A WORKBOOK FOR TECHNICAL TRAINING Biosafety and Risk Assessment in Agricultural Biotechnology Patricia L Traynor Robert Frederick Muffy Koch The Agricultural Biotechnology Support Project Institute of International Agriculture Michigan State University, USA Copyright © 2002 by the Board of Trustees, Michigan State University, East Lansing, MI All rights reserved Printed in the United States of America ISBN 1-56525-016-8 This publication was made possible through support provided by the U.S Agency for International Development, Bureau for Economic Growth, Agriculture and Trade, Office of Environment and Science Policy, under the terms of Cooperative Agreement No DAN-A-00-91-00126-00 and support of the U.S Agency for International Development, Cairo, Egypt, under the terms of Grant No 263-G-00-9600014-00 The opinions expressed herein are those of the author(s) and not necessarily reflect the views of the U.S Agency for International Development, Michigan State University, Virginia Polytechnic Institute and State University, or the U.S Environmental Protection Agency PHOTO CREDITS: pages vi, 18, 30, and 106: Scott Bauer, cour- tesy of the Agricultural Research Service, U.S Department of Agriculture; page 46: Francisco Santos Gonzales; page 66: Kelly Zarka; page 124: Jack Dykinga ADDITIONAL COPIES OF THIS WORKBOOK ARE AVAILABLE FROM: MSU Bulletin Office, 10-B Agriculture Hall, Michigan State University, East Lansing, MI 48824-1039, USA; tel (517) 355-0240; fax (517) 353-7168 MANAGING EDITOR: Andrea Johanson, Assistant Director, Agri- cultural Biology Support Project, Michigan State University EDITOR: Kathleen McKevitt, IDIOM LAYOUT AND DESIGN: Sharp Des!gns, Inc., Lansing, MI PRINTING AND BINDING: BRD Printing, Inc., Lansing, MI CONTENTS Acknowledgments v About the Authors vii PART ONE: Biosafety in Principle and in Practice Introduction Rationale and Objectives Audience Organization Context for Biosafety Review and Decision Making Factors Affecting Decision Making Terms of Reference for Biosafety Committees 11 Resource Requirements 16 Risk Assessment 23 Methodology for Biotechnology Risk Assessment 23 Organizing the Scientific Information 24 Practical Considerations 26 Scientific Issues for Environmental Risk Assessment 28 Human Health and Food Safety 33 Risk Management 39 Risk Management in the Laboratory and Greenhouse 39 Risk Management in the Field 41 Other Standard Risk-Management Procedures 43 Risk-Management Realities 44 Contents iii Monitoring 47 Background 47 Biosafety Monitoring 48 Scales of Monitoring 49 Practical Planning 51 Communicating about Risk and Biosafety 55 Introduction 55 Objectives of Risk Communication 55 Principles of Risk Communication 56 Risk Communication in Practice 59 PART TWO: Case Study Exercises Introduction 67 1: Application for Greenhouse Trials with Ralstonia Genetically Modified for Biocontrol of Bacterial Wilt in Potatoes 69 2: Application for Greenhouse Trials with Sunflower Genetically Modified for Fungal Tolerance 79 3: Application for Field Trials with Genetically Modified Bananas Containing a Vaccine Against Hepatitis B 89 4: Application for Field Trials with Cotton Genetically Modified for Increased Resistance to Insect Attack 97 5: Application for Commercial Release of Genetically Modified Herbicide-Tolerant Soya 107 6: Application for Commodity Imports of Genetically Modified Maize 111 Supplemental Crop Information 115 Sunflower as a Crop 115 Cotton as a Crop 117 Soybean as a Crop 118 Maize as a Crop 120 PART THREE: Appendixes Appendix 1: Glossary of Terms 125 Appendix 2: Annotated List of Internet Sites 129 Appendix 3: Sources and Suggested Reading 141 iv Contents ACKNOWLEDGMENTS his workbook is a product of the Agricultural T the workbook through numerous drafts, external Biotechnology Support Project (ABSP), an review, and final production Her dedication and international program funded by the U.S perseverance kept the project moving forward and Agency for International Development and based in on track despite our many distractions All the the Institute for International Agriculture at while, her patience and good humor made it a Michigan State University The workbook is a natural pleasure to work with her outgrowth of the many biosafety training activities We were extremely fortunate to have as ABSP has conducted over the past ten years in part- reviewers a group of leading experts in the fields of ner countries in Africa, Asia, and Latin America, biosafety and capacity building We wish to express and in regional programs reaching wider audiences our sincere appreciation and thanks to Julian We are grateful to Dr Catherine Ives, former direc- Kinderlerer, Martha Kandawa-Schulz, Javier Veras- tor of ABSP, whose enthusiasm and support tegui, David Heron, Piet van der Meer, and Andrew launched the workbook project, and to Dr Johan Matabiri Their insightful comments and sugges- Brink, current ABSP director, whose continuing sup- tions were extremely useful and led to numerous port has made it possible to see the workbook improvements in the text through to completion We would like to give special recognition and Any errors or omissions in the text are the sole responsibility of the authors our heartfelt thanks to Dr Andrea Johanson, assistant director of ABSP She managed the project PAT TRAYNOR, BOB FREDERICK, MUFFY KOCH throughout its development, successfully guiding July 2002 Acknowledgments v ABOUT THE AUTHORS Patricia (Pat) Traynor, Ph.D., is a research fac- Service for National Agricultural Research (ISNAR) ulty member in the Fralin Biotechnology Center at Biotechnology Service She was a member of the Virginia Tech (University) Since 1994, she has been core faculty for four biotechnology research man- a biosafety consultant to the Agricultural agement courses, conducted during 1997–2000 for Biotechnology Support Project (ABSP), a ten-year eight Southeast Asian countries She has published program of the U.S Agency for International research and analysis studies of biosafety systems Development She organized and conducted a two- in Argentina and Egypt; Kenya and Uganda studies week biosafety internship program at Michigan will be conducted in 2002 State University and has taught in national and regional training programs throughout Africa and in Robert (Bob) Frederick, Ph.D., is currently a Southeast Asia and Latin America During 1996–97, senior scientist in the Environmental Protection she served as an advisor to panels drafting national Agency’s Office of Research and Development at biosafety regulations in Egypt and Indonesia the National Center for Environmental Assessment From 1995 to 2001, Dr Traynor served as the (NCEA) With the agency since 1984, his responsibil- director of Information Systems for Biotechnology, a ities have included coordination of the project funded by the U.S Department of Agriculture Biotechnology Risk Assessment Research Program (USDA) providing information resources in biotech- and the risk assessment of genetically modified nology and biosafety She organized and conducted products He has served as an Environmental four regional training workshops for U.S scientists Protection Agency representative to a number of and regulators and a multidisciplinary scientific entities including the National Institutes of Health workshop in risk assessment Dr Traynor was editor Recombinant DNA Advisory Committee; a Federal of the ISB News Report and co-author of “A Practical Coordinating Biotechnology Research Guide to Containment: Greenhouse Research with Subcommittee; the United States–European Com- Transgenic Plants and Microbes” (2001) munity Task Force on Biotechnology Research; and Since 1997, Dr Traynor has also been working as a biosafety specialist for the International About the Authors the Office of Science and Technology Policy’s Biotechnology Research Crosscut working group vii In 1993–96, Dr Frederick was executive secre- ganisms and the genetic engineering of plants for tary of the Biotechnology Advisory Commission crop improvement She worked with the team first (BAC) at the Stockholm Environment Institute, to genetically modify plants in South Africa and set Stockholm, Sweden While with BAC, he organized up the first cereal transformation group in the and taught in six international workshops on country biosafety and biodiversity in Nigeria, Argentina, Ms Koch’s current work is centered on issues Zimbabwe, Kenya, and Sweden He has lectured and concerning the safety of genetically modified instructed on biosafety issues in many countries organisms During the 1990s she worked with gov- including Argentina, Chile, China, Cameroon, ernment task teams on the development of South Colombia, Denmark, Germany, Hungary, India, Africa’s GMO Act and the attendant regulations, Kenya, Malawi, Mexico, Namibia, South Africa, and South African position papers for the Inter- Sweden, Syria, Zambia, and Zimbabwe His publica- national Biosafety Protocol negotiations and for tions include more than fifteen on biotechnology the Codex Alimentarius Commission relating to food regulatory development and implementation labeling She is the chairperson of the AfricaBio working group on Biotechnology Education and Muffy Koch is head of Innovation Biotech- Training and editor of the monthly electronic nology, a biotechnology and biosafety consulting newsletter BioLines Ms Koch has organized nine firm she started in 1994 in Johannesburg, South regional biosafety training workshops in Africa and Africa Before that, she earned a degree in botany been an invited speaker at numerous international and microbiology from the University of the biosafety training workshops Her publications Witwatersrand and an MSc in microbial ecology include papers, book chapters, biosafety work- from the University of Stellenbosch Her earlier books, and biotechnology directories; to date, she research career took her to the CSIR, a leading has been commissioned to prepare four situation technology and research organization in Africa, analyses of biotechnology in South Africa and three where she investigated the genetics of soil microor- analyses of biosafety in developing countries viii About the Authors P A R T O N E Biosafety in Principle and in Practice “It is a maxim universally agreed upon in agriculture, that nothing must be done too late; and again, that everything must be done at its proper season; while there is a third precept which reminds us that opportunities lost can never be regained.” • Pliny the Elder (A.D c 23–A.D 79), Natural History • risk assessment The measures to estimate what harm might be caused, how likely it would be and/or survival of another organism transformation (a) The uptake and integration of to occur, and the scale of the estimated dam- DNA in a cell in which the introduced DNA is age intended to change the recipient organism in a risk communication (1) The science of understand- predictable manner; (b) the introduction and ing scientific and technological risk and how it assimilation of DNA from one organism by is communicated within a socio-political another structure (Dr Vincent Covello); (2) the presentation of information, sometimes technical in nature, regarding risk – its nature, magnitude, transgene A gene that has been introduced into a genetically modified or transformed organism transgenic (organism) (a) An organism in which one likelihood, consequences, management, etc – or more new genes (“transgenes”) have been in a manner that is accessible and understood integrated into its genome by genetic modifi- by a nontechnical audience cation; includes the offspring of a genetically risk management The measures to ensure that the production and handling of an organism are safe stakeholder (1) A person or group that has an investment, share, or interest in something, modified organism vector A self-replicating agent (for example, a plasmid or virus) used to deliver DNA into a cell weediness The plant phenotype of interfering with such as a business or industry; (2) somebody human activities, being a nuisance in agro- or something with direct interest — a person or nomic settings, and/or disrupting native group with a direct interest, involvement, or ecosystems A plant may be designated a weed investment in something, for example, the based on various traits, some of which may be employees, shareholders, and customers of a subjective, such as rapid growth, invasiveness, business concern persistence, pest and disease resistance, high toxin A biological compound produced by one organism that is deleterious to the growth 128 reproductive capacity, and causing reduced crop yields Appendixes APPENDIX 2: Annotated List of Internet Sites General Information also covers emerging issues of widespread interest, developments in the policy arena, and major media AgBiosafety coverage http://www.agbiosafety.unl.edu A source of scientific, regulatory, and educational materials relevant to crop biotechnology and the current debate on the genetic modification of AgBioWorld http://www.agbioworld.org Devoted to bringing information about techno- food The site offers up-to-date information on logical advances in agriculture to the developing current issues in biotechnology and food safety and world; provides information to teachers, scientists, a searchable database of safety information on GM journalists, and the general public on the relevance crops that have received regulatory approval in of agricultural biotechnology to sustainable devel- Canada, the United States, and elsewhere It pro- opment; maintains the declaration of “Scientists In vides educational resources and lesson plans on Support Of Agricultural Biotechnology,” and offers a crop biotechnology for both consumers and educa- discussion listserve tors and links to other biotech education sites Biotechnology Australia AgBiotechNet http://www.agbiotechnet.com Ag BiotechNet covers all aspects of the appli- http://www.biotechnology.gov.au Biotechnology Australia is a multidepartmental government agency responsible for coordinating cation of biotechnology and genetic engineering in nonregulatory biotechnology issues for the agricultural production and food processing and Commonwealth Government It seeks to provide marketing The focus is on scientific reports and balanced and factual information on biotechnology findings and technical analysis, although the site to the Australian community NOTE: The Web addresses in this list were correct as of July 2002 Given the dynamic nature of the Internet, over time some sites may be moved to a new address, become inactive, or closed Annotated List of Internet Sites 129 Checkbiotech http://www.checkbiotech.org The aim of this site, sponsored by Syngenta, is to provide trustworthy and up-to-date information Transgenic Crops: An Introduction and Resource Guide http://www.colostate.edu/programs/lifesciences/ TransgenicCrops on agricultural biotechnology and thereby to con- This Colorado State University site provides tribute to an open debate The collection of docu- broad coverage of the subject, including the history ments gives an overview of ongoing discussions in of plant breeding, a clear explanation of what trans- agricultural biotechnology The information pro- genic plants are and how they are made, biosafety vided comes from different sources and thus may evaluation and regulation, current and future trans- not always reflect the opinion of the sponsor This genic products, and a question-and-answer format site will be useful for people with a special interest for information on risks and concerns in the field of ag-biotech and GM-food, primarily opinion makers and decision makers around the globe It also serves as an informational and edu- International Organizations cational tool for the general public and for and Programs schools Agricultural Biotechnology Support Project (ABSP) Council for Biotechnology Information http://www.whybiotech.com This site carries extensive information organ- http://www.iia.msu.edu/absp ABSP is a project funded by the U.S Agency for International Development based in the Institute ized in sections for consumers, farmers, journalists, for International Agriculture at Michigan State teachers, and students Also found are up-to-date, University The project, which began in 1991, aims in-depth reports, publications, and news articles to assist developing countries in the development and management of the tools and products of agri- Information Systems for Biotechnology (ISB) cultural biotechnology http://isb.vt.edu and regulatory review of genetically modified BIO-EARN – East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development plants, animals, and microorganisms within the http://www.bio-earn.org Here you will find documents and searchable databases pertaining to the development, testing, United States and abroad The overall objectives of the BIO-EARN Programme are to: enable countries in the region to Life Sciences Knowledge Center (Monsanto) develop biotechnologies and policies according to http://www.biotechknowledge.monsanto.com their own needs, abilities, and opportunities; pro- This site maintains an evolving collection of mote collaboration in biotechnology, biosafety, and news items, technical reports, and other documents biotechnology policy development to address key representing many points of view on agricultural challenges and opportunities in the region; and biotechnology; sections on biotechnology basics, foster communication nationally and regionally glossary, topic library, and a discussion board between scientists, policy makers, biosafety regulatory officials, and private sector 130 Appendixes Biosafety Information Network and Advisory Service (BINAS) well as field trials; a number of free documents; http://www.binas.unido.org/binas used by governments, industry, other stakeholders, BINAS, a service of the United Nations and links to other related Web sites BioTrack is and all who need the information in the field Industrial Development Organization (UNIDO), monitors global developments in regulatory issues CamBioTec in biotechnology providing information on world- http://www.promega.com/latinamerica/ wide national regulations and field trials cambiotech.htm CamBioTec is an international network with the Biotechnology Advisory Center (BAC) (Stockholm Environment Institute) mission to facilitate biotechnology-based applica- http://www.sei.se/biotech/bac.html management in Latin America by promoting a The BAC was established to help meet the chal- tions in the fields of agri-food and environmental favorable environment for the development of the lenge of biosafety capacity building in developing industry, and by increasing public awareness on the countries The BAC’s support consists of three com- associated benefits and eventual risks ponents: training, independent advice, and biosafety and biotechnology information exchange The East Cartagena Protocol on Biosafety (CBP) African Regional Programme and Research Network http://www.biodiv.org/biosafety for Biotechnology, Biosafety and Biotechnology This is the main site for information about the Policy Development (BIO-EARN) is the main activity CPB, including the background and full text of the at present The principal objective of the BIO-EARN agreement, articles, updated list of signatures and programme is to build national capacity and compe- ratifications, meetings, and documents of the tence in biotechnology, biosafety, and biotechnology Intergovernmental Committee for the Cartagena policy Selected academic and governmental institu- Protocol (ICCP), the Biosafety Clearing House, and a tions in Ethiopia, Kenya, Tanzania, and Uganda will database of biosafety capacity-building activities receive support through a regional network BioTrack Online International Centre for Genetic Engineering and Biotechnology (ICGEB) http://www.oecd.org/EN/home/0,,EN-home-528- http://www.icgeb.trieste.it/~bsafesrv nodirectorate-no-no-no-27,FF.html BioTrack Online was created in 1995 as a pio- The Biosafety Unit of the ICGEB is dedicated to biosafety and risk assessment for the environmen- neer site at the Organization for Economic Coopera- tal release of genetically modified organisms It tion and Development (OECD) in the field of the offers information on biosafety concerns, upcoming safety in biotechnology This site focuses on infor- meetings and training courses, and a regularly mation related to the regulatory oversight of prod- updated index of selected scientific articles pub- ucts of biotechnology BioTrack Online currently lished on biosafety and risk assessment from 1990 includes: information related to major legislative onward This site also carries an outstanding col- developments in OECD member countries (including lection of links to databases on GMO releases, sci- details of the relevant regulatory authorities); an entific bibliographies, decision support systems, online database of products of biotechnology as patents, and numerous other topics Annotated List of Internet Sites 131 International Service for the Acquisition of Agri-biotech Applications (ISAAA) http://www.isaaa.org The primary site describes ISAAA’s activities and initiatives in biosafety, food safety, intellectual property, and technology transfer The Global National Biosafety Agencies Australia: Office of the Gene Technology Regulator (OGTR) http://www.health.gov.au/ogtr The OGTR was established in 2000 to be Knowledge Center on Crop Biotechnology section responsible for a national scheme to regulate (http://www.isaaa.org/activities/knowledge_cen- genetically modified organisms The new Gene ter.htm) is organized into several main areas Technology Technical Advisory Committee will pro- Global Network provides a status of biotechnology vide expert scientific advice on applications for in the developing countries of Asia, South America, contained research, field trials, and general and Africa Crop Biotech Update is a weekly sum- releases involving GMOs The scientific committee mary of world developments in agricultural will also provide advice on other matters related to biotechnology for developing countries Separate gene technology, GMOs, and GM products and on pages cover GM products and biotechnology issues the need for, and proposed content of, policy prin- ISAAA is a not-for-profit international organization ciples, policy guidelines, codes of practice, and co-sponsored by public and private sector institu- technical and procedural guidelines for GMOs and tions with the aim of facilitating the acquisition GM products and transfer of agricultural biotechnology applications from the industrial countries, particularly Belgium: Biosafety Server proprietary technology from the private sector, to http:// biosafety.ihe.be developing countries for their benefit This site is run by the Service of Biosafety and Biotechnology (SBB) and hosted by the federal UNEP-GEF Biosafety Project Scientific Institute of Public Health under the http://www.unep.ch/biosafety Belgian Ministry for Consumer Protection, Public The UNEP-GEF Biosafety Project is funded by Health and Environment It contains regulatory the Global Environmental Facility and is based on information for Belgium, Europe, and other coun- its “Initial Strategy for assisting countries to pre- tries; risk-assessment data; biosafety related pare for the entry into force of the Cartagena meetings, conferences, and courses Protocol on Biosafety” (GEF/C.16/4) The main objectives of this strategy are to assist countries in Canada: Canadian Food Inspection Agency the establishment of their national biosafety http://www.inspection.gc.ca/english/ppc/biotech/ frameworks; promote information sharing and col- bioteche.shtml laboration, especially at the regional and subre- The Canadian Food Inspection Agency (CFIA) is gional level; and promote collaboration with other responsible for the regulation of products derived organizations to assist capacity-building for the through biotechnology including plants, animal the Cartagena Protocol on Biosafety feeds and animal feed ingredients, fertilizers, and veterinary biologics For genetically modified crop plants, the CFIA assesses the potential risk of 132 Appendixes oversees import permits, confined trials, United States: Regulatory Oversight of Biotechnology unconfined release, and variety registration http://www.aphis.usda.gov/biotech/usregs.htm adverse environmental effects and authorizes and This site is a portal to the agencies primarily United Kingdom: Advisory Committee on Releases to the Environment (ACRE) responsible for regulating biotechnology: the U.S http://www.defra.gov.uk/environment/acre Protection Agency (EPA), and the Food and Drug ACRE, a nondepartmental public body, advises Department of Agriculture (USDA), Environmental Administration (FDA) Products are regulated the Department for Environment, Food and Rural according to their intended use; some products are Affairs on applications to field test or release for regulated under more than one agency commercial use agricultural GMOs The site has extensive background information on the release of GMOs in the European Union, lists of applications Field Test Information for experimental trials and to market GMOs, application formats for deliberate releases and market- BioBin ing of higher plants and organisms other than http://www.oecd.org/ehs/biobin higher plants, a statement on GM animals, and BioBin is a cooperative resource on safety in more The Guidance on Principles of Best Practice in biotechnology developed between OECD’s BioTrack the Design of Genetically Modified Plants docu- Online and Biotechnology Information Network and ments how the design and construction of GM Advisory Service (BINAS) sponsored by the United plants could be used to further improve their safety Nations Industrial Development Organization and/or to simplify the risk assessment (UNIDO) A resource for regulations, field trials, biotechnology product database, biotechnology United States: Department of Agriculture Animal and Plant Health Inspection Service (APHIS) libraries, and tools related to biosafety http://www.aphis.usda.gov/biotech International Field Test Web Sites This Web site contains detailed information on how the U.S Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) regu- http://www.isb.vt.edu/cfdocs/globalfieldtests.cfm This site is a list of links to information about field tests conducted in twenty-nine countries lates the movement, importation, and field testing through permitting and notification procedures It Organization for Economic Cooperation and Development (OECD) Database of Field Trials links to other sites containing information on per- http://www.olis.oecd.org/biotrack.nsf of genetically modified plants and microorganisms mits for other types of genetically modified organ- This database includes records of field trials of isms or products such as transgenic arthropods and genetically modified organisms that have taken veterinary biologics place in OECD member countries It also includes data from other countries that have been provided through UNIDO’s BINAS Annotated List of Internet Sites 133 Food Safety mission Directorates involved in establishing legislation related to food and feed Other aspects of Canada Food Inspection Agency the unit’s work are harmonization of analytical pro- http://www.inspection.gc.ca/english/toc/ cedures in order to produce reliable data for risk bioteche.shtml assessment, detection of fraud, and monitoring of This site carries comprehensive information compliance with labeling regulations about the structure and operations of Canada’s regulatory framework for biotech foods, consumer Health Canada Food Program: Novel Foods information, technical reports, and more http://www.hc-sc.gc.ca/english/protection/novelfoods.html Codex Alimentarius http://www.codexalimentarius.net The Codex Alimentarius, or the food code, has become the seminal global reference point for con- Information on Canada’s food safety reviews and decisions of GM commodities This site also has GM food fact sheets and frequently asked questions about biotechnology and GM foods sumers, food producers and processors, national food control agencies, and the international food Institute of Food Technologists (IFT) trade Codex standards have become the benchmarks http://www.ift.org against which national food measures and regula- The Institute of Food Technologists advances tions are evaluated This site carries provisional the science and technology of food through the agendas for forthcoming meetings and working exchange of knowledge This site features the papers and reports of Codex Meetings Of particular Biotech Board, weekly newsletter, related links, interest is the Preliminary Report of the ad hoc information about membership and benefits, meet- Intergovernmental Task Force on Foods Derived from ings and training opportunities, and a wealth of Biotechnology (final report due in 2003) additional information Food and Agriculture Organization (FAO) of the United Nations International Food Information Council (IFIC) Foundation http://www.fao.org/biotech/index.asp?/lang=en http://ific.org./food/biotechnology.vtml This site on food and agriculture is available in The purpose of the IFIC Foundation, a nonprofit Arabic, French, Chinese, Spanish, and English It organization based in Washington, D.C., is to pro- carries news and events, FAO documents, sectoral vide sound, scientific information on food safety overviews, and a glossary (English only) and nutrition to journalists, health professionals, educators, government officials, and consumers Food Products Unit (FPU) This link connects to the section on food biotech- http://food.jrc.it nology The FPU of the European Commission’s Joint Research Council works in two main areas: activities within the field of food safety and quality, and issues on genetically modified organisms The unit’s main clients and partners are the European Com- 134 Appendixes U.S Center for Food Safety and Applied Nutrition (CFSAN) costs and benefits, environmental impacts, policy, and more http://vm.cfsan.fda.gov/~lrd/biotechm.html the U.S Food and Drug Administration, is responsi- Center for International Development, Harvard University ble for promoting and protecting the public’s health http://www.cid.harvard.edu/cidbiotech CFSAN, in conjunction with the field staff of by ensuring that the nation’s food supply is safe, This site includes background papers and a sanitary, wholesome, and honestly labeled, and forum to promote exchange of views on topical that cosmetic products are safe and properly issues related to biotechnology and development labeled These include: the evolution of the biotechnology industry; biotechnology in international trade; U.S Food and Drug Administration (FDA): Biotechnology intellectual property rights in biotechnology; http://vm.cfsan.fda.gov prospecting; biotechnology in developing countries; The FDA regulates foods and feed derived from biotechnology and international relations; bioenvironmental aspects of biotechnology; biotech- new plant varieties (GMOs) as well as conventional nology and human health; and ethics, social values, products The biotechnology site carries extensive and biotechnology documentation on regulations, labeling, consumer information, and products approved for commercial sale Council for Agricultural Science and Technology (CAST) http://www.cast-science.org World Health Organization (WHO) – Biotech Foods http://www.who.int/fsf/GMfood/index.htm WHO has been addressing a wide range of issues CAST assembles, interprets, and communicates science-based information regionally, nationally, and internationally on food, fibre, agricultural, in the field of biotechnology and human health, natural resources, and related societal and envi- including safety evaluation of vaccines produced ronmental issues to stakeholders—legislators, using biotechnology, human cloning, and gene ther- regulators, policy makers, the media, the private apy This site briefly describes the activities of WHO sector, and the public in regard to biotechnology and food safety International Life Sciences Institute (ILSI) http://www.ilsi.org/site_search/index.cfm Commentary / Expert Opinion ILSI is a nonprofit, worldwide scientific research foundation seeking to improve the well- Ag Biotech Infonet being of the general public through the pursuit of http://www.biotech-info.net sound and balanced science Its goal is to further This site carries commentary on a wide variety the understanding of scientific issues relating to of genetic engineering topics Articles gleaned from nutrition, food safety, toxicology, risk assessment, newspapers and magazines around the world cover, and the environment This site lists ILSI publications for example, current uses for insect and disease pertaining to biotechnology resistance, herbicide tolerance and other traits, Annotated List of Internet Sites 135 Public Perception European Federation of Biotechnology (EFB) Task Group on Public Perceptions of Biotechnology Center for Consumer Research, University of California–Davis http://www.efbpublic.org http://ccr.ucdavis.edu and understanding of biotechnology and the life This site focuses on consumer attitudes toward This group works to increase public awareness sciences throughout Europe, to advance the public food safety and quality It includes an informative debate about their applications, and to facilitate section defining biotechnology and some current dialogue between interested parties The site’s pri- issues A “Biotechnology Message Board” allows for mary aim is to foster greater public awareness and questions and answers understanding of biotechnology and to encourage public debate Electronic Forum on Biotechnology in Food and Agriculture http://www.fao.org/biotech/forum.htm This site provides an open forum that will allow Food Future: Genetically Modified Crops and the Environment (United Kingdom) http://www.foodfuture.org.uk a wide range of parties, including governmental and The Food and Drink Federation’s Food Future nongovernmental organizations, policy makers, and program aims to improve public understanding of the general public, to discuss and exchange views genetic modification The program has initiated and experiences about specific issues concerning wider discussion of the technology – the perceived biotechnology in food and agriculture for develop- benefits and disadvantages as well as the ethical ing countries and moral concerns The site provides consumers with facts and figures about GM crops so that they European Federation of Biotechnology (EFB) Agri-Biotechnology (Europe) can make informed decisions about what they buy http://www.agbiotech.org risks, and regulation of GM crops in the United The EFB is an association of European scientific The site has informative sections on the benefits, Kingdom and technological societies in biotechnology companies, biotechnology associations, and indi- Genetically Engineered Organisms – Public Issues Education Project (GEO-PIE) vidual members Their mission is “ to promote http://www.comm.cornell.edu/gmo/gmo.html together with universities, scientific institutes, the safe, sustainable, and beneficial use of GEO-PIE was developed at Cornell University to Nature’s resources in the life sciences and tech- create objective educational materials exploring nologies; to facilitate exchange of people and the complex scientific and social issues associated ideas; and to contribute to a better understanding with genetic engineering to help readers consider and perception of biotechnology by the general those issues for themselves public in Europe.” 136 Appendixes Publications publishes the results of research related to science-based risk-assessment of GMOs Included are AgBioForum Magazine peer-reviewed original research papers and review http://www.agbioforum.org articles, as well as scientific correspondence on all AgBioForum publishes articles that enhance types of GMOs, including plants, animals, and the on-going dialogue on the economics and man- microbes The scope of material encompasses: eco- agement of agricultural biotechnology The purpose logical studies of the impact of novel organisms; of AgBioForum is to provide unbiased, timely infor- studies of their interactions with pests and mation and new ideas leading to socially responsi- pathogens; food- and feed-safety evaluation; ble and economically efficient decisions in science, impact of novel organisms on agronomy and farm- public policy, and private strategies pertaining to ing practice, effect on microbial populations; eco- agricultural biotechnology nomic and sociological studies; means for reducing or managing risk; and assessment of horizontal Bioline International Biosafety Journal Online gene flow http://bioline.bdt.org.br/by This free site provides peer reviewed journals containing papers on the effects of GMOs and intro- Donors duced species on people and the environment, and other materials in biotechnology, biodiversity, envi- McKnight Foundation, USA ronmental and ecological sciences, food/agricul- http://www.mcknight.org ture/veterinary science, medicine, microbiology, and taxonomy The mission of the McKnight Foundation is to improve the quality of life for present and future generations and to seek paths to a more humane Biotechnology and Development Monitor and secure world The foundation also hopes to con- http://www.biotech-monitor.nl tribute to food security by focusing attention on The Monitor provides a forum for discussion on often-neglected crops and on issues involved in the positive and/or negative impact of biotechno- food security Such issues include food storage, dis- logical innovations and international regulations on tribution, the dwindling supply of arable land, water issues such as economic growth, agricultural pro- shortages, agricultural education, indigenous farm- duction, food security, shifts in national and global ing practices, agricultural technology, and nutrition markets, access to technology, employment, social interdisciplinary and emphasize the integration of National Agricultural Biotechnology Council (NABC), United States theoretical and empirical information from social http://www.cals.cornell.edu/extension/nabc differentiation, and human rights The analyses are sciences and natural sciences The National Agricultural Biotechnology Council is a not-for-profit consortium of more than Environmental Biosafety Journal thirty leading agricultural research and teaching http://www.edpsciences.org/ebr universities in the United States and Canada The Environmental Biosafety Research (EBR) is a new interdisciplinary, international journal that Annotated List of Internet Sites organization has been hosting annual public meetings about the safe, ethical, and efficacious devel- 137 opment of agricultural biotechnology products which focuses on developments in medical and since 1988 NABC continues to provide all stake- pharmaceutical biotechnology holders the opportunity to speak, to listen, and to learn about the issues surrounding agricultural BIOTECanada biotechnology http://www.biotech.ca This site was created to help people gain a Novartis Foundation better understanding of biotechnology and how it http://www.foundation.novartis.com improves our quality of life It represents Canadian The Novartis Foundation is engaged in pro- health care, agricultural, food, research, and other grams in developing countries that directly con- organizations that are involved in biotechnology tribute to an improvement in the quality of life of BIOTECanada also offers a range of services to its the poorest people The Risk Fund, a fund for the members promotion of creative and out-of-the-ordinary commercial projects and programs in developing Biotechnology Industry Organization countries is highlighted http://www.bio.org This organization is the largest trade organiza- The Rockefeller Foundation, USA tion to serve and represent the emerging biotech- http://www.rockfound.org nology industry in the United States and around the The Rockefeller Foundation seeks long-term, globe The site includes a media guide to biotech- systemic, enduring change, and accomplishing that nology; a biotechnology food products list; a citi- takes time—far longer than just one year Grant- zen’s guide to biotechnology; laws and policies; and making is organized around four thematic lines: a guide to bioethics creativity and culture, food security, health equity, and working communities A cross-theme of global Council for Biotechnology Information inclusion supports, promotes, and supplements the http://www.whybiotech.com work of these themes In addition, the foundation Called Whybiotech, the site provides objective, supports a number of programs that are developing balanced information to help understand and or in transition appreciate the benefits that biotechnology offers, as well as to encourage informed debate about the issues it raises The site includes recent news arti- Business/Professional Organizations cles, essential background information, sections on the benefits and regulations of biotechnology, AfricaBio media and resource centers, frequently asked ques- http://www.africabio.com tions, links, and an events calendar AfricaBio seeks to promote the enhancement of the quality of life in Africa through the safe and EuropaBio responsible application of biotechnology The site http://www.europabio.org provides two e-publications: BioLines – AfricaBio’s “Biotechnology Headlines” — and MedBioLines, 138 EuropaBio, the European Association for Bioindustries, represents nearly forty member compa- Appendixes nies operating worldwide and eighteen national Miscellaneous biotechnology associations This site features an “Info Kit” with nineteen modules on topics includ- On-Line Courses in Biotechnology ing an introduction to biotchnology, environmental http://project.bio.iastate.edu effects and food safety of GM crops, and frequently Guided by faculty and administrators in seven raised arguments against biotechnology, commer- departments and programs at Iowa State Univer- cial GM crops, industrial biotechnology, and others sity, the program strives to develop and share biol- It also carries the latest news reports and informa- ogy education resources via the Internet tion on forthcoming events Annotated List of Internet Sites 139 APPENDIX 3: Sources and Suggested Reading Ammann, K., Jacot, Y., Simonsen, V., and Kjellsson, Assessment Methods for Environmental Appli- G (eds.) 1999 Methods for Risk Assessment cations of Biotechnology.” Final Report to the of Transgenic Plants Basel: Birkhäuser Verlag Office of Science and Technology Policy, Executive Office of the President Report No Dale, P “Short-Term Effects, Long-Term Effects and Standardization of Limits,” pp 57–62 Marvier, M A., Meir, E., and Kareiva, P “How NSF/PRA 8502286, National Science Foundation, Washington, D.C Keeler, K 1994 “The Keynote Presentation.” In OECD Environment Monographs No 91: Com- the Design of Monitoring and Control pendium of Methods for Monitoring Organisms Strategies Affect the Chance of Detecting in the Environment (pp 19–23) Paris: Organi- and Containing Transgenic Weeds?” pp zation for Economic Co-operation and 109–122 Development Pohl-Orf, M., Brand, U., Schuphan, I., and McLean, M A., Frederick, R J., Traynor, P L., Cohen, Bartsch, D “Monitoring the Environmental J I., and Komen, J 2002 “A Conceptual Impact of Transgenic Sugar Beet Beta vul- Framework for Implementing Biosafety: Policy, garis subspec vulgaris altissima Döll—Are Capacity and Regulation.” Briefing Paper for We Able to Ask the Right Questions?” pp International Service for National Agricultural 21–26 Research (ISNAR), ISSN 1021-2310 Rufener, P., Mazyad, A., and Ammann, K National Research Council (NRC) 1983 Risk “Biogeographical Assay and Natural Gene Assessment in the Federal Government: Flow,” pp 95–98 Managing the Process Washington, D.C.: Simonsen, V “Molecular Markers for Monitoring Transgenic Plants,” pp 87–93 National Academy Press National Research Council (NRC) 2000 Genetically Modified Pest-Protected Plants: Science and Covello, V T., and Fiksel, J R (eds) 1985 “The Suitability and Applicability of Risk Sources and Suggested Reading Regulation Washington, D.C.: National Academy Press 141 National Research Council (NRC) 2001 Ecological Monitoring of Genetically Modified Crops New York, N.Y.: McGraw-Hill, Inc The Royal Society 2002 “Genetically Modified Washington, D.C.: National Academy Press Plants for Food Use and Human Health—An National Research Council (NRC) 2002 Environ- Update.” Policy Document 4/02 The Royal mental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Washington, D.C.: National Academy Press Parker, I M., and Kareiva, P 1996 “Assessing the Society, London www.royalsoc.ac.uk Tiedje, J M., Colwell, R K., Grossman, Y L., Hodson, R E., Lenski, R E., Mack, R N., and Regal, P J 1989 “The Planned Introduction of Genetically Risks of Invasion for Genetically Engineered Engineered Organisms: Ecological Considera- Plants: Acceptable Evidence and Reasonable tions and Recommendations.” Ecology 70(2), Doubt.” Biological Conservation 78:193–203 298–315 Persley, G J., Giddings, L V., and Juma, C 1992 Tzotzos, G (ed) 1995 Genetically Modified Organ- Biosafety: The Safe Application of Biotech- isms: A Guide to Biosafety Wallingford, UK: nology in Agriculture and the Environment The CAB International Hague: International Service for National Agricultural Research Rissler, J., and Mellon, M 1996 The Ecological Risks of Engineered Crops Cambridge, Mass.: The MIT Press Ruckelshaus, William D 1985 “Risk, Science, and United Nations Environment Programme (UNEP) 1996 UNEP International Technical Guidelines for Safety in Biotechnology Nairobi, Kenya: UNEP van der Meer, Pieter 1993 “Potential Long-Term Ecological Impact of Genetically Modified Democracy.” Issues in Science and Technology, Organisms (A Survey of Literature, Guidelines Spring, 19–38 and Legislation).” Steering Committee for the Slovic, P 1987 “Perception of Risk.” Science, April 17, 1987, pp 280–285 Strauss, H S 1991 “Lessons from Chemical Risk Assessment.” In M A Levin and H S Strauss Conservation and Management of the Environment and Natural Habitats (CDPE) Nature and Environment, No 65 Strasbourg: Council of Europe Press (eds), Risk Assessment in Genetic Engineering 142 Appendixes ... who have an interest in the well as guided, hands-on practice in applying risk- responsible use of biotechnology for developing assessment and risk- management procedures using improved agricultural. .. as insect pest populations increas- Risk Assessment 31 ingly are exposed to high levels of Bt proteins over ining the frequency of recombination events in long periods, emergence of resistant individuals... 32 Biosafety in Principle and in Practice Risk- Assessment Research Biosafety reviewers often face uncertainty when certain data needed for a complete evaluation are missing Risk- assessment research