13219 Biosafty

Biosafety First Terje Traavik and Lim Li Ching (eds) BIOSAFETY FIRST – Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms © Norsk institutt for genøkologi (GenØk), Tromsø &Tapir Academic Press, Trondheim 2007 ISBN 978-82-519-2113-8 This publication may not be reproduced, stored in a retrieval system or transmitted in any form or by any means; electronic, electrostatic, magnetic tape, mechanical, photo-copying, recording or otherwise, without permission. Layout: Type-it AS Printed and binded by PDC Tangen As Cover photos: Thomas Bøhn. Tapir Academic Press N–7005 TRONDHEIM Tel.: + 47 73 59 32 10 Fax: +4773593204 E-mail: [email protected] www.tapirforlag.no Editors-in-Chief Professor Terje Traavik Norwegian Institute of Gene Ecology (GenØk), Tromsø, Norway Department of Microbiology and Virology, University of Tromsø, Norway Lim Li Ching Third World Network, Kuala Lumpur, Malaysia Editorial Board Thomas Bøhn Jan Husby Katrine Jaklin Anne Ingeborg Myhr David Quist Norwegian Institute of Gene Ecology (GenØk), Tromsø, Norway Kaare M. Nielsen Department of Pharmacy, University of Tromsø, Norway Lim Li Lin Third World Network, Kuala Lumpur, Malaysia Editorial Staff Marit H. Fenne Olga Goldfain Katrine Jaklin Kamilla Kjølberg Jannik Mennen Graphics Jannik Mennen Figures 1.1, 2.2–2.4, 3.1–3.4, 4.1–4.7 and timeline. Theviews expressed in this book are those of the contributors and do not necessarily represent those of the Editors, nor the organizations they represent. CONTENTS PREFACE 13 INTRODUCTION BY THE EDITORS 19 PART ONE Chapter 1 LIFE ON EARTH 25 Terje Traavik and Thomas Bøhn Chapter 2 INTRODUCTION TO SOME BASIC FEATURES OF GENETIC INFORMATION: FROM DNA TO PROTEINS 41 David Quist, Kaare M. Nielsen and Terje Traavik Chapter 3 THE COMPLEX AND INTERACTIVE PATHWAY FROM (TRANS)GENES TO PROTEINS 49 David Quist, Kaare M. Nielsen and Terje Traavik Chapter 4 GENETIC ENGINEERING OF LIVING CELLS AND ORGANISMS 65 Terje Traavik, Kaare M. Nielsen and David Quist Chapter 5 BASICS ON THE FIFTH NUCLEOTIDE IN DNA, 5-METHYLDEOXYCYTIDINE: A REGULATORY GENETIC SIGNAL 95 Walter Doerfler Biosafety First 8 Chapter 6 UNDERSTANDING THE UNCERTAINTIES ARISING FROM TECHNOLOGICAL INTERVENTIONS IN COMPLEX BIOLOGICAL SYSTEMS: THE CASE OF GMOS 107 Kaare M. Nielsen and Anne Ingeborg Myhr Chapter 7 GE APPLICATIONS AND GMO RELEASE: THE ETHICAL CHALLENGES 123 Anne Ingeborg Myhr and Terje Traavik PART TWO Chapter 8 GENETICALLY ENGINEERED CELLS AND ORGANISMS: SUBSTANTIALLY EQUIVALENT OR DIFFERENT? 137 Terje Traavik, Kaare M. Nielsen, and David Quist Chapter 9 GENETIC ENGINEERING AND OMITTED HEALTH RESEARCH: STILL NO ANSWERS TO AGEING QUESTIONS 153 Terje Traavik and Jack Heinemann Chapter 10 BIODIVERSITY, ECOSYSTEM SERVICES AND GENETICALLY MODIFIED ORGANISMS 169 Gábor L. Lövei, Thomas Bøhn and Angelika Hilbeck Chapter 11 INVASION OF EXOTIC SPECIES: LESSONS FOR GMOS? 189 Thomas Bøhn Chapter 12 VERTICAL (TRANS)GENE FLOW: IMPLICATIONS FOR CROP DIVERSITY AND WILD RELATIVES 205 David Quist Contents 9 Chapter 13 UNINTENDED HORIZONTAL TRANSFER OF RECOMBINANT DNA 221 Kaare M. Nielsen and Daniele Daffonchio Chapter 14 POTENTIAL HEALTH EFFECTS OF FOODS DERIVED FROM GENETICALLY MODIFIED (GM) PLANTS – WHAT ARE THE ISSUES? 239 Arpad Pusztai and Susan Bardocz Chapter 15 DNAVACCINES: MECHANISMS AND ASPECTS OF RELEVANCE FOR BIOSAFETY 253 Anne Ingeborg Myhr and Roy A. Dalmo Chapter 16 MODELS OF SCIENCE AND POLICY 263 Silvio Funtowicz and Roger Strand Chapter 17 THE ROLE OF PRECAUTIONARY MOTIVATED SCIENCE IN ADDRESSING SCIENTIFIC UNCERTAINTIES RELATED TO GMOS 279 Anne Ingeborg Myhr Chapter 18 INDIGENOUS KNOWLEDGE AND MODERN SCIENCE AS WAYS OF KNOWING AND LIVING NATURE: THE CONTEXTS AND LIMITS OF BIOSAFETY RISK ASSESSMENT 287 Brian Wynne Chapter 19 GENETIC ENGINEERING, BIOSAFETY AND INDIGENOUS PEOPLES 303 Victoria Tauli-Corpuz Chapter 20 POTENTIAL SOCIO-ECONOMIC, CULTURAL AND ETHICAL IMPACTS OF GMOS: PROSPECTS FOR SOCIO-ECONOMIC IMPACT ASSESSMENT 323 Elenita C. Daño Biosafety First 10 Chapter 21 PUTTING FARMERS FIRST IN SUSTAINABLE AGRICULTURE PRACTICES 337 Hira Jhamtani PART THREE Chapter 22 A GENERAL INTRODUCTION TO THE REGULATION OF GMOS AND GENE TECHNOLOGY 351 Jan Husby Chapter 23 DEFINITIONS OF GMO/LMO AND MODERN BIOTECHNOLOGY 365 Jan Husby Chapter 24 SUSTAINABILITY, SOCIAL AND ETHICAL CONSIDERATIONS IN REGULATIONS 375 Jan Husby Chapter 25 THE CARTAGENA PROTOCOL ON BIOSAFETY: HISTORY, CONTENT AND IMPLEMENTATION FROM A DEVELOPING COUNTRY PERSPECTIVE 389 Tewolde Berhan Gebre Egziabher Chapter 26 CARTAGENA PROTOCOL ON BIOSAFETY 407 Lim Li Lin Chapter 27 THE WTO AGREEMENTS: AN INTRODUCTION TO THE OBLIGATIONS AND OPPORTUNITIES FOR BIOSAFETY 427 Chee Yoke Ling and Lim Li Ching Contents 11 Chapter 28 INTERNATIONAL STANDARD SETTING ON BIOSAFETY: AN INTRODUCTION TO SOME OTHER INTERNATIONAL AGREEMENTS AND FORUMS 443 Lim Li Ching Chapter 29 THE PRECAUTIONARY PRINCIPLE IN GMO REGULATIONS 457 Anne Ingeborg Myhr Chapter 30 THE PRECAUTIONARY PRINCIPLE AND THE CARTAGENA PROTOCOL ON BIOSAFETY: DEVELOPMENT OF A CONCEPT 469 Hartmut Meyer Chapter 31 LIABILITY AND REDRESS FOR DAMAGE ARISING FROM GENETICALLY MODIFIED ORGANISMS: LAWAND POLICY OPTIONS FOR DEVELOPING COUNTRIES 483 Gurdial Singh Nijar Chapter 32 POST-COMMERCIALIZATION TESTING AND MONITORING (OR POST-RELEASE MONITORING) FOR THE EFFECTS OF TRANSGENIC PLANTS 507 Susan Bardocz and Arpad Pusztai Chapter 33 MONITORING GMOS RELEASED INTO THE ENVIRONMENT AND THE FOOD PRODUCTION SYSTEM 521 John Fagan Chapter 34 PUBLIC PARTICIPATION IN BIOSAFETY ISSUES 555 Lim Li Ching Biosafety First 12 Chapter 35 BIOSAFETY FORECAST SERVICE: THE PRECAUTIONARY APPROACH IN PRACTICAL BIOSAFETY 569 Camilo Rodriguez-Beltran, Billie Moore, Marina Cretenet, Jack A. Heinemann, Joanna Goven and Paul Roughan AUTHOR INDEX 581 GLOSSARY 589 SUBJECT INDEX 607 PREFACE Martin Khor Director, Third World Network Co-founder of the Biosafety Capacity Building Package New technologies often have great potential and promise much, but also need to be assessed adequately in order to ensure that they are safe, as well as envi- ronmentally and socially sustainable. Genetic engineering and genetically modified organisms (GMOs) are examples where, despite promises and expectations of benefits, concerns remain over their potential risks to human health and the environment. Moreover, there are many socio-economic considerations that need to be taken into account, particularly in developing countries where small farmers are the majority of the agricultural community, and even the population. For these reasons, developing countries were very active in the negotiations of the Cartagena Protocol on Biosafety, which came into force in 2003 and is a legally binding international instrument that regulates genetic engineering and GMOs, particularly with respect to transboundary movement. As countries most likely to be importers of GMOs, and as countries most vulnerable to their ecological and socio- economic impacts, developing countries were a strong driving force in ensuring that the principles of precaution and prior informed consent are incorporated in the Protocol. This was all the more necessary as most developing countries do not have adequate laws or regulations on biosafety, and lack the capacity, and technological and financial resources to regulate genetic engineering. This capacity is also increas- ingly questioned in industrialized countries as the science of genetic engineering is still ridden with gaps and uncertainties. Most, if not all, countries lack the capacity to monitor research and development activities and trends, conduct risk assessments, and examine the full health, environmental and socio-economic implications of genetic engineering and GMOs. Developing countries are particularly lacking in this capacity. As such, implementation of biosafety at the national level remains a major chal- lenge. The lack of scientific certainty and gaps in scientific knowledge, and the difficulties faced – even by industrialized countries – in performing risk assessments and evaluating the full impacts of GMOs, mean that capacity building on biosafety is paramount. With capacity building, the context, principles and tools for technology assessment and technology choices can be clarified, and shared with and among developing countries. Capacity building also needs to meet the challenges faced by Biosafety First 14 various countries in making biosafety a reality. Currently, many countries are facing legal, policy and technical issues in the implementation of the Cartagena Protocol on Biosafety, including the obligations of public participation, as well as pressures to approve research, trials, imports, and commercial releases of GMOs. Third World Network has been collaborating with the Norwegian Institute of Gene Ecology (GenØk) and the Centre for Integrated Research in Biosafety (INBI) in New Zealand on biosafety capacity building for several years now. The approach is unique in that it is holistic, which includes an assessment of the health, environment, socio-economic, and cultural aspects of genetic engineering technology. We believe that a science-based (including social sciences) approach, integrating legal, policy and regulatory issues, as well as public participation issues, helps to build the foundation on which developing countries can comprehensively and responsibly assess genetic engineering and GMOs, as well as develop approaches and policies to deal with the challenges. This book reflects the much-needed holistic approach

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