ENVIRONMENTALLY AND SOCIALLY 44 SUSTAINABLE DEVELOPMaIT work In pros 19019 for public dIscuslon Februn-a 999 Biotechnology and Biosafety A foru cospnsre *by AAA, Th osraion Fud CGAR -F,,AO, - Gvernment /s of Norwa and Swedent- , ICU i4 '"f I-E 1;9' N. IUN USNAS .. 1x, Smithsonian Instituin A f m CSpNsP,ored b, yO and The World Bank Group Ismail Serageldin and Wanda Collins, Editors ENVIRONMENTALLY AND SOCIALLY SUSTAINABLE DEVELOPMENT Biotechnology and Biosafety A forum cosponsored by American Association for the Advancement of Science The Conservation Fund Consultative Group on International Agricultural Research Food and Agriculture Organization of the United Nations Government of Norway Government of Sweden International Council of Scientific Unions Smithsonian Institution Third World Academy of Sciences Union of Concerned Scientists United Nations Development Programme United Nations Educational, Scientific and Cultural Organisation United Nations Environment Programme United Nations Industrial Development Organization U. S. National Academy of Sciences The World Conservation Union The World Bank Group Biotechnology and Biosafety was a forum associated with The Fifth Annual World Bank Conference on Environmentally and Socially Sustainable Development, held at the World Bank, October 9-10, 1997 Ismail Serageldin and Wanda Collins, Editors The World Bank Washington, D.C. Copyright i 1999 The International Bank for Reconstruction and Development/THE WORLD BANK 1818 H Street, N.W. Washington, D.C. 20433, U.S.A. All rights reserved Manufactured in the United States of America First printing February 1999 This report has been prepared by the staff of the World Bank. The judgments expressed do not necessarily reflect the views of the Board of Executive Directors or of the governments they represent. Cover photographs. Top: A peasant farmer in a northern volcanic area of Rwanda weeds potatoes grown on elevated beds. Bottom: A molecular virologist at the International Potato Center (CIP), Lima, loads an acrylamide "sequencing gel" to sequence the RNA of a potato virus; the resulting genetic finger- print is in the background. Both photos by permission of CIP, one of the centers of the Consultative Group on International Agricultural Research (CGIAR). Ismail Serageldin is vice president, Special Programs, at the World Bank. Wanda Collins is deputy director general for research, Intemational Potato Center (CIP), Lima, Peru, one of the 16 research centers of the Consultative Group on International Agricultural Research (CGIAR). Library of Congress Cataloging-in-Publication Data International Conference on Environmentally Sustainable Development (5th: 1997: World Bank) Biotechnology and biosafety : proceedings of an associated event of the fifth annual World Bank Conference on Environmentally and Socially Sustainable Development / Ismail Serageldin and Wanda Collins, editors. p. cm. - (Environmentally and socially sustainable development) ISBN 0-8213-4242-8 1. Biotechnology-Environmental aspects-Congresses. 2. Health risk assessment-Congresses. 3. Agricultural biotechnology- Congresses. I. Serageldin, Ismail, 1944- . II. Collins, Wanda WilLiams. III. Title. IV. Series: Environmentally and socially sustainable development series. TP248.2.1579 1997 660.6-dc2l 98-23586 CIP s The text and the cover are printed on recycled paper, with a flood aqueous coating on the cover. Contents Preface v Acknowledgments vi Abbreviations and Acronyms viii PART I. BIOTECHNOLOGY AND BIOSAFETY 1 Setting the Stage Introductory Remarks and Stating the Problem Ismail Serageldin 1 The Scientific Scene Werner Arber 5 The Special Case of Agricultural and Food Biotechnology Henry W Kendall 13 Discussion 16 The Promise and the Perils Overview Christopher R. Somerville 22 The Opportunities and the Risks Robert B. Horsch 25 Miguel A. Altieri 31 Discussion 39 Regulatory Framework Issues Chair Hamdallah Zedan 44 Presenters Desmond Mahon 50 Timothy W. Roberts 53 Discussion 57 Reviewing the Evidence Panel 1 Are the Opportunities of Genetically Modified Organisms Being Fully Exploited? Presenters George Tzotzos 60 Gabrielle Persley 62 Carlienne Brenner 63 iii iv Biotechnology and Biosafety Panel 2 Are the Risks of Developing and Releasing Genetically Modified Organisms Being Adequately Evaluated and Assessed? Presenters Rita R. Colwell 65 L. Val Giddings 67 Rebecca Goldburg 69 Discussion 72 Role of International Agricultural Research Biotechnology and Biosafety in the CGIAR System: An Efficient, Equitable, and Ethical Path Timothy G. Reeves 75 Research Partnerships in Biotechnology: Role of the Global Forum on Agricultural Research Fernando Osorio Chaparro 79 Perspectives from National Agricultural Research Systems Maria Jose A. Sampaiao 91 Genetic Engineering: Addressing Agricultural Development in Egypt Magdy Madkour 94 Discussion 99 Role of Public Policy Presenters Vernon W. Ruttan 105 Michel Dron 108 George A. Lloyd 116 Discussion 119 Recommendations for Action Synopsis Wanda Collins 122 Discussion 126 Wrap-up and Next Steps Ismail Serageldin 128 PART II. "ETHICS AND BIOTECHNOLOGY: REALITIES AND UNCERTAINTIES," EXCERPTED FROM ETHICS AND VALUES: A GLOBAL PERSPECTIVE 132 PART III. BIOENGINEERING OF CROPS: REPORT OF THE WORLD BANK PANEL ON TRANSGENIC CROPS 153 Appendixes A.Program 183 B. Presenters and Chairs 185 C. Cosponsors 189 D. Consultative Group on International Agricultural Research Secretariat and Centers 191 Preface B iotechnology-the technique of using liv- Nobel laureate for physics Henry W. Kendall. ing organisms or their parts to make or These findings, published by the World Bank in modify products, improve plants or ani- 1997 under the title Bioengineering of Crops: Re- mals, or develop microorganisms for specific port of the World Bank Panel on Transgenic Crops, use-comprises an important and powerful set are also presented in Part III of this report to pro- of enabling technologies with which to solve an vide the reader with essential background. array of problems. The power of these technolo- The "Biotechnology and Biosafety" conference, gies is unlike any the scientific world of biology an Associated Event of the Fifth Annual World has yet seen, and they are responsible for a true Bank Conference on Environmentally and So- biological revolution. The ability to move genes cially Sustainable Development, was open to the and groups of genes at will, to decipher, to "see," public. Participants represented a wide cross-sec- and to manipulate the molecular codes that make tion of stakeholders-academics, scientists, inter- us individuals, as well as to "demystify" the ge- national and national research organizations, and netic makeup of organisms in nature-these tools representatives from the private sector and civil are now spread before us. society. The special focus of debate was on how The potential risks of biotechnology go well the promises of biotechnology can be realized for beyond those we face directly as humans. They the benefit of the world's poor, the environment, go to the very heart of what makes our world and the safe management of biotechnology prod- survive: the ecosystems in which we live and the ucts and processes. Because of the significant role organisms, both plant and animal, that make of ethics and values in determining choices af- those ecosystems function. New technologies as fecting environmental conditions, an Associated powerful as those of biotechnology carry with Event on this topic was held prior to the Confer- them the burden of making wise and informed ence. The proceedings of this Event, Ethics and decisions of how to use them by asking and an- Values: A Global Perspective, include the chapter, swering questions about their safety and assess- "Ethics and Biotechnology: Realities and Uncer- ing what risks are acceptable to human society. tainties," which has been reprinted in Part II of It is up to all of us as scientists, policymakers, this book as an easy reference to the readers. and concerned members of civil society to make This publication summarizes the wide-ranging, those decisions. stimulating, and provocative presentations and How to maximize the potential of biotechnol- discussions that took place during the meeting. ogy while minimizing risk is a critical issue fac- While there are still dissenting opinions on some ing scientists and policymakers and was the topic issues, there was surprisingly broad agreement of an intensive, two-day conference at the World on many others. In areas of divergent opinion this Bank in October 1997. The event took as its start- frank and open public discussion served to more ing point the findings of a panel of experts com- clearly focus the debate and-just possibly- missioned by the World Bank Group and led by point the way forward. v Acknowledgments Cosponsors American Association for the Advancement of Science (AAAS) The Conservation Fund Consultative Group on International Agricultural Research (CGIAR) Food and Agriculture Organization of the United Nations (FAO) Government of Norway Government of Sweden International Council of Scientific Unions (ICSU) Smithsonian Institution Third World Academy of Sciences (TWAS) Union of Concerned Scientists (UCS) United Nations Development Programme (UNDP) United Nations Educational, Scientific and Cultural Organisation (UNESCO) United Nations Environmnent Programme (UNEP) United Nations Industrial Development Organization (UNIDO) U.S. National Academy of Sciences (NAS) The World Bank Group The World Conservation Union (IUCN) T his conference on Biotechnology and that brought together many of the world's most Biosafety was held as an Associated Event distinguished specialists. of the Fifth Annual World Bank Confer- The governments of Norway and Sweden de- ence on Environmentally and Socially Sustain- serve a very special expression of appreciation able Development (ESSD) and was hosted by the for their financial support, without which the World Bank Group under the auspices of the conference would not have occurred. ESSD vice presidency. In recognition of biotech- The World Bank Group also wishes to express nology's critical importance to science and gratitude to all who participated in this event by society, the event was cosponsored by 17 orga- making presentations or by taking part in the de- nizations. The cosponsors, listed above, deserve bate. Special thanks are due to Wanda Collins and a special expression of gratitude, having contrib- Sarwat Hussain, who organized the event; Joan uted to the organization of an outstanding event Martin-Brown, who oversaw day-to-day organi- vi Acknowledgments vii zation of the entire ESSD Conference and affili- and chairman of the board of the Union of Con- ated events; and Lisa Carlson and other staff of cerned Scientists. Dr. Kendall and the entire the World Bank Group, the CGIAR Secretariat, panel deserve special acknowledgment for their the International Food Policy Research Institute outstanding contribution to the success of the (IFPRI), and all the others whose contributions conference. The panel's report, which includes a made this event possible. list of the panel members, is reprinted in this The background document for this conference volume as Part III. was Bioengineering of Crops: Report of the World This proceedings was copyedited by Alison Bank Panel on Transgenic Crops, which was pre- Raphael, desktopped by Gaudencio Dizon, and pared by a panel of experts chaired by Professor coordinated by Lisa Carlson, Alicia Hetzner, and Henry W. Kendall, Nobel laureate for physics Virginia Hitchcock. Abbreviations and Acronyms AGERI Agricultural Genetic Engineering Research Institute (Egypt) AIDS Acquired immunodeficiency syndrome APHIS U.S. Animal and Plant Inspection Service ARC Agricultural research center BSE Bovine spongiform encephalopathy BSO Biological safety officer Bt Bacillus thuringiensis CBD Convention on Biological Diversity CGIAR Consultative Group on International Agricultural Research CIAT Centro Internacional de Agricultura Tropical CIMMYT International Maize and Wheat Improvement Center CIRAD Centre de Cooperation Internationale en Recherche Agronomique pour le Developpement COLCIENCIAS [Colombia Sciences] CONABIA National Biotechnology Commission CORPOICA Colombian National Research Corporation CTNBio National Technical Biosafety Committee DNA Deoxyribonucleic acid EMBRAPA Brazilian Agricultural Research Corporation EPA U.S. Environmental Protection Agency EU European Union FAO Food and Agriculture Organization of the United Nations FBEC French Biomolecular Engineering Commission FDA U.S. Food and Drug Administration GATT General Agreement on Trade and Tariffs GDP Gross domestic product GMO Genetically modified organism HRC Herbicide-resistant crop IARCS Intemational agricultural research centers IBC Institutional Biosafety Comrnittees ICRISAT Intemational Crops Research Institute for the Semi-Arid Tropics ICSU Intemational Council of Scientific Unions ICT Information and communication technology IFPRI Intemational Food Policy Research Institute viii Abbreviations and Acronyms ix IITA International Institute on Tropical Agriculture IP Intellectual property IPM Integrated pest management IPR Intellectual property rights ISNAR International Service on National Agricultural Research IUCN World Conservation Union KARI Kenyan Agricultural Research Institute LMO Living modified organism MAI Multilateral Agreement on Investment MVs Modern varieties NAGEL National Agricultural Genetic Engineering Laboratory (Egypt), now AGERI NARS National Agricultural Research Systems NBC National Biosafety Committee (Egypt) NGO Nongovernmental organization OECD Organisation for Economic Co-operation and Development ORSTOM French National Research Institute for Development Cooperation R&D Research and development r-DNA Recombinant deoxyribonucleic acid RNA Ribonucleic acid TAC Technical Advisory Committee TRIPS Trade-Related Aspects of International Property Rights UNCED United Nations Conference on Environment and Development UNDP United Nations Development Programme UNEP United Nations Environment Programme UNIDO United Nations Industrial Development Organization UPOV Union for the Protection of Varieties USAID U.S. Agency for International Development USDA U.S. Department of Agriculture WHO World Health Organization WTO World Trade Organization PART I. BIOTECHNOLOGY AND BIOSAFETY Setting the Stage Introductory Remarks and Stating the Problem Ismail Serageldin ebruary 22,1997 was the day on which the Biotechnology could be used to introduce en- F international community was compelled to vironmentally friendly resistance to disease and come to terms with the spectacular prog- pests. It could help develop hardier plants with ress of biotechnology: Dolly the sheep was intro- resistance or tolerance to drought, salt, and her- duced to the world. Dolly's creation immediately bicides. Plant characteristics could be genetically focused attention on a branch of science that is altered to adjust maturation speed, increase trans- little known and less understood by the public portability, reduce post-harvest losses (such as at large. shelf-life), water content, and stem size. All of The promise and perils of biotechnology have these aspects are of great relevance to poor farm- developed a mystique of their own, and the ers in low-potential environments. world was soon buffeted by conflicting stories Biotechnology is also relevant to the poor be- of the possible benefits of scientifically created cause it is seen to be scale-neutral. Unlike mecha- superabundance and possible disasters that nization, for example, it has no intrinsic bias raised fears from Frankenstein's monster to against the smallholder farmer. But the complex- Jurassic Park. More thoughtful concerns were ex- ity of managing refuge areas in Bt transgenic crop pressed about the possible health or environmen- plantings shows that it is not as easy to transfer tal effects of genetically modified organisms as might appear at first blush, unless seed mixes (GMOs), in addition to the ethical concerns of prove adequate to the task. tinkering with nature. In the case of livestock, so essential for the We need to be more dispassionate. Let us dis- smallholder farmer, biotechnology provides the entangle the issues. most important defense against disease, such as Biotechnology could help us to pursue the vaccines for east coast fever in east Africa. mission of environmental protection, poverty The biotechnology revolution is here. It is rel- reduction, and food security by helping to pro- evant to the problems of the world and to the mote a sustainable agriculture centered around work of the World Bank Group and the Consul- smallholder farmers in developing countries. tative Group on International Agricultural Re- Although the first fruits of the new technology search (CGIAR). But for many of us it raises are already benefiting the commercial crops of important questions relating to ethics, intellec- the industrialized countries, there is no inher- tual property rights, and biosafety. Let me say a ent reason why the tools of biotechnology could brief word about each of the two first sets of not be employed in pursuing the mission of issues-whichare not the topic of this conference- environmentally and socially sustainable de- and then try to frame the issues for the remain- velopment. ing discussions on biosafety. 1 2 Biotechnology and Biosafety The Ethical Issues in developing countries where there has been inadequate attention to issues of product safety Not everything that is technically feasible is ethi- in the past. But that should not translate into cally desirable. For some, transgenic tinkering the rejection of all types of activities that are with nature raises fundamental issues, which labeled biotechnology out of fear or ignorance. must be respected. Conversely this must be The correct balance has to be established when weighed against the possible benefits that bio- weighing the benefits against the risks of bio- technology, with adequate safeguards, can bring technology. to the poor and the environment. Fear exists that transgenic plants will turn into These issues were scrutinized yesterday at a weeds; or that biotechnology will provide paths special session that dealt with ethical issues in for new genes to move into wild plants that be- development; they were also the topic of a work- come weeds; or that it will create new viral strains shop held in Brazil under the auspices of the from virus-containing transgenic crops. In addi- CGIAR Genetic Resources Policy Committee tion there is concem regarding possible health some months ago. Such discussions constitute a or environmental impacts of these transgenic or- major step forward in disentangling the issues ganisms in food crops. and, hopefully, creating a consensus as to the Such concerns are real. They must be exam- domains that we should pursue and those that ined dispassionately, and we are gathered here we should eschew. There will always be areas of today in this important seminar, cosponsored by disagreement on such controversial issues, but the most distinguished scientific bodies in the to the extent that they are thoroughly debated world and key international bodies, to do just we should all be wiser for hearing each others' that. We are here to assess scientific evidence on point of view. the safety of biotechnology applications in agri- culture, which should constitute another step in Intellectual Property Rights disentangling the issues. There is no question that intellectual property Possible Actions should be protected. The results of recognition of IPR are increased rewards to the creative and I believe that this conference should lead to two mobilization of resources for research that would types of results. not occur if protection were not there. However First, a collective judgment, a consensus, on proprietary science is beginning to pose some the range of acceptable approaches to the issues problems of access for some of the poorer coun- of biosafety for both biotechnology research and tries and for those needing to use processes for application. I look to this gathering to replicate the purpose of producing public goods. in a small way the achievements of the Asilomar Balancing the need of private investors to have conference a generation ago. At that timne the IPR to recoup their investments and the needs of uncertainty surrounding the new science of re- the poor and future generations to have access combinant DNA research attracted much media to relevant science and suitable products is the attention, which shed more heat than light. Sci- real problem posed by IPR in this new biotech- entists met at Asilomar in California and es- nology revolution, which is not only producing tablished a set of guiding principles, based on undreamed-of breakthroughs, but also is creat- the best available science, to create appropri- ing a totally new environment for science-a ate protocols for research and the levels of domain of proprietary science with a whole new protection appropriate for different kinds of re- set of issues to address. I do not propose to ad- search. It is interesting to see that this set of dress these here. voluntary guidelines, based on a scientific con- sensus and subsequently adopted by many in- Safety Issues stitutions, has served the world well for over a quarter of a century. Nobody would argue that we should not be on Second, a specific set of decisions that each of the lookout for the safety of the public, especially us intends to pursue in the institutions where we Setting the Stage 3 work, which have a role in promoting the adop- nal successes and introduce improvements in tion of the kind of biosafety measures that this adapting new strains. consensus will underline. We will look into this. For the first, I await the results of your delib- erations. For the second, I can say something * Investment in International Agricultural about the World Bank Group and the CGIAR, Research Centers subject to modifications that may arise from the deliberations in the coming two days. The Bank should increase its support for research in biotechnology and related areas at interna- The World Bank Group and the CGIAR tional agricultural research centers, because these centers are in the best position to ensure that high- For the World Bank Group I am happy to endorse quality, environmentally sustainable agricultural the recommendations of the Kendall Panel Re- products and processes are developed and trans- port, entitled Bioengineering of Crops. I propose to ferred in developing countries. urge the Bank to act in accordance with its rec- Our support for the CGIAR will continue. ommendations. In fact, I am happy to note, some of the panel's recommendations are already be- * The Agricultural Challenge ing implemented. The Bank should continue to give high priority to - Support of Developing World Science all aspects of increasing agricultural productivity in the developing world, while encouraging the The Bank should direct attention to the need for necessary transition to sustainable methods. liaison with and support for the developing This is at the heart of our new rural develop- world's agricultural scientific community. ment strategy and the new emphasis that Presi- We will support the newly emerging Global dent James D. Wolfensohn has placed on rural Forum for International Agricultural Research. development. We will continue to support the regionally based For the CGIAR I am happy to report that the NationalAgricultural Research Systems (NARS). Technical Advisory Committee has just ap- pointed two panels, one to look at biosafety is- * Research Programs sues and one to look at IPR and the practice of proprietary science. We await their views for a The Bank should identify and support high-qual- debate on the topic at the annual meetings of ity research programs dedicated to exploiting the the CGIAR later this month. Yet one can still favorable potential of genetic engineering for advance some thoughts for consideration. The improving the lot of the developing world. principles that should guide the actions of the The recently approved loan for agricultural CGIAR can be articulated, fully recognizing research in Brazil is a model of our willingness that the devil is in the details and that the ap- to move in this direction. plication of the principles is where the diffi- culties will lie. * Surveillance and Regulation The CGIAR must play a role in ensuring that: * Access to the potential benefits is guaranteed The Bank should support the implementation of for the poor and the environment formal, national regulatory structures in its cli- * The risks of biotechnology are appropriately ent nations by seeing to it that these structures addressed and adequate biosafety provisions retain their vigor and effectiveness through the are made for developing countries that want years and by providing scientific and technical to benefit from this additional tool. support to the client nations as requested. The This means intensifying certain things we have Bank should support, in each developing coun- been doing. It means adding to our critical mass try, the deployment of an early warning system of scientific effort in the area of biotechnology, to identify any troubles that may arise and to sig- but not at the expense of the heartland issues of 4 Biotechnology and Biosafety people-centered policies, inclusion of the farm ture for the benefit of creating a better world- community, natural resource management, and free of hunger and misery, dedicated to the dig- biodiversity. Let us always remember, too, that nity of people, especially the poor and the future biotechnology is a tool to be used in conjunction generations from whom we have borrowed this with other tools, not an end in itself. planet. Can we define ways in which this can be accomplished in the domain of biotechnology? Envoi Can we create adequate safeguards for use of this powerful new technology? Can we find ways to We often speak of partnerships, of the comple- marry the interests of all these actors? I think that mentary roles played by the public and the pri- we can. I think that this conference will be a ma- vate, the national and the international, the jor step in that direction. formal and the informal, the farmer and the sci- The time for action is now. Let us move for- entist, nongovernmental organizations and ward with all the deliberate speed that practical NARS, and the synergies that we have to cap- wisdom would dictate. The Scientific Scene WernerArber M y intention is to provide background efficiency of gene expression. We may recall here information that could serve to facili- that gene expression usually results in the syn- tate the debate on biosafety. Advance thesis of a specific protein, the function of which in scientific research depends on a number of fac- is often to act as an enzyme; that is, to catalyze tors, of which I would like to briefly mention specific molecular interactions. three: the introduction of novel technologies, the Each gene has a specific length, which may application of new research strategies, and an range from between about 100 to more than essential widening of the knowledge basis, which 10,000 nucleotides. On DNA molecules the genes often involves new conceptual views on natural are linearly arranged, often with space-filling phenomena. For biotechnology all of these fac- nucleotides between individual genes. Interest- tors are relevant, and are in part also intercon- ingly, the genetically well-studied bacterium nected. In order to render their influence on E. coli carries all of its 4,288 genes on a single scientific advance more visible, it might be good DNA molecule, the bacterial chromosome, which to trace important steps in the history of genetics contains 4,639,221 nucleotides. Higher organisms and its applications, paying particular attention carry much more genetic information, which is to biosafety issues. found on a number of chromosomes. In each human cell, for example, the nucleus carries two Background Information on Genes sets of 23 chromosomes representing two sets of and Genomes about 3 x 109 nucleotides. The entire set of cellu- lar genetic information is called the genome. A few definitions might be helpful for a better Of particular interest to genetic engineering understanding. Genetic information is inscribed are small, autonomously propagating DNA mol- on long filamentous molecules of deoxyribo- ecules called plasmids. In some cases their size nucleic acid, or DNA. Its building blocks are four offers space for just a few genes, while in others different nucleotides, which are symbolized by there is space for up to 100 genes. This span of the letters A, T, C, and G. The linear sequences of sizes happens to coincide with the size of viral nucleotides encode the genetic information, simi- genomes, some of which can be carried for peri- lar to the information that I provide to the reader ods of time as plasmids in their host cells. by arranging letters in specific sequences to form In classical genetics a mutation is defined by a words and sentences. The unit of genetic infor- change in the phenotypic appearance of the or- mation is the gene. The two essential parts of a ganism, if such change is transmitted to the prog- gene are an open readingframe, with the informa- eny. In contrast, the molecular geneticist calls any tion becoming expressed if the gene gets acti- alteration in the sequence of nucleotides of the vated, and the signals serving to control time and genome a mutation. Many, but certainly not all, 5 6 Biotechnology and Biosafety changes in nucleotide sequences also cause a ducing particles of some bacterial viruses con- change in the phenotypic appearance of the tain hybrid DNA molecules composed of part of organisms. the viral genome into which a number of host genes had become inserted. Similar observations Roots of Molecular Genetics were made with some plasmids, in particular those involved in promoting bacterial conjuga- During the 1940s scientists realized that bacteria tion. Knowledge of these phenomena was firmly have genes that can mutate similarly to those of established in 1960 and, 10 years later, played the higher organisms. Between 1943 and 1953 they role of a model for vector DNA molecules in ge- discovered three basic natural strategies by which netic engineering. DNA becomes transferred from one bacterium During the pioneering phase of bacterial ge- (the donor cell) to another bacterium (the recipi- netics it had already become clear that natural ent cell): First, donor DNA can become liberated gene transfer by the three processes described into the ambient medium and later penetrate into above is relatively widespread among bacteria, a recipient cell. This process is called "transfor- but that various factors contribute toward seri- mation." Second, donor and recipient cells can ously limiting the efficiency of gene acquisition, enter into direct contact, a phase during which particularly if donor and recipient cells belong donor DNA can be transferred directly into the to different strains of bacteria. These limitations recipient cell. This is called bacterial "conjuga- reside in three areas: the requirement of appro- tion." Third, a virus replicating in the donor cell priate surface compatibilities for the uptake of may enwrap some donor DNA into a viral par- external DNA; the action of restriction enzymes, ticle, which may later infect a recipient cell with which can distinguish foreign DNA from the the donor DNA in a process called "transduc- cell's own DNA and subsequently cut incoming tion." All three processes of DNA transfer can be foreign DNA into fragments; and the need for followed by a recombinational integration of all functional compatibilities, both for the success- or part of the transferred donor DNA into the ful propagation of acquired genes and the bio- recipient genome. In these cases the acquired for- logical functions exerted by the acquired genes. eign DNA is inherited by the progeny of the re- Intracellular DNA fragments resulting from cipient cell, to which the acquisition of foreign restriction cleavage usually become degraded genetic information represents a mutation. within minutes by exonucleolytic enzymes. How- The experimental demonstration of transfor- ever as long as they are still present, they are an mation clearly identified DNA as the carrier of efficient substrate for recombinational integration genetic information. Indeed, if donor and recipi- into the host genome, provided that they find an ent had different genetic traits, a donor trait could opportunity to do so. Thus restriction seriously be acquired by the recipient upon uptake of do- limits DNA acquisition to tolerable levels, but it nor DNA, even if the DNA had been purified also stimulates the acquisition of genetic infor- from associated proteins. This discovery was mation in small steps; that is, of a small DNA seg- made almost 10 years before the double-helical ment at a time. This gives to the resulting complex structure of filamentous DNA molecules was a good chance not to lose functional compatibil- described in 1953. However, the roots of molecu- ity, and thus to survive. lar genetics reside in both microbial genetics and Many restriction enzymes cleave foreign DNA structural analysis of biological macromolecules. reproducibly at the sites serving for their recogni- At about the same time it became clear that tion as foreign. This type of enzyme is widely used some viruses can incorporate their genome in a in gene technology for cutting long filamentous recombinational process into the host chromo- DNA into shorter fragments, which can be sepa- some. The process is reversible, so that at a later rated according to size by gel electrophoresis. date the virus can again assume the virulent phase of its life cycle and produce infectious vi- Major Components of Gene Technology ral particles. It is during this process that some particles may incorporate host genes and later Around 1970 scientists, aware of the results of give rise to transduction. Interestingly, the trans- microbial genetics outlined above, considered Setting the Stage 7 applying this knowledge to develop strategies to as well as potential expression control signals and analyze the giant molecules of DNA that form open reading frames, which can give rise to gene the chromosomes of all organisms. The essential expression. Sequence similarities can suggest components of gene technology include: functional relatedness. 1. Site-specific cleavage of filamentous DNA 7. For experimental studies on the nature of molecules by restriction endonucleases into biological functions, molecular geneticists often shorter fragments. The sites of recognition and place specific mutations at appropriately chosen cleavage are often determined by enzyme-spe- sites in DNA sequences; for example, at strategic cific sequences of four to six nucleotides. Wher- locations in open reading frames or in expression ever such a recognition site is found by chance control signals. This strategy is called "site- in the genetic message, the DNA filament is cut. directed mutagenesis," and was developed in the Several hundred different restriction enzymes late 1970s. The mutagenized DNA sequences are were isolated from different bacteria and are now then introduced into living cells, either as addi- available for genetic analysis. tions to the genome or, more often, as substitutes 2. Gel electrophoresis is an excellent method for the analogous segment in the genome. The to separate DNA fragments of different sizes. It resulting genetically modified organism is then also serves to determine the size of each DNA analyzed for functional alterations, which can fragment resulting from a cleavage reaction. provide relevant information with regard to the 3. Following the model presented by viral biological functions of the genetic information in DNA and plasmids as natural gene vectors, DNA question. fragments can be spliced at will into such vec- tors. When the resulting recombinant DNA mol- Comparison of Classical and New Strategies ecules are introduced by transformation, or other of Genetic Research means, into appropriate host cells, the vector can undergo autonomous replication. In this process Molecular genetics, including gene technology, the inserted foreign DNA fragment also becomes has revolutionized genetic studies over the last replicated. This is thus a good method to prepare 20 years. The new approach, also called "reverse large quantities of a selected DNA fragment, genetics," is in many respects much more pre- which can later serve for further studies. Depend- cise, and thus safer, than classical genetic experi- ing on the particular structure of recombinant mentation. DNA molecules, the inserted genes may also be- In classical genetics scientists start to look for come expressed. In these cases biotechnological mutant organisms with an altered phenotypic uses of the resulting gene products can be con- appearance. If this alteration is inherited by the sidered. progeny, the change is likely to be caused by a - 4. In the 1980s an alternative method of ampli- genetic alteration. From the affected phenotype, fying specific DNA segments was developed on the scientists can often draw conclusions about the basis of knowledge of DNA replication. This biological function. Recombination between dif- is the polymerase chain reaction, which can be ferently affected individuals allows the scientist used if some short DNA sequences located in the to localize on the chromosomes the genetic in- neighborhood of genes to be studied are known. formation responsible for the observed pheno- 5. In the late 1970s efficient chemical methods typic alterations, which leads to the establishment were developed for the analysis of nucleotide of genetic maps. However classical genetics is an sequences. These methods allow the scientist to abstract approach, and does not require knowl- read nucleotide sequences starting from the end edge of which kind of biological molecules carry of a DNA fragment and extending through sev- the genetic information. Hence classical genetics eral hundred positions. Longer DNA sequences begins with observed functional alterations and can then be composed from individual analyses, eventually localizes genes on an abstract linear like a puzzle. map. In order to dispose of enough individual 6. Bioinformatic programs of sequence com- mutants, classical genetics often uses chemical or parison represent an efficient tool to search for radiation mutagenesis acting randomly on the sequence similarities and novel DNA sequences, entire genome. 8 Biotechnology and Biosafety In contrast, in new or "reverse" genetics the to improve yield and quality of the specific prod- scientist knows that genetic information is car- ucts by site-directed mutagenesis of open read- ried on filamentous DNA molecules. Investiga- ing frames and expression control signals. In tions start with DNA, which is purified and addition the specific genetic information to be relevant segments of which are amplified. The used can be introduced into the most appropri- subsequent sequence analysis can reveal poten- ate organism for reliable mass production. How- tial genes by identifying open reading frames and ever it must clearly be said that not all strategic potential expression control signals. Mutations plans designed by scientists lead to success. New are then placed at expected strategic sites by site- genomic combinations are always submitted to directed mutagenesis. The resulting mutants are the force of natural selection. Some genetic alter- reintroduced into the genome of living cells. Such ations may affect the functional harmony of a cell introduction into the germline can result in ge- to a degree that the cell may lose its viability or netically altered organisms. Their phenotypes may not be able to yield the expected product in may show specific alterations, as compared to the useful quantities. The risk of obtaining such nega- original organism. This can indicate which spe- tive responses grows substantially depending on cific biological function is encoded by the gene the extent of the introduced genetic alteration. under study. Hence reverse genetics starts from These considerations imply that a careful DNA as carrier of genetic information and inves- molecular genetic approach toward developing tigates the biological functions expressed by the beneficial uses of biological functions by biotech- studied DNA segment. nology can largely ensure the biosafety of the The strategies involved are very purposeful. productive organism. This statement can be sub- The researcher knows which kind of mutations stantiated as follows. Let us relate the genetic are placed at which specific sites in the genome information of genomes with the information and is also able to verify the result of the inter- contained in books by comparing the number of vention. This contributes strongly to the minimi- nucleotides of a genome with the number of let- zation of biohazards in the experimentation ters and open spaces in our written language. The process. The new genetics contrasts with the old genome of E. coli bacteria roughly corresponds habits of random mutagenesis practiced in clas- to the contents of a book the size of the Bible. sical genetics by the application of mutagens to Higher organisms, such as human beings and entire genomes without an efficient way to verify certain plants, have genomes with information the outcome of the manipulation. that would fill up an encyclopedia of about 1,000 volumes! A single gene may correspond to be- Gene Technology Benefits Biotechnology tween a few lines and one-to-two pages. In site- specific mutagenesis, usually one or relatively Biotechnology applies acquired knowledge on few letters are substituted by others, or they are biological functions by the strategic use of such deleted or added by insertion. Alternatively, in functions for the benefit of mankind and also, the production of a transgenic organism, one or more and more, to sustain ecosystems. The de- a few pages containing one or a few genes are velopment of biotechnology is very similar to that isolated from the encyclopedia of a given organ- of genetics. ism and transferred into a volume belonging to In classical biotechnology, appropriately se- the genetic encyclopedia of another organism. In lected organisms were used as they were found any of these manipulations the researcher can in nature. Improvements of quantity and quality clearly verify the result of the modification both of useful products were sometimes reached by at the level of the genome and at the gene prod- breeding strategies often using random mutagen- ucts. As expected such genetic alteration nor- esis and appropriate screening techniques at the mally does not affect the basic nature of the selection stage. concerned organism. A mouse is still a mouse, a Modern biotechnology proceeds quite differ- bacterium is still a bacterium, and a rice plant is ently. It benefits from the exploration of molecu- still a rice plant. The genetically altered organ- lar mechanisms of biological functions. In view isms may simply display changes in one or a few of a targeted use of such functions, it is possible of their phenotypic properties, which can easily Setting the Stage 9 be monitored. Again we see that advanced tech- Involvement of Evolutionary Genes nology ensures not only more efficiency but also in Microbial Evolution a considerable reduction of biohazards, if the appropriate controls are carried out responsibly Fifty years of intensive research in microbial ge- and conscientiously. netics with bacteria and their plasmids and vi- ruses yielded a large amount of experimental Genetic Engineering Involves Steps data, allowing researchers to develop an accu- in Biological Evolution rate picture of the molecular evolution of these organisms (see figure). Bacterial evolution de- Site-directed mutagenesis and the deliberate pends on three natural strategies of genetic varia- transfer of genetic information from a donor or- tion. The first of these strategies brings about ganism into a recipient organism, resulting in a small local sequence changes such as a nucleotide transgenic organism, represent alterations in the substitution, a small deletion, a small insertion, genome of the concerned cells and organisms. or a small sequence duplication. These changes These alterations may or may not lead to pheno- often result from replication infidelities that oc- typic changes in the concerned organisms, just cur spontaneously with low probability. Efficient as is the case with spontaneous mutagenesis. DNA repair systems considerably limit the fre- Let us recall that mutations are the driving quency of mutations produced by this route. The force of biological evolution, but that only a small same is true for local sequence changes due to proportion of spontaneously occurring genetic the action exerted on DNA by internal or envi- alterations result in better fit organisms. The term ronrnental mutagens. "better fit" in this context means that the mutant The second strategy of genetic variation in- experiences an advantage under the encountered volves the rearrangement of the genetic informa- living conditions, as compared to its parent that tion of the genome. This may be initiated by a did not suffer a genetic change. This process, mutagen such as ultraviolet or ionic radiation, called natural selection, occurs based on the but more often it depends on the activities of effects of all the gene products present in the liv- mobile genetic elements or of site-specific or other ing organism. One can thus state that the direc- recombination systems. These are very wide- tion of biological evolution is determined by the spread in bacteria, and they occasionally bring process of natural selection, although it also de- about a recombinational reshuffling of the ge- pends on the chance availability of better fit mu- nomic DNA. These processes are mediated by tants. In order to complete the inventory of factors specific enzymes encoded by genes forming the influencing biological evolution, we should also essential parts of mobile genetic elements and mention that reproductive and geographic isola- other recombination systems. tion can affect the evolutionary process. The third natural strategy to increase genetic Spontaneously occurring genetic alterations diversity is DNA acquisition. As noted earlier this are usually more or less random in time and with process involves horizontal transfer of DNA, regard to the location on the genome involved. which is normally also mediated by enzymes. In contrast the genetic engineer introduces de- In natural mixtures of bacterial populations liberate changes at well-chosen genome locations. any of these three strategies steadily yields new However, as is the case under natural conditions, genetic variants. With modern molecular genetic the products of genetic engineering are also sub- techniques it is possible, although labor-inten- mitted to the force of natural selection. The only sive, to determine the contribution of any single interference that the scientist may apply at this mechanism producing genetic alterations at the stage is to choose particular living conditions to genome level. The three strategies are not mutu- be offered under containment. This may play a ally exclusive; they work in parallel to each other role in biotechnological applications. These con- and each makes qualitatively different contribu- siderations suggest that a good understanding tions to the overall genetic variation. of the basic mechanisms of biological evolution Local sequence changes represent a major can be essential for the assessment of biohazards source of new biological functions and play an related to genetic engineering. important role in the step-by-step improvement Sources of genetic diversity j Limitations of genetic diversity Isolation Reprod. Strategy of Geogr. Genetic Variation: Sources of Mutation: Local . Replication sequence < infidelity Repair processes change _ Mutagens Genetic DNA Internal diversity rearrangement Environmental deA CD . Recombinational reshuff ling ^ reshuffxing Natural selection DNA i Horizontal Living conditions acquisition gene transfer L cnditi ns _ . Phys.-chem. environment . Biological environment Size of biosphere (- 1030 living cells) Note: Synoptic presentation of main factors involved in bacterial evolution. Source: Author. Setting the Stage 11 of available biological functions. One can assume efit of each individual cell, such as housekeep- that, in general, many consecutive steps of mu- ing genes and accessory genes of use under tagenesis are required before a properly function- particular life conditions, but also carries evolu- ing novel gene is obtained. Thus, per step of tionary genes, the products of which act to the mutagenesis, this strategy is relatively inefficient. benefit of the evolutionary development of popu- In contrast DNA acquisition is, from an evolu- lations. Obviously the products of some bacte- tionary perspective, a very efficient strategy. The rial genes may serve both purposes, but a good acquisition of a gene for a function that had ren- number of evolutionary genes make no essential dered service in a donor organism often brings contributions to individual life. an advantage to the recipient organism. The ac- A potential generalization of the theory of quisition strategy may have its main relevance molecular evolution, as presented here along for accessory genes of use under particular liv- main lines, has not yet been seriously discussed ing conditions, such as genes providing resistance by the scientific community. It is feasible that to antibiotics. But acquisition may also provide higher organisms also carry evolutionary genes. means to modify housekeeping genes by conver- It might, however, be more difficult to identify sion. Thus DNA acquisition can be seen as a shar- them because of the higher complexity of the life ing of successful developments made by others. cycle of higher organisms, including differen- DNA rearrangements can bring about an im- tiation, for which still other specific genes play provement of available capacities. The recombi- important roles. national fusion of gene segments representing different functional domains can bring about new Uniqueness of DNA Sequences Longer gene activity, and the fusion of an expression con- than 80 Nucleotides trol signal with a specific open reading frame can bring the latter under a different control element. In principle gene technology can aim to introduce At this point it should be reiterated that there any possible DNA sequence into a given genome. is no experimental evidence that any of these In reality, however, the proportion of possibili- processes would be principally adaptive; that is, ties that can be explored through experimenta- that they will respond specifically to a perceived tion is extremely small. This has to do with the need under an encountered living condition. fact that with the four-letter genetic alphabet, tre- Rather the genetic variations are nondirected, and mendous numbers of different sequences can be it is natural selection that favors the rare "better written. For a sequence with only ten letters there fit" mutants and disfavors a majority of the novel are 410 = 106 (one million) different ways to ar- mutants, which as a result will more or less rap- range the four letters. A row of 100 letters can be idly disappear from the mixed populations of arranged in 1060 different ways and a row of 1,000 genetic variants. letters (corresponding to a gene of medium size) Enzymes are involved in all of the molecular in 106°0 different ways. processes bringing about occasional genetic In this context it may be of interest to estimate variations. Many of these enzymes are not how often a given DNA sequence may reappear needed for the life of individual bacteria from in the course of the evolutionary process. To do one generation to the next. We therefore postu- so we can roughly estimate the biosphere of the late that the enzymes contributing in one way or planet Earth to accommodate about 1030 living another to increase genetic diversity in microbial cells at any time. This number results from the populations may primarily serve the purpose of estimated volume of the condensed biosphere biological evolution. The genes encoding these and from the known average volume of living enzymes are thus called evolutionary genes. In a cells. Let us further assume that, on average, each crude way these genes can be grouped into two living cell carries in its genome 105 different stan- classes: those which generate genetic variations dard genes. We know that life on Earth has ex- (by DNA reshuffling), and those which modu- isted for about three billion years, or about 1015 late the frequency of genetic variation (by DNA minutes. If we assume that in each of these genes repair). According to this view the bacterial ge- one new sequence had been explored per minute nome carries not only genes working to the ben- (which is far more than corresponds to today's 12 Biotechnology and Biosafety known mutation rates), we can calculate the to- edge on the mechanisms of molecular evolution tal number of sequences already explored in na- outlined above. ture to amount to 103 x 105 x 1015 = 1050 sequences, At present no theoretical basis for allowing sci- which may be unique if none of the sequences entists to devise a new kind of gene expressing a had been tested more than once. With these novel function is available. All that can be done simple considerations we can locate the thresh- is to start from existing genes (the functions of old of sequence lengths to uniqueness to be at which have already been explored) and to try to about 80 linearly arranged letters. Indeed, a se- change these functions to satisfy possible needs quence of 80 letters can be written in 1048 differ- for biotechnological applications. Even for such ent ways. We are aware that a sequence of 80 minor interventions we still lack general theoreti- nucleotides may roughly correspond to a func- cal rules, and predictability is accordingly low. tional domain or to a very small gene, while most However as was already said, gene technology genes are much longer than this and thus must offers a good means to experimentally test prop- be unique from the evolutionary standpoint. This erties of organisms with engineered genetic implies that genomes have a high degree of alterations. In this sense molecular genetic strat- uniqueness even in haploid clonal organisms egies are much more precise, more reliable, and such as bacteria, which is a stringent consequence thus less hazardous than classical breeding meth- of steadily exerted spontaneous mutagenesis. ods. Still, the tremendous richness of different What do such considerations have to do with potential DNA sequences, and the fact that na- biotechnology and biosafety? They can help us ture does not always precisely follow the plans to bring natural biohazard and biohazard-related designed by genetic engineers, justifies the call objections to genetic engineering into the right for caution and responsibility in any work done perspective, if we also are aware of the knowl- with genetic information, to minimize biohazards. The Special Case of Agricultural and Food Biotechnology Henry W Kendall J am grateful for the chance to speak today on The industrial world's population is hardly some of the problems and opportunities pre- growing at all, but in the developing world sented by the emerging technology of genetic growth rates are quite high. At the present time engineering of crops. I am grateful to Ismail there are roughly 1 billion people living in con- Serageldin for his initiation and support of the ditions that the World Bank Group describes as report that is the focus of this meeting and for utter poverty and another half-billion people his warm reception of its recommendation. who do not get enough to eat and suffer con- What I would like to stress in my remarks has tinued malnutrition. The group of half billion not so much to do with the science involved in people that I mention, in aggregate, is growing biotechnology. A particle physicist by trade, I at a rate of about 2.8 percent per year, which, if have been, over 25 years, involved in numerous continued, will result in a doubling in the size of controversies in the public domain in which sci- this group in 24 years-an extraordinarily short ence and technology have played a major role. time. These technologies have not always been care- The challenge is to ensure that the world's ex- fully managed, a root cause of difficulties and panding population has enough food to eat, to consequent controversy. As you know, the great avoid the continuing infliction of misery upon a power of science and technology can bring with fraction of them. A number of groups have stud- it both benefits and, in some cases, trouble. Thus ied prospective food demand, and there is a gen- the introduction of technical advances must be eral agreement that, because of improving thoughtfully managed in order to maximize the circumstances in much of the world, food de- benefits and minimize the side effects. Matters mand will double in roughly 30 years; that is, de- of this sort have received much of my attention mand will grow faster than population growth over many years. My remarks will be directed at over the next decades. the means of introducing this new technology as This doubling of demand comes at a point well as other problems that must be addressed when there is very little additional potentially in the agricultural sector. arable land for expansion, and what land there The biotechnology issue arises as one part of is to expand into is generally of much lower qual- the solution to a great nest of problems that the ity than that which is already in use. human race faces at the present time-problems Water is in short supply in the world. Forty of environmental pressures, many of them ad- percent of the world's present population lives verse and some quite damaging, as well as re- in areas that are chronically short of water, and source mismanagement problems, all of which the scale of human activity is so large that at the occur in the context of a continuing swell of the present time we already use more than one-half world's population. of all of the fresh water that is potentially avail- 13 14 Biotechnology and Biosafety able to us. Provision of adequate water supplies are inappropriate, such as the improved appear- represents a daunting challenge. ance of fruits or vegetables. We do not have the I think it is clear that the industrial world is mechanisms fully in place to get the necessary not going to suffer food shortages. No matter and important research and development carried what happens, they will always have the eco- out that will benefit developing world agricul- nomic resources, the strength and power, to feed ture. Here the World Bank Group can play a lead- themselves adequately in any manner they wish. ing role in expanding the horizons of helpful It is in the developing world that hardships will research and can aid in guiding it. be inflicted if there is an incapacity or failure to Biotechnology may prove to be a helpful fac- meet the growing demand for food. I want to tor in meeting the pressing need for expansion emphasize that in the face of the challenges in of food supplies. But by itself, it clearly cannot the food sector, 30 years is no time at all. suffice. Far more will be required. There is a list If demand is not met, there will be grave diffi- in the report of other actions that must be taken culties in the future-not the distant future, but and avenues that must be explored. We call at- soon. One can see pieces of these difficulties aris- tention to them because they are very important. ing at the present time, such as the production of The list includes such things as a continued em- migrants from environmentally injurious activi- phasis on improvements by conventional genetic ties in the host countries; migrants that stream techniques, integrated pest management, and the within countries and across national borders. control of a very troubling difficulty in agricul- Such displaced people are already becoming a ture, which is agricultural activities that are dam- challenge to the developing world and to indus- aging arable land and harming sources of water trial nations, and their numbers are increasing. for irrigation. Thus while the industrial nations will remain These damaging activities are numerous and well fed into the indefinite future, the difficul- very serious. Erosion continues to be a major ties that arise from food shortages will not be re- problem in many parts of the world. There are stricted to the developing nations where they are substantial uncertainties in estimates of the rate most troubling, but will affect all nations in our at which soil is being washed away, eroded, and interdependent world. It is not true that one end lost to agriculture. But they suggest that this loss of a boat can sink. We will all feel troubled and may be in the vicinity of 0.7 percent per year. That bear a heavy burden if the industrial nations do sounds very small, a loss which might be easily not help to expand world food supplies. accommodated, almost negligible. Indeed the It is necessary to exploit every avenue that may consequences over a few years can go unnoticed, potentially benefit the expansion of food sup- easily masked by improvements in agricultural plies. Biotechnology is one element that can aid techniques. For a short period increases in pesti- in such an expansion. It is a powerful technol- cide or fertilizer use will conceal the conse- ogy. Its full potential has not yet been explored quences of soil loss. But if the loss rate persists (much less exploited) and like all powerful tech- over half a century or a century, very substantial nologies it must be guided carefully so that fractions of the world's soil will be lost. By the unexpected harm does not accompany its utili- year 2100, at the current rate, we will have lost zation. In addition biotechnology must be ex- over 30 percent of the world's soil, an irrevers- ploited in such a way as to maximize the benefits. ible loss, nearly impossible to make up and with Much of the incentive to develop biotechnol- a major impact on agricultural productivity. One ogy improvements in crops arises in the indus- can see the consequences of harsh erosion, for trial nations. It is the industrial nations that have example, in Haiti, where large sections of former the resources, both intellectual and economic, to agricultural land have been reduced to barren push the research necessary to exploit the technol- fields, where no further erosion is even possible. ogy and bring the results to widespread adoption. So there is much to do. The incentives that drive these improvements There are also difficulties in water manage- are those of the industrial world. But for the de- ment: over-pumping from fossil water supplies, veloping world the needs are different, and so which are only very slowly recharged; intrusions some of the incentives drive developments that of salt water in coastal fresh water aquifers that Setting the Stage 15 are being pumped for irrigation; and over-irri- nations are growing as well. Many of them con- gation and resulting buildup of salt in the soil. tribute not only through fossil fuel use, but also Thus water management is another problem area by the cutting and burning of forests, both tropi- that needs more attention than it is currently cal rain and temperate forests. The need to start getting. the transition away from fossil fuels is immedi- One additional difficulty is very likely to be ate, in no small measure because avoiding dis- damaging in the future: disruption of the climate ruption of agriculture is of such great importance. from greenhouse gas warming. These gases are There is suddenly, and I may say happily, very largely, although not entirely, the consequence of much increased attention to this issue through- fossil fuel use. Possible climatic change has out the world. In the United States President claimed the attention of climate experts for many Clinton has, within the past few months, seized years. Indeed, warming of the climate from fos- it as a major topic and a high priority for him sil fuel use was identified as a possibility in the and his Administration. The hope is that the first last century, although scientists' warnings have binding agreements between nations on sched- been neglected until recently. ules and goals for the reduction of global carbon From the scientific information now on hand dioxide emissions will soon come into being. it appears that human activities already have had In order to carry out the changes I have men- a discemible effect on the climate. I have con- tioned, plus a number that I have not mentioned, cluded that the most damaging and widespread there is a great need for competent science in the consequence of climatic change is going to be felt developing world. This issue is mentioned in the in agriculture, because agriculture is a system that recommendations of our report. One recommen- is already coming under stress and experiencing dation calls for an outreach that fosters the edu- daunting pressures that will continue in the de- cation of scientists in developing nations; gives cades ahead. them links to scientists in the industrial world; What should be done about possible climate and allows them to be part of their government's disruption? The broad conclusion of the scien- planning, organization, and control not only of tific community is that the human race must di- biotechnology, but of the great changes in energy minish greatly its use of fossil fuels, substituting use which will have to accompany all of these energy sources that are benign, renewable, and changes. do not put heavy pressure on the global environ- The World Bank Group has a critical role to ment. This includes energy captured from the play in all of these matters-biotechnology as a sun, the winds, the oceans, and if possible from piece of the food problem; the World Bank Group biomass-so-called energy crops. Nuclear power as a helper with the greater problems of energy might contribute, provided its difficulties related change and energy use in the developing world; to safety, economics, waste disposal, and public and with the development of scientific liaison, acceptance can be resolved. It is both technically the scientific networks that are so important to and economically feasible to make such an en- the developing world; and the proper use (and ergy transition, although the scale of energy use control of misuse) of biotechnology and other worldwide makes it an enormous enterprise. technologies. Implementing the transition is thus a daunt- Over the years I have been on a number of ing challenge in its own right. The industrial na- panels of one sort or another and every now and tions so far have been the greatest emitters of then I chair one. It is uncommon that the reports carbon dioxide, the principal greenhouse gas. But are carefully read by the host organization. It is emissions in the developing world are increas- even more rare that the recommendations are ing rapidly. At present China is the second larg- embraced as warmly as the ones in this report, est emitter of carbon dioxide in the world, after and for that the panel is extremely grateful. the United States; emissions in other developing Again, my thanks to Ismail Serageldin. Discussion Moderator: Peterj Matlon Peter Matlon: The Kendall Report sets out a as though there are potential benefits, but only uniquely accessible and thoughtful set of perspec- hypothetical risks. tives and recommendations on the issue of biosafety. Over the next two days we will be try- Werner Arber: The historical development of ing to move toward a consensus as to what the antibiotic resistance in enterobacteria is a very institutional responses to the opportunities and interesting case. I think we must be aware that challenges of biosafety should be. We will address thanks to this development, microbial genetics the question of how to work together more effec- has made more rapid and larger advances toward tively in regard to biosafety issues, and we will better understanding the evolutionary process, work toward the creation of regulatory mecha- because in around 1960 this became a serious nisms and stimulation of greater awareness medical problem and many investigations were among decisionmakers in developing countries devoted to understanding what has happened. so that they can address these issues in a thought- This horizontal transfer is a normal process. It ful and responsible way. usually occurs at low rates; but if it occurs in large populations, and these large populations are then Mae-Wan Ho: I am here representing the Third exposed to more than one antibiotic, only the few World Network as a scientific adviser. What lucky bacterial cells that recently have acquired Werner Arber might have also mentioned in his such genes will survive and very quickly over- presentation is that the viruses and plasmids used grow the previous population. in horizontal gene transfer also carry antibiotic The measures taken beginning early in the resistance genes, which are routinely used as se- 1950s and particularly in the early 1970s were lectable markers for genetic engineering. A main first, to be quite careful and not prescribe antibi- concern is the possibility that horizontal gene otic treatment if it is not really needed. Second, transfer might inadvertently generate new vi- you may be aware that in the first enthusiasm ruses, new pathogens, which in this case which about the action of antibiotics, they were mixed are also antibiotic-resistant. into cattle feed in order to prevent infectious dis- I would like to ask Werner Arber whether there eases and improve their health. But when this is a need to reexamine this very large-scale com- antibiotic resistance came up, an agreement was mercial genetic engineering biotechnology that rapidly reached between the medical and agri- we are engaged in, because the whole orienta- cultural world to use diffrent antibiotics for hu- tion of industry is to facilitate and enhance hori- man medicine and animal feed additives. zontal gene transfer between unrelated species. We have to live with these resistances, and the I also want to ask whether, if we do not have ad- industry has undertaken to look for new antibi- equate regulations, it is a good idea to proceed otics. I think this is a good example of the need 16 Setting the Stage 17 to be aware that we have no absolute security. Henry Kendall: I find it both interesting and Evolution goes on and fills gaps that all of a sud- pleasing that all of the questioners are raising den open up. We have to live with that. The only issues that go beyond biotechnology itself to message I can give you is that it is quite impor- touch on either closely or distantly related tant that the knowledge of the evolutionary pro- problems. It is important to do that in general, cess at the molecular level become better to take a look at the breadth and depth of diffi- understood. I think one can also learn from be- culties. This is becoming increasingly important havior, particularly with regard to measures for in our society. biosafety, if one understands the natural evolu- Let me come to the remark that may have been tionary process. misunderstood with respect to the industrial What can we do about it? I do not think that world and the developing world and the capac- we have any way to change the course of natural ity of those groups to feed their people now and evolution, but we can learn. Once we understand, in the future. There is hunger in the industrial we can be aware and watch it more closely. world. There is hunger and malnutrition in the United States; this has been a growing problem, Michel Petit: I am with the World Bank Group. I especially since the 1980s. The way this was would like to ask the two panelists, particularly stated in the biotechnology report is as follows: Werner Arber, who was not a member of the "The wealthy nations have high levels of nutri- Kendall panel, to comment on the following. tion and will have little problem supplying all In the Kendall Report four risks are identified, their citizens with adequate food when they wish and my understanding is that these are indeed to do so." The resources are certainly there to do the risks that biosafety should be concerned with: so in the wealthy nations. This is not necessarily gene flows to wild plants; development of new true in the developing world. viruses; the effect of plant-produced insecticides; and more broadly, ecosystem damage. Ismail Serageldin: I have one brief comment, be- My question is: Are these really the four risks? cause there is an implication that sometimes Are there others that we should be concerned things have to be mutually exclusive. When you with? And does he have any advice for us to pass talk about India being food self-sufficient or not, on to governments about what they should be the fact is that right now India has some 33 mil- doing to develop biosafety regulations? lion tons of surplus grain; surplus in the sense that it is available in storage. The big problem is Audience question: My main question is about access and distribution, which is associated with long-term impact. When you discuss issues of extreme poverty. This is not to say that if it were genetics, you are discussing issues that may just a matter of production there would not be a have impact at this very point or maybe within single hungry person in the United States, but five years. But sometimes impact will only be that is not the issue. felt after 25 or 30 years, and by then it may be Production is extremely important, because if irreversible. there is not sufficient production, prices will in- The Green Revolution in India is a classic ex- crease and those who do not have access will be ample, which leads me to the second question. even greater in number. So production is a nec- We worked on the study of Green Revolution, essary, but not sufficient, condition to deal with which supposedly brought bountiful food to In- the issue of world hunger. I think this is an abso- dia. We are told by the government that India is lutely essential point. It is not an either/or issue; food self-sufficient. In reality, it is not. but if you do not have production, then you will Today, according to the government of India, have hunger because there will be greater ration- one out of five Indians are malnourished; there ing of available resources. is insufficient food available to them. That is the Having plentiful resources does not mean that case practically all over the developing world. everybody has access. The operative words in the So the question of this bountiful food that may Kendall Report is that the industrialized coun- come due to all these kind of changes, I think, tries can feed everybody in their societies if they should be examined more carefully. so wish, if they have the political will to ensure 18 Biotechnology and Biosafety that there is access to the poor and the margin- There is a well-documented study from the alized and the excluded in society. School of Microbial Ecology at Michigan State The issue of increasing production within the University that shows that even organisms from available parameters of land and water requires virgin soils already have antibiotic-resistant that we make use of all the tools that we can, but marker genes, where no one in the recorded his- taking care of two things: safety, and ensuring tory of that piece of land or soil had ever even that we do not rush blindly into things, while at stepped. the same time being fully aware that the produc- The other important technological advance tion side is only one half of the equation. coming on the horizon is that once a marker gene The recommendation of the Report, which the is put into transgenic plants, once a selection is World Bank Group certainly adopts, is that pro- already done, there are mechanisms by which duction is only one piece of the problem. Biotech- you can get rid of these marker genes. These nology is only one piece of production; it is not a things are coming along, and hopefully in the silver bullet, but rather one piece of the whole very near future we will have technologies that picture. would completely get rid of these so-called marker genes. Then the transgenic crop lines or Henry Kendall: There is a widely believed, but organisms that will be eventually field-tested mistaken, idea that turns up in public opinion may not have these genes at all. polls in the United States that science and tech- nology will in some way rescue us from these Jeremy Wright: I am from the Wellness Founda- difficulties that we have been discussing. The tion and I would like to ask a question about what senior scientific community in the world does not we do if something goes wrong and how is that believe that, because the problems are at root handled. I would like to ask the panel questions human problems, not purely technical problems. about liability, about responsibility, and how in- That is not to say that science and technology dividual citizens, and indeed governments, will are not important. They are critically important deal in the future not just with the containment and, in fact, science and technology have become issue if something goes wrong, but with public a life-support system for the human race as it health issues, and also with the issue of liability currently carries out its activities. Science and and responsibility for global health issues that technology will play extremely important roles- can arise from a major mistake. biotechnology is one example-in securing a de- cent future. But many profound changes have to Henry Kendall: I would like to respond to the be made in the human approach to these prob- very interesting and important questions con- lems before we will really be in a position to solve cerning what to do if something goes wrong. This them. is clearly the other side of the question that our Report addresses in detail, which is how to make Sivramiah Shantaram: First and foremost, gene sure that everything goes right. But that is never escape is only possible in the plant kingdom guaranteed. through vertical gene transfer, which is through Because the important biotechnology improve- sexual transmission among sexually compat- ments that will be needed prospectively have not ible species. It is not very clearly known whether yet been carried through and deployed widely there is horizontal gene transfer from plants to in the developing world, any answer I give as to other organisms, such as animals and micro- what to do-what will get done, as opposed to organisms. what should get done should something go Second, fear of the antibiotic-resistant marker wrong-has to be answered hypothetically. We genes that are in use comes from the examples have recourse only to historical, idiosyncratic that people have now gotten from clinical envi- data, which unfortunately is scattered. ronments. I think it is mostly due to the misuse Various sorts of things that have gone wrong or overuse of antibiotics and chemotherapy, as in the past in other technologies have been dealt opposed to the resistance gene itself. In fact, the with in a variety of ways, some of them good, resistance gene has already spread. but by no means all of them. In the area of bio- Setting the Stage 19 technology our panel has attempted to set out crops, the tremendous multiplicity of food sys- the circumstances that would lead to controls tems that farmers all over the world have devised before widespread injury is visited on somebody over the centuries. as a result of something going wrong. Such con- Ismail Serageldin mentioned that biotechnol- trols would require support by the World Bank ogy does not discriminate against the small Group and other people of appropriate regula- farmer. Theoretically, scientifically, that is true; tory structures in each nation that will be exploit- but institutionally, socially, and economically, the ing biotechnology advances. It would not be the way things are organized now, it may not be true. World Bank Group's responsibility, but many of I would like to invite people to address that in us believe that this is needed badly in the United this session and in the sessions that follow. States, as well. Maybe the World Bank Group can help there. Ismail Serageldin: I think there is a major set of So in most cases it is possible, in principle, to issues that deal with socioeconomic organiza- identify who should be responsible if something tion-governance issues, marginalization of the goes wrong. The challenge is to get the mecha- poor and particular constituencies, discrimina- nisms in place to make that identification, set up tion against women farmers, in particular-in the guidelines, make sure that everybody knows many of the parts of the world. For example, in who would be responsible, and have obvious Africa women produce 80 percent of the food, mechanisms for redress so that there is some cau- yet they receive 10 percent of the wage labor and tion in the marketplace. That is what one hopes 1 percent of the land. There are many such issues. will happen. Biotechnology does not discriminate against The sad alternative would be not to do that the poor farmer or the smallholder farmer to the adequately. Then other mechanisms come into extent that the delivery mechanism does not as- play, and if there is overt damage there will be a sume an organizational structure such as mecha- response. But one must live with the damage, and nization, for example, which inherently favors it might be in some measure irreversible, which larger land parcels over smaller land parcels in no one wants. order to be able to work; that is, it does not in- herently have a bias against the poor. Kathy McAfee: I am from Grass Roots Interna- That does not mean that whether it is vaccines tional and the University of California at Berke- for children or seeds for new varieties or credit ley. This discussion of the health and safety risks that is available, there may not be other discrimi- leaves me wondering whether or not we might natory barriers. All I was saying is that inherently expect-given the current, increasingly market- biotechnology does not seem to discriminate. oriented structure of incentives that determine That is why I flagged that. I simply pointed out scientific research priorities-adequate or pro- that inherently there were some possibilities there portional research going into the safety risks. that seemed to be scale-neutral. I want to ask a parallel question that might It is difficult, but I think we should try to dis- broaden the issue a little bit. Werner Arber gave entangle the issues and really focus on the issue us a mind-boggling figure of the numbers of ge- of safety, because the access and discrimination netic combinations that have never been experi- issues are there. They require a different kind of mented with in either nature or science, leaving discussion, but they are there in a wide range of us with the suggestion that there is so much more issues. They are there in access to credit, titling that science might be able to create. of land, and many other issues, from vaccination But I wonder whether or not this focus on the of children to nutritional content. You can have technological possibilities may cause us to move surplus grain sitting in silos in India and still have forward at the expense of adequate attention to malnourished children. There are many other is- an equally mind-boggling number of possibili- sues involved. ties that nature has already created and that na- But can we at least reach a consensus on some ture, interacting with human beings, has already of the safety issues and liability questions that created. I am thinking of the hundreds of thou- emerge. We need to continue to try to disentangle sands of existing landraces of important food the issues. 20 Biotechnology and Biosafety Audience comment: Regarding the Kendall Re- will have to address is to prove the benefit, and port and the increase of food demand, we do re- when we can prove it and prove that it will not alize that increasing production is not going to pose additional serious risks, then we can look solve the problem, because 60 to 70 percent of our further. But the proof of the benefit really is production is lost after harvest. So implementing necessary. and developing biological technologies or bio- technology for preservation is really a critical el- Ismail Serageldin: When you talk about private ement in the strategy to respond to food demand. sector research, the proof of the benefit is very simple. It is whether people will buy the prod- Audience comment: With regard to this question uct, and whether the farmers who buy the prod- of responsibility, are we not in a situation in uct find that there is value in paying for it. Since which, if there is a risk, it puts a terrible burden the private sector is not giving products away, on the initiators of experiments if the risk is not but rather selling them, there is a real market test. shared? That is why I think that the involvement They can go out of business if that product does of the Consultative Group on International Agri- not deliver the presumed benefit. cultural Research, the World Bank Group, and It is important to focus on the risks, because others is so fundamental. We are talking about there may be hidden risks that are not sufficiently potential risks of a magnitude that we cannot understood by the public and must be flushed predict. We operate in an area fraught with sub- out into the open. Farmers may buy because there stantial limits, and we should not forget it. We is a short-term gain, but may not be fully aware should give all the support we can to multi- of the longer-term risk. That is why the discus- lateral involvement in this responsibility. sion should focus on safety issues. Shifting discussion to the safety side, the fo- Ricarda Steinbrecher: I am a genetic scientist and cused side, the risk side seems to me to be the consultant to the Women's Environmental Net- right way to go. That would really educate the work and the Third World Network. I would like public and make us better understand what the to address a point concerning the benefits, or so- tradeoffs are and whether, in fact, the prices re- called benefits, especially in relation to whether ally reflect the full environmental and social costs. smallholder farmers benefit as well, or whether they have a problem with this new technology. Henry Kendall: One questioner mentioned cor- For example, if we look at the herbicide-resis- rectly that the testing of some of these biotech- tant plants currently being genetically engineered nology activities is different in the developing for wide use, we find two major herbicides, world than in the industrial world. That is cor- Roundup(® and Buster. These are being used be- rect, and this matter is addressed in the report cause there is a single gene available for this re- that we have prepared. Biotechnology needs in sistance, so it is easy to genetically engineer and the developing world are quite different than one can put it in all different kinds of plants very what will be occurring here. quickly. In the United States, for example, the commer- The situation we hear about with respect to cial ethic and the various drives are in quite dif- the benefit is difficult, because there is no proof ferent directions than they would be in a of the benefit. We keep talking about proof for developing nation; for example, in a tropical area. the risk. We should have a proof for the risk as This is something that the panel identified very well, obviously, but most of all we should have a clearly, felt was a significant problem, and to proof of the benefit. I have asked different com- which a number of the recommendations were panies, including Monsanto, for proofs of the addressed. But they were addressed in the direc- benefits. I have not seen any yet. tion of supporting science and technology and If we look, for example, to the promises and scientists in the developing world so that these the future, there will be crops which are resistant different needs can be identified. to salinity, drought-resistant; these are multigene We specifically asked the World Bank Group traits. Therefore, it will take a long, long time to to pay attention to these priorities and support create that, if ever. So I feel one thing we really those that need support. Many of them will need Setting the Stage 21 support, unlike, for example, decreased blem- largely been followed, contribute to that. That ishes on foods sold in the United States, which does not mean that we should not always make will naturally bubble to the top in the commer- efforts to improve. This is a very important ques- cial sector. tion about which we scientists are always con- cerned. My organization, the International Werner Arber: I have given much thought to risk. Council of Scientific Unions, has made quite a It is eventually the involved people and the larger number of contributions during the past 20 years society that together should have that responsi- toward harmonizing guidelines and conduct bility. In our world of democratic governments worldwide, because our nongovernmental orga- it is not easy. And we should be aware that it was nization spans all the countries that carry out also said today that there is no zero risk; there is activities. I think we have been successful, at least always some remaining risk. to some extent, but new problems always come We should try to minimize that, and I think up. You never are actually at the end, and we are the measures proposed up to now, which have willing to continue in this way. The Promise and the Perils Overview Christopher R. Somerville B y the year 2003 we will have the fully se- ally go in and determine the function of every quenced genomes of at least 20 bacteria, gene in Arabidopsis and probably in rice. It is the two fungi, one nematode, one insect, and significance of that effort in this context that I one plant. I suspect it will be at least two plants wanted to convey, to stress that biotechnology is and 50 bacteria. We already have the full se- not some sort of dabbling approach. We are build- quence of ten bacteria, one fungus, and about half ing agricultural biotechnology on a very solid a nematode. base of knowledge. The plant that is going to be sequenced is the We do not have complete knowledge yet, but Arabidopsis. We already have about 20 percent of it is within sight. Certainly in the timeframe by this plant sequenced, and I suspect we will have which innovations will arrive in the developing it completely finished by 2001. This plant is a world, we will have a very profound knowledge model for all higher plants. By "fully sequenced," of what we are doing at some level, so that when I mean the complete chemical structure of all the we make a modification of a plant we will know DNA in this organism has been analyzed. very clearly what the significance of such an ac- The second plant will almost certainly be rice, tion is. which I suspect will probably be finished by 2003 One of the tools that will facilitate this work is or 2004. The Japanese government just provided new technologies, such as a newly developed a grant for US$100 million to one laboratory, and gene chip that allows introduction of a sample a bill is currently working its way through the of DNA into a small hole in its center and can U.S. Congress that would allocate a large portion subsequently be used to simultaneously read the of a US$40 million-a-year grant to study of the expression of thousands of genes at a time. rice genome. This kind of technology will allow us to look There are 100,000 base pairs of Arabidopsis ge- at the expression of all the genes in an organ- nome; we already know the function of many ism simultaneously, in response to any changes genes, and we plan to literally work our way that we make, changes in environmental con- through the whole genome, assigning function ditions, and anything that might affect the ex- to every gene. pression. At this point we can assign general function My point is that biotechnology is being built to nearly 60 percent of all the genes that we en- on a much larger base of basic knowledge, which counter in a plant; about 44 percent we cannot will allow us to proceed in a real engineering yet assign function to at present. One of the things context. Most of us think of engineers as people that the full sequencing of these genomes allows who, when they build a bridge, have a very good is the assignment of function to every gene. Dur- idea of what they are doing. I hope that because ing the next 10 to 15 years, researchers will actu- of this kind of work, in the foreseeable future the 22 The Promise and the Perils 23 directed manipulations we make will be built on most important discoveries of the last several a similarly deep biological base. years was reported in Nature. A poplar tree, an The opportunities are obvious: we can alter aspen, was induced to flower within three nutritional quality and feed efficiency; decrease months by the introduction of a gene, making it losses to pests and pathogens, and increase stress a transgenic aspen tree. As you probably know, tolerance. I think there is a possibility for intrin- poplar and many other trees normally flower in sic yield increases as well. We can adapt plants the timeframe of 12-to-15 years. As a result very through agricultural practices and facilitate hy- little breeding has been done on these species, so bridization, presumably realizing large gains in that we actually do not know what their yield productivity by extending hybrid vigor. potential is in comparison to vegetative species Another possibility, which is not talked about on which a great deal of breeding is done because very much, is that we could also accelerate do- of the annual cycles. mestication. Many of us would like to expand I think this is a very exciting discovery because the number of plants that are used, and I believe it raises the possibility of breeding in a rapid cycle that biotechnology offers certain tools that may on very important tree species and, at the last be useful in this respect. Most of these things are stage, after some rounds of breeding, crossing out discussed at length in the Kendall Report, so I the gene and producing an improved fiber spe- thought I would mention a few things that may cies. Man does not live from food alone; a sig- have been overlooked and that have conse- nificant proportion of our resources are used to quences for this discussion. produce fiber, both for fuel and other purposes. The kinds of gains that we might realize by There is a wide range of other products that actually solving or understanding pest and are relevant. Because a large proportion of the pathogen resistance are tremendous. A large pro- surface of the Earth is used for fiber production, portion of plant productivity is lost to pests and there are many opportunities to use biotechnol- pathogens; in Africa and Asia it is estimated that ogy to imnprove the efficiency with which we use about 40 percent of total productivity is lost. it. It is a very dirty industry, and I think that by Such targets are rather well-suited to the ap- modifying trees we will be able to improve that. plication of biotechnology, because plants can be There have been many opportunities to pro- engineered for very specific resistance; it is not duce specialty chemicals; I will give you a few accidental that the some of the first applications examples. There are also many opportunities to have been in this domain. produce polymers and to alter plant architecture In addition, however, biotechnology could for efficiency. For example, a plant like kapok, have implications for yield. Research indicates which is a tropical species that used to be widely that that the record yield for all the important used as a fiber crop, has gone out of production- plants greatly exceeds the average yield. This displaced by synthetics-partially because it has indicates that the architecture, the intrinsic pro- to be harvested at fairly high expense. ductivity, of plants has a long way to go. This is There is a reasonable possibility that the tools in some respect what the long-term targets of bio- of biotechnology can alter the architecture of technology are-to learn how to engineer plants kapok so that it could be more easily harvested. to more regularly achieve record yields rather But there are many applications like this and I than their current average yields. Generally this do not think in the short time I have I can go is going to be achieved by adaptation to various through them, other than to raise them as nonbiotic stresses. examples. I think this is very hopeful in that it shows that Perhaps one of the most dramatic examples the limitations are not intrinsic to the plants, but that will illustrate the point I want to make is a rather related to the circumstances under which plant that is 15 percent, by weight, plastic! we are growing them, or their adaptation to those Through electron micrograph photographs, circumstances. grains of biodegradable thermoplastic in the leaf I want to move now to the kind of applica- sections of plants can be seen. tions that received far less discussion, and which This plastic has the following properties: it is I think raise some important issues. One of the truly biodegradable, so it is renewable because 24 Biotechnology and Biosafety it can be grown. Perhaps equally important is the I think such problems can probably be solved; fact that it sells for many, many times the price there are many conceivable solutions. One that of food on a per-pound basis. This particular comes to mind is that we only produce technical material currently sells for around US$4 a pound. materials in plants that are already poisonous, Cornstarch sells for around US$0.05 a pound, and such as the castor plant, which is certainly one of this is a problem. the most poisonous plants around but is still Higher plants also make a wide variety of grown widely in the tropical world, in Brazil, In- what I would call technical materials. Several lip- dia, and Thailand. This plant is fairly productive ids with interesting chemical groups on them and could be engineered to produce other tech- might lend themselves to industrial applications. nical materials. I do not think anyone would con- One, for example, is ricinoleic acid, the most use- fuse it with something that might be eaten. ful natural material in the world. It has 400 non- There are other consequences that need to be food uses and sells for approximately twice as thought about, and they are probably the most much per pound as edible oil, just because of the serious. The first is that because these materials presence of the hydroxyl group there.' have higher value than food, a situation might Almost all the genes that make these chemi- evolve in which acreage is used to produce non- cal modifications are now available and can be food cash crops. The value of these things can be used to make transgenic plants that produce vari- sufficiently high and the demand very large. Let ants of these technical oils. These are things that me put it this way: the entire U.S. corn crop could should not be eaten, as anyone knows who has not satisfy world demand for polyethylene if it had castor oil. The utility of these things in one were converted quantitatively. So the demand for context is that they have high unit value. Mak- technical materials is very high, and as these ing a transgenic plant that produces castor oil things become available they will pose a threat. will add considerable value to that plant because It will undoubtedly create the growth of pri- of its industrial uses. vate markets, I do not know the full extent of that, It is possible to produce environmentally be- but it is an inevitable consequence. Because these nign, renewable, biodegradable materials. Devel- things will be created by people with access to oping countries can use these as domestic sources technology, various traits may be bundled to- of materials with industrial uses. Malaysia, for gether that impose restrictions on how these ma- example, is developing an oleochemical indus- terials can be used. try based on palm. The ability to diversify the I want to conclude with one final point. Intro- chemical industry can pay obvious dividends by ducing the Rambo gene for total resistance may increasing the value of that oil. It displaces the have been a mistake. This is the scenario that dependency on petroleum. Particularly over the many people are apparently concerned about in long term, that is going to be an issue. Palm is an regard to transgenic plants. But there are other excellent example of a plant that will benefit by concerns that are probably more significant, the application of this technology-if you con- which are the sociological, rather than the directly sider making technical materials a benefit. biological, consequences. However this is an area where there are genu- ine risks. One obvious risk is that these technical Note materials will be placed in plants that are other- wise used as food and confused with food crops. 1. For example, castor oil is obtained from the seeds A second risk is that they might be placed in of the Ricinus communis plant. It consists principally of plants susceptible to being eaten by wildlife. the triglyceride of ricinoleic acid (hydroxyoleic acid). The Opportunities and the Risks Biotechnology and Sustainable Development Robert B. Horsch G reen plants are the primary renewable demess, rain forest, or marginal lands that sup- source of energy and biomaterials on port biodiversity and vital ecosystem services -j Earth and one of the key recyclers of air, * Reducing post-harvest loss of food and im- water, and bioavailable minerals. Agriculture is proving the quality of fresh and processed the foundation of human economies and peoples' foods, thus boosting the "realized nutritional well being. As crop yields have increased, the cost yield" per acre (1 acre = 0.405 hectares) of food has dropped, allowing simultaneous in- * Displacing resource- and energy-intensive in- crease in the food supply and available income puts, such as fuel, fertilizers, or pesticides, thus to be invested in better healthcare, education, reducing unintended impacts on the environ- cultural pursuits, and other facets of an improved ment and freeing those resources to be used standard of living. Agriculture is also responsible for other purposes or conserved for the future for humankind's biggest impact on nature, be- * Encouraging reduction of environmentally cause it is the largest source of competition for damaging agricultural practices and adoption land and water between humans and nature. of more sustainable practices, such as conser- vation tillage, precision agriculture, and inte- Opportunities grated crop management Stimulating a new kind of economic growth- In agriculture the challenge and the opportunity more benefit with less throughput and harm. is to simultaneously increase the productivity of Plant breeders have been introgressing genes agriculture per unit of land, resources consumed, into crops for a wide range of beneficial traits for and negative impact on the environment with- millennia. Most of our major food plants do not out systematically reducing the sustainability of even resemble their original wild relatives. Genes agriculture. Just as increasing economic produc- for improved resistance to pests, tolerance to en- tivity is the key to economic growth, so increas- vironmental stresses, ability to take up nitrogen ing resource productivity is the key to sustainable and other soil nutrients, growth habit, yield, qual- growth, waste reduction, and environmental pro- ity of proteins, oils, and starches have all been tection. Biotechnology provides huge break- intensely concentrated in modern varieties from throughs on all of these fronts by substituting sources as distantly related as possible. Using "information for stuff" and by doing so in cyclic, biotechnology, we now have the ability to more photosynthetic, and nonpolluting ways. broadly introgress genes from virtually any other The key contributions of biotechnology will be organism and to directly engineer those genes severalfold. before introduction into the crop. Our experience Producing more food on the same area of land, over the past 20 years supports the assertion that thereby reducing pressure to expand into wil- biotechnology will be just as powerful as plant 25 26 Biotechnology and Biosafety breeding for continuing to improve all aspects of which previously were killed by a broad- crop growth and development for the benefit of spectrum insecticide. humans. Biotechnology must be combined with One more illustration of the power of biotech- the best that breeding has to offer so that it am- nology is provided by Roundup Ready® soy- plifies the importance and contribution that beans, another Monsanto product that was breeding continues to make. Biotechnology also introduced last year in the United States. Weeds meshes well with integrated crop management are the most serious pest of cultivated crops, in- and precision agriculture technologies. The bio- cluding soybeans. Some herbicides used on soy- technology pipeline is full of traits for resistance beans are persistent enough to control weeds for to fungi, insects, viruses, nematodes, and other the full growing season, and may even present a pests; tolerance to a host of environmental carry-over problem for crop rotation the next year. stresses; improved utilization of nitrogen; im- Roundup® herbicide is nonpersistent. It biode- proved quantities of oils, proteins, starches, and grades within a few weeks and is highly unlikely other compounds; and even improved-yields. to migrate into ground water, since it binds tightly to soil particles. Glyphosate, the active ingredi- Examples ent in Roundup®, has the most favorable toxico- logical property rating that the U.S. I would like to use as an example the New Leaf® Environmental Protection Agency (EPA) gives; it potato, a Monsanto product. Using actual figures works by inhibiting an essential pathway in plants for insecticide use on the leading variety of pota- that animals, including people, do not have. It is toes in the United States, I calculated what it also very effective at killing weeds-so effective would take to manufacture, distribute, and ap- that it will control soybeans as well as weeds. Thus ply those products for one year. Since the same it cannot be used to control weeds growing within chemistry is often used to control Colorado po- a soybean crop. Or rather it could not be used until tato beetle and potato leaf roll virus vector in- we developed Roundup Ready® soybeans, which sects, I made a projection for the amount of are "substantially equivalent" to ordinary soy- pesticide that could be replaced by genetic resis- beans after processing. Roundup Ready® soy- tance for both pests. The main point from this beans have an added protein, which is able to analysis is the environmental load conventional overcome the inhibitory property of glyphosate. Russett Burbank potatoes carry compared to New Thus Roundup Ready® soybeans will thrive even Leaf PlusTM potatoes genetically improved to re- when sprayed with typical doses of Roundup® sist Colorado potato beetle and leaf roll virus. This that effectively eliminate weeds interspersed with load includes 4 million pounds of raw materials the soybean plants. to make conventional insecticides, resulting in 2.5 Let us compare three situations: a soybean million pounds of manufacturing waste, 180,000 farm without weed control; a soybean farm with containers, and 150,000 gallons of fuel to transport a typical spectrum of herbicides and plowing for and apply the pesticides. Most of the insecticide weed control; and a soybean farm with No-till, never reaches the target pest and contributes fur- Roundup® herbicide and Roundup Ready® soy- ther to the environmental load of pest control. beans. In the first scenario (no weed control ) Compare this to the New Leaf® potato, where weeds would steal the sunlight, water, and nu- you teach the plant how to use sunshine, air, and trients from the soybeans, and the harvest would nutrients to make a biodegradable protein that be contaminated with weed seeds. The magni- affects one specific insect pest and only those in- tude of the problem varies by year and location dividual insects that actually take a bite of the but is sufficiently bad that virtually all soybeans plants. The genetically improved potato costs the grown in the U.S. today are treated with herbi- farmer less to grow, works better at controlling cides, and most are also plowed every year. the pest, is better for the environment, and is In the second scenario a typical Iowa farmer more ecoefficient. We do not yet know how growing soybeans would: (a) burn fuel for plow- significant the benefit will be from sparing the ing, (b) spray or soil-incorporate a variety of her- lives of beneficial insects in the potatoes fields, bicides, (c) lose several tons of topsoil per acre The Promise and the Perils 27 from wind and water erosion, (d) lose some of have targeted biotechnology as a key to solving the soil nitrate due to runoff and leaching, and food production problems in developing coun- (e) lose valuable carbon from the soil due to more tries. However while resource costs are dramati- rapid oxidation after plowing. cally reduced with biotechnology, and there are In the third scenario, combining no-till with often less expensive research and registration Roundup® herbicide and Roundup Ready® soy- costs than for agricultural chemicals, biotechnol- beans, the same Iowa farmer would save fuel, ogy is more expensive than traditional breeding reduce C02 emissions, and reduce machinery and will require more education of growers to wear by avoiding plowing. The farmer would capture maximum benefit. It will also be even also conserve almost all of his or her topsoil, in- more important to deliver top quality seeds of crease soil organic matter, reduce nitrate runoff, the best adapted varieties for each region. Thus and cut loss of soil carbon. In some soil types car- for most effective transfer of biotechnology, we bon would actually be accumulated in the soil must do a better job with the more traditional rather than lost to the atmosphere on a net basis. technologies as well. Risk management issues The increase in use of Roundup® herbicide have a regional component that should be ad- would be offset by a reduction in the use of more dressed locally. persistent herbicides, in many cases decreasing To gain maximum advantage from biotechnol- the total amount of herbicide-active ingredient ogy in resource-poor areas it will be even more used on the crop. important than in industrial countries to make In addition the farmer who decides to plant sound choices that target the greatest opportu- Roundup Ready® soybeans while using conser- nities first and minimize both cost and risk. Ag- vation tillage techniques and Roundup® herbi- ricultural research and development, both cide typically can reduce production costs, public and private, is underfunded in compari- compared with use of traditional practices. The son to its benefit and the need for improve- lower herbicide cost more than offsets the higher ments. A fundamental policy issue facing Roundup Ready® seed costs. Better weed con- developing countries and international insti- trol can lead to higher yields, especially under tutions is the degree to which private invest- intense weed pressure, which also can increase ment is fostered, both locally and globally, for economic returns. Thus farmers will not need to research and development, seed production and compromise price and performance to improve distribution, other inputs, and on-farm services. their efficiency and sustainability, while reduc- This will be determined largely by choices about ing environmental impact. A study commis- intellectual property rights, contract law, pre- sioned by Monsanto last year surveyed more than dictable and science-based regulation, and in- 1,000 Roundup Ready® soybean growers and ternational trade practices. found that an overwhelming majority expressed Even if a very favorable climate is created for satisfaction with the performance of the soy- private investment and business development, beans, as well as with weed control and crop there will still be a large underserved constitu- yields. Acreage of Roundup Ready® soybeans ency of resource-poor farmers who do not have has been limited by availability of seed, but none- access to the funds, information, or markets nec- theless increased from about 1 million acres in essary to make investments or obtain returns in 1996 to about 9 million acres in 1997 in the United their own "businesses." There will also be a num- States. ber of important crops and traits that will not attract investment, even under favorable condi- Fulfilling the Opportunities tions, which will need to be improved in public sector or nonprofit programs. There are a num- Because biotechnology reduces the need for re- ber of examples of public-private partnerships source consumption in agriculture, it is urgent to transfer technology for some of these "orphan to explore the potential of biotechnology to help applications," which provide paradigms for try- resource-poor farmers around the world. Anum- ing to help resource-poor farmers without dis- ber of public and nongovernmental organizations couraging private investment and business 28 Biotechnology and Biosafety development. In the United States, with its long Risks history of private investment in agricultural products, technologies, and services, public Risk is the degree of possibility of loss or injury. institutions play a vital role in education; basic A hazard is something that is able or likely to scientific discovery; extension services; and com- inflict injury. Injury occurs only when a hazard prehensive, unbiased local testing of competing coincides with exposure to circumstances under products and technologies. Thus the public sec- which the hazard inflicts injury. Thus risk equals tor will play a necessary role even in a flourish- the degree of hazard times the degree of expo- ing market economy, and public-sector funding sure to the hazard. We manage risk by the deci- needs to be fostered and increased as well. sions we make about hazardous substances or One project that we have been pursuing in situations and exposure to the circumstances partnership with the Kenyan Agricultural Re- under which injury could occur. A decision is a search Institute (KARI) since 1991 is the devel- determination or choice arrived at after consid- opment of genes for resistance to a devastating eration. We make decisions to gain benefit as well virus of sweet potatoes. Beginning with Dr. Flo- as to manage risk. rence Wambugu's work on the tissue culture and For example, electricity is a serious hazard at transformation of Kenyan varieties during 1991- 110 or 220 volts. We could drop the voltage en- 94, her work has been continued by Daniel tering our homes to 12 volts to reduce the haz- Maingi, Charity Macharia, and now, Dr. Duncan ard. Why don't we? One reason is that it would Kirubu. The director of KARI, Dr. Cyrus Ndiritu, cost a fortune to replace everything with 12-volt has been instrumental in supporting the project appliances. But even more importantly, 12 volts with some of his best scientists. Dr. Maud would required huge currents of electrons to Hinchee of Monsanto has provided tireless lead- deliver the equivalent power. The thickness of ership and support for the project. Despite fac- the wires would have to be greatly increased ing an unexpectedly difficult technical problem, and we would need much more copper and the team now has in hand more than 200 inde- stronger poles. The loss of power over trans- pendent transgenic lines of sweet potato, which mission lines would be much larger; more coal are being prepared for shipment to Kenya for would have to be burned for the same benefit. testing, hopefully next year. Early testing in So instead of reducing the hazard by reducing growth chambers indicates a number of very the voltage, we use circuit breakers, insulation, promising lines that are not infectable with the recessed outlets, and sealed appliances to ef- virus. Because sweet potato produces enough fectively reduce exposure to the hazard. Thus calories globally to feed 400 million people, but we make the risk low and the benefit high. One is devastated by chronic virus diseases in Africa, more point with this example: electricity is less our hope is that this single target will have a hazardous and exposure to its hazard can be large impact on food security in Africa. The managed better than is the case with most al- project involved several strategies that I believe ternative sources of power. For example, the are important. risk of fire and lung ailments from the use of 1. The choice of target and technology was electric light bulbs is much lower than from the made by KARI and Dr. Wambugu. use of oil lamps. The implication is that many 2. The project involves training of local scien- key decisions are based on comparing risk to risk tists. in proportion to benefit-not by looking nar- 3. The work has led to development of tech- rowly at absolute risk. nological infrastructure for a vital "orphan crop." What are the potential risks of biotechnology, 4. The program has fostered broad cooperation and how do we make decisions to manage those among public, private, and nongovernmental risks? Over the past decade an elaborate system organizations for the benefit of resource-poor farm- of checks and balances has been developed by ers. Participants include Monsanto, KARI, the U.S. government regulatory agencies, scientific expert Agency for Intemational Development, the Inter- panels, and industry working groups to look for national Service for the Acquisition of Agri-biotech potential risks and make appropriate decisions Applications, and several universities. to identify and address issues of risk-both The Promise and the Perils 29 hypothetical and real. A number of science-based In the United States all food crops with engi- regulations, reviews, and decision trees have been neered genes are reviewed by the Food and Drug developed, discussed, debated, and deployed Administration for human food and animal feed regarding these key issues. safety and by the Department of Agriculture for The most important issue is food safety. Plants safety to agriculture and the environment. Crops commonly contain toxic compounds that we with traits for pest resistance are also reviewed must either avoid eating or consume only in by the EPA. The professional staff of these agen- quantities that our bodies can tolerate. Breeding cies evaluate the safety of proposed new traits can cause unintended changes in nutritional con- and crop varieties, while scientific expert panels tent or toxicants in foods, but since the probabil- review regulatory policy and safety assessment ity of these changes is low, centuries of ignoring approaches, as appropriate. the potential risk in classical breeding has not yet The first transgenic plants were precisely en- resulted in a serious problem. However, crops gineered in 1982. To date more than 3,600 field improved with biotechnology methods are com- trials have been authorized at over 15,000 indi- prehensively analyzed for changes in the com- vidual test sites in at least 34 countries and with position of key nutrients- and toxicants that may at least 56 different crops. At least 35 different occur before regulatory approvals are granted. genetically modified plant products have been Another key issue is the safety of the newly approved by at least one country. This year, 1997, added gene and the protein it encodes. Requests represents the second year of large-scale commner- to regulatory agencies for approval of new prod- cial planting of genetically modified crops. Ap- ucts include results of a variety of studies or proximately 30 million acres of genetically tests to evaluate the digestive fate, toxicity, modified crops were planted globally in 1997, a allergenicity, and animal-feeding effects of the significant increase from the 4 to 6 million acres new protein. Other studies examine the environ- planted in 1996. These introductions were pre- mental effects of the gene in the recipient crop, ceded by a comprehensive safety analysis and as well as the potential for outcrossing to a wild decisionmaking process carried out in science- relative species that might coexist with the crop. based ways by companies, government agencies, These studies are not conducted for traditional and scientific expert panels. The bottom line is breeding, even though modern food crops con- that every review concluded that there are no new tain dozens of intended genes and hundreds or risks inherent in the process itself, and that the thousands of unintended genes. None of these products approved so far are substantially new genes introduced by breeding or their cor- equivalent to their traditional counterparts. responding proteins are usually characterized for Moreover, the new proteins added to these ge- toxicity, allergenicity, or environmental impacts, netically modified crops have been shown to pose despite the fact that they have been genetically no significant risks. Review will continue on a introgressed from wild species collected around case-by-case basis as the science and the technol- the world. ogy evolve and expand. Companies involved with agricultural biotech- nology have examined these issues early and Choices made choices not to develop specific products that may carry a risk. For example, one company Critics and proponents of biotechnology alike are stopped development of a nutritionally enhanced creative at spinning scenarios of theoretical risks soybean when their tests showed the new pro- that biotechnology might cause. No one can guar- tein to be an allergen. My guess is that the cost of antee that biotechnology will never cause an un- managing exposure to that hazard would exceed foreseen problem. That is why biotechnology is the value of the product. Thus it was a l.ogical regulated and scrutinized by a comprehensive decision to stop the work. Monsanto has decided system of checks and balances. But the critics dis- not to pursue the development of Roundup re- miss our ability to assess and manage these pos- sistance in sorghum, a crop that outcrosses to sible risks and seem to believe that the world is johnson grass, which is a weed currently con- fine the way it is or that we should adopt a low- trolled by herbicides such as Roundup. tech version of agriculture. 30 Biotechnology and Biosafety I fear that continuing the status quo or return- to avert the serious and irreversible harm that is ing to low-tech agriculture will lead us to plow, occurring even as we speak. Failure to move for- drain, or degrade much of the rest of the planet- ward with new technology, global trade, business rainforests, wetlands, temperate forests, prairies, development, and other forms of sustainable de- streams, lakes, and seas. This would be disastrous velopment and economic growth is probably the for other species with which we share the Earth biggest risk we face. Inertia will harm us for sure and for ecosystems that provide essential services if we act too slowly. to the biosphere. But it would be even more di- The complete solution set will span technologi- sastrous for us. The economic consequences cal, economic, social, and political innovations. would plunge more people into poverty, malnu- No one part of this set can solve the sustainability trition, and starvation, while reducing the ability crisis alone. But working together I believe we and willingness of wealthier people and nations can rise to the challenge. I believe increasing glo- to help those less fortunate. The actual situation bal investment in plant science, agricultural sci- is less binary than these simple alternatives. Too ence, and agricultural biotechnology is one the little investment or over-regulation will result in best ways to reduce the risk of environmental foregoing benefits we might otherwise have real- degradation and economic stagnation. Real gains ized. Too much investment or too little oversight in productivity, such as those biotechnology will result in opportunity cost and excessive risk. brings to agriculture, are the surest way to alle- The Earth is a large space ship, a closed sys- viate poverty. Sustain means to support and nur- tem. We receive an income of sunlight. We dis- ture, not just to continue. Develop means to grow pose of radiant heat. We are otherwise limited to and change. The industry and economy of the the resources and energy stores already on Earth, future must grow and change to increase the level and we are stuck with whatever waste we make. of support for people, while decreasing the Our population will increase by several billion throughput and the harm-similar to substitut- people in the next 40 to 50 years. Even today we ing "information for stuff"-as biotechnology are not caring adequately for many of the world's does for agriculture. My colleagues and I at inhabitants, human or other species. The precau- Monsanto are eager to work with others who are tionary principle tells us that even without full also determined to meet the challenge of sustain- certainty about the paths ahead, we should act able development. The Opportunities and the Risks The Environmental Risks of Transgenic Crops: An AgroecologicalAssessment Miguel A. Altieri G_ enetic engineering is an application of * The potential transfer of genes from pesticide- biotechnology involving the manipula- resistant crops to wild or semidomesticated -Jtion of DNA and the transfer of gene relatives, thus creating superweeds. components between species in order to encour- * Herbicide-resistant crop volunteers become age the replication of desired traits (OTA 1992). weeds in subsequent crops. Although there are many applications of genetic * Vector-mediated horizontal gene transfer engineering in agriculture, the current focus of and recombination to create new pathogenic biotechnology is on developing herbicide-toler- bacteria. ant crops and pest- and disease-resistant crops. * Vector recombination to generate new virulent Transnational corporations such as Monsanto, strains of virus, especially in transgenic plants DuPont, Norvartis, and others, which are the engineered for viral resistance with viral genes. main proponents of biotechnology, view trans- * Insect pests will quickly develop resistance to genic crops as a way to reduce dependence on crops with biotechnology toxin. inputs such as pesticides and fertilizers. It is * Massive use of Bt toxin in crops can unleash ironic that the biorevolution is being brought for- potentially negative interactions, affecting eco- ward by the same interests that promoted the first logical processes and nontarget organisms. wave of agrochemically based agriculture. But The above impacts of agricultural biotech- this time, by equipping each crop with new "in- nology are evaluated here in the context of secticidal genes," they are promising the world agro- ecological goals aimed at making agri- safer pesticides, reduction of chemically inten- culture more socially just, economically viable, sive farming, and more sustainable agriculture. and ecologically sound (Altieri 1996). Such As long as transgenic crops follow closely the evaluation is timely, given that worldwide pesticide paradigm, such biotechnological prod- there have been over 1,500 approvals for field ucts will do nothing but reinforce the pesticide testing transgenic crops (the private sector has treadmill in agroecosystems, thus legitimizing the accounted for 87 percent of all field tests since concerns that many scientists have expressed re- 1987), despite the fact that in most countries garding the possible environmental risks of ge- stringent procedures are not in place to deal netically engineered organisms. The most serious with environmental problems that may de- ecological risks posed by the commercial-scale use velop when engineered plants are released into of transgenic crops are listed below. (See Rissler the environment (Hruska and Lara Pav6n and Mellon 1996; Krimsky and Wrubel 1996.) 1997). A main concern is that international pres- *The spread of transgenic crops threatens crop sures to gain markets and profits are resulting genetic diversity by simplifying cropping sys- in a situation in which companies are releas- tems and promoting genetic erosion. ing transgenic crops without proper consider- 31 32 Biotechnology and Biosafety ation for the long-term impacts on people or the Biotechnology and Agrobiodiversity ecosystem (Mander and Goldsmith 1996). Although biotechnology has the capacity to cre- Actors and Research Directions ate a greater variety of commercial plants, the trend of transnational corporations is to create Most innovations in agricultural biotechnology broad international markets for a single product, are profit-driven rather than need-driven, so that thus creating the conditions for genetic uniformity the thrust of the genetic engineering industry is in rural landscapes. In addition patent protection not really to solve agricultural problems, but to and intellectual property rights espoused by the create profitability. This statement is supported General Agreement on Trade and Tariffs (GATT), by the fact that at least 27 corporations have which inhibit farmers from reusing, sharing, and initiated herbicide-tolerant plant research, in- storing seeds raise the prospect that a limited cluding the world's eight largest pesticide com- number of varieties will dominate the seed mar- panies (Bayer, Ciba-Geigy, ICI, Rhone-Poulenc, ket. Although a certain degree of crop uniformity Dow/Elanco, Monsanto, Hoescht, and DuPont) may have certain economic advantages, it has two and virtually all seed companies, many of which ecological drawbacks. First, history has shown have been acquired by chemical companies that a huge area planted to a single cultivar is very (Gresshoft 1996). vulnerable to a new, matching strain of pathogen In the industrialized countries from 1986-92, or pest. Second, the widespread use of a single some 57 percent of all field trials to test transgenic cultivar leads to a loss of genetic diversity crops involved herbicide tolerance, and 46 per- (Robinson 1996). cent of all applicants to the U.S. Department of Evidence from the Green Revolution leaves no Agriculture (USDA) for field testing were chemi- doubt that the spread of modern varieties (MVs) cal companies. Crops currently targeted for ge- has been an important cause of genetic erosion, netically engineered tolerance to one or more as massive government campaigns encouraged herbicides include: alfalfa, canola, cotton, corn, farmers to adopt MVs and abandon many local oats, petunia, potato, rice, sorghum, soybean, varieties (Tripp 1996). The uniformity caused by sugarbeet, sugar cane, sunflower, tobacco, to- increasing areas sown to a smaller number of va- mato, and wheat. It is clear that by creating crops rieties is a source of increased risk for farmers, as resistant to its herbicides a company can expand the varieties may be more vulnerable to disease markets for its patented chemicals. The market and pest attack, and most of them perform poorly for herbicide-resistant crops (HRCs) has been in marginal environments (Robinson 1996). estimated at more than US$500 million by the All the above effects are not ubiquitous to MVs, year 2000 (Gresshoft 1996). and it is expected that, given their monogenic na- Although some testing is being conducted by ture and fast acreage expansion, transgenic crops universities and advanced research organiza- will only exacerbate such effects. tions, the research agenda of such institutions is being increasingly influenced by the private Environmental Problems of Herbicide- sector in ways never seen in the past. Some 46 Resistant Crops percent of biotechnology firms support biotech- nology research at universities, while 33 of the According to proponents of HRCs this technol- 50 U.S. states have university-industry centers for ogy represents an innovation that enables farmers the transfer of biotechnology. The challenge for to simplify their weed management requirements such organizations will be not only to ensure that by reducing herbicide use to post-emergence situ- ecologically sound aspects of biotechnology are ations using a single, broad- spectrum herbicide researched and developed (such as N fixing and that breaks down relatively rapidly in the soil. drought tolerance), but to carefully monitor and Herbicide candidates with such characteristics control the provision of applied nonproprietary include Glyphosate, Bromoxynil, Sulfonylurea, knowledge to the private sector, to ensure that and Imidazolinones among others. such knowledge will continue in the public do- However the use of herbicide-resistant crops main for the benefit of all society. is actually likely to increase herbicide use, as well The Promise and the Perils 33 as production costs, and cause serious environ- bolic degradation in plants, questions about food mental problems. safety also arise. Herbicide Resistance Creation of "Superweeds" It is well documented that when a single herbi- Although there is some concern that transgenic cide is used repeatedly on a crop, the chances of crops might themselves become weeds, a major herbicide resistance developing in weed popu- ecological risk is that large-scale releases of lations greatly increases (Holt and others 1993). transgenic crops may promote transfer of The sulfonylureas and the imidazolinones are transgenes from crops to other plants, which may particularly prone to the rapid evolution of re- then become weeds (Darmency 1994). The bio- sistant weeds, and up to now 14 weed species logical process of concern here is introgression; have become resistant to sulfonylurea herbicides. that is, hybridization among distinct plant spe- Cocklebur, an aggressive weed of soybean and cies. Evidence indicates that such genetic ex- corn in the southeastern U.S., has exhibited re- changes among wild, weed, and crop plants sistance to imidazolinone herbicides (Goldburg already occur. The incidence of shattercane (Sor- 1992). ghum bicolor), a weedy relative of sorghum, and The problem is that given industry pressures the gene flows between maize and teosinte dem- to increase herbicide sales, acreage treated with onstrate the potential for crop relatives to become these broad-spectrum herbicides will expand, serious weeds. This is worrisome given that a exacerbating the resistance problem. For ex- number of U.S. crops are grown in close proxim- ample, it has been projected that the acreage ity to sexually compatible wild relatives. There treated with glyphosate will increase to nearly are also crops that are grown near wild or weedy 150 million acres. Although glyphosate is con- plants that are not close relatives but may have sidered less prone to weed resistance, increased some degree of cross compatibility, such as the use of the herbicide will result in weed resistance, crosses of Raphanus raphanistrum X R.. sativus (rad- even if more slowly, as has already been docu- ish) and Johnson grass x sorghum (Radosevich mented with populations of annual ryegrass, and others 1996). quackgrass, birdsfoot trefoil, and Cirsium arvense (Gill 1995). Reduction of Agroecosystem Complexity Ecological Impacts of Herbicides Total weed removal via the use of broad-spectrum herbicides may lead to undesirable ecological Companies affirm that bromoxynil and glypho- impacts, given that an acceptable level of weed sate, when properly applied, degrade rapidly in diversity in and around crop fields has been docu- the soil, do not accumulate in groundwater, have mented to play important ecological roles, such no effects on nontarget organisms, and leave no as enhancement of biological insect pest control, residues in food. There is, however, evidence that better soil cover, and reducing erosion. (Altieri bromoxynil causes birth defects in laboratory 1994). animals, is toxic to fish, and may cause cancer in HRCs will probably enhance continuous crop- humans. Because bromoxynil is absorbed ping by inhibiting the use of rotations and dermally, and because it causes birth defects in polycultures susceptible to the herbicides used rodents, it is likely to pose hazards to farmers with HRCs. Such impoverished, low-plant-diver- and farmworkers. Similarly, glyphosate has been sity agroecosystems provide optimal conditions reported to be toxic to some nontarget species in for unhampered growth of weeds, insects, and the soil-both to beneficial predators such as spi- diseases because many ecological niches are not ders, mites, carabid, and coccinellid beetles and filled by other organisms. Moreover HRCs, to detritivores such as earthworms, as well as to through increased herbicide effectiveness, could aquatic organisms, including fish (Pimentel and further reduce plant diversity, favoring shifts in others 1989). As this herbicide is known to accu- weed community composition and abundance, mulate in fruits and tubers suffering little meta- which in turn favors competitive species that 34 Biotechnology and Biosafety adapt to these broad-spectrum, post-emergence survival, whereas some predators could theoreti- treatments (Radosevich and others 1996). cally thrive on dead or dying prey. Natural enemies could also be affected directly Environmental Risks of Insect- through intertrophic-level interactions. Evidence Resistant Crops from studies conducted in Scotland suggest that aphids were capable of sequestering the toxin Resistance from Bt crops and transferring it to its coccinellid predators, thus affecting reproduction and lon- According to the industry the promise of gevity of the beneficial beetles (Birch and others transgenic crops inserted with Bt genes is the re- 1997). Sequestration of plant allelochemicals by placement of synthetic insecticides now used to herbivores, which then affect parasitoid perfor- control insect pests. Since most crops have a di- mance, is not uncommon (Campbell and Duffey versity of insect pests, insecticides will still have 1979). The potential of Bt toxins moving through to be applied to control pests other than Lepi- food chains poses serious implications for natu- doptera that are not susceptible to the endotoxin ral biocontrol in agroecosystems. expressed by the crop (Gould 1994). Bt toxins can be incorporated into the soil But several Lepidoptera species have been re- through leaf materials, where they may persist ported to develop resistance to Bt toxin in both for two-to-three months, resisting degradation by field and laboratory tests, suggesting that major binding to clay particles while maintaining toxin resistance problems are likely to develop in Bt activity (Palm and others 1996). Bt toxins that end crops, which through the continuous expression up in the soil and water from transgenic leaf lit- of the toxin create a strong selection pressure ter may have negative impacts on soil and aquatic (Tabashnik 1994). Given that a diversity of dif- invertebrates and nutrient cycling processes ferent Bt-toxin genes have been isolated, biotech- (James 1997). All of these issues deserve serious nologists argue that if resistance develops, further inquiry. alternative forms of Bt toxin can be used (Kennedy and Whalon 1995). However, because Downstream Effect insects are likely to develop multiple resistance or cross-resistance, such strategy is also doomed A major environmental consequence resulting to failure (Alstad and Andow 1995). from the massive use of Bt toxin in cotton or other Others, borrowing from past experience with crops occupying a large area of the agricultural pesticides, have proposed resistance-manage- landscape is that neighboring farmers who grow ment plans with transgenic crops, such as the use crops other than cotton, but share similar pest of seed mixtures and refuges (Tabashnik 1994). complexes, may end up with resistant insect In addition to requiring the difficult goal of re- populations colonizing their fields. As Lepi- gional coordination between farmers, refuges dopteran pests that develop resistance to Bt cot- have met with little success for chemical pesti- ton move to adjacent fields where farmers use cides because insect populations are not con- biotechnology as a microbial insecticide, they strained within closed systems and incoming may render farmers defenseless against such insects are exposed to lower doses of the toxin as pests, as they lose their biological control tool the pesticide degrades (Leibee and Capinera (Gould 1994). Who will be accountable for such 1995). losses? Impact on Nontarget Organisms Impacts of Disease-Resistant Crops By keeping pest populations at extremely low Scientists have attempted to engineer plants for levels Bt crops can starve natural enemies, as resistance to pathogenic infection by incorporat- these beneficial insects need a small amount of ing genes for viral products into the plant ge- prey to survive in the agroecosystem. Parasites nome. Although the use of viral genes for virus would be most affected, because they are more resistance in crops has potential benefits, there dependent on live hosts for development and are also some risks. Recombination between RNA The Promise and the Perils 35 virus and a viral RNA inside the transgenic crop 4,000-5,000 acres in the Mississippi Delta (New could produce a new pathogen, leading to more York Times 1997) points to the erratic performance severe disease problems. Some researchers have of HRCs when subjected to varying agroclimatic shown that recombination occurs in transgenic conditions. Monsanto claims that this is a very plants, and that under certain conditions it pro- small, localized incident that is being used by duces a new viral strain with altered host range environmentalists to overshadow the benefits (Steinbrecher 1996). that the technology brought to 800,000 acres. The possibility that transgenic, virus-resistant From an agroecological standpoint, however, this plants may broaden the host range of some vi- incident is quite significant and merits further ruses or allow the production of new virus strains evaluation, since assuming that an homogeniz- through recombination and transcapsidation de- ing technology will perform well through a range mands careful further experimental investigation of heterogeneous conditions is incorrect. (Paoletti and Pimentel 1996). Conclusion Performance of Field-Released Transgenic Crops We know from the history of agriculture that plant diseases, insect pests, and weeds become Thirteen genetically modified crops that were more severe with the development of monocul- already on the market or in the fields for the first ture, and intensively managed and genetically time had been deregulated by the USDA by early manipulated crops soon lose genetic diversity 1997. Over 20 percent of U.S. soybean acreage was (Altieri 1994; Robinson 1996). Given these facts planted with Roundup®-tolerant soybean, and there is no reason to believe that resistance to about 400,000 acres of maximizer Bt corn were transgenic crops will not evolve among insects, planted in 1996. Such acreage expanded consid- weeds, and pathogens as has happened with pes- erably in 1997 (transgenic cotton to 3.5 million ticides. No matter what resistance-management acres, transgenic corn to 8.1 million acres, and strategies may be used, pests will adapt and soybean to 9.3 million acres) due to marketing overcome the agronomic constraints (Green and and distribution agreements entered into by cor- others 1990). Diseases and pests have always porations and marketers (for example, Ciba Seeds been amplified by changes toward homogeneous with Growmark and Mycogen Plant Sciences agriculture. with Cargill). The fact that interspecific hybridization and Given the speed with which products move introgression are common to species such as sun- from laboratory testing to field production, are flower, maize, sorghum, oilseed rape, rice, wheat, transgenic crops living up to the expectations of and potatoes provides a basis to expect gene flow the biotechnology industry? According to evi- between transgenic crops and wild relatives to dence presented by the Union of Concerned Sci- create new herbicide-resistant weeds. Despite the entists, there are already signals that the fact that some scientists argue that genetic engi- commercial-scale use of some transgenic crops neering is not different from conventional breed- poses serious ecological risks and does not de- ing, critics of biotechnology claim that rDNA liver the promises of industry (see table 1). technology enables new (exotic) genes into The appearance of "behavioral resistance" by transgenic plants. Such gene transfers are medi- bollworms in cotton; that is, when the herbivore ated by vectors derived from disease-causing was capable of finding plant tissue areas with low viruses or plasmnids, which can break down spe- Bt concentrations, raises questions not only about cies barriers so that they can shuttle genes be- the adequacy of the resistance-management plans tween a wide range of species, thus infecting being adopted, but also about the way biotech- many other organisms in the ecosystem. nologists underestimate the capacity of insects But the ecological effects are not limited to pest to overcome genetic resistance in unexpected resistance and creation of new weeds or virus manners (The Gene Exchange 1996). strains. Transgenic crops can produce environ- Similarly, poor harvests of herbicide-resistant mental toxins that move through the food chain cotton due to phytotoxic effects of Roundup®D in and also may end up in the soil and water, af- 36 Biotechnology and Biosafety Table 1. Field performance of some recently released transgenic crops Transgenic crop Performance Reference 1. Bt transgenic cotton Additional insecticide sprays needed due The Gene Exchange, 1996; to Bt cotton failing to control bollworms in Kaiser 1996 20,000 acres in eastern Texas 2. Cotton inserted with Bolls deformed and falling off 4,000- Lappe and Bailey 1997; Roundup ReadyTm gene 5,000 acres in Mississippi Delta Myerson 1997 3. Bt corn 27 percent yield reduction and lower Hornick 1997 Cu foliar levels in Beltsville trial 4. Herbicide-resistant Pollen escaped and fertilized botanically Scottish Crop Research oilseed rape related plants 2.5 km. away in Scotland Institute 1996 5. Virus-resistant squash Vertical resistance to two viruses and not Rissler, J. (personal to others transmitted by aphids communication) 6. Early FLAVR-SAVR Did not exhibit acceptable yields and Biotech Reporter 1996 tomato varieties disease-resistance performance 7. Roundup Ready Canola Pulled off the market due to contamination Rance 1997 with a gene that does not have regulatory approval 8. Bt potatoes Aphids sequestered the Bt toxin apparently Birch and others 1997 affecting coccinellid predators in negative ways 9. Herbicide-tolerant crops Development of resistance by annual Gill 1995 ryegrass to Roundup® fecting invertebrates and probably ecological dramatic effects of rotations and intercropping processes such as nutrient cycling. on crop health and productivity, as well as of the Many people have argued for the creation of use of biological control agents on pest regula- suitable regulation to mediate the testing and tion have been confirmed time after time by sci- release of transgenic crops to offset environmen- entific research (Altieri 1994; NRC 1996). The tal risks, and have demanded a much better as- problem is that research at public institutions sessment and understanding of ecological issues increasingly reflects the interests of private associated with genetic engineering. This is cru- funders at the expense of public-good research, cial, as many results emerging from the environ- such as biological control, organic production mental performance of released transgenic crops systems, and general agroecological techniques suggest that in the development of "resistant (Busch and others 1990). Civil society must de- crops," not only is there a need to test direct ef- mand a response to the question of who the uni- fects on the target insect or weed, but that the versity and other public organizations are to indirect effects on plants (such as growth, nutri- serve and request more research on alternatives ent content, or metabolic changes), soil, and non- to biotechnology. There is also an urgent need to target organisms must also be evaluated. challenge the patent system and intellectual prop- Others demand continued support for ecologi- erty rights intrinsic to the GATT, which not only cally based agricultural research, as all the bio- provide multinational corporations with the right logical problems that biotechnology aims at can to seize and patent genetic resources, but also be solved using agroecological approaches. The accelerate the rate at which market forces encour- The Promise and the Perils 37 age monocultural cropping with genetically uni- Campbell, B.C., and S.C. Duffy. 1979. "Tomatine and form transgenic varieties. Parasitic Wasps: Potential Incompatibility of Plant The various recommendations for action that Antibiosis with Biological Control." Science 205: NGOs, farmers' organizations, and citizen groups 700-2. should bring forward to local, national, and in- Darmency, H. 1994. "The Impact of Hybrids between ternational fora include: Genetically Modified Crop Plants and Their Related * End publicly funded research on transgenic Species: Introgression and Weediness." Molecular crops that enhance agrochemical use and pose Ecology 3: 337-40. environmental risks. Fowler, C., and P. Mooney. 1990. Shattering: Food, Poli- * HRCs and other transgenic crops should be tics, and the Loss of Genetic Diversity. University of regulated as pesticides. Arizona Press: Tucson. * All transgenic food crops should be labeled as . . . such. Gill, D.S. 1995. "Development of Herbicide Resistance * .ca in Annual Ryegrass Populations in the Cropping * Increase funding for alternative agricultural Belt of Western Australia." Australian Journal of Exp. technologies. Agriculture 3: 67-72. * Ecological sustainability, alternative low-input technologies, the needs of small farmers, and Goldburg, R.J. 1992. "Environmental Concerns with human health and nutrition should be pursued the Development of Herbicide-Tolerant Plants." with greater vigor than biotechnology. Weed Technology 6: 647-52. * Trends set by biotechnology must be balanced Gould, F. 1994. "Potential and Problems with High- by public policies and consumer choices in Dose Strategies for Pesticidal Engineered Crops." support of sustainability. Biocontrol Science and Technology 4: 451-61. * Measures should encourage sustainable and Green, M.B., A.M. LeBaron, and W.K. Moberg, eds. multiple use of biodiversity at the community 1990. Managing Resistance to Agrochemicals. Ameri- level, with an emphasis on technologies that can Chemical Society: Washington, D.C. promote self-reliance and local control of eco- nomic resources as a means to foster a more Gresshoft, P.M. 1996. Technology Transfer of Plant Bio- equitable distribution of benefits. technology. CRC Press: Boca Raton, Fla. Holt, J.S., S.B. Powles, and J.A.M. Holtum. 1993. 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There were only a few Bts that were of ap- serious concerns that natural and native knowl- plication in agriculture, because we did not have edge is being lost, that biotechnology will accel- the expertise of biotechnology to explore the va- erate that process, and that its applications are riety of strains that are there and develop them much overstated. Robert Horsch and Miguel into a number of different, highly useful genes Altieri have presented very different views on and products. these matters. So I think it is a bit disingenuous to make the The fact is that we have a growing population. argument that biotech is going to be the destruc- We have as many as 20 million people in cities tion of Bt. I would argue, on the contrary, that and certain concentrated areas. It is very diffi- biotech has definitely helped Bt in terms of its cult to feed 20 million in the city, even with fam- utility in agriculture. ily farms that are fully sustainable. We need to It is also disingenuous to argue that this tech- produce much more food at relatively low cost. nology is not being effectively deployed in ad- In the U.S. we have the luxury of living with dressing developing-country problems, and then food costs that are in the range of 10 to 12 per- to put numerous roadblocks in the way so that cent of take-home income. This is not the case in the technology cannot get there. USAID decided other parts of the world. Sometimes we in the to put its resources into the development of a U.S. speak with the arrogance of plenty, of wealth. genetically engineered, heat-stable version of the It is important to recognize that this wealth is not rinderpest vaccine. In three years the scientist, available in most of the world.* an Ethiopian-born professor at the University of California-Davis, developed the vaccine. It took Judith Chambers: For those who are concerned an additional four years to get it through all of about biotechnology and the resistance that may the regulatory hoops that it had to jump through be developing because of the deployment of Bt to actually get this vaccine to the point where we transgenic plants, let me remind you that up un- could test it-even under very contained condi- til the advent of genetic engineering, Bt had been tions in Africa. Four years! a fairly useless product. It was very underused As a result there was no more money to carry in most of the world, with the exception of a few out the test; it had all been spent on regulatory places in Southeast Asia, where it was heavily approvals and licenses-not from the Africans, used. It breaks down in sunlight in its native who were wondering what was taking us so * Following his introductory remarks, Roger N. Beachy asked Judith Chambers of the U.S. Agency for International Development to moderate the discussion. 39 40 Biotechnology and Biosafety long-it was the international organizations and Another area where we could have agreement nongovernmental organizations (NGOs) that goes back to my question this morning. The were opposed to the deployment of the technol- Kendall Report identified four risks. Two or three ogy, and sad to say, to the U.S. government. were touched upon by Miguel Altieri. The threat What is the upshot? We now have a wonder- to the ecosystem, development of new viruses, ful vaccine. It is highly effective at controlling the pesticide-resistance, and the transfer of genes to disease and is heat-stable. It is still in develop- weeds. ment because of the delay. Meanwhile, right now Do we have an agreement that these are the in Africa 70 to 80 percent of the wild buffalo and risks? Is there a consensus? I did not hear any lesser kudu in the game parks on the Serengeti difference of view on this, so hopefully we agree. border between Kenya and Tanzania are being What I heard is disagreement about the magni- destroyed by a mutant variety of rinderpest. If tude of the risks involved. Can this be reconciled? that is not a threat to biodiversity, I do not know A second set of issues about which there might what is. be consensus is that if we accept that risks exist, what can be done to mitigate them? That is the Michel Petit: I am a little frustrated, frankly, biosafety precaution. And do we get any guid- because we have here two camps and, as hap- ance, because Robert Horsch referred obviously pened yesterday in the debate on ethics and bio- to the U.S. case where the industry is regulated. technology, it is a dialogue of the deaf. So I am It is regulated in Organisation for Economic Co- going to try to sort out the differences and hope- operation and Development member countries, fully see where they are irreconcilable and where but in many developing countries the question there may be some consensus. For the World Bank we ask is what kind of regulatory framework Group the existence of these two camps is pro- should be put in place. voking paralysis. We should have a clear view of what the risks First, there is clearly a philosophical difference are and how they can be mitigated. Is the recom- that is not going to be reconciled this afternoon. mendation that the regulatory framework that Miguel Altieri expressed it clearly. He criticized applies in the U.S. be simply transferred to de- biotechnology as being the pursuit of a reduction- veloping countries? Is this feasible? Does it mean ist approach, opposed to what I think he would that they will not adopt biotechnology because call ecological agriculture. it will not have a proper regulatory framework? I do not believe that we can get to an agree- These are the questions which I very much would ment on these two different philosophies, but I like to see addressed. would be glad to get comments from the two speakers. Audience comment: What I heard today, espe- Hopefully the problem can be treated in more cially from Robert Horsch, is that the perception specific cases, and that is where possibly we can is that private industry is trying to get away from achieve some degree of consensus. One area regulation. where we have an agreement is that biotechnol- I want to remind you that thalidomide, be- ogy is developed in the private sector and, very cause of the strength and courage of a lady who properly, the private sector is seeking profits; was heading the U.S. Food and Drug Adminis- since we rely on market mechanisms, we know tration, was not allowed to be used in the United that when this happens the public good is going States. It was used outside, and we know the di- to be neglected. So we all agree. sasters that happened. In the World Bank Group we are dealing with I disagree also with the moderator in the sense governments; we advise them, provide support, that she wants to weaken the regulation. We have and therefore we are interested in seeing how we to find a middle ground. We cannot really de- can help them seek the public good in comple- regulate. She said that regulation stopped the mentarity with what the private sector will do. progress of that vaccine. So I do not believe we have a disagreement on this-that the public good is not necessarily go- Judith Chambers: My point was not regulation, ing to be served by profit-seeking firms. per se, but excessive regulation, overregulation, The Promise and the Perils 41 in proportion to the risk for doing a contained is absolutely critical, and I certainly have no ar- field test. gument at all with Miguel Altieri in relation to diversity being key for sustainable systems. Audience comment: That is debatable. You are But in order to gain diverse systems in the com- saying that the risk is one to minus 30. Maybe plex world in which we now exist, we need to that is too much safety, but I think Miguel Altieri think of using the tools of science, biotechnol- is correct that we have to be careful. ogy-all of the advances we can devise to build Christopher Somerville, when he presented the diverse systems. overview of the case, showed that there are risks, We could use a new technology to drive to- and we should talk about them. We should not ward monoculture, but I would argue that you deregulate it completely. We have to be on the could use the same technology to aid diversifi- conservative side. cation of systems. If resource-poor farmers can The last point I want to make is that I do not grow their food needs on half of the small piece think the World Bank Group is equipped to talk of land they have, the other half can be released about regulation. We have to discuss this in a for more diverse crops, woodlots, agroforestry more concentrated debate, not in a four- or five- situations, or livestock. day conference. If we can harness this technology to increase productivity so that those basic needs can be pro- Audience comment: I want to make three points. duced on a smaller area, we do not have rifts out First, six weeks ago Monsanto introduced bovine there. We have an opportunity to put these tech- growth hormone milk in India. Nobody knew nologies together to build diverse systems. about it. Unlike in this country, there are no regu- lations, and no kind of analysis was carried out Robert Horsch: The question here is not what has in India. Monsanto claimed biotechnology can do for the Second, in 1800 we had about 42,000 varieties people of the developing world. The question is: of rice in India. Today the number hardly reaches is there or should there be, can there be, public- 2,800. What happened to the species of rice that private collaboration that can take what is well- existed, developed through millions of years of established to be a very powerful and very useful experiment? We are in a hurry, and there are too technology and transfer it such that it can be of many people and everybody wants the same benefit? thing. I think it is time to recognize the larger To the points on biosafety, I think that there impact on the ecological system, before all these are some intelligent dialogues that we can have varieties of rice disappear. on what we can do to make intelligent choices The third point: in 1991, the World Health Or- and what can be done to share and transfer tech- ganization (WHO) told us that in India we have nology. If that is a completely wrong world-view, in mother's milk nine times more DDT than is if we want a world that does not have private even allowed by WHO. A study on Indian chil- companies, that does not have products that dren showed that 12 percent are suffering from come from more than 15 miles away from their neurological disabilities. There are no regulations. source, then that is a question I do not even know Nobody goes to court. how to begin addressing. The price for this risk is paid by society. Un- I think Michel Petit's question is a good one. It der these circumstances claims by biotechnology is one for which I do not have a final answer to- companies that there is a utopia waiting-there day, but it occurs to me that we have a lot of in- will be no ecological problems, there will be no frastructure and experience in the U.S. that is problems to humans, there will be no waste- available to be shared. Europe, Japan, and a num- have to be challenged by people who understand ber of countries-Mexico and to some extent the real nature of crisis we are facing. Costa Rica and, I think, Kenya-have invested effort in this. I am sure there are dozens of other Timothy Reeves: I would like speakers to com- countries that have already begun to question ment on a point that Michel Petit made. This what they are going to do about technologies whole question of diversity in sustainable systems such as biotechnology. 42 Biotechnology and Biosafety I would recommend that the answer be logi- need to take account of much wider visions, cal and science-based, and that it should look at because the problems are not only technologi- getting benefit at the best-cost equation. I also cal. They are also sociological, economic, and agree that the World Bank Group is not equipped political, and therefore we need the participa- to answer that question. You need some other tion and partnership of several groups, using source of experts. the different tools that are available, including Biodiversity is an interesting issue. In a sense biotechnology. diversity is a kind of high information content, As chairman of the NGO Committee of the and it goes to my point about the importance of Consultative Group on International Agricultural information technologies, information densities, Research, I have pointed out many times that that goes to management practices, that goes to there is a tremendous potential for biotechnol- crop rotation, that goes to good genotypes, that ogy to be utilized for drought resistance, pest goes to blending the best genotypes with the best resistance, and other challenges that farmers practices. throughout the developing world, and even in I think that economic forces alone will drive the industrial world, are facing. that in a naturally beneficial direction. My pre- I think that what is going to be critical here is diction is that the tools of biotechnology, the mo- that somehow these partnerships that we are try- lecular markers and the coupling with precision ing to promote get to the field and do the work agriculture kinds of technologies, will drive us together. Otherwise we are going to continue towards a more diverse agriculture in the future. with these arguments. Scientists can express dif- Just the very basic energetics of the system that ferent views, depending on their worldviews and Christopher Somerville pointed out-we actually the pressures they are receiving from different waste a huge amount of the sunlight that hits land sources. because our plants are not in full growth until We need to try to come up with the best ex- the middle of the summer, and then they senesce pertise, including peasants and indigenous and dry down well before the frost in the fall. We people's scientific approaches (ethnoscience), in are wasting a lot of sunlight; more diverse sys- addition to the scientific expertise of the univer- tems should be able to capture more of that. sities and international centers and the practical This natural drive toward more productivity knowledge of NGOs working with the poor on is going to take us back in the direction of more concrete projects. diversity. I think, though, you have to put this There are tremendous success stories that we on the table as a question. Who do you want to can identify throughout the world, but it has been make grow these diverse genotypes so that they tremendously difficult to obtain the partnerships are preserved? And is it a rational choice to say and funds to scale them up to the level that will you are forbidden other technologies or you must show impact. use this other technology because otherwise the The South is tired of hearing: "You are going world will lose a resource? And who are you go- to miss the train." What if the train goes to the ing to insist keep growing the old varieties when wrong station? There has been failure after fail- other more productive varieties are available? Or ure of top-down development. We need now is there another mechanism-germplasm banks, participation by local people in deciding what preservation programs, wilderness set-aside ar- kind of technology they need, and we need to eas? Is that perhaps another way to do it, and have different partners, policies, and incentives then let growers pick whatever works best in their to support sustainable agriculture. individual situation? My main worry about risk is not so much fo- cused on whether Bt transgenic crops are going Miguel Altieri: I have tried to expand the view to become resistant or not. They are going to be- of the risks to encompass the fact that we cannot come resistant. We all know that. The issue is that allow the complex systems and problems we are you can delay the resistance by deploying strat- facing today to be dominated by solutions that egies. Or you can make more combinations of mix are reductionist and are also profit-driven. We varieties and delay that. The Promise and the Perils 43 If we take only a genetic, deterministic kind versity. So I am not saying do not use biotech- of approach, it will undermine the possibilities nology if it is appropriate and the developing of a sustainable agriculture that relies on much countries want it. more holistic approaches and will promote di- Regulatory Framework Issues Panel Presentation Hamdallah Zedan B iotechnology, biodiversity, and biosafety lems; and improving environmental manage- are now household words, thanks to the ment. However, although biotechnology with Convention on Biological Diversity signed its advanced techniques will generate consid- at the Rio Earth Summit in 1992. Although the erable rewards for humanity, its benefits are three are closely linked, each has a complex web accompanied by controversy. Like many tech- of issues and stakeholders. nologies, modern biotechnology may not be It must be emphasized that biotechnology is a without problems. term that has been used broadly and has a vari- Two major issues will, however, affect the ety of meanings in different contexts. It is com- transfer and application of modern biotechnol- prised of a continuum of technologies ranging ogy and modern bioproducts for sustainable eco- from long-established and widely used classical nomic development in developing countries. The technologies (based on the use of microbes and biotechnology industry should do more to har- other living organisms) through the more ad- ness the potential of biotechnology to satisfy the vanced, modern technologies (based on the use expectations and aspirations not only of devel- of recombinant DNA techniques, cell and tissue oping countries but also the global public. culture, cell fusion, and novel bioprocessing The first major issue of concern to developing methods). countries is that not enough is being done to har- It must also be emphasized that biotechnol- ness recent innovations in biotechnology to their ogy is as old as man. Its development could be needs. The technologies developed in industrial divided into three parts: (a) the early period, countries are not always suited or easily adapt- when primitive biological processes were dis- able to the problems of developing countries. A covered by accident and incorporated into daily large share of the products of biotechnology re- life; (b) a middle period, beginning around the search are not specifically aimed at developing 17th century, when scientific explanations for countries. Most of the research and development some of these primitive processes began to be in this field addresses the pressing issues facing established and followed; and (c) the modern industrial, rather than developing, countries. Two period, during which microbes have become the areas deserve high priority, namely drylands basis of great industries and modern techniques agricultural productivity and health problems have given us new and far-reaching powers. caused by tropical, vector-borne diseases. There The products of biotechnology offered, and were once great hopes that the biotechnology will undoubtedly continue to offer, immense ben- revolution, with its new techniques and bioprod- efits to society by increasing the production of ucts, would contribute to the solution of these food, energy, specialty chemicals, and other raw problems. But to date modern biotechnology is materials; alleviating or mitigating health prob- far from being harnessed to assist those living in 44 The Promise and the Perils 45 dryland agricultural areas. Likewise, little has The second major issue is the regulatory cli- been done to combat tropical, vector-borne mate governing the safe development and appli- diseases. cation of biotechnology and the safe transfer and Many developing countries have substantial use of modern bioproducts. areas of their potentially productive land located There are questions about not only the human in drylands. Drylands represent about one-third health, but also the environmental, social, and of the total land area of the world and are inhab- economic implications of developing and using ited by significant numbers of people-almost biotechnology products. The focus of concern in one-third of the total population, estimated at industrial countries in the early days of biotech- 5.77 billion in mid-1996. This contradicts the com- nology was on human health. Now, however, mon belief that drylands are uninhabitable. environmental impacts are becoming the main Biotechnology can and should play a crucial concern in industrial countries, while the threat role in sustainable drylands management. This to socioeconomic security of many people is sur- will require access to the best available knowl- facing as another focus of considerable concern edge and technologies. Degradation of drylands in developing nations. is severe, posing a threat to the carrying capaci- ties and biological diversity of these lands. It also Environmental Concerns poses a threat to the stability of the physical land- scape and to the almost 2 billion people and their There is no consensus between the views of mo- neighbors who live in other ecosystems closely lecular biologists and ecologists on the possible linked to the drylands. environmentally harmful effects of introducing An estimated 10 million square kilometers of genetically modified organisms (GMOs) into the Africa is infested by various species of Glossina. environment. There is, however, consensus that The habitat of these tsetse flies also happens to risk analysis should be based on the end product be some of the more fertile agricultural soils on designed for release, rather than the method by the continent, which receive adequate rainfall. which it was produced. Questions that arise on Heavy infestation has made these virgin lands the deliberate release of genetically engineered inaccessible to human agriculture. It is estimated organisms into the environment include: that 25 to 30 percent of the potential livestock * Will these organisms survive? production areas in Africa are not utilized due to * Will they multiply? livestock trypanosomiasis. * Will they disturb fundamental ecosystem pro- It is often argued that tsetse fly infestation has cesses? had positive consequences. Large tracts of land * Will they affect nontarget organisms? in the heartland of Africa remain ungraded; * Will they be transported to unintended sites? woodlands, such as those in Tanzania, and for- * Will they transfer the inserted genetic mate- ests in Zaire are untouched, thus supporting di- rial to other organisms? versified flora and fauna. This argument, * What are the conditions that encourage trans- however, does not support the concept of sus- fer or maintenance of the inserted genes? tainable utilization of resources, now encom- * If transferred, will the new genetic material be passed within conservation. expressed? There is a need to develop partnerships in rel- * If transferred and expressed, will there be any evant aspects of biotechnology with the aim of positive or negative environmental conse- improving the scientific and technical capability quences? of developing countries in this field and respond- * Will seemingly benign forms somehow mutate ing effectively to their needs. Although many beyond laboratory and field-testing expecta- developing countries are reshaping their eco- tions when they spread in the environment? nomic polices to reflect the needs of the agricul- * Can quantitative environmental risk assessment ture and health sectors, only a few seem to have be madefor comparison of risks andbenefits and formulated biotechnology policies, while others determination if the risk is "unreasonable?" have incorporated biotechnology concerns into What role can the scientific community play, their national development strategies. given these concerns? 46 Biotechnology and Biosafety * Identify scientifically sound general principles * Abundance of traditional techniques, tech- and approaches upon which methodologies nologies, and practices already mastered by for field testing and assessment can be devel- developing countries oped. This will allow for more accurate ex- * New types of technological dependence and trapolation of laboratory and small-scale increased external dependence on industrial- testing to predictions of large-scale and com- ized countries mercial application and the reduction of sci- * Direction of biotechnology towards export entific uncertainty associated with risk products rather than products for local needs assessment. * Increased competition among nations and be- * Define deficiencies in our knowledge regard- tween industrial and developing countries for ing various testing parameters that might limit traditional markets the applicability of the general principles. * Inequitable distribution of biotechnology ben- * Conduct coordinated research and develop- efits and income as industrial and developing ment programs to correct identified deficien- countries' needs may differ considerably cies. * Erosion of the genetic diversity required for * Provide a global forum for free information ex- continuous agricultural and industrial devel- change by which a continuous dialogue be- opment. tween scientists, regulators, and policymakers The impact of these changes is likely to be pro- can be maintained. found and irreversible, particularly on develop- ing countries, since these changes are taking place Socioeconomic Concerns and most countries have not made policy deci- sions on how to respond to them. The socioeconomic impacts of biotechnology are a focus of considerable concern and controversy Regulatory Concerns in developing countries. Questions arise regard- ing the likely socioeconomic consequences of bio- There is no consensus on the need for, or scope technology for vulnerable sections of the and nature of, a globally binding regulatory population. Among these concerns and questions framework for safety in biotechnology, particu- are those listed below: larly on the release of GMOs. Some feel that * Substitution of developing countries' agricul- modern biotechnology is in the early stages of tural and/or industrial exports development, during which advances in tech- * Lower commodity and raw material sales and niques and ideas for application are proceed- prices due to overproduction ing in the absence of appropriate regulatory * Increased or decreased agricultural land value control. Over the past decade biotechnology * Relocation of the production of certain mate- has been perceived as a subject of contained rials from developing country farms to indus- scientific research, and appropriate regulatory trialized countries' laboratories measures were accordingly developed and * Decreased dependence of industrial countries imposed. These measures were not particularly on developing countries designed to regulate the uncontained applica- * Relocation of the production of certain mate- tions of biotechnology products and processes rials from one country to the other developed from basic research, such as the re- * Fall in employment if conditions necessitate lease of GMOs from the laboratory to the envi- less work ronment. It is therefore important that a * Increased marginalization of small farmers thorough assessment be undertaken for each and strengthening of large-scale farms development that will make use of biotechno- * Accelerated migration from rural areas and logical advances. At the same time the biotech- overcrowding in urban settlements nology industry feels that too much attention • Northern and private enterprise domination is being paid to remote and negligible risks and and foreign control of the technology is expressing great concern about the prospects * Inequitable conditions for acquiring new bio- of excessive restrictions that could limit bio- technologies technology research and application. The Promise and the Perils 47 Questions arise regarding the capacity of ex- vances in basic technology research were made isting regulatory approaches and institutions to in public academic institutions, the application address issues related to safety in biotechnology. of research findings is being undertaken by the From a review of existing guidelines and legisla- private sector. Over the years large biotechnol- tion at both the national and international levels, ogy corporations have formed a wide range of it may be noted that: (a) relative to safety consid- institutional arrangements with universities and erations associated with contained applications, research institutions to ensure the continuity of little attention has been paid to uncontained ap- innovation, accessibility of scientific findings, and plications of biotechnology; (b) a large number rights to license the resulting technologies. De- of countries have no national safety framework velopment and diffusion of any technology regulating living modified organisms (LMOs) would essentially be based on the international resulting from biotechnology; (c) existing na- exchange of technology through technology- tional biosafety regulations address only activi- transfer agreements, training, and research col- ties relating to domestic handling and use of laboration. Procedures and policies that would LMOs; (d) efforts at promoting international promote widespread access to these technologies agreements on biosafety often address issues are still lacking. The fact that most biotechnol- from different perspectives; and (e) relevant in- ogy information is governed by secrecy and in- ternational agreements and guidelines currently tellectual property rights reduces the amount of under consideration are limited in scope. In es- information available to the scientific and regu- sence they lack the qualities that would charac- latory communities and the public. This increases terize effective biosafety frameworks; that is, they uncertainty and reduces the capacity of the pub- should be flexible, transparent, predictable, fo- lic to make appropriate decisions about the risks cused with clear objectives, cost-effective, and involved. adaptable to accommodate different environmen- Strict regulations in some of the industrialized tal, socioeconomic, and cultural conditions. countries on the release of GMOs or their prod- ucts might encourage some biotechnology indus- Political and Public Concerns tries to conduct their experiments in developing and Perceptions countries without government knowledge or approval, because of lack of regulation, techni- Also of concern are the risks of biotechnology cal information, and public accountability. It is applications whose environmental or socio- strictly legal, as there are no laws in these coun- economic long-term impact, or both, is unknown, tries requiring prior government clearance or and the possible diversion of research in this area consent. Existing guidelines adopted by some to the production of organisms that are hazard- industrial countries to govern the release of ous to health or the environment and could be GMOs do not contain provisions for testing and deliberately released in case of war or conflict. application of organisms in other countries. This The difficulty posed by their detection and moni- opens the door for the biotechnology industry to toring is mobilizing public and political concerns enter into bilateral agreements with other coun- at the national, regional, and international levels. tries (where legislation is nonexistent) to test new Another key concern is the limited flow of in- biotechnology products and probably to locate formation and resulting lack of transparency due their production facilities in these countries. The to the dramatic changes being seen in the area of biotechnology industry, while respecting the en- property rights. The biotechnology industry in vironmental legislation of their countries, should industrial countries is "locking up" the new tech- also comply with this legislation elsewhere. nologies through patents, and this trend is grow- While biotechnology should address more ef- ing. In the past most inventors were satisfied with fectively the needs of sustainable development, the product type protection. Under the existing some biotechnology research is being directed patent systems of industrial countries, biotech- towards unsustainable development and does nology industries are allowed to protect the prod- not necessarily reflect the long-term interests of uct as well as the process, and therefore to limit the international community. In theory biotech- the flow of technical information. Although ad- nology would help to make agricultural practices 48 Biotechnology and Biosafety more environmentally sound by eliminating or In Article 19(3) the parties are called upon to con- reducing heavy reliance on potentially polluting sider the need for and modalities of a protocol agrochemicals. But now biotechnology is being for the safe transfer, handling, and use of LMOs used to extend the agrochemicals era. For ex- resulting from biotechnology that may have an ample, instead of fusing the technology to make adverse effect on the conservation and sustain- crops resistant to pests and thus reduce the need able use of biological diversity. Article 19(4) states for pesticides, biotechnology is being used to that each party is obliged directly, or by requir- develop plants resistant to pesticides, thus in- ing any natural or legal person under its juris- creasing the use of these chemicals. diction providing the organisms referred to in paragraph 19(3), to provide any available infor- Need for an International Framework mation about the use and safety regulations re- on Biosafety quired by that party in handling such organisms, as well as any available information on the po- Adequate safety mechanisms and international tential adverse impact of the specific organisms agreements on safety in biotechnology can concerned, to the party into which those organ- contribute to the sustainable development of bio- isms are to be introduced. technology and to international trade in biotech- As a follow-up to some of the actions called nological products. For biotechnology, as with for in Chapter 16 of Agenda 21, and in support any new technology, the rate of development and of the work undertaken by the Conference of the level of success are dependent not only upon the Parties to the Convention on Biological Diversity scientific and technical capabilities of the coun- on development of a protocol on the safe trans- try, but also upon a supportive infrastructure and fer, handling, and use of LMOs resulting from accepting environment in which to introduce and modern biotechnology that may have adverse use it. A key component in the formulation of a effects on the conservation and sustainable use "biotechnology-accepting" environment is the of biological diversity, guidelines have been de- establishment of adequate national and interna- veloped by the United Nations Environment tional regulatory frameworks. Programme, based on a draft prepared by the Recently the biosafety issue was considered in Netherlands and U.K. departments of the envi- two global fora. At the United Nations Confer- ronment. The guidelines reflect common ele- ence on Environment and Development (UNCED), ments and principles derived from relevant Chapter 16 of Agenda 21 on "Environmentally national, regional, and international instru- Sound Management of Biotechnology" recog- ments, regulations, and guidelines, and draw nized that the community at large can only ben- upon experience already gained through their efit maximally from the potential of modern preparation and implementation. They are biotechnology if it is developed and applied ju- based on the premise that adequate mecha- diciously, to avoid possible negative side-effects nisms for risk assessment, risk management, that have diminished the potential of many new and capacity building through-among other technologies in the past. Chapter 16 highlighted things-the exchange of information and the the need for internationally agreed-upon prin- use of these guidelines at the national, regional, ciples as a basis for guidelines to be applied for and international levels can contribute signifi- safety in biotechnology. cantly to safety in biotechnology. The issue of safety in biotechnology was also The guidelines address the human health and considered within the framework of the Conven- environmental safety of all types of application tion on Biological Diversity in Articles 8(g) and of biotechnology, from research and development 19, paragraphs 3 and 4. In Article 8(g) parties to to commercialization of biotechnological prod- the Convention are called upon to establish or ucts containing or consisting of organisms with maintain means to regulate, manage, or control novel trait(s). They recognize that before such the risks associated with the use and release of biotechnological products are placed on the mar- LMOs resulting from biotechnology that are ket they must comply with any specific product likely to have adverse impacts on the conserva- requirements, such as food safety, efficacy, and tion and sustainable use of biological diversity. quality; but these matters are not addressed in The Promise and the Perils 49 the guidelines. The guidelines can be imple- will, in and of themselves, ensure the safe devel- mented by using existing structures and mea- opment and application of biotechnology. There sures or by introducing new ones. must be a capacity to implement the regulations However it must be stressed that neither an based on sound scientific principles with consis- international biosafety protocol nor guidelines tency, competence, and expedience. Regulatory Framework Issues Biosafety Regulations and Processes Desmond Mahon T his meeting is on biosafety; so far I have tual property is one, indigenous knowledge is heard a great deal about biotechnology, another, equitable sharing of wealth and tradi- but not very much about biosafety. So I tional methods are others. Everything we have would like to take the discussion back to bio- talked about during this conference is addressed safety by spending a few minutes talking about under the CBD, but these issues are not biosafety. the Convention on Biological Diversity (CBD), They are aspects of biodiversity and the protec- because it addresses a number of the issues that tion and use of biodiversity. have been talked about here, and then focusing Biosafety is addressed twice in the CBD. It is on biosafety under the Convention. first addressed in Article 8(g), which says that We are talking about international regulatory each Party to the Convention should develop or mechanisms. You can look at this as two sepa- maintain the procedures required to be able to rate and independent components or as an inter- assess the risks associated with living modified national regulatory framework. The international organisms and their release into the environment. framework could consist of two pieces, a national The governments that are Parties to the CBD have regulatory framework that is integrated from all agreed to this, and are developing national the individual states, and an international frame- systems. work that requires loss of sovereignty, or a com- The second reference to biosafety is in Article bination of both. With the CBD, you come up with 19(3), which says the Parties shall determine the both. need for, and the structure and modalities of, a What does the Convention say about regula- protocol on biosafety. That protocol would be an tory frameworks for biotechnology? The Conven- international instrument. tion's objective is to ensure the conservation and In looking at the proposed protocol the first sustainable use of biodiversity. In other words, thing one must consider is the mix-up between there are two halves. It does not just say we policy, science, and legislation. The discussion of should keep biodiversity, it is good, and we need whether or not there is a need for such a protocol it. It is says we must work on mechanisms by is past. Eighteen months ago the Parties to the which we can safely use biotechnology to increase CBD (168 states and one economic region)agreed the wealth of the world, to increase equity and that we need an international protocol. So there benefits worldwide. So there are three consider- is no longer dispute as to whether or not to have ations under the CBD: conservation, sustainable a protocol, because the Parties have decided to use, and equitable sharing of benefits. have one. This was a policy decision. The CBD also contains a variety of articles that The basic premise that we accept is that the call upon sovereign states to address specific governments who made those decisions sought items, preferably in a consensual mode. Intellec- advice from their scientific advisers and either 50 The Promise and the Perils 51 acted upon it or declined to use it. It does not will get eventually is a science-based methodol- really matter. The decision has been made, so ogy of assessment that is as up to date as pos- there will be a protocol. sible, based on current science. What is the difference between the protocol and Risk management is not a science-based ap- the Convention? The Convention lays out policies proach; it is a pragmatic approach. It may be ab- that governments have agreed to, and then says: solutely perfect in one scenario and absolutely "Go away and do it your way" In other words, useless in another. You cannot take an interna- Article 8(g) does not say: "Here is how you will tional system and say: "Apply this method of risk establish your national regime and this is what it management in these conditions." If it works in must do." It simply says you must have one. North Dakota, it is highly unlikely to work in the Under these circumstances the U.N. Environ- Central African Republic. It is simply not appro- ment Programme international technical guide- priate. You can only provide guidance on risk lines on biosafety have been an extremely useful management. tool. The guidelines lay out, for those countries Another difference between the Convention that do not have a regulatory structure, the steps and the protocol is what the protocol does and to follow in developing one, taking into account does not do. I have constantly heard the termi- the flexibility and fluidity of the system. But they nology "regulation." The protocol would require do not demand; they simply say: "These can be that an exporting entity provide sufficient infor- of benefit." mation to the competent authority in the import- The protocol, however, is a law, and law is not ing country to allow the latter to make a risk subject to flexible interpretation. The law will be assessment. implemented by Parties that ratify the protocol Terminology is incredibly important. I do not as a separate instrument to the Convention. consider a requirement to provide information What stage have we reached with the proto- for a risk assessment or the development of a risk col? In the first phase we reached the point of assessment to be regulation of either an industry looking at the content of the protocol; that is, the or a product. When the competent authorities in articles. Governments were requested to provide the importing country have made a decision, they specific ideas and, if they could, possible text for may decide to regulate the product, impose con- articles under the protocol, and we received many ditions, or reject the application. That is regula- good ideas. The next meeting on the protocol will tion. So the protocol does not regulate the try to put this material into a form from which industry; it simply requires that a sovereign state the actual articles can be put on paper for nego- be provided with the information it needs to tiation. make a decision. The protocol also indicates that In other words we have not yet arrived at a it is a sovereign right of the importing country to real negotiation process. What we have is rather make that decision. a need to get to a negotiating text from which By definition the protocol also has other con- everyone can start to negotiate what they want sequences. It automatically brings about harmo- in and want out. It will have to be a concrete dis- nization, which is a benefit to society and to the cussion focusing on what is wanted from the pro- industry. It establishes a transparent process be- tocol and what role it should play. cause it will be visible to everyone what infor- When the Parties to the Convention sit down mation, at a minimum, has to be provided for an to draft the protocol, many of the articles will assessment. What that information is will be de- address procedures, but some will address spe- termined by the Parties, because they must make cific issues. Clearly, if the protocol is to address these decisions in the design of the protocol. Gov- potential risks, both risk assessment and risk ernments will presumably have sought advice management must be addressed. It is absolutely from their scientists, from their own legislators, clear that risk assessment is, in general, a scien- from any group they felt could provide them with tific issue. There is a consensus, at least in the competent advice. I feel that groups here can pro- developed world, that regulation should be based vide them with competent advice, but they have on a science-based risk assessment, and every- got to focus on what point the Parties have body believes it for their own reasons. What you reached in the process. 52 Biotechnology and Biosafety There are several other outstanding issues, The terms of reference provided by the Con- which I call "generic" issues, that await discus- ference of the Parties restricts the scope of the sion, such as socioeconomics, liability and com- protocol at this point to transboundary move- pensation, and scope. ment; in other words, taking an organism and The question of socioeconomics was tabled moving it across a border to a receiving country. during the process of developing the protocol. It So the scope of the protocol in terms of its ge- is a significant issue. A basic question being posed neric application is quite restricted. But the scope by many countries is the inclusion of socio-eco- of the protocol in terms of what products or or- nomics in a protocol, and then subsidiary to that, ganisms would fall under it and the requirement its inclusion in a risk assessment. Are socioeco- for advanced, informed procedures has not been nomic factors an appropriate item to be included determined. in a risk assessment? And if not in the risk as- It may be useful to bear in mind that for many sessment, is it appropriate to include them in the reasons the international and national instru- protocol-keeping in mind that the protocol will ments, while they may differ in scope, really can- do more than simply look at risk assessment? not differ dramatically regarding the procedure The second items that clearly will come up for used for determining or assessing risk. Because discussion are liability and compensation, which if you have the same product produced inside are particularly thorny issues. This was touched the country-as opposed to imported into the upon this morning. These two items will be ma- country-the assessment procedure under a jor issues for debate by the Parties over the next variety of international instruments must be week, because they will have to begin to reach similar. consensus on what to include in the protocol. My last comment is that having done the as- The third absolutely critical item is scope, and sessment, the final decision may have abso- by scope I mean: to what will the protocol ap- lutely nothing to do with science. The risk ply? The scope is already somewhat limited, in assessment may and probably should be sci- that it is a protocol on living modified organisms, ence-based, but the decision on regulating or which is wider than genetically modified organ- import need not be. Legislators are the people isms (GMOs) because there is obviously interna- who make decisions, and very few of them are tional debate as to what a GMO is. That differs practicing scientists. So do not expect the deci- from country-to-country, and indeed from sion to mirror science. There are many more agency-to-agency within any country. So the Par- aspects that go into the making of a decision ties wisely elected to use a neutral term and wait than, to use a colloquial term, a "science-based to see if the discussion will be resolved. risk assessment." Regulatory Framework Issues Intellctual Property Rights, the Private Sector, and the Public Good Timothy W Roberts W A That has intellectual property (IP) to do "Traditional" forms of IP are of two types. The with biosafety? While the connection first includes copyrights, trademarks, and de- is not direct, it was decided that this signs. While some doubt whether it is fair to give conference should have some discussion of IP monopolies to inventors, few challenge the right because of the level of interest in the subject. This of authors or composers to protect against copy- talk is a rapid survey. ing. The second type, including patents and plant First, why do we have IP at all? Madame Curie variety rights, is more relevant to biotechnology. was quoted this morning, to the effect that all Traditional safeguards, which are essential to knowledge is for humanity. That is the general rule: a proper balance of rights include: all knowledge should be free and freely available * Limited term (except trademarks). Copyright for use. This is a subset of the general principle is for the life of the author plus 70 years in Eu- that people should be free to do as they choose rope; patent rights are generally for 20 years insofar as it does not damage others. IP is an ex- from the date when the patent specification ception to this rule, but it must be kept in balance. was filed. Note that development can take ten "We must always bear in mind that monopoly years off this patent life. legislation is the end result of a balancing act; is * "You cannot stop people from doing what they the restraint on competition justified by the ben- were doing before." This is a general principle. efits it gives to society at large?"' If it seems to be violated, either there is a mis- What are the objectives of IP? They are of two understanding or something has gone wrong types: and needs to be put right. The fundamental 1. Societal goals: To encourage invention, invest- principle is that you cannot take existing ment in innovation, and disclosure of new tech- knowledge out of the public domain by pat- nology enting. This means that public goods are pro- 2. Equity goals: To recognize and reward the tected from expropriation. innovator. How do these principles apply in biotechnol- The patent system makes a bargain with the ogy? Biotechnology innovations are expensive to inventor: in return for disclosure of the inven- develop, particularly because of essential safety tion, the inventor receives the exclusive right to testing, and easy to copy-in fact, they copy use it for a limited period. I remark in passing themselves. Thus there is a special need for strong that inventors are often highly motivated and protection. need little encouragement. Investors are more But does this mean allowing people to protect cautious. Innovation requires investment as well natural genes that they have not invented? We as invention, and without the protection of a see many patents apparently claiming natural patent such investment will often not be made. genes; this causes great concern. In Europe, par- 53 54 Biotechnology and Biosafety ticularly, the law says that you cannot patent dis- Several questions arise. Is it wrong that indus- coveries, you can only patent inventions. Genes try should monopolize existing traditional are discoveries, therefore they cannot be pat- knowledge? It is not difficult to answer that ques- ented. This argument does not apply in America tion; it is surely contrary to everyone's idea of because the law is differently phrased. An inven- equity and common sense. It is equally contrary tion is defined as an invention or discovery (35 to the fundamental patent principle mentioned USC 100). But in fact, though different words are above. To be fair, it seems quite doubtful that the used, there is little if any difference on this point Neem tree patents that caused the trouble did, between U.S. and European law. I speak as one in fact, infringe this principle. What was being who has spent most of his working life patent- claimed was not the traditional uses of the Neem ing discoveries, mostly of pesticidal activity in tree extract, but a new, improved formulation of chemicals. The important principle is that pat- that extract, which allegedly lasted longer. How- ents must not stop people from doing what they ever, there are other patents that may well in- were doing before. Thus, a patent related to a fringe this principle. There is a U.S. patent on natural gene sequence must be limited to the use male-sterile plants of the South American cereal of something that did not exist before; the iso- quinoa in a form suitable for making hybrids. It lated sequence, for example, or recombinant DNA is claimed that such plants have been known for containing it. Most U.S. "gene" claims do this many years in Bolivia. There is a U.S. patent on explicitly; some European patents do not (which the use of the spice turmeric to heal wounds, a is a pity, as it causes misunderstanding), but they use for turmeric that has apparently been known will have the same effect as the U.S. claims. for centuries in India. As well as such "traditional" IP rights we have A more difficult question is whether industry an emerging area of newer rights, not always should be free to develop and improve traditional considered as intellectual property but neverthe- knowledge. It has contributed nothing to the pro- less directly analogous. These include the Con- duction of such knowledge. I suggest that we vention on Biological Diversity (CBD), "farmers' should apply the principle set out at the begin- rights," and traditional resource rights of indig- ning of this paper, that is, all knowledge is free enous peoples. unless there is a good reason why it should not The CBD asserts sovereignty over genetic re- be. If traditional knowledge can be developed sources held within borders and sets norms for and improved, then there does not seem to be the use of those resources by others. "Farmers' sufficient reason to prevent such improvements rights" is an idea only enunciated in the 1980s, from being patented, provided the original although its roots go much further back. Newer knowledge remains free. still is the idea of indigenous resource rights. This Now some further consideration of farmers' comprises the rights of indigenous people to their rights. These were defined in the United Nations way of life and all that it involves, including the Food and Agriculture Organization International technologies that they practice, which hold con- Undertaking in the 1980s as: "Rights arising from siderable promise in some areas. This is an im- the past, present, and future contributions of portant and contentious issue; I mention it only farmers in conserving, improving, and making to introduce a brief discussion of the use by oth- available plant genetic resources." At that time ers of traditional knowledge-or its misuse, they were vested in the international community, sometimes called "biopiracy." which was seen as a trustee to conserve the rights Many people are aware of the controversy and distribute benefits arising from their use. about patents on the Neem tree. There is a com- However, this formulation does not fit well with plex of around 40 patents, mostly filed in the U.S. the national rights in germplasm now recognized in the names of various patentees, based on uses by the CBD. In consequence the International of the neem extract derived from the Neem tree. Undertaking is being renegotiated-slowly and This is an Indian tree that has many traditional with great difficulty. It would be reckless to pre- uses, in particular, as a natural insecticide, and dict how that will come out. its properties have been known and used in In- The CBD has three main objectives: conserva- dia for thousands of years. tion of biodiversity, sustainable use of biodiver- The Promise and the Perils 55 sity, and equitable sharing of the benefits of such 27.1 "Patents shall be available... with- use. What is the relevance of intellectual prop- out discrimination as to ... thefield of technology." erty rights, in particular, patents, to these objec- 27.2 "Inventions, the prevention within tives? They do not contribute significantly to their territory of the commercial exploita- conservation. They do provide an incentive to tion of which is necessary to protect public develop sustainable uses (and, of course, order or morality, including ... to avoid seri- nonsustainable uses). Their greatest use can be ous damage to the environment" need not in recovering from ultimate consumers a propor- be patented. [emphasis added] tion of the value such uses generate. Such value 27.3 Plants and animals need not be pat- is then available to be shared with suppliers of ented, but plant varieties must have some the biodiversity. form of effective protection. An important current controversy is whether the Convention should be backdated to earlier The general rule is that all types of invention than the date on which it entered into force (29 must be allowed patents, regardless of the field December 1993). If so, how far? Any backdating of technology (27.1). However there are public will amount to retrospective legislation, always policy exceptions (27.2). If commercial exploita- difficult to administer and often unfair. A mod- tion of an invention has to be prevented for vari- est backdating (10 years or so) hardly seems to ous public policy reasons, including serious meet the perceived problem, while a back- dat- damage to the environment, no patent need be ing of several centuries or more would raise all granted. It does not include ethical objections to sorts of difficult historical questions. This diffi- patenting lifeforms, unless these are so serious culty is best settled by specific voluntary that commercial exploitation of such lifeforms is arrangements. also forbidden. There is a not good deal about intellectual Article 27.3 provides further special excep- property in the CBD. Generally, the drafters seem tions. According to 27.3, not all lifeforms are to have assumed that IP was a problem rather required to be patented: it is not obligatory than an opportunity. But the CBD clearly recog- under TRIPs to offer patent protection for nizes intellectual property rights. Article 16.2 plants and animals. But plant varieties have to requires transfers of technology under the Con- have some form of protection; for example, by vention to take proper account of IP. I quote Ar- plant variety rights, in accordance with the ticle 16.5: "The Contracting Parties, recognizing Union for the Protection of Varieties Conven- that patents and other intellectual property rights tion. may have an influence on the implementation The negotiation of Article 27.3 was extremely of this Convention, shall cooperate in this re- controversial, and the ultimate compromise gard subject to national legislation and inter- suited few. In consequence it was agreed that it national law in order to ensure that such rights would be reviewed four years from the start of are supportive of and do not run counter to its the Convention; that is, in 1999. There are widely objectives." differing views about what will happen. One While it is generally assumed that this is a view is that the only option will be to narrow the warrant for limiting the application of IP to ge- restriction on patenting, or even to abolish it. This netic resources, it can also be argued that IP can is said to be supported by the history of the ne- support the objectives of the Convention and gotiations. Another view is that this will be a therefore should be extended. splendid opportunity to confirm and widen the There is another very important international existing exceptions, which many TRIPs partici- convention that relates to IP and is often seen as pants want. being directly opposed to the CBD. This is TRIPs To conclude, I have two questions. First, is (Trade-Related aspects of Intellectual Property), there a conflict between the CBD and TRIPs? a creature of the World Trade Organization that Some people see these two conventions as being lays down minimum IP standards for members. in partial or even direct opposition. If this were I quote and paraphrase parts of Article 27: correct, it is not clear how the conflict would be 56 Biotechnology and Biosafety settled. I suggest that there is no inevitable con- will go away. We will have to work out practical flict. One would not expect one, since over 100 accommodations. Above all we shall need mod- countries have subscribed to both conventions eration and patience. and they can readily be construed to be consis- tent with one another. Second, in the face of all Note these rights, of so many diverse kinds, how can anytiing new and useful ever be developed and 1. J. Laddie, "Copyright: Over-strength, Over-regu- exploited? It is not simple, and there are no easy lated, Over-rated?" Stephen Stewart Memorial Lecture, answers- such as hoping that some of the rights 1995. Discussion Moderator: Hamdallah Zedan Sivramiah Shantharam: I would like to comment pened in industrial countries. What if they let an on the statement that the intellectual property unsafe product pass? rights (IPR) issue may not have much to do with Finally, should the protocol have a clause to biosafety, which should be the focus of discus- state liability of the producer if, down the road, sion here. In every forum I have gone to in the product shows safety hazards in developing developing countries, these biosafety, IPR, and countries, away from the countries that have re- ethical issues in biotechnology get so intertwined ally strong laws on that? that you can make very little progress towards facilitating safe deployment of genetically engi- Desmond Mahon: I did not say there is no so- neered organisms. cioeconomic factor in the protocol. I said that Biosafety should be delinked from discussions what is happening is that socioeconomics is cur- on ethics and IPR because at this stage, in most rently one of the major items to be discussed, and of the developing countries, what we are look- there are two views on it. ing for is safe, effectively terminated field test- One is that it should be included in the risk ing under closely monitored conditions using assessment. Another is that it should not be in reasonable available physical, biological, and the risk assessment or potentially even in the temporal biosafety safeguards. protocol. We seem not to be making any progress to- The question was, if you make a science-based wards that goal at all. risk assessment, whereas there is relative agree- ment on the Western sciences in molecular Audience comment: Desmond Mahon raised biology and many of the risk assessment compo- some very serious issues about the Convention nents, there is not international agreement on the on Biological Diversity and the biosafety proto- science of socioeconomics. So it is extremely dif- col. One issue is that there is no socioeconomic ficult to put it into an instrument. factor in the risk management or risk assessment Should the protocol indude it? That is for the process. Should the protocol take into account the Parties to the Convention to decide. It is not an socioeconomic factor? issue that the secretariat can have a position on. Second, he stated that the decisionmaking pro- It is something the Parties are going to discuss in cess is not scientific in nature and the sovereign great detail and potentially at great length. state makes decisions based on political and other Clearly the decisionmaking process is not sci- factors. Are there safeguards in the event that ence-based. If we use a science-based risk assess- industry does not buy the decision? This is not ment, the determination of risk is science-based. done only in developing countries; it has hap- The determination of acceptable risk is not. It is 57 58 Biotechnology and Biosafety a political decision that stays with the sovereign Desmond Mahon: With respect to the comment states. on the protocol, by definition the biotechnology When risk is assessed for any given LMO, the protocol-any protocol under a convention-is importing country will make a decision. It may a legally binding instrument for those who be- not be based upon the level of risk. It might be come parties to the protocol. It is a nested series. based upon a dozen different factors. That is true Currently 169 countries and organizations have in every country in the world. But the determi- ratified the Convention. That means the Conven- nation of risk should be singular and unique. That tion is binding on those 169. Some countries have is a different thing. not, so it is not binding on them. Under the Convention a protocol is developed. Mae-Wan Ho: Many countries have been argu- The process is the same. The 169 countries who ing within the protocol process for a legally bind- ratified the Convention are asked to ratify the ing international biosafety protocol. Desmond protocol. If 110 of them do, it is binding on those Mahon seemed to say that that is not true and 110. It is not binding on the others. So it is a le- that it was up to the importing and exporting gally binding instrument for those who ratify it. parties themselves to decide on the precise na- On the second question, you must remember ture of what information is going to be given and that I am in the position of telling you what other accepted. people have done, not what they are going to He did say that the importing country has the agree to in the end. They are in the middle stage. sovereign right to make a decision on whether to In that middle stage they are developing ar- accept. I wonder whether that is part of the le- ticles. Potentially the articles will include a de- gally binding international biosafety protocol, scription of the information that must be because if it is not, then it is still up to individual provided to an importing competent authority. countries to intimidate another country into There are a variety of options in that. There are accepting their products. options that say the company must provide the There is a natural link between intellectual information, that the state must provide the in- property rights and biosafety, which is the issue formation, that the state must do the risk as- of responsibility and liability. The biotechnology sessment or the state must not do the risk company, or whoever is benefiting commercially assessment. from the patent, should also have responsibility These decisions have not been made by the for liability. This brings up another very crucial parties yet. There is now a series of options laid biosafety issue-segregation and labeling, with- down upon which a consensus will eventually out which there is no way we can trace or pros- be reached as to which ones will be included in ecute the liable party. the Convention. But it is relatively clear that there will be an identification of the information that Timothy Roberts: Regarding the point about re- should be provided in the notification under the sponsibility of the patentee in cases where the protocol, and that will be binding. That will be invention proves dangerous, I can see that this is the minimum. Clearly an importing country will a very attractive proposition, but I really do not always have the option to state "we want more." think it is accurate. The responsibility if anything Safe handling and use is included in the con- goes wrong lies with the person who put it on text of the protocol. It is transboundary move- the market. ment of living, modified organisms and it is a An invention will be exploited in a particular biosafety protocol on transport, handling, and form, and that particular form is the form that use. But that will clearly be interpreted different must be tested and regulated to make sure that it ways by parties in the discussions, so I have no is safe. It is the responsibility of whoever puts final say on what they will mean by "use." that on the market to make sure that it is safe. It Regarding labeling and segregation: segrega- is not the responsibility of the patentee. The pat- tion is not an issue that has been dealt with yet; entee is somebody who has had a broad idea, like labeling is an issue that has been dealt with in somebody writing a book. packaging, in terms of transboundary movement The Promise and the Perils 59 and transport, so that will be within a compo- cal or anything else. It is the specific form that is nent of the protocol. chosen that is crucial there. Finally, liability and responsibility: if as a sov- ereign state you have to make a decision as to Jeremy Wright: I agree with you totally on the whether or not to import, then with sovereign principle that whoever introduces something responsibility goes sovereign liability. It is some- should be held responsible. My question was to thing you choose or do not choose. The strength do with the fact that, in practice, there is no re- of liability or compensation will be determined course and no enforceability of that theoretical by the Parties. responsibility. Jeremy Wright: I am from the Wellness Founda- Kheryn Klubnikin: When the Biodiversity Con- tion, and I have a question on patents and intel- vention was being assembled, one of the prob- lectual property. The intent of the law, as I lems was the disconnect between the traditional understand it, is to give a certain group of people English notion of rights-in this case intellectual the right to exploit something "for profit." rights-and traditional rights. But when it comes to who assumes responsi- The recent application for quinoa patents bility when something goes wrong, it is fine, in might be a good example of indigenous knowl- theory, when you say it is the sovereign nation edge about the use of plants. The knowledge was or the corporation that introduces it. When you developed under a different system of rights and come to the actual case though, suddenly there a different understanding, which is about the is bankruptcy and nobody can get compensated, rights of the community. It has nothing to do with or the public health authorities take over or some- rights of individuals. thing like that. Arguments over who will pay the Is it moral and appropriate to impose the West- cost of the cleanup can go on for decades. ern world's notion of intellectual property rights So the issue of accountability and responsibil- on a traditional group, or is there a need to bring ity is not nearly as clear-cut as you indicated that the two different concepts of rights and law to- it might be, from a very practical point of view. gether in a more equitable way? Timothy Roberts: Intellectual property is gener- Timothy Roberts: The point on traditional rights ally not the right to exploit something for profit. is a very serious question. The quinoa patents, It is the right to stop other people from exploit- on the face of it, look like a serious injustice to ing it. And it may well be that it cannot be safely the people of South America, whose material has exploited; if not, then there is a need for appro- been appropriated without their permission, as priate laws to stop people from exploiting it. That well as a defect in a patent system. is quite separate from the intellectual property As a patent attorney I would be inclined to side. come up with a technical solution for that, but But I maintain my view that those who actu- the point is that these things happen. I do not ally do something are responsible for the conse- know how traditional rights are to be reconciled quences of their actions, not those who suggested with a Western system. This is not going to be a that it might be done or even those who have problem only in the intellectual property sphere. acquired the legal right to prevent others from It may be a more general problem, but I am all in doing it. It is the form in which it is done that is favor of keeping an open mind as to what the crucial to whether it is safe or profitable or ethi- answer is. Reviewing the Evidence Are the Opportunities of Genetically Modified Organisms Being Fully Exploited? Panel Presentation George Tzotzos Jn the late 1970s and early 1980s there was Indirect answers may be afforded by an widespread belief that biotechnology could assessment of the transgenic crops that are cur- revolutionize agriculture by genetically en- rently undergoing field trials or being commer- gineeringplantstofixnitrogenorresistbioticand cialized. This reveals the dominant role of abiotic stresses. Accomplishing research goals has international agrobiotechnology enterprises in been a more painstaking exercise than originally setting priority research and development thought, and it is only now that we are observ- (R&D) targets. Transformation of crops of im- ing the first commercial applications of biotech- portance for the developing world (such as nology. Yet the pace of scientific advancement has sweet potato or cassava), perennials such as been such that many breakthrough technologi- cocoa and coffee, and legumes are conspicu- cal innovations are used routinely, and an increas- ous for their absence from the list of priorities ing number of laboratories in the developing of the agrobiotechnology industry. However world make use of powerful and sophisticated this situation is likely to change as several na- technologies and equipment. As a consequence tional and international research programs fo- the scope of National Agricultural Research Sys- cus on the transformation of some of these tems (NARS) has been expanded tremendously. crops (for example, cassava and sweet potato). Nonetheless, attempting to assess biotechnol- Should this be the case, some of the potential ogy's potential impact-or lack thereof-as a socioeconomic benefits of biotechnology at the source of economic growth and social benefit in level of small-scale farming communities may the developing world is a task confounded by materialize. the infancy of technological commercialization Although technological innovation in agricul- and the concomitant lack of paradigms. ture has been driven by the private sector, it can- The derivative question of whether the oppor- not be taken for granted that efficiency and profit tunities presented by transgenic crop plants are are the exclusive criteria for the development of being fully exploited, with particular reference new products. In industrialized countries re- to poor farmers in rural areas, requires the fol- search has often been guided toward products lowing to be addressed: with greater public acceptance. The situation is * Is biotechnology responding to the needs of different in the developing world, where consum- farmers? ers' purchasing power does not provide a sig- * Are selected farming sectors benefiting from nificant incentive for private investment into biotechnology at the expense of others? research directed to local needs. * Are farmers playing a role in shaping the in- Nonetheless technological innovation and dif- novation strategies of agrobiotechnological fusion are not determined by commercial con- research? siderations alone. The role of mediators, such as 60 Reviewing the Evidence 61 venture capital institutions and other financial all and end-all. It is, nonetheless, critical in over- brokers, also influences the capital flow to pub- coming some severe bottlenecks of conventional lic and private institutions and firms, particularly agricultural programs and enhancing their de- the new technology-based firms. Government livery prospects. policies, likewise, have often been instrumen- The role of the international research system tal in guiding the pathways of innovation in supporting national R&D programs cannot be through funding of research, regulation, tech- overemphasized. However the situation to date nology transfer legislation, and appropriate pat- is not promising. International donor and tech- enting policies. nical support agencies have been reluctant to re- In the nonindustrialized world, market failure, direct funds from conventional types of capacity coupled with the absence of mediator mecha- building and R&D programs in favor of biotech- nisms and inappropriate government policies on nology. This is attested to by the fact that fund- biosafety, intellectual property protection, and ing for biotechnology-related R&D pales in technology transfer constitute significant impedi- comparison with public-sector investment in ag- ments to private investment and innovation in ricultural research in industrialized countries- biotechnology. In this regard the effectiveness U.S. federal funding for agricultural research in with which biotechnology can meet domestic 1996 was an order of magnitude higher-and is needs is crucially dependent upon actions that totally eclipsed by private investment. strengthen the capacity of public and private re- Due to the shortcomings mentioned above, it search systems. Such actions include both the is likely that the major impacts on the farming absorption of technological spin-offs that can be systems of the developing world will come from adapted to serve domestic needs, and the intro- the importation of transgenic crop varieties. Al- duction of policy and institutional reforms con- though trade globalization makes this inevitable, ducive to investment in biotechnology. the pace at which such varieties are introduced It is therefore expedient that developing coun- will depend on the price premium they carry, and tries gear an important part of their biotechnol- consequently, on the purchasing power of farm- ogy research capacity building toward the ers. The push of transgenic seed upon develop- effective exploitation of existing knowledge, ing countries is seen at times to be part of a rather than the generation of new knowledge. strategy of the agrobiotechnology industry to The use, assimilation, and adaptation of new generate export markets rather than solve agri- knowledge should be an integral part of the cu- cultural problems. Even if this were so, there are mulative learning process that would increase a occasions where the two may coincide. Such co- country's potential for upgrading its R&D capa- incidental convergence of interest should be ex- bility. Clearly biotechnology alone is not the be- ploited whenever possible. Are the Opportunities of Genetically Modified Organisms Being Fully Exploited? Panel Presentation Gabrielle Persley I would like to approach this discussion by particularly those which have proved to be in- looking at five different areas: perceptions, tractable to more conventional approaches. The issues, objectives, activities, and outcomes. It Striga in Africa comes to mind, as do a number has struck me over the past few days that when of plant diseases and malaria. the international development community thinks A second key objective is to build national about biotechnology, we tend to take a top-down capability, not only in terms of scientific capabil- approach, focusing on perceptions and, in de- ity, but also legal capability and investment. Busi- creasing order of priority, issues, objectives, ac- ness communities must be able to look at tivities, and outcomes. adequately funding both the research and devel- It might enliven the debate if we focused more opment aspects of biotechnology and at new on what are the desirable outcomes to which bio- paths toward public and private sector partner- technology could contribute, and then work up ships. the list discussing what activities and objectives If we look, then, at the issues that might affect would help us achieve those outcomes. What are these programs, we must also consider the im- the key issues that impact on achieving the out- plications of international treaties and regulatory comes? And finally, what are the perceptions from frameworks, management of intellectual prop- which we will derive the key issues? erty rights, public and private investment, and In terms of outcomes I think we could all agree lest we forget, the need to attract the best and that increasing the wealth of people in develop- brightest science and the best and brightest ing countries, increasing people's health, reduc- young scientists to deal with global issues. This ing environmental damage, and conserving gives a key role to the universities in both devel- biodiversity would be desired outcomes. We oping and industrial countries. could have a lively debate as to how biotechnol- Such an approach might help put in perspec- ogy can contribute to these outcomes. tive the public perception of risk associated with In terms of objectives and activities, obviously, new technologies, consumer acceptance of the it is very important to identify specific problems new products, and the ethics associated with risk that could be tackled through biotechnology, assessment and patenting. 62 Are the Opportunities of Genetically Modified Organisms Being Fully Exploited? Panel Presentation Carlienne Brenner I propose to bring a somewhat different per- and development (R&D) in developing countries; spective to the discussion, based on the cur- the second, changing public and private sector rent status of agricultural biotechnology in a roles; and the third, the regulatory framework number of developing countries. (including biosafety) and public policy. At the outset I would like make it clear that I With respect to the first set of issues I would firmly believe that most countries should have like to place biotechnology R&D in the broader their own national science and agricultural re- context of global trends in investment in agricul- search capacity and that there is a need for tech- tural research. One particularly significant sta- nological innovation within developing countries. tistic that should be kept in mind is that in OECD There are clear limits to how much technology member countries agricultural research intensity can be "imported" unless the know-how to make ratios-that is, public agricultural R&D as a share the best use of the technology is available. It is of agricultural gross domestic product-averages also important that there be a proper balance about 2.39 percent. For developing countries this between the share of research and technology ratio is only 0.51 percent. development conducted within developing coun- Against that background a growing number tries and the share of imported technology, be- of developing countries are investing in agricul- cause the kinds of agricultural biotechnology tural biotechnology R&D. In some cases they are being developed in industrialized countries may even setting up new biotechnology institutes. The not be those most appropriate for production fact that biotechnology is perceived as offering conditions in developing countries. potential for more environmentally friendly tech- My presentation is based on the experiences nologies in agricultural production provides a of a number of countries I have studied in the strong incentive. course of my research at the Organisation for Pressure is also strong simply to "get into the Economic Co-operation and Development act." Countries are very susceptible to the real or (OECD) Development Centre. These countries perceived fear that the technological gap may be include: in Africa, Kenya and Zimbabwe; in Asia, widening. Thus in many situations biotechnol- India, Indonesia, and Thailand; and in Latin ogy R&D has been very much science-driven. In America, Colombia and Mexico. I hope that the other cases, as George Tzotzos has pointed out, evidence drawn from these countries might it has been donor-driven. present a middle-of-the-road approach between Thus far biotechnology R&D in developing the diametrically opposed views that were ex- countries is largely uncoordinated. In most cases pressed yesterday. institutions conduct their research quite indepen- The presentation will cover three sets of issues. dently of any national coordination effort. Re- The first is agricultural biotechnology research search is also undertaken without a sense of 63 64 Biotechnology and Biosafety national priorities for biotechnology research and for an increasing number of plants. It is unlikely, with very little awareness of what would be ap- however, that in the short term the private sector propriate given the priorities that have been set is going to become involved in segments of the for agriculture. market where growth prospects are poor or in The research taking place is still very predomi- crops grown by smallholders. nantly public-sector research carried out in na- There is therefore a need to foster public-pri- tional agriculture research institutes and, vate sector collaboration and to seek a better bal- increasingly (depending on the country), in uni- ance in the roles played by the two sectors. This versities. Levels of investment are nevertheless is reflected in a diversity of new public-private still very low compared with those of industrial- sector initiatives for technology development and ized countries. transfer occurring in developing countries, al- If we think about innovation in agriculture we though there is no time to go into detail here. It is have to admit that research is only a small part- important that incentives be given to promote and perhaps the easiest and least costly part-of private sector activity in areas where there is creating a new technology and having that tech- strong potential demand for technology. Such in- nology transferred to the farmer's field. It is what centives would enable the public sector to focus happens beyond successful laboratory research, more sharply on those areas where there is a per- during the development phase and the distribu- ceived social need, but where short-term market tion or marketing of a new agricultural biotech- prospects are poor. An example of such an area is nology, when the difficulties occur for national where poor farmers, rather than purchasing seed agricultural research institutes and universities. from the market, exchange it among themselves. This brings me to the second set of issues: Finally, with respect to the third set of issues changing public and private sector roles. Fol- and, more specifically, intellectual property lowing the advice of the World Bank and the In- rights, most countries have signed the Trade-Re- ternational Monetary Fund, a growing number lated aspects of Intellectual Property Rights of countries have adopted structural adjustment Agreement. Governments are therefore commit- and liberalization policies. This has meant strong ted to the establishment of some kind of national pressure to privatize economic activities formerly system for intellectual property protection. While undertaken by the public sector. the agreement allows some scope with regard to It has also resulted in problems of maintain- the forms of protection allowed for plants and ing levels of investment for research and devel- animals (patents, plant breeder's rights, or a sui opment in public research institutions. In generis system) the timeframe is limited. It is addition the development aspect of R&D-usu- important, in deciding what system is most ap- ally more costly and time-consuming than the propriate for a given country's needs, that gov- research phase-has often been neglected, with ernments help to create an environment that the result that no funds have been allocated. stimulates local innovation. A third problem facing national agricultural Although there is no time to go into it, I would research systems at present is that traditional be happy to answer questions on the impact of channels for technology transfer (public exten- strengthening and extending intellectual prop- sion systems) are in many cases in the process of erty rights. Overall, impact is likely to be mixed, being either dismantled or privatized, without but it does pose important questions with respect alternative mechanisms to replace them. In some to the future of "public-good technologies." This instances nongovernmental organizations are is something all of us need to be thinking about. stepping in to perform that role. Finally, and of particular relevance to this In most countries there is still very little pri- meeting, if developing countries are to take ad- vate sector investment in agricultural bio- vantage of what agricultural biotechnology has technology research. There are, however, a to offer, it is important that biosafety policy be growing number of small biotechnology compa- addressed-whether as national legislation or nies, particularly in tissue culture. A growing simply as guidelines. Thus far very few countries number of small tissue culture companies are pro- have established national biosafety procedures viding improved, disease-free planting material and practices. Are the Risks of Developing and Releasing Genetically Modified Organisms Being Adequately Evaluated and Assessed? Panel Presentation Rita R. Colwell Iplan to very briefly cover the changing per- This process is being used in the Chernobyl ceptions from the first cloning of genes in the area of Russia, where weedy plants are being put early 1970s to the present. The 15-plus years in place and the concentration of the radio- that have intervened have not resulted in any nucleides allows transformation of sites such as documentable adverse effect of the use of geneti- this in a reasonable period of time. It has been cally engineered organisms, whether they be carried out in plots by several investigators at plants, microorganisms, insects, or any other Rutgers University, at Savannah in Georgia, and forms. The record is fairly clear. current studies in the Chernobyl area of Russia, The only report that I know of with regard to where phytoremediation allows reclamation and use of genetically engineered microorganisms is a translocation capture of radionucleides and a study done by a team at the U.S. Environmen- heavy metals. tal Protection Agency, in which they showed The phytoextraction allows recycling of mate- some changes in the mixture of fungi after the rials, and by using engineered organisms for introduction of an engineered organism into soil. heavy metal uptake and concentration it is pos- This was reproducible, but subsequent studies sible to restore to use farmland that would oth- did not confirm such a change. erwise be unable to be utilized for decades. I think that it is important to review the re- It is important to look at the potential in terms markable progress that has been made in the last of economic value, and I think the potential is 15 or so years, especially since the first structure being realized. In most cases the biotechnology analysis was done by Watson and Crick in the promise has been exceeded by practice. cracking of the code, cloning of genes in the 1970s, We have come quite a long way from the furor and formation of monoclonal antibodies. We now over the use of the bovine hormone. I have seen have a good portion of the human genome se- an advertisement from a farmer in Wisconsin quence, some half-dozen microorganisms are who guaranteed synthetic-hormone free milk. fully sequenced, and the plant genome sequenc- That claim that might have been challenged, since ing initiative is well on its way. there are many synthetic hormones other than One aspect of application is phytoremediation. bovine growth hormone. I think this provides a very dramatic example We should also remember the planting of en- of the potential application of biotechnology. gineered strawberries in which moon-suited sci- In this case it is simply using plants, (phyto- entists were spraying the strawberries as extraction, filtration of plant roots) to remove reporters from several publications stood on the toxic metals from polluted waters and soils, and sideline in blue jeans and tennis shoes. So, as to phytostabilization. perceptions we have come quite a long way. 65 66 Biotechnology and Biosafety The familiarity principle, as espoused and pro- account harmonizing biosafety guidelines. That mulgated in a U.S. National Academy of Sciences is probably the most important message I would report about a decade ago, is that when an or- like to convey. It is time now for an organization, ganism about which relatively little genetic in- such as the International Council of Scientific formation is known is introduced to a new Unions or an international body such as the U.N. environment, it may pose an example in which Development Programme, to bring together sci- regulation might be more acute. entists from all countries and develop harmo- Introducing a rhizobium into a field from nized, international regulations. which it had been isolated prior to being engi- Release of engineered organisms has been ex- neered for specific properties represents a famil- traordinary. By 1991 about 150 field tests had iar application of a familiar organism; the been carried out in the U.S.; by 1997 more than restrictions, if any, need not be severe. 1,000 field tests had been carried out. As I said in Nevertheless the concerns are really for safe my introductory comment, there has been no application of biotechnologies for agriculture and adverse effect. environmental applications. I think the example Neither those who hyperbolized biotechnol- of the Swedish Institute of the Environment's ogy and said it was going to accomplish great Special Committee on Biotechnology is instruc- things-such as the giant potato-nor those tive. This mechanism provided developing coun- who were concerned about adverse effects at the tries lacking expertise with a committee to advise other extreme have had their predictions realized. when a question or an opportunity to employ It is time to take a more balanced perspective, engineered crops or engineered organisms came analyze the successes, and declare victory in that up. The team from the Swedish Institute of the the regulations that are in place and the proce- Environment was available, and it included ex- dures that have been employed have allowed perts from countries around the world. us to utilize biotechnology productively, if per- The pattem of analysis outlined by that par- haps a bit more slowly than we would have ticular committee, I think, is useful and takes into preferred. Are the Risks of Developing and Releasing Genetically Modified Organisms Being Adequately Evaluated and Assessed? Panel Presentaton L. Val Giddings F irst, I want to follow up on some of the ma- egory is related to product quality, such as im- terial that was presented yesterday and proved nutritional profiles of cornmodity crops give some updated numbers from the Ani- and other areas that will lead to more direct ben- mal and Plant Health Inspection Service (APHIS) efits to the ultimate consumers. It currently con- of the U.S. Department of Agriculture. APHIS car- stitutes 27 percent of the activities. ries out regulatory oversight for genetically en- Not only is work being done on the majority gineered organisms in the environment. of cash-producing commodity crops-an area I do not see any of my colleagues from APHIS where existing market incentives encourage pri- here today, so we are in the ironic position of hav- vate investment-but there is a great deal of work ing someone from the regulated community de- being done on smaller crops of interest to fending the regulators. smallholders. This information represents only Based on field trials conducted in the United the work that is being done in the United States, States through March of this year, 27 percent of as indicated by regulatory approvals carried out research and development (R&D) activities sub- by APHIS over the past decade. ject to regulatory oversight by APHIS was related Now I would like to talk about the subject that to herbicide-tolerant plants. Most of the numbers I am supposed to talk about-whether or not the presented by critics of biotechnology in agricul- risks of developing and releasing genetically ture dramatically overstate the extent of work modified organisms (GMOs) are being ad- that is being done with herbicide-tolerant plants equately evaluated and assessed. and misstate some of the implications of the ex- First, I would like to distill things and present tent of R&D in this area. some essential messages that I think all too often We are seeing substantial and dramatic de- get lost. If we can introduce this perspective into clines in the amount of herbicides used as weed- our discussions of biosafety, it will help move, or- control technologies. Furthermore some of the ganizations like the World Bank beyond the pa- ancillary benefits lead to reductions in the ralysis that was described yesterday, in which amount of chemical pesticides for associated they are caught between conflicting viewpoints pests and insect pests. and cannot resolve the situation and move forward. Most of the research being done is aimed at Although it is absolutely essential that regu- solving problems of production resulting from lation be firmly grounded in science, regulations constraints due to diseases or insect pests. Viral themselves and the regulatory decisions made by resistance constitutes about 10 percent, and fun- regulators are not acts of science. They more gal resistance and other applications about 12 closely approximate art. This means that much percent, of the current activities subject to regu- of the discussion about conflicting views over latory oversight. The most rapidly growing cat- whether or not something is adequately regulated 67 68 Biotechnology and Biosafety is more akin to a debate over taste in art than a As we consider how to calibrate our decision- scientific debate over a testable proposition. making on risk, there is a great temptation to Much of our discussion on risk has been approximate, to try to reach absolute certainty framed in terms of inappropriate context; that is, on questions where there is, in fact, insufficient in terms of trying to avoid risk altogether; trying research data or experience. The regulator is faced to apply a standard of zero risk. This is the path with making a decision on a particular proposi- to paralysis. You cannot achieve zero risk. It is tion-for example: "Is this herbicide-tolerant unattainable. plant safe enough to allow to go forward in a field I submit that it is far more useful to frame our trial?" The regulator must ask whether the weight discussion in terms of what acceptable risk might of R&D experience available on this herbicide- be-zero risk versus acceptable risk. This is where tolerant plant is adequate to demonstrate that it differences of viewpoint come into play. How generates no risk different from nontransgenic much weight do you put upon this or that po- plants and, therefore, that the organism is more tential for harm? What kind of context do you than sufficiently safe to be allowed to enter into put that in? commercialization. Talking about risk and trying to apply rigid, As we weigh those sorts of questions, it is use- quantitative standards is extremely difficult be- ful to keep one bellwether in mind. We must bear cause many of the questions do not have the in mind the distinction between what is nice to kinds of ultimately perfect answers that we know and what is needed to know to make a would like to see, that science strives for. So I decision about the relative costs and benefits, or think it is more appropriate to couch discussions the relative risks; to make a wise decision about in terms of absolute versus relative risk. whether or not something should go forward. Are the Risks of Developing and Releasing Genetically Modified Organisms Being Adequately Evaluated and Assessed? Panel Presentation Rebecca Goldburg J am going to examine the question of whether management plans for these crops to slow the the risks of biotechnology products are be- evolution of Bt-resistant pests. ing adequately evaluated and assessed, based These plans are based on sound scientific on my experience working in the United States. theory, including mathematical models and some Experience in the U.S. is especially relevant be- small-scale greenhouse and laboratory experi- cause it is here that the majority of field testing ments, but there is no large-scale experimenta- and commercialization of genetically engineered tion or field experience on which to base these crops has occurred to date. resistance-management plans. In other words our I will argue that even in the "advanced" United current resistance-management plans for Bt crops States we have not done enough to address have not been scientifically validated. biosafety, in terms of both developing scientific There are a number of other scientific issues information and regulatory capacity. I will use regarding Bt resistance-management plans that two examples, one in the area of science and one remain unresolved. For example: in the regulatory field. * Current resistance-management plans assume To begin, I will discuss the development of a very simple genetic model of pest resistance resistance-management plans for so-called "Bt to Bt. What steps should be taken if data show crops"-crops genetically engineered to contain that resistance traits involve more than one insecticidal proteins from the bacterium bacillus allele or do not follow patterns of Mendelian thurengiensis. The development of these plants inheritance? has generated considerable concern that pests e Most of resistance-management theory is de- will evolve resistance to Bt toxins, which have signed to prevent one target pest from evolv- been widely used in the U.S. in nonengineered ing resistance. But Bt corn and cotton have spray formulations for several decades. Bt sprays multiple pests that are affected by their Bt tox- are used both by conventional and organic farm- ins. How do resistance-management plans ers and are some of our safest insecticides. As a address the different susceptibilities and be- result there is considerable interest in retaining haviors of different pests? the efficacy of Bt toxins, rather than squandering * What action should be taken if resistance is de- them on a few years of use in Bt crops. tected? Three such crops, cotton, corn, and potatoes * How should integrated pest management are now sold commercially in the U.S. Several (IPM) practices be integrated with resistance- different varieties of Bt corn containing different management plans? genetic constructs of Bt toxins are on the market. Given the rather primitive state of resistance The U.S. Environmental Protection Agency (EPA) management for Bt crops, it is no surprise that has compelled companies to develop resistance- experience is revealing significant problems with 69 70 Biotechnology and Biosafety current resistance-management plans. At least behavior in order to implement these standards. two examples of insect pests have been demon- Although many corporations may comply with strated to have substantial survival rates on Bt these standards and follow through on promises crops. The survival of these pests violates one of to the public of safe practices, there are at least the two fundamental principles underlying re- two instances where they have not. sistance-management plans: Bt crops should ex- First, Northrup King Company produced and press very high doses of toxins to kill virtually marketed Bt corn without having obtained the all the pests on the crop. In short, in some in- registration legally required by the EPA. The stances current resistance-management plans are agency fined the company in 1996. being invalidated by experience. Second, Calgene, Inc. violated promises to la- Yet we in the United States seem to be merrily bel its FLAVR SAVR genetically engineered to- forging ahead without revising resistance- mato. Calgene commercialized this tomato at a management plans. Bt crops are being planted on time when issues concerning labeling of geneti- huge numbers of acres; enough area, for example, cally engineered foods were new and contentious that the EPA is having to consider resistance- in the U.S. The company promised the public that management measures for locales where 75 per- the company would label all of its genetically cent of cotton acreage is planted with Bt cotton. engineered tomatoes as such. However Calgene It appears that we are being rather reckless experienced quality problems with its genetically with Bt. We are not taking adequate, scientifically engineered tomatoes and decided not to sell cautious, iterative steps because we do not ap- many of them as branded products. The company pear to have the societal restraint to go forward then sold many of its genetically engineered to- in a more cautious fashion. matoes as ordinary, unlabeled fresh-market to- Regarding biosafety regulation in the U.S., I matoes, violating Calgene's promises to the will consider two examples: one concerning field public. releases of genetically engineered organisms and To sum up, the risks of genetically modified one concerning food safety. I argue that the U.S. organisms are not being adequately evaluated regulatory system does not adequately protect and addressed in the United States. Since the U.S. public health and the environment from the risks is the world's largest producer of biotechnology of genetically engineered organisms. products and a country with considerable re- Field releases of genetically engineered crops sources, this conclusion is extremely troubling. in the U.S. now receive minimal oversight. Vir- I would like to make one last point in response tually any genetically engineered crop can be to Rita Colwell's remark that there have not been field tested after simply notifying the U.S. De- any adverse effects to date of genetically engi- partment of Agriculture, even if the crop can po- neered organisms. She is correct that there have tentially transfer genetic material, via pollination, not been any biotechnology disasters. Biotech- to wild relatives. In other words even if a crop nology has not, to date, resulted in any Androm- exhibits the characteristic that most scientists eda Strains-or more realistically, in any new agree is the foremost biosafety concern for ge- pests. netically engineered crops, no formal public risk But experience with biotechnology products assessment is necessary before field testing. has not been entirely smooth either. Unexpected A similar situation exists in regard to food events continue to raise a cautionary flag. As I safety regulation. The U.S. Food and Drug Ad- mentioned, there are now a couple of examples ministration requests that companies voluntar- of biotechnology crops that do not adequately ily consult with the agency before marketing control pests for purposes of resistance manage- genetically engineered crops. ment. For both field releases and food safety the rel- Genetically engineered crops have also unex- evant government agencies have admittedly es- pectedly exhibited agronomic problems. For ex- tablished safety standards that companies are ample, a recent headline from the Clarion Ledger supposed to meet. But as I have indicated, the in Jackson, Mississippi read: "Genetic Cotton U.S. is virtually dependent on companies' good Misfire." The story discusses recent problems of Reviewing the Evidence 71 Mississippi farmers with genetically engineered, and expend considerable effort testing for good herbicide-tolerant cotton plants in which the cot- agronomic performance. If companies cannot ton bolls shed or are misshapen. make a number of these crops perform as ex- Shedding cotton bolls is not strictly a biosafety pected, what does that imply about the results of concern. Nevertheless, this problem raises a real generally less rigorous, largely voluntary tests for red flag. Biotechnology companies focus on de- biosafety, which is far less central to companies' veloping crops with particular agronomic traits mission? Discussion Moderator: Michel Petit Donald Winkelmann: I am chair of the Techni- neered biotechnology showing resistance as a cal Advisory Committee of the Consultative result of intensive use. Group on International Agricultural Research, and I have a question for George Tzotzos. Desmond Mahon: Two concepts were brought Typically one would expect the output of bio- up in the presentations of Rita Colwell and Val technology to lead to increased productivity, Giddings: the concept of familiarity and uncer- hence higher output, hence lower prices, so that tainty in assessing risk from Rita Colwell, and consumers should be the ultimate beneficiary of then acceptable risk from Val Giddings. I do not the bulk of the effort in biotechnology. Would think there is anybody in the room who can live consumers be willing to pay the extra costs asso- with zero risk. This is nonsense scientifically and ciated with the product? And can farmers pay as a regulation. the potential extra technology costs of transgenic What I would like you to comment on is cou- seeds? pling the two, specifically for the developing world and for agriculture. When you couple un- Judith Chambers: My question is directed to certainty with acceptable risk, who sets the level Rebecca Goldburg. I get concerned when the of acceptable risk? Has it got to be equivalent in products of biotechnology, such as transgenic every scenario, or should it be set for the situa- plants, are held up to a different standard of tion in which the product is going to be devel- safety and environmental management than the oped, and by whom? traditional forms of biotechnology have been. The very first reported incident of biotechnology Audience comment: We have a situation in resistance took place approximately seven years which both as a community of scientists and as ago, before any transgenic plants were on the part of the public, we have to think: do we want market, and was written up in a reputable, peer- zero risk or do we want a low risk, or is it accept- reviewed scientific journal. The incident took able or not? But you cannot just say zero risk is place in Thailand where biotechnology was be- intolerable. Therefore, I would like to have the ing used to control insects, mostly on crucifer- panel address the question of whether there has ous plants, and being intensively used by people been a good risk assessment. who are advocates of the traditional form of bio- technology. Mae-Wan Ho: I am dismayed at the complacency There we had a form of resistance occurring, shown by the first two speakers of the second and I was wondering where the environmental panel. Such attitudes make me feel that the only community was in complaining about that par- alternative is to have a moratorium and an inde- ticular incident, in which we had a nonengi- pendent inquiry into all the risks, based on the 72 Reviewing the Evidence 73 most up-to-date scientific findings in peer- There is a level of scrutiny applied to these new reviewed, well-referenced journals. products that exceeds any level that has been Let me comment on what I regard as fatal flaws applied to other products in agriculture in the in food safety assessment. The joint Food And history of humanity. It may be argued that this is Agriculture Organization/World Health Organi- appropriate, but it certainly cannot be argued that zation biotechnology and food safety report pro- we are underscrutinizing things. poses a model of risk assessment based on the Even under existing notification standards of "no need, don't look, and don't see" triangle. Ef- the U.S. Department of Agriculture (USDA), field fectively, the biotechnology industry is given trials that are allowed to go forward must be con- carte blanche to pass whatever they like. ducted in accordance with performance criteria If we are not careful, a list of gruesome prod- that essentially amount to biological isolation. ucts is going to appear on our dinner tables, in- Although the potential for gene flow may occur, cluding failed transgenic experiments and the field trial is conducted under circumstances possibly also the residues of plants from which that prohibit or prevent such gene flow. So there industrial chemicals have been extracted, after are still rigorous criteria applied, even under the which they can be processed for food or animal most streamlined avenue of regulation available feed. under USDA. The Kendall report has excluded that from its scope, so now I ask: Who or what is responsible Rebecca Goldburg: I was asked some questions for regulating all these things? about resistance management with Bt crops. First of all, are we applying a different standard to bio- Rita Colwell: I apologize for my brevity, which technology crops than we have for other crop may have been misinterpreted as complacency. I plants? The answer is most definitely yes. Is there chaired the Environmental Protection Agency's a good reason for that? Yes, there are two good Biotechnology Advisory Committee for about six reasons. years. I served on the National Institutes of One is that in many ways Bt (Bacillus thurin- Health Panel on Biotechnology and also on the giensis) toxins are different than synthetic chemi- Food and Drug Administration's Food Advisory cals, which have historically been applied as Committee, where we spent at least three days commercial insecticides. Synthetic chemical pes- hearing evidence and discussing risks with re- ticides are developed by particular companies spect to the FLAVR SAVR® tomato. An enormous and are proprietary. Bt has a long history of use. amount of work has been done over the last 10- It is a natural chemical. Many people would ar- to-15 years looking at risks and assessing ben- gue that it is a public good; I would argue that as efits for the population. a public good, it is appropriate for us to have In the case of some of the issues that are men- strong public stewardship of Bt. tioned with respect to biotechnology products, Second, I would argue that even regarding such as allergenicity, I think this is, in general, synthetic chemicals, insecticides, or drugs the something that has to be faced whether it is en- U.S.-and probably almost every other country gineered or not. That is a function of proper la- in the world-is only now really beginning to face beling of food. up to problems with the evolution of resistant diseases. We need to know more to do more. Val Giddings: The number of field trials that What we are doing with Bt is a step in the right have been conducted in the United States to date direction, and we should start looking for other exceeds 3,000 at over 12,000 field-trial test sites. types of products as well for resistance manage- Until five months ago I was with the division of ment. APHIS that conducted the environmental assess- Finally, the example was brought up of the ments of these, and far from being complacent evolution of resistance to Bt products with natu- or from being guided by a "no need, don't look, rally occurring Bt spore preparations, an example don't see" criterion, we applied a rigorous crite- from Thailand. That is not the only example; there rion of "turn over every stone." are several examples in which overuse of Bt spore 74 Biotechnology and Biosafety products has led to the evolution of local resis- George Tzotzos: With respect to the question tant insects, and that concerns me greatly. about purchasing ability of farmers in the devel- The difference between these incidents and oping world to absorb transgenic seed, one finds those of transgenic Bt crops is that Bt microbial that productivity will increase by bringing in spore preparations are still used on very little trans-genic seed. Prices may even drop. But acreage in most of the world. Transgenic crops small-scale farmers simply do not have the pur- are catching on at a tremendous rate; they are chasing capacity to buy transgenic seed, or even being used on millions and millions of acres and hybrid seed. have the potential to exert a much stronger se- This discussion seems to have been polarized lection pressure on pests, in part because most of and has addressed only the transgenic applica- these crops express Bt toxins in virtually all of tions of genetic engineering. There are other ap- their tissues virtually all of the time. plications of genetic engineering, and they might have significantly higher impacts in increasing Gabrielle Persley: Some have expressed surprise productivity in the developing world, for ex- that some of the findings from experimentation ample, molecular-assisted breeding. were not as predicted. I would simply say that this is the nature of science. It would be very strange if Michel Petit: There seems to be a consensus that experimentation did not yield new knowledge both what is at stake in risk assessment is the level of in terms of ecology and genetics. Within the inter- acceptable risk. But we do not agree on what level national development community we have two of risk is acceptable or even what scientific con- choices, to be either observers of the progress of siderations need to be involved. science or participants. Role of International Agricultural Research Biotechnology and Biosafety in the CGIAR System: An Efficient, Equitable, and Ethical Path Timothy G. Reeves T he issues of biotechnology and biosafety world has produced since 10,000 B.C., which is are often viewed only through the eyes of almost all the food that has been produced since the developed world. When those of us in people first began to practice agriculture. the development community think about these We know that technology, including biotech- issues, however, the images that come to mind nology, is one means of transforming food scar- often differ greatly from stereotypical notions of city into food security; but technology alone is biotechnology and biosafety in industrial coun- not the answer. The technologies that we develop tries. It is often forgotten that the biotechnologi- to feed the world must meet four important cri- cal revolution occurring in the industrial world teria: they must be environmentally sound, eco- is gaining momentum in developing countries, nomically viable, socially acceptable, and and for this reason biosafety issues are assuming politically supportable-the four pillars of agri- even greater importance worldwide. In this pa- culture. In addition they should promote equity per I would like to discuss these issues as they between people, regions, and generations. Agri- are perceived by the Consultative Group on In- cultural systems that meet these criteria are criti- temational Agricultural Research (CGIAR), the cal for resource-poor farmers, and they are family of international agricultural research cen- certainly critical for developing countries rely- ters whose mandate is to help the poor people of ing upon agriculture to power economic growth. this world. Biosafety must be a key component of such sys- We believe that every man, woman, and child tems to ensure that the well-being of future gen- has the right to sufficient food to lead a healthy, erations is not imperiled. productive life, and we are affronted by the fact We also know that technological development that this right is not yet a reality. Every day 40,000 has to occur within the right policy framework. people still die from hunger-related diseases. Without political will the best agricultural tech- Every day about 1 billion people have less than nologies and systems may never benefit the US$1 to meet their basic needs. This is the world world's poor. that the CGIAR has resolved to change for the It is within this framework of fostering sus- better through research; yet this goal becomes tainable, socially just agriculture that I wish to more elusive as our population continues to grow. discuss the potential contributions of biotechnol- During the next three decades the population of ogy research by the CGIAR centers. I will briefly the developing world will grow by around 200 describe the kinds of research in which the cen- people per minute. Where will these people get ters are engaged, with a view to highlighting the the secure supply of food that should be their ways that this research differs from much bio- birthright? To feed us all, within the next 50 years technology research pursued elsewhere. Next I we will have to produce as much food as the will discuss how this different research orienta- 75 76 Biotechnology and Biosafety tion has implications for the way that we and our varieties and hybrids are inadequate infrastruc- partners must approach the challenges that are ture and policies for effective maize-seed indus- emerging as we attempt to apply the newest ag- tries. In many areas the private sector is not yet ricultural research tools to solving some of the delivering improved seed to small-scale farmers, world's oldest problems: poverty and hunger. and the private sector may never have sufficient incentives to meet the needs of the most marginal Biotechnology Research and the CGIAR farmers. For farmers who cannot obtain or af- ford commercial seed, apomictic maize would The CGIAR has an investment in biotechnology be nothing short of revolutionary. We regard of around US$30 million per year. This invest- this research as true biotechnology for poor ment may seem small, but it differs greatly from people. most investments in biotechnology because it The work on apomixis, like many other efforts focuses on research that is appropriate to the in biotechnology, has considerably widened the needs of the poor. For example, the International scope for genetic resources to contribute to plant- Crops Research Institute for the Semi-Arid Trop- improvement research. Biotechnology research ics (ICRISAT) is using biotechnology to develop is also changing our view of how research can downy, mildew-resistant pearl millet, and the ultimately enhance agrobiodiversity. We be- International Institute for Tropical Agriculture lieve that agrobiodiversity can be enhanced (IITA) is developing insect-resistant cowpeas. directly through greater diversity in the pedi- These areas of research are far from being high grees of the varieties that we develop with our priorities for private-sector investment. partners and through prebreeding research, At the International Maize and Wheat Im- and indirectly by allowing a greater diversity provement Center (CIMMYT) we are using bio- of plant and animal species to flourish in agri- technology to deliver research results to farmers cultural systems. more efficiently and effectively. To cite just one example, we are using molecular marker tech- Pedigree Diversity niques to shorten the time needed to develop drought-tolerant maize. The approach currently Recent evidence from CIMMYT suggests that the under evaluation could cut the development time bread wheats that have been most widely for drought-tolerant maize in half, as well as sub- adopted in the fields of developing country farm- stitute selection in the laboratory for much work ers also possess some of the most complex in the field. Given that the world is still too fa- pedigrees. The top ten crosses grown in the de- miliar with the macabre effects of drought, the veloping world in 1990 are genetic powerhouses. merit of this research is obvious. They contain an average of 44 landraces, 19 gen- Another significant research effort at CIMMYT erations, and 1,192 parental combinations in their seeks to take advantage of a trait called "apo- pedigrees, of which about 20 percent were used mixis" (asexual reproduction through seed), only once. (For comparison, note that for all of which results in plants that are exact clones of the different crosses grown in the developing the mother plant. For several years scientists world in 1990, the average number of distinct from the French National Research Institute for landraces per pedigree is 36.) This gives some Development Cooperation (ORSTOM), working idea of the considerable, and continuing, invest- at CIMMYT, have sought to transfer apomixis to ment made by farmers (landraces) and by scien- maize from Tripsacum, a relative of maize. If tific plant breeders (generations and parental farmers had apomictic versions of improved combinations) in the diversity of the world's maize varieties and hybrids, they could replant bread wheat crop. seed from their own harvests each year and still maintain high yields, instead of having to pur- Prebreeding Research chase fresh seed. Numerous studies in the devel- oping world have emphasized that the real The plant improvement centers of the CGIAR, barriers to farmers' adoption of improved maize including CIMMYT, also concentrate on pre- Role of International Agricultural Research 77 breeding. Through innovative breeding tech- Efficient, Equitable, and Ethical Research: niques, desirable genetic traits from landraces Challenges Ahead and wild relatives of crop species are continu- ally built into breeding lines that our partners in In partnership with our colleagues throughout developing countries can use to develop variet- the world, the CGIAR has developed working ies of interest to local farmers. Biotechnology is a guidelines in relation to intellectual property significant contributor to prebreeding research. rights. A key feature of these guidelines is that CGIAR centers will not work with biotechnol- Indirect Effects on Species Diversity ogy processes, particularly with transgenic ma- terial, in any country that lacks biosafety Finally, in developing new varieties that enable legislation and regulations. We believe that this farmers to obtain higher yields from the same is a good practice. But we also know that many amount of land, biotechnology and conventional of our partners lack biosafety legislation or a breeding can contribute to greater biodiversity regulatory framework to support such legisla- in the cropping system. Varietal diversity is criti- tion, though they urgently wish to conduct bio- cal. CIMMYT, for example, is not working to technology research. One of our sister centers, the cover the Earth with maize and wheat varieties. International Service for National Agricultural We do not want one variety of any crop domi- Research (ISNAR), is helping national programs nating the landscape. We want diverse cropping to develop appropriate technology and establish systems and agricultural enterprises, because we legislative guidelines that will enable new tech- think that is the way to achieve sustainability. We nologies to be tested safely. We think that this want a patchwork of modern varieties, good va- sort of hands-on approach helps governments rieties, different varieties, because we believe that and public sector research institutions consider this is important for agrobiodiversity. By devel- complex biosafety issues in a careful, timely fash- oping a continuous stream of new varieties and ion, with respect for the interests of less power- working with our colleagues in national agricul- ful members of society. tural research systems and public and private In Mexico, where very good biosafety legisla- organizations, we can facilitate that diversity. tion is in place, CIMMYT is helping the govern- A poor farmer in Africa, for example, needs ment examine particular dilemmas arising from her whole farm to produce the 1,000 kilograms biotechnology research, such as sound biosafety of maize that will keep her family alive. If in some procedures for working with transgenic maize way we can help to produce that 1,000 kilograms in a center of genetic diversity still populated by of maize on half of the farm area, the other half is wild relatives of maize. The procedures devel- freed for other crops, exotic or indigenous, or for oped in Mexico are designed to deal with real wood lots or agroforestry. If that farmer can get issues, and they are expected to be extremely a more diverse, sustainable, and profitable rota- useful for the rest of the world. tion going thanks to the results of sensible and The CGIAR is also concerned about drafting safe biotechnology research, that would be an ethical guidelines that will enable us to do all in achievement to celebrate. our power to ensure that we and our partners All of these examples of biotechnology re- can engage in biotechnology research in a way search and its potential benefits highlight our that is efficient, equitable, and ethical. One of the concern that the technologies we develop with most pressing issues is to determine what ap- our research partners should be environmentally proach the CGIAR should take with respect to and economically sound and easily available to biosafety in relation to biotechnology. If we were poor people. However other important and of- to take a hands-off approach, we would have ten controversial issues may strongly influence nothing to do with biotechnology, because there the potential effectiveness of biotechnology re- is a debate over biosafety in the public arena at search, and the CGIAR centers are extremely con- the moment and we do not want to get criticized. cerned about them. These issues include biosafety Is that the right way to go? Or should we adopt a and related issues of ethics and equity. hands-on approach and try to help solve some 78 Biotechnology and Biosafety of the problems related to biosafety and find a gate how transgenic maize fits into IPM pro- way forward? Under that scenario we would grams; help them conduct the research necessary work with our partners in the South, jointly re- to ensure that the resistance in transgenic maize solving such issues as licensing agreements, help- is useful over the long run? ing to define appropriate financial involvement We believe that partnerships can offer a way and assess ways of meeting costs. These are all forward through the welter of complex issues very real issues that research systems and gov- transforming agricultural research. Our range of erunents must confront sooner or later. partners is much greater than it used to be, Although the world remains divided over including national research systems, CGIAR cen- which approach might be better-a hands-on or ters, advanced research institutions, nongovern- a hands-off approach-it is our belief that we mental organizations, and increasingly, the cannot abandon our research partners to the private sector. The CGIAR is listening to and at- vagaries of an increasingly competitive, profit- tempting to understand the needs of these part- oriented environment for research and develop- ners, because only successful partnerships can ment. For example, we have colleagues in Africa foster efficient, equitable, and ethical research who wish to study the potential of using arrangements. Together we must devise solu- transgenic maize as part of an integrated pest tions to the many challenges for agricultural management (IPM) strategy to combat Striga, a research, including the new challenges posed parasitic weed species. Do we leave our col- by biotechnology and biosafety. Together we leagues to deal directly with companies that want must work towards a sustainable and socially just to work in this area? Or do we help them investi- agriculture. Research Partnerships in Biotechnology: Role of the Global Forum on Agricultural Research Fernando Osorio Chaparro T his conference provides us with an excel- Changing Context lent opportunity to exchange ideas on the of Agricultural Research role biotechnology plays in agricultural research for development, on the forces that are There are four dimensions in the present context shaping this process, and on the role different of agricultural research that are having a deep actors play in this area of research. I will approach influence on the present and future directions of these issues from the perspective of the National agricultural research. These are: (1) the socioeco- Agricultural Research Systems (NARS) of devel- nomic context, (2) the knowledge, or science, con- oping countries; thus one of the issues I will ad- text, (3) the institutional context, and (4) the dress is the participation of developing countries process of globalization. in global biotechnology research. In this paper I will address three main issues: Socioeconomic Context 1. A brief analysis of some of the important trends shaping the present context in which re- Despite the very important technological ad- search and technological development for sus- vances of this century, including those of the tainable agriculture is taking place Green Revolution, the world is still faced with 2. New opportunities and challenges that are increasing poverty in both urban and rural ar- being generated by the development of biotech- eas. The figures are staggering: nology and other strategic research areas, in the * More than 800 million people remain under- present context of more science-intensive agricul- nourished. tural production systems * One third of pre-school-age children are in this 3. The role of research partnerships and situation, which has a severe impact on school transnational research networks in seeking more performance and future productivity. cost-effective approaches to agricultural research; * In some countries more than 65 percent of the integrating research groups in developing coun- population live below the poverty line. tries (NARS) into these efforts; and mobilizing Recent studies carried out by the International the research capacity of different actors in the Food Policy Research Institute and other organi- global scientific community and applying it to zations have clearly pointed out a set of contra- development research. In this third point I will dictory trends that are presently taking place and analyze the role the Global Forum on Agricul- will tend to dominate the coming decades. The tural Research can play in this process, as an ini- aggregate supply and demand picture for food, tiative aimned at facilitating and promoting such as compared to population, presents a rela- research partnerships. tively balanced picture- if present investment 79 80 Biotechnology and Biosafety levels in agricultural research are maintained or 1. Biotechnology and its various applications increased. But despite this positive picture at the 2. Research areas related to sustainable agri- global level, the world will continue to face a dual culture and contradictory situation, based on two differ- 3. Information and communications technol- ent realities. Wealthy countries, together with a ogy (ICT). small number of developing countries (mainly These new research areas do not replace plant from Asia), will enjoy low food prices and food breeding and production systems research (in- surpluses, or affordable imports. But less devel- cluding on-farm research). On the contrary the oped, slowly growing countries will face a grow- new research areas are generating enabling tech- ing problem of food security that will have to be nologies that complement and deepen previous solved through food imports. approaches. They provide new tools for address- Food surpluses will be generated in industrial ing these issues, which can be combined with countries, especially the United States, and a other, very important research tools related to growing food deficit requiring growing food crop improvement and crop management. The imports will predominate in developing coun- latter will continue to be the mainstream of agri- tries. The proportion of the malnourished popu- cultural research. lation, especially in the case of vulnerable These new areas of science and the enabling populations, will continue to increase. If instead technologies they generate represent a great po- of maintaining present rates of investment in tential for increasing our capacity to respond to agricultural research, national and international the social and economic challenges we face: pov- institutions further cut back their investments the erty, resource degradation, and food security. If relatively favorable aggregate food situation well utilized, they can significantly increase our could worsen, generating a global food security capacity to cope with these problems and pro- crisis and worsening environmental problems mote development. At the same time we also and sustainability. face the clear possibility of widening technology Desertification, deforestation, and environ- gaps between industrial and developing coun- mental deterioration are growing problems, even tries, due to differentials in research capacities in countries well endowed with natural re- and the increasing limitations of accessing these sources. With the population likely to increase technologies, given their nature as proprietary by another four billion by the year 2020 and the technologies. This is what a recent report of the problems of growing natural resource degrada- Consultative Group on International Agricul- tion, agricultural research is faced with a series tural Research (CGIAR) Private Sector Commit- of daunting challenges: to improve farm family tee calls "barriers to the freedom to operate" income to alleviate poverty, increase food pro- that research institutions and developing coun- duction, provide employment opportunities for tries will face, due to the increasing number of the resource poor and landless farmers to ensure proprietary technologies. household food security, while at the same time This trend reflects an important change tak- conserving natural resources in a sustainable ing place in the nature of biological technologies. fashion. In evolving from technologies that manipulate plants (species, varieties) to technologies that The Knowledge, or Science, Context manipulate cells and molecules, we have wit- nessed the emergence of technologies that are Agricultural production is becoming increasingly much more easily appropriated. It is not easy to knowledge-based and science-intensive. New reproduce or duplicate either the biotechnologi- strategic research areas have emerged and devel- cal process that has led to the final product or oped, with profound effects on our capacity to the final product itself, given the complexity of produce food and manage natural resources and the knowledge involved and the investment re- the environment. There are three new key areas quirements. The fact that an increasing propor- of knowledge that could play a critical role in tion of the relevant knowledge and techniques strengthening our capacity to respond to these are of a proprietary nature has two important growing challenges: implications. First, the flow of knowledge is Role of International Agricultural Research 81 increasingly constrained by this new reality. Sec- tions (NGOs), and the private sector. Farmers ond, in order to participate in the technology have become more organized, and have been able development process it is important for any re- to build on the learning experience generated by search institute (such as NARS) to develop a re- a variety of participatory research schemes and search capacity as well as generate research rural development projects. This has allowed for results (a knowledge asset), that enables it to par- the emergence of approaches to research and ex- ticipate in active knowledge exchanges, through tension that places the farmer at the center of the joint ventures or other relevant research partner- process, as a key actor, and not just as a user of ships. As a recent report points out: "If a global technology. Similarly, in many countries NGOs 'trait market' evolves, developing countries and have either complemented the role of the State [research] centers will be able to participate in or filled in the gap generated by the weakness of this market more effectively if they have a cache public research institutions, especially in terms of 'trading chips' in the form of traits generated of reaching and working with farmers (inefficient through their own research." The knowledge- technology transfer mechanisms). In Latin exchange capacity and bargaining power of re- America and the Caribbean, in Africa and in Asia search institutions becomes an important element there is an increasingly rich experience with in the new context. NGOs, community organizations, and participa- The challenge here is to develop a framework tory research approaches that could provide the or environment that may facilitate strategic alli- basis for more efficient research and technology ances and joint ventures between the various ac- transfer systems. tors involved in these research efforts, bringing The role of the private sector has become in- closer together the normative framework and creasingly important, reflecting the fact that bio- incentive structure related to the development of logical research and the technology generated by technologies of a public good nature, with the it has become more privatized, as a result of in- framework and incentives that prevail in the bio- vestment incentives. Presently it is estimated that technology industry and the development of pro- the private sector is responsible for approxi- prietary technologies. mately 80 percent of the research in plant bio- technology worldwide. By 1992 the U.S. private Institutional Context sector alone was spending $US559 million in ag- ricultural biotechnology research, reflecting a 50 A more diversified institutional structure of percent increase over 1985. One reason for this stakeholders has developed in recent years in the surge is that the market for agricultural inputs is area of agricultural research and natural resource large. Farmers in the U.S. purchase US$3.5 bil- management, at both the national and global lev- lion of planting seed per year. It is estimated that els. Traditionally, given the nature of the knowl- total global sales of agricultural biotechnology edge and technology related to these fields, most products will reach US$3 to 5 billion by the year research has been carried out by national public 2000. research institutes or by international research The private sector has thus become an impor- centers concerned with the generation of knowl- tant player in the basic research end of the range edge that could be characterized as "international of activities that constitute the basic-strategic- public goods." Given the fact that the technol- applied-adaptive research continuum. This is a ogy was not easily appropriated, the private sec- fundamental change with respect to the tradi- tor played a relatively marginal role, especially tional role this sector traditionally played, which in the area of development research. The other was basically being an user of knowledge and two important actors were universities (espe- research findings generated by the public sector cially in industrial countries) and advanced re- (as public goods). These changes also raise the search institutes or centers of excellence, quite related issue of property rights and plant often with close links to universities. breeder's rights and the role they play in the In more recent years three other actors have knowledge generation and dissemination process. started to play a central role in this process: farm- This evolving institutional environment has to ers' organizations, nongovernmental organiza- be taken into consideration in the process of 82 Biotechnology and Biosafety strengthening science and technology for sustain- knowledge flows and technology transfer be- able agriculture, and in developing new ap- cause of the increasing importance of proprietary proaches to cooperation in this area through technology. strategic alliances and research partnerships. There is another important aspect of the im- These partnerships, built on collaboration and pact of globalization as it affects agriculture, re- mutual benefit, are becoming much more effective search, and development. This is the fact that the than traditional "aid programs." This is an im- challenges represented by poverty, food security, portant dimension of the new joint ventures and environmental deterioration in developing among interested stakeholders, especially in the countries are no longer an issue of concern only present context of diminishing funds for tradi- to those countries. Given the increasing interde- tional overseas development assistance. pendence of the world, they are rapidly becom- ing global issues. Much in the same way that the Process of Globalization global context has an impact on smallholders and peasants and their viability as producers, these The fourth dimension of the present context in development issues have an impact on the well- which we operate is the process of globalization, being of urban dwellers in New York or in any the symptoms of which are all around us. Glo- large metropolitan center, and on the global ca- balization has clearly changed the way financial pacity to assure sustainable development. Glo- markets and the economy operate, where the balization requires us to take a fresh look at transnational dimension, a global view of mar- institutional arrangements and collaborative kets, and a capacity to operate in them, has be- mechanisms, based on common interests and come an essential part of being competitive in mutual benefits to those involved. the present world. This is true even for the small- holder, given the increasing importance of the Biotechnology Research in Developing global context for everyday life and well-being. Countries: Role of NARS The global dimension is no longer of interest only to large and export-oriented producers. It is part In biotechnology we are witnessing the very rapid of the context in which everyone operates, with development of the application of molecular bi- a direct impact on farmers' viability as produc- ology to a range of agricultural production prob- ers and the well-being of their families. lems and issues of sustainability. The best known But globalization is also reflected in changes application is that of genetic engineering that is that are taking place in the scientific community leading to an increasing availability of transgenic and the organization of research. Technological plants with the specific characteristics that one innovations are seldom generated by individual wants to maximize. This is quite a recent devel- research institutions or firms. They are increas- opment, since the first transgenic plants were sold ingly the product of transnational research net- in the United States in 1996. But their commer- works, or "networks of learning" that are playing cial success is clearly encouraging an increasing a central role in the process of knowledge gen- effort of the private sector in that direction. eration, dissemination, and application. In some But the role of biotechnology goes beyond ge- areas of research, such as sugar cane, these netic engineering in addressing the problems of transnational networks are responsible for hav- development. In this section I will analyze three ing generated most of the varieties with present related aspects: (a) the development of a relevant commercial utilization. We will return to this biotechnology research agenda in the context of point in a subsequent analysis of the role of re- developing countries, (b) the development of a search partnerships and strategic alliances. research capacity in this area, and (c) the devel- Given the increasing importance of proprietary opment of an appropriate environment for the technology, the process of globalization is char- establishment of research partnerships between acterized by two contrasting trends. On the one the public and private sectors, as well as partici- hand globalization is taking place in terms of pation in transnational research networks. The markets and final products. But on the other, we first two points will be analyzed in the first sub- are witnessing increasing constraints in terms of section. Role of International Agricultural Research 83 The use of biotechnology in developing coun- ers and the development of relevant research soft- tries goes far beyond genetic engineering, cover- ware, this research technique can speed up ing a broad range of research techniques and their genetic improvement research of value to devel- applications. As an example of the biotechnol- oping countries. An example of this can be found ogy research agenda that is presently being dis- in the development of maize and soya varieties cussed in developing countries, I would like to resistant to acid soils that may be integrated into summarize the results of a recent strategic sustainable production systems of the savanna planning exercise carried out by the Colom- regions found indifferent parts of Latin America, bian National Research Organization, known as Africa, and Asia (such as the Ilanos in Colombia "CORPOICA," on this topic. The objective of this and Venezuela or the cerrados of Brazil). The exercise was to identify the main research issues maize research program carried out in Colom- that should orient local research efforts, in many bia, Venezuela, and Brazil in collaboration with cases through strategic alliances with interna- CIMMYT and CIAT, took many years to develop tional agricultural research centers (IARCs), such the first varieties resistant to acid soils. After that as the Intemational Center on Agricultural Re- first effort, the introduction of molecular marker search (CIAT) in Colombia, or with agricultural techniques and computers has significantly ac- research institutions in Europe or North America. celerated the research process. The research strategy that CORPOICA is de- 3. Genetic engineering is leading to increasing veloping involves two dimensions. For some top- availability of transgenic plants with the specific ics research programs are being put in place, in characteristics that one wants to maximize. The most cases on the basis of strategic alliances with new products being developed are having pro- other partners in the region or in industrial coun- found effects on production costs and environ- tries. In other cases, where it is considered that mental impact as well as sustainability, markets, the required investments are too high to tackle and competitiveness. These technological or the critical mass of researchers is not yet avail- changes may totally change the comparative ad- able, a clear strategy is being put in place to fol- vantages among countries in the production of low the cutting edge of research very closely basic foodstuffs (and thus world trade). These simply to understand what is going on and be technological breakthroughs can increase our glo- able to have easier access to, and stronger absorp- bal capacity to cope with food security, but they tive capacity of, the technologies and the know- can also deepen inequalities among industrial how that is being generated in these research and developing countries, if not well managed. areas. The training of researchers, through gradu- Until now most of the work related to transgenic ate training and joint ventures with advanced plants has been related to temperate crops, such research institutions, is an important component as soybeans; 60 percent of the production in of this strategy. North America already comes from these variet- Five research areas of biotechnology were ies. This concentration generates "orphan mar- identified in this strategic planning exercise as ket-segments," where the private sector has not having a particularly important role in develop- had any incentive to invest. When these coincide ment oriented research. with national priorities, they represent potential 1. Tissue culture, through which we can make areas of concentration for NARS. massive multiplication of genetic material, as 4. Bolstering of immune systems through biotech- well as carry out genetic improvement and germ- nological applications in vaccines and in diag- plasm conservation. The main applications are nostic kits. in cleaning of plant material and protoplast fu- 5. Applications of biotechnology in developing sus- sion. This is the most established research area tainable agriculture, where some of the most rapid in developing countries, but it still faces many developments are taking place in terms of problems of quality control and dominating the biopesticide research and new products being relevant research techniques. introduced on the market as part of efforts to use 2. Molecular markers play a key role in charac- biological control or integrated pest management terization of genetic variability and in genetic (IPM) techniques. Research on management of improvement. Coupled with the use of comput- genetic resources, through which the gene pools 84 Biotechnology and Biosafety of commercial agricultural products have been A specific effort is being made to identify the enriched with those of wild varieties, also plays applications of biotechnology that are relevant an important role. to the small producer and to peasant economies. Within each of these five research areas, the Biotechnology is not only related to the develop- strategic planning exercise identified the princi- ment of transgenic plants. Many of the research pal research techniques and main applications areas and techniques mentioned above have ap- relevant for the effective use of biotechnology in plications that are of clear interest to the produc- tackling the development problems of the coun- tion problems of smallholders and peasant try. This information is presented in a series of economnies. In the case of Colombia's CORPOICA tables in an annex to this paper. It should be an emerging biotechnology research program pointed out that this effort of identifying key aimed at addressing the needs of small-scale research areas and research techniques that are producers is starting to produce its first results. relevant for the country is presently being They include the development of high-quality complemented with an analysis of the develop- seed for peasant communities obtained through ment needs of the country and opportunities for tissue culture (plantain, cassava) and participa- new production efforts, in order to relate the re- tory technology-transfer schemes for the dissemi- search techniques to priority crops and the sus- nation of different biotechnological applications tainable production problems of Colombia. The relevant to small-scale producers. technology supply approach that was used in identifying the "research map" presented in the Developing an Appropriate Environment: annex is being complemented with a more in- Policy Issues depth analysis of development needs and oppor- tunities in this field. Besides developing an appropriate research Although this part of the exercise is still un- agenda and building up the research capacity to der way, five criteria have been defined to iden- carry it out, it is of great importance to promote tify priorities among the different research lines the development of an environment with incen- and applications that could be pursued. tives to facilitate the establishment of strategic 1. Since most of the private sector's involve- research partnerships, within the country and ment with agricultural biotechnology in indus- with firms and research institutions abroad. Four trial countries is related to temperate crops, policy issues have to be addressed in doing so: priority will be given to tropical or Andean 1. Establishing intellectual property rights crops of importance to Colombia in genetic (IPR) engineering research (orphan market-segments 2. Establishing biosafety regulations argument). 3. Developing information and communica- 2. The development of strategic alliances with tion technology capacity as a means of facilitat- firms or research centers that could provide genes ing research partnerships and alliances or "traits" that could facilitate the development 4. Funding mechanisms and direct State of the desired characteristics in these crops. This support. requires developing a capacity to use the tech- The growing importance of proprietary tech- niques related to inserting and manipulating the nology and of the private sector in agricultural genes in cells, through plant transformation sys- research and development (R&D), is leading to tems and selectable markers. the need to develop IPR regulations in each coun- 3. Priority is being given to IPM, and thus to try. It is equally important to be able to influence the applications of biotechnology in the area of the establishment of the main principles and cri- biopesticides. teria that will shape the IPR frameworks of the 4. Biotechnology research related to biodiver- future, since once established, they will deter- sity management, especially germplasm conser- mine very basic questions of accessibility to tech- vation, is of high priority. nology. This is particularly important in light of 5. Biotechnology research related to the char- the emergence of a "trait market" for technolo- acterization of ecosystems, management of natu- gies at the molecular level, which provides criti- ral resources, and farm practices (agroecology). cal inputs to the process of bundling several traits Role of International Agricultural Research 85 into germplasm, or enriching existing germplasm tional firms. This is a particularly important ele- to solve food security problems of developing ment in developing countries given the weakness countries. of their financial systems. A variety of interest- In order to promote the involvement of the ing experiences in terms of funding mechanisms private sector and facilitate the establishment of and schemes have emerged in various industrial strategic alliances between the public and the and developing countries. private sector in pursuing common objectives, it A very important factor in developing coun- is important to develop a regulatory environment tries is the role of the state in producing, through that, while protecting the public good, also pro- research, public goods related to important bio- vides the proper incentives for the private sector technological inputs. Due to limited private-sec- to invest. tor capacity to respond to the above-mentioned The IPR issue in biotechnology is not limited incentives, the role of the state is particularly to the establishment of appropriate regulations. important in these countries. Public research It is also related to the development of research institutions, either through their own programs capacities in the CGIAR and in NARS, in part- or in partnership with other research institu- nership with the private sector, to be able to ef- tions, have tended to move to upstream tech- fectively participate in the biotechnology market nologies that provide basic inputs to other of the future. Given the number of new, propri- institutional actors. Examples of this are: iden- etary technologies that are being generated and tification of genes with potential to be trans- the critical role certain "traits" or genes can play formed through biotechnological processes; in controlling the development of valuable development of gene maps for the main crops of germplasm, smaller players will be facing in- the country; and research on critical metabolism creasing barriers to the "freedom to operate" and processes that could lead to the identification of have access to the enabling technologies that the potential new products. biotechnology revolution is generating. The development of biosafety regulations is Research Partnerships, Strategic equally important, given the potential impact of Alliances, and the Global Forum new varieties with regard to people and the en- on Agricultural Research vironment. Existing regulatory schemes pay at- tention to both the impact of the new variety on It is now clear that the recent advances in science human health and on the immediate ecosystem, and technology achieved in new strategic re- as well as to the process used in the production search areas-mainly biotechnology and ICT- of a transgenic plant, because of environmental can play a key role in overcoming the global concerns. problems of poverty, food security, and envi- Third, the development of an ICT capacity in ronmental degradation in developing coun- developing countries and in NARS is of great tries. Biotechnology alone cannot solve these importance to enable research institutes in these problems. But if used in conjunction with other countries to interact with their peers through research tools related to plant breeding and transnational research networks and different crop management, biotechnology can contrib- types of research partnerships. The latter play a ute to a quantum leap in agricultural produc- particularly important role in the area of biotech- tion, reducing production costs, and increasing nology research. The different forms they take is sustainability. analyzed in the next section. If we are to take advantage of the opportuni- A fourth important aspect of the process of ties generated by this knowledge revolution, establishing an appropriate environment for the however, a strategy of facilitating and develop- development of biotechnology has to do with ing research partnerships and strategic alliances funding mechanisms, incentives, and the role of among the different stakeholders should be the state in developing countries. In addition to followed, on the basis of the following con- IPR, it is important to establish fiscal incentives siderations: and risk capital facilities to promote private sec- * Increasing research needs and requirements, tor investment from both multinational and na- and thus expanding research agendas 86 Biotechnology and Biosafety * Decreasing availability of public resources de- In order to participate actively in such net- voted to research, as reflected in both real ex- works, NARS and their institutions have to de- penditure per researcher and the annual velop a collaborative advantage or capability growth rate in research expenditure permitting them to do so. This involves having * The impact of globalization on promoting co- sufficient research capacity to contribute to and operation in tackling global issues profit from such exchanges, as well as needed * Innovation and technical change is increas- skills and organizational flexibility for entering ingly the product of transnational research net- into such agreements. works facilitated by advances in ICT, making These research partnerships take various communication among researchers across the forms, but the most common modalities are: (a) globe faster and less costly. loose or open research networks, (b) research con- This last point is particularly important. Re- sortia (when the networks become more formal- search carried out on innovative processes and ized), (c) joint ventures (in specific projects), and systems has clearly emphasized the role of "in- (d) licensing arrangements The relevance and novation networks" as the main agent of knowl- advantage of each modality varies from case to edge generation and technical change in different case. industrial and agroindustrial sectors. The same These four types of research partnerships de- is true of biotechnology, in which corporations fine a range of options that go from the open re- form partnerships as part of a strategy to increase search networks constituted by peers in the their competitive advantage. A recent CGIAR scientific community working in a specific area report points out that: "Having an internal re- or topic, to other forms of collaborative R&D search capacity is necessary but not sufficient for characterized by increasing levels of formality, innovation. The complexity of the problems faced often based on contractual relationships between and the rapidity of the advances in knowledge partners that agree to collaborate in the develop- compel companies and their researchers to reach ment of a proprietary technology. Thus there is a out widely for partners." Another study points strong commercial relationship in these cases. It out that "when the knowledge base of an indus- is important to point out that in the case of the try is both complex and expanding and the development of proprietary technologies, joint sources of expertise are widely dispersed, the ventures and licensing agreements play a much locus of innovation will be found in networks of more important role. learning, rather than in individual firms." Open research networks are usually based on These partnerships may involve universities, the flow of public information between research- research institutes, international research centers, ers or research groups that share a common area and private firms, and thus they involve strate- of interest. These networks are better suited for gic alliances between the public and the private sec- the development of nonproprietary technologies tors. For this to be feasible, it is important to (this is the case of some biotechnological appli- develop a regulatory framework that, while pro- cations in developing countries) or for the ex- tecting the public good, also provides adequate change of general information that does not lead incentives for the private sector to invest. This to biotechnological access. Here they can play a environment requires a change in organizational very important role. culture in many research institutions, since it re- The commercial dimension becomes much quires new attitudes and forms of interaction more important in the case of the research part- between public research centers oriented towards nerships located at the other end of this range of the development of public goods, and firms options: joint ventures and licensing arrange- which are profit-oriented and interested in ments. The latter also require partners with a clear proprietary technologies. It also involves possibility of exchanging research results and transnational research networks from both North technologies, and thus having the basis for inter- and South, especially if we want to integrate acting in such types of strategic alliances. Thus NARS and avoid the dangers of increasing tech- this typology of research partnerships identifies nology gaps. different organizational modalities that play dif- Role of International Agricultural Research 87 ferent roles, and that are better suited for differ- new opportunities that are emerging, it is neces- ent objectives and circumstances. sary to promote the development of a global sys- tem for agricultural research, based on cost- Global Forum on Agricultural Research effective partnerships and strategic alliances among the various institutional actors related It is within this context that the question of new to agricultural research, aimed at three major approaches to global cooperation in this area, objectives: through strategic alliances and research partner- 1. Reducing poverty ships, becomes of paramount importance. Four 2. Ensuring food security key questions emerge in this regard: 3. Ensuring the conservation and management 1. How can we mobilize the global scientific of biodiversity and the natural resource base. community in a concerted effort to address these This involves the active participation of NARS, issues, facilitating the harnessing of knowledge IARCS, advanced research institutes in universi- to the solution of development and global prob- ties or centers of excellence around the world, lems, complementing and strengthening the the private sector, NGOs and farmers' organiza- work already being done by the CGIAR? tions. The IARCs are particularly well placed to 2. How can we develop a capacity in the de- play an important role in this process, given the veloping world (in the NARS), to avoid the dan- high-quality research infrastructure they have, gers of growing technology gaps that could their knowledge of tropical agriculture, the net- emerge in the new strategic research areas (such work of contacts in developing countries, their as biotechnology), with the concomitant impact germplasm collections, and the highly trained on equity, sustainability, and development research staff that constitute one of their main possibilities? assets. Many of the transnational research net- 3. How can we develop strategic alliances and works that can be generated through the Global research partnerships among the various stake- Forum can be coordinated by specific IARCs, holders related to biotechnology and develop- working in close collaboration with other stake- ment-oriented agricultural and natural resources holders. research, building on the strengths and compara- The origins of the Global Forum lie in the re- tive advantages of each one? cent efforts of the CGIAR to broaden its partner- 4. How can we take advantage of the new op- ships with the above-mentioned institutions. This portunities the development of science offers, as process involved consultation with groups of well as the ICT revolution, to develop a knowledge- NARS at the regional level on the substance of brokerage capacity that could mobilize exper- research collaboration, leading to the emergence tise and knowledge, wherever it may be, and of representative regional groupings, and, finally, apply it to the solution of specific problems of to the Global Forum. a policy, institutional or technological nature? In the last two years Regional Forums have This entails involving the high-technology been established by the NARS of developing groups into the agricultural research effort, ad- countries in Africa, East Asia and Pacific, East- dressing both the global and development ern Europe, Central Asia, and Latin America and problems we face. the Caribbean. These are the main components These are the questions that led, at the end of of the Global Forum. These Regional Forums are last year, to the initiation of a process aimed at aimed at facilitating collaboration among NARS, building up a Global Forum on Agricultural Re- at the regional and subregional levels, and at fa- search, as a collective endeavor to facilitates ex- cilitating their insertion into the global research change of information and research partnerships arena. In certain regions these collaborative ef- among the various stakeholders involved in this forts have crystallized into new and innovative area of research. The Global Forum emerged from cooperative mechanisms, such as the Regional the conviction that, in order to respond to the Agricultural Technology Fund established in increasing challenges and research needs we Latin America and the Caribbean, to promote and presently face, as well as take advantage of the facilitate cooperation in this area, both within the 88 Biotechnology and Biosafety region as well as with advanced research insti- In developing the Global Forum on Agricul- tutes around the world. tural Research, the new information and tele- At the national level similar considerations communication technologies will be used, have led to major institutional reforms in the relying heavily on electronic networks orga- NARS of developing countries, where new policy nized around specific topics and on Internet approaches and institutional frameworks are be- linkages, and using the new institutional mod- ing tried out in seeking to develop new partner- els of virtual organizations and dynamic learn- ships in a multi-stakeholder environment, and ing processes. The different organizational to increase the effectiveness of agricultural re- modalities of research partnerships mentioned search systems. The evolution of national agri- above will be explored and facilitated. How- cultural research institutes to NARS, and the ever, a clear strategy for addressing the vari- integration of the latter, is generating major in- ous issues raised in this paper will also have stitutional and organizational reforms in many to be developed. A strategy is necessary to en- developing countries, leading to new organiza- sure the participation of NARS in this process tional structures based on public-private sector and to make use of the full potential of biotech- cooperation and joint ventures. This is changing nology and the other strategic research areas the structure of the traditional technology re- in coping with the challenges of alleviating search institutes in both the agricultural and in- poverty, ensuring food security, and achieving dustrial sectors. sustainable development. Role of International Agricultural Research 89 Annex. Research Techniques and Research Applications in Biotechnology Identified in the Strategic Planning Exercise of CORPOICA (Colombia) Technique Application Plant tissue culture Conventional micropropagation methods Cleaning and multiplication Micropropagation in bioreactors * Artificial seed production Conventional methods of in vitro conservation Germplasm banks * Cryo-preservation * Haploid production Plant breeding * Protoplast fusion * Cell culture Production of secondary metabolites * Organ culture Genetic engineering Recombinant DNA Use of transgenic plants in plant breeding Ti plasmid-mediated genetic transformation Broadening of crops genetic base to improve their Biolistics characteristics Viral vectors Conservation, characterization, and improvement of Direct genetic transformation of plant proteins crop and microorganisms germplasm Microinjection Development of desired characteristics Electroporation * Tolerance to: Liposome fusion Herbicides (glyphosate) Insects (Bacillus thuringiensis) Fungi (chitinase) Bacteria (lysozymes) Virus (protein envelope) * Protein quality (seeds, tubers) * Starch metabolism * Physiological characteristics Synthesis of ethylene Cold tolerance Lignin content Soluble sugars Delayed fruit ripening * Flower pigments * Male sterility Nuclear Cytoplasmic Modification of structure or composition of plant lipids Improvement of vegetable oil quality * Production of monoclonal and polyclonal antibodies Diagnosis * DNA probes * DNA fingerprinting * PCR (polymerase chain reaction) * Vaccine production in fruits Vaccines Molecular markers * RFLPs Evaluation of genetic variability * RAPDs Molecular animal and plant mapping * DNA fingerprinting Plant breeding * PCR Germplasm characterization * Microsatellites (SSP) Selection of desirable genotypes * SCARs Pedigree and population analysis * AFLP 90 Biotechnology and Biosafety Annex (continued) Technique Application Bioprocessing enzymes Carbohydratases Brewing, baking, sweets, sweeteners, textile fibers, fruit juices, drugs, foods, dairy products, sugar beet Proteases Brewing, meats, drugs, baking, cheese, detergents Hydrolases Drugs, foods, dairy products, baking, detergents, leather tanning Oxidoreductases Perspectives from National Agricultural Research Systems MariaJoseA. Sampaio O ne of the main challenges to expanding the Convention on Biological Diversity (CBD) agricultural production in the decades was opened for signature. ahead is to develop new crops with in- In Latin America the first workshops for re- creased yield, pest resistance, and drought toler- gional discussions of biosafety issues took place ance. To drive agriculture towards sustainability in 1990, sponsored by the Inter-American Insti- is to add to those characteristics reduced depen- tute for Cooperation on Agriculture. Harmonized dency on pesticides and herbicides. These are proposals came out of meetings held in Argen- some of the tasks that can be addressed by mod- tina (1992), Colombia (1994), and Costa Rica em biotechnology. (1994). These workshops were very valuable in However, as with all new tools, biotechnology the sense that participants, most of them work- must be assessed in terms of benefits and costs. ing for National Agricultural Research Systems Experience shows that some problems, such as (NARS), had the chance to discuss scientific and gene flow from modified plants to wild relatives, policy issues. The United Nations Development potential development of new viruses, pathogen- Programme has played a major role by provid- derived resistance, or ecosystem damage are the ing some countries with the possibility of devel- same as those faced 30 years ago during the Green oping joint biotechnology projects and raising Revolution, and they need be addressed again awareness of biosafety and the need for risk as- to safeguard the environment and human health. sessment. Also, the U. S. Department of Agricul- Not all development-oriented basic or applied ture, the Stockholm Environment Institute, and research need be conducted in the country where the United Nations Industrial Development Or- engineered crops are to be grown. However se- ganization have been giving strong support to lection of traits of interest, confirmation in the newly formed national committees for the orga- field of the agronomic value of the new crop, and nization of workshops and seminars in Latin the study of its interaction with a given ecosys- America. Other developing countries, such as tem need to be done on site, thus creating an op- China and India, are receiving similar attention. portunity for the transfer of biotechnology to Under the CBD parties have decided to pre- developing countries. pare a binding protocol that will establish rules To evaluate potential risks and establish regu- for the transboundary movement of living modi- lations to discipline the use of biotechnology, a fied organisms. A first draft is being prepared new "scientific area" has been created, which is during a series of meetings of member-country commonly known as biosafety. Discussions of representatives, and will be submitted to the biosafety began to receive more attention after Committee of the Whole during the fourth meet- the Earth Summit in Rio de Janeiro in 1992, when ing of Conference of the Parties, scheduled for 91 92 Biotechnology and Biosafety May 1998. A final document should emerge be- agriculture by the turn of the century. Therefore fore year 2000. regulations and regulating authorities would be Since 1992 countries have been discussing needed to allow for the development of the tech- the types of national legal infrastructure nec- nology and its further use in the country. In 1993 essary for the implementation of biosafety. leading scientists from the Brazilian Agricultural When discussing options such as guidelines, Research Corporation (EMBRAPA), the major protocols, and directives for the management component of the NARS, with support from col- of genetically modified organisms (GMOs), leagues at the Oswaldo Cruz Foundation, a re- decisions have to be made regarding binding search institute linked to the Ministry of Health, instruments, such as a special law or ministe- prepared a proposal that was submitted to the rial decree, or nonbinding instruments, such as Brazilian Congress for discussion. In January guidelines and directives. 1995 the Biosafety Law was enacted by Congress. Different countries in Latin America have de- In December of the same year, a complementary cided to take different approaches. So far Brazil statute regulating the law was published. is the only country in the region to adopt a The Biosafety Law establishes safety proce- biosafety law. Other countries, while discussing dures and mechanisms for supervision of the use the possibility of having a law in the future, are of genetic engineering techniques in the construc- using ministerial decrees under existing quaran- tion, cultivation, manipulation, transportation, tine laws or regulations; some have decided to commercialization, consumption, release, and start using guidelines, mostly based on the United disposal of GMOs, aiming to protect the health Nations Environment Programme model. But al- and lives of human beings, animals, plants, and most all countries have already formed a national the environment. biosafety committee to deliberate about field tests The mechanism proposed for implementation and other issues related to GMOs. The commit- of activities comprises: tees are usually linked to ministries of agricul- 1. A National Technical Biosafety Committee, ture, environment, or science and technology. formed by representatives of the following ministries: science and technology, agriculture, Biosafety in Latin America: health, environment, education, and foreign Supervisory Authorities affairs. Other members are nominated by asso- ciations representing consumers' rights, corpo- Argentina National Biotechnology rations working with biotechnology, and workers' Commission (CONABIA) health. Finally, eight scientists nominated by the Bolivia National Biosafety Committee scientific community complement the group. Brazil National Technical Biosafety 2. The formation of an Internal Biosafety Com- Committee (CTNBio) mission by every public or private institute or Chile National Biosafety Committee organization that deals with biotechnology and Colombia National Biosafety Committee the manipulation of DNA. This Commission is Costa Rica National Biosafety Committee ultimately responsible for all activities relating Cuba National Biosafety Commnittee to GMOs under their supervision. Ecuador Under discussion 3. The need for every public or private labora- Mexico National Biosafety Committee tory working with biotechnology research to Paraguay National Biosafety Committee apply and obtain a Certificate of Quality in Bio- Peru National Biosafety Committee safety, after having its infrastructure reviewed by (under discussion) the National Committee. Venezuela National Biosafety Committee Under the law public or private institutions Brazil is a good example of the early involve- are considered technically and scientifically re- ment of NARS in national-level decisionmaking sponsible for activities and projects in which they about the management of biotechnology and re- become involved, regardless of whether or not lated biosafety issues. In the early 1990s it could they are carried out on their own premises. already be foreseen that genetically engineered Supervisory responsibilities pertain to agen- crops would play an important role in Brazilian cies of the Ministry of Agriculture, Ministry of Role of International Agricultural Research 93 Environment, and Ministry of Health within their due to the numerous lobbies that try to influence areas of jurisdiction, observing the conclusive decisions in the biosafety arena. Countries lack- technical analysis of the National Committee. The ing this capacity are systematically lagging be- law establishes punishments for different viola- hind, both in the acquisition, adaptation, and tions and crimes, which range from the payment development of biotechnology for in-house use of fines to imprisonment for 20 years. and the formulation of biosafety regulations. This During 1997 the National Committee issued in turn, and given present trends, will represent eight rulings covering: requirements for the is- a tremendous bottleneck for the agricultural de- suance of the Certificate of Quality in Biosafety, velopment of these nations. importation for research of genetically modified As the use of GMOs in agriculture spreads plants and seeds, field release of GMOs, trans- worldwide, the coordination capacity of NARS portation of GMOs, classification of organisms in both industrial and developing countries will according to risk and levels of containment, ex- be critical for the design of national and regional perimental and industrial management of GMOs monitoring programs, which will have to involve under containment, genetic manipulation, and both private and public research initiatives. Po- human cloning. The National Committee has re- tential problems could get out of control if these ceived many petitions for field releases of GMOs. programs are not put in place in a very timely Small-scale releases started during the 1997 crop fashion. For these programs nothing will be more season. National Committee members, industry important than the gathering by NARS of basic and governmental research institutes, and soci- ecological, botanical, and agronomic data on the ety are learning together the best way to design undisturbed environrnent and its changes after risk assessment and apply risk management. The the introduction of genetically modified crops. important fact to be observed is that all of this, which seems to be taken for granted now, would References not have been possible if the NARS had not re- acted and acted in time. Kendall, H.W., Beachy, R., Eisner,T., Gould, F., Herdt, The involvement of NARS, through their sci- R., Raven, P.H., Shell, J.S., and Swaminathan, M.S. entific leadership, has also been decisive in the 1997. Bioengineering ofCrops: Report ofthe World Bank design of biosafety measures adopted in Argen- Panel on Transgenic Crops. Washington, D.C.: World tina, Chile, Costa Rica, Mexico, and Uruguay The Bank. Reprinted in this volume as appendix C. experience in the Latin American region has Sampaio, M.J.A. 1995. "Biosafety Regulations in Bra- shown that the existence of a strong NARS facili- zil." African Crop Journal 3: 315-17. tates the design and implementation of biosafety 1998 (forcomng). 'BiosafetyinLatinAmerica: measures, because the system usually provides Building up Experience and a Framework for Ge- scientists from different fields of expertise with netically Modified Organisms Management since the necessary background knowledge to face the 1990." Biosafety Workshop on the Environmental Im- challenge and take on the coordination of the pact Analysis of Transgenic Plants in the Asia Pacific process. The latter is a strongly needed capacity Region. London: Oxford Press. Genetic Engineering: Addressing Agricultural Development in Egypt Magdy Madkour T he challenge facing the world today is to National Perceptions provide food, fiber, and industrial raw materials for an ever-growing world popu- The Government of Egypt is increasingly aware lation without harming the environment or af- that it must use its own limited resources in a fecting the future productivity of natural cost-effective way. Failure to develop its own ap- resources. Meeting this challenge will require the propriate biotechnology applications and inabil- continued support of science, research, and edu- ity to acquire technology developed worldwide cation. A high demand for attention to these prob- could deny Egypt timely access to important new lems lies in developing countries, where 90 advances capable of overcoming significant con- percent of the world's population growth will straints to increased agricultural productivity. take place within the next two decades. A very significant contribution to increased In Egypt agriculture represents the spearhead food production could be made by protecting of socioeconomic development, accounting for more crops from losses to pests, pathogens, and almost 28 percent of national income and employ- weeds. The total loss of worldwide agricultural ing almost 50 percent of the workforce. Agricul- production ranges from 20 to 40 percent, includ- tural commodities generate more than 20 percent ing both pre- and post-harvest losses, which oc- of the country's total export earnings. A limited cur despite the widespread use of synthetic arable land base, coupled with an ever-growing pesticides. population (annual birth rate 2.7 percent), are the It is in areas such as crop protection that bio- main reasons for the increasing food production/ technology, especially genetic engineering, could consumption gap. Egypt's population will grow offer great benefits to the environment by replac- to about 70 million by the year 2000 and swell to ing the present policy of blanket sprayings of 110 million by 2025. In recent years only 15 per- crops with herbicides, fungicides, and pesticides, cent of production for total agricultural commod- with a combination of inherent engineered resis- ity exports in Egypt has been exported, which is tance to pests and diseases. Thus genetic engi- indicative of increased domestic demand due to neering is very suitable to agriculture in the increased population growth. Increasing the ag- developing world, since it is "user-friendly." If it ricultural land base from a 7.4- to a 14-million is applied in a sensible manner, there can be no feddans cropping area would satisfy only 50 per- doubt that this technology is "green." cent of the requirement of the current popula- tion of 59 million. To bridge the food gap and One of the major targets of the application fulfill the goal of self reliance, an expansion of - of genetic engineering is the production of the land base and optimization of agricultural transgenic plants conferring resistance to outputs are urgently needed. both biotic stress resulting from pathogenic 94 Role of International Agricultural Research 95 viruses, fungi, and insect pests and abiotic cally modified plants prior to their release to the stress, including such unfavorable environ- field. mental conditions as salinity in the soil and Moreover AGERI has dedicated 1.5 acres of irrigation water, drought, and high tempera- land to serve as an open-field experimental sta- tures. tion for field testing of genetically engineered plant material. The production of transgenic plants tolerant The staff of AGERI is composed of 17 highly to enviromnental stress could significantly help accomplished senior scientists. Each is a vital link Egypt's efforts toward horizontal expansion of in the program's goals for crop improvement. The agricultural lands toward the desert. This would senior scientists have institutional affiliation in increase the agricultural land base by about I six Egyptian universities, in addition to their sci- million acres. entific responsibilities within AGERI. They work The Agricultural Genetic Engineering Re- at AGERI on a joint-appointment basis, which search Institute (AGERI) represents a vehicle maximizes their interaction between the aca- within the agricultural arena for the transfer and demic and research domains. application of this new technology. The original AGERI continues to play a role as the inter- establishment of AGERI in 1990 was the result of face between the international scientific com- a commitment of expertise in agricultural bio- munity and Egypt. Various seminars and technology. At the time of it's genesis, AGERI was conferences have been held at AGERI with the named the National Agricultural Genetic Engi- participation of highly qualified international neering Laboratory (NAGEL). The rapid progress consultants. Some 40 study tours have taken both of its activities during the first three years encour- senior scientists and junior assistants from AGERI aged the Ministry of Agriculture and Land Rec- to various international biotechnology centers in lamation to authorize the foundation of AGERI, Asia, Europe, and North America to attend con- which represents phase two of the national goal ferences or training courses. for excellence in genetic engineering and biotech- Condensed short courses and seminars nology. AGERI is now aiming to adopt the most concentrating on vital basics of biotechnology. advanced technologies available worldwide and have been conducted by AGERI. Educational apply them to contemporary problems facing activities have been promoted as a result of this agriculture in Egypt. linkage and cooperation with international re- AGERI is housed within the Agricultural Re- searchers and laboratories, and opportunities search Center (ARC), which not only facilitates have arisen for the exchange of genes, genetic an interface with ARC's ongoing research pro- probes, DNA libraries, and vectors. Such con- grams, but also provides a focal point for bio- tacts with centers worldwide have been initi- technology and genetic engineering for crop ated and encouraged to facilitate meaningful applications in Egypt. interactions. AGERI runs its present activities from a build- ing with a net space of 1,500 square meters, which Research and Scientific Collaboration houses 13 modern, well-equipped laboratories, a central facility containing major equipment AGERI has been successful in attracting funds to used commonly, and a controlled environment sponsor its research from the following interna- chambers facility (11 units) to host transgenic tional organizations: plant material for acclimatization. * United Nations Development Programme, as A state-of-the-art Biocontainment Greenhouse a cofunding agency supporting the initial re- Facility is now in full function. This facility com- search at NAGEL (currently AGERI). plies with the most advanced regulations of the * A cooperative research agreement between U.S. Environmental Protection Agency and Ani- AGERI and the Agricultural Biotechnology for mal and Plant Health Inspection Service, as well Sustainable Productivity Project based at as United Nations Environment Programme Michigan State University, which is funded by guidelines for containment and isolation. The the U.S. Agency for International Develop- facility is dedicated to confined testing of geneti- ment/Cairo under the National Agricultural 96 Biotechnology and Biosafety Research Project. This activity allowed inter- 2. Engineering of insect-resistant plants with action between AGERI's scientists and re- Bacillus thuringiensis crystal protein genes. Bt searchers from a number of eminent American genes are used for the transformation of cotton, universities, including Michigan State Univer- maize, potato, and tomato plants to resist their sity, Cornell University, University of Califor- major insect pests. nia, the Scripps Research Institute, University 3. Genetic engineering for fungal resistance of Maryland, University of Wyoming, Univer- using the chitinase gene concept for the devel- sity of Arizona, and the Agricultural Research opment of transgenic maize, tomato, and faba Service of the U.S. Department of Agriculture. bean expressing resistance to fungal diseases * Recently, the International Center for Agricul- caused by Fusarium sp., Alternaria sp., and Botrytis tural Research in DryAreas, located inAleppo, fabae. Syria, contracted AGERI to conduct research 4. Enhancing the nutritional quality of faba on some of their mandated crops. bean seed protein by the successful transfer of The projects carried out at AGERI are based the sulphur-rich genes to faba bean plants. on the concept of maintaining a program focused 5. Cloning the genes' encoding for important on the problems of Egypt. The immediate objec- economic traits in tomatoes, faba beans, and cot- tives are to develop and deliver transgenic culti- ton, especially those related to stress tolerance vars of major economically important crops in (that is, heat shock proteins and osmoregulation Egypt. Thus the most recent and successful ge- genes). netic engineering techniques are being employed 6. Mapping the rapeseed genome in order to to address this need. These projects also repre- develop cultivars adapted to the constraints of sent a spectrum of increasingly complex scien- the Egyptian environment, thus securing a good tific challenges requiring state-of-the-art genetic source of edible oil. engineering and gene transfer technologies. Gene 7. Developing efficient diagnostic tools for the manipulation techniques such as cloning, se- identification and characterization of major vi- quencing, modifications, construction of genomic ruses in Egypt. and cDNA libraries, plant transformation, and These projects are relevant to Egyptian agri- regeneration in tissue culture are just few ex- culture, since they reflect a significant positive amples of the cellular and molecular biology impact on agricultural productivity and foreign methodologies that are utilized for production exchange. For example, Egyptian Bt transgenic of transgenic plants. cotton, resistant to major insect pests, would The successful implementation of these result in substantial savings of the US$50 mil- projects would build a national capacity within lion spent annually on the purchase of im- Egypt for the sustainable production of crops ported pesticides. Mapping of rapeseed oil has crucial to the economy and to a safer, cleaner a potential to substantially reduce the 400,000 environment. tons of edible oil imported into Egypt annu- ally. Similarly, transgenic potato varieties re- Examples of Projects Carried Out sistant to selected viruses and insect pests at AGERI would prevent the expenditure of approxi- mately US$33 million per year in the import of 1. Genetic engineering of virus-resistant seed potatoes. potato to the most important viruses in Egypt The goals of AGERI in the agricultural com- (PVX, PVY, PLRV); production of transgenic to- munity are summarized below: matoes resistant to geminiviruses such as Tomato * Advance Egyptian agriculture using biotech- Yellow Leaf Curl Virus (TYLCV); introduction of nology and genetic engineering capabilities virus resistance in squash and melon against available worldwide to meet contemporary Zuccini Yellow Mosaic Virus (ZYMV); and finally, problems of Egyptian agriculture the production of transgenic faba bean confer- * Broaden the research and development ca- ring resistance to Bean Yellow Mosaic Virus pabilities and scope of the Agricultural Re- (BYMV) and Faba Bean Necrotic Yellow Virus search Center in the public and private (FBNYV). sectors (for example, initiation of new pro- Role of International Agricultural Research 97 gram areas and application to a wider array To formulate a biosafety system for Egypt, infor- of crop species) mation was gathered from different counties re- * Expand and diversify the pool of highly quali- garding their regulations, guidelines, and fied, trained professionals in the area of bio- systems design. A draft document entitled "The technology and genetic engineering Establishment of a National Biosafety System in * Provide opportunities for university-trained Egypt: Regulations and Guidelines," was pre- professionals (faculty, researchers, and teach- pared by AGERI, with regulations and guide- ers), the Ministry of Agriculture (professional lines adapted to Egyptian conditions. This researchers), and private venture companies document was revised by the NBC and ap- to cooperate in agricultural genetic engineer- proved by government authorities as a bind- ing research ing law for biosafety in Egypt (Ministerial * Promote opportunities for private sector de- Decree 136, February 1995). velopment The NBC includes representatives from the * Achieve the desired level of self-reliance and ministries of agriculture, health, industry, envi- self-financing within AGERI to mobilize the ronment, education, and scientific research. funds necessary for maintaining laboratories. Representatives from the private sector, policy- AGERI is seeking to fulfill a role in Africa and makers, and consultants knowledgeable in poli- the Middle East as an emerging center of excel- cies and applicable law, as well as nontechnical lence for plant genetic engineering and biotech- members representing community interests (non- nology. AGERI will act as an interface between governmental organizaions) are also active mem- elite centers and laboratories from the interna- bers of the NBC. tional scientific community and research centers, universities, and the private sector in Egypt, Af- NBC Activities rica, and the Middle East. The major goal is to assist and provide the mechanism for proper * Formulation, implementation, and updating technology transfer to benefit their respective of safety codes agriculture mandates. * Risk assessment and license issuance - Training and technical advice Overview of Biosafety Status in Egypt * Annual reporting to government authorities * Coordination with national and international In Egypt, as in other developing countries, a na- organizations tional biosafety system will ensure the safe de- velopment of biotechnology products and Principal Investigator facilitate collaborative research activities with other countries. Until 1995 Egypt's regulations The principal investigator is an NBC member did not include guidelines for handling trans- with the following scope of duties: genic materials under contained conditions, nor * Receive permit requests for the release of did they cover the release of genetically modi- GMOs fied organisms into the environment. * Visit locations for inspection of facilities AGERI is the primary institute dealing with * Submit a report to the NBC upon which a per- biotechnology in Egypt. As AGERI's research mit will be issued or denied projects have now reached the stage of field * Instruct and advise staff in practices and tech- evaluation of genetically modified organisms, the niques to assure level of safety concern. Egyptian government has moved forward to build a national biosafety policy to regulate such Institutional Biosafety Committees activities. The Egyptian National Biosafety Committee Each institute or organization actively involved (NBC) was established by Ministerial Decree 85 in genetic engineering research is mandated to in January 1995. This committee is responsible establish its own biosafety committee. Institu- for putting together policies and procedures to tional Biosafety Committees (IBCs) should govern the use of biotechnology in the country. include: 98 Biotechnology and Biosafety * Experts in r-DNA technology Overview of Intellectual Property Rights * Experts in biological safety and physical con- Status in Egypt tainment * Consultants knowledgeable in institutional Intellectual property rights (IPR) are important committees, policies, and applicable law for biotechnology; they can provide incentives * A biological safety officer. to local researchers and firms, they have come to be required by international law, and they IBC Activities can assist in the international transfer of tech- nology. * Establish an inspection program As Egypt moves toward genetic engineering, * Assemble a set of oriented guidelines that com- it needs to ensure that the developer of a novel ply with NBC guidelines gene can obtain appropriate protection. Egypt * Assess facilities, practices, and procedures is already moving to strengthen its law. The old * Periodicallyreviewr-DNAresearchconducted 1949 patent law had no food or pharmaceuti- in the institute cal product protection, only a possibility of a * Adopt emergency plans covering accidental 10-year process protection. According to the spills and personal contamination law's explanatory memorandum, food prod- * Periodically review containment measures ucts are excluded on the grounds that they do * Monitor changes in intellectual property rights not constitute an invention and that a mo- * Report annually to the NBC. nopoly over producing such products is harm- ful to the public's health. Biological Safety Officer As Egypt undergoes a major agricultural re- form, in which the private sector will play an es- The Biological Safety Officer (BSO) is an active sential role, the government is modifying the member of the IBC responsible for: existing patent law. Under a new law agriculture, i Enforcing policies and regulations approved foodstuffs, medical drugs, pharmaceutical com- in the institute pounds, plant and animal species, and microbio- - Ensuring that all facility standards are rigor- logical organisms and products are included as ously followed patentable subject matter. This is a significant - Ensuring safety of all facility work and pre- strengthening of the previous law and brings venting the accidental escape of GMOs Egypt in line with international standards. - Maintaining a database on all aspects of bio- New laws such as this, along with an expanded safety related to mandated crops understanding of IPR, should assist Egypt to ac- * Checking and giving advice on biosafety is- quire technology earlier and enter into more ef- sues on a day-to-day basis fective scientific strategic alliances that will help * Monitoring worldwide biosafety requirements in developing new technologies and strengthen- for the r-DNA technology. ing local research capabilities. Discussion Moderator: Louise 0. Fresco Wanda Collins: I would like for Magdy Madkour wheat in the desert now using such genes, and and Maria Jose Sampaio to tell us what the pub- yesterday there was some discussion that stress lic perception is in their countries of existing and salinity are multigenic traits. Well, we are biosafety provisions. Has there been a change in talking now about a single-gene trait. In the Min- public perception, or at what level is it? istry of Agriculture we do not have alternatives. Also, I got a fair idea of how Brazil approaches We have the desert, and we have to increase our the magnitude of risk that they are willing to ac- vertical production. We have no other new tech- cept. Could Magdy Madkour give us more in- nology that would allow us to do this. formation on how Egypt will approach that issue. Public perception in terms of biosafety has not yet been tested, but there was one incident in Maria Jos6 Sampaio: Public perception has been which the Egyptian Ministry of Health released changing slowly. Remember that Brazil is field a decree to ban imports of genetically engineered testing for the first time this year, and even food. This was done after a recommendation by though every proposal for the committee has the committee on food safety within the Ministry been published in the press, there has not been of Health in response to some wrong information. much of a reaction from the public so far. Let us This is where coordination and collaboration see when the field crops start to be planted in should take place. The national biosafety com- October, November. mittee existed in Egypt, but it was not consulted on this issue. We brought members of the food Magdy Madkour: Regarding the public percep- safety committee and Ministry of Health together tion in Egypt, so far we have been doing small- with the national biosafety committee. As a re- scale field trials, which are confined to a certain sult we amended the earlier Health Ministry de- stand. We have not yet gone for a large-scale field cree to allow for the importation of genetically trial. The first large-scale field trial that will take engineered material as long as it has been ap- place in Egypt will be on potatoes. proved in the country of origin and we have We have not yet encountered any public resis- enough evidence of the kind of technology used tance in terms of accepting the concept of bio- to develop this kind of transgenic material. technology in Egypt. In Egypt we cannot produce This was tested for two months in Egypt, and any more from the existing crop and crop pack- I think the public has responded very favorably. ages that we have and the technology package Both the opposition and the government party we have. We have another tool to use, which is have been involved, and we have come to this biotechnology. resolution. I think the public perception is in fa- We see that biotechnology can address expan- vor of providing safe technology that will allow sion into the desert. We know that we can grow Egypt to meet its demand for food production. 99 100 Biotechnology and Biosafety Peter Matlon: Maria Jose Sampaio concluded her cide case by case, because of the ecological varia- statement by underlining the need for regional tion, which brings new challenges every time. harmonization in biosafety regulations, and I would like to explore with the panel what might Louise Fresco: Maybe one idea that could be ex- be a more proactive and ambitious approach, plored further in this context is to see how we depending upon subregional organizations. can use the approach developed in the Consul- When we look at Africa right now, as far as I know tative Group on International Agricultural Re- we have biosafety regulations in place only in search (CGIAR) on agroecological zoning. This Egypt, South Africa, and Zimbabwe. The capaci- would identify areas of broad ecological homo- ties of national programs are extremely weak. geneity as a basis for extrapolation of field test- They will require outside assistance to develop ing and regulations. regulations. To do this on a country-by-country basis, I think most optimistically, would take Fernando Osorio Chaparro: The issue that Peter 15 to 20 years before regulations are in place. Matlon has brought up is one that has been dis- The risks posed by different transgenic crops cussed mainly at the subregional level, where you that might be introduced are identical across can get easier consensus on action and on com- neighboring countries in similar agricultural mon legal frameworks. systems. For example, the Andean countries already Would it be feasible politically to consider us- have approved a broad common framework ing subregional organizations as a base to de- within which the national regulatory mecha- velop intergovernmental agreements whereby a nisms are being approved. single set of biosafety legislation, perhaps model The Latin American and Caribbean region is legislation, could be developed? A single set of probably the only subregion that has been able regulations would be applied uniformly, through to move in that direction. I am aware of the fact government agreement, through subregional or- that in the Southern Cone, within Mercosur, there ganizations, to identify points of entry-countries are also discussions along those lines. with the strongest infrastructural and human re- But that is a broad framework for national leg- source capacities-so that containment facilities islation to be formulated and enforced. A second would be concentrated in one or two countries common element that is being carried out at the in the subregion. subregional level is capacity building. There you Once the materials have passed through and do have collective efforts to develop economies been verified as being of acceptable risk, they of scale and a larger impact, because if we go on could then be circulated to other countries that a country-by-country basis, as Peter Matlon was have agreed to this approach without requiring pointing out, probably time will run out on us. additional containment and field testing. Third, campaigns of public awareness. In Is this politically feasible? Is it technically Prociandino there is an effort to move in that di- acceptable? rection. The issue of having joint mechanisms for screening has been discussed, but without much Maria Jose Sampaio: In relation to South agreement. It is much more complicated to have America, when you ask whether it would be pos- formal collective action at the transnational level. sible to have intergovernmental agreements, the answer is yes. But the problem is that you have Samuel Dryden: I would like to address the part- to analyze every case and every trait. For instance nership question that Louise Fresco posed. I think if I had something to analyze between Argentina that introducing a private sector perspective and southern Brazil, it would be very easy to have might be important to this discussion, because it one field test organized between both countries. helps to think in terms of the collaborative ad- But if a crop is going to be planted near the Ama- vantages and respective roles that a partnership zon, for instance, there is no reason why data might have and that each party brings to it. acquired in the south would be the same. There are two private sector perspectives that Harmonization has to happen, at least for the I would like to identify, and then ask for com- minimum requirements. But you do have to de- ments. One has to do with a market perspective. Role of International Agricultural Research 101 The private sector views many of the develop- thoughts of different groups of local farmers? ing countries in a more refined way, as emerging Often we have incorporated farmers only at later markets and then within a given country, there stages or using them as a testing ground. are relevant market segments. That leaves by subtraction those countries that Timothy Reeves: The way that CIMMYT ap- are noncommercial and not really within the view proaches its priorities is very much to try to get of the private sector. Even within countries where all of the partners around the table. A good ex- there is a commercial market, there are noncom- ample is that we are thinking of starting some mercial market segments. I think that public sec- work on risk management in southern Africa. The tor participants would do well to dialogue with approach has been to have a number of round- the private sector enough to understand what are table meetings, national programs, involving the emerging commercial countries and what are farmers and the local community, to identify the the market segments within those, as well. risks that farmers face each day. How do they A second perspective has to do with develop- categorize the risks? What are their current lev- ing countries as technology collaborators. From els of managing those risks? And what ways do a private sector perspective, the comparative and they see to better manage risk, both climatic and collaborative advantage that any particular coun- the associated economic risk, and, of course, en- try has as a developer of germplasm is impor- vironmental risk? tant; in the end, while the technology that is being The sort of approach that we believe that we developed is important, the ability to integrate need to adhere to is to have a win-win situa- that into the relevant germplasm is going to be tion. A major emphasis, for example, of our the most important. current work in Africa is to develop maize va- Beyond that, in terms of the more advanced rieties that are more drought resistant and more technologies, I think the private sector is view- tolerant of low-nitrogen conditions. This ma- ing countries in two ways. First, as a group of terial does not depend on inputs; it performs countries that are technology innovators (here I better at the low-nitrogen, low-water end of the think of countries that have large, integrated pro- scale. But when you are able to provide inputs grams, such as Brazil, China, Egypt, India, and to it, it is also better at the top end of the scale. Mexico, and a critical mass to develop technolo- This is the win-win sort of technology that we gies; over the next 10 years such countries will look for. actually be innovators of these technologies); and second, countries that are technology integra- Robert Blake: I am chair of a committee on agri- tors-those that have the ability to take technol- cultural sustainability, and I have some concep- ogy that has been innovated elsewhere and tual problems regarding how to bring the private integrate it into the germplasm. sector together with the CGIAR centers and na- If the public sector and the private sector can tional systems. dialogue on market issues as well as technology You need some leadership to find ways to issues, it will provide the opportunity for better bring incentives to bear, to bring more research partnerships and collaboration. possibilities to the fore at a time when the needs are enormous and we have to move very fast. Charles Jumbe: In reference to Timothy Reeves' How do we do that? Could the World Bank, presentation, we are faced now with a problem for example, be designated to, and provide some where technology was introduced to the farm- monies to, begin to find ways to tap the vast re- ers, but the farmers have gone back to their local sources of the private sector for many things that varieties. These technologies came with some do not have any immediate profit, to bring those additional inputs that the farmers could not resources to "poor person's agriculture?" accept. Somehow we have got to get over that gap What would be the potential of the technolo- between the huge potential of the work being gies that are being developed amid this environ- done by the private sector and the access of de- ment? Another issue that I would like to ask veloping country scientists to it, as well as the about is how do you incorporate the ideas and finances to work. We do not have any time. We 102 Biotechnology and Biosafety need some kind of leadership. Where will we get contrasting incentive with regulation does bring it? up the main issue, which is how can we have public accountability from the private sector? For Derek Byerlee: I am from the World Bank Group, consumers this is the most worrying aspect, and I want to make one small comment on a par- because it is not just a matter of regulation or ticular question that we struggled with during a incentives. recent agricultural research project in India; that is, the relationship between national programs Louise Fresco: I think one of the things coming and the private sector, particularly the multina- forward from this discussion is that the more tional private sector. open the partnership, the earlier you sit around We had earmarked funds to try to develop that a table to discuss this, the greater the chances are collaboration, particularly interchanges between that public accountability will be part of the multinational companies that may have technol- operations. ogy and Indian agricultural research institutions. It is a small step in trying to develop the link- Michel Petit: The issue raised by Robert Blake, ages to be able to access the technology. It is an as I understand it, is what can the World Bank experimental step, because we do not know re- Group do-and is it the proper role of the World ally how it is going to work out. Bank Group-to provide incentives to foster col- laboration? I will try to answer, because I think it Mahendra Shah: I am with the CGIAR systems is important for all the partners around this room review. I would like to ask about what opportu- to understand what the Bank can do; it can be nities we can create for the private sector in this influential, undoubtedly, but there are limitations area? What strategies are we going to have to under which we work. obtain private sector involvement? The Bank is an important financial institution, but bear in mind that most of its resources are in Maria Jose Sampaio: Private sector involvement loans to government. So we are not going to come in Brazil is coming. We do not need to force it, up with subsidies to promote partnership. It is because the market is so huge. The private sec- not an instrument that we are able to utilize. tor is interested, however, only in a commodity What do we do? We make loans to govern- that can produce profit. We want to involve the ments and we, in turn, dialogue with govern- private sector in also working in crops that have ments. So clearly, in helping governments create a social value, and this is the major opportunity an environment favorable to partnerships with and task for a national system, to try to promote the private sector, we can play a useful role. that link. Another instrument is that we provide finan- cial resources to the CGIAR. I believe that what Louise Fresco: I think we ought to focus this dis- the Bank says in the CGIAR is listened to and cussion a little bit back to the issue of biosafety. heard. They do not necessarily do what we say, One of the inferences from what both Maria but they do not ignore what we say. So our role, Sampaio and Fernando Chaparro have said is together with others, in the governance of the that the private sector is, or should be, very in- CGIAR has an impact. terested in developing biosafety regulations in Finally, a small but effective role that we can close conjunction with the government. In the play has to do with our ability to conduct pilot long term it is also to their benefit, not just for operations. We get involved in some activities. the local situation but certainly for the interna- Some of you are familiar with the fact that, for tional situation. This is something to be capital- instance, we administered and are still adminis- ized upon in possibly varying partnerships tering a banana improvement project for which depending on who and what commodity will be we receive funding from the Common Fund for involved. Commodities; we are the implementing agency for that project. Mae-Wan Ho: Just a short comment to bring us We are in the process of exploring with the back to biosafety. I think the previous speaker private sector, which plays a very important role Role of International Agricultural Research 103 in the export banana business, whether they the government, we should be very worried would be willing to fund at least part of that re- about that and make it happen. search. Of course, the World Bank Group is in- terested in the research because it would be of Audience comment: I will address my comments potential benefit also to the growers of plantain to Robert Blake's important point, which is that and cooking bananas and to the workers on plan- there is no time to hang around, no time to waste tations of export bananas, who suffer from pesti- when talking about fruitful and positive partner- cide use. ships. The point is that we are engaged in a pilot One of the big opportunities of marshaling a operation to see if we can develop a partnership public-private partnership relates to genome with the private sector. One major limitation fac- mapping. This is going on already to a certain ing the World Bank Group is that it has never extent, but if we understood a lot more about the done this before. It has to deal with intellectual genomes of all of these crops that we want to property rights. We would have to devise a work with, both the big ones and the small ones, policy, and we are on very tentative grounds. It this would be a real win-win situation. seems like a very simple idea, but it is compli- It would help the companies, of course, and it cated to put it in place. I hope this has given you would also help the public sector tremendously. an idea of what the World Bank Group can do on It would also help in the characterizing of genetic those matters. diversity. It would help, I believe, in understand- ing a little better some of the issues of biosafety. Val Giddings: I am with the Biotechnology In- So that is the one area where we could get to- dustry Organization, and I would like briefly to gether and make things move ahead. The reality address the issue of accountability. is that the competitive advantage for any com- I think there is a great temptation in discus- pany in making a little more progress in the short sions in this arena, when our minds turn to the term will be short-lived, because in the end we issue of accountability, to assume that the only will have this information. The sooner we get means of effecting accountability-particularly there and everyone has it, the better it will be. of large transnational corporations-is through government mandates and formal regulations Louise Fresco: Let me highlight what I think are and laws. the major issues that came across in this meet- I would point out that the most effective, im- ing, which I found very stimulating and very mediate, and sometimes brutal mechanism for important. making accountability a reality lies in the deci- First, there are obviously major differences sions made by the individual consumer at the between national systems in developing coun- point of purchase. If the products we are talking tries. Sam Dryden used the typology of technol- about do not pass that muster, in the face of a ogy innovators and technology integrators. Their relentlessly skeptical and conservative consum- needs are different, but some of the needs are ing public, these products will not survive. Pre- similar. Some of those have to do with the need liminary indications to date are that these for information, for a monitoring system, for products have a bright but still somewhat rocky skills development, and for national capacity future. building. There is also a need to learn from the example of others in terms of regulatory mea- Louise Fresco: The devil's advocate would say sures, and legislation. that the public needs to be informed before it can The differences between national programs, as make a choice, and I think accountability also is well as the experiences within the CGIAR and about information. advanced research institutions in Western coun- tries, can help provide a basis for what is pro- Maria Jose Sampaio: I agree with Val Giddings. posed as a proactive regional partnership, where Accountability will be done by the final con- some regional problems, rather than being solved sumer, but the consumer will need to be very well on a country-by-country basis, could be tackled informed in all senses of the word. If we were on a regional basis. Possibly the CGIAR could 104 Biotechnology and Biosafety play an important role through its bases of net- esting crops but also for crops that are essen- works of research stations according to certain tial to livelihoods. The focus needs to be on ecological zones, which would help harmonize those crops or varieties that may be in the pro- some of the field testing. cess of disappearing. I wonder whether we The other issue that came forward very should somehow visit the idea of a more mas- strongly is accountability. While we did not speak sive effort in terms of mobilizing the world very much about it, another area for possible col- community in the same way that our fellow laboration is the review of participatory ap- scientists from the climate community have proaches to get consumers and society at large done through, for example, the Intergovern- much more involved early in the process of pri- mental Panel on Climate Change. ority setting and understanding some of the regu- The time may have come, in a period where lation measures. agriculture has fallen from grace in so many Last but not least, the plea for more massive urban communities, for urban-based decision- efforts to get biotechnology going in develop- makers to think about a global coalition for bio- ing countries, not just for commercially inter- technology to solve the food problem. Role of Public Policy Panel Presentation Vernon W Ruttan A s we look at the role of public policy, in Safety ,A,cluding support for research; the evolu- tion of intellectual property rights; and The initiative taken by leading researchers in environmental, health, and market regulation it molecular biology and biotechnology in call- is useful to remind ourselves of its importance in ing attention to potential health and environ- the development of the biotechnology industry. mental dangers was unprecedented in any field of science. The 1975 Asilomar Conference, or- Research Support ganized by Paul Berg and Maxine Singer, was the landmark event. The conference concluded More than any other industry, the biotechnology that "there are certain experiments in which the industry in the United States owes its origin to potential risks are of such a serious nature that public support. Prior to the mid-1970s almost all they ought not to be taken given presently research in molecular biology and biotechnology available containment facilities" and recom- had been conducted by universities (with foun- mended a moratorium on such experiments dation and federal funding) and by federal gov- until more secure facilities could be built and ernment (primarily the National Institutes of appropriate protocols developed. Health) laboratories. The initial motivation was By the mid-1980s the legacy of the Asilomar the potential contribution to the solution of hu- Conference had largely been reversed. In the man health problems. The flow of federal fund- biomedical area almost the entire spectrum of liv- ing into biomedical research associated with ing things had been opened to genetic manipu- President Nixon's "war on cancer" focused much lation, with controls remaining only for limited of the early research in the biomedical area. classes of experiments. One observer noted: "It Plant molecular biology and agricultural bio- is quite remarkable how quickly doubts about technology developed later and more slowly. safety receded once it appeared that profits could Progress was inhibited by: (a) the dramatic be made in this new technology." success of plant breeders, drawing on the tech- As this conference indicates, however, safety niques of "classical" Mendelian genetics; (b) ini- concerns have remained stronger in the area of tial skepticism by plant breeders about the agricultural than pharmaceutical biotechnol- claims being made by molecular biologists; and ogy. These concerns include the effects of in- (c) funding constraints in the field of plant troducing transgenic crops on the genetic molecular biology, integrity of wild species and the emergence of 105 106 Biotechnology and Biosafety new and more troublesome weeds and other account for 90 percent of total sales. However pests and pathogens. agrochemical and agrobiological biotechnology, which accounted for only about 2 percent of sales Intellectual Property Rights in 1995, are now the most rapidly growing seg- ment of the industry. Plant patent and patent-like (plant variety reg- The field of nonmedical diagnostics (to detect istration) property rights have evolved slowly chemicals, pathogens, and other contaminants in in the U.S. and other industrial countries since the food supply and environment) is also grow- 1930. The landmark in intellectual property ing rapidly. rights for biotechnology was the 1980 decision by the U.S. Supreme Court (Diamond vs. Industrial Organization Chakrabasty) that extended patent protection to new microorganisms. During the 1990s the market structure of the phar- A major issue that remains unresolved is how maceutical industry underwent a major transfor- broadly life forms can be patented. Recent deci- mation. For much of the postwar period the sions by the U.S. patent and trademark office industry had been composed of large, research- seem to favor broad interpretations. For example: intensive, vertically integrated (from laboratory 1. The decision to grant a patent for gene to distribution) firms. The rise of specialized com- therapy that encompasses virtually all gene putational biology centers is dramatically alter- therapy involving in vivo technique (to Kelly, ing the structure of the industry. It is now composed Palella, and Levine) of a few marketing firms; many small, knowledge- 2. The Abbott-Geneit application to patent ge- intensive biotechnology firms; associated univer- netic markers (of the single nucleotide polymor- sity research laboratories; and the foundations phism-SWPS type). and government agencies that support biologi- Students of patent policy have generally con- cal, biochemical, and biotechnology research. We cluded that broad grants of property rights are are now, however, seeing a wave of consolidation more likely to inhibit competition than more nar- among the major pharmaceutical companies. row rights. Researchers are concerned that the The structure of the agricultural biotechnol- broader grants could inhibit research. ogy industry is becoming consolidated even more rapidly than that of the pharmaceutical indus- Commercial Development try. Four (possibly five) corporate groupings, including Monsanto, Novartis (formed by Ciba- Commercial development of biotechnology has Geigy and Sandoz) and Dow-Elanco, AgrEvo been slower than was anticipated two decades (Hoechst and Sheriny), and Pioneer-DuPont are ago. By the mid-1990s there were still fewer than evolving. 30 biotechnology therapeutics and vaccines on the market. During the last several years, how- Developing Countries ever, new product approvals by the U.S. Food and Drug Administration have increased rapidly. The experience of Japan, which tried to develop Profitability and sustainability of specialized bio- a biotechnology industry based on its dominance technology firms have remained problematic. It in fermentation products, seems to indicate that seems clear, in retrospect, that in addition to a sufficient depth in both basic science and bioengi- potentially promising commercial product, a few neering are difficult to acquire for those who lag "delusion genes" have also been important in behind, such as developing countries. starting up a new biotechnology company. A country may not need to be at the leading In the case of agriculture it is only in the last edge in the development of either biomedical or two years that biotechnology products have be- agricultural biotechnology to make effective use come commercially important (bovine soma- of the technology. China maybe the leading coun- totropin, herbicide resistant soybeans, Bt corn try in the development, testing, and utilization and cotton). Agricultural biotechnology is, at of transgenic plants. Brazil, Egypt, India, and present, a very small industry. Pharmaceuticals Mexico are also making rapid progress. Role of Public Policy 107 Another culture and genetic marker tech- leum prices would be below the levels of the early niques are being used by plant breeders in many 1970s. developing countries. Biopesticides based on bio- It is not possible to anticipate surprises. The technology are being used in a number of devel- future will be different than the past because it oping countries. has not yet occurred! It is not unreasonable to Substantial scientific and technical capacity expect "surprises" in population, health, agricul- will be required in developing countries if they tural production, and the environment. The ca- are to introduce and manage the diffusion of pacity to advance knowledge and technology is these technologies safely and productively. the only "reserve army" available to deal with There will be winners and losers in both in- surprise. Most of the time our research is focused dustrial and developing countries. The health on normal science and incremental technical concerns of the rich, the old, and the fat will con- change. When confronted by surprise, the trajec- tinue to be served, while the institutional reforms tory of technical change can be redirected-but necessary to enable the poor to lead a healthier only if the "reserve army" is in place. life will be neglected. Producers of agricultural My sense is that the biotechnology industry products that continue to be sold as "commodi- stands, in its development, at about the same ties" (undifferentiated maize, oil seeds, and cot- stage as computers in the late 1950s, before ton) will lose while those who produce the higher vacuum tubes were replaced by transistors. No value-added fibers, grains, and oilseeds will gain. one committed to 1950s mainframe computer development anticipated the personal com- Capacity to Respond to Surprise puter. We are just emerging from the first-generation No one in the 1950s, and few in the 1960s or 1970s, stage: doing what we can do by working with would have anticipated that agricultural com- single genes. The second generation will involve modity prices would continue their long-term multiple genes and the modification of plants, decline into the 1990s. Wheat prices have declined animals, and human components. The third gen- since the middle of 19th century; rice prices have eration will involve the modification of whole declined since the middle of the 20th century. organisms. An excessive commitment to avoid- Almost no one, particularly the World Bank ing surprise will also mean that we avoid the Group, anticipated that in the mid-1990s petro- benefits of biotechnology. Panel Presentation Michel Dron T he question of public policy for the safe prove more appropriate in some local contexts management of biotechnology products than those adopted in the North, such as human and processes in developing countries can- or animal vaccination through plants or mosquito not be fully covered within the framework of a bites or high-yield plant varieties needing only short presentation. Therefore this overview will limited agrochemical inputs. leave aside many important considerations and Biotechnology may also partially help to over- focus instead on a small number of features stem- come problems more specific to the South: de- ming from the direct experience of scientists ac- velopment of hardier plant varieties tolerant to tive in this field. It will selectively highlight a few different stresses, maize apomixy avoiding the questions or personal feelings on current debates, annual purchase of higher-yielding hybrid seeds, rather than advance many certainties. When and clonal propagation of rubber trees resistant speaking of biotechnology in general, this over- to South American leaf blight. view will mostly refer implicitly to genetic engi- neering for agricultural purposes, or even more Expansion of Biotechnology in the South specifically to the release of genetically modified organisms. With the world population forecast to double over the next 50 years, there is no way that the Biotechnology for the South required increase in productivity can be reached without a technological breakthrough, which can Biotechnology is obviously not the only solution hardly be envisioned without the intensive use to the development problems of agriculture in of biotechnology. The same reasoning may be developing countries, and such basics as sound applied to sustainability, since the doubling of agricultural practices, conventional breeding, or present food-production levels with current tech- integrated pest management will remain pre- niques would undoubtedly prove disastrous for dominant concerns. the environment. Biotechnology must also be considered from Unique Opportunities of Biotechnology a defensive point of view. Developing countries must anticipate the development of new tech- Nevertheless, it is widely recognized that biotech- niques in the North that may displace some of nology holds exceptional promise for improving their commercial markets: the production of agricultural production and ensuring that such lauric oil from rapeseed will reduce the de- improvements are environmentally sound. mand for copra; aroma culture in bioreactors Biotechnology may provide original and easy- is a threat to vanilla, coffee, cocoa, and orange to-use solutions to general problems that will production. 108 Role of Public Policy 109 Less than 5 percent of all transgenic plant field Policy Issues trials in the world take place in the South at the present time. Public policy is directly responsible for many fac- tors affecting the development of biotechnology. Characteristics of Biotechnology Development To name but a few: training; defining a regula- in the South tory framework that will take into account the advantages and constraints of genetically modi- Not all development-oriented research, whether fied organisms (GMOs) and respect the interests basic or applied, need necessarily be conducted of every partner (seed grower, farmer, agribusi- in developing countries. Conversely, there is no ness, consumer); specifying the respective roles reason not to perform such research in the South of the public and private sectors; creating appro- whenever the prerequisites for efficiency prevail, priate incentives; ensuring public acceptance; and let alone whenever it is imperative. Gene trans- orienting public research. fer may be carried out anywhere, but the same is Governments must direct resources toward not true for selection of traits of interest, confir- research topics that will enable a better assess- mation in the field of the agronomic value of the ment of the ecological, toxicological, or economic plants, or the study of tropical ecosystems. risks associated with GMOs, such as the conse- Safety issues should not be treated more su- quences of induced changes in plant metabolism, perficially in the South than in the North. This is gene flows, or the prevention of insect resistance. both a moral imperative (let us not repeat with Concerning plants, priority should probably biotechnology the counterexample of the use of be given: pesticides) and a global necessity stemming from * In the short term to the application of well- the fact that environmental hazards cannot be mastered biotechnology techniques; to the spe- contained within national borders. cies of major importance in the South, which Safety issues are matters of national sover- are of little concern to the private sector; and eignty. However the implementation of this prin- to a better knowledge of these species ciple is dependent on the capacity of each country * In the medium term to physiological mecha- to exercise its prerogatives, the responsibility of nisms, resistance to pests or diseases, or envi- the technique or product provider, and trans- ronmental impacts border cooperation needs. * In the long term to resistance to salt or drought Not all countries can develop high-performance stress and nitrogen fixation. research in the different fields of biotechnology, The growing appropriation of public-interest but all countries should aim at building up the transformation techniques and genes is of prime minimum level of expertise needed to define their concern for public research and developing coun- own policies (including regulation and monitor- tries. Excesses are becoming apparent. While rec- ing) and carry out a fruitful exchange with for- ognizing the necessity for maintaining financial eign specialists. The first step toward a safety inducements that enable strong private invest- policy is the creation of an endogenous technical ment in these areas, new balances will have to be capacity. found. This will not be an easy task since oppos- ing needs must be reconciled not only between Role of Science in Defining economic interests, but also between national and Public Policy international legislation, cultures, and values. Science currently plays a key role in establishing Overview of National Regulatory Approaches the founding principles of public policies: defin- ing their content, implementing them, and creat- An overview of national regulatory approaches ing the conditions for their social acceptance. It and sensibilities leads to contrasting pictures. is now mainly at the implementation stage that * In North America, which relies on a product- doubts and uncertainties, or even paradoxes, based approach, several million hectares of ge- arise. netically engineered cotton, corn, soybean, 110 Biotechnology and Biosafety rapeseed, or tomatoes were sown this year substantial influence on some governments with overall acceptance from a public that re- and opinion leaders. A large number of coun- jected GMOs until fairly recently. Risk assess- tries have expressed a will to take common ment and regulation controls are carried out stands in international negotiations, most Af- by the same authority. The bulk of legal liabil- rican countries having at one point endorsed ity is borne by the companies marketing the a proposal calling for a moratorium on all products. When hazards are still conjectural, GMO releases. These countries are pressing for guidelines are usually considered more appro- compulsory international biosafety regulations priate than laws. within the framework of the Rio Earth Sum- * Europe has also built up extensive experience mit Convention on Biological Diversity. On the in laboratory research and field trials under entire African continent only Egypt and South stringent regulations and monitoring. Recent Africa have set up effective biosafety regula- major problems in areas that are related in tory procedures so far. Kenya, Zimbabwe, and people's minds (blood contamination, bovine a few other countries have made headway in spongiform encephalopathy-BSE) or ethical that direction. considerations (the first cloning of mammals) The representative of the Group of 77 demands have kept alive significant public distrust, a protocol that would cover research and devel- which has prevented the cultivation of any opment (R&D), transfer, use, and disposal involv- transgenic crop on an industrial scale. Con- ing any biotechnologically altered organism that sumer groups are very sensitive to the issues may adversely affect the conservation and sustain- of traceability and product labeling, which able use of biological diversity. These countries have not yet been fully settled. Aware of these wish to be protected by an international instru- trends, governments have occasionally disso- ment from any harm resulting from imported ciated themselves from the advice of their own modified organisms. They emphasize the need to expert commissions, as was demonstrated consider liability and compensation issues. recently in France in the case of an herbicide- However most industrialized countries prefer resistant maize. Risk assessment and regula- restricting the protocol to transboundary move- tion controls are usually carried out by ments. They consider R&D, domestic handling, different bodies, and governments are more use, and disposal to be matters of national sov- directly involved in legal responsibilities. ereignty not subject to regulation by international * China is engaged in the large-scale growing protocol. of transgenic rice, tobacco, and tomatoes, with apparent priority given to quantitative results, Root Safety Policies in Local Societies little heed to public opinion, and a general lack and Cultures of sensitivity among farmers to environmen- tal issues. Science alone cannot define good practice rules * Emerging countries such as Brazil, India, and capable of universal application. Regarding Mexico have developed a substantial domes- GMOs, for example, and stemming from the tic research base, which provides them with a same range of proven knowledge, the United large absorption capacity. The regulatory sys- States has adopted a more clearly "product- tems that are progressively being set up in based" approach than the European Union (EU). these countries usually follow closely those of Before the EU harmonized its national regula- other countries or regions, mainly the U.S. and tions, Denmark and Spain had developed radi- Europe. cally opposing philosophies from the same data, * Many developing countries have a simulta- the former practically banning GMOs on the neous fear of being left behind by progress- grounds that they involved new types of risks, which will further increase the inequalities and the latter considering that none of their char- between nations-and becoming risk experi- acteristics called for new rules. mentation grounds for industrialized coun- Administrative cultures also differ from coun- tries. Nongovernmental organizations have try to country; while some may enact laws pro- Role of Public Policy 111 viding for preliminary authorizations, others rally subjective and vulnerable to outside influ- may exert a posteriori controls and rely on indi- ences. It is reasonable to assume that an expert's vidual and business liabilities. advice may be formulated differently according More importantly, problems are necessarily to the perceived stakes. For example, will the weighed differently in different countries. Inter- certainties and doubts of a person questioned about national conferences on such global issues as de- "mad cow" disease be expressed in the same way forestation or emissions of polluting gases are if he or she feels the objective is to protect Europe- proof enough that, to some extent, environment ans from a potentially dramatic epidemic, manage and development issues may be in conflict and cattle health, or straighten out the beef market? priorities cannot be the same in different contexts. Scientists acting as experts are too often asked to make decisions when their role should be lim- Role and Duties of Scientists ited to providing knowledge. But they cannot refuse to answer, for where else can politicians To be better prepared to answer the questions of and civil servants go for enlightened advice? tomorrow, scientists must be able to anticipate On major issues expertise should be organized emerging problems or potential crises and trans- in a collective form with debates that feature both late them into scientific approaches sides of the issue, do not hide minority opinions, and clearly distinguish between conclusions Helping Define and Implement Public Choices drawn from scientific certainties and those re- lated to economic or political choices. In areas The experience and evolution of the French such as biosafety, where the need is greatest, Biomolecular Engineering Commission (FBEC) permanent networks or committees might be may be of interest in this regard. Created to pre- set up to discuss potential problems before ac- pare administrative approval for GMO field tion is needed. Many disciplines, including the trials, the commission has expanded its role to social sciences, should be represented in these include early interaction with applicants, with a fora, as should nonspecialists. The conclusions view to improving the quality of the projects sub- should be worth publishing as actual contri- mitted. Capitalizing on a growing body of expe- butions to knowledge, even when still not fi- rience, it has also engaged in in-depth analyses nal. It is more important to create a procedure of the philosophy of dissemination, exploring capable of expanding the scope for scientific some of the possible consequences of a generali- critiques of possible options than to reach pre- zation of genetically engineered specific products mature consensus. in agriculture. The FBEC then characterized dif- ferent scenarios that could enable decisionmakers Increasing Public Awareness to better assess situations with which they might be confronted and help them react more appro- Public anxiety about biotechnology is fed as priately. The goal would then be to offer a much by the progress of science, which simulta- decisionmaking tree for biomonitoring purposes. neously produces and warns about new dangers, as by the feeling that experts are unable to reach Acting as Experts certainties and provide solutions. Scientists have a duty to bring references to Increasingly, scientists are requested to give ex- the public, so that the latter becomes less sensi- pert advice to decisionmakers. The questions are tive to campaigns organized by particular lob- most frequently asked in a form, and with time bies or irrational and demagogic postures. If the constraints, that require experts to express clear permanent expert networks or committees al- answers that go well beyond their own compe- luded to previously were to be set up, one of their tence and what they consider to have been scien- main tasks would be to provide credible bench- tifically proven. Their opinions necessarily stem marks for public opinion and the media, so that from both the state of current knowledge and subsequent decisions might be taken in the most their convictions as individuals, which are natu- transparent way. 112 Biotechnology and Biosafety But popularizing knowledge is not enough. through classical breeding (the border between Individually, or as a group, scientists are also re- "classical breeding" and "biotechnology-assisted sponsible for the image of science in society. They breeding" itself being somewhat fuzzy), or with must take part directly in debates with non- the disruption of an ecological balance through specialists-either decisionmakers (what propor- the introduction of an exogenous organism into tion of a country's representatives who will vote a given environment. Some go as far as to esti- on bioethics or biosafety laws really grasp their mate that the potentially undesirable conse- significance?) or the general public, which can quences of biotechnology products are indeed demand or prevent technically justified measures fewer, due to greater concern for their safety and according to its feelings about their legitimacy. better control of that which is being inserted into the organisms. Acting Ethically Most existing authorization committees have developed a common "philosophy" that can be A number of the points raised above deal with summarized as follows: the ethics of science itself: making scientific con- Assessment of the potential risks associated troversies explicit, clearly indicating the nature with a transgenic plant requires a precise char- of "personal convictions" when providing expert acterization of the plant, the transgene actu- advice, calling for real debate, and maintaining ally integrated, and the transgenic plant's a responsible relationship with the media (an- behavior in its natural ecosystem. nouncement of unproved results, formulation of * The ideal transgenic fragment inserted into a unlikely hypotheses). plant should be short, fully characterized, stable, and restricted to whatever is strictly Safety Issues necessary to obtain the desired effect. o The goal of genetic engineering in agriculture There is no need to elaborate upon why safety is not only to produce more, but also to pro- issues must be addressed with extreme caution. duce with increased safety standards. The main reasons are: the number of unsolved * Some phenomena undetectable in small-scale questions, the extent and dimension of potential tests could be observed under conditions of damage, the irreversibility of some environmen- large-scale cultivation of transgenic plants. tal consequences, our responsibility toward fu- Science frequently proves unable to provide ture generations, and the fact that GMOs ignore in due time the required certainties for a fully national borders. enlightened decision. Conversely, just as too much information may result in confusion, too Precautionary Principle great a perception of potential risks may para- lyze decisionmaking capacities, since research- Everybody will agree on the necessity to take ers will find it increasingly difficult to certify the preventive measures, even before the reality of total harmlessness for human health or the envi- the risks involved is fully demonstrated. How- ronment of a given substance or technique. ever, implementation of the "precautionary Nevertheless the precautionary approach principle" raises many conceptual and practical means seriously taking into account marginal or difficulties. dissident opinions within the scientific commu- The first major debate focuses on the intrinsic nity (for example, the initial appraisal of the Ac- danger of biotechnology processes. There seems quired Immunodeficiency Syndrome, or AIDS, to be a fairly broad consensus within the scien- epidemic)-even the most dubious ones-de- tific community that biotechnology bears no par- spite the risk of creating unjustified anxiety or ticular danger in and of itself, and that risk economic disruption (such as the drop in con- assessments must be carried out exclusively on sumption of red meat in Europe following the the products resulting from its use. "Traditional" BSE crisis). techniques may present the same kind of risks, It must be borne in mind that most modern or associated, for example, with the toxicity or traditional human activities or techniques that allergenicity of a new plant variety obtained might have an impact on the environment would Role of Public Policy 113 be banned if the precautionary principle were to spread use of more efficient techniques; for ex- be strictly applied, demanding that proof be ample, loss of more traditional agricultural know- given of the nonexistence of any kind of risk in how, reduction of biodiversity, disruption of the long run, or focusing exclusively on disaster ecological balance, or the emergence of new re- scenarios. The very high resulting costs would sistance in pests. These problems call for collec- be considered unbearable. The same excesses tive management of risks over long periods of threaten biotechnology. One must therefore re- time on a supranational level. vert to the notion of "tolerable risk," which raises new questions: Specific Safety Issues in the South * How can we define "tolerable risk" from the social or legal point of view? Jurisprudence is The nature of the problem is not different in far from being settled in any country. It has North and South, but coping with it may prove evolved considerably in recent years in a con- more difficult in the latter, due to less develop- text of sanitary and political disaster and emer- ment in some key areas. gency (AIDS virus-contaminated blood, the * Scientific knowledge is often more limited with BSE epidemic), which may not be the most regard to tropical plants, microorganisms, and appropriate framework for due consideration ecosystems. Plant species such as cotton, rice, of environmental issues. soybean, maize, or vegetables, which are of * How can we foresee totally unknown dangers? common interest to North and South, are al- Chlorinated fluorocarbons (CFCs) were widely ready being genetically engineered and culti- used for decades before the hole in the ozone vated in large quantities in industrialized layer was discovered and attributed partially countries. Pressure will be strong to have simi- to the very chemical inertia that led them pre- lar seeds adapted everywhere, even though viously to be considered the safest of all gases. much less will be known about dissemination * In our societies who will bear the costs of pub- risks in other environments. lic interest? Total herbicides are very limited * Many countries will lag behind for some time in number and bound to disappear with the in their domestic capacity to define their own development of resistant varieties through ge- regulatory systems-even when inspired by netic engineering. Will the risk of escape of foreign experiences-and monitor their imple- herbicide-resistant genes lead to the preserva- mentation. We have drawn up a proposal to tion of a few total herbicides? Who will make alleviate this constraint as an appendix to this the decision? How will the proprietary firms contribution. be compensated for their loss of income? * The large-scale use of new techniques will raise questions of compatibility between individual Internationalization and collective interests, which may prove more difficult to reconcile in places where the aver- GMO release agreements will increasingly tend age technical level is lower. This may be the to be granted by groups of countries, if only be- case for good agricultural practices aimed at cause international scientific cooperation will preventing the appearance of new resistance make risk assessment procedures more similar among insects. to one another. Some people even predict that * Generally speaking, it is likely that regional some biotechnology products may be declared cooperation should be promoted to make up intrinsically safe by internationally recognized for the lack of domestic expertise. institutions and therefore receive simultaneous * Last, without neglecting either the absolute ne- worldwide clearance. But paradoxically, environ- cessity of acting with extreme care or legiti- mental dangers should, in many instances, be mate national sovereignty concerns, there is a appreciated for each specific ecosystem on a fear that biosafety matters may, in some much smaller scale than that of most countries. instances, serve as excuses for two harmful, Most attention has focused thus far on the in- opposing attitudes: the refusal of high-perfor- dividual risk presented by new products. But mance products or processes for want of com- other types of risks could be attached to the wide- plete safety assurances, on the one hand, and 114 Biotechnology and Biosafety the acceptance of dangerous practices by in- to pressures and may become instruments in competent authorities on the other. power games. Both the quality of scientists' an- swers and their freedom to research could be pro- Conclusion tected through a collective organization of appraisal functions. Risk The role of economics and social sciences to help make and legitimize decisions in uncertain There is no such thing as "zero risk." Therefore, environments must not be underestimated. a "tolerable level of risk" has to be assessed. The acceptance by a community of a given level Reasonable Management of Precautions of risk will depend on the perceived potential benefits, the risk of nonintervention, and the Science will be unable to provide clear answers local situation. The "precautionary principle" to some essential problems for a considerable bears no meaning if its most rigorous applica- time. This uncertainty must not be used, deliber- tion is not restricted to relatively exceptional cir- ately or not, to prevent decsionmaking. We must cumstances. accept a continuous evolution of risk assessments and a gradual approach to regulatory require- Evolution of Scientists' Responsibilities and Role ments that will improve the basis of further decisions. Science is bound to create anxiety through the very questions and doubts it raises, but the rate Primacy of Politics of increase of proven knowledge is not suffi- ciently rapid to provide decisionmakers with the Biology is obviously not the only discipline con- desired answers in due time. cerned about biosafety matters. Industrial engi- Collective decisionmaking is becoming increas- neers, economists, lawyers, political scientists, ingly dependent upon scientific activity, and scien- and many others have to cooperate with biolo- tists now have to act more and more as go-betweens gists, since risk management clearly has ecologi- between knowledge and decision-making. This cal, economic, and social dimensions. But even situation grants them considerable influence, if only all these experts together (fortunately) cannot through the public expression of mere speculation dictate the choices of executive authorities or so- capable of upsetting entire industries. ciety in general. Governments, which are called upon to enact In a democracy the final choices on matters regulations, solve environmental crises, and cope affecting society are political. It is therefore the with all kinds of risks, are steadily becoming sci- duty of society, or its representatives, to ensure entists' main "customers." Many social protago- that they are made in the public interest and to nists, including the numerous lobbies that try to offer solutions that most people will consider influence policies or public opinion, have a simi- reasonable. lar need for scientific expertise. This leads to the We conclude by paraphrasing a famous state- increasing meddling of society as a whole into ment: "Biosafety is too serious a matter to be left scientific affairs. Scientists are being submitted to biologists." Role of Public Policy 115 Annex. Proposal for the Establishment of an International Biomolecular Engineering Commission for Tropical Agriculture The countries of the South cannot refrain from specific tropical environments. The docu- the use in agriculture of genetically modified or- ments might result from syntheses made by ganisms (GMOs), which may bring original, ap- the members of the commission themselves, propriate, and powerful solutions to some of their from studies on the state of current knowl- needs to increase productivity, limit inputs, and edge commissioned from outside experts, or achieve sustainable development. from the results of specific research, which However many of them will not have access could be initiated on issues insufficiently ad- in the near future to the domestic expertise that dressed. In all cases the resulting conclusions would enable them to define their own policies would be subject to rigorous debate within the regarding biosafety matters with full knowledge international scientific community before their of the case or to implement their own regulatory formal adoption. The commission could also mechanisms without outside help. act as a permanent forum in which similar Countries of the North have begun to accu- national bodies might publicly discuss their mulate significant expertise, part-but not all- experiences. of which might be transferred, since their * The authorization of GMO releases for research specialized commissions know little about tropi- or business purposes. Projects might be re- cal cultures or ecosystems. ferred to the commission by governments, re- Therefore it is suggested that a study be car- search institutes, or companies. Beyond formal ried out to determine under what conditions an approval, their study would provide the op- international biomolecular engineering commis- portunity for in-depth dialogue between the sion for tropical agriculture might be established, project initiators and the commission, in or- the advice of which might be requested by gov- der that safety requirements might be better ernments on a case-by-case basis on the follow- accounted for in trial design or full-scale ing topics: operations. - General policies regarding GMOs and regu- One of the ways to reach these goals might lations regarding releases; the mandate of be to establish a small, permanent secretariat the commission might be extended, if so de- close to an existing institution. Its task would sired, to encompass the release of all exog- consist of mobilizing an international network enous organisms. of experts, both scientific and nonscientific, * Definition of technical references regarding who would commit themselves to a minimum the assessment of different types of risks in annual availability. Panel Presentation George A. Lloyd F irst and foremost, I must acknowledge the spective of how correct they may be. Our major contributions of technology in answering concern, therefore, is to ensure that sufficient safe- the vexing problems of uncontrolled popu- guards are put in place when introducing new lation growth, nonavailability of sustainable technology. land, and growing food demand. At the same We have to accept that biotechnology is al- time one cannot overlook the environmental con- ready having an impact on the marketplace and cems and fears of unknown safety implications will play an ever-increasing role in the econom- when introducing new technology. ics of the world. Our focus must now move to History has shown that it is very difficult to addressing the major concerns of health, environ- implement scientifically proven remedies if mental issues, ecological concerns, ethical con- they come up against financial considerations. siderations, and biosafety. While the risk remains, A good example of this is something that af- the role of public policy should be to ensure that fects people from my region very directly; that sufficient safeguards are put into place. These is, the failure to implement the many resolutions safeguards must contain regulatory mechanisms of international agreements on anthropogenic gas that include enforcement through legislation on emissions. an internationally accepted basis. As a result one approaches new technology It is imperative that the regulatory framework with a certain amount of trepidation. The main ensures safe, expeditious, and economic devel- fear is that if technology is not well managed, opment and use of such products and processes the solution provided may become the root cause to be developed. This will enable a country to of other, often more serious, problems. Exami- capture the present and future benefits of nation of this phenomenon leads to the belief that biotechnology's introduction of new products. we appear to be treating the symptoms and not To achieve this, there is a need to ensure that the root cause of many problems confronting national regulatory frameworks and interna- mankind. Inaction is having a devastating im- tional frameworks are similar. We have been told pact on the environment. The political will to act that 169 countries have already signed the Con- appears to be lacking. vention on Biological Diversity. The negotiation With the advent of information technology, of protocols, therefore, provides us with the last decisionmakers are more apt to respond to forum in which to address the fears expressed public opinion polls than to correct, scientifi- by the different lobbies. cally based studies. If any policy is to have a There is undoubtedly a need for an interna- meaningful impact, we must take into consid- tional watchdog to ensure compliance. Some of eration the fact that politicians will not take a the functions of such a watchdog should include stand on the side of unpopular decisions, irre- control of introductions, field testing, import, and 116 Role of Public Policy 117 export. This point I particularly address to some national partnerships and commercial credits of the smaller countries that would find it very through governments to the private sector should difficult to finance some of these controls. be encouraged. The developing countries have a need for new Markets and economies must be opened up. technologies, particularly those which are scale- Impediments restricting trade, such as border neutral, to combat hunger. Unfortunately, bio- tariffs and levies, should be gradually done away technology is only one of the tools in this fight. with. Intellectual property rights and patents The developed world's governments must be must be recognized and enforced. Planning made to realize that the real enemy is not in should be on a regional basis. The principle of the trenches of some foreign country where comparative advantage should be exploited to they spend nearly one trillion U.S. dollars on the fullest if we are to avoid the white elephant military activity. The new war is being fought projects of the past. This includes any biotech- in laboratories that are trying to find solutions nology projects that might be undertaken. to the growing problems of poverty and hunger. The world has an uphill battle if it is to har- Technologies such as biotechnology will help in ness the full promise of biotechnology for the this battle. However we must convince the world benefit of the world's poor, the environment, and that we are losing the war against poverty and the safe management of products and processes. that the casualties are much higher than in all No doubt this is another weapon against hun- other human conflicts. ger, and its use should go a long way in combat- I must also address the imbalances between ing this scourge. the haves and the have-nots, which is growing Public policy should have at its core the con- and will continue to grow until an equitable form cept of environmentally sustainable develop- of trade is established. The most well-intentioned ment, based on the idea that it is possible to policy is doomed to failure as long as these im- improve the basic living of the world's growing balances exist. There is a need for the world to population without necessarily depleting the change the way in which policies are made, be- world's finite natural resources. At the center of cause the whole world is influenced by the deci- this policy should be the belief that emerging bio- sions and actions of each of its parts. technologies offer novel approaches for striking Technological solutions can be found in the a balance between development needs and envi- developed world for many of the developed ronmental conservation. world's problems. However, these lead to a false At the same time a wider diffusion of biotech- sense of security. The climatic changes that are nology is essential to giving the world access to occurring may not have an immediate negative its positive attributes. Since most of the world's impact on the industrialized countries, and may poor come from countries whose economies are even appear to have some beneficial effect. The not in a position to finance much of the research problems also often appear remote. Most of the required, innovative finance mechanisms should negative effects are taking place in the less-de- be explored and built into policy. Without such veloped tropics, where climate change is com- mechanisms most developing countries will not pounding existing problems. be able to build the infrastructure to acquire, ab- Poverty and ignorance often mean that mor- sorb, and develop the technology, nor will they tality rates are high. Therefore, large families be able to build up local scientific and techno- appear to be the answer for survival, labor, and logical competence. There is a need to put in place security in old age. This further compounds the mechanisms for technological transfer, training problem. The developing world must also take of scientists, creation of international partner- stock, and unpopular decisions will have to be ships, and transfer of spillover technology. made. Here, also, a new approach is necessary. The approach in the developing world may Interregional trade must be encouraged. The have to include use of existing national scien- developing world must make itself attractive to tific research centers. However, to achieve self- entice investment. Reliance on aid cannot and sustainability over the long term, it may be should not be taken for granted. Instead, inter- necessary to rethink the modes of financing, as 118 Biotechnology and Biosafety most will not be high on the list of government ments and organizations representing stakehold- spending. ers at both the national and regional levels. I am It maybe possible to innovate and develop own- convinced that, given the right environment, Afri- ership and responsibility-sharing between govern- can private business will rise to the challenge. Discussion Moderator: Per Pinstrup-Andersen Per Pinstrup-Andersen: I would like to hear level needed in that country will be a little dif- comments by some of the panelists regarding the ferent from the ones that we might have in Eu- potential tradeoff between biosafety and poverty rope, where we have the luxury of imposing and hunger. In other words, whose biosafety are much more stringent regulations. we looking after? Whose standards are we us- If you look at the world level, you might say ing, and do poor and rich have the same accept- that in China there is far less stringent regula- able risk levels? tion. It is probably important for them to have a It seems to me that this is one of the issues that more flexible regulatory system, but danger has this session should address. If we set standards no frontier and everybody is concerned. So it is for "the rich, the fat, and the old," then it is pos- really difficult to know how much international sible that we are really not looking after the society has to be involved in this issue of regula- biosafety of the many millions of people who are tory issues in one country and who has to decide trying to feed their children, but are unable to do on that. so, by setting standards that are so high that we I think this is the reason why you are propos- are plucking out of the market opportunities for ing an international panel that will involve all using modem science to benefit poor people. the different people who are concerned in it, but Would any of you like to comment on these respect national sovereignty, because they are tradeoffs, what kind of policies we need, and how deciding what they need. we avoid the prediction made by Vernon Ruttan that we are going to run this show the way we Vernon Ruttan: If we are interested in the health run many other shows, namely that the rich are of the poor, then we do not need to wait for going to benefit and the poor are going to lose? biotechnology. When you look at new pharma- ceutical products coming out of the biotechnol- Panelist comment: I think the biosafety level in ogy industry, they are not the kinds that are going relation to the need of different populations, the to reduce infant mortality or raise life expectancy. poor compared to the rich, is an area where we They are valuable to the limited numbers of must ask: Who will decide? people who are able to pay for the products. If That is why countries have national sover- directed to areas largely unattractive to the pro- eignty to decide what biosafety rules they need. prietary products and whose use would have to They need to have information and, of course, be substantially subsidized, one could visualize we have to put together all the information. When advances in biotechnology making important they get the information, they will decide what impacts, but not being profitable. they need in relation to their specific issues. For The problem in the U.S. is that we find it much example, if there is a need for food, the biosafety easier to look for silver bullets than to make the 119 120 Biotechnology and Biosafety institutional reforms that would go a long way dent and multidisciplinary, with the possibility toward improving the health of the poor. of enhancing specific efficiencies in its standing membership with ad hoc members as necessary. Per Pinstrup-Andersen: Let me turn back to the However it was very difficult for them to get specific proposal that is before us, Michel Dron's people to come to them with requests for assis- proposal for a committee. Does anybody have tance for a whole variety of reasons related to comments on that proposal? Is that what we need governance, responsibility, and to the sovereignty at this point? attached to decisions about safety for products in individual countries. Audience comment: I think this committee These sorts of problems need to be overcome would only be useful if it were truly indepen- in order to make this kind of committee work dent, interdisciplinary, and comprehensive, so effectively. Perhaps the World Bank Group could that there would be an inquiry into the risk as make some progress in this direction by provid- well as assessment of the benefits; that is, how ing such a committee-based service to its the technology can be used safely and to the ben- members or to states that take out loans for bio- efit of all, not only the fat and the rich. But other technology products. But there are a whole host than that, I think it will be yet another window of practical problems of that sort that will have dressing exercise. to be overcome before such a committee could have the confidence necessary to elicit requests Val Giddings: I do not like to be argumentative, for help that result in the kinds of decision-facili- but I have to take at least partial exception to the tating exercises we hope for. suggestion from Vernon Ruttan that we do not need to wait for biotechnology to help the poor. Vince Morton: I am a private agricultural con- This is certainly true. There are many things that sultant, and I would like to address not so much could be done-but have not been done-that policy but implementation. do not rely upon biotechnology. But it is a mis- At the present time biotechnology is being in- take to lead others to infer that important health troduced via the seed. I would suggest that one improvements cannot be accomplished with the of the things we have to address is how to get use of biotechnology. the most out of seed and emergence-one seed I mention a couple of examples that should be in the ground, one plant emerging-and that in- well known. There have been a number of recom- cludes getting it into the ground, getting it to the binant hepatitis vaccines produced in the recent farmer, and maybe, as UNIDO has done, offer- years. Hepatitis has been a scourge, especially in ing seed treatment. But this certainly will have developing countries. This is an unprecedentedly to be addressed if biotechnology is introduced effective way of solving a serious problem. into developing countries, because it will be There are vast possibilities for improvements through the seed. of human nutrition via the improvements in various commodity crops, or what is coming Vernon Ruttan: Many of the things that we are to be known as "nutraceuticals." There are all discussing now were discussed 20 years ago in sorts of possibilities for meeting presently connection with the Green Revolution. Issues of unmet nutritional or health needs of people in equity, of whether poor farmers could afford it, the developing world to benefit from biotechnol- whether short, stiff-strawed varieties would keep ogy innovations. farmers from feeding straw to their buffalo, a There may be some merit in the committee whole set of issues. Most of them were wrong. idea, but there is also a problem. The Stockholm Farmers in a municipality in Central Luzon, Environment Institute has had over the past de- in the Philippines, where the IR6 was first intro- cade a Biotechnology Advisory Commission to duced, adopted it faster than Iowa farmers perform many of the same sorts of functions now adopted hybrid corn, even though they had to being suggested for the committee we are talk- pay for seed, because the cost of the seed was so ing about. The Commission was largely indepen- small relative to increment and use. Role of Public Policy 121 If we introduce biotechnology in that form, I George Lloyd: I wanted to respond to the ques- think it will be adopted very rapidly. If it is intro- tion about introduction of biotechnology through duced in forms that involve a technology fee, dif- seed. Even in the least developed countries fusion will occur more slowly. I always remember mechanisms for supplying seed to the most re- the farmer in the Philippines with a sixth-grade mote areas actually exist. education who, when asked whether he would In Zambia we have what is called an outgrow- adopt something, said: "I am going to push my er scheme. Normally this entails commercial pencil first." Farmers are pretty good at pushing farmers actually having on their periphery their pencils, even small-scale farmers. smaller-scale farmers whom they look after and Peasant farmers all over the world are tied into supply inputs to. And vice-versa, the small-scale the market already. Only in extremely remote farmers market their produce back through the areas do you find farmers not tied into the mar- commercial system. We have found that even the ket. When technology is made available, it is in- smallest of farmers actually buys hybrid seed if credible. If you find a new technology being it is available and is given to them on time, and introduced but not being adopted, ask what is that they can actually see the benefits derived wrong with the technology. from using hybrids. Recommendations for Action Synopsis Wanda Collins T his Associated Event was held in con- technology and biosafety and make it very diffi- junction with the Fifth Annual World Bank cult for us to address those issues dispassionately. Conference on Environmentally and So- 2. Biotechnology is here, will continue to be cially Sustainable Development. The focal point here, and is proceeding slowly but surely for- for the event was the recently released Bioengi- ward. neering of Crops: Report of the World Bank Panel on 3. Biotechnology-derived solutions are part of. Transgenic Crops, prepared under the leadership a strategy to solve problems. They may or may of Dr. Henry Kendall. This particular event was not become the major part of a particular solution organized to focus on the question of biosafety. to a particular problem; agricultural biotechnol- We were exhorted by World Bank Group Vice ogy products must be adjusted for regions and President Ismail Serageldin in his opening speech for crops. to disentangle ourselves from the other contro- 4. Many biotechnology tools of use in agricul- versial issues surrounding the application of bio- ture are uniformly seen as helpful (for example, technology and focus on the issue at hand. marker-aided selection and diagnostic tools). We have had wide-ranging, provocative dis- 5. There are risks inbiotechnological solutions, cussions over the past two days. During these as is the case with any other solutions (including discussions we demonstrated again and again plant-breeding methodologies that do not use how difficult it is to look at a single issue in a molecular techniques). There are no zero-risk solu- dispassionate, unbiased way and to disentangle tions, but we do not agree on the level of accept- it from other issues. But it was equally obvious able risk or who should make this determination. that there is broad agreement on many points, 6. There are also benefits; and there are poten- and I hope I can summarize them without bias. tially undesirable outcomes in food issues, health, There are areas where consensus or agreement and public safety if available technology is not was not possible, but I believe we have given a used to solve intractable problems. clearer focus to those areas where our opinions 7. There are dangers in unduly lax or unduly continue to diverge. I will try to summarize these stringent regulation. In the U.S., regulations gov- as well. erning biotechnology products have been much more rigorous than those governing equivalent Biotechnology: Areas of Agreement products developed using nonmolecular tech- and Lack of Agreement niques. 8. There is genuine lack of agreement over the 1. Related issues such as ethics, morals, and potential benefits of biotechnology. Neither the worldviews are entangled with the science of bio- eternal optimists nor the eternal pessimists have 122 Recommendations for Action 123 had their dreams realized! In the long term, how- the likely outcomes in high-risk situations? ever, benefits will emerge through market forces. What additional risks do individual users face The resulting level of benefits will be an aggre- at the farm level (opportunity costs and direct gate of failures and successes, which may or may costs; probably mainly an economic issue)? not allow an evaluation of the value of the tech- What risks do consumers face in choosing the nology itself. product and how do they recognize those in- dividual risks? Two issues are involved: What Must We Do? 1. Food safety is not, for the most part, an * We must, insofar as possible, separate the is- individual choice. There are national guide- sues and view biosafety dispassionately. lines, rules, and regulations (such as those * We must be unbiased in attributing the effects of the Food and Drug Administration in the of biotechnological solutions. For example: U.S.) that determine the safety of foods; monoculture exists; added biotechnological unsafe foods are not allowed on the mar- solutions may exacerbate the problems of ket. In countries where the opposite extreme mono-culture, or they may be totally neutral, is the case (there is no legal framework for or they may contribute added stability and di- food safety) then it is impossible to address versity. Only when we can attain that unbiased relative food safety questions without the view can we ask if our scientific information appropriate reference points from which to is such that we have a sufficient database to make comparisons. say that a biotechnology-derived risk is no 2. Food choice is a matter of choosing larger than a nonbiotechnology-derived risk. among safe foods, or foods that are allowed * We must clearly and scientifically define the by a ountry to be marketed. The consumer risks in categories such as: can and should be informed through label- 1. Gene flows to wild plants (ecological risks) ing the contents of a food choice. Labeling 2. Development of new and more virulent has little to do with safety and everything pathogens (viruses) to do with informed choice). 3. Effects of plant-produced insecticides (Bt) 4. Ecosystem damage (transfer of DNA to * We must also provide science-based mecha- other organisms). nisms to monitor relative risks; for example, * We must clearly and cautiously define the rela- how does a country follow the changes as tech- tive magnitude of the risks within categories; nologies are implemented and continue to not generally, but crop-by-crop and region-by- make informed decisions as information ac- region, and based on available, sound scien- cumulates? tific data, not speculation. * As possible risks are being monitored, we must * Choices will be made about relative risks. We provide as much scientific underpinning as must leave choices about acceptance of those possible to the understanding of how to man- risks where those choices will be made (for ex- age the risks. Risk management is not a sci- ample: at the national government level, will ence-based activity; it is pragmatic and we or won't we allow the technology; at the resource dependent. But we can provide sci- individual client level, will we or won't we use entific information that allows the best deci- the embodied technology; and at the indi- sions to be made. vidual consumer level, will we or won't we * We must understand the complexity of bio- use this product of the technology). These are technology and biosafety within a develop- political or personal choices and are seldom ment and international context; that is, based on scientific evidence alone. economically, distributionally, and scientifi- * We must, however, provide science-based cally. mechanisms by which choices of acceptance It appears that throughout the two days of the can be made in an informed way. For example: Conference on Biotechnology and Biosafety, these What magnitude of risk is acceptable by a gov- positions were agreed upon by participants from emnment in accepting the technology? What are all perspectives. 124 Biotechnology and Biosafety The most basic point of disagreement con- tion, both for better management practices and cerned the relative magnitude of the risks posed to avoid the paralysis associated with unwilling- by the use of the tools of biotechnology and the ness or inability to make decisions. resulting products. To a lesser extent, there was divergence of opinion on the subsequent man- Opportunities and Needs Are Evident agement of risk. Reconciliation regarding the magnitude of the risks will only occur through There is much potential for biotechnology; the sound science directed towards specific solutions vastness of its potential is unknown to us, and to specific questions. It will most likely be based we have barely scratched the surface of its capa- on a matrix of crop-x-region solutions rather than bilities. The question posed was: "Is that poten- generalized, speculative, all-encompassing state- tial being fully exploited for small farmers?" ments. There was agreement that an element of These sessions of the conference reinforced the caution must be included. critical nature of effective partnerships. Discus- Scientific data are already being collected; in sion focused on the roles and complementarities some cases years of data have been collected. of the public and private sectors and the neces- Some of these data point to very safe solutions to sity of finding a balance that will allow the pri- very difficult problems, such as transferring plant vate sector to reach its financial objectives, while genes for resistance to devastating diseases. Some also providing opportunities to contribute to the data point to potential magnitudes of risk, such public good. What are their incentives? as biotechnology resistance in insects. As was There are major differences between national stated during the conference, there is not yet suf- systems to address the issues associated with ficient, large-scale experience with management biosafety. They have some similar needs (for ex- of resistance. However at the present time no data ample, information, monitoring, skills, good prac- point to obvious adverse results to human health tice examples), but they also have differing needs or to the environment from any of the biotech- (for example, for internal processes and experi- nology products on the market. ences in each country and site-specific determi- Are these data derived through reductionist nations of biosafety risks). Capacity building approaches? Yes, and they are appropriate ap- within national systems of developing countries proaches. However the value of more holistic was seen as a particularly critical necessity. agroecological approaches must be incorpo- The value of proactive regional partnerships rated in the translation of these data to effec- for efficiency was recognized during the confer- tive criteria for decisionmaking. They must be ence, as was the potential value of the interna- utilized in a similarly appropriate, broader con- tional agricultural research centers of the text that takes into account the complexities of Consultative Group on International Agricultural farming systems and farmers' choices, needs, Research. Regional cooperation was seen as be- and preferences. ing of overriding importance in assisting in the The overriding factor is that the scientific data development of competence in developing coun- must be very carefully scrutinized and consid- tries, particularly in conducting biosafety reviews. ered in order to make science-based, informed decisions and provide sound advice. Moving Forward Is Necessary However, in trying to resolve this divergence of opinion on relative magnitude of risks, we Positions and points were identified upon which must not forget that risk has to be weighed all agreed, at least implicitly. On other issues, against potential benefit; for example, the case which are now more narrowly focused, disagree- of black Sigatoga in bananas-where no other ment remains. How do we address those issues? solution has yet emerged and both smallholders Continuing dialogue is needed to arrive at con- and the environment are suffering-and late sensus opinions on the magnitude of the risks blight of potato, the most economically devas- associated with the use of biotechnology. This tating disease in the world. The issue comes down should involve very careful scrutiny of scientific to information and the proper use of informa- evidence, identification of gaps in the research Recommendationsfor Action 125 that are critical for immediate decisions, and in- 1. To promote mutual understanding and terpretations that are unbiased and realistic. make progress, concrete projects and concrete Eventually viewpoints will begin to converge, actions must be a result of this event. whether based on scientific data or on simple 2. A comprehensive inquiry is needed, includ- experience. ing socioeconomic impacts of biotechnology-de- We must move forward, in the words of Miguel rived products. Altieri, to allow the partnerships to develop, get 3. Research should be supported in specific into the field, work together, and provide solu- areas. tions to maximize the potential of biotechnology 4. Safe and legitimate uses of biotechnology in complex systems. should be recognized (for example, in marker- These steps are necessary to build on those ar- aided genetic selection), and its power as a tool eas where agreement was identified and build of research should not be undervalued. effective partnerships to address those areas 5. Information exchanges should be supported where disagreement still abounds. It is essential, so that both successes and failures can be made in the words of two participants, to move from a known. "dialogue of the deaf" to a dialogue of "mutual 6. Post-market monitoring of products is de- learning." sirable. 7. Support should also be given to alternative Suggestions by Participants approaches to biotechnology-derived solutions; that is, those which emphasize peoples' liveli- As a result of the two days of discussions, sev- hoods and the conservation of biodiversity, eral participants offered suggestions for future agroecological approaches. actions. No mechanism was in place by which 8. Another independent study should be con- these suggestions could be agreed upon by the ducted to further explore the issues raised dur- entire group, so they are presented here as indi- ing this event and on which opinions continue to vidual suggestions. diverge. Discussion Moderator. Alexander E McCalla Miguel Altieri: I think we all agree from the syn- mating the magnitude of risk. I am sure that is opsis that we are calling for a more informed right. It was also pointed out that this had to be approach to risk. We want to avoid any ap- balanced against the potential benefits, but I proaches in biotechnology that are going to un- would like to highlight that we have an equally dermine the objectives of the agenda-reducing basic disagreement about the value of the poten- poverty and increasing food security and envi- tial benefits. On one side, we perhaps overstate ronmental protection-by emphasizing genetic them wildly. On the other side, we perhaps mini- uniformity or reducing the possibility of devel- mize or say they are not really benefits at all. The oping more sustainable systems. So if biotech- variation is at least as great as with the disagree- nology can be geared in that direction, I think ment about risk. that mutual understanding is already happening. Since this session is a call for action, I think we Mae-Wan Ho: I have a list of five recommenda- need to stress that the only way we are going to tions for action that might be constructive. The be able to come up with answers and an integra- first is to have a broad, comprehensive inquiry tion of approaches is by getting into concrete into the risks involved, including socioeconomic projects. I would like to see three or four pilot impacts. We really need to support targeted re- projects in which we integrate the different ap- search into some of the risks that I and others proaches of biotechnology that are offered by in- have highlighted-such as horizontal gene trans- dustry, the Consultative Group on International fer-in order to develop rational safety assess- Agricultural Research (CGIAR), nongovernmen- ments and regulations, because in the opinion of tal organizations (NGOs) and universities, obvi- some of us, these do not exist yet. ously with the participation of farmers. Second, this is an opportunity to consider the In that regard we could take a small farming safe and legitimate uses of genetically engineered system in which one portion is put into produc- biotechnology; for example, using markers to aid tion with transgenic crops or biotechnologically in plant breeding. I do not undervalue the power appropriate crops, and the rest maintained in a of the technique as a research tool. It is poten- diversified mode. That way we can start integrat- tially very valuable. ing the two approaches, avoiding the possibility Third, there should be support for information of erosion of genetic diversity and maybe pro- exchange and total transparency, so that failures viding refuge and examples for delaying resis- as well as successes will be completely transpar- tance development. ent and available to the public, in order to en- courage public participation. Timothy Roberts: One conclusion of the synop- Fourth, we should support post-market moni- sis was that we had a basic disagreement on esti- toring. This is very important; in order to do so, 126 Recommendations for Action 127 we really must have segregation and labeling. If development of competence based upon two com- we do not do that, it means we are not taking ponents, training and information availability. risks seriously at all. My last point is a plea for support of alterna- Donald Winkelmann: As I understood the ob- tive approaches, such as those discussed by servations about food safety, it was describing Miguel Altieri, with emphasis on livelihoods and the circumstances in the U.S., where we know that conservation of biodiversity as an ecological ap- if food is in the stores, it is safe. It seems to me proach, which is in contrast to the reductionist that there was some discussion about food safety approach. in countries that do not have these kinds of regu- lations, and I wonder if the synopsis should say Val Giddings: Like one of the earlier commenta- something to that effect. tors, I had singled out one area of the synopsis Second, to the extent that we encourage indi- where I was not sure I agreed, which was in the vidual nations or regions to make judgments invocation of significant disagreement over the about acceptable levels of risk, implicit in that is magnitude of risk involved. Let me illustrate with the assumption that there will be no spillover one example. from that region into other parts of the world. So My eight years with the U.S. Department of what might be perfectly safe and perfectly toler- Agriculture doing environmental assessments for able in one place, were a spillover to occur, might these types of modified crops was marked by be discovered to be unacceptable-in the sense repeated disagreements with one of my closest that we have been using that word-in other parts colleagues. We would try to define the nature of of the world. This occurred to me because of the our disagreement. Ultimately, we would reach strength of that particular recommendation. the same conclusion: we agreed on the quantita- tive value of the risk, but differed in the way we Alexander McCalla: The point you are making judged whether or not it was acceptable. is that with each individual country making its I think that illustrates the need for making risk own set of rules, there can be an influence on the decisions based on analysis of relative risk. This freedom with which goods and products move point could be stressed more in the synopsis and in international trade and whether or not these serve as guidance to future consideration of these kinds of activities can become technical barriers issues. to trade. That is an issue that I did not hear in I also agree with Miguel Altieri that the real this discussion, but is worth raising. test will come as we move into the consider- I got the sense from the synopsis and the dis- ation of concrete proposals. This means that cussion that there is a general recognition that more donors will have to be galvanized to come the challenge ahead of us is very large, very com- up with more money to support worthwhile plicated, and will have no single solution. The projects. solution will call for the best of our capacities, no matter where they come from, no matter what Desmond Mahon: What I got out of the discus- paradigm they use, no matter what way they go sions of the last two days was the overriding at this, to address the overall issue. importance of the regional perspective in both I sense an agreement, or some willingness to biosafety and risk assessment and risk manage- say let us get together, recognizing that there are ment in the application of biotechnology and its differences in the way that we measure risk and acceptability-the critical nature of the regional, the weights we attach to risk. But there is also a as opposed to the global. willingness to say, let us move ahead and see The second point is that if one were to make a where we can cooperate, collaborate, to address recommendation on biosafety, purely in the re- what I think is an enormous challenge ahead: gional context, it would be the need to assist in the feeding the world over the next 25 to 30 years. Wrap-up and Next Steps Ismail Serageldin F irst, I would like to say a profound thank Sometimes there is a fear of setting reduction- you to the people who organized this event, ism up too much as a straw man, because many specifically Wanda Collins and Sarwat of the top scientists in the world would not ad- Hussain, and more generally Joan Martin-Brown, here to the view of reductionist science. Roger who has been the impresario of the multiplicity Penrose, for example, who is a mathematician, of events this week, as well as Lisa Carlson and wrote a beautiful essay in a book called Nature's many other staff members from the CGIAR Sec- Imaginings in which he shows why even the struc- retariat, the World Bank Group, the International ture of mathematics, which due to its inherent Food Policy Research Institute, and others who structure is assumed to be the most reductionist, have worked so patiently, along with our cospon- recognizes that there are things that remain out- sors, to made this event possible. side of the reductionist approach. It has, indeed, been a compelling two days and, In many instances we use the concept of re- if nothing else, serves as an interesting starting ductionism as an artifact; the problems are too point. There are actually some 16 different orga- complex, and we try to bring them down to a nizations, including conservation groups, scien- more comprehensible level. I am fond of point- tific groups, international agencies, and bilateral ing out that on one level human beings are noth- agencies that agreed to cosponsor this event, ing more than three buckets of water and a which speaks to the importance that we all at- handful of minerals held together by chemical tach to this issue. reactions. That extreme reductionist view has I think that we have done reasonably well in try- served us extremely well in medicine, bringing ing to disentangle a number of the issues, includ- about enormous advances in treatment and lon- ing an effort to start with the more general ethical gevity of human beings. issues and then deal separately with legal regimes. Yet it is a view that misses the difference be- But the comment that Alexander McCalla made at tween a Mother Teresa and a Hitler, or between the end about World Trade Organization (WTO) a Mozart and a Stalin. It fails to take into account and nontariff barriers brings back the whole is- everything that we refer to as a human being. In sue of links between the WTO, other conventions, the same way no doctors or medical practitio- legal arrangements, and intellectual property ners would assume that this reductionist view is rights, which is a topic that deserves a separate, in- the entire totality of human beings, even though depth discussion in its own right. they find it convenient to do so. The decision was to confine this particular dis- In some ways there has also been a tendency- cussion to the safety issues related to biotechnol- perhaps less so in this group than in others-to ogy, and I feel that we have made considerable hold up economics as a discipline as being re- advances. ductionist in an unacceptable way, by reducing 128 Recommendationsfor Action 129 a society to the sum of its economic and financial choices are being made about levels of accept- transactions, which is equivalent to reducing a able risk, and they vary. human being to three buckets of water and a Defining the level of acceptable risk is not an handful of minerals. issue that can be determined by science. Science I think there is something there of value. But I may be able to help determine the magnitude of sense that the other side of that equation is really the risk or the probability of its occurrence, but concern for the complexity of the interactions and ultimately the choices have got to be there. It is synergistic effects present in the idea of under- in that context that I think Wanda Collins' com- standing an ecosystem in its entirety, not just its ment reminding us about the question of choice individual organisms, and that takes a more ho- between things that have already passed accept- listic approach to sort out. able risk is especially pertinent. This is a debate that has also permeated the I would like to add two other dimensions to Convention on Biological Diversity, as one of pro- our concern, since much of what drives me and tecting species or entire habitats in ecosystems, my colleagues is concern with the poor and the and that is where I think we need to have a larger impoverished in the developing world. The first discussion. I have spent much time debating with is that discussions of standards must always be colleagues on how to bridge the differences be- weighed with the interests of those who do not tween microbiologists and ecologists in their gen- have voice in many of these debates in mind. We eral perception of life. need to remember that. We should not allow the I think we need to engage others in discussing noxious practices of dumping toxic materials on this. Miguel Altieri said earlier that science is too them. We should not allow the sale of expired serious to leave to the scientists, paraphrasing a medicines to developing countries or other prac- famous leader talking about war being too seri- tices of which we are fully aware. ous to be left to the generals. Nevertheless there At the same time we also must be concerned is a scientific basis and a scientific viewpoint for about the pressures of the counter-factual. For dealing with ecological interactions as well. example, in another domain I have worked for But we are not just about settling perceptions many years on issues of accessibility to water and in science; we are also about trying to move for- sanitation. When governments insisted that they ward with realities. With every passing minute would have a certain level of service-now, mind we have 200 additional people on the planet, you, this is not risk, this is service, levels of ser- three per second. They will be demanding food, vice the net result was that they rationed out a nutrition, shelter, housing, and habitats, and lot of people. They ended up having subsidized enormous pressure is going to be coming upon water running from the taps of the middle class, us. It is important that actions are being taken. while very large numbers of poor people had no Delaying action is an action. It is a choice. It is access to water. Women had to travel for five not postponing a choice; it is a choice. hours a day to get water; children were playing The balance is between perception and real- in the filth, causing all sorts of diseases. Mean- ity. The tradeoffs are there and they are inescap- while the claim was that: "We cannot reach those able. They will require that we try to find ways people because we are trying to provide water at of dealing with the disagreements that we have. a certain standard." That is counter-factual: we Val Giddings, I think, rightly pointed out the dis- are trying to reach everyone, but our self-imposed agreements about what is acceptable risk. Even standards do not actually allow us to reach the if you have defined the level of risk, what is people who need it most. acceptable? In the same way I think that we have to look Acceptable risk is not really a scientific issue, at a range of approaches capable of improving but rather a social and political issue. We accept the productivity and income of the poor, includ- airlines as being safe, yet planes do crash. So there ing and only in part-and here I concur with is a level of risk. We can build in a redundancy Wanda Collins-the issue of biotechnology, system and a second. There is no end to how far which is being seen only as a subsidiary to that we can go, but it is implicit that at certain points larger problem. 130 Biotechnology and Biosafety On the ecological side is the issue of pressure Second is movement within the same species, on habitats, which is important because debates wheat and wheat. We take genetic material from around the Green Revolution still continue to- one wheat and put it into another wheat. We day. But at the same time it is important to know could probably produce the same result by con- that if we had not had significant yield increases, ventional breeding over a longer period of time we would have had 300 million more hectares and, therefore, there is not much of a problem under cultivation, and the net result of that in there in terms of acceptance. terms of additional forests destroyed and addi- Third would be closely related species. It hap- tional species lost would have been very severe- pens in nature and it happens to conventional plus the fact that there would have been breeding programs. Triticale is the result of a cross colonization of the hillsides, erosion of the soil, between wheat and rye, so we are still fairly close and a lot of other negative consequences. to conventional techniques, even if we used a So we need to balance these issues-the needs transfer technique that enabled us to do it more and demands versus the risks. None of these quickly and the gene to express itself. But, fun- choices are easy. Many of them are not going to damentally, we are not breaching much of what be scientific choices, but rather societal choices. could be achieved at a slower pace in a conven- On this point I join our colleagues from the Third tional manner. World Network who spoke about the need for Then we get into more complex areas of mov- greater information sharing and transparency in ing from organisms where the transfers would public debate, and I hope that this event has con- not likely occur, including, for example, the bio- tributed to that. technology gene coming from a bacterium into a Disagreement about benefits is easier. To the plant. Then you enter into suggestions of entire extent that we can prevent fraudulent claims and restructuring of the genome and changing the safeguard with scientific scrutiny against fraudu- architecture of plants by putting traits together. lence and incorrect claims, then the question as I think we can start by building partnerships to who is making the claims of benefits (of course, where people feel a common comfort level and mostly these are people on the industry side) is then work outwards from that. To the extent that whether they are willing to bet their money that additional evidence comes in, additional safe- this will prove economically viable. If the ben- guards are employed, and the comfort levels of efits are there, farmers will use the technology people are satisfied, then we can move with all and it will be economically viable. If not, the tech- deliberate caution on all of these problems. nology will disappear. That requires us, finally, to add two more Our job as decisionmakers and informed things to make it feasible to have an effective fol- people is to ensure that the prices are real and low-up. One is to work on clusters of specific that they incorporate the full environmental and problems, and I think Wanda Collins' comment social costs. Because to the extent that you have about black Sigatoga in bananas is a very perti- distorted prices or hidden subsidies, decision- nent one. Next week I will be meeting with a making about whether or not the alternative group of people from industry, developing coun- choices are more beneficial and more economi- tries, and research institutions to discuss whether cal would be unsound and distorted. Therefore such a partnership is feasible around the issue of incorporation and internalization of the externali- black Sigatoga in bananas, and whether such a ties becomes essential. partnership could also benefit plantains, which It seems to me, finally, that there are two points would benefit some very poor people in another that can pull us together in terms of movement. commercial crop, even if it also benefits the des- If we look at everything that is being done and sert banana, which is a commercial export crop. discussed in biotechnology, we can go from a To determine whether or not this is feasible, level of comfort to less and less comfort. The high- we will have to bring in the lawyers. It seems est level of comfort would be the use of genetic that nothing can be done without lawyers nowa- markers, tissue culture. It is mainstream. Nobody days, but that is part of the bane of proprietary worries about it. It is being done very well. science and many other things. But lawyers also Recommendations for Action 131 have fashioned wise constraints that keep us free, manner that will benefit the poor generations to so I hope that the lawyers will live up to that lofty come and the environment as a whole. and noble description of their profession. I am also optimistic that we will be able to raise And that, of course, is where we need to move additional funds if they are required, but to do towards a partnership. Partnership, we said, so will require that we define more accurately moves beyond the dialogue of the deaf toward a the scope of the interventions for which these learning relationship. Yes, but it also has to be a funds need to be raised. I hope it will not be at definition and understanding of what it is that the expense of some of the other activities that each one of us brings to the table. What we bring we want to undertake. to the table is different knowledge, different per- It is with these notes that I would like to leave spectives, different abilities, so this is where we you, with a deep vote of thanks to each and ev- will have to work together. ery one of you that have taken time from your In that working together around specific clus- busy schedules to share with us your concerns, ters of problems in specific projects, I take up your visions, your knowledge, your experience, Miguel Altieri's appeal to the noble forum: when your expertise, your fears, and your hopes. For you have the ability to say let us fuse our efforts in the end there is nothing that exists today that around a specific problem, and in so doing you was not once before imagined, and there is noth- go on a journey, not just for the discovery of the ing that will exist in the future that we will not other but also for discovery of the self. That is ourselves imagine. our goal in partnerships, and that is what will The future is very much what we will make allow us to finally reach mutual agreement on of it, and I believe that by our thoughts and more issues. our actions we are creating the future right now, I have always been an optimist, and I am con- this instant, in this room, in the very crucible vinced that we will be able to forge the partner- of our minds, by defining the limits of the ships that we have been talking about in a possible. PART II. Emics AND BIOTECHNOLOGY: REALITIES AND UNCERTAINTIES (excerpted from Ethics and Values: A Global Perspective) Introduction Kamla Chowdhry In this session on ethics and biotechnology we It seems to me that the whole problem of sci- have three very distinguished speakers. But ence and technology-the way they have devel- this has also been a conference on partner- oped in the past 100 to 200 years-is that they ships. We have been talking about partnerships have given human beings almost unlimited a great deal, so I would like to quote this little power and control over nature. But this has not poem from Alice's Adventures in Wonderland taughthumankindhow to control itself. This lop- (Carroll 1865): sided development threatens the future of humanity; the battle for the survival of the hu- I passed by his garden and marked, man race must involve ethics and a concern for with one eye, values of equity. How the Owl and the Panther The early history of science and technology were sharing a pie. is steeped in violence. Scientists and technolo- The Panther took the pie-crust, gists have used science for the domination of and gravy, and meat, nature, and the domination of nature for peo- While the Owl had the dish ple's use. The underlying social and cultural val- for his share of the treat. ues sanctioned the exploitation of nature in any When the pie was all finished, form, including the exploitation of women, for the Owl, as a boon the benefit of humanity. Was kindly permitted to pocket To illustrate my point, let me give you some the spoon: quotations from Francis Bacon, one of the fathers But the Panther obtained both the fork of the scientific movement.1 "Nature has to be and the knife, hounded in her wanderings," "bound into ser- So when he lost his temper, the Owl vice," "made a slave," "put into constraint." The lost his life. aim of science, Bacon said, is to "torture nature's (Presenter's version) secrets from her." Nature was female, and could therefore be exploited and violently dealt with. If we are involved in fostering partnerships, we One can see the violence with which nature was should see to it that we do not have these kinds to be dealt with by the way it was utilized for the of partnerships-in which one stronger partner benefit of humans. Science and technology also eats the other partner. This session is about part- developed specialization to an extent that it is dif- nerships between biotechnology and ethics. ficult to see people in society as a holistic part of Hopefully, we will think of the panther and the nature anymore. This is what the ecological sci- owl as we go along. ences are bringing us back to, what Captain 132 Ethics and Biotechnology: Realities and Uncertainties 133 Cousteau was able to bring to us, a holistic vision between technology and ethics. With the growth of nature and its relations with living beings. of science and technology we are constantly con- The yearning of mortals for prolonging life fronted with issues and choices which require by biochemical processes and gene manipula- supreme wisdom. The length and reach of our tion is creating moral and ethical questions. actions in space and time put people's responsi- Death is no longer considered as a necessity bility and their ethics in center stage. belonging to the nature of life, but as an avoid- Let us hear what wisdom our panel members able end, or at least one which can be postponed. have to suggest on this topic. How desirable is this for the individual and for the species? These questions involve the very Editor's Note meaning of our finiteness, the attitude toward death, and the balance of death and procreation. 1. In many cases in which Francis Bacon refers to The promised gifts of technology have raised "nature," his meaning is "human nature." questions of choice never raised before. These questions have to be dealt with ethically, not Reference merely by greater scientific endeavors or by market benefits, but by greater partnerships Carroll, L. 1865. Alice's Adventures in Wonderland. Panelist's Remarks Ismail Serageldin F ew technological changes have caused as agriculture, especially in developing countries. much debate as the recent changes in It is relevant to hold that thought because the biotechnology (Bt). Unfortunately, much of issue of better food production in the develop- this debate has been dominated by the sensa- ing world involves many of the same argu- tional and the visceral, and little coverage in the ments, even though the debate in the North is media has been truly deliberative, rigorous, or largely among people whose most likely nutri- based on scientific evidence in framing the issues. tional problem is obesity, not hunger. The hun- gry in the Northern industrial societies are Defining the Problem largely the marginalized, and they do not par- ticipate in the debate to ban or not to ban geneti- I would like to define the scope of the topic first cally modified organisms (GMOs)! by limiting it to agricultural biotechnology, that The second delineation of the problem relates is, the bioengineering of crops, especially food to what we mean by biotechnology. Bio- crops, and livestock, fish and trees. These activi- technology is a continuum of tools that has only ties are distinct from the bioengineering of medi- recently evolved into the part that bothers critics: cines for human health. Medical bioengineering the transformation of the genetic makeup of does not seem to elicit the same criticism as agri- organisms by recombinant techniques, especially cultural bioengineering. Critics of biotechnology when we introduce the genes of other species into do not seem to address their critiques to medical the target species-for example, introducing the research, on the grounds that the resulting medi- Bt gene from a bacterium into a plant. cines or treatments would help people in distress. Transforming the genetic makeup of a variety Nevertheless, it is important to remember of plant through genetic transfer from another that most people who do not object to medical variety of the same species should not pose much uses of biotechnology, while objecting to its use of an ethical problem. In fact it would simply be in agriculture, take that position because they an accelerated way of achieving by biotechno- place a value on reducing human suffering and logical means that which we could achieve prolonging human life, which is held to be in- through conventional breeding programs and trinsically worthwhile. This argument, which I therefore should not pose ethical or safety prob- believe emanates from a correct system of val- lems for anyone not opposed to the latter. ues (that is, one in which minimizing human suf- We might arguably extend this acceptance to fering and prolonging human life is held to be the bioengineered product of a genetic transfer positive), is important to retain as we move to between closely related plants, such as wheat the domain that we will discuss here, namely, and barley. Here we are already tinkering with 134 Ethics and Biotechnology: Realities and Uncertainties 135 nature, but the boundary with the conventional argument must include human welfare, regard- "natural" breeding system is so close that, for less of whether one assumes that human beings many, that also would be acceptable. The result are a privileged species or not. There is no rea- of such a gene transfer is unlikely to significantly son to argue for the welfare of animals if one is modify or denature the plant. Triticale is such an not going to extend the same argument to hu- interesting cross. man beings. Indeed, it is instructive that the Beyond that we get on the slippery slope first legislation to protect children against the leading to the design of new plant types, based abuses of child labor was sponsored by the on the assemblage of desirable traits from indi- Society for the Prevention of Cruelty to Animals! vidual plant species or even from other organ- It is difficult to argue that hunter-and-gath- isms. Are we now "playing God," with the likely erer societies living "in harmony with nature" results of the "sorcerer's apprentice"? That is should be encouraged to stay as they are, even if part of this discussion. that means enormous infant mortality rates and The other, related problem that people have short life. expectancies. Humane treatment is with the idea of cloning, or the forced asexual would mean improving diet, education, and reproduction of an organism that naturally health. The resulting reduction in infant mortal- reproduces sexually. This qualification is neces- ity and increases in consumption are likely to sary because the critics of biotechnology gener- put pressure on the natural system. The ques- ally, and of cloning specifically, obviously have tions then become how to handle that pressure, no difficulty with the reproduction of plants how to ensure that the patterns of development through cuttings, a practice as old as civilization. that are adopted are sustainable. Even arguing With the domain of the discussion delineated from a human-centric point of view, surely it in this manner, the issues can be usefully grouped does not make sense to undermine the ecosys- into ethical issues relating to: tems on which our long-term survival depends. e Tinkering with the natural order of things Biotechnology fits into the class of tools that • The likely risks associated with the new tech- humans are mastering for the potential benefit nology, which may well far transcend the of humanity, and that holds both promise and actual users of the products of that technology perils that should be weighed intelligently, on the * The patenting of life forms. basis of the best available evidence, to determine Against this set of issues we must address the whether, when, and how it should be used. potential benefits that would be forgone if we do Viewed thus, the matter becomes a simple calcu- not use biotechnology to address the problems lus of the potential benefits and potential risks of the world today. This moral calculus must be associated with the new technology. undertaken if we are to chart an ethical course However, let me add some qualifiers to the on this complex set of issues. argument. We must recognize that the ethical is- sue of purposively changing the natural order of Tinkering with Nature things is qualitatively different from trying to survive as best we can in this world in which we There is a profound distrust about people taking find ourselves. A course of action that tinkers with it upon themselves to change the natural order the natural order of things is equivalent if and of things. One can argue, rightly, that by our very only if it can be demonstrated that there is no presence on this planet we are changing the natu- alternative to pursuing that course, and that it ral order of things, and that our increasing num- has enough unique benefits in improved living bers, ever-more powerful technology, and conditions for human beings to outweigh the insatiable appetites for consumption and pollu- moral questions it raises. tion are indeed affecting nature, mostly in nega- Stated thus, the issues become propositions tive and potentially dangerous ways. Witness that can be elucidated by the best available sci- global warming and biodiversity loss. entific evidence about the issues of agriculture, Yet, against this general proposition we must poverty, food security, sustainable develop- set the welfare of the human species. Any moral ment, and the potential of alternative means to 136 Biotechnology and Biosafety reach the goals of food security for all in an eco- Clearly, it is not possible to entirely exclude logically sustainable world system. Here the evi- certain classes of risk, any more than one would dence is mixed: the challenge of ensuring food be able to exclude the risk of an asteroid hitting security is profound, and the likelihood of meet- the earth or of being struck by lightning. Yet ing it without recourse to the bioengineering of these risks are considered so remote that one crops is remote. Indeed, some authors, ranging goes through life ignoring them. I am not say- from Henry Kendall and David Pimentel to ing that the potential risks of releasing geneti- Lester Brown and Hal Kane, have cast doubt on cally modified organisms into the environment the world's ability to feed its growing popula- are in the same class of probability as asteroids tion in a sustainable fashion under any scenario. or lightning. However, the discussion should However, I do not take that view and would not start with the premise that any potential argue that we do have the chance to develop and risk, no matter how remote, would automati- intensify agriculture to meet that challenge. I cally veto the potential application of a technol- would not argue that enhancing food security is ogy. After all, in a case much closer to everyday possible if the potential use of biotechnology in life, we could ask whether people would be this enterprise is prohibited. Remember that if willing to accept a technology that contributes we fail to reach the goal of sustainable agricul- to global warming, kills about 50,000 people a ture for food security in the developing coun- year and maims another 500,000 in the United tries, it implies enormous misery for an States alone, and adds nothing vital to our enormous number of human beings. That dis- lifestyles except the convenience of personal- tributive and income policies are equally impor- ized fast travel. Yet no one would be able to per- tant in ensuring food security does not in any suade the average person to agree to ban the way diminish the need to have the production automobile. side in hand. The production side is necessary So we come back to assess the real risks of but not sufficient to meet the challenge of biotechnology in terms of how to ensure its safe hunger. Its absence makes discussion of income use so that its benefits can accrue safely to the or redistributive policies largely academic. many who need it. This is the topic of a two-day If this position is defensible, then the ques- symposium, entitled "Biotechnology and Bio- tion becomes one of managing the safety and safety," starting tomorrow in which a large num- other aspects of the technology, not proscribing ber of distinguished authorities will participate it a priori. On the other hand, if the goal of sus- (Serageldin and Collins 1998). tainable agriculture for food security in devel- oping countries can be achieved by other means, Patenting of Life Forms and Other Issues then the ethical argument against tinkering with of Patenting nature remains intact for those who support it. We must always remember that not all that is The third broad area of ethical issues involved in technologically feasible is ethically desirable. biotechnology is that of patenting. One of the eth- ical questions raised is whether the patenting of Ethical Issues of Safety life forms is acceptable. There is no direct answer, but the ownership of animals and plants, as well In the case of biotechnology that would lead to as the right to own a particular breed, is recog- releasing genetically modified organisms into nized. It could be argued that allowing owner- nature, the issues of safety acquire a different ship rights to other life forms is a matter of degree. level of concern. Is there a risk that we would After all, the varieties of flowers or livestock are affect the very ecosystems on which we all themselves owned and sold, and breeding of depend? What if these scientific efforts produce horses and other show animals is recognized. So "super weeds" or "super viruses" that have a what is more offensive in patenting, that is, estab- broad impact on many? Again the question is lishing an ownership claim on, a gene or gene one of evaluating the scientific evidence and sequence, than in asserting ownership of a whole assessing to the best of our ability the likely risks. plant or animal or a variety thereof? Ethics and Biotechnology: Realities and Uncertainties 137 The difference lies in the idea of owning a On the first, I am concerned by a growing gap "building block of life" rather than the living in knowledge between the North and South, creature itself. The assumption is that the build- which is exacerbated by the privatization of the ing block can then be part of many other living knowledge enterprise. Elsewhere, I have called things. This is an issue that I still struggle with this an emerging scientific apartheid. and cannot easily define to my satisfaction. But the problems posed by the new environ- Nevertheless, the issue is one that affects ment of proprietary knowledge are different. many people, and we should strive to under- They lead to the hoarding of information, and stand their qualms and to accommodate them. they are changing the character of the scientific No legislature can function if it does not have research enterprise, especially in the universi- the broad support of the majority of the ties, with their claim of promoting the advance population, and the views of the minority to- of knowledge and its diffusion. The race to pub- day could well be those of the majority to- lish is being replaced by the race to patent. morrow. However, such a transformation is Increasingly, the proprietary climate that best achieved by education and scientific evi- governs research on genome mapping and the dence, not by assertive preemptive action by a patenting of genes and gene sequences has re- vocal minority. created the world of the mapmakers of the 15th Why do I say this? Because the lessons of his- and 17th centuries, eloquently evoked by Daniel tory teach us so. A comparison between the Boorstin: United States' experience of its failed banning of alcohol (prohibition) and its effective quasi ban- Geographic knowledge, a product of dis- ning of smoking is instructive. Efforts to reduce covery, was a precious international cur- smoking benefited from a protracted education rency, coveted by everyone, easily stolen, campaign that resulted in a significant shift in and valuable to hoard. Anybody's new bit popular attitudes; the banning of alcohol did of information about an easy passage or a not. The substance of that education campaign treacherous shore could be added to any- was scientific evidence increasingly linking body else's in the race for gold and glory... smoking to a plethora of health issues. In this grand universal enterprise of In the same spirit should we not marshal the discovery, all scientists, explorers, and nav- resources of science to assess the substantive igators were collaborating willy-nilly, inten- claims of the contrarian view, be it for or against tionally or unintentionally. Collaboration, the patenting of life forms, to explain the differ- while necessary, was both desired and ence between that and outright ownership of feared. All realized that they were working animals and plants? toward the same end, a more accurate map There is another side to the patenting story. It of the earth. And their efforts bore fruit. raises another set of ethical issues that I would (1994, pp. 20-23) like to put before this assembly. These include the progressive monopolization of knowledge In both examples the issue is not that the and the increasing marginalization of the major- research efforts do not bear fruit, but that the cli- ity of the world's population. Concomitantly, mate of that research becomes more like the selective focusing research and applications of competitive and secretive climate of military new biotechnologies skew their benefits to the research, and less like the open and participa- potential markets of the rich and exclude the tory climate of the research university that we concerns of the poor. have come to know in this century. This propri- The issues operate at two levels: etary research culture threatens the open part- * Privatization of the scientific research enter- nerships of science that were established from prise and the meaning of proprietary science the 18th century onward. in the coming century The emergence and rapid dominance of this * Proprietary aspects of biotechnology in terms proprietary science pose difficult issues for insti- of both process and product. tutions of higher learning in countries such as 138 Biotechnology and Biosafety the United States. Here the need to maintain a patenting is increasingly enforced around the not-for-profit status and retain the 501c(3) tax world through the trade-related intellectual prop- deduction is at odds with the pursuit of lucrative erty (TRIPs) agreements under the World Trade and interesting research with the giants of the Organization (WTO) rules. What do we find? private sector. They also pose questions about Malaria today affects some 200-400 million ensuring the ready accessibility of knowledge, human beings, severely affects some 10 million surely a function of the university. persons, and kills about a million people annu- Equally powerful is the claim of the private ally. Yet, there is no significant private sector sector that if it is to mobilize and invest large sums research for a malaria vaccine. Why? Because in research, it must be able to recoup its invest- malaria is not a disease of the industrial coun- ment. To do so, the protection of intellectual prop- tries, and because the millions of people affected erty rights (IPR) is the key. From the view of the are poor and live in very remote areas, making investor simple justice would demand that intel- them an unattractive market. Compare this to lectual property rights be respected. the research being done on AIDS. It is plentiful So we have an ethical dilemma posed by the and, it is hoped, is leading to a real cure for this conflict between two desirable ends-two com- devastating disease. But the cure will cost at best peting claims to a just and fair treatment. The way between US$5,000 and US$10,000 per patient. out of this dilemma is to recognize the domains With enormous luck the cost could be brought of the claims more precisely. Public goods should down to US$1,000 per patient. This is an enor- be left to the public, and the private goods that aid mous advance, but one that will leave the vast in achieving these public goods should be treated dif- majority of very poor AIDS victims in such ferently than the private goods produced by the countries as India, Rwanda, and Uganda with private sector directly for the end user. no accessible treatment. This is a subtle argument, but an important I do not say this to fault the private sector one. In the past institutions such as the In- companies. They are doing what they are sup- ternational Agricultural Research Centers posed to do. I fault the public bodies that use the (IARCs) supported by the Consultative Group enormous presence of the private sector in med- for International Agricultural Research had ical research to justify a retreat from the pursuit access to the basic science and could apply it to of what are essentially public goods in the clas- the problems of the poor. The results were avail- sical economic definition of the term. Biotech- able to all for free, a public good. Today, this is nology in agricultural research poses many of no longer possible because the patenting of both the same problems. We should recognize the process and product continue unabated. importance of public goods research to accom- I would not mind if private companies pat- pany and complement the massive private sec- ented the products that they choose to sell. tor research. In this context we must reassess However, I do mind if their patents prevent the the ethical aspects of preemptive patents and IARCs from using the same basic scientific the patenting of process as well as product. processes to make products of interest to the New ways of collaborating with the private poor-products that the private sector patenters sector while respecting its right to intellectual are not going to make precisely because of their property rights protection must be found to ac- public goods nature. Surely, there is an ethical cess the process side of the biotechnology work question here, not just a legal one. for public goods research. Of course, this does not argue for abolishing patenting or nationalizing private research. It Envoi argues for an imaginative approach that recog- nizes the interests of the vast majority of the poor I have argued for defining more narrowly the in the world today. scope of the discussion, limiting it to the issues This is not a hypothetical question. Look at of biotechnology in agricultural research. I have pharmaceuticals, an areas in which the private tried, wherever possible, to isolate the issues sector has dominated research for a long time and that could be framed as scientific questions, Ethics and Biotechnology: Realities and Uncertainties 139 allowing us to assess the evidence and make ing skeptism with concern and compassion. Let informed decisions based on a cost-benefit or us be firm in the determination to do good and risk assessment, from the issues where the prob- to remember our responsibilities toward the lems are inherently normative and the argu- poor and the marginalized and the future gen- ments are based on values. The difference erations of human beings as well as other between these approaches is the same as that species. And let us adopt an inquisitive posture between an argument against surrogate mother- that will also remember that issues such as these hood based on religious or other ethical values are never settled, but must be constantly re- and one based on the safety of the procedure for viewed and weighed in the light of new devel- the mother or the fetus. The safety argument is opments and new evidence. Only in this way one that can be resolved in scientific terms, sub- will we be able to tackle our problems and, per- ject to another set of decisions about how much haps, also fashion the wise constraints that will risk is acceptable. The ethical is not debatable in set us all free in the truest and most profound the same terms. So it is with some of these ques- sense of the word. tions of biotechnology and patenting. Whatever the difficulties, the ethical debate is Reference one that we must all join in seriousness and in depth. There are few technologies on the market Boorstin, Daniel J. 1994. Cleopatra's Nose: Essays on the today that are more transformative. There are few Unexpected. New York: Vintage Books. that pose as many serious questions for our con- Serageldin, I., and W. Collins. 1998. Biotechnology and sciences and our minds, even when we cir- Biosafety. Proceedings of an Associated Event of the cumscribe the debate as narrowly as I have tried Fifth Annual World Bank Conference on Environ- to do here d mentally and Socially Sustainable Development, toSdo here. us go forthintothesenewdomains "Partnerships for Global Ecosystem Management: So let us go forth into these new domains Science, Economics and Law," Washington, D.C.: with open minds and sensitive hearts, combin- World Bank. Panelist's Remarks Klaus Leisinger am going to talk about the risks and benefits able between 1961 and 1963. If the yield per J of biotechnology and genetic engineering in hectare had not doubled, achieving the results the food crops of developing countries. First, recorded from 1991 to 1993 would have required it is important to remember what we have doubling the land under cultivation-a sheer learned from the green revolution. impossibility without causing an ecological dis- The original objective of the green revolution aster by destroying the last remaining forests was to increase yields, and this it certainly and converting them to cropland. accomplished. It did this by developing seed Of course the Green Revolution also had neg- varieties that had several advantages: short veg- ative impacts. The technologies themselves and etation periods, which allowed more than one the benefits of using them were not distributed harvest a year; the ability to turn high fertilizer equitably. When the new seeds were introduced, inputs into high crop yields rather than stem and those who already had access to land, irrigation, leaf growth; relative insusceptibility to fluctua- or extension services were at a distinct advantage. tion in daylight; resistance to or tolerance of plant The poor were left further behind. Another nega- diseases and animal pests; and tolerance to irreg- tive effect was the reduced use of biodiversity- ular irrigation, poor soils, and other stress fac- as people gained access to the new, high-yielding tors. The result was substantial yield increases varieties, they abandoned traditional ones. for rice, maize, and wheat ranging from 100 per- Turning to genetic engineering and biotech- cent to 170 percent boosts in productivity. nology, we can also see potential benefits for The Green Revolution also had the welcome food crops and some possible negative impacts. effect of improving the nutrition of the poor by First the benefits: as diagnostic aids, these tech- moderating food prices. Where the new tech- nologies can help identify plant diseases; gene nologies allowed second or third harvests in a mapping allows the rapid identification of com- year, there was also an increase in employment mercially and biologically interesting genetic and thus in income. At the same time the higher- material; most significantly, seeds can be created yielding seed varieties proved to be a land-sav- that have resistance to, or tolerance of, plant dis- ing technology, providing at least temporary eases and animal pests, as well as tolerance of relief of some of the pressures on forests and stress factors. Soon we may be able to transfer biological diversity. As an illustration of this genes that confer the ability to fix nitrogen to process, consider that if India had to produce grain. Last but not least, the quality of food can today's harvest with the technology of the 1960s, be improved by overcoming vitamin or mineral it would need to use 208 million hectares of deficiencies. To illustrate these likely benefits, arable land, 116 million more than were avail- we can look at rice, based on work by Ingo 140 Ethics and Biotechnology: Realities and Uncertainties 141 Potrykus at the Federal Institute of Technology ing disparities in the distribution of income and in Zurich: wealth within poor societies, and loss of biolog- * Fungal diseases destroy 50 million tons of ical diversity. It is imperative to distinguish here rice a year; varieties resistant to fungi could between risks that are inherent to a technology be developed through the genetic transfer of and those that transcend it-a distinction sel- proteins with antifungal properties. dom made when the green revolution is dis- * Insects cause the loss of 26 million tons of rice cussed. There are major differences between a year; the genetic transfer of proteins with these risks, and technology should not be insecticidal properties would mean an envi- blamed for problems that are part of the politi- ronmentally friendly insect control. cal and social environment of a country. * Viral diseases devastate 10 million tons of The risks inherent to technology are those rice a year; transgenes derived from the potential hazards-unforeseeable problems or Tungro virus genome allow the plant to unwanted side effects-that might occur during develop defense systems. the research, development, or implementation * Bacterial diseases cause comparable losses; of a technology designed to improve an existing transgenes with antibacterial properties are situation. Examples of these include the unex- the basis for inbuilt resistance. pected and harmful interaction of genetically * Vitamin A deficiency causes health problems engineered organisms with the environment, for more than 100 million children; trans- and the reduced use of biodiversity by farmers genes can provide provitamin A with the rice who now have access to higher-yielding vari- diet. eties. (This does not mean, however, that the * Iron deficiency in the diet is a health prob- traditional varieties need be lost, for they can be lem for more than 1 billion women and chil- kept in vitro or farmers could be offered an dren; transgenes can supply sufficient iron in incentive to continue using them.) the diet. In contrast, technology-transcending risks Similar benefits can also be cited for cassava, stem from the application of a technology in cer- also based on work by Ingo Potrykus at the tain political and social circumstances. In devel- Federal Institute of Technology in Zurich: oping countries today these risks arise from both - The African Mosaic virus causes immense the current course of the global economy and the damages in cassava; transgenes interfering specific situation in certain countries. Consider, with the life cycle of the virus could lead to for instance, the varying impact of introducing a virus-resistent varieties. new technology in a country that has policies • Cassava contains toxic cyanogenic glyco- that support small farmers (tenure reform, sides; the integration of transgenes could in- access to extension services) and in a country hibit their synthesis. where 95 percent of the land is in the hands of 2 * Cassava roots store starch efficiently but do percent of the people and where the poor have not contain protein; the transfer of genes for no access to services. storage proteins would improve cassava's Some of these risks can have the effect of nutritional quality substantially. aggravating the prosperity gap between North * Cassava roots have a basic capacity for pro- and South. The ability to produce tropical agri- vitamin A synthesis; transfer of appropriate cultural products in the laboratory or in temper- genes could lead to regulated accumulation. ate zones, for example, can have a significant Most of these properties in rice and cassava can impact on developing-country exports. The gap only be achieved through genetic engineering between North and South can also be widened and biotechnology, not through traditional plant when control of plant genetic resources is given research. free of charge. Now let us look at the potential risks of these The story of thaumatin illustrates both these technologies. These include dangers to the envi- trends. Some 10 years ago Nigerian researchers ronment and to public health, aggravation of the at the University of Ife identified the sweetener prosperity gap between North and South, grow- thaumatin in the berries of Thaumatococcus 142 Biotechnology and Biosafety danielli, which is common in the forests of that in a laboratory in Switzerland or England. Or do part of Nigeria. At that time no industry was we wish that to be controlled by politics. Market interested in using the fruit as a sweetener. With "logic" tells us that if "lab vanilla" or "lab sugar" the advent of biotechnological possibilities, (thaumatin) is cheaper or has some other edge- however, the gene for thaumatin-a protein that is healthier than the natural product, for exam- gram-for-gram is some 1,600 times sweeter than ple-then the innovation or substitution will sugar-has been cloned and is now being used simply happen. for the industrial production of sweetener in the Similarly, the price of copper is determined by confectionery industry. Patents on the process the metal's electrical conductivity. Once electric have been registered, but the people from whose current can be conducted cheaper and better by lands the gene was obtained never received any glass or carbon fibers, copper will in due course compensation. And countries like Cuba or no longer be used for this purpose-with not sur- Mauritius, which depend on sugar cane for a prising consequences for demand and thus price. decisive share of their export earnings, could The substitution will take place despite crum- find themselves extremely hard-pressed should bling copper prices and rising unemployment in the industrial manufacture of thaumatin or sim- countries such as Chile and Zambia. ilar substances broadly supplant sugar cane. The discussion here should not be how we Technology-transcending risks can also can prevent such a substitution from happening, aggravate disparities in income and wealth in but how to create an early warning system to poorer countries themselves. For it is certainly find out what kinds of crops are vulnerable to true that where land ownership and tenancy sys- substitution, and then help countries and com- tems, access to key services, and credit and mar- munities to diversify. A larger allocation of inter- keting channels are governed by a power national development funds to diversification structure that favors only a small minority, tech- efforts is therefore called for. A comprehensive nological progress cannot possibly be neutral in risk-benefit analysis of the substitution of agri- impact. cultural commodities from the tropics should How can we manage these risks? Again, it is also examine potential alternative uses of the important to look at the two categories separately. land freed up in this way-for increasing local First, risks inherent to technology. Biosafety risks food production perhaps, or for reforestation. are normally evaluated by specialists, controlled There should also be fair compensation for by good scientific practices and an appropriate the use of genetic resources. Suppose for in- regulatory framework. The only ethical risk here stance, that a private seed company discovers is if an institution supported by public funds used a property in an Ethiopian barley strain that different standards of risk in the North and the makes it resistant to certain plant diseases. The South. We have an ethical duty to use the highest company transfers this property genetically to a standards everywhere. wheat variety which is then commercialized in As a social scientist I am not qualified to pass Ethiopia. Obviously, the farmers of Ethiopia judgment on biosafety risks, but I draw to your have contributed something by selecting and attention the comment of the U.S. National preserving this variety for a long time, but with- Academy of Sciences on this issue: "The safety out the research and development of the seed assessment of a recombinant DNA-modified company this characteristic would not have organism should be based on the nature of the been turned to use outside Ethiopia or in food organism and the environment into which it will grains other than barley. So both the farmers of be introduced, not on the method by which it Ethiopia and the seed company have contrib- was modified" (Persley 1990). uted to the new wheat variety, and both have Management of technology-transcending some kind of intellectual property right, and risks is more difficult, for it involves more play- thus a right to compensation. ers. Political wishes, for example, cannot deter- Although most industrial countries have mine whether vanilla is produced in Madagascar, signed the Convention on Biological Diversity, where it creates an income for 100,000 people, or few national legislatures have ratified it. An Ethics and Biotechnology: Realities and Uncertainties 143 important step in satisfying claims to compen- nance in this case includes land reform, tenancy sation would be to work out binding national reforms, extension services for small farmers, and international regulations. What especially appropriate credit and marketing systems, and needs unequivocal regulation is who should so on. In short, the economic and social impact compensate whom for what, and how much the of genetic engineering and biotechnology can compensation should amount to. As a rough only be as good as the sociopolitical soil in which first approach, I have recommended for some the resulting new varieties are planted. time that the issue be dealt with through license One more point must be made about reduc- agreements, with the price left to the mechanism ing disparities both between the North and the of supply and demand. Those who benefit South and within countries. The private sector should pay the license fee to those who, over the needs to be asked to cooperate further. For centuries, helped preserve the varieties in ques- example Novartis, has made a gene of Bacillus tion. It is crucial to ensure that remuneration, thuringiensis available to the International Rice through whatever mechanism, does not land in Research Institute. If the World Bank asked the the pockets of those who have ready access to it, five or six largest biotechnology companies to while those the funds are meant to help end up consider where private-sector research could be empty-handed once again. As the Consultative made available in poor countries-not in com- Group on International Agricultural Research peting markets-they could surely come up (CGIAR) already exists and does excellent work with some useful recommendations. for the poor farmers of the world, no new insti- In conclusion, when assessing the impact of tution need be created to address this problem. genetic engineering and biotechnology on food If license fees were funneled to CGIAR, the security, we must live with ambivalence. It is funds would go toward research on plants that intrinsic to every technical advance. But the exis- improve the living circumstances in communi- tence of ambivalence and ethical dilemmas ties that are responsible for these crops. should not paralyze us. On the contrary, they must In addition, to help with diversification and serve to clarify the course of action and expand fair compensation for genetic resources, another our horizon of responsibility. There are both clear way to avoid aggravating the North-South pros- benefits and clear risks in this case. Balancing perity gap is to provide more publicly financed them will require a permanent political assess- research for the South and in the South, where ment process regarding what is acceptable under there are many excellent research capacities. specific circumstances. Certainly there are no tech- The second major technology-transcending nical solutions to social or political problems, nor risk described earlier is the growing disparity in is there a silver bullet answer waiting to be dis- the distribution of income and wealth within covered. Nevertheless underlying the political developing countries. Managing this risk re- process should be the understanding that sustain- quires good governance-a quality that is un- able food security will not be achieved without fortunately in short supply lately. Take the better governance and a new dimension of soli- case of Nigeria, to cite just one example. Nigeria darity between the "rich" and "poor" of this has had an income from crude oil of hundreds world. But it will also require new technologies, of billions of dollars over the past 20 years. Have such as genetic engineering and biotechnology. the multinationals wrecked this country? Or is it a lack of good governance? In giving these is- Reference sues serious consideration, we must not release governments from their responsibility to do their Persley, G. J. 1990. "Beyond Mendel's Garden: Bio- job-serve their countries, not use them as ille- technology in the Service of World Agricul- gitimate resources for private gain. Good gover- ture. " World Bank, Washington, D.C. Panelist's Remarks MiguelAltieri F or years academicians have assumed that of reductionist science and a multinational agriculture poses no special problem for monopolistic industry. These jointly perceive environmental ethics, despite the fact that agricultural problems as genetic deficiencies of human life and human civilization depend on organisms, treat nature as a commodity, and will the artificial use of nature for agricultural pro- take agriculture further down a misguided route duction. Even critics of the environmental im- (Levidow and Carr 1997). pacts of pesticides and of the social implica- This paper challenges the false promises made tions of agricultural technology have failed to by the genetic engineering industry: that it will conceptualize a coherent environmental ethics move agriculture away from a dependence on applicable to agricultural problems (Thompson chemical inputs, that will increase productivity, 1995). Most supporters of sustainable agricul- as well as decrease input costs and help reduce ture, driven by a technological determinism, do environmental problems (OTA 1992). By chal- not understand the structural roots of the envi- lenging the myths of biotechnology we expose ronmental degradation linked to capitalist agri- genetic engineering for what it really is; another culture. Therefore, by accepting the present "technological fix" or "magic bullet" aimed at cir- socioeconomic and political structure of agricul- cumventing the environmental problems of agri- ture as a given, they are prevented from putting culture (which themselves are the outcome of an in place an alternative agriculture that chal- earlier technological fix), without questioning the lenges this structure (Levins and Lewontin flawed assumptions that gave rise to the prob- 1985). This is worrisome, especially today, as lems in the first place (Hindmarsh 1991). Bio- profit motivations rather than environmental technology develops single-gene solutions for concerns shape the type of research and modes problems that derive from ecologically unstable of agricultural production prevalent throughout monoculture systems, designed on industrial the world (Busch and others 1990). models of efficiency. Such a unilateral approach Here we contend that the key problem facing was already proven ecologically unfit in the case agroecologists is that modern industrial agricul- of pesticides (Pimentel and others 1992). ture, today epitomized by biotechnology, is founded on philosophical premises that are fun- Ethical Questions about Biotechnology damentally flawed. These premises are precisely the ones that need to be exposed and criticized Environmentalists critical of biotechnology in order to advance toward a truly sustainable question the assumptions that biotechnological agriculture. This is particularly relevant in the science is value free; that it cannot be wrong or case of biotechnology, where there is an alliance misused, and call for an ethical evaluation of 144 Ethics and Biotechnology: Realities and Uncertainties 145 genetic engineering research and its products * What are the social goals and ethical criteria (Krimsky and Wrubel 1996). Supporters of that guide research problem choices? biotechnology are perceived as having a utilitar- * What social and agronomic goals can be ian view of nature and as favoring the free trad- achieved by biotechnology? ing of economic gains for ecological damage with indifference to the human consequences Biotechnology Myths Games 1997). At the very heart of the critique are biotechnology's effects on social and economic The agrochemical corporations which control the conditions and religious and moral values giv- direction and goals of agricultural innovation ing rise to questions such as: through biotechnology claim that genetic engi- * Should we alter the genetic structure of the neering will enhance the sustainability of agri- entire living kingdom in the name of utility culture by solving the very problems affecting and profit? conventional farming, and will spare farmers in * Is there something sacred about life, or developing countries from low productivity, should life forms, including humans, be poverty, and hunger (Molnar and Kinnucan viewed simply as commodities in the new 1989; Gresshoff 1996). By matching myth with biotechnological marketplace? reality the following section describes how and * Is the genetic makeup of all living things the why current developments in agricultural common heritage of all, or can it be appro- biotechnology do not measure up to such priated by corporations and thus become the promises and expectations. private property of a few? * Who gave individual companies the right to Myth 1: Biotechnology Will Benefit Farmers in the the monopoly over entire groups of organ- United States and in the Industrial World. isms? * Do biotechnologists feel they are masters of Most innovations in agricultural biotechnology nature? Is this an illusion constructed on sci- are profit driven rather than need driven, there- entific arrogance and conventional econom- fore, the thrust of the genetic engineering indus- ics, blind to the complexity of ecological try is not to solve agricultural problems as much processes? as to create profitability. Moreover biotechnol- * Is it possible to minimize ethical concerns ogy seeks to further industrialize agriculture and reduce environmental risks while keep- and to intensify farmers'dependence on indus- ing the benefits? trial inputs, aided by a ruthless system of intel- There are also questions that arise specifically lectual property rights which legally inhibits the from the nature of the technology, while others right of farmers to reproduce, share, and store such as the domination of agricultural research seeds (Busch and others 1990). By controlling the agendas by commercial interests, the uneven germplasm from seed to sale and by forcing distribution of benefits, the possible environ- farmers to pay inflated prices for seed-chemical mental risks, and the exploitation of the poor packages, companies are determined to extract nations'genetic resources by rich ones demand a the most profit from their investment. deeper inquiry: Because biotechnology is capital intensive, it * Who benefits from the technology? Who will continue to deepen the pattern of change in looses? U.S. agriculture, increasing the concentration of * What are the environmental and health con- agricultural production in the hands of large sequences? corporate farms. Biotechnology increases pro- * What alternatives have been sacrificed? ductivity, and as with other labor-saving tech- * To whose needs does biotechnology re- nology, tends to reduce commodity prices and spond? set in motion a technology treadmill that forces * How does the technology affect what is being out of business a significant number of farm- produced, how it is being produced, and for ers-especially small-scale farmers. The ex- what and for whom? ample of bovine growth hormone confirms the 146 Biotechnology and Biosafety hypothesis that biotechnology will accelerate future (Mander and Goldsmith 1996). It is esti- the foreclosure of small dairy farms (Krimsky mated that nearly 10 million sugar farmers in and Wrubel 1996). developing countries may face a loss of liveli- hood as laboratory-processed sweeteners begin Myth 2: Biotechnology Will Benefit Small invading world markets. Fructose produced by Farmers and Favor the Hungry and Poor biotechnology has already captured over 10 per- of Developing Countries. cent of the world market and caused sugar prices to fall, throwing tens of thousands of Green revolution technology bypassed small workers out of jobs. But such foreclosures of and resource-poor farmers, who will be further rural opportunities are not limited to sweeten- marginalized by biotechnology which is under ers. Approximately 70,000 vanilla farmers in corporate control and protected by patents. Madagascar were ruined when a Texas firm pro- Biotechnology is expensive and inappropriate to duced vanilla in biotech labs (Busch and others the needs and circumstances of indigenous peo- 1990). The expansion of Unilever-cloned oil ple (Lipton 1989). As biotechnology is primarily palms will substantially increase palm oil pro- a commercial activity, this reality determines the duction with dramatic consequences for farmers priorities of investigation, application, and ben- producing other vegetable oils (groundnut in efit. While the world may lack food and suffer Senegal and coconut in the Philippines). from pesticide pollution, the focus of multina- tional corporations is profit, not philanthropy. Myth 3: Biotechnology Will Not Transgress the This is why biotechnologists design transgenic Ecological Sovereignty of Developing Countries. crops for new marketable quality or for import substitution, rather than for greater food pro- Ever since the North became aware of the vital duction (Mander and Goldsmith 1996). In gen- role of biodiversity-of which the South is the eral biotechnology companies are emphasizing major repository-developing countries have a limited range of crops for which there are large witnessed a "gene rush" as multinational cor- and secured markets, targeted at relatively cap- porations aggressively scour forests, crop ital-intensive production systems. As transgenic fields, and coasts in search of the South's crops are patented plants, indigenous farmers genetic gold (Kloppenburg 1988). Protected by can lose rights to their own regional germplasm the WTO, multinational companies freely prac- and not be allowed under the World Trade tice "biopiracy," which the Rural Advancement Organization (WTO) to reproduce, share, or Foundation estimates is costing US$5.4 billion store the seeds of their harvest (Crucible Group a year through lost royalties from food and 1994). It is difficult to conceive how such tech- drug companies using indigenous farmers' nology will be introduced in developing coun- germplasm and medicinal plants (Levidow and tries to favor the masses of poor farmers. If Carr 1997). biotechnologists are really committed to feeding Clearly, indigenous people and their biodi- the world, why is the scientific genius of biotech- versity are viewed as raw materials for the nology not turned to develop varieties of crops multinational companies, which have made bil- more tolerant to weeds rather than to herbi- lions of dollars on seeds developed in U.S. labs cides? Or why are more promising products of from germplasm that farmers in developing biotechnology, such as nitrogen-fixing and countries have carefully bred over generations drought-tolerant plants not being developed? (Fowler and Mooney 1990). Meanwhile peasant Biotechnology products will undermine farmers go unrewarded for their millenary farm- exports from the developing countries, espe- ing knowledge, while multinational companies cially from small-scale producers. The de- stand to harvest royalties from developing coun- velopment of a thaumatin product through tries estimated at billions of dollars. So far biotechnology is just the beginning of a transi- biotechnology companies offer no provisions to tion to alternative sweeteners, which will re- pay farmers from developing countries for the place developing countries'sugar markets in the seeds they take and use (Kloppenburg 1988). Ethics and Biotechnology: Realities and Uncertainties 147 Myth 4: Biotechnology Will Lead to Biodiversity approach has proven to be easily overcome by Conservation. pests, which are continuously adapting to new situations and evolving detoxification mecha- Although biotechnology has the capacity to cre- nisms (Robinson 1996). ate a greater variety of commercial plants, and There are many unanswered ecological ques- thus contribute to biodiversity, this is unlikely to tions regarding the impact of the release of trans- happen. The strategy of multinational compa- genic plants and micro-organisms into the nies is to create broad international seed markets environment. Among the major environmental for a single product. The tendency is toward uni- risks associated with genetically engineered form international seed markets (MacDonald plants are the unintended transfer to plant rela- 1991). Moreover the provisions of the patent sys- tives of the "transgenes" and the unpredictable tem prohibiting farmers to reuse the seed ecological effects (Rissler and Mellon 1996). yielded by their harvests-dictated by the multi- Given the above considerations, agroecolog- national companies-will affect the possibilities ical theory predicts that biotechnology will exac- of in situ conservation and on-farm improve- erbate the problems of conventional agriculture, ments of genetic diversity. and by promoting monocultures will also The agricultural systems developed with undermine ecological methods of farming such transgenic crops will favor monocultures, which as rotation and polycultures (Hindmarsh 1991). are characterized by dangerously high levels of As presently conceived, biotechnology does not genetic homogeneity leading to higher vulnera- fit into the broad ideals of a sustainable agricul- bility to biotic and abiotic stresses (Robinson ture (Kloppenburg and Burrows 1996). 1996). As the new bioengineered seeds replace the old, traditional varieties and their wild rela- Myth 6: Biotechnology Will Enhance the Use tives, genetic erosion will accelerate in develop- of Molecular Biologyfor the Benefit of All Sectors ing countries (Fowler and Mooney 1990). Thus of Society. the push for uniformity will not only destroy the diversity of genetic resources, but will also dis- The demand for the new biotechnology did not rupt the biological complexity that underlines the emerge as a result of social demands, but it sustainability of traditional farming systems emerged out of changes in patent laws and the (Altieri 1994). financial interests of chemical companies in link- ing seeds and pesticides. The supply emerged Myth 5: Biotechnology Is Ecologically Safe and out of breakthroughs in molecular biology and Will Launch a Period of Chemical-Free the availability of venture capital as a result of Sustainable Agriculture. favorable tax laws (Webber 1990). The danger is that the private sector is influencing the direction Biotechnology is being pursued to patch up the of public sector research in ways unprecedented problems that have been caused by previous in the past (Kleinman and Kloppenburg 1988). agrochemical technologies (pesticide resistance, As more universities enter into partnerships pollution, soil degradation, and so on) which with corporations, serious ethical questions were promoted by the same companies now emerge about who owns the results of research leading the biorevolution. Transgenic crops and what research is carried out. The trend developed for pest control follow closely the toward secrecy by university scientists involved pesticide paradigm of using a single control in such partnerships raises questions about per- mechanism, which has proven to fail over and sonal ethics and conflicts of interest. In many uni- over again with insects, pathogens, and weeds versities a professor's ability to attract private (National Research Council 1996). Transgenic investment is often more important than his aca- crops are likely to increase the use of pesticides demic qualifications, taking away the incentives and to accelerate the evolution of "super weeds" for scientists to be socially responsible. Fields and resistant insect pests strains (Rissler and such as biological control and agroecology which Mellon 1996). The "one gene-one pest" resistant do not attract corporate sponsorship are being 148 Biotechnology and Biosafety phased out and this not in the public interest temporary biotechnology-must be reversed by (Kleinman and Kloppenburg 1988). a more holistic approach to agriculture, to ensure that agroecological alternatives are not neglected Conclusions and that only ecologically sound aspects of biotechnology are researched and developed. In the late 1980s Monsanto issued a statement The time has come to counter effectively the chal- indicating that biotechnology would revolution- lenge and the reality of genetic engineering. As it ize agriculture in the future with products based has been with pesticides, biotechnology compa- on nature's own methods, making farming more nies must feel the impact of environmental, farm environmentally friendly and more profitable labor, animal rights', and consumers'lobbies, so for the farmer (Office of Technology Assessment that they start reorienting their work for the over- 1992). Moreover, plants would be provided with all benefit of society and nature. The future of built-in defenses against insects and pathogens. biotechnology-based research will be deter- Since then many others have promised several mined by power relations; farmers and the pub- more valuable rewards that biotechnology can lic in general, if sufficiently empowered, could bring through crop improvement. The ethical influence the direction of biotechnology toward dilemma is that many of these promises are sustainable agriculture. unfounded, and many of the advantages or ben- efits of biotechnology have not, or may not, be References realized. Although clearly biotechnology holds promise for an improved agriculture, given its Altieri, M.A. 1994. Biodiversity and Pest Management in present orientation it mostly holds promise for Agroecosystems. New York: Haworth Press. environmental harm, for the further industrial- Busch, L., W.B. Lacy, J. Burkhardt, and L. Lacy. 1990. ization of agriculture, and for the intrusion of Plants, Power and Profit. Oxford: Basil Blackwell. Crucible Group. 1994. People, Plants and Patents. Ot- private interests too far into public interest sec- tawa: IDRC. tor research. Until now the economic and politi- Fowler, C., and P. Mooney. 1990. Shattering: Food, Poli- cal domination of the agricultural development tics and the Loss of Genetic Diversity. Tucson: Univer- agenda by multinational companies has thrived sity of Arizona Press. at the expense of the interests of consumers, Gresshoff, P.M. 1996. Technology Transfer of Plant Bio- farm workers, small family farms, technology. Boca Raton, Fla.: CRC Press. farmHfarms, wildlife, and Hindmarsh, R. 1991. "The Flawed 'Sustainable' Promise of the environment. Genetic Engineering." The Ecologist 21: 196-205. It is urgent for society to have earlier entry James, R.R. 1997. "Utilizing a Social Ethic toward the points and broader participation in technologi- Environment in Assessing Genetically Engineered cal decisions so that corporate interests do not Insect-Resistance in Trees." Agriculture and Human dominate scientific research. National and inter- Values 14: 237-49. national public organizations such as the Food Kleinman, D.L., and J. Kloppenburg. 1988. "Biotech- national public organizations such as the Food nology and University-Industry Relations: Policy Is- and Agriculture Organization of the United sues in Research and the Ownership of Intellectual Nations (FAO) and the Consultative Group for Property at a Land Grant University." Policy Studies International Agricultural Research (CGIAR) Journal 17: 83-96. will have to monitor carefully and control the Kloppenburg, J., and B. Burrows. 1996. "Biotechnology to provision of applied, nonproprietary knowl- the Rescue? Twelve Reasons Why Biotechnology Is edge to the private sector, to make sure that such Incompatible with Sustainable Agriculture." The Ecolo- gist 26: 61-7. knowledge will continue in the public domain Kloppenburg, J.R. 1988. First the Seed: The Political for the benefit of rural societies. Regulatory Economy of Plant Technology. Cambridge: Cambridge regimes which are publicly controlled must be University Press. developed and used to assess and monitor the Krimsky, S., and R.P. Wrubel. 1996. Agricultural Biotech- environmental and social risks of biotechnolog- nology and the Environment: Science, Policy and Social ical products (Webber 1990). Issues. Urbana: University of Illinois Press. Levidow, L., and S. Carr. 1997. "How Biotechnology Finally, the trends toward a reductionist view Regulation Sets a Risk/Ethics Boundary." Agri- of nature and agriculture-set in motion by con- culture and Human Values 14: 29-43. Ethics and Biotechnology: Realities and Uncertainties 149 Levins, R., and R. Lewontin. 1985. The Dialectical Bi- Office of Technology Assesment. 1992. A New Tech- ologist. Cambridge, Mass.: Harvard University nological Erafor American Agriculture. Washington, Press. D.C.: U.S. Government Printing Office. Lipton, M. 1989. New Seeds and Poor People. Baltimore: Pimentel, D., and others. 1992. "Environmental and The Johns Hopkins University Press. Economic Costs of Pesticide Use." Bioscience 42: MacDonald, D.F. 1991. "Agricultural Biotechnology at 750-60. the Crossroads." NABC Report 3. Union Press of Rissler, J., and M. Mellon. 1996. The Ecological Risks of Binghamton. Engineered Crops. Cambridge, Mass.: MIT Press. Mander, J., and E. Goldsmith. 1996. The Case against the Miguel Altieri to Reduce Pesticide Resistance. Davis, Global Economy. San Francisco: Sierra Club Books. Calif.: AgAccess. Molnar, J.J,. and H. Kinnucan. 1989. Biotechnology and Thompson, P.B. 1995. The Spirit of The Soil: Agriculture the New Agricultural Revolution, Boulder, Col.: and Environmental Ethics. London: Routledge. Westview Press. Webber, D.J., ed. 1990. Biotechnology: Assessing Social National Research Council. 1996. Ecologically Based Pest Impacts and Policy Implications. Westport, Conn.: Management. Washington D.C.: National Academy Greenwood Press. of Sciences. Discussion Ismail Serageldin: Klaus Leisinger said some address. But it will take time, and we have two very important things that I hope we will focus whole days for that, tomorrow and the day on. One was that if we are concerned about the after. inadequacy of public resources, one of the ways to tackle that is to increase public investment in Audience comment: I was very interested in the research that the private sector is not going to do. comment on how Ciba-Geigy is handling this There is a balance between the two: there are issue of licensing, allowing the Consultative some things that the public sector will do, and Group on International Agricultural Research there are some things that the private sector access to licenses. I have experience with a some- needs to do. what different system, which we have practiced Miguel Altieri highlighted the set of what he within the Biofocus Foundation. Many private referred to as the kinds of biotechnology that companies with which we have been in touch should be done, and he was happy that the have accepted it without hesitation. We favor Novartis Foundation is funding some of that, patenting, but we also say that the license fee working in the Sahel. But we cannot expect that should be tied to the GNP per capita in the coun- the Novartis, which is a profit-making institu- try where the intellectual property right is prac- tion, would necessarily invest its money in ticed. That may be a variety of the same doing that kind of research, except through the' approach that you take. removal from commercial considerations. The second point of concern is that we need Pat Mishey: I am taken by the question that you to try to resolve the degrees of risks that really raised of the biotechnology being driven by are associated with that question. Over the market forces, rather than concern for the com- next two days some very distinguished people mon good of poverty and hunger alleviation. I will be addressing that. Professor Werner would like that addressed. And the question of Arber, the president of the International who is responsible and accountable when Council of Scientific Unions and a Nobel Prize things go wrong? And what about the precau- winner for research in enzymes, will be our tionary principle, to prevent harm? How can opening speaker tomorrow, and Henry we hold companies accountable for the pre- Kendall, of the Union of Concerned Scientists, vention of harm? Is the burden on the people to and a Nobel Laureate in physics, also will be deal with a disaster after it happens, or is the speaking. The question of just how much risk burden on the companies to show, in advance there is, and how we can guard against it-that of applying the technology, that it will do no is a separate set of issues which we can also harm? 150 Ethics and Biotechnology: Realities and Uncertainties 151 Audience comment: It is not the companies that Last but not least, and I do not want to be are responsible for the mess that we are in, or the unfriendly or politically incorrect, but I have multinationals, but rather our whole economic heard a lot of this diffused uneasiness about our system, which is incompatible with ecological economic system not being fit for the survival of well-being. humanity. Well, about eight years ago we had another system collapse. So there are not too Gabby Balsheart: I have two questions. First, do many alternatives. The political task is to make consumers want genetically manipulated organ- the market economy socially compatible and eco- isms in their food? Second, do small farmers in logically sustainable. There are no instant solu- developing countries want the seeds that they tions. For many countries this will be a matter of cannot use any way they want to? trial and error, which is going to be developed over many years. One element that was men- Klaus Leisinger: On the last questions first, I am tioned by Ismail in the morning session will pro- very much in favor of open labeling, because duce a lot of progress-let us try anything to then consumers have the choice. If they want to make prices tell the ecological truth. Once it is no buy a tomato, they should be able to see whether longer possible to externalize ecological costs, it is a "normal" one or a flavor-saver, and then then all of a sudden it will be the consu- they can make the choice. mers'choice. Do the farmers in the developing countries Last, if we put the burden of proof about risks want genetically engineered varieties? They on those who innovate, we will not have any want varieties that bring them an economic ben- more innovation. Because we can never guaran- efit. If a farmer with one or two hectares can feed tee that we have not missed a risk during the his or her family with one variety and cannot research stage. We have to use the best available feed his family with the other variety, his choice knowledge to minimize the probability that will be obvious, and he will not care about severe risks may emerge. That is the precaution- whether that variety was modified by tradi- ary principle today. Most companies cease tional methods or by genetic engineering. producing products that show ecological in- Miguel Altieri, I can give you, for free, the compatibility in the early stages. results of our 12 years' research on striga. If you intercrop with cowpeas, the striga goes down by Lori Thrupp: I found it very interesting that 85 percent without any chemicals being used. both Dr. Serageldin and Dr. Leisinger pointed to The choice is not between the most modern the fact very lucidly that, to use your exact biotechnology and traditional technologies. words, "there are no technological solutions to There must be technological pluralism. The right social and political problems." And that was mix very much depends on the circumstances. It preceded by a very strong point which many of depends on the time. Ten years from now more us have acknowledged for many years, that the than 50 percent of the people in developing root of food insecurity is largely related to social countries will be urban people who cannot pro- and political factors. Food production, therefore, duce food for themselves. Then we might have is not sufficient, we acknowledge that. to look at a dual agriculture, where part of the Yet it seems ironic that we come back re- food is mass produced, and we have to do any- peatedly to funding, to investing tremendous thing that is possible to help the marginal farmer amounts of funds from the private sector and the to survive. And to bring up this Manichean pic- public sector in purely technological solutions. If ture-it is either bad or good-this is simply not we are looking at issues that are largely related to my perception of the world. Do farmers buy distributional questions, to ensuring sustainabil- things they do not benefit from? Is the propa- ity over the long term, which requires a change in ganda of the multinationals so powerful that paradigm, of production, related to the sort of they can overcome the economic judgment of model of science and of society that Miguel farmers? If so they must be very different from alluded to, then why do we come back repeatedly the farmers we have in Switzerland or Germany. to look for technological solutions? I am not deny- 152 Biotechnology and Biosafety ing that there is a food insecurity issue, or that we Second, and I tried to emphasize this point, do not need more production. But I think that we the fact that we recognize that the distribu- are looking for the wrong solution by investing tional issues are absolutely essential does not huge sums of money into largely technological remove the fact that the production side is solutions. I wonder if some of you might want to extremely important. Everybody agrees on the address that? demand side-that we will need roughly twice as much production of food on this planet Ismail Serageldin: This discussion is focusing within a generation and a half, partly due to onbiotechnologybecausethatistheissuebefore population growth, partly due to income this panel. The issue of biotechnology as a tech- growth. Before we worry about the distribu- nology raises many issues of a visceral nature, of tional aspects, if we do not have the overall bal- an ethical nature. This is not to say that other ances, we know who is going to be squeezed issues are not important: the bulk of the World out. It will not be the rich who will go hungry, Bank's investments in agriculture, which are it will be the poor. That was Amartya Sen's running at US$3.5 billion a year, in support of major observation: that people who focus only maybe a total of US$7 billion of spending by the on the production side and who say that if the developing countries, is largely not in technol- balances are in place then everything takes care ogy. Out of that there may be a couple of hun- of itself are not correct, a point that Norman dred million that are going to technological Myers reminded us of. improvements. The bulk of it is going to issues This conversation is not a total picture, but it from land reform to rural roads to agricultural is focusing on one subset of it. In that light we credit to access-a whole range of issues, chang- are not denying the importance of all these other ing the prices that you were talking about. aspects. PART III. BIOENGINEERING OF CROPS Report of the World Bank Panel on Transgenic Crops About the Authors Roger Beachy Henry W. Kendall Scripps Family Chair, Scripps Research Institute; J. A. Stratton, Professor of Physics, Massachusetts full member, Department of Cell Biology; Head, Institute of Technology Chair, Union of Con- Division of Plant Biology. Co-director, Interna- cerned Scientists. Awarded 1990 Nobel Prize in tional Laboratory of Tropical Agricultural Bio- Physics. technologies. Fellow, American Association for the Advancement of Science. Received 1991 Peter H. Raven Commonwealth Award for Science and Inven- Director, Missouri Botanical Garden. Professor of tion. Member, National Academy of Sciences. botany, Washington University. Home secretary, National Academy of Sciences. Fellow, thirteen Thomas Eisner other national academies of science. Awarded Schurman Professor of Chemical Ecology and numerous honorary degrees and other awards, director, Cornell Institute for Research in including the Japan International Prize for Bio- Chemical Ecology, Cornell University Fellow, logy, and jointly received the Sasakawa Prize, the National Academy of Sciences, and several Volvo Prize, and the Prize of the Institut de la Vie. other nations' academies of science. Awarded 1994 National Medal of Science. lozef S. Schell Director, Department of Genetic Principles of Fred Gould Plant Breeding, Max Planck Institut fur Ziuch- Reynolds Professor of Entomology, North tungsforschung. Professor, plant molecular biol- Carolina State University. Research areas: inte- ogy, College de France. Member, ten national grated pest management, population ecology academies, including the Deutsche Akademie and genetics, evolutionary biology. Consultant, der Naturforscher Leopoldina, the National Aca- International Rice Research Institute. Received demy of Sciences, and the Royal Swedish Aca- U. S. Award for Excellence in Integrated Pest demy of Sciences. Winner of numerous awards Management. and distinctions, including the Wolf Prize, the Sir Hans Krebs Medal, and the Australia Prize. Robert Herdt Director, agricultural sciences, Rockefeller M. S. Swaminathan Foundation, with responsibility for the founda- UNESCO Professor in Ecotechnology and chair, tion's agricultural work throughout the world. M.S. Swaminathan Research Foundation, Madras, Agricultural economist, International Rice India. Fellow, Royal Society of London. Foreign Research Institute, 1973-83. Faculty member, associate, National Academy of Sciences, and sev- University of Illinois, and science adviser, World eral other nations' academies of science. Awarded Bank, 1983-86. Fellow, American Association numerous honorary degrees and other awards, for the Advancement of Science. including the World Food Prize. 153 Acknowledgments T his volume was prepared for the World important issues, leading to useful changes Bank and the Consultative Group on In- in the paper. We are grateful for their help, ternational Agricultural Research. The although the authors of the report remain solely authors wish to express their thanks to Ismail responsible for its content. The reviewers were Serageldin, vice president for Environmentally Nina Fedoroff, Pennsylvania State University; and Socially Sustainable Development (ESSD), Rebecca Goldberg, Environmental Defense World Bank, for initiating this study and Fund; Mardi Mellon, Union of Concerned supporting it throughout its course. Robert Scientists; Per Pinstrup-Andersen, International T. Watson, Director of the World Bank's En- Food Policy Research Institute; Alison G. Power, vironment Department, provided aid and ad- Cornell University; and Virginia Walbot, vice that advanced the project. Stanford University. A number of thoughtful people reviewed the We also wish to thank Barbara Corbisier for manuscript. Their comments provided an array her work in preparing and maintaining the Web of additional checks on the work and raised site that proved so useful during our work. 154 Introduction T he primary objectives of the World Bank much to contribute, but it is a novel system and Group are to alleviate poverty, malnutri- possible risks need to be evaluated carefully. tion, and human misery in developing Opposition to bioengineering research and its nations while encouraging and supporting a application has already arisen, not all of it care- transition to environmentally sustainable activ- fully thought out. As the World Bank has recog- ities. The issue of providing adequate food, nized, a considered and technically competent based on sustainable agricultural practices, understanding of both the potential and the per- looms large in gaining these objectives, for fail- ceived risks of bioengineered crops is a requisite ure in this area will virtually guarantee failure to their successful development and use. Public to meet other objectives. Moreover, failure will perceptions that genetically engineered crops make certain continued misery for many of our and animal products pose specific dangers must fellow human beings. Agricultural systems are be carefully considered and addressed if such already under stress, and they will become more products are to reach widespread use. stressed as populations continue to swell and In 1996 Ismail Serageldin, the World Bank's the need for food supplies increases. vice president for Environmentally and Socially The World Bank has made important contri- Sustainable Development and chairman of the butions to the alleviation of hunger and malnu- CGIAR, initiated a study panel to assess the trition through its programs that aid agriculture potential of crop bioengineering as well as the in the developing world. Its aid was a major inherent risks. The panel was to provide the factor in making India self-sufficient in food Bank with guidance in its activities, including its production in the difficult time after World War support to the CGIAR. This is the panel's report. II. Similarly, its support to the Consultative In what follows we review the status of Group on International Agricultural Research world food supplies and the prospects and (CGIAR) was instrumental in enabling the needs for the future with emphasis on the devel- CGIAR to be a major player in introducing the oping world. We then describe bioengineering Green Revolution, which contributed so much technology and the potential contributions that to economic growth in the developing world.' transgenic crops might make to the alleviation of But despite contributions by the Bank and other problems of food security. After that we deal organizations and by nations, the need to en- with possible risks from the widespread deploy- hance food security in much of the develop- ment of genetically altered crops. Finally, we ing world will remain a critical problem for offer some conclusions and recommendations. many years to come. Among the numerous approaches to ex- Note panding food supplies in the developing 1. Henry Owen, 'The World Bank: Is 50 Years world in environmentally benign ways is the Enough?"ForeignAffairs73(September/Octoberl994): bioengineering of crops. Bioengineering has 99. 155 CHAPTER 1 World Food Supplies C urrent and future demands for food and zens with adequate food when they wish to do the pressures and stress on the world's so. Indeed, well over one-third of world grain agricultural sector generate the need to production is fed to livestock to enhance the set priorities among a cluster of problems and supply of animal protein, which is consumed available solutions, including the bioengineering most heavily in the industrial world. of crops.' This section of the report sets out and In the developing world, matters are differ- assesses the challenges as they stand today and ent. More than 1 billion people do not get evaluates what the future may bring. enough to eat on a daily basis and live in what the World Bank terms "utter poverty"; about Current Circumstances half of that number suffer from serious malnu- trition. A minority of nations in the developing We are now facing the following challenges. world are markedly improving their citizens' standard of living: in some fifteen countries 1.5 Population billion people have experienced rapidly rising incomes over the past twenty years. But in more The world's population stands at 5.8 billion and than a hundred countries 1.6 billion people have is growing at about 1.5 percent a year. The experienced stagnant or falling incomes. Since industrial, wealthy nations, including Japan 1990 incomes have fallen by a fifth in twenty-one and the nations of Europe and North America, countries of eastern Europe. have about 1.2 billion people. These nations are Had the world's food supply been distrib- growing at a slow rate, roughly 0.1 percent a uted evenly in 1994, it would have provided an year. adequate diet of about 2,350 calories a day per Population in the developing world is 4.6 bil- person for 6.4 billion people, more than the lion and is expanding at 1.9 percent a year, a rate actual populations.2 that has been decreasing somewhat in the past In addition to the food shortages suffered by decade. The least developed nations, with a total many in developing' countries, there are wide- population of 560 million, are growing at 2.8 spread deficiencies in certain vitamins and min- percent a year. If they continue to grow at this erals. Vitamin A appears to be lacking from rate, their population will double in twenty-four many diets, especially in Southeast Asia, and years. At present about 87 million people are there is deficiency in iron, which contributes to added to the world's population each year. widespread anemia among women in the devel- oping world.3 Food: Nutrition and Malnutrition Food prices have been declining over the past several decades, and some observers have The wealthy nations have high levels of nutri- argued that the decline is a sign that adequate tion and little problem supplying all their citi- food for all is now available. But those in utter 156 Bioengineering of Crops 157 poverty do not have the resources to purchase of prime farm land for nonfarm uses, make it adequate food, even at today's prices. More re- essential for these two countries to adopt eco- cently, food prices have risen, while grain logically sustainable, intensive, and integrated stocks have fallen to their lowest level in thirty farming systems (see appendix). years.4 In China land is communally owned but indi- vidually cultivated under the country's House- Agriculture hold Responsibility System. In India land is individually owned and agriculture constitutes About 12 percent of the world's total land sur- the largest private-sector enterprise in the coun- face is used to grow crops, about 30 percent is try India's population of 950 million is growing forest or woodland, and 26 percent is pasture or at about 1.9 percent annually, while China's meadow. The remainder, about one-third, is stands at 1.22 billion and is growing at 1.1 per- used for other human purposes or is unusable cent a year. China has nearly 50 percent of its cul- because of climate or topography. In 1961 the tivated land under irrigation, while less than 30 amount of cultivated land supporting food pro- percent of India's cultivated area is irrigated.6 duction was 0.44 hectares per capita. Today it is Agriculture in both countries must provide about 0.26 hectares per capita, and based on not only more food but also more employment population projections, it will be in the vicinity and income. Modern industry is frequently of 0.15 hectares per capita by 2050.5 The rate of associated with economic growth, but growth expansion of arable land is now below 0.2 per- without adequate expansion of employment. cent a year and continues to fall. The bulk of the Modern agriculture can foster job-led economic land best suited to rainfed agriculture is already growth. Therefore, farming cannot be viewed in under cultivation, and the land that is being either country as merely a means of producing brought into cultivation generally has lower more food and other agricultural commodities; productivity. instead, it must be looked upon as the very foun- Urbanization frequently involves the loss of dation of a secure livelihood. New technologies, prime agricultural land, because cities are usu- such as biotechnology, information and space ally founded near such land. Losses of prime technologies, and renewable energy, are pivotal land are often not counterbalanced by the open- to building vibrant agricultural sectors, to pro- ing of other lands to production because the ducing more from less land and water, and to infrastructure that is generally required for mar- strengthening local economies. ket access is frequently lacking on those lands. Irrigation plays an important role in global Pressures on Agricultural Systems food production. Of the currently exploited arable land, about 16 percent is irrigated, pro- Widespread injurious agricultural practices, in ducing more than one-third of the world crop. both the industrial and the developing worlds, Irrigated land is, on balance, over two and a half have damaged the productivity of land, in some times more productive than rainfed land. cases severely.7 These practices have led to The situation in India and China is particu- water- and wind-induced erosion, salination, larly acute because their people account for compaction, waterlogging, overgrazing, and nearly half of the developing world's popula- other problems. For example, the estimated loss tion. Both countries have expanding popula- of topsoil in excess of new soil production is esti- tions and diminishing per capita arable land and mated to be about 0.7 percent of the total topsoil water resources. The average farm size in both each year; this loss amounts to some 25 billion countries is one hectare or less. Agriculture, tons, equivalent to the total in Australia's wheat including crop and animal husbandry, forestry, growing area. An additional 0.7 percent annual and fisheries, has been a way of life and a means loss occurs from land degradation and the to achieve a livelihood for several thousand spread of urbanization. Erosion has made a bil- years. Expansion in population and increases in lion hectares of soil unusable for agriculture purchasing power, coupled with the diversion over past years.8 Asia has the highest percentage 158 Biotechnology and Biosafety of eroded land, nearly 30 percent, but in all a basis for a humane future or from partial or major regions the percentage exceeds 12.9 It is complete destruction of the resource base, which estimated that 17 percent of all vegetated land would bring widespread misery was degraded by human activity between 1945 and 1990. The Future The effects of erosion on crop yield are not well documented because researching such In future years we are likely to face the follow- effects is difficult and expensive and because ing challenges. degradation can be masked for short periods of time by more intensive agricultural practices. Population However certain data are available.'0 Erosion can ultimately destroy the land's productive Although fertility has been declining worldwide capacity by stripping off all of the soil, as has in recent decades, it is not known when it will occurred in Haiti. "Haiti suffers some of the decline to replacement level. There is broad world's most severe erosion, down to bedrock agreement among demographers that if current over large parts of some regions, so that even trends are maintained, the world's population farmers with reasonable amounts of land cannot will reach about 8 billion by 2020, 10 billion by make a living."'" 2050, and possibly 12 to 14 billion before the end Irrigation practices continue to contribute to of the next century Virtually all of the growth in salinization and other forms of land damage. For coming decades will occur in the developing example, more than half of all irrigated land is world. in dry areas, and 30 percent of that land is moder- ately to severely degraded. Salinization is a Food Demand serious problem in Australia, Egypt, India, Mexico, Pakistan, and the United States. Some To provide increased nutrition for a growing 10 percent of the world's irrigated land suffers world population, it will be necessary to expand from salinization. food production faster than the rate of popula- There are also serious problems with sup- tion growth. Studies forecast a doubling in plies of water-much of the world is in short demand for food by 2025-30.16 Dietary changes supply."2 Worldwide, nations with some 214 and the growth in nutritional intake that accom- river or lake basins and 40 percent of the world's pany increased affluence will contribute to mak- population now compete for water.'3 Much irri- ing food demand larger than the projected gation depends on "fossil" underground water increase in population. supplies, which are being pumped more rapidly Asia, which has 60 percent of the world's than they are being recharged.'4 This problem population, contains the largest number of the affects portions of Africa, China, India, the world's poor; 800 million people in Asia live in United States, and several countries in the absolute poverty and 500 million live in extreme Middle East, especially Israel and Jordan. The poverty. Projections by the United Nations Food human race now uses 26 percent of the total ter- and Agriculture Organization (FAO), the World restrial evapotranspiration and 54 percent of the Bank, and the International Food Policy Re- fresh water runoff that is geographically and search Institute show that the demand for temporally accessible. Most land suitable for food in Asia will exceed the supply by 2010.17 rainfed agriculture is already in production.'" China, the world's most populous nation, has It is now clear that agricultural production is more than 1.2 billion people and an annual currently unsustainable. Indeed, human activi- growth rate of 1.1 percent a year. The country ties, as they are now conducted, appear to be will face considerable challenges in years ahead approaching the limits of the earth's capacity from stress resulting from major environmental These unsustainable activities, like all unsus- damage, shortages of water, and diversion or tainable practices, must end at some point. The degradation of arable lands."8 Animal protein end will come either from changes that establish has increased in the Chinese diet from about 7 Bioengineering of Crops 159 percent in 1980 to more than 20 percent today, products.22 The greatest challenges will be faced aggravating the country's food challenges. Most by nations that lack the capacity for substantial of the water available in China is used for agri- oil exports or other sources of wealth with which culture, and heavy use of fertilizers has polluted to purchase food imports. These nations include much of the water supply. Afghanistan, Cyprus, Egypt, Jordan, Lebanon, Lester Brown and Hal Kane have argued that Mauritania, Somalia, Tunisia, and Yemen, by 2030 India will need to import 45 million tons whose combined population exceeded 125 mil- of food grain annually and China 216 million lion in 1994. Food self-sufficiency is unattainable tons to feed their growing populations.19 The for most of these countries. Oil exporting na- widening gap between grain production and tions will, as their oil resources dwindle, join consumption in the two countries, caused by this less fortunate group. increases in population and purchasing power, Sub-Saharan Africa is the region whose will lead to the need for such imports. Brown prospective food supplies generate the greatest and Kane have pointed out that while demand concern; since 1980 agriculture there has grown will grow, production prospects are not bright at 1.7 percent a year, while population, now at owing to stagnation in applying yield-enhanc- 739 million, has grown at 2.9 percent a year.23 ing technologies and growing damage to the Some twenty years ago, Africa produced food ecological foundations essential for sustainable equal to what it consumed; today it produces advances in farm productivity. It is apparent that only 80 percent of the food it consumes.34 With a without substantial change there will not be population growth rate of close to 3 percent a enough grain to meet the needs of the two coun- year, Sub-Saharan Africa cannot close its food tries, a conclusion that at least some Chinese gap. The gap will likely grow, requiring in- scholars agree with.20 creased imports of food to prevent growing Latin America, which is economically and malnutrition and increased risk of famine. If pre- demographically advanced compared with sent worldwide decreases in foreign aid persist, Africa and Asia, appears to enjoy a relatively these imports may not be forthcoming. favorable situation with respect to food sup- plies and food security. Some regions are, how- Agriculture and Irrigation ever, under stress because of economic problems and continuing high rates of popula- As described above, the current rates of injury to tion increase. Bolivia, northeast Brazil, Peru, arable land are troubling. Since 1950, 25 percent much of Central America, and parts of the of the world's topsoil has been lost, and contin- Caribbean, especially El Salvador, Guatemala, ued erosion at the present rate will result in the Haiti, and Honduras, face important chal- further irreversible loss of at least 30 percent of lenges. Latin America's population is expected the global topsoil by the middle of the next cen- to increase from 490 million to nearly 680 mil- tury. A similar percentage may be lost to land lion by 2025, and it is possible that more than a degradation, a loss that can be made up only quarter of the area's annual cereal consumption with the greatest difficulty through conversion will be imported by 2020. The major countries of pasture and forest, themselves under pres- in the region, including Argentina, Brazil, Chile, sure. In Asia 82 percent of the potentially arable Colombia, and Mexico, appear to have the land is already under cultivation. Much of the resources necessary to meet their projected food land classed as potentially arable is not available needs, but doing so will require maintaining because it is of low quality or easily damaged. stable populations and implementing success- The FAO has projected that over the next ful land management programs.2" twenty years arable land in the developing coun- Countries in the Middle ]East and North tries could be expanded by 12 percent at satisfac- Africa have seen demand for food outpace tory economic and environmental costs, although domestic production. Differences in oil wealth such expansion would inflict major damage to and agricultural production determine differ- the world's remaining biodiversity.25 The yields ences in ability to import grains and livestock per hectare on this land would be less than on the 160 Biotechnology and Biosafety land already in production. This expansion is to production. Productivity is projected to be compared with the 61 percent increase in food increase in some areas and decrease in demand that is expected to occur in these coun- others, especially the tropics and sub- tries during the same period, according to a sce- tropics.... There may be increased risk nario discussed by the FAO. The last major of hunger and famine in some locations; frontiers that can potentially be converted to many of the world's poorest people- arable land are the acid soil areas of the Brazilian particularly those living in subtropical cerrado, the Ilanos of Colombia and Venezuela, and tropical areas and dependent on iso- and the acid soil areas of central and southern lated agricultural systems in semi-arid Africa. Bringing these unexploited, potentially and arid regions-are most at risk of in- arable lands into agricultural production poses creased hunger. Many of these at-risk formidable but not insurmountable challenges.26 populations are found in Sub-Saharan The prospects for expanding irrigation, so Africa; South, East, and Southeast Asia; critical to the intensification of agricultural pro- and tropical areas of Latin America, as ductivity, are also troubling. The growth of irri- well as some Pacific island nations.29 gated land has been slowing since the 1970s, owing to the problems discussed above as well Further deleterious changes may occur in as to "siltation" of reservoirs and the environ- livestock production, fisheries, and global sup- mental problems and related costs that arise plies of forest products. Salt intrusion into from the construction of large dam systems. The coastal area aquifers, many of which supply problems can include the spread of disease. water for irrigation, can occur as a result of ris- An important "wild card" in any assessment ing sea levels. While important uncertainties of future agricultural productivity is climatic about climatic change and its consequences will change resulting from anthropogenic emissions remain for some years, the matter must be con- of greenhouse gases. The consequences of such sidered in assessing the prospects for expanding change touch on a wide range of technical issues nutrition in the developing world. that will not be summarized here.27 However, the Intergovernmental Panel on Climate Change Prospects (IPCC) concluded in its second assessment report that the balance of evidence suggests that Today, there are hundreds of millions of people there is a discernable human influence on climate who do not get enough food. Given the circum- and that a global warming of about two degrees stances described above, it appears that over the Celsius, with a range of uncertainty from one to next quarter century grave problems of food three and a half degrees Celsius, will occur by security will almost certainly affect even more 2100. The consequences of a two-degree warm- people, as a number of observers have pointed ing would include regional and global changes out.30 in climate and climate-related parameters such as temperature, precipitation, soil moisture, and Given present knowledge, therefore, sea level. These changes could in turn give rise to maximum realization of potential land, regional increases in "the incidence of extreme and water, supplies at acceptable eco- high temperature events, floods, and droughts, nomic and environmental costs in the with resultant consequences for fires, pest out- developing countries still would leave breaks and ecosystem composition, structure them well short of the production in- and functioning, including primary productiv- creases needed to meet the demand sce- ity."28 According to the IPCC: narios over the next twenty years.31 Crop yields and changes in productivity The task of meeting world food needs to due to climate change will vary consid- 2010 by the use of existing technology erably across regions and among locali- may prove difficult, not only because of ties, thus changing the patterns of the historically unprecedented incre- Bioengineering of Crops 161 ments to world population that seem in- The application of modem techniques of evitable during this period but also be- crop bioengineering could be a key factor in cause problems of resource degradation implementing many of these improvements. and mismanagement are emerging. These techniques are a powerful new tool with Such problems call into question the sus- which to supplement pathology, agronomy, tainability of the key technological plant breeding, plant physiology, and other paradigms on which much of the expan- approaches that serve us now. sion of food production since 1960 has If crop bioengineering techniques are devel- depended.32 oped and applied in a manner consistent with ecologically sound agriculture, they could As is the case now, those in the lower tier of decrease reliance on broad spectrum insecticides, the developing countries will continue to be which cause serious health and environmental most affected by shortfalls in food production. problems. This reduction could be accomplished The industrial nations and the developing by breeding crop varieties that have specific tox- nations whose economies continue to improve icity to target pests but do not affect beneficial will face acceptable costs in providing their citi- insects. Furthermore, bioengineering techniques zens with adequate nutrition. The extent of could assist in the development of crop varieties deprivation and economic and environmental that are resistant to currently uncontrollable costs remains the subject of controversy between plant diseases. At their best bioengineering tech- optimists and pessimists.33 niques are highly compatible with the goals of sustainable agriculture because they offer surgi- Meeting the Challenges cal precision in combating specific problems without disrupting other functional components The main challenge is to expand agricultural of the agricultural system. production at a rate exceeding population While it is feasible to use biotechnology to growth in the decades ahead so as to provide improve the ecological soundness of agriculture, food to the hungry new mouths to be fed. This well-informed decisions must be made regard- goal must be accomplished in the face of a fixed ing which specific biotechnology projects are or slowly growing base of arable land offering encouraged and which are discouraged. For little expansion, and it must involve simultane- example, ten years ago, when crop bioengineer- ous replacement of destructive agricultural ing was being introduced in the United States, practices with more benign ones. Thus the call some projects were focused on engineering crops for agricultural sustainability.34 Owing to the for tolerance against a dangerous herbicide. The daunting nature of this challenge, every eco- projects were dropped after environmental nomically, ecologically, and socially feasible groups protested. Projects targeted for develop- improvement will have to be carefully exploited. ing countries will have to be scrutinized to make A list of potential improvements includes: sure that their long-term impacts are beneficial. * Introducing energy-intensive farming, inclu- Not all challenges to sustainable and pro- ding, in some areas, increased fertilizer use ductive agriculture can be addressed with * Conserving soil and water, with special pri- biotechnology. For example, improving soil and ority given to combating erosion water conservation, maintaining biodiversity, * Maintaining biodiversity and improving irrigation techniques must be • Improving pest control dealt with by other means. . Expanding irrigation and making it more We must emphasize that the improvements efficient in agriculture described in this report, while * Improving livestock management badly needed, do not address all of the difficul- * Developing new crop strains with increased ties faced by the lower tier of developing na- yield, pest resistance, and drought tolerance tions. There is almost no dispute that careful * Reducing dependency on pesticides and planning and selection of priorities, coupled herbicides. with substantial commitments from both indus- 162 Biotechnology and Biosafety trial and developing nations, will be required to 13. World Resources Institute, World Resources provide the food supplies that the future will 1992-93 (Washington, D.C., 1995). demand, to move to sustainable agricultural 14. Lester R. Brown, "Future Supplies of Land and practices, and to alleviate hardship in now- Water Are Fast Approaching Depletion," in Population and Food in the Early Twenty-First Century: Meeting impoverished nations. Future Food Demand of an Increasing Population, ed. Nurul Islam (Washington, D.C.: International Food Notes Policy Research Institute, 1995). 15. Sandra Postel, Gretchen Daily, and Paul Ehrlich, 1. See H. W. Kendall and David Pimentel, "Con- "Human Appropriation of Renewable Fresh Water," straints on the Expansion of the Global Food Sup- Science, 9 February 1996, 785-88. ply," AMBIO 23 (May 1994):198-205. 16. Donald L. Plucknett, "Prospects of Meeting 2. Norman E. Borlaug, "Feeding the World: The Future Food Needs through New Technology," in Challenges Ahead," in Meeting the Challenges of Population and Food in the Early Twenty-First Century, Population, Environment, and Resources: The Costs of 207-08; Borlaug, "Feeding the World: The Challenges Inaction, H. W. Kendall and others. (Washington, D.C.: Ahead." World Bank, 1996). 17. Kirit Parikh and S. M. Dev, "Comments: Asia," in 3. Robert W. Herdt, "The Potential Role of Biotech- Population and Food in the Early Twenty-First Century, nology in Solving Food Production and Environmental 117-18. Problems in Developing Countries," inAgricultureand 18. Vaclav Smil, "Comments: Asia," in China's Environment: Bridging Food Production and Environ- Environmental Crisis-An Inquiry into the Limits ofNational mental Protection in Developing Countries, ed. Anthony Development (Armonk, N.Y: M. E. Sharpe, 1993). S.R. Juo and Russell D. Freed, American Society of 19. Lester R. Brown and Hal Kane, Full House: Agronomy Special Publication 60 (Madison, Wis., Reassessing the Earth's Population Carrying Capacity 1995),33-54. (New York: W. W. Norton, 1994); Lester R. Brown, Who 4. Per Pinstrup-Andersen and James L. Garrett, Will Feed China? Wake-Up Call for a Small Planet (New Rising Food Prices and Falling Grain Stocks: Short-Run York: W. W. Norton, 1995). Blips or New Trends? 2020 Brief (Washington, D.C.: 20. "Malthus Goes East," Economist, 12August 1995,29. International Food Policy Research Institute, 1996). 21. Tim Dyson, Population and Food (London and 5. Robert Engelman and Pamela LeRoy, Conserving New York: Routledge, 1996). Land: Population and Sustainable Food Production 22. Thomas Nordblom and Farouk Shomo, (Washington, D.C.: Population Action International, "Comments: Middle East/North Africa," in Population 1995). and Food in the Early Twenty-First Century, 131. 6. World Resources Institute, World Resources 1994-95 23. World Bank, Rural Development: From Vision to A Report of the World Resources Institute Action(Washington,D.C.,1997). (Washington, D.C., 1995). 24. J. Cherfas, Science, 1990,1140-41. 7. See especially D. Norse and others, "Agriculture, 25. Food and Agriculture Organization of the United Land Use, and Degradation," inAn Agenda of Sciencefor Nations, Agriculture: Towards 2010; Pierre Crosson, in Environment and Development into the 21st Century, ed. Population and Food in the Early Twenty-First Century, J. C. I. Dooge and others (Cambridge, U.K.: Cambridge 143-59- University Press). 26. Borlaug, 'Feeding the World: The Challenges 8. Food and Agriculture Organization of the United Ahead.' Nations, Agriculture towards 2010 (Rome, 1993). 27. Intergovernmental Panel on Climate Change 9. Robert W. Herdt, "The Potential Role of Bio- (IPCC), Radiative Forcing of Climate Change-The 1994 technology in Solving Food Production and En- ReportoftheScientificAssessment WorkingGroup ofIPCC vironmental Problems in Developing Countries," (New York: IPCC, World Meteorological Organization, 33-54; World Resources Institute, World Resources and United Nations Environment Programme, 1994); 1992-93 (New York: Oxford University Press, 1993). John Houghton, Global Warming-The Complete Briefing 10. David Pimentel and J. Krummel, 'Biomass (Oxford: Lion Publishing, 1994). Energy and Soil Erosion: Assessment of Resource 28. IPCC, Summaryfor Policymakers: Impacts, Adapta- Costs," BioScience 14 (1987): 15-38. tion, and Mitigation Options, The Second Assessment Re- 11. World Commission on Environment and De- port of Working Group II (Washington, D.C., 1995). velopment, Our Common Future (New York: Ox- 29. IPCC, Summary for Policymakers. See also ADB ford University Press, 1987). (Asian Development Bank), Climate Change in Asia: 12. Sandra Postel, "Water and Agriculture," in Water Executive Summary (Manila, 1994); David W. Wolfe, in Crisis, A Guide to the World's Fresh Water Resources, "Potential Impact of Climate Change on Agriculture ed. Peter H. Gleick (New York: Oxford University and Food Supply" (Paper presented at the Center for Press, 1993), 56-62. Environmental Information's Conference on Bioengineering of Crops 163 Sustainable Development and Global Climate Change, 33. See John Bongaarts, "Can the Growing Human Arlington, Va., 4-5 December 1995). Population Feed Itself?" ScientificAmerican, March 1994, 30. Klaus M. Leisinger, Sociopolitical Effects of New 18; Alex F. McCalla, "Agriculture and Food Needs to Biotechnologies in Developing Countries, Food, Agriculture, 2025: Why Should We Be Concerned?" (Consultative and the Environment Discussion Paper 2 (Washington, Group on International Agricultural Research, Sir John D.C.: International Food Policy ResearchInstitute, 1995). Crawford Memorial Lecture, Washington, D.C., 27 31. Crosson, in Population and Food in the Early October 1994). Twenty-First Century, 157. 34. D. L. Plucknett and D. L. Winkelmann, 32. Peter A. Oram and Behjat Hojjati, in Population "Technology for Sustainable Agriculture," Scientific and Food in the Early Twenty-First Century, 167. American, September 1995,182-86. CHAPTER 2 Bioengineering Technology P lant scientists can now transfer genes into long been exploited by plant breeders. Bio- many crop plants and achieve stable inter- technology provides new tools to the breeder generational expression of new traits. to expand plant capacity. In the past crop breed- "Promoters" (deoxyribonucleic acid [DNA] se- ers were generally limited to transferring genes quences that control the expression of genes, for from one crop variety to another. In some cases example) can be associated with transferred genes they were able to transfer useful genes to a vari- to ensure expression in particular plant tissues or ety from a closely related crop species or a at particular growth stages. Transformation can related native plant. Genetic engineering now be achieved with greater efficiency and more rou- gives plant breeders the power to transfer genes tinely in some dicots (for example, tomatoes, to crop varieties independent of the gene's ori- potatoes) than in some monocots (for example, gin. Thus bacterial and even animal genes can be rice and wheat), but with determined effort nearly used to improve a crop variety. all plants can or will be modified by genetic engi- Bacillus thuringiensis (Bt), a bacterium that neering. produces an insect toxin particularly effective against lepidoptera (such as caterpillars and Gene Transformation moths), has been applied to crops by gardeners for decades. It is also effective against mosqui- Genetic transformation and other modern crop toes and certain beetles. Transformation of breeding techniques have been used to achieve tomato and tobacco plants with the gene that four broad goals: to change product characteris- produces Bt toxin was one of the first demon- tics, improve plant resistance to pests and strations of how biotechnology can be used to pathogens, increase output, and improve the enhance a plant's ability to resist damage from nutritional value of foods. insects.3 Transgenic cotton that expresses Bt Genetic modification to alter product charac- toxin at a level providing protection against cot- teristics is illustrated by the Flavr Sarv' tomato, ton bollworm has been developed, and a large one of the first genetically engineered plants to number of Bt-transformed crops, including corn receive approval from the U.S. Food and Drug and rice, are currently being field tested.4 Other Administration and to be made available for gen- strategies to prevent insect damage include eral consumption by the public; the fruit ripening using protein coding genes of plant origin, such characteristics of this variety were modified to as lectins, amylase inhibitors, protease inhibi- provide a longer shelf life.' Biotechnology has also tors, and cholesterol oxidase, that retard insect been used to change the proportion of fatty acids growth.' in soybeans, modify the composition of canola oil, Genes that confer resistance to viral diseases and change the starch content of potatoes.2 have been derived from the viruses themselves, Natural variability in the capacity of plants most notably with coat protein mediated resis- to resist damage from insects and diseases has tance (CP-MR). Following extensive field evalu- 164 Bioengineering of Crops 165 ation, a yellow squash with CP-MR resistance to cular marker techniques with exotic names such two plant viruses was approved for commercial as restriction fragment length polymorphism production in the United States.6 Practical resis- (RFLP), random amplified polymorphic DNA tance to fungal and bacterial pathogens has been (RAPD), and microsatellites. These techniques more elusive, although genes encoding enzymes allow scientists to follow genes from one gener- that degrade fungal cell walls or inhibit fungal ation to the next, adding to the tools at the dis- growth are being evaluated. More recently, nat- posal of plant breeders. In particular, the ural genes for resistance to pathogens have been techniques enable plant breeders to combine sev- cloned, modified, and shown to function when eral resistance genes, each of which may have transferred to susceptible plants.7 different modes of action, leading to longer-act- While protecting plants against insects and ing or more durable resistance against patho- pathogens promises to increase crop yield by sav- gens. Marking also makes it possible for the ing a higher percentage of present yield, several breeder to combine several genes, each of strategies seek to increase the potential crop yield. which may individually provide only a weakly These strategies include exploiting hybrid vigor, expressed desirable trait but in combination delaying plant senescence, and inducing plants to have higher activity. flower earlier and to increase starch production. Several strategies to produce hybrid seeds in Ongoing Research new ways will likely contribute to increasing yield potential. Cytoplasmic male sterility was Research continues to improve the efficiency widely used long before the age of biotechnol- and reduce the costs of developing transgenic ogy, but strategies to exploit male sterility crops and using genetic markers. As this re- require biological manipulations that can only search succeeds, it will be applied to different be carried out using tools from molecular plants and genes. biology; several of these strategies are well By far the greatest proportion of current advanced.8 Some of the strategies entail sup- research in crop biotechnology is being con- pressing pollen formation by changing the tem- ducted in industrial countries on the crops of perature or day length. Delayed senescence or economic interest in those countries. Plant "stay-green" traits enable a plant to continue biotechnology research in the fifteen countries of producing food beyond the period when a non- the European Union is probably a fair reflection transformed plant would, thereby potentially of current global research in plant biotechnol- producing a higher yield.9 Potatoes that produce ogy Almost 2,000 projects are under way, 1,300 higher starch content than nontransformed con- of them actually using plants (as opposed to trol potatoes have been developed.'" plant pathogens, theoretical work, and the like). Plants have been modified to produce a About 210 of the projects using plants are on range of lipids, carbohydrates, pharmaceutical wheat, barley, and other cereals; 150 of the pro- polypeptides, and industrial enzymes, leading jects are on the potato; 125 are on oilseed rape; to the hope that plants can be used in place of and about 90 are on maize.13 microbial fermentation." One of the more ambi- The worldwide record of field trials reflects tious of such applications is the production of the focus of research activities, and the record vaccines against animal and human diseases. shows that work on cereals was started some- The hepatitis B surface antigen has been ex- what later thanwork on otherplants. Some 1,024 pressed in tobacco, and the feasibility of using field trials were conducted worldwide through the purified product to elicit an immune re- 1993; 88 percent of those trials were in Or- sponse in mice has been demonstrated.'2 ganization for Economic Cooperation and Development (OECD) countries, with 38 per- Gene Markers cent in the United States, 13 percent in France, and 12 percent in Canada. Belgium, the Far-reaching possibilities for identifying genes Netherlands, and the United Kingdom each have been made possible through various mole- hosted about 5 percent of the total number of 166 Biotechnology and Biosafety field trials. Argentina, Chile, China, and Mexico techniques can be used to develop easy-to-use led in numbers of trials in developing countries, kits that can alert the farmer to the presence of but none had more than 2 percent of the total.'4 deoxyribonucleic acid (DNA) from the Tungro The largest number of field trials was con- virus in rice plants. Such knowledge can de- ducted on the potato (19 percent). Oilseed rape crease the frustration and money spent on accounted for 18 percent of the field trials, while solving the wrong problem. tobacco, tomatoes, and maize each accounted for about 12 percent. There were more than ten Current Efforts trials each on alfalfa, cantaloupe, cotton, flax, sugar beet, soybean, and poplar. Nine tests were Most biotechnology research in industrial coun- done on rice, and fewer than nine on wheat, tries is being conducted on human health issues sorghum, millet, cassava, and sugarcane, the rather than on agriculture. Government spend- crops that, aside from maize, provide most of the ing for biotechnology research in the United food to most of the world's people, who live in States is about $3.3 billion a year, with $2.9 bil- the developing countries. lion going to health issues and $190 million to Herbicide tolerance has been the most agricultural issues.7 It is estimated that between widely tested genetically engineered trait, 1985 and 1994 $260 million was contributed in accounting for 40 percent of the field trials for the form of grants to agricultural biotechnology agronomically useful transgenes. Twenty-two in the developing world; another $150 million percent of tests were conducted on ten different was contributed in the form of loans. An aver- types of modified product quality, including age of perhaps $50 million a year has been con- delayed ripening, modified processing charac- tributed in more recent years.'8 At least a third ters, starch metabolism, and modified oil con- and perhaps half of these funds have been used tent.'" About 40 percent of field trials in to establish organizations designed to help bring developing countries were for virus resistance. the benefits of biotechnology to developing Twenty-five percent of the trials were for crops countries. modified for herbicide resistance, and another Maize is the focus of much crop biotechnol- 25 percent were for insect resistance, with the ogy work in the United States. Most of this work balance for product quality, fungal resistance, or on maize is directed toward making it better agromatic traits.'6 suited for production or more capable of resist- Although much of the biotechnology re- ing the depredations of the pests in industrial search in agriculture has focused on bioengi- countries. The International Wheat and Maize neering (that is, gene transfer), the techniques of Improvement Center sponsors the largest inter- biotechnology extend beyond this approach. national effort directed at identifying traits of The techniques involved in tissue culture have maize that could be improved using biotechnol- been advanced and refined over the past decade. ogy, but the center spends barely $2 million a These techniques can be used to regenerate year on those efforts. plants from single cells and have proven espe- There are, at present, only four coherent, cially useful in producing disease-free plants coordinated programs directed specifically at that can be propagated and distributed to farm- enhancing biotechnology research on crops in ers. The use of these plants has resulted in sig- developing countries, one supported by the nificant yield improvements in crops as diverse U.S. Agency for International Development as potato and sugarcane. (USAID), one by the Dutch government, one by Another use for biotechnology is in develop- the Rockefeller Foundation, and one by the ing diagnostic techniques. Too often, poorly per- McKnight Foundation. forming crops have observable symptoms that The USAID-supported project, Agricultural are so general that the farmer cannot determine Biotechnology for Sustainable Productivity the specific cause. For example, Tungro disease (ABSP), is headquartered at Michigan State in rice produces symptoms that match those of University and implemented by a consortium of certain nutrient deficiencies. Biotechnology U.S. universities and private companies. It is tar- Bioengineering of Crops 167 geted at five crop/pest complexes: the potato About two hundred senior scientists and and the potato tuber moth, the sweet potato and three hundred trainee scientists are participat- the sweet potato weevil, maize and the stem ing in the program. The scientists are spread borer, the tomato and the tomato yellow leaf throughout all the major rice-producing coun- virus, and cucurbits and several viruses. The tries of Asia and a number of industrial coun- ABSP is an outgrowth of an earlier USAID-sup- tries. Researchers from the group transformed ported project on improving tissue culture tech- rice in 1988, a first for any cereal. Transformed niques for crops. It builds on the network of rice has been field-tested in the United States. A scientists associated with that earlier project and significant number of lines transformed with draws on other scientists as well. agronomically useful traits now exist and are The cassava biotechnology network, spon- being developed for field tests. RFLP maps, that sored by the Netherlands Directorate General is "road maps" that allow breeders to follow for International Cooperation, held its first genes, are being used to assist breeding, and meeting in August 1992. Its goals include using some rice varieties developed by advanced tech- the tools of biotechnology to modify cassava to niques not requiring genetic engineering are better meet the needs of small-scale cassava pro- now being grown by Chinese farmers. ducers, processors, and consumers. More than The McKnight Foundation recently estab- 125 scientists from 28 countries participated in lished its Collaborative Crop Research Program, the first network meeting. Funding to date has which links researchers in less developed coun- been about $2 million. An important initial tries with U.S. plant scientists in order to activity is a study of farmers' needs for technical strengthen research in selected countries and to change in cassava. The study will be based on a focus the work of U.S. scientists on food needs field survey of cassava producers in several loca- in the developing world. The program is being tions in Africa. funded at $12 to $15 million for the first six years. Another important initiative, the Inter- While crop engineering is not the sole research national Laboratory of Tropical Agricultural tool supported by the program, it plays an Biotechnology, is being developed at the Scripps extremely important role. Institute in La Jolla, California. It is jointly Early in the effort to apply bioengineering to administered by the institute and by L'Institut crop improvement, there was great hope placed francais de recherche scientifique pour le in the potential to engineer the capacity for nitro- developpement en coop6ration (ORSTOM), a gen fixation into crops without it. After the French governmental development agency. investment of millions of dollars in public and Funding for research in the control of diseases venture capital and many years of research, it of rice, cassava, and tomato through applica- has become apparent that the genetic machinery tions of biotechnology is provided in grants involved in nitrogen fixation by legumes is from ORSTOM, the Rockefeller Foundation, the extremely complex and beyond our current ABSP, and USAID. Most of the research is car- capacity for gene transfer and expression. At ried out by fellows, students, and other trainees some point in the future nitrogen fixation may from developing countries. be transferred to crops such as corn and rice, but The Rockefeller Foundation began to sup- such an achievement must be seen as a far-off port rice biotechnology in the developing world goal. in 1984. The foundation's program has two It is unlikely that the budgets of these four objectives: (1) to create biotechnology applicable focused crop biotechnology efforts, taken to- to rice to produce improved rice varieties suited gether, come to more than $20 million annu- to developing country needs and (2) to ensure ally. Total agricultural biotechnology research in that scientists in developing countries know the developing world may not greatly exceed how to use biotechnology techniques and are $50 million annually.'9 Brazil, China, Egypt, capable of adapting the techniques to their own India, and a few other countries have a reason- objectives. Approximately $50 million in grants able base for biotechnology, but most develop- have been made through the program. ing countries will find it difficult to develop 168 Biotechnology and Biosafety useful biotechnology products without sharply links between biotechnologists and plant breed- directed assistance. Little attention will be paid ers; the ability of scientists to identify the con- to crops of importance in the developing world straints and the genes that overcome them; the or to the pests, diseases, and stresses that afflict ability of scientists to get those genes into good them unless the crops are also important to the crop varieties; and the success of plant scientists more advanced countries. That is, while the and others in crafting meaningful biosafety gains in fundamental knowledge that apply to regulations. all organisms will be available, the programs It is likely that efforts to improve the rice may not produce applications in the form of yield in Asia through biotechnology will result transformation techniques, probes, gene pro- in a production increase of 10 to 25 percent over moters, and the like. the next ten years. The increase will come from improved hybrid rice systems in China; in other Potential Contributions of Transgenic Crops Asian countries it will come from rice varieties transformed with genes for resistance to pests Transgenic crops have the potential to con- and diseases. These transformed rice varieties tribute to increased production and food quality, will raise average yields by preventing crop environmental well-being, and human health. damage, not by increasing yield potential. The reason is simple: few strategies are being pur- Potential Applications to Improved Production sued to directly raise yield potential because few and Food Quality strategies have been conceived. The use of hybrid rice is one exception. Potential ways to How will the developments of molecular biology raise yield potential revolve around increasing contribute to solving the food production prob- "sink" size and "source" capacity. Adding to lems in developing countries in the years ahead? sink size involves increasing the number of Contributions may come through two different grains or the average grain size; increasing paths: (1) research in molecular biology directed source capacity means improving the capacity of specifically at food needs in the developing world the plant to fill these grains with carbohydrate. or (2) "spillover" innovations directed at issues in Both improvements are desired, but there are industrial countries but also beneficial to food only a few investigators thinking about how production in developing countries. biotechnology might help to achieve these The preceding section shows that the re- improvements, especially in rice crops. While sources directed at food crop production in there is a community of scientists working to developing countries are small, especially when understand basic plant biochemistry, including compared with those directed at crops in the photosynthesis, this work as yet offers no hints industrial world. Still, some important contribu- about which genes can be manipulated to ad- tions should come from the resources being vantage using the tools of molecular biology applied to developing countries. Training of sci- and genetic engineering. entists in developing countries under various Maize yields in developing countries may be programs means that there is a small cadre of affected by biotechnology if genes useful in trop- plant molecular biologists in a number of devel- ical countries are discovered in the course of the oping countries. The Rockefeller Foundation's great amount of research on maize under way in support for rice biotechnology should begin to the United States. Although most of the maize pay off in two to five years in the form of new research is being carried out by private firms, varieties available to some Asian farmers. In some discoveries may be made available for China varieties produced through anther cul- applications in developing countries either at no ture, a form of biotechnology, are now being cost or at low enough cost to make them com- grown on thousands of hectares by farmers in mercially feasible. Biotechnology applications rural areas near Shanghai. The speed with which beneficial to cassava are further in the future, as varieties get into farmers' hands depends are those on the smallholder banana and other largely on national conditions-the closeness of crops of importance in the developing world. Bioengineering of Crops 169 Herbicide resistance is potentially the sim- Drought is a major problem for nearly all crop plest of traits to incorporate into a plant, because plants, and the prospect of a "drought resistance application of the herbicide is an ideal way to gene" has excited many scientists. However, plant select a modified individual cell. A population scientists recognize that many traits contribute to of cells exposed to DNA that confers herbicide drought tolerance or resistance: long, thick roots; resistance can quickly be screened. A number of thick, waxy leaves; the ability to produce viable different herbicides are available, and there is a pollen when under drought stress; the ability to strong self-interest on the part of herbicide man- recover from a dry period; and others. Some of ufacturers to encourage farmers to use herbi- these traits can undoubtedly be controlled genet- cides. Thus a number of pressures are at work to ically, but little progress has been made thus far in ensure that transgenic crops with herbicide identifying the genes that control them. Salt toler- resistance are produced. Given that weeds cur- ance is often discussed along with drought toler- rently constrain crop yields in developing coun- ance because salt conditions and drought cause tries, crop yields may rise if herbicide use plants to react in similar ways. Unfortunately, increases. In addition, proper regulatory activi- some of the genes that confer drought tolerance ties may lead to increased use of herbicides that may be useless for salty conditions and vice versa. are less damaging to the environment (biode- Some early workers held that fusing cells of plants gradable herbicides, for example). In impover- tolerant to drought with nontolerant plants would ished countries cash-poor farmers typically do result in a useful combination, but that has not not have access to such herbicides, especially been demonstrated despite considerable effort. the expensive ones such as glyphosphate, for The possibility of increasing the starch content which resistance is being engineered. Thus her- of crops through genetic manipulation that mod- bicide resistance may not benefit the average ifies the biosynthetic pathways of the plant is farmer in impoverished countries unless the enticing. Some success has been demonstrated in cost of herbicides is reduced. It should be noted the case of the potato. This success holds out the that prices are decreasing as patent protection is hope that it may be possible to achieve the goal of lost. a significant increase in production potential in Prospects for incorporating pest and disease the potato and other root and tuber crops such as resistance into developing country crops are cassava, yams, and sweet potatoes.20 more favorable than prospects for increasing Prospects for achieving this goal may de- yields. Pest and insect problems are much sim- pend on two factors: (1) the extent to which pler to address, and much of the effort in biotech- there are alternative metabolic routes to the nology is focused on these problems. Many of the same product and (2) the extent to which genes that resolve insect and disease problems in control of plant metabolism is shared among the temperate crops may also be effective in tropical component reactions of individual pathways.2' crops. If they are, problems related to gaining "There may well be short pathways in plant access to the genes and transforming plants with metabolism where control is dominated by one them will remain, because most of the genes have or two steps, but the current evidence suggests associated intellectual property rights. In one that this is not so for the longer pathways. This case Monsanto made available to Mexico, with- conclusion has far-reaching effects on our ability out cost, the genes that confer resistance to to manipulate plant metabolism."2F important potato viruses and trained Mexican scientists in plant transformation and other skills Potential Applications to Environmental Problems needed to make use of the genes.. The trans- formed potatoes are now being field-tested in Genetic engineering holds out the possibility Mexico. Monsanto has also worked with USAID that plants can be designed to improve human and KARI to develop and donate a similar virus welfare in ways other than by improving crop control technology to Kenya and Indonesia for properties or yields. For example, a biodegrad- virus control in the sweet potato. These cases are, able plastic can be made from the bacterial stor- however, exceptional. age product polyhydroxbutyrate, and the 170 Biotechnology and Biosafety bacterial enzymes required to convert acetyl- duction of insoluble aggregates of the desired CoA to polyhydroxbutyrate have been ex- material that require resolubization before use. pressed in the model plant Arabidopsis Plant production of such proteins would avoid thaliana. This accomplishment demonstrates the the capital investment and would in most cases possibility of developing a plant that can accu- produce soluble materials. However, the cost mulate appreciable amounts of polyhydroxbu- involved in extracting and purifying proteins tyrate.23 The optimization of such a process in from plants may be significant and may offset a plant that will produce the substance in com- lower production costs, although the economics mercial quantities has not yet been achieved. of purifying proteins from plant biomass has not At present 80 percent of potato starch is been evaluated extensively.28 This disadvantage chemically modified after harvest. If starch can to some extent be offset by expressing the modification could be tailored in the plant, costs protein in the seed at a high level.29 might be lower, and the waste disposal prob- Plants can potentially be used as the produc- lems associated with chemical modification ers of edible vaccines. The hepatitis B surface would be reduced.24 antigen has been expressed in tobacco, and the The observation that certain plants can grow feasibility of oral immunization using transgenic in soils containing high levels of heavy metals potatoes has been demonstrated.30 The chal- such as nickel or zinc without apparent damage lenges involved in the design of specific vaccines suggests the possibility of deliberately removing include optimizing the expression of the anti- toxic substances using plants. Plants with the genic proteins, stabilizing the expression of pro- ability to remove such substances (hyperaccu- teins in the post-harvest process, and enhancing mulators) typically accumulate only a single ele- the oral immunogenicity of some antigens.31 ment and grow slowly. In addition, most have There are even greater challenges to developing not been cultivated, so their seeds and produc- effective protocols for immunization. tion techniques are poorly understood. One way around these limitations might be to genetically Notes engineer crop plants to hyperaccumulate toxic 1. R. G. Fray and D. Grierson, "Molecular Genetics of substances. Some increased metal tolerance has Tomato Fruit Ripening," Trends in Genetics 9 (1993): been obtained in transgenic Arabidopsis plants.25 438-43. The use of plants for decontamination of soil, 2. T. A. Voelker, and others, Science 257 (1992): 72-74; water, and air is still at a early stage of research D.M. Strak, K. P. Timmerman, G. R Barry, J. Preiss, and and development. "No soil has been success- G. M. Kishore, Science 258 (1992): 287-92. fully decontaminated yet by either phytoextrac- 3. F. J. Perlak and D. A. Fishoff, "Advanced En- gineered Pesticides," in Advanced Engineered Pesticides, tion or phytodegradation/'26 ed., Leo Kim (New York: Marcel Dekker, 1993),199-211. 4. F. J. Perlak and others, "Insect Resistant Cotton Potential Applications to Human Health Problems Plants," Bio/Technology 8 (1990): 939-43; see also www.aphis.usda.gov/bbep /bp, a U.S. Department of As a result of biotechnology, compounds that Agriculture site which provides biotechnology field were previously available only in limited quan- test information. titiesrfrom exotic plant species or other organ- 5. D. M. Shah, C. M. T. Rommens, and R. N. Beachy, tities or "romexoc pantspees r oherorgn- Resistance to Diseases and Insects in Transgenic isms can now be produced in domesticated Plants: Progress and Applications to Agriculture," crops. It has already proved feasible to produce Trends in Biotechnology 13 (1995): 362-68. carbohydrates, fatty acids, high-value pharma- 6. Shah, Rommens, and Beachy, "Resistance to ceutical polypeptides, industrial enzymes, and Diseases and Insects in Transgenic Plants: Progress and biodegradable plastics.27 Production of proteins Applications to Agriculture." and peptides has been demonstrated, and it has 7. W. Y. Song, G. L. Wang, and P. Ronald, "A been shown that plants have several potential Receptor Kinase-Like Protein Encoded by the Rice Disease Resistence Gene," Science 270 (1995): 1804-06. advantages over microbial fermentation sys- 8. M. E. Williams, "Genetic Engineering for tems. Bacterial fermentation requires significant Pollination Control," Trends in Biotechnology 13 (1995): capital investment and often results in the pro- 344-49. Bioengineering of Crops 171 9. S. Gan and R. M. Amasino, "Inhibition of 19. Brenner and Komen, "Intemational Initiatives in Leaf Senescence by Autoregulated Production of Biotechnology for Developing Country Agriculture: Cytokinin," Science 270 (1995): 1986-88. Promises and Problems." 10. D. M. Stark, K. P. Tirnrmerman, and G. F. Barry, 20. Stark, Timmerman, and Barry, "Regulation of the "Regulation of the Amount of Starch in Plant Tissues Amount of Starch in Plant Tissues by ADP Glucose by ADP Glucose Pyrophosphorylase," Science 258 Pyrophosphorylase." (1992):287-92. 21. Tom ap Rees, "Prospects of Manipulating Plant 11. 0. J. M. Goddijn and Jan Pen, "Plants as Metabolism," Trends in Biotechnology 13 (1995): 375-78. Bioreactors," Trends in Biotechnology 13 (1995): 379-87. 22. Brenner and Komen, "International Initiatives in 12. Y. Thonavala and others, in Proceedings of the Biotechnology for Developing Country Agriculture: National Academy of Sciences, USA 92 (1995): 3358-61. Promises and Problems." 13. L. P. Meredith Lloyd-Evans and Peter Barfoot, 23. Y. Poirier, Y. Nawrath, and C. Somerville, "EU Boasts Good Science Base and Economic Prospects "Production of Polyhydroxyalkanoates, A Family of for Crop Biotechnology," Genetic Engineering News 16 Biodegradable Plastics and Elastomers, in Bacteria and (1996). For a description of field testing being carried Plants," Bio/Technology 13 (1995): 142-50. on in the United States, see A. A. Snow and P. M. Palma, 24. Goddijn and Pen, 'Plants as Bioreactors.' "Commercialization of Transgenic Plants: Potential 25. R. B. Meagher and others, Abstract of the 14th EcologicalRisks," BioScience47 (February 1997): 86-96. Annual Symposium on Current Topics in Plant Bio- 14. P. J. Dale, "R&D Regulation and Field Trailling chemistry, Physiology, and Molecular Biology (Uni- of Transgenic Crops," Trends in Biotechnology 13 (1995): versity of Missouri, 1995), 29-30. 398-403. 26. Scott D. Cunningham, William R. Berti, and 15. Dale, "R&D Regulation and Field Trailling of Jianwei W. Huang, "Phytoremediation of Con- Transgenic Crops." taminated Soils," Trends in Biotechnology 13 (1995): 16. A. F. Krattinger, Biosafety for Sustainable 393-97. Agriculture (Ithaca, N.Y.: Stockholm Environmental 27. Goddijn and Pen, "Plants as Bioreactors." Institute and International Service for the Acquisition 28. Goddijn and Pen, "Plants as Bioreactors." of Agri-Biotechnological Applications, 1994). 29. E. Krebbers and J. van de Kerckhove, "Pro- 17. Office of the President, Budget of the United States duction of Peptides in Plant Seeds," Trends in Bio- (Washington, D.C.: U.S. Government Printing Office, technology 8 (1990): 1-3. 1992). 30. T. A. Haq, H. S. Mason, and C. J. Arntzen, "Oral 18. Carliene Brenner and John Komen, "International Immunization with a Recombinant Bacterial Antigen Initiatives in Biotechnology for Developing Country Produced in Transgenic Plants," Science 268 (1995): Agriculture: Promises and Problems," in Organisation 714-16. for Economic Co-operation and Development Technical 31. Hugh S. Mason and Charles J. Arntzen, Paper 100 (Organisation for Economic Co-operation "Transgenic Plants as Vaccine Production Systems," and Development Center, 1994). Trends in Biotechnology 3 (1995): 388-92. CHAPTER 3 Possible Problems A ll new technologies must be assessed in wide ranges in nature and can be recognized as terms of benefits and costs. This section a result of their distinctive characteristics. The ,Axoutlines a number of potential costs or characteristics of corn, wheat, and many other problems that may be associated with develop- crops were enhanced during the course of their ing and using the new tools of biotechnology in evolution as a result of hybridization with developing countries. Some of the problems related species or weedy or cultivated strains associated with biotechnology for crop improve- that were nearby; those related, infertile, and ment are not new. Indeed, some of the problems sometimes weedy strains have also been en- that were faced thirty years ago during the Green hanced genetically, in some instances follow- Revolution must be addressed once again to ing hybridization with the cultivated crop to safeguard the use of agricultural biotechnology. which they are related. The new tools of biotechnology give us more In view of these well-known principles, stud- power to make positive or negative impacts on ied for well over fifty years, it is clear that any the environment than was the case with conven- gene that exists in a cultivated crop or plant, irre- tional plant breeding, technologies used during spective of how it got there, can be transferred the Green Revolution. Thus it is essential that we following hybridization to its wild or semido- review critically the potential problems that have mesticated relatives. The transfer would occur been raised by scientists and environmentalists.' selectively if the gene or genes being transferred Our intention here is to present a balanced enhanced the competitive abilities of the related review of current knowledge concerning risks strains, and the weedy properties of some kinds and problems. of plants might be enhanced in particular in- stances as a result of this process. If so, those Gene Flow in Plants: Crops Becoming new strains might need special attention in con- Weeds trolling such plants, just as the many thousands of weedy strains of various plants that have In most groups of plants related species regu- developed over the history of cultivation need larly form hybrids, and the transfer of genes control. between the differentiated populations that Because most crops, such as corn and cotton, such hybridization makes possible is a regular are highly domesticated, it is unlikely that any source of enhancement for the populations single gene transfer would enable them to involved. Thus all white oaks and all black oaks become pernicious weeds. Of greater concern is (the two major subdivisions of the genus, the potential for less domesticated, self-seeding including all but a few of the North American crops (alfalfa, for example) and commercial tree species) are capable of forming fertile hybrids. varieties (pines, for example) to become prob- Some of the species and distinct races that have lems. These plants already have the capacity to evolved following such hybridization occupy survive on their own, and transgenes could 172 Bioengineering of Crops 173 enhance their fitness in the wild. For example, a less sustainable. Therefore, it is important to pine tree engineered for resistance to seed-feed- consider such gene transfer before investing in ing insects might gain a significant advantage specific biotechnology projects. Weeds can through decreased seed destruction, potentially evolve resistance to some herbicides without allowing it to outcompete other indigenous gene transfer, but the process takes much longer. species. If this happened, forest communities For example, herbicides such as glyphosate could be disrupted. (Round-Up) from Monsanto are difficult for plants to resist with their normally inherited Gene Flow in Plants: From Transgenic Crops genes. (It should be noted, however, that the to Wild Plants intensive use of glyphosate has led to weed resistance in Australia.) Crop varieties are often capable of breeding with the wild species from which they were derived. Development of New Viruses from Virus- When the two plant types occur in the same Containing Transgenic Crops place, it is possible for transgenes, like other genes in the domesticated plant, to move into Viral diseases are extremely destructive to the wild plants. In some cases these crop rela- plant productivity, especially in the tropics. tives are serious weeds (wild rices and Johnson Consequently, the genetic modification of grass, for example). If a wild plant's fitness was plants to resist viruses has been an important enhanced by a transgene, or any other gene, that objective of conventional breeding. Over the gave it protection from naturally occurring dis- past decade biotechnology has made possible eases or pests, the plant could become a worse the more rapid and precise production of indi- pest, or it could shift the ecological balance in a vidual strains resistant to particular viruses as natural plant community. Wild relatives of crops a result of the ability to move particular genes suffer from diseases and insect attack, but there into specific crop strains. One of the goals of are few studies that enable us to predict whether genetic engineering has been to identify novel the development of resistance to pests in wild virus-resistant genes that can be rapidly trans- plants would result in significant ecological ferred to many types of crops, thus easing the problems. Weeds often evolve resistance to dis- problems of the plant breeder and meeting the eases by natural evolutionary processes. needs of the farmer. Ashas alwaysbeen the case However, in some cases, gene transfer from with such efforts, the major challenge is to find crops could speed up this process by hundreds virus-resistant genes that cannot be over- of years. come easily by the action of natural selection of Wild rices are especially important weeds in the virus. Now, however, we have the potential direct-seeded rice (direct seeding of rice is an to react more efficiently to this challenge than agricultural practice that is becoming more before. widely used in Asia). It has been shown that One potential advantage of genetic engi- genes are often naturally transferred between neering is that it may make possible the trans- domesticated rice and weedy wild rices. ff a her- fer of multiple genes for disease resistance that bicide tolerance gene was engineered into a rice affect the disease organism by different mecha- cultivar, it would be possible to control the wild nisms. In many cases such a transfer would rice in commercial rice fields with the herbicide make adaptation by the disease organism more until the wild rice acquired the herbicide toler- difficult. Engineering multiple genes for disease ance gene from the cultivar. Once the wild rice resistance into crops requires advanced techni- obtained this gene, the herbicide would become cal effort, and the benefits of such an effort will useless. The wild rice would not become a worse only be seen years after the varieties are com- weed than it was before genetic engineering as a mercialized. Therefore, it is important that result of acquiring the herbicide tolerance gene. genetic engineers be given a mandate to de- However, this natural gene transfer would make velop genes that will protect crops for ex- the investment in the engineering effort much tended periods of time. 174 Biotechnology and Biosafety Pathogen-Derived Resistance * Virus-resistant plants may have a competi- tive advantage in the field, and outcrossing To date the most widely applied genetic engi- with weed species may confer increased neering technology for controlling plant viruses competition and weediness. As indicated has been the use of genes derived from the plant above, we lack data on how important this viruses themselves. When transferred to plants, problem can be. a set of genes called viral coat protein genes * The presence of transgenic viral sequences in inhibit replication of the virus. (Other virus- large crops would increase the likelihood of derived genes can have a similar impact when creating novel viruses because of recombina- they are transferred to plants in an appropriate tion between the transgenes and other manner.) viruses that infect the plant. While it is Transgenes encoding a variety of viral genes known that many crops are simultaneously have been tested in transgenic plants over the infected by multiple plant viruses, there are past ten years with a range of effects. Plants few examples of confirmed genetic recombi- that produce viral coat proteins have been nation between different viruses. And, while tested the most widely, and some of these there is evidence of recombination between plants have received approval for commercial like viruses or virus strains, there is no evi- sale in the United States and China. In 1995 the dence that this recombination would occur U.S. Department of Agriculture proposed a with greater frequency in transgenic plants rule that would substitute a notification re- than in typical situations of virus infection. quirement for the permit requirement now in In conclusion there is little evidence for the effect for most field tests of selected genetically contention that virus recombination will engineered crops. If this rule is formalized, cause ecological problems. researchers will only have to notify the depart- * Virus coat proteins produced by transgenic ment, not obtain a permit, before field-testing crops could combine with natural viruses certain genetically engineered plants, includ- and produce more harmful strains. It has ing those that express viral coat protein genes. been concluded that while such an occur- Some have found this proposed rule contro- rence is theoretically possible, the risk of it versial.2 The U.S. Environmental Protection is too low to be considered in assessing the Agency also ruled that coat proteins are not impacts of transgenic crops. pesticidal and are safe for environmental re- * Virus genes other than coat protein genes lease. The U.S. Food and Drug Administration could elicit greater safety concerns. Genes has approved for sale and consumption encoding ribonucleic acids (RNAS) that do foods derived from transgenic plants that not produce proteins yet provide resistance contain viral coat proteins. are likely to receive approval because there is no scientific expectation of risk. However, Concerns about Release of Plants Containing it is unclear whether or not other genes will Genes Encoding Viral Sequences receive approval. Viral genes that have the capacity to decrease infection by one virus As research and development of plants that but increase the chance of infection by exhibit pathogen-derived resistance moved another virus will probably not receive from the lab to the field, several concerns were approval unless they are mutated and made voiced about the release of plants that encode to act only in a protective manner. viral sequences, including the following: * Virus proteins may trigger allergic reactions Effects of Plant-Produced Insecticides on if included in foods. This concern has been Unintended Targets largely abandoned, in part because many foods are infected with plant viruses and In terms of plant-produced insecticides the only have been consumed for many years without insecticidal compounds that are currently com- known deleterious effects. mercialized are proteins that are naturally pro- Bioengineering of Crops 175 duced by Bacillus thuringiensis (Bt). These pro- Will the Gene Being Transferred Serve an teins are highly specific in their toxic effects. Important Function in the Targeted One group of these proteins affects only cer- Geographical Area? tain species of caterpillars (lepidoptera), while others affect only a restricted set of beetle species. The pests of a specific crop, such as cotton or None of these proteins has been shown to have corn, vary from one geographical region to a significantly disruptive effect on predators of another. For example, the caterpillars of two pest species (beneficial insects). The proteins insect species, the cotton bollworm and the bud- degrade rapidly when exposed to sunlight and worm, are major pests to the cotton grown in the have been shown to degrade even when pro- southern United States. A variety of cotton tected by being inside crop residues. Monsanto developed by Monsanto contains a specific pro- presented data to the Environmental Protection tein derived from Bacillus thuringiensis that is Agency that confirm the safety of the protein. highly toxic to these two closely related pests. In Studies with enzymes from the human diges- Central America the major insect pest species tive system indicated that these Bt proteins are that affect cotton are the fall armyworm and the quickly digested and are unlikely to cause boll weevil. Since the toxins in the cotton devel- harmful effects. oped by Monsanto have no impact on these pests; investing in the transfer of these seeds to Ecosystem Damage Central America would be futile. Instead, it would be better to invest resources in finding Unfortunately little is known about the flow of more appropriate genes that would truly control genetic information from plants to microorgan- Central American cotton pests.3 isms, making it difficult to assess the risk of A number of companies have engineered genes spreading from plants to soil organisms. corn varieties that tolerate herbicide sprays. At It is a fact that soil organisms, especially bacte- this point the commercial corn varieties that pos- ria, are able to take up DNA from their envi- sess herbicide tolerance are developed by cross- ronment and that DNA can persist when bound ing a parent corn line that contains the transgene to soil particles. Although one can speculate for herbicide resistance with another line that about a gene-flow situation in which plant DNA does not contain the gene. Therefore, all of the is released from plant material, bound to soil commercially sold corn seeds contain one copy particles, and subsequently taken up by soil of the herbicide-resistance gene and are resistant bacteria, such a scenario is highly unlikely. Any to the herbicide. In the United States farmers potential risks of such a transfer can be elimi- buy hybrid corn seed every year and plant it nated by making transgenes that bacteria are only once so that all of their plants are tolerant unable to use (those with introns, for example). of the herbicide spray. While this system works It is even more speculative to consider the pos- well in the United States and other similar sible transfer of genes to soil-dwelling funguses economies, it will not work well in agricultural (molds), since gene transfer to funguses is gen- settings in most developing countries unless erally much more difficult than gene transfer to changes are made. For example, in El Salvador bacteria. many farmers buy hybrid corn seed only once every three years, because it is very expensive. Assessing the Cost-Benefit Ratio The first year they plant the commercial seed, of Genetically Engineered Crops and the next two years they plant the offspring from the plants. Because of genetic segregation Two questions that must be addressed before in the offspring, only three-quarters of the corn investing in a project to engineer a crop cultivar plants in the second and third year have the her- are (1) will the gene being transferred serve an bicide-resistance gene, so the farmer kills half of important function in the targeted geographical the crop by applying the herbicide. It has proven area and (2) how long will the gene continue to too difficult for seed companies to put the gene serve its function? in both parents of the plant. Clearly, an agricul- 176 Biotechnology and Biosafety tural plan that works in a developed country corn, cotton, and rice, that produce insecticidal may not work in a developing country proteins are planted intensively over wide It is often said that biotechnology is a trans- areas, the chance for insect adaptation is high ferable technology because "the technology is all unless care is taken in developing and deploy- in the seeds." It is important to recognize that the ing the insect-resistant varieties. interface between seed traits and worldwide The U.S. Environmental Protection Agency crop production is not always simple. As indi- has put restrictions on the sale of cotton contain- cated above, sending herbicide-resistant corn ing Bacillus thuringiensis to ensure that every U.S. seed to El Salvador without educating farmers farm has some fields planted with varieties that do about the problem of using the second genera- not produce the Bt proteins. These restrictions are tion seed could lead to immediate economic an example of the kinds of strategies that can be losses, and it could also lead to rejection of the employed to "conserve resistance." The fields new technology. Similarly, breeding a corn vari- planted with non-Btproducing varieties act as ety in the United States and then sending it to refuges for individual pests that are susceptible. West Africa would be useless if the corn was The insects produced in these refuges will mate resistant to U.S. pests but not to West African with resistant insects emerging from fields where pests. It should be noted that corn pests are not the transgenic varieties are planted, diluting the even the same in all West African countries, so frequency of insects that are resistant to the Bt pro- varieties must be developed by tailoring them to teins and leading to more sustainable resistance. specific problems. Instituting such practices in developing counties Once a variety is matched with local pest would probably be difficult. Furthermore, the problems, the technology may be transferable refuge strategy works best if the transgenic vari- simply by supplying the seed, although doing so ety produces enough Bt protein to kill dose to 100 does not mean that the seed will provide a sus- percent of the susceptible insects that feed on it. tainable solution to the pest problem. There is A variety developed to kill 100 percent of the pest abundant evidence indicating that pests will individuals of a species that occurs in Mexican overcome genes for pest and disease resistance, corn may kill only 80 percent of the insects in a regardless of whether the genes have come Nigerian cornfield. Therefore, attempts to build through biotechnology or classical plant breed- one transgenic corn type to fit the needs of a num- ing, unless seeds are used properly. Getting ber of countries may be misguided. farmers to use seeds properly will require edu- Adaptation problems similar to those de- cational efforts. scribed for insects may affect crops engineered for resistance to disease and tolerance of herbi- How Long Will the Gene Continue to Serve cides. Although there are some types of herbi- Its Function? cides, such as glyphosate (Round-Up), that are considered "immune" to weed adaptation, it is Insects, disease-causing organisms, and weeds not clear that this immunity will hold up when are known to adapt to most pesticides and crop there is intensive use of the herbicides.4 varieties that contain resistant genes. In some When investing in biotechnology for crop cases adaptation occurs within one or two protection, it is important to consider the global years. Some insect strains have evolved the abil- effectiveness of the protection and how long it ity under laboratory and field conditions to tol- will last. The same is true of agriculture in gen- erate high concentrations of the toxins derived eral. Improved strains of any kind of crop or from the Bacillus thuringiensis that are produced domestic animal, regardless of how the genetic by transgenic cotton and corn sold commer- modification was attained, must be carefully cially in the United States. Considerable theo- managed to be as productive as possible. retical and empirical research has assessed Integrated systems involving the best and most whether certain insect pests will overcome the sustainable practices of soil preparation; the effects of transgenic crops that produce these most conservative and appropriate use of water, insecticidal proteins. If major crops, such as fertilizers, and pesticides (if pesticides are used); Bioengineering of Crops 177 and the selection of the best and most appropri- oping countries. For example, tissue culture can ate strains of a particular crop are the key to be used to produce disease-free plants and to success in agriculture. These practices are help increase the productivity of farms in devel- important to all agricultural systems, and they oping countries. But tissue culture can also be are necessary for improving systems, regardless used to shift the production center for specialty of the exact methods used to genetically modify agricultural products from developing to indus- the crop strains being grown. trial countries. Vanilla is typically considered a Investments in new and improved crop tropical product, but recent workwith tissue cul- strains must also be judged by their global effec- ture allows its production in the laboratory. If tiveness, irrespective of how the strains were such innovations in tissue culture proliferate, it produced. The Green Revolution succeeded in is possible that other tropical products will be enhancing productivity in many areas because manufactured in the laboratory as well. of the system of cultivation that was built up around the new strains of crops, not solely Notes because of the properties of those strains. The design of plantings has a great deal to do with 1. A. A. Snow and P. M nPalma, "Comgercialization the longevity of resistance to particular diseases BioScience 47 (February 1997). and pests, but design has not always been care- 2. Personal communication. fully considered in efforts to introduce geneti- 3. N. Strizhov and others, "A Synthetic crylC Gene, cally engineered strains or other novel strains. Encoding a Bacillus Thuringiensis D-Endotoxin, Confers The design of plantings may need special atten- Spodoptera Resistance in Alfalfa and Tobacco," in tion in developing countries with respect to the Proceedings of the National Academy of Sciences USA particular conditions found there. (forthcoming). As mentioned above, biotechnologies other 4. J. Gressel, "Fewer Constraints Than Proclaimned to the Evolution of Glyphosate-Resistant Weeds," than bioengineering can be used to improve agri- Resistant Pest Management 8 (1996): 2-5; B. Sindel, culture in developing countries. But use of such "Glyphosate Resistance Discovered in Annual technologies can also have drawbacks for devel- Ryegrass," Resistant Pest Management 8 (1996): 5-6. CHAPTER 4 Conclusions and Recommendations T he panel's recommendations to the World cultural science community. Bank are based on its members' belief that It is of the greatest importance to the devel- urgent priority must be assigned to the opment of sound agriculture, based on the best expansion of agriculture and to increased pro- environmental principles, to enhance the capa- duction of food in the developing world. It is bilities of science and scientists in the develop- critically important that increases in food pro- ing world. A specific and urgent need is the duction outpace population growth. Damaging training of developing world scientists in agricultural practices must be replaced with biotechnology methods so that each nation will lower-impact, sustainable activities so that the have a cadre of scientists to assist it in setting global capacity to produce food does not de- and implementing its own policies on biotech- cline. Only by these means will it prove pos- nology research and biosafety. sible to lessen hunger and improve food security The education of farmers can be greatly facil- in the poorest nations in the years ahead. itated with the aid of scientists from their own Because transgenic technology is so power- nations. These scientists can contribute to the suc- ful, it has the ability to make significant positive cess of newly introduced crop strains and help to or negative changes in agriculture. Transgenic implement early warning systems to identify any crops are not in principle more injurious to the troubles that arise during the introduction of new environment than traditionally bred crops. This crops or new agricultural methods. report has outlined a number of criteria that can be used to determine whether a specific bio- Research Programs technology program is likely to enhance or detract from ecologically sound crop produc- The Bank should identify and support high-quality tion. Transgenic crops that are developed and research programs whose aim is to exploit the favor- used wisely can be very helpful, and may prove able potential of genetic engineeringfor improving essential, to world food production and agri- the lot of the developing world. cultural sustainability. Biotechnology can cer- As noted earlier in this report, not all of the tainly be an ally to those developing integrated research in progress in the industrial nations pest management (IPM) and integrated crop will, even if successful, prove beneficial to the management (ICM) systems. developing world. Research should be planned The recommendations to the World Bank so that key needs are met. Much of the necessary follow. research will need to be done in advanced labo- ratories in industrial countries in conjunction Support of Developing World Science with laboratories in developing countries. Research priorities should focus on promoting The Bank should direct attention to the needfor liai- sustainable agriculture and higher yields in the son with and support of the developing world's agri- developing world as well as on decreasing the 178 Bioengineering of Crops 179 variation in food production arising from, for to identify any troubles that may arise and to intro- example, environmental stresses. duce improvements in adapting new strains. Variance in production can result in food As an early warning system helped to iden- shortages with numerous attendant complica- tify troubles, it would also spot unexpected suc- tions. Crops with resistance to insects and dis- cess, so that gains could be exploited and eases, including crops developed by genetic duplicated elsewhere. The system would also modification, can decrease production variance provide feedback to speed up and optimize the if the crops are developed and deployed in ways introduction of new plant varieties. that minimize the ability of pests and diseases to overcome the resistance factors in the crop. A Investment in International Agricultural poorly conceived strategy for developing and Research Centers deploying crops can have the opposite effect if pests or diseases adapt to resistant cultivars. If The Bank should increase its support of research in farmers are taught to depend solely on a crop's biotechnology and related areas at international agri- ability to ward off pests and diseases, the farm- cultural research centers because these centers are in ers will not be prepared to use alternative means the best position to ensure that high-quality, envi- of control when pests become adapted to the ronmentally sustainable agricultural products and resistance factors in the crop. processes are developed and transferred to developing countries. Surveillance and Regulation International agricultural research centers are well placed to assist in the implementation The Bank should support the implementation offor- of many of our recommendations. Investment in mal, national regulatory structures in its client biotechnology research at these centers is mar- nations by seeing to it that these structures retain ginally low. Although some of the centers have their vigor and effectiveness through the years and healthy but small programs in place, most of by providing scientific and technical support to the them lack the infrastructure and personnel client nations as requested. needed to conduct high-quality biotechnology Effective regulatory structures will prove research. The Bank should determine how best critical should problems arise during the intro- to invest in infrastructure and personnel at each duction of transgenic crops or, indeed, of other site. The Bank should adopt a broad perspective tools of industrialized agriculture, including on biotechnology research that includes support chemical inputs, some of which may be pro- for marker-assisted breeding, development of moted in conjunction with genetically engi- transgenic plants, development of molecular- neered herbicide-tolerant crops. These tools can based but farmer-friendly diagnostics, and all pose problems for developing countries. genetic analysis of crop pests and pathogens. Effective, comprehensive regulatory structures Research should emphasize development of appear to exist in few nations, if any, including agricultural products and processes that are the United States. To provide the basis for a unlikely to be provided by the private sector, strong national regulatory structure, there must such as those that would alleviate problems spe- be a designated agency with a clear mandate to cific to subsistence farmers. Any increased protect the environment and the economy from investment in new agricultural technology must risks associated with the uncritical application be accompanied by significant investment in of new methods, including inappropriate new ecological and sociological research to ensure strains of crops or animals that may pose spe- that new products and processes support safe cial risks for the environment. The agency must and sustainable food production. have the technical capacity to develop compe- In implementing Bank support for interna- tent risk assessment and the power to enforce its tional agricultural research centers, two mat- decisions. ters are important. The first is for the Bank to The Bank should support, in each developing ensure that leaders of research organizations country, the deployment of an early warning system are aware of the potential and importance of 180 Biotechnology and Biosafety supporting biotechnology research. The sec- * Ensuring that adequate energy and water ond is for the Bank to ensure that the recom- become available and that procedures for mendations-to focus on liaison and to their efficient use are made known and identify and support high-quality research- adopted are adopted in the implementation of a pro- * Ensuring the introduction of modern means gram of enhanced support for international of controlling pests, including the use of inte- agricultural research centers. Increases in grated pest management systems, safe chem- funding for agricultural biotechnology should icals, and resistant crops involve cooperation with scientists from * Supporting the transition to sustainable developed countries, and any facilities that activities and the reduction of waste and loss may be built at the centers should match the in all elements of the agriculture enterprise scientific capabilities that are to be maintained * Providing the necessary education to farmers over the long term. so that they can implement the array of new techniques that are needed (integrated pest The Agricultural Challenge management, for example) * Ensuring that the changes in agriculture will The Bank should continue to give high priority to all provide the employment opportunities that aspects of increasing agricultural productivity in the will be needed in the developing world. developing world while encouraging the necessary The scale and importance of the challenge transition to sustainable methods. that the Bank faces in the agricultural sector are While genetically engineered crops can play formidable. We have concluded that the Bank an important role in meeting the goal of im- should establish a permanent technical and sci- proved food security, their contribution alone. entific advisory group to deal broadly with the will not suffice. Their use must be accompanied goal of improving food security while ensuring by numerous other actions, as we have noted in the transition to sustainable agricultural prac- preceding sections of this report. These actions tices. The group should deal with all the ele- include: ments that comprise a successful program and * Increasing priority on conventional plant provide the required liaison to the scientific breeding and farming practices communities in the target nations. APPENDIX Integrated Intensive Farming Systems Intensive Farming water so that it can be used in conjunction with other sources of water. Where water is the major China and India, as well as numerous other constraint, technologies that can help to opti- developing nations, must achieve the triple goals mize income and jobs from every liter of water of more food, more income, and more liveli- must be chosen and adopted. Maximum empha- hoods from their land and water resources. One sis should be placed on efficient on-farm water approach that can be adopted is the integrated use and on the use of techniques such as drip intensive farming systems methodology (IIFS). irrigation to help optimize the benefits from the The M. S. Swaminathan Research Foundation available water. has designed a bio-village program to convert IIFS from a concept into a field-level reality. By Crop and Pest Management making living organisms both the agents and beneficiaries of development, the bio-village Integrated nutrient supply (INS) and integrated serves as a model for human-centered develop- pest management (IPM) systems form impor- ment. The pillars of the IFS methodology follow. tant components of IIFS. The precise composi- tion of the INS and the IPM systems should be Soil Health Care chosen on the basis of the farming system and the agro-ecological and soil conditions of the Soil health care is fundamental to sustainable area. Computer-aided extension systems intensification of agriculture. The TIFS approach should be developed to provide farm families affords the opportunity to include stem-nodu- with timely and precise information on all lating legumes such as Sesbania rostrata in the aspects of land, water, pest, and postharvest farming system and to incorporate Azolla, or management. blue-green algae, and other sources of symbiotic and nonsymbiotic nitrogen fixation. Vermi- Energy Management culture constitutes an essential component of IIFS. PIFS farmers maintain a soil health card to Energy is an important and essential input. In monitor the impact of farming systems on the addition to the energy-efficient systems of physical, chemical, and microbiological compo- land, water, and pest management described nents of soil fertility. above, every effort should be made to harness biogas, biomass, solar, and wind energies to the Water Harvesting, Conservation, and Man- maximum extent possible. Solar and wind agement energy can be used in hybrid combinations with biogas for farm activities such as pumping IIFS farm families include in their agronomic water and drying grains and other agricultural practices measures to harvest and conserve rain- produce. 181 182 Biotechnology and Biosafety Postharvest Management Information, Skills, Organization, and Management IIFS farmers should not only adopt the best available threshing, storage, and processing To succeed, IIFS farms need a meaningful and measures, but should also try to produce value- effective information and skill empowerment added products from every part of the plant or system. Decentralized production systems have animal. Postharvest technology assumes partic- to be supported by a few key centralized ser- ular importance in the case of perishable com- vices, such as the supply of seeds, biopesticides, modities such as fruits, vegetables, milk, meat, and diagnostic and control methods for plant eggs, fish, and other animal products. A mis- and animal diseases. Ideally, an "information match between production and postharvest shop" should be set up by trained local youth in technologies adversely affects both producers order to give farm families timely information and consumers. As this report has noted, grow- on meteorological, management, and marketing ing urbanization leads to a diversification of factors. Organization and management are key food habits. This diversification will increase elements to success, and depending on the area demand for animal products and processed and farming system, steps have to be taken to food. Agro-processing industries can be pro- provide to small producers advantages of scale moted on the basis of an assessment of consumer in processing and marketing. IIFS farming is demand. Such food-processing industries best developed through participatory research should be promoted in villages in order to between scientists and farm families. This increase employment opportunities for rural approach helps to ensure economic viability, youth. environmental sustainability, and social and Investment in sanitary and phyto-sanitary gender equity in IIFS villages. The starting point measures is important to providing quality food is to learn from families who have already devel- for domestic consumers and for export. To assist oped successful IIFS procedures. the spread of IIFS, govermnents should make It should be emphasized that IIFS will suc- major investments in storage facilities, roads, ceed only if centered on humans; a mere tech- communication, and sanitary and phyto-sani- nology-driven program will not work. The tary measures. essence of IIFS is the symbiotic partnership between farming families and their natural Choice of Crops and Other Components resource endowments of land, water, forests, of the Farming System flora, fauna, and sunlight. Without appropriate public policy support in areas such as land In IIFS it is important to give careful consi- reform, security of tenure, rural infrastructure, deration to the composition of the farming input and output pricing and marketing, small system. Soil conditions, water availability, farm families will find it difficult to adopt IIFS. agro- climatic features, home needs, and above The eco-technologies and public policy mea- all, marketing opportunities have to determine sures needed to make IIFS a mass movement the choice of crops, farm animals, and aqua- should receive concurrent attention. The pro- culture systems. Small and large ruminants gram will fail if it is based solely on a techno- have a particular advantage among farm ani- logical quick-fix approach. On the other hand mals since they can live largely on crop bio- the HFS program can trigger an "ever-green rev- mass. IIFS farming has to be based on both olution" if mutually reinforcing packages of land-saving agriculture and grain-saving ani- technology, training, techno-infrastructure, and mal husbandry. trade are introduced. Appendix A Program Biotechnology and Biosafety An Associated Event of the Fifth World Bank Conference on Environmentally and Socially Sustainable Development Held at the World Bank, Washington, D.C. October 9-10, 1997 SESSION I: Setting the Stage Chair: Thomas E. Lovejoy, The Smithsonian Institution Introductory Remarks and Stating the Problem Ismail Serageldin, World Bank Group The Scientific Scene Wemer Arber, Intemational Council of Scientific Unions The Special Case of Agricultural and Food Biotechnology Henry W. Kendall, Union of Concemed Scientists Discussion SESSION II: The Promise and the Perils Chair: Roger N. Beachy, Scripps Research Institute Overview Christopher R. Somerville, Carnegie Institution of Washington TIhe Opportunities and the Risks Robert B. Horsch, Monsanto Company Miguel A. Altieri, University of California at Berkeley Discussion Regulatory Framework Issues Chair: Hamdallah Zedan, United Nations Environment Programme Desmond Mahon, Convention on Biological Diversity Timothy Roberts, Roberts and Company Discussion SESSION III: Reviewing the Evidence Chair: Michel Petit, World Bank Group Panel 1: Are the Opportunities of Genetically Modified Organisms Being Fully Exploited? George Tzotzos, UNIDO Discussants: Gabrielle Persley, AusBiotech Alliance Carlienne Brenner, Consultant, Science, Agriculture and Technology 183 184 Biotechnology and Biosafety Panel 2: Are the Risks of Developing and Releasing Genetically Modified Organisms Being Adequately Evaluated and Assessed? Rita R. Colwell, Biotechnology Institute, University of Maryland Discussants: L. Val Giddings, Biotechnology Industry Organization Rebecca Goldburg, Environmental Defense Fund Discussion SESSION IV: Role of Intemational Agricultural Research Chair: Louise 0. Fresco, FAO The Consultative Group on International Agricultural Research Timothy G. Reeves, CIMMYT The Global Forum Fernando Osorio Chaparro, COLCIENCIAS Perspectivesfrom National Agricultural Research Systems Maria Jose A. Sampaio, EMBRAPA Magdy Madkour, AGERI Discussion SESSION V: Role of Public Policy Chair: Per Pinstrup-Andersen, IFPRI Vernon W. Ruttan, University of Minnesota Michel Dron, CIRAD George A. Lloyd, Zambian Grain Growers and Marketing Association Discussion SESSION VI: Recommendations for Action Chair: Alexander F. McCalla, World Bank Group Synopsis of Sessions Wanda Collins, CGIAR Discussion Wrap-up and Next Steps Ismail Serageldin Appendix B Presenters and Chairs Miguel A. Altieri Carlienne Brenner SANE General Coordinator 4, Alle du Bord de l'eau University of California, Berkeley Paris 75016, France College of Natural Resources Tel: 33-1/4651-9700 Center for Biological Control Fax: 33-1/4651-9700 1050 San Pablo Avenue Email: brenner@oecd.fr Albany, CA 94706, USA Tel: 510/642-9802 Fernando Osorio Chaparro Fax: 510/642-0875 Director General Email: agroeco3@nature.berkeley.edu COLCIENCIAS Transversel 9A, No. 133-28 Werner Arber Apartado Aereo 051580 President Santafe de Bogoti, DC, Colombia International Council of Scientific Unions Tel: 571/216-9800 c/o Biocentre Fax: 571/625-1788 University of Basel Email: info@colciencias.gov.co Basel CH-4056, Switzerland Tel: 41-61/267-2130 Wanda Collins Fax: 41-61/267-2118 Deputy Director General for Research International Potato Center Roger N. Beachy Apartado 1558 Head, Division of Plant Biology, BCC 206 Lima 12, Peru The Scripps Research Institute Tel: 51-1/349-5779 10550 No. Torrey Pines Road Fax: 51-1/349-5638 La Jolla, CA 92037, USA Email: W.Collins@cgnet.com Tel: 619/784-2550 Fax: 619/784-2994 Email: beachy@scripps.edu 185 186 Biotechnology and Biosafety Rita R. Colwell Robert B. Horsch President Director of Technology, General Manager University of Maryland Biotechnology Institute Monsanto Company 4321 Hartwick Road, Room 550 8520 University Green College Park, MD 20740, USA Middletown, WI 53562, USA Tel: 301/403-0501 Tel: 608/836-7300 Fax: 301/454-8123 Fax: 608/836-9710 Email: colwell@umbi.umd.edu Email: robert.b.horsch@monsanto.com Michel Dron Henry W. Kendall Centre de Cooperation Internationale en Chairman of the Board Recherche Agronomique pour le Union of Concerned Scientists Developpement (CIRAD) c/o 24-514 MIT 42, rue Scheffer Cambridge, MA 0139, USA Paris 75116, France Tel: 617/253-7584 Tel: 33-1/53-70-2035 Fax: 617/253-1755 Fax: 33-1/5370-2133 Email: hkendall@mit.edu Email: mdron@cirad.fr George A. Lloyd Louise 0. Fresco Chairman Director Zambian Grain Growers and Marketing Research, Extension, and Training Division (SDR) Association Food and Agriculture Organization PO Box 50960, 8537 Mwembeshi Road Sustainable Development Department Heavy Industrial Area Viale delle Terme di Caracalla, D-446/7 Lusaka, Zambia Rome 00100, Italy Tel: 260-1/286-619 Tel: 39-6/5705-3363 Fax: 260-1/291-717, 254-283 Fax: 39-6/5705-5246 -or- Email: louise.fresco@fao.org 33 Lime Gardens West End L. Val Giddings Southampton S030 3RG, United Kingdom Vice President for Food and Agriculture Tel: 44-1703/471-748 Biotechnology Industry Organization (BIO) Fax: 44-1703/471-748 1625 K Street, NW, Suite 1100 Washington, DC 20006-1604, USA Thomas E. Lovejoy Tel: 202/857-0244 Counselor to the Secretary for Biodiversity Fax: 202/857-0237 and Environmental Affairs Email: lvg@bio.org The Smithsonian Institution 1000 Jefferson Drive, SW, Suite 317 Rebecca Goldburg Washington, DC 20560, USA Biologist Tel: 202/786-2263 Environmental Defense Fund Fax: 202/786-2304 257 Park Avenue South New York, NY 10010, USA Tel: 212/505-2100 Fax: 212/505-2375 Appendix B: Presenters and Chairs 187 Magdy Madkour Michel Petit AGERI Director Agricultural Research Center Agricultural Research Group (ESDAR) 9 Gamaa Street Rural Development Giza 12619, Egypt World Bank Group Tel: 20-2/ 1818 H Street, NW, Room MC 4-113 Fax: 20-2/568-9519 Washington, DC 20433, USA Email: madkour@ageri.sci.eg Tel: 202/473-0340 Fax: 202/522-3246 Desmond Mahon Email: mpetit@worldbank.org Senior Program Officer Convention on Biological Diversity Per Pinstrup-Andersen World Trade Center Director General 393 St. Jacques, Suite 300 International Food Policy Research Institute Montr6al, Quebec H2Y 1N9, Canada 1200 17th Street, NW, Suite 200 Tel: 514/287-7023 Washington, DC 20036-3006, USA Fax: 514/288-6588 Tel: 202/862-5600 Email: desmond.mahon@biodiv.org Fax: 202/467-4439 Email: P.Pinstrup-Andersen@cgnet.com Peter J. Matlon Chief, Food Security and Agriculture Programme Timothy G. Reeves Sustainable Energy and Environment Division Director General United Nations Development Programme CIMMYT 304 E. 45th Street, 10th Floor Lisboa 27, Apartado Postal 6-641 New York, NY 10017, USA Mexico, D.F. 06600, Mexico Tel: 212/906-6408 Tel: 52-5/726-9091 Fax: 212/906-6973 Fax: 52-5/726-7585 Email: peter.matlon@undp.org Email: username@alphac.cimmyt.mx Alexander F. McCalla Timothy W. Roberts Director Roberts and Co. Rural Development 13, Spring Meadow World Bank Group Bracknell 1818 H Street, NW, Room S 8-055 Berks RGR 2JP, United Kingdom Washington, DC 20433, USA Tel: 44-1344/422-902 Tel: 202/458-5028 Fax: 44-1344/869-059 Fax: 202/522-3207 Email: twr@compuserve.com Email: amccalla@worldbank.org Vernon W. Ruttan Gabrielle Persley Regents Professor National Manager, Biotechnology Applied Economics Department Australian Trade Commission University of Minnesota Level 13, 145 Eagle Street 332 C Classroom Office Building GPO Box 1061 2381 Commonwealth Avenue Brisbane, Qld 4000, Australia St. Paul, MN 55108, USA Tel: 61-7/3365-4939 Tel: 612/625-4701, 2729, 6245 Fax: 61-7/3365-7093 Fax: 612/625-1222 Email: g.persley@mailbox.uq.edu.au 188 Biotechnology and Biosafety Maria Jose Amstalden Sampaio Fax: 650/325-6857 EMBRAPA Email: CRS@andrew.stanford.edu Department of Research and Development SAIN - Parque Rural - Final AV. George Tzotzos W/3 Norte - Ed. Sede, PO Box 04.0315 Biotechnology Programme Coordinator, ITPD/TS Brasilia - DF CEP70770-901, Brazil United Nations Industrial Development Tel: 55-61/348-4433 Organization Fax: 55-61/347-1041 PO Box 300 A-1400 Vienna, Austria Ismail Serageldin Tel: 43-1/21131-4336 Vice President Fax: 43-1/21131-6810 Special Programs Email: george@binas.unido.org World Bank Group 1818 H Street, NW, Room MC 4-123 Hamdallah Zedan Washington, DC 20433, USA United Nations Environment Programme Tel: 202/473-4502 Chief, Biodiversity Unit Fax: 202/473-3112 PO Box 30552 Email: iserageldin@worldbank.org Nairobi, Kenya Tel: 254-2/623-260 Christopher R. Somerville Fax: 254-2/624-300 or 226-890 Director Carnegie Institution of Washington 290 Panama Street Stanford, CA 94305-4102, USA Tel: 650/325-1521, x203 Appendix C Cosponsors American Association for the Advancement Food and Agniculture Organization of the of Science (AAAS) United Nations (FAO) Rita R. Colwell Louise 0. Fresco President Director, Research, Extension, and Training University of Maryland Biotechnology Institute Division (SDR) 4321 Hartwick Road, Room 550 Food and Agriculture Organization College Park, MD 20740 Sustainable Development Department Tel: 301/403-0501 Viale delle Terme di Caracalla, D-446/7 Fax: 301/454-8123 Rome 00100, Italy Email: colwell@umbi.umd.edu Tel: 39-6/5705-3363 Fax: 39-6/5705-5246 The Conservation Fund Email: louise.fresco@fao.org Lawrence A. Selzer Vice President, Sustainable Programs International Council of Scientific Unions The Conservation Fund (ICSU) PO Box 1746 ICSU Secretariat Sheperdstown, WV 25443 51 Boulevard de Montmorency Tel: 304/876-2815 75016 Paris, France Fax: 304/876-0739 Tel: 33-1/4525-0329 Fax: 33-1/4288-9431 Consultative Group on Intemational Email: icsu@lmcpjussieu.fr Agricultural Research (CGIAR) http://www.lmcpjussieu.fr/icsu/ Alexander von der Osten Executive Secretary The Smithsonian Institution Consultative Group on International Thomas E. Lovejoy Agricultural Research Counselor to the Secretary for Biodiv. & 1818 H Street, NW, J 4-073 Environmental Affairs Washington, DC 20433 Smithsonian Institution Tel: 202/473-8918 1000 Jefferson Drive, SW Fax: 202/473-8110 Suite 317 Email: avonderosten@worldbank.org Washington, D.C. 20560 Tel: 202/786-2263 Fax: 202/786-2304 189 190 Biotechnology and Biosafety Third World Academy of Sciences (TWAS) United Nations Environment Programme M.H.A. Hassan, Executive Director (UNEP) Third World Academy of Sciences Hamdallah Zedan c/o International Centre for Theoretical Physics United Nations Environment Programme Strada Costiera 11 Biodiversity Unit P.O. Box 586 PO Box 30552 34100 Trieste, Italy Nairobi, Kenya Tel: 39-40/224-0327 Tel: 254-2/623-260 Fax: 39-40/224-559 Fax: 254-2/624-300 or 226-890 Email: twas@ictp.trieste.it United Nations Industrial Development Union of Concerned Scientists (UCS) Organization (UNIDO) Henry W Kendall George Tzotzos Chairman of the Board Biotechnology Programme Coordinator, Union of Concerned Scientists ITPD/TS c/o 24-514 MIT United Nations Industrial Development Cambridge, MA 0139 Organization Tel: 617/253-7584 PO Box 300 A-1400 Fax: 617/253-1755 Vienna, Austria Email: hkendall@mit.edu Tel: 43-1/21131-4336 Fax: 43-1/21131-6810 United Nations Development Programme Email: george@binas.unido.org (UNDP) Peter J. Matlon U.S. National Academy of Sciences (NAS) Chief, Food Security and Agriculture 2100 C Street, NW Programme Washington, DC 20418 Sustainable Energy and Environment Division, Tel: 202/334-2000 UNDP http://www.nas.edu/ 304 E. 45th Street, 10th Floor New York, NY 10017 World Bank Group Tel: 212/906-6408 Ismail Serageldin Fax: 212/906-6973 Vice President for Special Programs Email: peter.matlon@undp.org World Bank Group 1818 H Street, NW, MC 4-123 United Nations Educational, Scientific and Washington, D.C. 20433 Cultural Organisation (UNESCO) Tel: 202/473-4502 Professor Indra K. Vasil Fax: 202/473-3112 Chairman Email: iserageldin@worldbank.org Laboratory of Plant, Cell,and Molecular Biology The World Conservation Union (IUCN) University of Florida David McDowell, Director General PO Box 110690, Bldg. 885 28 Rue Mauverney, 1196 Gland Gainesville, FL 32605-3498 Switzerland Tel: 352/392-1193 Tel: 41-22/999-0001 Fax: 352/392-9366 Fax: 41-22/999-0002 Email: ikv@gnv.ifas.ufl.edu Email: mail@hq.iucn.org http: / /www.iucn.org Appendix D Consultative Group on International Agricultural Research Secretariat and Centers Consultative Group on International Science Advisor: Manuel Lantin Agricultural Research Phone: (1-202) 473-8912 E-mail: m.lantin@cgnet.com Chair: Ismail Serageldin Vice President Special Programs Finance Team: Ravi Tadvalkar The World Bank Phone: (1-202) 473-8894 1818 H Street, NW E-mail: r.tadvalkar@cgnet.com Washington, DC 20433, USA Phone: (1-202) 473-4502 Information Team: Shirley Geer Cable: INTBAFRAD Phone: (1-202) 473-8930 Fax: (1-202) 473-3112 E-mail: sgeer@worldbank.org Management Team: Selcuk Ozgediz CGIAR Secretariat Phone: (1-202) 473-8937 E-mail: s.ozgediz@cgnet.com Executive Secretary: Alexander von der Osten 701 18th Street, NW Documents/Information Center: Danielle Room J-4073 Lucca Washington, DC 20433, USA Phone: (1-202) 473-8949 Phone: (1-202) 473-8918/8919 E-mail: dlucca@worldbank.org E-mail: avonderosten@worldbank.org a.von-der-osten@cgnet.com Public Awareness Campaign for Agriculture Secretariat: Phone: (1-202) 477-1234 (IBRD Operator) Director of Operations: Barbara Alison Rose (1-202) 473-8951 (Secretariat) 701 18th Street, NW Fax: (1-202) 473-8110 Room J-4029 E-mail: cgiar@cgnet.com Washington, DC 20433, USA Website: http://www.cgiar.org Phone: (1-202) 473-4734 Fax: (1-202) 473-8110 Mailing Address: E-mail: brose@worldbank.org The World Bank b.rose@cgnet.com CGIAR Secretariat 1818 H Street, NW Washington, DC 20433, USA 191 192 Biotechnology and Biosafety Mailing Address: Regional Offices: Public Awareness Campaign for Agriculture The World Bank Brazil (Cassava) 1818 H Street NW EMBRAPA Room 1-4029 Centro Nacional de Pesquisa de Mandioca Washington, DC 20433, USA e Fruticultura Tropical (CNPMF) Caixa Postal 007 Projects Assistant: Geralynn Batista CEP 44380-000 Cruz das Almas-BA, Brazil Phone: (1-202) 473-3553 Phone: (55-75) 7212534 E-mail: gbatista@worldbank.org Fax: (55-75) 7212534 g.batista@cgnet.com E-mail: ospina@cnpmf.embrapa.br Ecuador (Beans Andean Project/PROFRIZA) CGIAR Centers MAG/INIAP/CIAT Avn. Eloy Alfaro y Amazonas CIAT Edificio MAG Piso 4 Quito, Ecuador Centro Internacional de Agricultura Tropical Phone: (593-2) 567-645 (INIAP) Apartado Aereo 6713 Phone: (593-2) 524-238 (UCA) Cali, Colombia Fax: (593-2) 500-316 Phone: (57-2) 445-0000 (CIAT Headquarters) (1-415) 833-6625 (USA direct) Guatemala (Beans) Fax: (57-2) 445-0073 (CIAT Headquarters) Regional Network for Beans in Central (1-415) 833-6626 (USA direct) America (PROFRIJOL) E-mail: ciat@cgnet.com Apartado Postal 231-A Internet: http://www.ciat.cgiar.org IICA Office Primera Avenida 8-00 Chair: Robert D. Havener Zona 9 2859 Stadium Drive Guatemala, Guatemala, C.A. Solvang, California 93463, USA Phone: (502) 3610925 Phone: - (1-805) 688 3204 Fax: (502) 3316304 Fax: (1-805) 688 4574 E-mail: profrijol@guate.net E-mail: R.Havener@cgnet.com Honduras (Hillsides) Director General: Grant M. Scobie IICA/CIAT Phone: (57-2) 445 0027 Apartado Aereo 410 Fax: (57-2) 445 0099 Edificio Palmira, 2 piso E-mail: g.scobie@cgnet.com Frente Hotel Honduras Maya Tegucigalpa, Honduras Information Officer: Nathan Russell Phone: (504) 321-862 E-mail: n.russell@cgnet.com Fax: (504) 391-443 E-mail: ciathill@hondutel.hn Librarian: Elizabeth Goldberg E-mail: ciat-library@cgnet.com Appendix D: CGIAR Secretariat and Centers 193 Malawi (Beans) Uganda (Beans) CIAT-Malawi Regional Program on Beans in Eastern Africa Chitedze Research Station Kawanda Agricultural Research Institute P.O. Box 158 P.O. Box 6247 Lilongwe, Malawi Kampala, Uganda Phone: (265) 822-851 Phone: (256-41) 567-670 Fax: (265) 782-835 Fax: (256-41) 567-635 E-mail: v.aggarwal@cgnet.com E-mail: ciat-uganda@imul.com Nicaragua (Hillsides) CIAT-Nicaragua CIFOR Apdo. Postal LM-172 Managua, Nicaragua Center for International Forestry Research Phone: (505-2) 663010/667328/669155 Jalan CIFOR Fax: (505-2) 784089 Situ Gede, Sindangbarang E-mail: r.vernooy@cgnet.com Bogor Barat 16680, Indonesia Philippines (Tropical Forages) Mailing Address: Forage for Smallholder Project P.O. Box 6596 JKPWB AUSAID/CIAT/CSIRO Jakarta 10065, Indonesia IRRI/CIAT Phone: (62-251) 622 622 (operator) Los Bafios, Laguna Phone: (62-251) 622 070 (direct extension) c/o P.O. Box 933 Fax: (62-251) 622 100 1099 Manila, The Philippines E-mail: cifor@cgnet.com Phone: (63-2) 818-1926 or 844-3351 Internet: http://www.cgiar.org/cifor Fax: (63-2) 891-1292 or 817-8470 E-mail: w.stur@cgnet.com Chair: Gill Shepherd Research Fellow Tanzania (Beans) Overseas Development Institute SADCC/CIAT Regional Program on Beans Forestry Research Programme in Southern Africa Portland House, Stag Place Selian Agricultural Research Institute London SWlE 5DP, United Kingdom P.O. Box 2704 Phone: (44-171) 393-1600 Arusha, Tanzania Fax: (44-171) 393-1699 Phone: (255-57) 2268 E-mail: g.shepherd@odi.org.uk Fax: (255-57) 8558/8264 E-mail: ciat-tanzania@cgnet.com Director General: Jeffrey Sayer E-mail: j.sayer@cgnet.com Thailand (Cassava) CIAT Regional Office for Asia Director of Information Services: Michael Ibach Field Crops Research Institute E-mail: m.ibach@cgnet.com Department of Agriculture Chatuchak, Bangkok 10900 Thailand Director of Communications: Sharmini Blok Phone: (66-2) 579-7551 E-mail: s.blok@cgnet.com Fax: (66-2) 940-5541 E-mail: ciat-bangkok@cgnet.com Librarian: Yuni Soeripto E-mail: y.soeripto@cgnet.com 194 Biotechnology and Biosafety CIMMYT Bolivia CIMMYT Centro Internacional de Mejoramiento de Maiz c/o ANAPO y Trigo Casilla 2305 Lisboa 27 Santa Cruz, Bolivia Apartado Postal 6-641 Phone: (591-3) 423011/423030 06600 Mexico, D.F. Mexico Fax: (591-3) 427194 Phone: (52-5) 726-9091 E-mail: cimmyt@mitai.nrs.bolnet.bo Telex: 1772023 CIMTME Fax: INTL (52-595) 54425 Colombia E-mail: cimmyt@cimmyt.mx CIMMYT cimmyt@cgnet.com c/o CIAT username@cimmyt.mx Apartado Aereo 67-13 Internet: http://www.cimmyt.mx Cali, Colombia Phone: (57-2) 4450-025 Chair: Wally Falcon (57-2) 4450-495 Director, Institute for International Studies Fax: (57-2) 4450 025 Stanford University E-mail: cdeleon@cgnet.com 200 Encina Hall Stanford, CA 94305-6055, USA Costa Rica Phone: (415) 725 1496 CIMMYT Telex: 372871 Stanuniv Apartado 55 Fax: (415) 725 2592 2200 Coronado E-mail: Wally.falcon@forsythe.stanford.edu San Jose, Costa Rica Phone: (506-2) 292457 Director General: Timothy Reeves Fax: (506-2) 292457 Fax: (52-5) 726-7585 E-Mail: gsain@iica.ac.cr E-mail: treeves@cimmyt.mx Ethiopia Director of External Relations: Tiffin D. Harris CIMMYT Fax: (52-5) 726-7536 P.O. Box 5689 E-mail: tharris@cimmyt.mx Addis Ababa, Ethiopia Phone: (252-1) 613215/615017 Library, Head: Corinne de Gracia Fax: (252-1) 611 892 E-mail: cdgracia@cimmyt.mx E-Mail: cimmyt-ethiopia@cgnet.com Publications, Head: Kelly Cassaday Guatemala E-mail: kcassaday@cimmyt.mx CIMMYT 12 Calle 1-25 Zona 10 Edificio Geminis Regional Offices: Torre Norte, 16 Nivel, Of. 1606 Apartado Postal 231-A Bangladesh Guatemala, Guatemala CIMMYT Phone: (502) 335 3418 P.O. Box 6057, Gulshan (502) 335 3428 Dhaka-1212, Bangladesh Fax: (502) 335 3407 Phone: (880-2) 89 30 64 E-mail: cimmyt@ns.guate.net Fax: (880-2) 88 35 16 E-mail: cm@cimmyt.bdmail.net Appendix D: CGIAR Secretariat and Centers 195 Honduras Turkey CIMMYT CIMMYT CIAT-Laderas P.K. 39 Emek c/o IICA-Honduras 06511 Ankara, Turkey Apdo. Postal 1410 Phone: (90-312) 287 35 95/96/97 Tegucigalpa, DC 11101 Honduras Fax: (90-312) 287-8955 Phone: (504) 321862/322502 E-mail: cimmyt-turkey@cgnet.com Fax: (504) 315472 E-mail: "'ciathill@hondutel.hn" Uruguay CIMMYT-Uruguay Kenya CC 1217 CIMMYT Montevideo, Uruguay P.O. Box 25171 Phone: (598-2) 928 522/923 630 Nairobi, Kenya Fax: (598-2) 928 522/923 633 Phone: (254-2) 632054/632206/ E-mail: cimmyt@inia.org.uy 630165 Fax: (254-2) 631 499/630 164 Zimbabwe E-mail: cimmyt-kenya@cgnet.com CIMMYT P.O. Box MP163 Nepal Mount Pleasant CIMMYT Harare, Zimbabwe P.O. Box 5186 Phone: (263-4) 30 18 07 Kathmandu, Nepal Fax: (263-4) 30 13 27 Phone: (977-1) 417 791, 422 773 E-mail: cimmyt-zimbabwe@cgnet.com Fax: (977-1) 414 184 E-mail: phobbs@cimmyt.mos.com.np CIP Syria CIMMYT Centro Internacional de la Papa Cereal Improvement Program Apartado 1558 ICARDA Lima 12, Peru P.O. Box 5466 Phone: (51-1) 349-6017 Aleppo, Syria Fax: (51-1) 349-5638 Phone: (963-21) 213 433 ext. 510 E-mail: cip@cgnet.com Fax: (963-21) 213 490 cip@cipa.org.pe E-mail: m.nachit@cgnet.com Internet: http://www.cgiar.org/cip Thailand Street Address: CIMMYT Avenida La Universidad 795 P.O. Box 9-188 La Molina, Lima 12, Peru Bangkok 10900, Thailand Phone: (66-2) 579 05 77 Chair: David R. MacKenzie (66-2) 579 48 58 NERA Fax: (66-2) 561-4057 0106 Symons Hall E-mail: bangkok@cimmyt.mx University of Maryland College Park, MD 20742-5580 USA Phone: (1-301) 405-4928 Fax: (1-301) 405-5825 Email: dml84@umail.umd.edu 196 Biotechnology and Biosafety Director General: Hubert Zandstra Cameroon Office Phone: (51-1) 349-2124 BP 279 Fax: (51-1) 349-5638 c/o Delegation of Agriculture, North West E-mail: cip-dg@cgnet.com Province Bamenda, Cameroon Information Officer: Steven Kearl Phone: (237) 362289 E-mail: s.kearl@cgnet.com Telex: 58442 (NWDA) Fax: (237) 363921/363893/363284 Regional Offices: Uganda PRAPACE/Uganda (Network) Peru P.O. Box 22274 Latin American and Caribbean Kampala, Uganda Apartado 1558 Phone: (256-41) 223-445 Lima 12, Peru Fax: (256-41) 341242 Phone: (51-1) 349-6141 E-mail: iita-uganda@imul.com Fax: (51-1) 349-5638 iita-uganda@cgnet.com E-mail: f.ezeta@cgnet.com nbluta@imul.com Bolivia CIP Project/PROINPA Uganda Liaison Office Casilla Postal 4285 P.O. Box 7878 Cochabamba, Bolivia Kampala, Uganda Phone: (591-42) 49506 and 49013 Phone: (256-41) 241-554 Fax: (591-42) 45708 Fax: (256-41) 236-918 E-mail: proinpa@papa.bo E-mail: iita-uganda@imul.com devaux@papa.bo iita-uganda@cgnet.com Ecuador n.smit@imul.com Estacion Experimental INIAP Santa Catalina Km 14, Panamericana Sur Nigeria Liaison Office Quito, Ecuador c/o IITA Phone: (593-2) 690-362/63 PMB 5320 (593-2) 690-990 Ibadan, Nigeria Fax: (593-2) 692-604 Phone: (234-22) 400-300/318 E-mail: cip-quito@cgnet.com 871-145-4324 Fax: 871-145-4325 via INMARSAT Kenya Satellite or (234-22) 412-21 Sub-Saharan Africa Regional Office Telex: TROPIB NG (903) 31417/31159 P.O. Box 25171 Cable: TROPFOUND,IKEJA Nairobi, Kenya E-mail: iita@cgnet.com Phone: (254-2) 632-054/632-206 Fax: (254-2) 630-005/632-151 (ILRI) Egypt Telex: 22040 Middle East and North Africa Regional Office Cable: CIPAPA Nairobi P.O. Box 17 E-mail: cip-nbo@cgnet.com Kafr El Zayat, Egypt Phone: (20-40) 586-720 Fax: (20-40) 580-800 Telex: (927) 23605 PBTNA UN E-mail: cip-egypt@cgnet.com Appendix D: CGIAR Secretariat and Centers 197 India China Office South and West Asia Regional Office c/o The Chinese Academy of Agricultural c/o International Potato Center Sciences IARI Campus Bai Shi Qiao Road No. 30 New Delhi 110012, India West Suburbs, Beijing Phone: (91-11) 574-8055 People's Republic of China (91-11) 573-1481 Phone: (86-10) 6217-9141 Telex: 3173140 FI IN Fax: (86-10) 6217-9135 3173168 EIC IN Telex: (716) 222720 CAASCN or 22233 Cable: CIPAPA, New Delhi Cable: AGRIACA E-mail: cip-delhi@cgnet.com E-mail: cip-china@cgnet.com Indonesia East and Southeast Asia ICARDA and the Pacific Regional Office c/o CRIFC, Jalan Merdeka 147, Bogor 16111 International Center for Agricultural Research or in the Dry Areas P.O. Box 929 P.O. Box 5466 Bogor 16309, West Java, Indonesia Aleppo, Syrian Arab Republic Phone: (62-251) 317951/313687 Phone: Tel Hadya (963-21) Fax: (62-251) 316264 213433/213477/225112/225012 E-mail: cip-bogor@cgnet.com DG Office (963-21) 210741 Fax: Tel Hadya (963-21) 213490 Philippines Office DG Office (963-21) 225105 c/o IRRI Telex: (492) 331208,331263 ICARDA SY P.O. Box 933 E-mail: icarda@cgnet.com Manila, The Philippines Internet: http://www.cgiar.org/icarda Phone: (63-94) 536-1662, 536-0235, 536-0015 City Office: Fax: (63-2) 845-0606 Phone: (963-21) 743104, 746807, 748964 E-mail: cip-manila@cgnet.com Fax: (963-21) 744622 Telex: (492) 331206 ICARDA SY Liaison Office Philippines UPWARD Network Chair: Alfred Bronnimann c/o IRRI Director P.O. Box 933 Swiss Federal Research Station for Agroecology Manila, The Philippines and Agriculture Phone: (63-94) 536-0235 Reckenholzstrasse 191 Fax: (63-94) 536-1662 8046 Zurich, Switzerland Phone: (41-1) 3777 111 Indonesia Fax: (41-1) 3777 201 Lembang Liaison Office: P.O. Box 1586 Director General: Adel El-Beltagy Bandung 40391, Indonesia Phone: (963-21) 225517 Phone: (62-22) 278-8151 E-mail: a.el-beltagy@cgnet.com Fax: (62-22) 278-6025 E-mail: cip-indonesia@cgnet.com Head, Information Services: Surendra Varma Phone: (963-21)213433 ext.260 E-mail: s.varma@cgnet.com 198 Biotechnology and Biosafety Damascus Office Regional Offices: ICARDA Hamed Sultan Building, 1st Floor Nile Valley and Red Sea Regional Program Abdul Kader Gazairi Street Abu Rommaneh - Malki Circle Egypt P.O. Box 5908 ICARDA Damascus, Syrian Arab Republic 15 G. Radwan Ibn El-Tabib Str. Phone: (963-11) 3331455/3320482 P.O. Box 2416 Telex: 492 412924 ICARDA SY Cairo, Egypt Fax: (963-11) 3320483 Phone: (20-2) 5725785/5735829/5724358 E-mail: icarda-damascus@cgnet.com Telex: 91 21741 ICARD UN Fax: (20-2) 5728099 Abdul Karim El Ali E-mail: ICARDA-CAIRO@cgnet.com Barze, Bldg. no. 6 Apt. 3,3rd Floor Nagwa Lotfi Damascus Cairo Phone: 5118414 (home) Phone: 3363272 (home) Lebanon North Africa Regional Program ICARDA Dalia Bldg. 2nd Floor Tunisia Rue Bashir El Kassar mailing address: P.O. Box 114/5055 ICARDA Tunis Office Beirut, Lebanon B.P. 435 Phone: (961-1) 813303/804071 El-Menzah 1004 Telex: 494 22509 ICARDA LE Tunis, Tunisia Fax: (961-1) 804071 Phone: (216-1) 232207, 767829 Fax: (216-1) 75166 Anwar Agha Telex: (409) 14066 ICARDA TN Ramlet-El Baida E-mail: icarda-tunis@cgnet.com Saniyah Habboub Street Sea Star Bldg, 8th Floor Building address: Beirut, Lebanon 8 rue Ibn Khaldoun Phone: 802415 (home) 1004 El-Menzah 1 B.P. 84 Terbol Station Tunis, Tunisia ICARDA Beka'a Valley Abderrezak Belaid Terbol, Lebanon 57 avenue Salah Ben-Youssef Phone: (961-3) 211553 2092 El-Menzeh 9A Fax: (961-3) 598008 Tunis, Tunisia E-mail: icarda-terbol@destination.com.lb Phone: 883276 (home) Appendix D: CGIAR Secretariat and Centers 199 Morocco Iran ICARDA Office Agricultural Research Education & Extension Station Experimentale INRA (Guich) Organization (AREEO) B.P. 6299 Ministry of Agriculture Rabat-Instituts, Rabat, Morocco Tabnak Avenue, Evin Phone: (212-7) 682909 P.O. Box 111, Tehran 19835, Iran Telex: 407 36212 ICARDA M Phone: (98-21) 2400094 Fax: (212-7) 675496 Fax: (98-21) 2401855 E-mail: icarda-iran@cgnet.com West Asia Regional Program Mr. Tahir Jordan House 34 ICARDA Street 21, Velenjak P.O. Box 950764 Tehran, Iran Amman 11195, Jordan Phone: 2404533 (home) Phone: (962-6) 825750, 817561 Telex: 493 23278 ICARDA JO Arabian Peninsula Regional Program Fax: (962-6) 825930 E-mail: ICARDA-Jordan@cgnet.com United Arab Emirates ICARDA-APRP Habib Halila P.O. Box 13979 Amman, Jordan Dubai, U.A.E. Phone: 5513963 (home) Phone: (971-4)230338 Fax: (971-4) 247501 Highland Regional Program E-mail: j.peacock-t@cgnet.com icdub@emirates.net.ae Turkey Mailing address: Building address: ICARDA Room 602 P.K. 39 Emek Ministry of Agriculture & Fisheries Bldg. Ankara 06511, Turkey 124, 40c Street Phone: (90-312) 2873595/96/97 Opp. Al-Riqa Rost Office Telex: (607) 44561 CIMY TR Nr Clock Tower Roundabout Fax: (90-312) 2878955 Dubai, UAE E-mail: icarda-turkey@cgnet.com John Peacock Building address: Phone: (971-50) 6521385 (mobile) ICARDA Eskisehir Yolu, 10km Yemen Lodumlu ICARDA-AREA - Yemen Program Ankara, Turkey P.O. Box 87334 Dhamar, Republic of Yemen S.P.S. Beniwal Phone: (967-6) 500768, 500684 41/13, Cayhane Sokak E-mail: icarda@ynet.ye Ghazi Osman Pasa aprp-yemen@cgnet.com Ankara 06700, Turkey Phone: 4470371 (home) Fax: 4463002 (home) 200 Biotechnology and Biosafety Sana'a Director General: Meryl J. Williams Phone: (967-1) 417556 Phone: (63-2) 812-8641 to 47 Fax: (967-6) 509414/509418 (63-2) 818-0466 (63-2) 815-3873 (home) S.V.R. Shetty, Team Leader, Dhamar Fax: (63-2) 816-3183 Phone: 506854 (home) (63-2) 812-3798 (direct) E-mail: m.j.williams@cgnet.com Latin America Regional Program Information and Training Division: Mexico Joanna Kane-Potaka, Leader ICARDA Phone: (63-2) 818-0466 ext. 222 c/o CIMMYT E-mail: j.kane@cgnet.com Lisboa 27 P.O. Box 6-641 Library and Information Services Unit: Mexico 06600, D.F., Mexico Rosalinda M. Temprosa, Manager Phone: (52-5) 726 9091 Phone: (63-2) 818-0466 ext. 101 Telex: 22 1772023 CIMTME E-mail: I.temprosa@cgnet.com Fax: (52-5) 726 7559/7558 E-mail: cimmyt@cgnet.com cimmyt@cimmyt.mx Outreach Offices: Solomon Islands ICLARM ICLARM Coastal Aquaculture Centre International Center for Living Aquatic P.O. Box 438 Resources Management Honiara, Solomon Islands MC P.O. Box 2631 Makati Central Post Office Phone: (677) 29255 0718 Makati City, The Philippines Fax: (677) 29130 Phone: (63-2) 812-8641 to 47 E-mail: iclarm@welkam.solomon.com.sb (63-2) 818-0466 Fax: (63-2) 816-3183 Bangladesh E-mail: iclarm@cgnet.com ICLARM Bangladesh Office Internet: http://www.cgiar.org/iclarm House 75, Road 7 Block-H, Banani Model Town Dhaka, Bangladesh Chair: Kurt J. Peters Phone: (880-2) 871151/873250 Department of Animal Breeding in the Tropics Fax: (880-2)871151 Institute of Applied Animal Sciences E-mail: iclarm@dhaka.agni.com Humboldt University of Berlin Lentzeallee 75 Malawi D-14195 Berlin (Dahlem), Germany ICLARM Malawi Project Office Phone: (49-30) 31471100 P.O. Box 229 (49-30) 31471339 Zomba, Malawi Fax: (49-30) 31471422 Phone: (265) 531-274/531-215 E-mail: k.peters@cgnet.com Fax: (265) 522-733 E-mail: rbrummett@cgnet.com Appendix D: CGIAR Secretariat and Centers 201 British Virgin Islands Director General: Pedro A. Sanchez ICLARM Caribbean/Eastern Pacific Office Phone: (254-2) 521003 PO. Box 3323, Road Town Fax: (254-2) 520023 Tortola, British Virgin Islands E-mail: p.sanchez@cgnet.com Phone: 1-809-494 5681 Fax: 1-809-494-2670 Head of Information: Michael Hailu E-mail: j.munro@cgnet.com E-mail: m.hailu@cgnet.com Regional Office: Librarian: William Umbima E-mail: w.umbima@cgnet.com Egypt ICLARM Research Center for Africa Regional Offices: and West Africa P.O. Box 2416 Cairo, Egypt Kenya 1st floor, 15 G Radwan Ibn El Tabib ICRAF Research Station, Machakos Giza, Egypt P.O. Box 953 Machakos, Kenya Deputy Director-General Africa-West Asia: Phone: (254-145) 20229/20286 Roger Rowe Phone: (202) 572-5785 Cameroon (202) 573-5829 ext. 21 ICRAF/IRAD Agroforestry Research Project (202) 572-4358 P.O. Box 2123 Fax: (202) 572-8099 Yaounde, Cameroon E-mail: iclarmca@intouch.com Phone: (237) 237560 Telex: 1140 KN Yaounde Fax: (237) 237440 ICRAF E:mail: b.duguma@camnet.cm International Centre for Research in Indonesia Agroforestry ICRAF-Southeast Asia Regional Programme United Nations Avenue Jalan Gunung Batu No. 5 P.O. Box 30677 P.O. Box 161 Nairobi, Kenya Bogor 16001, Indonesia Phone: (254-2) 521450 Phone: (62-251) 315 234 Telex: (987) 22048 Fax: (62-251) 315 567 Fax: (254-2) 521001 E-mail: icraf-indonesia@cgnet.com E-mail: icraf@cgnet.com Internet: http://www.cgiar.org/icraf Kenya KARI-KEFRI-ICRAF Regional Research Project Chair: Yemi M. Katerere P.O. Box 27 IUCN Rosa Embu, Kenya No. 6 Lanark Road, Belgravia Phone: (254-161) 20116/20873 P.O. Box 745 Fax: (254-161) 30064 Harare, Zimbabwe E-mail: icraf-embu@cgnet.com Phone: (263-4) 728266/7 Fax: (263-4) 720738 E-mail: yek@iucnrosa.org.zw 202 Biotechnology and Biosafety KEFRI/KARI/ICRAF Agroforestry Research Peru Project ICRAF Latin America Regional Programme P.O. Box 25199 c/o INIA-Centro Forestal Otonglo, Kisumu, Kenya Carretera Federico Basadre Km 4.2 Phone: (254-35) 51245, 51164, 51163 Apartado Postal 558 Fax: (254-35) 51592 Pucallpa, Peru E-mail: afresmaseno@form-net.com Phone: (511) 436 6920 Fax: (511) 435 1570 Malawi E-mail: d.bandy@cgnet.com SADC-ICRAF Agroforestry Project Makoka Agricultural Research Station Philippines P.O. Box 134 ICRAF-Philippines Zomba, Malawi 2/F College of Forestry Administration Phone: (265) 534277, 534209/534250 Building Telex: 44017 (ICRAF Malawi) P.O. Box 35024 Fax: (265) 534283 UPLB, College E-mail: fkwesiga@malawi.net Laguna 4031, The Philippines Phone: (63-49) 536 2925 Mali Fax: (63-49) 536 2925 ICRAF Sahel Programme E-mail: icrafphi@irri.cgnet.com c/o ICRISAT B.P. 320 Tanzania Bamako, Mali ICRAF-Tanzania Agroforestry Research Project Phone: (223) 223375/227707 c/o HASHI Telex: ICRISAT 2681 MJ P.O. Box 797 Fax: (223) 228683 Shinyanga, Tanzania E-mail: e.bonkoungou@cgnet.com Phone: (255 68) 763099 Telex: 48102 OXMAC TZ Mexico (c/o OXMAC Ltd.) ICRAF-Mexico Programme Fax: (255 68) 762172) Km 3.5 Carretera. Chetumal-Bacalar E-mail: rotsyina@intafrica.com Apartado Postal No. 388 C.P. 77000 Chetumal Thailand Quintana Roo, Mexico ICRAF-Chiang Mai Phone: (52-983) 28350 Computer Service Center Fax: (52- 983) 28350 Chiang Mai University E-mail: jhaggar@mpsnet.com.mx Chiang Mai 50200, Thailand Phone: (66-53) 943799 Niger Fax: (66-53) 894133 ICRAF-Niger E-mail: icraf@loxinfo.co.th c/o ICRISAT Sahelian Centre B.P. 12 404 Uganda Niamey, Niger ICRAF-Uganda AFRENA Project Phone: (227) 722529 Forest Research Institute Telex: 5406 N.I. P.O. Box 1752 Fax: (227) 734329 Kampala, Uganda E-mail: icrisat.sc@cgnet.com Phone: (256-41) 232071 Fax: (256-41) 220268 E-mail: aluma@starcom.co.ug Appendix D: CGIAR Secretariat and Centers 203 ICRAF-Uganda AFRENA Project Chair: Ragnhild Sohlberg P 0 Box 311 Vice President, External Relations and Special Kabale, Uganda Projects Phone: (256-486) 23931 Kabale Corporate Staff Telex: 68032 KBUB PUB TLX Norsk Hydro a.s. Fax: (256-486) 23931 (Project Office) Bygdoy alle 2 E-mail: afrenakb@starcom.co.ug N-0240, Oslo, Norway Phone: (47) 22432851 Fax: (47) 22432615 Zambia E-mail: ragnhild.sohlberg@chr.hydro.com ICRAF-Zambia AFRENA Project c/o Provincial Agriculture Office Director General: Shawki M. Barghouti (Eastern Province) P.O. Box 510046 Interim Director, Information Management: Chipata, Zambia Mark D. Winslow Phone: (260-62) 21404 Telex: ZA 63020 Chipata Regional Offices: Fax: (260-62) 21404 E-mail: zamicraf@zamnet.zm India New Delhi Liaison Office Zimbabwe IARI Campus, Pusa SADC-ICRAF Agroforestry Project New Delhi 110 012, India c/o Department of Research and Specialist Phone: (91-11) 5819294 Services Fax: (91-11) 5819287 5th Street Extension E-mail: icrisatnd@cgnet.com P.O. Box CY 594, Causeway Harare, Zimbabwe Liaison Officer: P.M. Menon Phone: (263-4) 704531 Telex: 734646 ZW Niger Fax: (263-4) 728340 ICRISAT-Niamey E-mail icraf-zimbabwe@cgnet.com BP 12404 Niamey, Niger (via Paris) Phone: (227) 722529/722626 ICRISAT Fax: (227) 734329 E-mail: icrisatsc@cgnet.com International Crops Research Institute for the Semi-Arid Tropics ICRISAT Country Representative: K Anand Kumar Corporate Office and Headquarters Asia Region Patancheru 502 324 Mali Andhra Pradesh, India ICRISAT-Bamako Phone: (91-40) 596161 B.P. 320 Telex: 422203 ICRI IN Bamako, Mali Fax: (91-40) 241239/596182 Phone: (223) 223375/227707 E-mail: ICRISAT@cgnet.com Fax: (223) 228683 Internet: http:/ /www.cgiar.org/icrisat E-mail: icrisat-w-mali@cgnet.com ICRISAT Country Representative: F. Waliyar 204 Biotechnology and Biosafety Nigeria IFPRI ICRISAT-Kano IITA Office International Food Policy Research Institute Sabo Bakin Zuwo Road 2033 K Street, NW PMB 3491 Washington, DC 20006, USA Kano, Nigeria Phone: (1-202) 862-5600 Phone: (234-64) 662050 Telex: 440054 IFPR UI Fax: (234-64) 663492/669051 Cable: IFPRI E-mail: icrisat-w-nigeria@cgnet.com Fax: (1-202) 467-4439 E-mail: ifpri@cgnet.com ICRISAT Representative: 0. Ajayi Internet: http://www.cgiar.org/ifpri Zimbabwe Chair: Martin Pineiro ICRISAT-Bulawayo Director, Group CEO SADC/ICRISAT Sorghum and Millet Consultores en Economia y Organizacion Improvement Program (SMIP) Hipolito Yrigoyen 785 Matopos Research Station Piso 5, oficina "M" P.O. Box 776 Buenos Aires (Capital Federal) 1086 Bulawayo, Zimbabwe Argentina Phone: (263-83) 8311/8314 Phone: (54-1) 342-1395 Fax: (263-83) 8253 (54-1) 331-0035 (263-9) 41652 Fax: (54-1) 342-8153 E-mail: icrisatzw@cgnet.com Director General: Per Pinstrup-Andersen ICRISAT Country Representative: E-mail: p.pinstrup-andersen@cgnet.com L. K. Mughogho Director of Information: Donald Lippincott Kenya E-mail: d.lippincott@cgnet.com ICRISAT-Nairobi P.O. Box 39063 Librarian: Patricia Klosky Nairobi, Kenya E-mail: t.klosky@cgnet.com Phone: (254-2) 521450 (ICRAF) Fax: (254-2) 521001 (ICRAF) E-mail: icrisat-kenya@cgnet.com IIMI ICRISAT Country Representative: S. N. Silim International Irrigation Management Institute P.O. Box 2075 Malawi Colombo, Sri Lanka ICRISAT-Malawi Phone: (94-1) 867404/869080/869081 Chitedze Agricultural Research Station Telex: 22318, IIMIHQ CE P.O. Box 1096 Fax: (94-1) 866854 Lilongwe, Malawi E-mail: iimi@cgnet.com Phone: (265) 720968/720906 Internet: http://www.cgiar.org/iimi Fax: (265) 741872 E-mail: icrisat-malawi@cgnet.com ICRISAT Country Representative: P. Subrahmanyam Appendix D: CGIAR Secretariat and Centers 205 Chair: Zafar Altaf Niger Chairman IIMI, Niger National Team Pakistan Agricultural Research Council BP 10883 Plot 20, Ramna 5/1 Niamey, Niger P.O. Box 1031 Phone: (227) 73-29-53/73-23-94 Islamabad 44000, Pakistan Fax: (227) 75-23-94 or, through backup Phone: (92-51) 9203966 services 44-1-491-832002 Fax: (92-51) 9202968 E-mail: iimi-niger@cgnet.com Director General: David Seckler Pakistan E-mail: d.seckler@cgnet.com IIMI, Pakistan National Program 12 km, Multan Road Head of Communications and Donor Relations: Chowk Thokar Niaz Baig James Lenahan Lahore 53700, Pakistan E-mail: j.lenahan@cgnet.com Phone: 92-42 5410050/53 (4 lines) Fax: 92-42 5410054 Librarian: N. U. Yapa E-mail: iimi-pak@cgnet.com E-mail: n.yapa@cgnet.com Turkey Documentalist: Ramya de Silva IIMI, Turkey National Program E-mail: r.desilva@cgnet.com c/o Director, Agrohydrology Research and Training Center National Programs: 35600 Menemen Izmir, Turkey Sri Lanka Phone: 90-232-8310512 IIMI, Sri Lanka National Program Fax: 90-232-8311051 127, Sunil Mawatha E-mail: j.brewer@cgnet.com Battaramulla, Sri Lanka Phone: (94-1) 867404/869080/869081 Fax: (94-1) 872185 IITA E-mail: iimi@cgnet.com International Institute of Tropical Agriculture Burkina Faso PMB 5320 IIMI, Burkina Faso National Team Ibadan, Nigeria 01 B.P. 5373 Phone: (234-2) 241-2626 Ouagadougou 01, Burkina Faso 871-1454324 (via INMARSAT) Phone: (226) 308489 Telex: (905) 31417 or 31159 TROPIB NG Telex: 5381 SAFGRAD BF(attn: IIMI) Cable: TROPFOUND, IKEJA Fax: (226) 310618 Fax: 871-1454325 (via INMARSAT) E-mail: iimi-Burkina@cgnet.com (234-2) 2412221 Regular E-mail: iita@cgnet.com Mexico Internet: http://www.cgiar.org/iita UMI, Mexico National Program c/o CIMMYT International Mailing Address: Lisboa 27, Colonia Juarez IITA, Ibadan, Nigeria Apdo. Postal 6-641 c/o L.W. Lambourn & Co. 06600 Mexico, D.F. Mexico Carolyn House Phone: (52-595) 54400/54410 26 Dingwall Road Fax: (52-595) 54425 or (52-5) 7267558/9 Croydon CR9 3EE, United Kingdom E-mail: iimi-mex@cgnet.com Phone: (44-181) 686-9031 Telex: 946979 LWL G Fax: (44-181) 681-8583 206 Biotechnology and Biosafety Chair: Enrico Porceddu Regional Offices: Dipartimento di Agrobiologia e Agrochimica Universita Degli Studi Della Tuscia Nigeria Via S.C. del Lellis IITA Kano Station 01100 Viterbo, Italy Sabo Bakin Zuwa Road Phone: (39-761) 25 72 31 PMB 3112 Telex: 614076 TUSVIT Kano, Nigeria Fax: (39-761) 35 72 56 Phone: (234-64) 645350; 645351;645353 E-mail: porceddu@unitus.it Telex: (905) 77330; enrypo@pelagus.it 77444 (box 189) TDS KN NG Cable: AGRISEARCH KANO Director General: Lukas Brader Fax: (234-64) 645352/669051 E-mail: l.brader@cgnet.com E-mail: icrisat-w-nigeria@cgnet.com Deputy Director General: Robert Booth Contact: Bir B. Singh E-mail: r.booth@cgnet.com IlTA/High Rainfall Station Onne Director, Corporate Services Division: PMB 008, Nchia-Eleme William P. Powell Port Harcourt, Nigeria E-mail: w.powell@cgnet.com Phone: (234-090)501380 (cellular) Fax: 871-682 341882 (via INMARSAT) Director, Crop Improvement Division: E-mail: iita-onne@cgnet.com Frances M. Quin E-mail: m.quin@cgnet.com Contact: Piers D. Austin Director, International Cooperation Division: Republique du Benin Michael W. Bassey IITA/Benin Research Station E-mail: m.bassey@cgnet.com B.P. 08-0932 Cotonou Republique du Benin Director, Plant Health Management Division: Phone: (229) 350553/350186/360600-1 Peter Neuenschwander Telex: (972) 5329 ITA BEN Phone: (229) 350553/350186/3606001 Fax: (229) 350556 E-mail: p.neuenschwander@cgnet.com E-mail: iita-benin@cgnet.com Acting Director, Resource and Crop Contact: Peter Neuenschwander Management Division: Horst Grimme E-mail: h.grimme@cgnet.com Cameroon IITA Humid Forest Station Head, Information Services: Jack Reeves B.P. 2008 (Messa) E-mail: j.reeves@cgnet.com Yaounde, Cameroon Phone: (237) 237434 Head, Library Services: Yakubu A. Adedigba Fax: (237) 237437 E-mail: iita@cgnet.com E-mail: iita-humid@cgnet.com Contact: Stephan F. Weise Appendix D: CGIAR Secretariat and Centers 207 Ghana Fax: (265) 74 42 05 IITA Research Liaison Office, Ghana E-mail: sarrnet@eo.wn.apc.org c/o Crops Research Institute P.O. Box 3785 Contact: James M. Teri Kumasi, Ghana Telex: 3036 BTH 10 GH Mozambique 2630 MNM KSI USAID/SADC/IITA/CIP-SARRNET 3014 BTH 26 GH c/o INIA Fax: (223) 5125306 FPLM Malvane E-mail: jsuhiita@ncs.com.gh CP 2100 Maputo, Mozambique Contact: Joseph B. Suh Phone: (258-1) 460097/99 Telex: 6-166 SEEDS MO C6te d'Ivoire Fax (258-1) 460074 UITA Liaison Office, Bouak6, C6te d'Ivoire E-mail: madrade@zebra-uem.mz 01 B.P. 2551 Bouak6, C6te d'Ivoire Contact: Maria I. Andrade Phone: (225) 634514/632396/ 633242 Zambia Telex: 69138 ADRAO BOUAKE CI USAID/SADC/IITA/CIP-SARRNET Fax: (225) 634714 Mutanda Research Station E-mail: j.fajemisin@cgnet.com Luapula Reg. Research Station PO 710129 Contact: Joseph M. Fajemisin Manza, Zambia Phone: (260-08) 82 12 42/82 12 30 Uganda Telex: IRDP-LP ZA 59050 IITA/EARRNET Project Fax: (260-08) 82 19 13 c/o IITA-East and Southern Africa Regional Center (ESARC) Contact: Ambayera Muimba-Kankolongo P.O. Box 7878 Kampala, Uganda Tanzania Phone: (256-41) 223460 USAID/SADC/I1ITA/CIP SARRNET Telex: 61000 ESARC UGA Kibaha Research Station Fax: (256-41) 223459 P.O. Box 2066 E-mail: iita-uganda@cgnet.com Dar-Es-Salaam, Tanzania jwhyte@imul.com Phone: 255-811-324355 (255-11) 700986 Contact: Jim B.A. Whyte Telex: c/o FAO 41320 FOODAGRI TZ Fax: c/o FAO (255-51) 112501 Malawi E-mail: n.mahungu@cats-net.com IITA/SARRNET Project Pagat House Contact: Nzola-Meso Mahungu P.O. Box 30258 Capital City, Lilongwe 3 Malawi Phone: (265) 74 02 61/74 41 39 Telex: 45281 IITA MI 43055 ROCKFND MI 208 Biotechnology and Biosafety Zimbabwe Regional Sites: USAID/SADC/IITA/CIP-SARRNET Grassland Research Station Ethiopia P.O. Box 3701 Marondera Debre Zeit, Ethiopia Zimbabwe P.O. Box 5689 Phone: (263-79) 23 526 Addis Ababa, Ethiopia E-mail: i@kasele.icon.co.zw Phone: (251-1) 339566 Fax: (251-1) 338755 Contact: Idumbo N. Kasele E-mail: ilri-ethiopia@cgnet.com Nigeria ILRI ILRI/Ibadan PMB 5320 International Livestock Research Institute Ibadan, Nigeria P.O. Box 30709 Phone: (234-22) 400300/14 Nairobi, Kenya Telex: 31417/31159 TROPIB NG Phone: (254-2) 630743 E-mail: ilri-ibadan@cgnet.com Telex: 22040 Cable: ILRI Peru Fax: (254-2) 631499 ILRI/CIP E-mail: ilri@cgnet.com Apartado 1558 Internet: http://www.cgiar.org/ilri Lima 12, Peru Phone: (51-1) 436-6920/435-0266/ P.O. Box 5689 435-9367/435-4354 Addis Ababa, Ethiopia Fax: (51-1) 435-0842/435-1570 Phone: (251-1) 613215 E-mail: cip@cgnet.com Telex: 21207 ILRI ET cip@cipa.org.pe Cable: ILRI-ADDIS ABABA Fax: (251-1) 611892 Colombia E-mail: ilri-ethiopia@cgnet.com ILRI/CIAT Apartado Aero 6713 Chair: Neville P. Clarke Cali, Colombia Centeq Research Plaza, Suite 241 Phone: (57-2) 4450-000 The Texas A & M University System Fax: (57-2) 4450-073 College Station, Texas 77843-2129, USA E-mail: ciat@cgnet.com Phone: (1-409) 845-2855 Fax: (1-409) 845-6574 Niger E-mail: n-clarke@tamu.edu ILRI/ICRISAT Sahelian Center B.P. 12404 Director General: Hank Fitzhugh Niamey, Niger P.O. Box 30709 Phone: (227) 723071 Nairobi, Kenya Telex: (ICRISAT) 5406/5560 NI Phone: (254-2) 630743 Fax: (227) 734329 Fax: (254-2) 631259 E-mail: ilri-niamey@cgnet.com E-mail: h.fitzhugh@cgnet.com Head of Publications: Paul Neate E-mail: p.neate@cgnet.com Appendix D: CGIAR Secretariat and Centers 209 India Deputy Director General Programmes: ILRI/ICRISAT Masaru Iwanaga Patancheru 502 324 Phone: (39-6) 51892200/249 Andhra Pradesh, India Fax: (39-6) 575-0309 Phone: (91-40) 596 161 E-mail: m.iwanaga@cgnet.com Fax: (91-40) 241 239 E-mail: icrisat@cgnet.com Director Finance and Administration: Koen Geerts Burkina Faso Phone: (39-6) 51892201 ILRI/CIRDES Fax: (39-6) 575-0309 01 B.P. 454 E-mail: k.geerts@cgnet.com Bobo-Dioulasso, Burkina Faso Phone: (226) 972-638 System-Wide Genetic Resources Programme Fax: (226) 972-320 Secretariat (SGRP) E-mail: toure@ouaga.orstom.bf Coordinator: Jane Toll c/o IPGRI Via delle Sette Chiese 142 IPGRI 00145 Rome, Italy Phone: (39-6) 51892225/245 International Plant Genetic Resources Institute Telex: 4900005332 (IBR UI) (via USA) Via delle Sette Chiese 142 Fax: (39-6) 575-0309 00145 Rome, Italy E-mail: j.toll@cgnet.com Phone: (39-6) 518921 Fax: (39-6) 575- 0309 Director Documentation, Information, and E-mail: ipgriI@cgnet.com Training: Lyndsey Withers Internet: http://www.cgiar.org/ipgri Phone: (39-6) 51892237/268 E-mail: l.withers@cgnet.com Chair: Marcio de Miranda Santos Head, Department for Research and Development Director Genetic Resources Science and EMBRAPA Technology: Jan Engels SAIN Parque Rural Phone: (39-6) 51892222/401 Av. W3 Norte-final E-mail: j.engels@cgnet.com 70 770-901 Brasilia-DF 02138, Brazil Phone: (55 61) 340 5518 Information/Public Awareness: (55 61) 348 4451 Ruth D. Raymond Fax: (55 61) 347 2061 Phone: (39-6) 51892215 (direct) E-mail: marcio@sede.embrapa.brazil E-mail: r.raymond@cgnet.com Director General: Geoffrey C. Hawtin Library: Julia-Anne Dearing Phone: (39-6) 51892247/202 Phone: (39-6) 51892216 (direct) Fax: (39-6) 51892405 E-mail: j.dearing@cgnet.com E-mail: g.hawtin@cgnet.com Manager of Editorial and Publications Unit: Assistant Director General: Dick van Sloten Paul Stapleton Phone: (39-6)51892239/241 Phone: (39-6) 51892233 (direct) Fax: (39-6) 51892405 E-mail: p.stapleton@cgnet.com E-mail: d.vansloten@cgnet.com 210 Biotechnology and Biosafety IPGRI Offices: India South Asia Office Kenya c/o NBPGR Sub-Saharan Africa Regional Office Pusa Campus c/o ICRAF New Delhi 110012, India P.O. Box 30677 Phone: (91-11) 578-6112 Nairobi, Kenya Telex: 31-77257 NBPGR IN Phone: (254-2) 522150/521514 Fax: (91-11) 573-1845 Fax: (254-2) 521209 E-mail: ipgri-delhi@cgnet.com E-mail: ipgri-kenya@cgnet.com Syria Regional Director: Franck Attere West Asia & North Africa Regional Office c/o ICARDA Republique du Benin P.O. Box 5466 West Africa Office Aleppo, Syria c/o IITA-Benin Research Station Phone: (963-21)231412 BP 08-0932 Telex: (924) 331206 ICARDA SY Cotonou, Republique du Benin (924) 331208 ICARDA SY Phone: (229)350553/350189/360600-1 (924) 331263 ICARDA SY Telex: (972) 5329 ITA BENIN Fax: (963-21) 225105/213490 Fax: (229) 350556 E-mail: ipgri-wana@cgnet.com E-mail: a.goli@cgnet.com Regional Director: George Ayad Scientist, Conservation Strategies: Ankon Goli Malaysia Colombia Asia, Pacific & Oceania Regional Office Americas Regional Office P.O. Box 236 c/o CIAT UPM Post Office Apartado Aereo 6713 43400 Serdang Cali, Colombia Selangor Darul Ehsan, Malaysia Phone: (57-2) 445 0048/445 0049 (IPGRI) Phone: (60-3) 942-3891-4 (57-2) 4450000 (CIAT) Fax: (60-3) 948-7655 IVDN: 625-3329 E-mail: ipgri-apo@cgnet.com Telex: 05769 CIAT CO Cable: CINATROP Regional Director: Ken Riley Fax: (57-2) 445-0096 (IPGRI) (57-2) 445-0073 (CIAT) China IVDN Fax: 625-3273 East Asia Office E-mail: ciat-ipgri@cgnet.com c/o CAAS 30 Bai Shi Qiao Road Regional Director: Ramon Lastra Beijing 100081, China Phone: (86-10) 62183744 Telex: 222720 CAAS CN Fax: (86-10)62174159 E-mail: ipgri-caas@cgnet.com Coordinator: Zhou Ming-De Appendix D: CGIAR Secretariat and Centers 211 Italy Uganda Europe Regional Office East and Southern Africa Office c/o IPGRI P.O. Box 24384 Via delle Sette Chiese 142 Kampala, Uganda 00145 Rome, Italy Phone: (256-41) 223502 Phone: (39-6) 51892229/221 Fax: (256-41) 223503 Telex: 49900005332 (IBR UI) (via USA) E-mail: inibap-esa@imu.com Fax: (39-6) 575-0309 E-mail: t.gass@cgnet.com Regional Coordinator: Eldad Karamura Regional Director: Thomas Gass Philippines Asia and Pacific Office IPGRIIINIBAP Offices: c/o PCARRD Los Bafios, Laguna 3732, Philippines INIBAP Phone: (63-94) 536 0014 International Network for the Improvement Telex: (754) 40860 PARRS PM of Banana and Plantain Fax: (63-94) 536 0016 Parc Scientifique Agropolis II Montpellier Cedex 5, 34937 France Costa Rica Phone: (33) 4 67611302 INIBAP Latin American and Caribbean Office Fax: (33) 4 67610334 c/o CATIE E-mail: inibap@tcgnet.com 7170 Turrialba, Costa Rica Phone: (506) 556 62 431 Director: Emile Frison Fax: c/o (506) 556 62 431 E-mail: e.frison@cgnet.com E-mail: lyega@catie.ac.cr Information/Communication: Claudine Picq Regional Coordinator: Franklin Rosales E-mail: c.picq@cgnet.com Honduras Belgium INIBAP INIBAP Transit Centre c/o FHIA c/o Katholieke Universiteit Leuven Apartado Postal 2067 Faculteit Landbouwkundige en Toegepste San Pedro Sula, Honduras Biologische Wetenschappen Phone: (504) 682078/682470 Kardinaal Mercierlaan 92 Fax: (504) 682313 B-3001 Heverlee, Belgium Phone: (32-16) 321417 Associate Scientist, Nematology: Nicole Viaene Telex: 25941 elekul b Fax: (32-16) 321993 E-mail: lab.trop@agr.kuleuven.ac.be IRRI Officer-in-Charge: Ines van den Houwe International Rice Research Institute P.O. Box 933 Cameroon Manila, The Philippines Sub Saharan Africa Office Phone: (63-2) 845-0563/0569/0570/0573/ c/o CRBP, BO 832 0575 Douala, Cameroon (Trunk Hunting Lines) Phone: (237) 427129/426052 762-0127 (for international calls only) Fax: (237) 425786 (1-415) 833-6620 IVDN: 620-0 IRRI Operator Regional Coordinator: Ekow Akyeampong 620-670 IRRI Fax 212 Biotechnology and Biosafety Telex: (fIT) 40890 RICE PM (Los Banios) Regional Offices: CAPWIRE: 14519 IRI LB PS (mailbox) Bangladesh Cable: RICEFOUND, Manila IRRI Dhaka Office Fax: (63-2) 891-1292 House 30, Road 10B, Block H (63-2) 717-8470 Banani, Dhaka (63-2) 761-2404 Bangladesh (63-2) 761-2406 (for international fax Phone: (880-2) 885341; 601197 only) Telex: 642671 HBP BJ (1-415) 833-6621 671010 DHL BJ Internet: Cable: RICEFOUND DHAKA IRRI Website: http://www.cgiar.org/irri Fax: (880-2) 885341/883416 Information About Rice: http://www.riceweb.org E-mail: irri.dhaka@drik.bgd.toolnet.org IRRI Library: http://wwwricelib.irri.cgiar.org irri.dhaka@driktap.tool.nl IRRI Rice Museum: http://wwwriceworld.org Myanmar Chair: Roelof Rabbinge IRRI Representative Office Professor, Department of Theoretical P.O. Box 1369 Production Ecology Yangon, Myanmar Wageningen Agricultural University Phone: (95-1) 663590 Bornsesteeg 47 Telex: 21311 AGRICO BM 6708 PD Wageningen, The Netherlands Fax: (95-1) 667991 Phone: (31-31) 748-3988 E-mail: Fax: (31-31) 748-4892 garcia%remote.undp-mya@nylan.undp.org Telex: 75209 abw nl E-mail: office@sec.tpe.wau.nl India LRRI-India Liaison Office Director General (interim): Robert Havener C-18, Friends Colony (East) Phone: (63-2) 810-5337 New Delhi 110065, India Fax: (63-2) 892-0354 Phone: (91-11) 692-4290/692-5070 E-mail: r.havener@cgnet.com Fax: (91-11) 692-3122 E-mail: irri@giasdl0l.vsnl.net.in Information Center: Ian M. Wallace, Head Phone: (63-2) 845563/0569/0570/ Indonesia 0573/0575 Cooperative DEPAGRI-IRRI Program E-mail: i.wallace@cgnet.com P.O. Box 205 Bogor 16002, Indonesia Library and Documentation Service: Phone: (62-251) 334391 Ian M. Wallace, Librarian Cable: IRRIAID Bogor Fax: (62-251) 314354 Cormmunication and Publications Service: E-mail: irri-bogor@cgnet.com Eugene Hettel, Head Phone: (63-2) 845-0563/0569/0570/ Thailand 0573/0575 IRRI Cooperative Project with the Ministry of Agriculture and Cooperatives Computer Services: Ian Moore, Manager P.O. Box 9-159 Phone: (63-2) 845-0563/0569/0570/ Bangkhen, Bangkok 10900, Thailand 0573/0575 Phone: (66-2) 579-5249/579-9493/ E-mail: i.moore@cgnet.com 561-1581 Telex: 84478 INTERAG TH Appendix D: CGIAR Secretariat and Centers 213 Fax: (66-2) 561-4894 Vietnam E-mail: irri-bangkok-t@cgnet.com IRRI Vietnam Office (for general administration) Department of Science Technology and irri-bangkok@cgnet.com Product Quality (for accomodation and travel) Ministry of Agriculture and Food Industries irri-bangkok-account@cgnet.com 2 Ngoc ha, Ba dinh (for financial matters) Hanoi, Vietnam Japan Phone: (84-4) 823-4202 IRRI Japan Liaison and Library Office Fax: (84-4) 823-4425 c/o JIRCAS E-mail: 113@remotel.msm.cgnet.com 1-2 Ohwashi, Tsukuba Ibaraki 305, Japan Phone: (81-0298) 386339 ISNAR Fax: (81-0298) 386339 Telex: 3656156 TARC JP International Service for National Agricultural Cable: MAFFTROPICAL TSUCHIURA Research E-mail: kfbO3331@niftyserve.orjp" Laan van Nieuw Oost Indie 133 2593 BM The Hague, The Netherlands Madagascar-IRRI Rice Research Project Phone: (31-70) 349-6100 B.P. 4151 Telex: 33746 ISNAR NL Antananarivo (101), Madagascar Cable: ISNAR Cable: IRRIMAD, Antananarivo Fax: (31-70) 381-9677 Fax: (261-2) 34883 (Attn. 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Michelsen Institute Development Studies and Human Rights Fantoftvegen 38 N-5036 Fantoft, Norway Phone: (47-55) 574-000 Telex: 40 006 CMIN THE WORLD BANK 1818 H Street, N.W. Washington, D.C. 20433 USA Telephone: 202-477-1234 Facsimile: 202-477-6391 Telex: MCI 64145 WORLDBANK MCI 248423 WORLDBANK World Wide Web: http://www.worldbank.org/ E-mail: books@worldbank.org COSPONSORS American Association for the Advancement of Science The Conservation Fund Consultative Group on International Agricultural Research Food and Agriculture Organization of the United Nations Government of Norway Government of Sweden International Council of Scientific Unions Smithsonian Institution Third World Academy of Sciences Union of Concerned Scientists United Nations Development Programme United Nations Educational, Scientific and Cultural Organisation United Nations Environment Programme United Nations Industrial Development Organization U. S. National Academy of Sciences The World Conservation Union The World Bank Group Biotechnology and Biosafety was a forum associated with The Fifth Annual World Bank Conference on Environmentally and Socially Sustainable Development, held at the World Bank, October 9-10, 1997 ENVIRONMENTALLY AND SOCIALLY 44 SUSTAINABLE DEVELOPMENT 1!242 9 780821 342428 ISBN 0-8213-4242-8