 74 and some written
suggestions were submitted prior to BSWG- 2.75
The submissions of the African region and Norway
included language on taking appropriate “ legal,
administrative and other measures to implement
and enforce the provisions of this Protocol, includ-ing
measures to prevent and punish conduct in
contravention of the Protocol.” These proposals
constitute the origin of the first paragraph of the
final text. The starting point of the article’s second
paragraph can be traced to the African region pro-posal,
which however, went further by referencing
risks to human and animal health, biological diver-sity,
the environment and socio- economic welfare
of societies. 76 Finally, the African region text also
included language on Parties imposing additional
requirements that are consistent with the Protocol
and in accordance with the rules of international
law, providing the basis for the fourth paragraph
of the final text. BSWG- 2 delegates held no dis-cussions
on this issue, but agreed to retain it and
address it at a later stage. 77
A number of delegations submitted text for con-sideration
at BSWG- 3.78 The EC’s proposal included
language on the sovereignty of States over their
territorial sea, drawn from Article 4.12 of the Basel
Convention on the Control of Transboundary
Movement of Hazardous Wastes and their Dis-posal.
This provision remained unaltered in the
final text. 79 By the end of the meeting, delegates
had agreed to consolidate options submitted by
the African region, Australia, Brazil, Colombia, the
EC, Norway, South Africa and Switzerland. 80 SWG- II
was then requested to define elements or develop
legal text.
74 UNEP/ CBD/ BSWG/ 1/ 4, Annex.
75 UNEP/ CBD/ BSWG/ 2/ 2, pp. 48- 51, contains the submissions of the African region, Norway and Switzerland.
76 UNEP/ CBD/ BSWG/ 2/ 2, p. 43.
77 UNEP/ CBD/ BSWG/ 2/ 6, para. 176.
78 UNEP/ CBD/ BSWG/ 3/ 5 contains the submissions of the African region, Australia, Brazil, Colombia, EC, South Africa and Switzerland.
79 See Article 2( 3).
80 UNEP/ CBD/ BSWG/ 3/ 6, para. 82, and Annex I, see Article 1bis.
20
III. TEXT OF THE PROTOCOL
More submissions were received prior to BSWG- 4,81
and Chair Koester consolidated different options
to facilitate negotiations. 82 With several delega-tions
calling for brevity, discussions resulted in the
retention of four bracketed options, 83 including
a zero ( no provision) option as suggested by the
US. 84
Prior to BSWG- 5, a number of governments sub-mitted
their views. 85 Debate in SWG- II focused
on the need for such a provision and the level of
detail required. The outcome of the discussions
at BSWG- 5 was a single bracketed option with
paragraphs on: implementation measures; coop-eration
for implementation; prohibition of LMO
exports until an AIA is obtained; 86 prevention or
reduction of risks to biological diversity; the sov-ereignty
of States over their territorial sea; and the
right of a Party to take action that is more protec-tive
of biodiversity. 87
The article on general provisions took its final form
in the Chair’s proposed text88 at BSWG- 6. The fifth
paragraph, on Parties taking into account avail-able
expertise in the area of risks to human health,
was added as part of a compromise related to the
inclusion of a reference to risks to human health
in the Protocol’s objective. Following revision by
the Legal Drafting Group, the title of the provision
was changed to “ General Provisions.” 89 Delegates
in the resumed ExCOP addressed the article’s
fourth paragraph as part of the thematic cluster
related to the relationship of the Protocol to other
international agreements, 90 and the second para-graph
in the context of discussions under Article
18 ( Handling, Transport, Packaging and Identifica-tion).
However, the language remained unaltered
and only editorial corrections were made prior to
the article’s final adoption on 26 January 2000.
81 UNEP/ 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.
82 UNEP/ CBD/ BSWG/ 4/ Inf. 2, p. 2- 8.
83 UNEP/ CBD/ BSWG/ 4/ 4, Annex II, see Article 1bis.
84 UNEP/ CBD/ BSWG/ 4/ 2, p. 9.
85 UNEP/ CBD/ BSWG/ 5/ 2, pp. 16- 22 contains the submissions of Ecuador, Kenya, Mexico, New Zealand, Peru, Slovenia, Thailand and Venezuela.
86 As suggested earlier by the African region, see UNEP/ CBD/ BSWG/ 3/ 5, p. 8.
87 UNEP/ CBD/ BSWG/ 5/ 3, Annex, Article 1bis.
88 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 2.
89 UNEP/ CBD/ BSWG/ 6/ L. 2/ Rev. 2, see Article 2.
90 UNEP/ CBD/ ExCOP/ 1/ 3, para. 33.
21
III. TEXT OF THE PROTOCOL
Article 3: Use of Terms
For the purposes of this Protocol:
( a) ‘ Conference of the Parties’ means the Con-ference
of the Parties to the Convention;
( b) ‘ Contained use’ means any operation,
undertaken within a facility, installation
or other physical structure, which involves
living modified organisms that are con-trolled
by specific measures that effec-tively
limit their contact with, and their
impact on, the external environment;
( c) ‘ Export’ means intentional transbound-ary
movement from one Party to another
Party;
( d) ‘ Exporter’ means any legal or natural
person, under the jurisdiction of the Party
of export, who arranges for a living modi-fied
organism to be exported;
( e) ‘ Import’ means intentional trans-boundary
movement into one Party from
another Party;
( f) ‘ Importer’ means any legal or natural
person, under the jurisdiction of the Party
of import, who arranges for a living modi-fied
organism to be imported;
( g) ‘ Living modified organism’ means any
living organism that possesses a novel com-bination
of genetic material obtained
through the use of modern biotechnology;
( h) ‘ Living organism’ means any biological
entity capable of transferring or replicat-ing
genetic material, including sterile
organisms, viruses and viroids;
( i) ‘ Modern biotechnology’ means the
application of:
a. In vitro nucleic acid techniques, includ-ing
recombinant deoxyribonucleic acid
( DNA) and direct injection of nucleic acid
into cells or organelles, or
b. Fusion of cells beyond the taxonomic
family, that overcome natural physiologi-cal
reproductive or recombination barriers
and that are not techniques used in tradi-tional
breeding and selection;
( j) ‘ Regional economic integration organi-sation’
means an organisation constituted
by sovereign States of a given region, to
which its member States have transferred
competence in respect of matters gov-erned
by this Protocol and which has been
duly authorised, in accordance with its
internal procedures, to sign, ratify, accept,
approve or accede to it;
( k) ‘ Transboundary movement’ means the
movement of a living modified organism
from one Party to another Party, save that
for the purposes of Articles 17 and 24
transboundary movement extends to
movement between Parties and non- Par-ties.
The definition of terms was an item included in all
proposals on the possible contents of the future
Protocol, 91 and discussion started in BSWG- 1 with
some delegations stressing the need to use defi-nitions
found in existing instruments. 92 Following
the compilation of such terms by the Secretariat, 93
governments submitted additional definitions
contained in national or regional legislation for
consideration at BSWG- 2.94 A contact group,
chaired by Dr. Gert Willemse ( South Africa) and Dr
Helen Marquard ( United Kingdom), reviewed avail-able
definitions in order to recommend action, as
delegations had decided that there would be no
attempt to define terms at that stage. The contact
group recommended preparation of an alphabeti-cal
list of terms requiring definition, with country
submissions for each, for consideration at BSWG-
3. The group stressed that the terms appearing
on the list would not necessarily mean that they
would need to be defined in the Protocol and that
any definitions would need to be developed to
reflect their use in the Protocol and the context in
which they appeared. 95
91 UNEP/ CBD/ BSWG/ 1/ 4, Annex, p. 22.
92 UNEP/ CBD/ BSWG/ 1/ 4, paras. 74 – 76.
93 UNEP/ CBD/ BSWG/ 2/ 5.
94 UNEP/ 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.
95 UNEP/ CBD/ BSWG/ 2/ 6, paras. 161 – 164.
22
III. TEXT OF THE PROTOCOL
At BSWG- 3, the contact group on definitions,
now Contact Group 1, resumed its work. CG- 1
continued discussions on definitions at BSWG- 3
on the basis of the revised compilation of terms96
and additional country submissions. 97 Delegates
identified about thirty terms that would need to
be defined as a priority, on the understanding
that, in the course of negotiations, the elaboration
of other terms might be required. 98 The identi-fied
terms at that stage were: accidental release;
competent authority; contained use; deliberate
release; 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 move-ment;
transboundary release; unconfined release;
unintended release; and unintended transbound-ary
movement. The African region’s suggestion for
the definition of an LMO included ‘ parts thereof’, 99
so Contact Group 1 briefly addressed the issue of
‘ LMOs and products thereof’, but noted that it was
not within the group’s mandate to enter into such
a discussion. 100 The Co- Chairs of CG- 1 then pre-pared
a draft consolidating suggestions for each
term, and delegates bracketed text and proposed
further options. 101 This draft was used as the basis
for CG- 1 deliberations in BSWG- 4, while Colombia
and the US submitted additional suggestions. 102
At BSWG- 4, CG- 1 noted that its deliberations had
to be approached from a purely scientific and
technical point of view, in order to provide SWG- I
with the least possible number of options. 103 CG- 1
worked in collaboration with CG- 2, where neces-sary,
regarding the legal questions of definitions,
as well as in close contact with SWG- I, which pro-vided
comments. 104 CG- 1 deliberations resulted
in a bracketed list of terms containing: LMO;
organism; transboundary movement; export;
import; exporter; importer; Party of export; and
Party of import. 105 Regarding the definitions of
terms relating to export, import and transbound-ary
movement, CG- 1 and CG- 2 noted that further
progress could only be made after the resolution
of fundamental issues, such as the Protocol’s appli-cation
to transit or to movements between Parties
and non- Parties. 106 For that reason, the bracketed
definitions of export and import excluded transit,
and references to Parties or States also remained
bracketed. 107 CG- 1 also addressed the definition
of “ LMO”, considering whether to focus on process
or on the result of modification, and deciding to
include both in the draft definition. 108
Further country submissions were received prior
to BSWG- 5.109 CG- 1 focused on the definition of
“ LMO”, deciding to develop definitions for: LMO;
living organism; and modern biotechnology. The
definitions were refined following input by SWG-I,
while a pending issue was whether modern
biotechnology covered cell fusion techniques. 110
The definitions of other terms were forwarded to
BSWG- 6 as agreed upon at BSWG- 4. An informal
discussion on ‘ products thereof’ was held in paral-
96 UNEP/ 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 in
national 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.
97 UNEP/ CBD/ BSWG/ 3/ 5 contains the submissions of the African region, Belarus, Colombia, Malaysia, Mexico, South Africa and Sri Lanka.
98 UNEP/ CBD/ BSWG/ 3/ 6, para. 92.
99 UNEP/ CBD/ BSWG/ 3/ Inf. 1, p. 18.
100 UNEP/ CBD/ BSWG/ 3/ 6, para. 93.
101 UNEP/ CBD/ BSWG/ 3/ 6, Annex, see Article 2.
102 UNEP/ CBD/ BSWG/ 4/ 3, pp. 2- 5.
103 UNEP/ CBD/ BSWG/ 4/ 4, para. 22.
104 UNEP/ CBD/ BSWG/ 4/ 4, para. 27.
105 UNEP/ CBD/ BSWG/ 4/ 4, Annex IV.
106 UNEP/ CBD/ BSWG/ 4/ 4, para. 27.
107 UNEP/ CBD/ BSWG/ 4/ 4, Annex IV.
108 Id.
109 UNEP/ 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.
110 UNEP/ CBD/ BSWG/ 5/ 3, para, 36.
23
III. TEXT OF THE PROTOCOL
lel, influencing deliberations on the use of terms.
The provision was put in brackets, to reflect the
fact that the issue of ‘ products thereof’ was still
pending. 111 The list of terms forwarded to BSWG- 6
contained: LMO; living organism; modern biotech-nology;
transboundary movement; export; import;
exporter; importer; Party of export; and Party of
import. 112
BSWG- 6 concluded work on the use of terms,
with CG- 1 agreeing definitions of “ LMO”, “ living
organism”, and “ modern biotechnology”. 113 The
term ‘ contained use’ was introduced and CG- 1
held discussions on its definition. CG- 2 then dis-cussed
the definitions of: export; exporter; import;
importer; regional economic integration organisa-tion;
and transboundary movement. As the issue
of transit was involved, these were forwarded to
SWG- I. Following resolution of the issue, delegates
substituted “ Parties” for “ States” in the definitions
of export, import and transboundary movement.
With respect to the definition of “ transbound-ary
movement”, the Chair’s text114 contained an
additional cross- reference to the provisions on:
bilateral, regional and multilateral agreements
and arrangements; unintentional transboundary
movements and emergency measures; and non-
Parties ( then Articles 11, 14 and 21 respectively).
On 17 February 1999, BSWG- 6 provisionally
adopted the definitions of exporter, importer,
LMO, living organism, modern biotechnology and
regional economic integration organisation. 115
During the deliberations of the resumed ExCOP,
the reference to the provision on bilateral, region-al
and multilateral agreements and arrangements
under the definition of transboundary movement
was excluded. Article 3 was adopted in its final
form on 26 January 2000.
111 UNEP/ CBD/ BSWG/ 5/ 3, para. 38.
112 UNEP/ CBD/ BSWG/ 5/ 3, Annex, see Article 2.
113 UNEP/ CBD/ ExCOP/ 1/ 2, para. 30.
114 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 3( j).
115 UNEP/ CBD/ ExCOP/ 1/ 2, para. 38.
24
III. TEXT OF THE PROTOCOL
Article 4: Scope
This Protocol shall apply to the trans-boundary
movement, transit, handling
and use of all living modified organisms
that may have adverse effects on the con-servation
and sustainable use of biologi-cal
diversity, taking also into account risks
to human health.
The scope of the Protocol proved to be a highly
contentious issue, the debate having been initiat-ed
during COP- 2, and at the expert meetings held
prior to the COP, over the scope of the negotiating
mandate of BSWG. The language of decision II/ 5
was apparently a compromise between the pref-erence
of developing countries for a Protocol on
biosafety in the field of “ safe transfer, handling and
use of LMOs” and that of developed countries for a
focus on “ transboundary transfer of any LMO.”
Following initial discussions in BSWG- 1, where
the EU suggested the exclusion of LMOs identi-fied
as being unlikely to have adverse effects on
biodiversity, 116 written proposals were submit-ted
for consideration at BSWG- 2.117 Differences
of opinion were apparent: the African proposal
included LMOs and ‘ products thereof’, while
Switzerland favoured a Protocol limited to the
intentional transboundary movement of LMOs to
be introduced in the environment, excluding con-tained
use and trade in commodities. The EU and
Japan called for the exclusion of LMOs unlikely
to have adverse effects, while Japan also wished
to exclude the transboundary transfer of LMOs
covered by other international agreements. The
EU and Norway included a reference to risks to
human health. Canada suggested that the scope
of the Protocol be determined at a later stage.
The issue was not discussed in BSWG- 3, although
some delegations made submissions. 118 The issue
formed part of the mandate of SWG- I, established
at BSWG- 3. Discussion in BSWG- 4 revolved around
whether and how the scope of the Protocol as a
whole would differ from the scope of application
of the AIA procedure. The options contained in
the consolidated text119 at the end of BSWG- 4 pro-vided
for: no provision on scope; scope equivalent
to the scope of the AIA procedure; and bracketed
language detailing activities covered and not cov-ered
by the Protocol. Regarding the latter option,
the transboundary movement of LMOs was cov-ered,
with reference to human health, but han-dling
and use were bracketed. A second paragraph
excluded LMOs not likely to have adverse effects,
requirements for transport operations, transit and
movement destined for contained use.
BSWG- 5 did not make significant progress. A num-ber
of delegations had submitted their views, 120
and SWG- I agreed to work on the option detail-ing
the areas of applicability of the Protocol. At
the end of the negotiations in SWG- I, the article
on scope had been clarified but major questions
remained to be resolved: provisions related to
“ products thereof”; handling and use of LMOs; ref-erence
to human health; socio- economic impacts;
and exceptions, with reference to LMOs unlikely
to have adverse effects, transport operations, con-tained
use and transit. 121
Positions were polarised in BSWG- 6. SWG- I agreed
to delete the bracketed reference to transport
operations being excluded from the Protocol’s
scope. However, they could not reach consensus
on the remaining unresolved issues. Negotiations
in the informal groups created to discuss con-tained
use, ‘ products thereof’ and human health
also failed to reach agreement.
116 UNEP/ CBD/ BSWG/ 1/ 4, p. 18.
117 UNEP/ CBD/ BSWG/ 2/ 2, pp. 44- 48 contains the submissions of the African region, Canada, EU, Japan, Norway and Switzerland.
118 UNEP/ CBD/ BSWG/ 3/ 5 contains the submissions of Australia, Brazil, EC, Mexico and Switzerland.
119 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Article 3A.
120 UNEP/ CBD/ BSWG/ 5/ 2 contains the submissions of Ecuador, Kenya, New Zealand, Peru, Slovenia, Thailand and Venezuela.
121 UNEP/ CBD/ BSWG/ 5/ 3, para. 31; and Annex, see Article 3A; UNEP/ CBD/ BSWG/ 6/ 8, Annotated Draft Negotiating Text of a Protocol on Biosafety, see
Article 4. See also section on Article 5 below.
25
III. TEXT OF THE PROTOCOL
The Chair’s proposed text attempted to draft com-promise
language. 122 The Chair’s text presented to
the BSWG retained references to handling and
use, as well as to human health, while omitting
the references to ‘ products thereof’ and socio-economic
well- being. A general statement was
introduced into the paragraph on exceptions, to
preserve the right of Parties to subject all LMOs to
risk assessment prior to decisions on import. The
exceptions included transboundary movements
of LMOs unlikely to have adverse effects, and of
LMOs which are pharmaceuticals for humans.
Transit and contained use were covered in certain
articles only. On February 19, the Chair’s text was
reviewed by the Friends of the Chair group, as
well as by informal and regional groups, which
expressed general dissatisfaction. It became
apparent that the issue of scope could stall finali-sation
of the Protocol. At Minister Mayr’s initiative,
a Friends of the Minister group continued nego-tiations
on February 20, without however reach-ing
agreement. The text was not altered, and with
a minor adjustment made by the Legal Drafting
Group, was submitted for the consideration of the
ExCOP. 123 Following the suspension of the ExCOP,
negotiations on the issue continued in the infor-mal
consultations ahead of the resumption of the
ExCOP.
According to the Chairman’s summary of the
Vienna informal consultations, 124 the negotiating
groups retained their initial positions. Most groups
could accept the text as it stood, apart from the
Like- Minded Group, which then proposed a single
paragraph which provided for the Protocol to
apply to the transboundary movement, transit
and handling and use of all LMOs that may have
an adverse effect on the conservation and sustain-able
use of biological diversity, taking also into
account risks to human health. Exceptions would
then be addressed under specific articles. 125 Since
most groups needed time to examine the pro-posal,
consultations did not progress any further.
Suggested texts were incorporated into Chair
Mayr’s non- paper in December 1999, to assist the
negotiation progress.
During the Montreal consultations before the
resumption of the ExCOP in January 2000, a con-tact
group was created specifically to address the
issue of scope. 126 The Like- Minded Group reiter-ated
its position of retaining a comprehensive
provision to cover all LMOs and addressing excep-tions
under other articles. Other groups preferred
to retain the text from Cartagena. 127 A small group
was established to address exceptions and to
develop language on scope. On January 23, one
day before the beginning of the resumed ExCOP,
the group came up with an agreed single para-graph
to address all LMOs, although reference
to transit was still bracketed. New articles were
drafted to address exceptions.
Negotiations in the contact group on scope,
chaired by Mr. John Herity ( Canada) continued
during the resumed ExCOP. As the negotiation
progressed the contact group on commodities
( see section on Article 11) and on scope were
merged under the joint chairmanship of Mr.
Herity and Mr. François Pythoud ( Switzerland). 128
Delegates finally agreed to a provision addressing
the transboundary movement, transit, handling
and use of all LMOs that may have adverse effects
on the conservation and sustainable use of bio-diversity,
taking also into account risks to human
health. Following this agreement, the negotiations
focused mainly on the new draft articles on phar-maceuticals,
transit and contained use. 129 Article 4
on scope was adopted with the rest of the Proto-col
on 29 January 2000.
122 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 4.
123 UNEP/ CBD/ ExCOP/ 1/ 2, Appendix I, see Article 4.
124 UNEP/ CBD/ ExCOP/ 1/ INF/ 3, p. 4.
125 UNEP/ CBD/ ExCOP/ 1/ INF/ 3, Informal consultations on Biosafety Protocol, Vienna 15- 19 September 1999, Chairman’s Summary, p. 5.
126 UNEP/ CBD/ ExCOP/ 1/ 3, para. 12.
127 UNEP/ CBD/ ExCOP/ 1/ 2, Appendix I, see Article 4.
128 UNEP/ CBD/ ExCOP/ 1/ 3, para. 53.
129 UNEP/ CBD/ ExCOP/ 1/ 3 pp. 26, 28- 29 and 31. See sections on Articles 5 and 6 below.
26
III. TEXT OF THE PROTOCOL
Article 5: Pharmaceuticals
Notwithstanding Article 4 and without
prejudice to any right of a Party to subject
all living modified organisms to risk
assessment prior to the making of deci-sions
on import, this Protocol shall not
apply to the transboundary movement of
living modified organisms which are phar-maceuticals
for humans that are addressed
by other relevant international agree-ments
or organisations.
Discussion on pharmaceuticals started at BSWG-
5, during the debate on scope ( see section on
Article 4). A footnote was then inserted into the
bracketed paragraph on the areas of non- applica-bility
of the Protocol which included “ LMOs which
are pharmaceuticals for humans” in the annex of
LMOs unlikely to have adverse effects, 130 and con-sequently
exclude them from the Protocol’s scope.
On 15 February 1999, during SWG- I negotiations
at BSWG- 6, the footnote was replaced with a refer-ence
in the text of the article, excluding the “ trans-boundary
movements of LMOs that are pharma-ceuticals
for humans.” The Chair’s text131 produced
at BSWG- 6, also excluded from the scope of the
Protocol transboundary movements of LMOs that
are pharmaceuticals for humans.
The creation of a separate article on pharma-ceuticals
originated from the proposal of the
Like- Minded Group presented during the Vienna
informal consultations, to have a comprehensive
provision on scope to cover all LMOs and address
the exceptions in other articles. 132 This group sug-gested
including language in the article on the
application of the AIA procedure, 133 allowing the
Party of import to decide not to apply the AIA
procedure to LMOs that are pharmaceuticals for
human use.
When the consultations continued in Montreal,
it became clear that a compromise would be dif-ficult
to reach. The negotiating groups had oppos-ing
views: the Miami Group expressed the view
that pharmaceuticals would not have adverse
effects on biodiversity, while the EU noted other
international bodies that could cover future devel-opments.
On the other hand, the Like- Minded
Group did not wish to exclude pharmaceuticals. In
an attempt to reconcile these views, the contact
group on scope at the resumed ExCOP drafted
language on 23 January 2000, exempting the
transboundary movement of pharmaceuticals for
humans, without prejudicing the rights of Parties
to subject all LMOs to a risk assessment prior to a
decision on import.
The issue was finally resolved during the resumed
ExCOP following negotiations in the contact
group on scope and intense informal consulta-tions.
134 While some delegations noted that the
World Health Organisation would be the com-petent
forum to deal with the issue of LMOs that
are pharmaceuticals for humans, the Like- Minded
Group expressed concern regarding develop-ments
in pharmaceutical applications, such as
gene- therapy, for which no other standards or
institutional provisions existed. While the Chair of
the contact group on scope continued informal
discussions to explore flexibility on the issue, it
was suggested that the exemption should be
qualified by limiting the exemption to LMOs that
are covered by other international agreements
and organisations or that would not be intention-ally
introduced into the environment. These provi-sions
remained in brackets. The first of these sug-gestions
was included in the final text adopted on
29 January 2000.
130 UNEP/ CBD/ BSWG/ 5/ 3, Annex, see Article 3A, footnotes; see also Appendix I to this document on ‘ Deleted Draft Articles’.
131 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 4( c).
132 UNEP/ CBD/ ExCOP/ 1/ INF/ 3, Informal consultations on Biosafety Protocol, Vienna 15- 19 September 1999, Chairman’s Summary, p. 5.
133 See section on Article 7 below.
134 UNEP/ CBD/ ExCOP/ 1/ 3 paras. 28, 45, 51 and 61.
27
III. TEXT OF THE PROTOCOL
Article 6: Transit and contained use
1. Notwithstanding Article 4 and without
prejudice to any right of a Party of transit
to regulate the transport of living modi-fied
organisms through its territory and
make available to the Biosafety Clearing-
House, any decision of that Party, subject
to Article 2, paragraph 3, regarding the
transit through its territory of a specific
living modified organism, the provisions
of this Protocol with respect to the
advance informed agreement procedure
shall not apply to living modified organ-isms
in transit.
2. Notwithstanding Article 4 and without
prejudice to any right of a Party to subject
all living modified organisms to risk
assessment prior to decisions on import
and to set standards for contained use
within its jurisdiction, the provisions of
this Protocol with respect to the advance
informed agreement procedure shall not
apply to the transboundary movement of
living modified organisms destined for
contained use undertaken in accordance
with the standards of the Party of import.
Article 6( 1): Transit
At BSWG- 2 initial discussions were held on transit
together with the issues of handling, transport
and packaging. 135 By the end of BSWG- 2, realis-ing
its complexity, delegations agreed to treat
the question of transit of LMOs separately. 136
The debate started in BSWG- 3, at which the EC’s
submission proposed excluding transit from the
Protocol’s scope. 137
Diverging views became apparent at BSWG- 4. CG-
1 and CG- 2 considered that the issue of whether
the Protocol should apply to LMOs in transit was
one of the fundamental questions to be resolved
in order for the negotiations to progress. 138 The
issue was incorporated into the discussions on
scope, 139 application of the AIA procedure, and
notification, during BSWG- 4, 5 and 6.
In the Chair’s proposed text at BSWG- 6,140 transit
was excluded from the scope of the Protocol,
except as regards the provisions on Parties’ gen-eral
obligations ( Article 2), unintentional trans-boundary
movements and emergency measures
( then Article 14), and handling, transport, packag-ing
and identification ( then Article 15). The Miami
Group questioned the latter reference141 and, in
the general disagreement over the scope of the
Protocol, the issue of transit remained pending.
According to the Like- Minded Group’s proposal,
submitted at the Vienna informal consultations
in September 1999, transit of LMOs would have
been included in the scope of the Protocol142 and
notification of transit of LMOs would have been
required. The issue remained under negotiation
during the Montreal informal consultations. While
the contact group on scope agreed on a compre-hensive
provision to address all LMOs, reference
to transit under the provision on scope remained
bracketed and discussion started on the devel-opment
of a new provision. Requirements for
advance notification and necessary documenta-tion
for transit also caused intense disagreement.
Following extensive discussions in the contact
group on scope during the resumed ExCOP, as
well as informal consultations, delegations agreed
to include LMOs in transit in the Protocol’s scope.
They also started drafting a new provision to
address the issue. On 26 January 2000, the contact
group was presented with a text based on infor-
135 UNEP/ CBD/ BSWG/ 2/ 6, paras. 145- 149.
136 UNEP/ CBD/ BSWG/ 2/ 6, Annex II, Item I.
137 UNEP/ CBD/ BSWG/ 3/ 5.
138 UNEP/ CBD/ BSWG/ 4/ 4, para. 27.
139 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Articles 3A, 3B and 4.
140 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 4.
141 UNEP/ CBD/ ExCOP/ 1/ 3, Annex III, p. 17.
142 See section on Article 4 above.
28
III. TEXT OF THE PROTOCOL
mal consultations, which suggested that the AIA
procedure would not apply to LMOs in transit. The
text was accepted. The final issue to be resolved
was the right of a State to regulate LMOs in transit
through its territory. Following resolution of this
issue, the provision was adopted on 29 January
2000.
Article 6( 2): Contained Use
Early discussions during BSWG- 2 indicated the
complex nature of this issue, as Canada, the
EU, Norway and Switzerland suggested exclud-ing
LMOs destined for contained use from the
Protocol’s scope, while most developing country
delegations supported inclusion of all intended
uses. 143 At BSWG- 3, Norway proposed language
on minimum national regulations for biosafety, 144
including the development of an annex on
national measures applied to contained use. This
proposal was withdrawn during BSWG- 6. Norway
maintained however that the Protocol should
include a provision to ensure that Parties guaran-teed
safety in the contained use of LMOs. 145
Following negotiations at BSWG- 4, language pro-posed,
but not agreed, on scope and on the appli-cation
of the AIA procedure, excluded contained
use. 146 At the beginning of BSWG- 6, Chair Koester
identified contained use as one of the key issues
requiring resolution, as there seemed to be no
point of agreement. SWG- I held lively discussions
on whether LMOs destined for contained use
should be excluded from the AIA procedure. 147
Many developing country delegations stressed
that LMOs in containment should be subject to
the same provisions as other LMOs, while other
delegations argued that such transboundary
movements should not be covered by the AIA
procedure, or even that LMOs destined for con-tained
use should be outside the scope of the Pro-tocol.
Discussion continued in an informal group,
co- chaired by Australia and Peru, but did not prog-ress
further than crystallising the three positions
noted above. The lack of an agreed definition of
contained use, in light of the fact that discussion
in the contact group on definitions were still con-tinuing,
further complicated discussions. 148
At BSWG- 6, in the Chair’s proposed text, 149 LMOs
destined for contained use were not covered by
the AIA procedure. They were only partially cov-ered
by the Protocol’s scope, with reference to
the provisions on general obligations of Parties
( Article 2), unintentional transboundary move-ments
and emergency measures ( then Article
14), handling, transport, packaging and identi-fication
( then Article 15), and some paragraphs
of Article 17 on information- sharing and the
Biosafety Clearing- House. 150 The Like- Minded
Group expressed its concern, 151 calling for the
inclusion of LMOs destined for contained use in
the Protocol’s scope and in the AIA procedure. In
its proposal submitted during the Vienna informal
consultations, the Like Minded Group suggested
that, while the scope of the Protocol should cover
all LMOs, the Party of import could decide not to
apply the AIA procedure to LMOs destined for
research in contained use. 152
As discussions on the issue continued during
the resumed ExCOP, both informally and in the
contact group on scope, delegations reached
general agreement on scope and on 25 January
2000, started exploring options for dealing with
contained use. On 26 January, new Article 6 was
presented. The provision was adopted on 29 Janu-ary
2000.
143 UNEP/ CBD/ BSWG/ 2/ 6, paras. 33- 34.
144 UNEP/ CBD/ BSWG/ 3/ 5.
145 UNEP/ CBD/ ExCOP/ 1/ 2, para. 24.
146 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Article 3B.
147 See section on Article 7 below.
148 See section on Article 3 above.
149 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 5.
150 Ibid., see Article 4( b).
151 UNEP/ CBD/ ExCOP/ 1/ 3, Annex IV.
152 UNEP/ CBD/ ExCOP/ 1/ INF/ 3, Informal Consultation on Biosafety Protocol, Vienna 15 – 19 September 1999, Chairman’s Summary, p. 5.
29
III. TEXT OF THE PROTOCOL
Article 7: Application of the
Advance Informed Agreement
Procedure
1. Subject to Articles 5 and 6, the advance
informed agreement procedure in Articles
8 to 10 and 12 shall apply prior to the first
intentional transboundary movement of
living modified organisms for intentional
introduction into the environment of the
Party of import.
2. ‘ Intentional introduction into the envi-ronment’
in paragraph 1 above, does not
refer to living modified organisms intend-ed
for direct use as food or feed, or for
processing.
3. Article 11 shall apply prior to the first
transboundary movement of living modi-fied
organisms intended for direct use as
food or feed, or for processing.
4. The advance informed agreement pro-cedure
shall not apply to the intentional
transboundary movement of living modi-fied
organisms identified in a decision of
the Conference of the Parties serving as
the meeting of the Parties to this Protocol
as being not likely to have adverse effects
on the conservation and sustainable use
of biological diversity, taking also into
account risks to human health.
An advance informed agreement procedure was
identified as a priority consensus element in the
meeting of the Open- ended Ad Hoc Group of
Experts on Biosafety before COP 2 in 1995.153 The
scope of the AIA procedure was addressed at
BSWG- 1.154 Switzerland, supported by New Zea-land
and the US, suggested that the AIA proce-dure
should apply only to the first transboundary
movement of LMOs intended for use in the envi-ronment,
while notification would be sufficient
for subsequent movements. Following remarks by
Australia and the EU, delegations also had initial
discussions on the categorisation of LMOs accord-ing
to the degree of potential risk to biodiversity
and the relevance of such categorisation to the
application of the AIA procedure.
A more extensive debate took place at BSWG- 2155
and BSWG- 3, on the basis of country submis-sions.
156 As discussion focused on the two above
issues, most developing countries expressed the
view that the AIA procedure should apply to all
movements, initial and subsequent, while Brazil,
Norway and the US, among others, suggested a
simpler procedure for subsequent movements.
During BSWG- 3, SWG- I prepared an elements
paper, 157 drawing from country submissions. The
paper compiled options for elements of the scope
of the application of the AIA procedure. It was sug-gested
that the procedure cover: all LMOs; all first
time transboundary movements of LMOs; all LMOs
except those explicitly excluded and exempted;
and specific LMOs based on detailed criteria or on
criteria listed in an annex. A further option left it to
the discretion of the importing State as to wheth-er
the exporter should apply national regulations
or the Protocol. Chair Koester streamlined these
options for BSWG- 4,158 where discussions focused
on: the scope of AIA in relation to the scope of the
Protocol; the application of the AIA procedure
only to specific categories of LMOs; its application
to LMOs in transit or destined for contained use;
the exemption of low- risk LMOs and the type of
agreement required for this exemption.
153 UNEP/ CBD/ COP/ 2/ 7, Annex I, para 18( a).
154 UNEP/ CBD/ BSWG/ 1/ 4, paras. 39- 43.
155 UNEP/ CBD/ BSWG/ 2/ 6, paras. 23- 72.
156 UNEP/ 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/ 3
contains the submissions of the African region, Belarus, Brazil, Colombia, Cuba, EC, India, Japan, Madagascar, Malaysia, Mexico, Norway, Peru, South
Africa, Sri Lanka, Switzerland and the US.
157 UNEP/ CBD/ BSWG/ 3/ 6, para. 85; and Annex I, see Article 3.
158 UNEP/ CBD/ BSWG/ 4/ Inf. 1, pp. 2- 4.
30
III. TEXT OF THE PROTOCOL
By the end of BSWG- 4, it was agreed to draft sepa-rate
provisions on the scope of the Protocol and
on the application of the AIA procedure. Discus-sions
resulted in four options for the application
of the AIA procedure. 159 These covered: all LMOs
defined in the Protocol; the first movement of an
LMO unless an exemption was provided for; spe-cific
categories of LMOs listed within the article; or
LMOs covered by criteria listed in an annex.
During BSWG- 5, a drafting group produced a sin-gle
bracketed option for consideration by SWG- I:
This text contained a detailed paragraph on
LMOs to be covered by the AIA ( positive list) and
another on exemptions ( negative list). Although
some delegations commented on the two draft
paragraphs’ contradictory approaches and called
for their consolidation, the group could not agree
on whether to include a positive or a negative list,
so both paragraphs were retained. 160 Discussion
then focused on the application of the AIA proce-dure
to transit and contained use, and the scope
of exemptions in general. The issue of whether the
AIA would apply to all transboundary movements
of LMOs or only the first transboundary movement
also remained unresolved. A number of footnotes
indicated the remaining pending issues. 161
As a result, the bracketed text submitted to BSWG-
6 contained two paragraphs, the first detailing the
categories of LMOs to which AIA would apply and
the second addressing the exemptions from the
AIA procedure. Regarding the first paragraph, the
issue of whether AIA would apply to the first or
to all transboundary movements, and the inclu-sion
of ‘ products thereof’, remained bracketed.
LMOs covered by the AIA procedure were those
intended for field testing or deliberate release in
the Party of import, those banned in the Party of
export and those destined for contained use. Cat-egories
to be excluded from the AIA procedure
were: LMOs in transit; those exempted under the
domestic regulatory framework; those destined
for contained use; those identified in a decision
of the Meeting of the Parties as not likely to have
adverse effects on biodiversity; 162 and, under con-ditions,
those destined for placing on the market
of the Party of import. 163
The application of the AIA procedure to commodi-ties
caused intense debate during and following
BSWG- 6.164 Some developed countries argued
that LMOs intended for human or animal con-sumption
would not pose a significant threat to
biodiversity and called for their exclusion, while
many developing countries advocated applica-tion
of the AIA procedure to all LMOs, stress-ing
the possibility of accidental releases. On 17
February 1999, delegations agreed that the AIA
procedure would apply to the first transbound-ary
movement of an LMO. However, the issue of
commodities remained unresolved. According to
the Chair’s proposed text at BSWG- 6, the AIA pro-cedure
would cover the first transboundary move-ment
of LMOs “ destined for growth, reproduction
and propagation in the environment.” 165 It would
not apply to LMOs not likely to have adverse
effects on biodiversity, taking into account risks
to human health, as identified in a decision of
the MOP, nor to LMOs destined for placing on the
market in the Party of import under certain condi-tions.
Parties could, under domestic law, require
procedures consistent with the AIA procedure for
other LMOs. 166 This latter provision implied that
159 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Article 3B.
160 UNEP/ CBD/ BSWG/ 5/ 3, Annex, see Article 3B.
161 UNEP/ CBD/ BSWG/ 5/ 3, para. 31, and Annex, see Article 3B.
162 The possibility for the Meeting of the Parties to the Protocol to exclude LMOs from the application of the AIA originated from language proposed by
Japan., 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 were
made 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 of
the 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.
163 UNEP/ CBD/ BSWG/ 6/ 2, pp. 7- 9.
164 The treatment of commodities in relation with the AIA procedure had implications for several provisions of the Protocol. See Background above,
and section on Article 11 below.
165 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 5.
166 UNEP/ CBD/ BSWG/ 6/ L. 2, See Article 5.
31
III. TEXT OF THE PROTOCOL
commodities could be covered by AIA procedures
under national legislation. In the revised version
of the document containing the Chair’s text, the
phrase “ growth reproduction and propagation in
the environment” was replaced by “ intentional
introduction into the environment”. It was speci-fied
that this term did not refer to “ LMOs intended
for direct use as food or feed, or for processing”
( LMO- FFPs), the phrase used thereafter to refer to
commodities. 167
Following review by the Friends of the Chair, as
well as regional and informal groups, the provision
remained under negotiation in the Friends of the
Minister group, the most difficult issue remaining
whether or not the AIA procedure would apply to
commodities.
Delegations reacted to the Chair’s proposed text
as revised by the Legal Drafting Group on 22
February. 168 The issue of the application of the AIA
procedure to LMO- FFPs remained a core focus
of discussion in the first session of the ExCOP.
The various negotiating groups put forward dif-ferent
proposals for addressing the issue. The
Like- Minded Group proposed subjecting the first
transboundary movement of all LMOs to AIA,
but allowing Parties of import not to apply AIA
to LMO- FFPs. 169 The Miami Group supported the
Chair’s text on this issue, 170 and the EU proposed
that the first meeting of the Parties to the Proto-col
should decide how the AIA procedure should
apply to LMO- FFPs. 171
The application of the AIA procedure to commodi-ties
remained one of the core pending issues at
the suspension of the first session of the ExCOP,
and was further examined during the Vienna infor-mal
consultations, when the Compromise Group
presented a concept paper to facilitate discus-sion
on developing an alternative procedure for
commodities. 172 It was proposed that reference to
this alternative procedure in the provision on the
application of the AIA procedure would replace
the reference to domestic legislation. All groups
found the proposal constructive and agreed to
consider it, 173 with the Like- Minded Group insist-ing
on a procedure as robust as the AIA procedure.
This proposal created the basis for developing a
separate provision on LMO- FFPs. 174 Negotiations
continued in Montreal, both informally and dur-ing
the resumed ExCOP, where a contact group,
chaired by Mr. François Pythoud ( Switzerland)
discussed as a cluster the issues of the application
of the AIA procedure, development of an alterna-tive
procedure for commodities, and the provision
on handling, transport, packaging and identifica-tion.
As the provision on the application of the
AIA procedure depended on resolution of the
debate on LMO- FFPs, 175 the text of Article 7 was
finalised in parallel with Article 11 on a procedure
for LMO- FFPs. Therefore, the final text of Article 7,
which excludes LMO- FFPs from the application
of AIA, referencing Article 11, was adopted on 29
January 2000.
167 UNEP/ CBD/ BSWG/ 6/ L. 2/ Rev. 1, see Article 5.
168 UNEP/ CBD/ ExCOP/ 1/ 2, para. 40.
169 UNEP/ CBD/ ExCOP/ 1/ 3, Annex IV.
170 UNEP/ CBD/ ExCOP/ 1/ 3, Annex III.
171 UNEP/ CBD/ ExCOP/ 1/ 3, Annex II.
172 UNEP/ CBD/ ExCOP/ 1/ INF/ 3, Informal Consultations on Biosafety Protocol, Vienna, 15- 19 September 1999, Chairman’s Summary, p. 3.
173 Id.
174 See now Article 11.
175 See section on Article 11 below.
32
III. TEXT OF THE PROTOCOL
Article 8: Notification
1. The Party of export shall notify, or
require the exporter to ensure notifica-tion
to, in writing, the competent national
authority of the Party of import prior to
the intentional transboundary movement
of a living modified organism that falls
within the scope of Article 7, paragraph 1.
The notification shall contain, at a mini-mum,
the information specified in Annex I.
2. The Party of export shall ensure that
there is a legal requirement for the accu-racy
of information provided by the
exporter.
Following a general discussion of the AIA proce-dure
at BSWG- 1,176 the African region submitted
to BSWG- 2 a detailed text on the notification
procedure prior to a transboundary movement of
LMOs. 177 Part of the first paragraph of the African
proposal required the State of export to notify, or
require the exporter to notify by application in
writing through the channel of the competent
authority of the State of export, the competent
authority of the States concerned and the Biosafe-ty
Clearing- House, of any proposed transbound-ary
transfer of LMOs or products thereof. Such
applications were to contain the declarations and
information to be specified in Annex I to the Pro-tocol.
Elements of the final text can be recognised
in this early proposal. BSWG- 2 delegates discussed
who should trigger the notification procedure:
the Party of export, the exporter or the receiving
entity in the Party of import. 178
Several written proposals were submitted to
BSWG- 3.179 India’s submission included language
on notification to the Clearing House, as well as on
the requirement for the accuracy of information
provided by the exporter, while Canada, whose
proposal favoured notification by the importer
to the Party of import, suggested that each Party
make its importers responsible for the accuracy of
provided information. The options resulting from
both the written submissions and the discussion
were consolidated for consideration by BSWG- 4.180
The Chairman’s note for BSWG- 4181 further organ-ised
these options. The primary issue of whether
the exporter or the importer would trigger the
notification procedure was still to be resolved.
BSWG- 4 discussions in SWG- I revolved mainly
around the issue of who should trigger the noti-fication
procedure. The questions of who should
bear the responsibility for accuracy of the pro-vided
information, and whether the required
information should be specified in an Annex or
in a list to be established by the meeting of the
Parties, also provoked some debate. The outcome
was a consolidated bracketed text merging differ-ent
options. On the requirement for accuracy of
information, the zero ( no provision) option was
retained. 182 Discussions on the content of the
required information were held in parallel in
CG- 1.183
BSWG- 5 did not make significant progress on
this issue. Some governments submitted views184
and discussions took place in SWG- I, while CG- 2
addressed the question of how other internation-al
agreements referred to the issue of triggering
notification.
176 UNEP/ CBD/ BSWG/ 1/ 4, paras. 39- 43.
177 UNEP/ 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.
178 UNEP/ CBD/ BSWG/ 2/ 6, paras. 62- 65.
179 UNEP/ 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.
180 UNEP/ CBD/ BSWG/ 3/ 6, Annex I, see Articles 4, 5, 6, and 7.
181 UNEP/ CBD/ BSWG/ 4/ Inf. 1, pp. 4- 5.
182 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Article 4.
183 See section on Annex I below.
184 UNEP/ CBD/ BSWG/ 5/ 2 contains the submissions of Ecuador, New Zealand, Peru, Thailand, US, Uruguay, and Venezuela.
33
III. TEXT OF THE PROTOCOL
Many delegations in SWG- I expressed the view
that responsibility for notification should fall on
the exporter, or that the Party of export should
ensure that the exporter notified the Party
of import. Since others still preferred placing
responsibility on the importer, no agreement was
reached. The question of responsibility for the
accuracy of information was not resolved either.
The requirement to notify the Biosafety Clearing-
House, which was deleted in BSWG- 4, was also re-introduced.
By the end of the session, delegates
deleted the zero ( no provision) option regarding
responsibility for accuracy of information, and
agreed that notification should include, at a mini-mum,
the information specified in Annex I to the
Protocol. The rest of the provision remained brack-eted
to reflect the different options. 185
BSWG- 6 discussions mainly revolved around the
question of notification to the Biosafety Clear-ing-
House, which was finally excluded, and the
requirement for accuracy of information. As the
issue was not resolved in SWG- I, consultation
continued in the Friends of the Chair group. The
Chair’s text produced at BSWG- 6 contained com-promise
language on the issue. 186 The text of the
provision then remained unaltered until its adop-tion
on 29 January 2000.
Notification of transit
The issue of notifying transit countries arose in
BSWG- 3, with a number of delegations submitting
text for a separate provision on notification of tran-sit.
187 Some governments had also included related
language in their proposals on notification. 188
The options were consolidated for BSWG- 4,189
while the US suggested that no provision on
notification of transit was necessary. 190 During the
debate, other delegations also viewed the provi-sion
as unnecessary, while others suggested text
requiring the Party of export to obtain consent
from Party and non- Party transit States. Both the
zero ( no provision) option and text providing for
notification to the transit State, acknowledge-ment
of notification and documentation for LMOs
in transit, were retained in the consolidated text at
the end of BSWG- 4.191
Further views were submitted to BSWG- 5.192
Delegations debated deleting the provision,
but most developing countries objected to this
option. Following discussions in SWG- I and work
in a drafting group, delegations finally agreed to
deletion of this provision, on the basis that these
elements could be adequately addressed under
the provisions on notification, acknowledgement
of receipt of notification, decision procedure for
AIA, handling, transport and packaging, and liabil-ity
and compensation. 193
Following the deletion of the provision, a debate
on notification of transit was held under the gen-eral
provision on notification in BSWG- 6, resulting
in its final exclusion. 194
185 UNEP/ CBD/ BSWG/ 5/ 3, Annex, see Article 4.
186 UNEP/ CBD/ BSWG/ 6/ L. 2, see Article 6.
187 UNEP/ CBD/ BSWG/ 3/ 3, pp. 23- 25, contains the submissions of Australia, Brazil, Mexico, Peru, Malaysia and Norway.
188 UNEP/ CBD/ BSWG/ 3/ 3, pp. 8- 13. The submissions of the African group and India proposed a reference to “ States concerned”, while Colombia and
Peru included specific reference to Parties or countries of transit.
189 UNEP/ CBD/ BSWG/ 3/ 6, Annex I, see Article 8.
190 UNEP/ CBD/ BSWG/ 4/ 3, p. 9.
191 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Article 8.
192 UNEP/ CBD/ BSWG/ 5/ 2, pp. 47- 49, contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.
193 UNEP/ CBD/ BSWG/ 5/ 3, para. 32, and Annex, see Article 8.
194 UNEP/ CBD/ ExCOP/ 1/ 2, para. 39.
34
III. TEXT OF THE PROTOCOL
Article 9: Acknowledgement of
Receipt of Notification
1. The Party of import shall acknowledge
receipt of the notification, in writing, to
the notifier within ninety days of its
receipt.
2. The acknowledgement shall state:
( a) The date of receipt of the notification;
( b) Whether the notification, prima facie,
contains the information referred to in
Article 8;
( c) Whether to proceed according to the
domestic regulatory framework of the
Party of import or according to the proce-dure
specified in Article 10.
3. The domestic regulatory framework
referred to in paragraph 2 ( c) above, shall
be consistent with this Protocol.
4. A failure by the Party of import to
acknowledge receipt of a notification
shall not imply its consent to an inten-tional
transboundary movement.
The time limit for the response of the import-ing
country and the consequences of a failure to
acknowledge receipt were the major contentious
issues under this provision. Discussions on the
issue of the time limit started in BSWG- 2, although
there was no clear distinction at the time between
acknowledgement of receipt of notification and
response, including decision, of the importing
Party. 195 While some noted the importance of time
limits, most developing country delegations were
opposed to prescriptive time limits after which
implicit consent might be assumed, while some
agreed to consider an indicative time period for the
acknowledgement of receipt of notification. 196
On the basis of written submissions, 197 BSWG- 3
consolidated different options for elements of the
AIA procedure as a whole. Elements identified as
relevant to the acknowledgement of receipt of
notification198 included: its time frame, information
to be given to the notifier, and consequences of a
failure to respond in a specified time frame. These
options were further organised in the Chairman’s
note prepared for BSWG- 4.199 The note contained:
a zero ( no provision) option, as suggested by
some developing countries; an option with lan-guage
on acknowledgement of receipt, which
would include confirmation that the notification
contains prima facie the information required for
notification, 200 the date of receipt, 201 advice on car-rying
out a risk assessment and/ or a request for
further information where necessary; an option
with language on review of the content of the
request in a specific time period; and language on
informing the notifier to proceed according to the
AIA procedure or the domestic regulatory frame-work,
provided that this included a control mecha-nism
consistent with the Protocol. All references to
time frames remained open and bracketed.
Discussions in BSWG- 4 revolved around the same
issues, with several delegations still opposing a
precise time period for responding to notification.
The zero option was retained and the remain-ing
suggestions were consolidated into a single
option. 202 The text mainly addressed acknowl-edgement
of receipt, but also included language
on informing the notifier about proceeding with
or without written consent, which would later
be introduced into the provision on decision
procedure. 203 On the consequences of a failure to
acknowledge receipt, some developing countries
supported text stating that failure to acknowledge
receipt would not result in any consequences,
nor would it imply consent to a transboundary
195 See also section on Article 10 below.
196 UNEP/ CBD/ BSWG/ 2/ 6, paras. 56 - 58.
197 UNEP/ CBD/ BSWG/ 3/ 3, pp. 19- 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.
198 UNEP/ CBD/ BSWG/ 3/ 6, Annex I, see Article 5.
199 UNEP/ CBD/ BSWG/ 4/ Inf. 1, p. 6.
200 As suggested by Canada, see UNEP/ CBD/ BSWG/ 3/ 3, p. 19.
201 As suggested by Japan, see UNEP/ CBD/ BSWG/ 3/ 3, p. 21.
202 UNEP/ CBD/ BSWG/ 4/ 4, Annex I, see Article 5.
203 See section on Article 10 below.
35
III. TEXT OF THE PROTOCOL
movement. Similar language had been suggested
earlier by Belarus204 and Switzerland. 205
Following submission of new government propos-als206
and some discussion at BSWG- 5 on the need
for the provision, delegations in SWG- I agreed
to delete the zero option. 207 Debate focused on
the time frame: with several delegations calling
for acknowledgement of receipt within 30 days,
and others preferring reference to a “ reasonable”
period of time, the group finally double- bracket-ed
a compromise option of 90 days. Delegations
then agreed that the acknowledgement should
state the date of receipt of the notification and
whether the notification, prima facie, contained
the information specified under the provision
on notification, as well as agreeing that failure to
acknowledge receipt upon notification would not
imply consent. Regarding the requirement for the
acknowledgement to state whether to proceed
according to the AIA procedure or the domes-tic
regulatory framework, delegations debated
moving this to the provision on the decision
procedure, but ultimately retained and bracketed
the reference. The debate continued at BSWG- 6,
where delegations agreed to keep such language.
The remaining outstanding issue of the time limit
was also resolved at BSWG- 6. Delegations agreed
to the previously bracketed 90 day time frame
and the provision was adopted with the rest of
the Protocol on 29 January 2000.
204 UNEP/ CBD/ BSWG/ 3/ 3, p. 19.
205 UNEP/ CBD/ BSWG/ 3/ 3, p. 23.
206 UNEP/ CBD/ BSWG/ 5/ 2, pp. 34- 36, contains the submissions of Ecuador, New Zealand, Peru, Slovenia, Thailand and Venezuela.
207 UNEP/ CBD/ BSWG/ 5/ 3, Annex, see Article 5.
36
III. TEXT OF THE PROTOCOL
Article 10: Decision Procedure
1. Decisions taken by the Party of import
shall be in accordance with Article 15.
2. The Party of import shall, within the
period of time referred to in Article 9,
inform the notifier, in writing, whether the
intentional transboundary movement
may proceed:
( a) Only after the Party of import has
given its written consent; or
( b) After no less than ninety days without
a subsequent written consent.
3. Within two hundred and seventy days of
the date of receipt of notification, the
Party of import shall communicate, in
writing, to the notifier and to the Biosafe-ty
Clearing- House the decision referred to
in paragraph 2 ( a) above:
( a) Approving the import, with or without
conditions, including how the decision
will apply to subsequent imports of the
same living modified organism;
( b) Prohibiting the import;
( c) Requesting additional relevant informa-tion
in accordance with its domestic regu-latory
framework or Annex I; in calculating
the time within which the Party of import is
to respond, the number of days it has to
wait for additional relevant information
shall not be taken into account; or
( d) Informing the notifier that the period
specified in this paragraph is extended by
a defined period of time.
4. Except in a case in which consent is
unconditional, a decision under para-graph
3 above, shall set out the reasons
on which it is based.
5. A failure by the Party of import to commu-nicate
its decision within two hundred and
seventy days of the date of receipt of the
notification shall not imply its consent to an
intentional transboundary movement.
6. Lack of scientific certainty due to insuf-ficient
relevant scientific information and
knowledge regarding the extent of the
potential adverse effects of a living modi-fied
organism on the conservation and
sustainable use of biological diversity in
the Party of import, taking also into
account risks to human health, shall not
prevent that Party from taking a decision,
as appropriate, with regard to the import
of the living modified organism in ques-tion
as referred to in paragraph 3 above,
in order to avoid or minimise such poten-tial
adverse effects.
7. The Conference of the Parties serving as
the meeting of the Parties shall, at its first
meeting, decide upon appropriate proce-dures
and mechanisms to facilitate deci-sion-
making by Parties of import.
The AIA procedure is at the core of the Protocol,
and its importance was reflected in a long and
complex negotiation process. The time limit for
communication of the decision of the importing
Party, the consequences of a failure to communi-cate
a decision, as well as the inclusion of the pre-cautionary
principle in the article on the decision
procedure caused lengthy debates.
The AIA procedure was identified as a consensus
element in the Madrid report208 before COP2 and
in decision II/ 5. BSWG- 1 discussed it as a priority, 209
noting procedures set out in other international
instruments as well as the differentiated capacity
of countries to carry out risk assessment and risk
management. Some delegations submitted their
general views on the AIA procedure for consider-ation
at BSWG- 2.210 At that meeting, a debate was
initiated on the time limit for the response of the
importing Party and the consequences of a failure
to communicate a decision. 211 Many developing
country delegations opposed time limits for a
decision and the interpretation of a failure to com-municate
a decision as implicit consent, stressing
capacity constraints. Norway proposed a 90- day
time limit; 212 the US preferred a specified period to
208 UNEP/ CBD/ COP/ 2/ 7, Annex I, para 18( a).
209 UNEP/ CBD/ BSWG/ 1/ 4, paras. 39 - 43.
210 UNEP/ CBD/ BSWG/ 2/ 2, pp. 15- 28, contains the submissions of the African region, Australia, Canada, Japan, Norway and the US.
211 UNEP/ CBD/ BSWG/ 2/ 6, Annex II, Item A. See also section on Article 9 above.
212 UNEP/ CBD/ BSWG/ 2/ 2, p. 54.
37
III. TEXT OF THE PROTOCOL
respond, after which consent would be deemed to
have been given. 213 The EU and Japan suggested
flexible time limits depending on various fac-tors,
such as the need for further information. 214
Delegations also discussed the range of possible
actions to be taken by the importing Party fol-lowing
notification, outlining prohibition of the
import, approval with or without conditions, and
request for further information. Proposed ele-ments
were presented in the Chairman’s summary
of elements. 215
Following an invitation for new submissions to
BSWG- 3,216 a number of delegations submitted
their views. 217 During the meeting, a drafting
group consolidated the different options for
approval by SWG- I. 218 Elements relevant to this
article in its final form were outlined under provi-sions
on response to notification and on the deci-sion
by the Party of import. Chair Koester organ-ised
the different options further, with a view to
reducing them for BSWG- 4.219 The draft provision
on response to AIA notification contained options
on interim response, time period for decision, and
extension of this time period. The draft provision
on decision by the Party of import contained
options 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. This
note was the basis for the negotiations in BSWG- 4,
while Colombia and the US submitted additional
written proposals. 220
During BSWG- 4, discussion in SWG- I focused on
the time limit for the d