Natural resource MaNageMeNt aNd Policy Series Editors: David Zilberman department of agricultural and resource economics university of california, Berkeley Berkeley, ca, usa Renan Goetz department of economics university of girona, spain Alberto Garrido department of agricultural economics and social sciences technical university of Madrid, spain For further volumes: http://www.springer.com/series/6360 EDITORIAL STATEMENT there is a growing awareness to the role that natural resources, such as water, land, forests and environmental amenities, play in our lives. there are many competing uses for natural resources, and society is challenged to manage them for improving social well-being. Fur- thermore, there may be dire consequences to natural resources mismanagement. renewable resources, such as water, land and the environment are linked, and decisions made with re- gard to one may affect the others. Policy and management of natural resources now require interdisciplinary approaches including natural and social sciences to correctly address our society preferences. this series provides a collection of works containing most recent findings on economics, management and policy of renewable biological resources, such as water, land, crop protec- tion, sustainable agriculture, technology, and environmental health. it incorporates modern thinking and techniques of economics and management. Books in this series will incor porate knowledge and models of natural phenomena with economics and managerial decision frameworks to assess alternative options for managing natural resources and environment. The Series Editors Karinne Ludlow • Stuart J. Smyth • José Falck-Zepeda editors socio-economic considerations in Biotechnology regulation 1 3 Editors Karinne ludlow José Falck-Zepeda Faculty of law international Food Policy research inst. Monash university Washington, dc Vic district of columbia australia usa Stuart J. Smyth university of saskatchewan saskatoon canada isBN 978-1-4614-9439-3 isBN 978-1-4614-9440-9 (eBook) doi 10.1007/978-1-4614-9440-9 springer New york dordrecht Heidelberg london library of congress control Number: 2013954721 © springer science+Business Media, llc 2014 this work is subject to copyright. all rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, reci- tation, broadcasting, reproduction on micro films or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. du- plication of this publication or parts thereof is permitted only under the provisions of the copyright law of the Publisher’s location, in its current version, and permission for use must always be obtained from springer. Permissions for use may be obtained through rightslink at the copyright clearance center. Violations are liable to prosecution under the respective copyright law. the use of general descriptive names, registered names, trademarks, service marks, etc. in this publica- tion does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publica- tion, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. the publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper springer is part of springer science+Business Media (www.springer.com) Abbreviations cBd convention on Biological diversity cPB cartagena Protocol on Biosafety Fao Food and agriculture organization gM genetically modified gMo genetically modified organism Ht Herbicide tolerant iP intellectual property iPr intellectual property right lMo living modified organism sec socio-economic consideration ssa sub-saharan africa tK traditional knowledge v Preface the pace of change seems boundless. New technologies, new products and new ideas emerge on such a rapid basis that simply staying abreast of the changes not only seems, but proves, daunting. innovations in the tripartite fields of information, technology and communications (itc) continue to advance based on Moore’s law. some have boldly predicted, if not the end of this rapid rate of change, a slowdown in the pace of innovation, however, these predictions are all for naught. it is not out of reason that the twenty-first century will witness a greater degree of innovation than the innovation that occurred in all the centuries preceding it. accompanying innovation is change and change brings a multitude of responses. change can be welcomed or rejected by some or can bring uncertainty for others, leading to trepidation, nervousness and in some instances fear. although modern society is based on innovation, it is important to keep in mind that adoption occurs at varying rates for all sorts of reasons, with some countries and cultures leading the way, with others closely following, and yet others languish. innovation displaces current practices and processes, most of these changes being beneficial, but not all. one thing common to all innovations is that they create considerable discourse. agricultural biotechnology and the resulting genetically modified products have triggered rigorous international discussions, debates and dilemmas. response to the innovation of genetically modified organisms (gMos) has been diverse; with some jurisdictions preferring to rely on the market to determine the success of gMos, while others have rationalized a more centralist approach and heavily regulated gM crops. the global debate regarding the acceptance of gM crops has grown particularly acrimonious of late. Most opponents and advocates of the technology continue to talk past each other, with progress on resolving the regulation and trade of gM crops and food products moving at a glacial pace at best. the discussions are spo- radically populated with evidence and facts, however, they are frequently rift with myths, rumours and innuendos. one way to distill the issue to its core is to observe that for the large part, many of the countries that have adopted and produced gM crops, have largely done so using science-based regulations, while non-adopters have often included socio-economic considerations (secs) in domestic biosafety vii viii Preface regulations, as is allowed under article 26 of the cartagena Protocol on Biosafety (cPB). given the global context of the debate on the regulation of gM crops and food products, there is a strong need for a book that compiles expert assessments of the issues relevant to sec assessment of gMos which are, ultimately, also fundamen- tal for decisions regarding whether to undertake such assessments at all. to this end, we have produced an authored and edited book that provides an overview of the inclusion of sec assessment in the regulation of gMos, that: 1. looks at the rationale for the inclusion of secs, in the context of the existing science-based risk assessment systems; 2. through the use of a chapter template, reviews the various factors that can and have been suggested for inclusion in sec assessment; and 3. Provides a meaningful dialogue about the contrasts, benefits and tradeoffs that are, and will be, created by the potential move to the inclusion of secs in the regulation of gMos. it is not intended to assess whether the inclusion of secs should or should not oc- cur. that is a policy decision to be made by policy-makers in each of the federal jurisdictions contemplating the inclusion of secs into their domestic regulatory frameworks. instead, this book is intended to assist in the development of best prac- tice, methods and policy guidelines for sec evaluation implementation and inclu- sion in decision-making. the compilation of materials found in this book will mean that countries and policy-makers will have a clearer, more consistent understanding of the issues raised by each sec and what is required for the evaluation of them so that better informed decisions can be made regarding the inclusion of secs in biotechnology regulation and decision-making. this book is intended to be a resource for a broad audience, not just an audience that supports or opposes gM agriculture. the book focuses on agricultural gM plants and animals. Nevertheless, it can be expected that much of the learning will be relevant to other gMos and sectors. the invited authors represent a spectrum of disciplines and jurisdictions, providing readers with a thorough discussion of relevant issues. it is our hope that the compilation of a volume containing this in- formation will be a resource for all delegates participating in the intergovernmental committee meetings for the cPB. in addition, we hope that this information will be of value to policy-makers in the countries that will be formulating national and regional policy, as well as to industry and non-governmental organizations on these issues. of course, the production of this large undertaking required many hands and the authors are deeply appreciative of the contributions from the invited experts. Without their contributions, the content of the book would be a pale imitation of this highly insightful and knowledgeable compendium. Contents Part I Governance of Agricultural Biotechnology 1 Introduction to Socio-Economic Considerations in the Regulation of Genetically Modified Organisms �������������������������������������� 3 Karinne Ludlow, Stuart J. Smyth and José Falck-Zepeda 2 T he State of Science-Based Regulation and Genetically Modified Crops ������������������������������������������������������������������������������������������� 15 Stuart J. Smyth, José Falck-Zepeda and Karinne Ludlow 3 International Context of Socioeconomic Considerations and the Regulation of Genetically Modified Organisms �������������������������������� 37 José Falck-Zepeda, Karinne Ludlow and Stuart J. Smyth Part II Analysis of Socio-Economic Considerations 4 Benefits to Producers and Society ������������������������������������������������������������ 55 José Falck-Zepeda and Melinda Smale 5 Consumer Choice ��������������������������������������������������������������������������������������� 67 Vivian Moses and siglinde Fischer 6 Environmental Impacts ����������������������������������������������������������������������������� 81 Justus Wesseler and Richard Smart 7 Ethics and Equity ��������������������������������������������������������������������������������������� 97 Paul B. thompson 8 Food Security and Safety��������������������������������������������������������������������������� 109 debra M. strauss 9 Health Impacts ������������������������������������������������������������������������������������������� 125 Martina Newell-Mcgloughlin ix x contents 10 Impact on Biodiversity ������������������������������������������������������������������������������ 145 José Falck-Zepeda, Patricia Zambrano and Melinda Smale 11 Traditional Knowledge ������������������������������������������������������������������������������ 159 Peter WB Phillips 12 Intellectual Property ���������������������������������������������������������������������������������� 177 charles lawson 13 Labor Impacts �������������������������������������������������������������������������������������������� 189 Marnus gouse 14 Market Access and Trade �������������������������������������������������������������������������� 201 crina Viju 15 National Trade Interests ���������������������������������������������������������������������������� 215 guillaume P. gruère 16 Producer Choice ����������������������������������������������������������������������������������������� 229 ari Novy and latha Nagarajan 17 Culture and Religion ���������������������������������������������������������������������������������� 247 alexandra coe 18 Animal Welfare ������������������������������������������������������������������������������������������� 259 Leslie J. Butler Part III Navigating the Challenges �������������������������������������������������������������� 275 19 Ensuring Functional Biosafety Systems ��������������������������������������������������� 277 Karinne Ludlow, Stuart J. Smyth and José Falck-Zepeda 20 Assessing the SEC Landscape and Moving Forward ����������������������������� 295 Karinne Ludlow, Stuart J. Smyth and José Falck-Zepeda About the Authors �������������������������������������������������������������������������������������� 307