《生物技术与人类》课程教学资源（经典阅读）Application of Modern Biotechnology to Food and Agriculture Food Systems Perspective

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Volume:35·Issue:06·2003·December·Page: Journal of Nutrition Education and Behavior 319 VIEWPOINT Application of Modern Biotechnology to Food and Agriculture:Food Systems Perspective Christine MeCullum,PhD,RD:;!Charles Benbrook,PhD;2 Lori Knowles,LLB,BCL,MA,LLM:3 Susan Roberts,JD,MS,RD,LD;4 Tamara Schryver,MS,RD5 1 Center for Health Promotion and Prevention Research,School of Public Health,University of Texas- Houston,Health Science Center,Houston,Texas,2 Benbrook Consulting Services,Sandpoint,Idaho;3 The Hastings Center,Garrison,New York;4 Agricultural Law Center,Drake University Law School, Des Moines,Iowa;5 Food Science and Nutrition Department,University of Minnesota,St.Paul, Minnesota ABSTRACT The purpose of this article is to provide nutrition educators with an introduction to a range of considerations and forces that are driving the application of modern biotechnology in the food and fiber sector based on a food systems perspective.In doing so,the following issues are critically assessed:(1) the global debate on how to regulate genetically engineered(GE)foods and crops,(2)cultural differences in public perceptions of GE foods,and(3)evaluation of selected GE traits against the principles of social,economic,and ecological sustainability,including the potential of modern agricultural biotechnology to enhance global food security.Where appropriate,we also review other agricultural technologies and the broader political,social,and economic contexts in which these technologies have been introduced.Finally,we offer recommendations for how multiple stakeholder groups,including policy makers,biotechnology advocates,and nutrition educators,can move toward a more informed dialogue and debate on this issue. KEYWORDS modern biotechnology,food and agriculture,food systems perspective INTRODUCTION The Convention on Biological Diversity(CBD)has defined biotechnology as "any technological application that uses biological systems,living organisms,or derivatives thereof,to make or modify products or processes for specific use."Interpreted in this broad sense,biotechnology covers many contemporary agricultural and food manufacturing tools.However,when biotechnology is used in a more narrow sense,it refers only to new deoxyribonucleic acid(DNA)techniques,molecular biology, and reproductive technological applications ranging from gene transfer to DNA typing to cloning of plants and animals.Whereas there is little controversy about many aspects of biotechnology and its application,there has been considerable controversy about the use of modern biotechnology in food and agriculture,particularly the use of genetic engineering and genetically engineered organisms(GEOs). Genetically engineered(GE)crops were first introduced for commercial production in 1996.Since then, their use has increased rapidly.In 2002,GE crops were planted on 145 million acres worldwide.The earliest applications of genetic engineering to agriculture have focused primarily on simplifying pest management in widely planted crops.Technology targets have been chosen by the private sector based

VIEWPOINT Application of Modern Biotechnology to Food and Agriculture: Food Systems Perspective Christine McCullum, PhD, RD;; 1 Charles Benbrook, PhD; 2 Lori Knowles, LLB, BCL, MA, LLM; 3 Susan Roberts, JD, MS, RD, LD; 4 Tamara Schryver, MS, RD 5 1 Center for Health Promotion and Prevention Research, School of Public Health, University of TexasHouston, Health Science Center, Houston, Texas; 2 Benbrook Consulting Services, Sandpoint, Idaho; 3 The Hastings Center, Garrison, New York; 4 Agricultural Law Center, Drake University Law School, Des Moines, Iowa; 5 Food Science and Nutrition Department, University of Minnesota, St. Paul, Minnesota The purpose of this article is to provide nutrition educators with an introduction to a range of considerations and forces that are driving the application of modern biotechnology in the food and fiber sector based on a food systems perspective. In doing so, the following issues are critically assessed: (1) the global debate on how to regulate genetically engineered (GE) foods and crops, (2) cultural differences in public perceptions of GE foods, and (3) evaluation of selected GE traits against the principles of social, economic, and ecological sustainability, including the potential of modern agricultural biotechnology to enhance global food security. Where appropriate, we also review other agricultural technologies and the broader political, social, and economic contexts in which these technologies have been introduced. Finally, we offer recommendations for how multiple stakeholder groups, including policy makers, biotechnology advocates, and nutrition educators, can move toward a more informed dialogue and debate on this issue. modern biotechnology, food and agriculture, food systems perspective INTRODUCTION The Convention on Biological Diversity (CBD) has defined biotechnology as "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use." Interpreted in this broad sense, biotechnology covers many contemporary agricultural and food manufacturing tools. However, when biotechnology is used in a more narrow sense, it refers only to new deoxyribonucleic acid (DNA) techniques, molecular biology, and reproductive technological applications ranging from gene transfer to DNA typing to cloning of plants and animals. Whereas there is little controversy about many aspects of biotechnology and its application, there has been considerable controversy about the use of modern biotechnology in food and agriculture, particularly the use of genetic engineering and genetically engineered organisms (GEOs). Genetically engineered (GE) crops were first introduced for commercial production in 1996. Since then, their use has increased rapidly. In 2002, GE crops were planted on 145 million acres worldwide. The earliest applications of genetic engineering to agriculture have focused primarily on simplifying pest management in widely planted crops. Technology targets have been chosen by the private sector based Journal of Nutrition Education and Behavior Volume: 35 • Issue: 06 • 2003 • December • Page: 319 ABSTRACT KEYWORDS

on two factors:what the tools of genetic engineering could feasibly accomplish and potential market size and profitability.One major category includes crops engineered for disease and insect resistance to prevent crop losses (eg,insect-resistant corn and cotton),and the second category encompasses herbicide-tolerant(HT)crops(eg,glyphosate-resistant,or Roundup Ready [RR]soybeans [Monsanto Co,St.Louis,MO]),which allow farmers to spray broad-spectrum herbicides over growing crops. During the period from 1996 until 2002,the dominant trait used has been herbicide tolerance,which now occupies 75%of the total acres planted globally.Bacillus thuringiensis Bt crops (engineered for insect resistance)occupy 17%of the total acres planted globally.In 2002,3 countries accounted for 95% of the total area(total number of acres)of GE crops planted globally:the United States(66%), Argentina(23%),and Canada(6%).The principal GE crops grown were soybeans,corn,and cotton The purpose of this commentary is to provide nutrition educators with an introduction to a range of considerations and forces driving the evolution of the application of modern biotechnology in the food and fiber sector based on a food systems perspective.The Figure Figure.Conceptualization of the interrelated components of local food systems. depicts the interrelated components of local food systems,which include the production,processing, distribution,access,use,and recycling/composting of food.These interrelated components are influenced by (1)natural resource allocation,(2)use of technological systems,and (3)society and culture (eg,values and beliefs,cultural norms,food practices),which are,in turn,influenced by broader forces,including governing institutions and public policies.Here we critically assess the following issues from a food systems perspective:(1)the global debate on how to regulate GE foods and crops,(2) cultural differences in public perceptions of GE foods,and(3)an evaluation of selected GE traits against the principles of social,economic,and ecological sustainability,including the potential of GE crops and modern biotechnology to enhance global food security.Where appropriate,we review other agricultural technologies and the broader contexts in which these technologies have been introduced.Finally,we offer recommendations for how policy makers,biotechnology advocates,and nutrition educators can move toward a more informed dialogue on this issue. GLOBAL DEBATE:HOW TO REGULATE GE FOODS AND CROPS In the United States,three federal agencies regulate different aspects of GE foods:the Environmental Protection Agency (EPA),the Food and Drug Administration(FDA),and the Department of Agriculture (USDA).These agencies operate under separate statutes and are overseen by different committees of Congress.They coordinate their efforts under the 1986 Coordinated Biotechnology Framework.The Table Table.US and Selected International Agencies with Legal Authority in Regulating Genetically Engineered(GE)Plants and GE Organisms* Agency Authority Specific Regulations Responsibility White House Executive 1986 Coordinated Coordination of federal Framework activities US Department Plant Protection Act 7CFR 340 New pests,environmental impact of Agriculture US Environmental Federal Food,Drug,and FFDCA rules,FIFRA rules Plant incorporated protectants

on two factors: what the tools of genetic engineering could feasibly accomplish and potential market size and profitability. One major category includes crops engineered for disease and insect resistance to prevent crop losses (eg, insect-resistant corn and cotton), and the second category encompasses herbicide-tolerant (HT) crops (eg, glyphosate-resistant, or Roundup Ready [RR] soybeans [Monsanto Co, St. Louis, MO]), which allow farmers to spray broad-spectrum herbicides over growing crops. During the period from 1996 until 2002, the dominant trait used has been herbicide tolerance, which now occupies 75% of the total acres planted globally. Bacillus thuringiensis ( Bt ) crops (engineered for insect resistance) occupy 17% of the total acres planted globally. In 2002, 3 countries accounted for 95% of the total area (total number of acres) of GE crops planted globally: the United States (66%), Argentina (23%), and Canada (6%). The principal GE crops grown were soybeans, corn, and cotton. The purpose of this commentary is to provide nutrition educators with an introduction to a range of considerations and forces driving the evolution of the application of modern biotechnology in the food and fiber sector based on a food systems perspective. The Figure Figure. Conceptualization of the interrelated components of local food systems. depicts the interrelated components of local food systems, which include the production, processing, distribution, access, use, and recycling/ composting of food. These interrelated components are influenced by (1) natural resource allocation, (2) use of technological systems, and (3) society and culture (eg, values and beliefs, cultural norms, food practices), which are, in turn, influenced by broader forces, including governing institutions and public policies. Here we critically assess the following issues from a food systems perspective: (1) the global debate on how to regulate GE foods and crops, (2) cultural differences in public perceptions of GE foods, and (3) an evaluation of selected GE traits against the principles of social, economic, and ecological sustainability, including the potential of GE crops and modern biotechnology to enhance global food security. Where appropriate, we review other agricultural technologies and the broader contexts in which these technologies have been introduced. Finally, we offer recommendations for how policy makers, biotechnology advocates, and nutrition educators can move toward a more informed dialogue on this issue. GLOBAL DEBATE: HOW TO REGULATE GE FOODS AND CROPS In the United States, three federal agencies regulate different aspects of GE foods: the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA). These agencies operate under separate statutes and are overseen by different committees of Congress. They coordinate their efforts under the 1986 Coordinated Biotechnology Framework. The Table Table. US and Selected International Agencies with Legal Authority in Regulating Genetically Engineered (GE) Plants and GE Organisms* Agency Authority Specific Regulations Responsibility White House Executive 1986 Coordinated Framework Coordination of federal activities US Department Plant Protection Act 7 CFR 340 New pests, environmental impact of Agriculture US Environmental Federal Food, Drug, and FFDCA rules, FIFRA rules Plant incorporated protectants

and GEOs.In the United States,risk assessment requires the agency to analyze and interpret the scientific data and make informed predictions about the risks imposed by an activity.After assessing risk,risk management requires that the agency make legal and policy judgments about how to employ regulatory options that are available to the agency under its governing statute.Policy debates surrounding GE foods and crops are not only in the scientific and administrative communities but also increasingly with the public,which is showing a wariness of the technology.For example,focus groups commissioned by the FDA revealed that the majority of participants were surprised and outraged to learn that GE foods were on the market without their knowledge.The global debate on how to regulate GE foods,crops,and GEOs encompasses a multitude of issues:(1)food safety risks,(2)environmental risks,(3)use of the precautionary principle for dealing with scientific uncertainty,(4)who participates in risk analysis and risk decision making,and(5)labeling and consumer right to know issues,each of which is described below in more detail. Food Safety In 1992,the FDA adopted a regulatory policy that specified that foods produced through genetic engineering techniques or containing GE substances substantially similar in"structure,function,and composition"to substances already in the food supply (proteins,carbohydrates,fats,and oils)were to be considered "generally recognized as safe".This terminology was later changed to "substantially equivalent".Under current FDA regulatory policy,if foods produced through GE techniques are deemed generally recognized as safe or substantially equivalent,they are not required to undergo mandatory premarket approval or premarket testing.The 1992 policy was opposed by FDA's own scientists,as was shown in documents that were forced to be released during a 1998 lawsuit against the FDA charging failure to fulfill its regulatory duties.In January 2001,the FDA proposed modifications to its regulatory policy and called for a 120-day premarket notification for any bioengineered food that would be brought to market.However,to date,the previously proposed change in FDA regulatory policy has not yet been approved. In January 2003,the nonprofit Center for Science in the Public Interest(CSPI)released a report concluding that the FDA's safety review process for the regulation of GE crops and foods needs to be strengthened to improve the quality of the FDA's regulatory oversight and to improve public confidence in the safety of foods made from these crops.Through examination of 14 submissions obtained under the Freedom of Information Act,CSPI found that when the FDA requested additional information to conduct a complete and thorough safety assessment,companies refused the FDA's request for more information 50%of the time (3 of 6).According to the CSPI report,several biotechnology companies declined to provide requested scientific data to the FDA about strains of GE insect-resistant corn.The report revealed technical shortcomings in data provided by the companies and errors that the FDA failed to detect.It also was noted that inadequacies in the FDA's review process will be exacerbated when more complex changes are made in the metabolism of plants and a wider range of genes are used. To address the observed shortcomings in the FDA's current regulatory policy,CSPI recommended that Congress provide the FDA with legal authority for mandatory review and safety approval of GE crops, including the authority to require any data it deems necessary to conduct a thorough food safety assessment.CSPI also has recommended that the FDA(1)develop detailed safety standards and testing guidelines;(2)require developers to submit complete details about their testing methods and the actual data from safety tests,including statistical analyses of those data;(3)establish an approval process that is transparent and provides the public with an opportunity to comment on submissions;(4)perform and make available to the public detailed assessments of commercialized GE crops;(5)reassess the safety of commercialized GE crops if new safety concerns are recognized or new tests become available;and(6) ask developers of current GE crops to provide additional data to give greater assurance of safety than the summary data previously provided to the agency.Finally,CSPI has recommended that when the FDA

and GEOs. In the United States, risk assessment requires the agency to analyze and interpret the scientific data and make informed predictions about the risks imposed by an activity. After assessing risk, risk management requires that the agency make legal and policy judgments about how to employ regulatory options that are available to the agency under its governing statute. Policy debates surrounding GE foods and crops are not only in the scientific and administrative communities but also increasingly with the public, which is showing a wariness of the technology. For example, focus groups commissioned by the FDA revealed that the majority of participants were surprised and outraged to learn that GE foods were on the market without their knowledge. The global debate on how to regulate GE foods, crops, and GEOs encompasses a multitude of issues: (1) food safety risks, (2) environmental risks, (3) use of the precautionary principle for dealing with scientific uncertainty, (4) who participates in risk analysis and risk decision making, and (5) labeling and consumer right to know issues, each of which is described below in more detail. Food Safety In 1992, the FDA adopted a regulatory policy that specified that foods produced through genetic engineering techniques or containing GE substances substantially similar in "structure, function, and composition" to substances already in the food supply (proteins, carbohydrates, fats, and oils) were to be considered "generally recognized as safe". This terminology was later changed to "substantially equivalent". Under current FDA regulatory policy, if foods produced through GE techniques are deemed generally recognized as safe or substantially equivalent, they are not required to undergo mandatory premarket approval or premarket testing. The 1992 policy was opposed by FDA's own scientists, as was shown in documents that were forced to be released during a 1998 lawsuit against the FDA charging failure to fulfill its regulatory duties. In January 2001, the FDA proposed modifications to its regulatory policy and called for a 120-day premarket notification for any bioengineered food that would be brought to market. However, to date, the previously proposed change in FDA regulatory policy has not yet been approved. In January 2003, the nonprofit Center for Science in the Public Interest (CSPI) released a report concluding that the FDA's safety review process for the regulation of GE crops and foods needs to be strengthened to improve the quality of the FDA's regulatory oversight and to improve public confidence in the safety of foods made from these crops. Through examination of 14 submissions obtained under the Freedom of Information Act, CSPI found that when the FDA requested additional information to conduct a complete and thorough safety assessment, companies refused the FDA's request for more information 50% of the time (3 of 6). According to the CSPI report, several biotechnology companies declined to provide requested scientific data to the FDA about strains of GE insect-resistant corn. The report revealed technical shortcomings in data provided by the companies and errors that the FDA failed to detect. It also was noted that inadequacies in the FDA's review process will be exacerbated when more complex changes are made in the metabolism of plants and a wider range of genes are used. To address the observed shortcomings in the FDA's current regulatory policy, CSPI recommended that Congress provide the FDA with legal authority for mandatory review and safety approval of GE crops, including the authority to require any data it deems necessary to conduct a thorough food safety assessment. CSPI also has recommended that the FDA (1) develop detailed safety standards and testing guidelines; (2) require developers to submit complete details about their testing methods and the actual data from safety tests, including statistical analyses of those data; (3) establish an approval process that is transparent and provides the public with an opportunity to comment on submissions; (4) perform and make available to the public detailed assessments of commercialized GE crops; (5) reassess the safety of commercialized GE crops if new safety concerns are recognized or new tests become available; and (6) ask developers of current GE crops to provide additional data to give greater assurance of safety than the summary data previously provided to the agency. Finally, CSPI has recommended that when the FDA

lacks the authority to implement some of these recommendations,Congress should pass new legislation. Significant progress toward a global consensus on how to regulate the safety of GE foods was made when the Codex Alimentarius Ad Hoc Task Force on Foods Derived from Biotechnology completed draft principles for the human health risk analysis for GE foods.The draft principles stated that all GE foods should include a premarket safety assessment on a case-by-case basis for both intended and unintended effects and that all countries should include risk management measures,including a system for postmarket monitoring for the purpose of facilitating withdrawal of products from the market when a risk to human health was identified.These guidelines were adopted by the Codex Alimentarius in July 2003.This is considered a critical development globally because the World Trade Organization (WTO) considers the standards of the Codex Alimentarius Commission to be the global science-based standard. and,thus,immune to international trade challenges. Environmental Risks The EPA is the federal agency that evaluates and licenses pesticides under the Federal Insecticide, Fungicide,and Rodenticide Act(FIFRA)and the Federal Food,Drug,and Cosmetic Act(FFDCA).For plant-incorporated protectants,for example,GE crops with insecticidal properties,the scrutiny of the EPA encompasses environmental risks and human health concerns,although it is limited to pesticidal substances(the inserted DNA and the protein it produces).The USDA,under the Plant Protection Act, regulates all GE plants that have pest potential(see Table).A report issued by The National Research Council (NRC)on the environmental effects of transgenic plants has concluded that the USDA needs to (1)more rigorously review GE crops before approving them for commercial issue,(2)more actively seek outside scientific peer review of crop applications and advice on changes in regulatory policy,(3) more actively solicit public comment,and(4)monitor transgenic crops more closely after their approval In another recent NRC report entitled Animal Biotechnology:Science-Based Concerns,it was noted that for some applications of transgenic (GE)animals,scientific uncertainty will be a particular concern owing to the novelty of the health and environmental questions posed and the lack of established scientific methods for answering them. At the international level,controversy has stemmed from whether the Cartagena Protocol on Biosafety, commissioned by article 19 of the 1992 CBD,is needed to regulate living modified organisms(LMOs that are introduced into the environment.This international treaty,which is based on the precautionary principle,gives countries the right to bar imports of GE seeds,microbes,animals,and crops seen as a threat to their environment.Under what is known as the Advance Informed Agreement(AIA)procedure, any Party shipping LMOs for intentional introduction into the environment for the first time shall have to give prior notification to the importing country that is a party to the Protocol and provide sufficient information to enable it to make an informed decision.LMOs intended for food,feed,and processing are subject to information sharing requirements through a central Biosafety Clearinghouse.Countries can also decide whether or not to import these commodities based on their own scientific risk assessment.Finally,exporters must ensure that all shipments are accompanied by appropriate documentation that is required under the Protocol.The Cartagena Protocol,which was approved by over 130 countries in January 2000,became legally binding to its signatories in September 2003,90 days after it was ratified by 50 countries.Although the United States has not ratified the protocol,it must adhere to its provisions when shipping GE products to countries that are signatories to the protocol. The Precautionary Principle as a Basis for Dealing with Scientific Uncertainty The precautionary principle has its origins in the German word Vorsorgeprinzip,which is freely translated as the obligation to "foresee and forstall"environmental harms.The precautionary principle was established as a concept of environmental law in the 1970s.Since that time,it has been invoked in

lacks the authority to implement some of these recommendations, Congress should pass new legislation. Significant progress toward a global consensus on how to regulate the safety of GE foods was made when the Codex Alimentarius Ad Hoc Task Force on Foods Derived from Biotechnology completed draft principles for the human health risk analysis for GE foods. The draft principles stated that all GE foods should include a premarket safety assessment on a case-by-case basis for both intended and unintended effects and that all countries should include risk management measures, including a system for postmarket monitoring for the purpose of facilitating withdrawal of products from the market when a risk to human health was identified. These guidelines were adopted by the Codex Alimentarius in July 2003. This is considered a critical development globally because the World Trade Organization (WTO) considers the standards of the Codex Alimentarius Commission to be the global science-based standard, and, thus, immune to international trade challenges. Environmental Risks The EPA is the federal agency that evaluates and licenses pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). For plant-incorporated protectants, for example, GE crops with insecticidal properties, the scrutiny of the EPA encompasses environmental risks and human health concerns, although it is limited to pesticidal substances (the inserted DNA and the protein it produces). The USDA, under the Plant Protection Act, regulates all GE plants that have pest potential (see Table). A report issued by The National Research Council (NRC) on the environmental effects of transgenic plants has concluded that the USDA needs to (1) more rigorously review GE crops before approving them for commercial issue, (2) more actively seek outside scientific peer review of crop applications and advice on changes in regulatory policy, (3) more actively solicit public comment, and (4) monitor transgenic crops more closely after their approval. In another recent NRC report entitled Animal Biotechnology: Science-Based Concerns , it was noted that for some applications of transgenic (GE) animals, scientific uncertainty will be a particular concern owing to the novelty of the health and environmental questions posed and the lack of established scientific methods for answering them. At the international level, controversy has stemmed from whether the Cartagena Protocol on Biosafety, commissioned by article 19 of the 1992 CBD, is needed to regulate living modified organisms (LMOs ) that are introduced into the environment. This international treaty, which is based on the precautionary principle, gives countries the right to bar imports of GE seeds, microbes, animals, and crops seen as a threat to their environment. Under what is known as the Advance Informed Agreement (AIA) procedure, any Party shipping LMOs for intentional introduction into the environment for the first time shall have to give prior notification to the importing country that is a party to the Protocol and provide sufficient information to enable it to make an informed decision. LMOs intended for food, feed, and processing are subject to information sharing requirements through a central Biosafety Clearinghouse. Countries can also decide whether or not to import these commodities based on their own scientific risk assessment. Finally, exporters must ensure that all shipments are accompanied by appropriate documentation that is required under the Protocol. The Cartagena Protocol, which was approved by over 130 countries in January 2000, became legally binding to its signatories in September 2003, 90 days after it was ratified by 50 countries. Although the United States has not ratified the protocol, it must adhere to its provisions when shipping GE products to countries that are signatories to the protocol. The Precautionary Principle as a Basis for Dealing with Scientific Uncertainty The precautionary principle has its origins in the German word Vorsorgeprinzip , which is freely translated as the obligation to "foresee and forstall" environmental harms. The precautionary principle was established as a concept of environmental law in the 1970s. Since that time, it has been invoked in

numerous international treaties,including the Rio Declaration on Environment and Development,the Bamako Convention on Hazardous Waste in Africa,the Convention on Biological Diversity,and the Stockholm Convention on Persistent Organic Pollutants.A 1998 consensus statement characterized the precautionary principle in this way:"when an activity raises threats of harm to human health or the environment,precautionary measures should be taken even if some cause and effect relationships are not fully established."The 4 central components necessary to achieve its implementation include (1)taking preventive action in the face of uncertainty,(2)shifting the burden of proof to the proponents of an activity,(3)exploring a wide range of alternatives to possibly harmful actions,and(4)increasing public participation in decision making.As noted by Applegate,"properly construed,this principle defines a process for taking environment-and health-protective actions while the dangers of not taking such protective action remain uncertain....It seeks to anticipate the risks of new and existing technologies so as to avoid or minimize them.In December 2002,the British Medical Association(BMA)issued a statement on GE foods in which it reiterated its support for the precautionary principle. Adherence to the precautionary principle is consistent with at least 3 different tenets of scientific analysis.First,it fits with the desire to minimize type II error(false-negative).Scientists in the fields of ecology,conservation biology,and natural resources management have been increasingly concerned about the tendency to downplay type II error in studies that aim to inform environmental policy.As explained by Kapuscinski, this is because the potential for harm is greater if conclusions commit a Type Il error (false negative) compared to a Type I error (false positive)since recovery from most harm to ecosystems or human health involve large time lags,and are sometimes irreversible.Type I errors,on the other hand,are usually limited to short-term economic costs borne by the developers and marketers ofGEOs. Second,the precautionary principle assists in accounting for another type of uncertainty that arises from ecological systems research,something that is inherent in all biological systems.With regard to the release of GEOs into the environment,uncertainty arises from gaps in current knowledge about the behavior of a GEO,the novel traits modified,variability in the environment,and limits in predicting the evolution of GEOs subsequent to their release in the environment.Third,by broadening participation in the risk characterization process,the precautionary principle may be helpful in reducing type III error, which occurs when scientists provide an accurate answer to the wrong problem,that is,they ask the wrong question.A realistic way to cope with such inherent uncertainty in complex biological systems is to implement an adaptive management approach to biosafety governance.Such an approach for assessing the ecological and human health effects for the release of GEOs into the environment that is consistent with the CBD adherence to the precautionary principle has been developed by the Scientists' Working Group on Biosafety. It should be acknowledged that the precautionary principle has been criticized by some as being overly vague.Other criticisms of the precautionary principle include(1)current regulatory processes are already precautionary,(2)the precautionary principle is not scientifically sound because it advocates making decisions without adequate scientific justification,and(3)if it were implemented,the precautionary principle would stifle innovation by requiring proof of safety before new technologies could be introduced.However,a recent analysis has concluded that implementing the precautionary principle is not only good science,it is also good economics for at least 4 reasons:(1)precautionary action benefits workers,(2)precautionary action does not impose damaging costs on industry,(3) precautionary policies can stimulate technological innovation,and(4)economic logic supports timely action to avoid substantial health and environmental costs. Who Participates in Risk Analysis and Risk Decision Making?

numerous international treaties, including the Rio Declaration on Environment and Development, the Bamako Convention on Hazardous Waste in Africa, the Convention on Biological Diversity, and the Stockholm Convention on Persistent Organic Pollutants. A 1998 consensus statement characterized the precautionary principle in this way: "when an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established." The 4 central components necessary to achieve its implementation include (1) taking preventive action in the face of uncertainty, (2) shifting the burden of proof to the proponents of an activity, (3) exploring a wide range of alternatives to possibly harmful actions, and (4) increasing public participation in decision making. As noted by Applegate, "properly construed, this principle defines a process for taking environment- and health-protective actions while the dangers of not taking such protective action remain uncertain.... It seeks to anticipate the risks of new and existing technologies so as to avoid or minimize them." In December 2002, the British Medical Association (BMA) issued a statement on GE foods in which it reiterated its support for the precautionary principle. Adherence to the precautionary principle is consistent with at least 3 different tenets of scientific analysis. First, it fits with the desire to minimize type II error (false-negative). Scientists in the fields of ecology, conservation biology, and natural resources management have been increasingly concerned about the tendency to downplay type II error in studies that aim to inform environmental policy. As explained by Kapuscinski, this is because the potential for harm is greater if conclusions commit a Type II error (false negative) compared to a Type I error (false positive) since recovery from most harm to ecosystems or human health involve large time lags, and are sometimes irreversible. Type I errors, on the other hand, are usually limited to short-term economic costs borne by the developers and marketers of GEOs. Second, the precautionary principle assists in accounting for another type of uncertainty that arises from ecological systems research, something that is inherent in all biological systems. With regard to the release of GEOs into the environment, uncertainty arises from gaps in current knowledge about the behavior of a GEO, the novel traits modified, variability in the environment, and limits in predicting the evolution of GEOs subsequent to their release in the environment. Third, by broadening participation in the risk characterization process, the precautionary principle may be helpful in reducing type III error, which occurs when scientists provide an accurate answer to the wrong problem, that is, they ask the wrong question. A realistic way to cope with such inherent uncertainty in complex biological systems is to implement an adaptive management approach to biosafety governance. Such an approach for assessing the ecological and human health effects for the release of GEOs into the environment that is consistent with the CBD adherence to the precautionary principle has been developed by the Scientists' Working Group on Biosafety. It should be acknowledged that the precautionary principle has been criticized by some as being overly vague. Other criticisms of the precautionary principle include (1) current regulatory processes are already precautionary, (2) the precautionary principle is not scientifically sound because it advocates making decisions without adequate scientific justification, and (3) if it were implemented, the precautionary principle would stifle innovation by requiring proof of safety before new technologies could be introduced. However, a recent analysis has concluded that implementing the precautionary principle is not only good science, it is also good economics for at least 4 reasons: (1) precautionary action benefits workers, (2) precautionary action does not impose damaging costs on industry, (3) precautionary policies can stimulate technological innovation, and (4) economic logic supports timely action to avoid substantial health and environmental costs. Who Participates in Risk Analysis and Risk Decision Making?

Another controversy surrounding the development and use of GE foods and crops is who participates in risk analysis and the risk decision-making process.Risk analysis is the integration of science-based risk assessment with inputs from public policy,which integrates science into a wider context of social, cultural,political,and economic determinants.Whereas risk assessment is a highly formalized and detailed process that is carried out by technical experts,risk analysis is characterized as an analytic- deliberative process that seeks input from stakeholders regarding how uncertainty should be addressed The rationale and importance of engaging in risk analysis have been summarized by Auberson-Huang: Opening the dialogue between precaution and risk with civil society is a move towards a systems approach,where all variables are admitted simultaneously for the characterization,framing, management,and communication of risks.A dialogue between precaution and risk is a dialogue between science and society. In the risk analysis process,good science is considered necessary and indispensable but not sufficient for good risk characterization because risk decisions are ultimately public policy choices.On a societal level,use of a risk analysis approach to inform public policy making could be achieved through use of various deliberative processes:expert panels,citizen juries,stakeholder decision analysis,and deliberative polling.And while participatory approaches to risk analysis and risk decision-making have been used in various parts of the world,for example,Denmark,Norway,the United Kingdom,and Japan,their use in the United States has been limited In 1996,the NRC Committee on Risk Characterization released a report in which it recommended that federal agencies incorporate iterative interaction between technical analysis and social deliberation when developing health,safety,and environmental regulations.In this framework,there are 3 rationales for including broad participation in risk characterization:normative,substantive,and instrumental. Normative rationale is that governments should obtain the consent of the governed and that citizens have a right to participate meaningfully in public decision making and to be informed about the bases for government decisions.S ubstantive rationale is that participation by people with diverse experiences will provide key information and insights to risk analysis.Instrumental rationale is the premise that broad participation enhances the chances of reducing conflict and increases acceptance and trust in risk decisions made by governments and international bodies.Crucial to this framework is the recursive interplay between analysis and deliberation in reaching some degree of agreement among scientists governments,and affected and interested social groups over the risks that should be treated as possible hazards.The Scientists'Working Group on Biosafety and the biotechnology "Safety First Initiative, that is,a public-private partnership formed to facilitate the transparent development of proactive safety standards that anticipate and resolve safety issues as far upstream as possible,are two examples of recent projects that have used the NRC risk characterization process to assess the environmental and human health effects of GEOs. Labeling and the Consumer Right to Know Labeling issues span science,public policy,consumer education,and consumer right to know issues. Currently,the FDA does not require labeling of foods derived from bioengineering because it believes that the process used in producing a crop or food is irrelevant as long as the nutritional content remains the same as its nonbioengineered counterpart.In 2001,the FDA proposed guidance to the food industry for voluntary labeling of GE foods.However,without stricter government regulations regarding cross- contamination of GE and non-GE crops,the FDA's guidance is of little value,and food labels such as "biotech free"may prove to be misleading.Also misleading,according to the FDA,is the fact that such phrases could imply that nonbioengineered food is superior to bioengineered food.Hence,the FDA's proposed labeling guidance shifts the burden of responsibility from the companies developing and marketing GE foods onto producers and companies marketing the product,which are typically those

Another controversy surrounding the development and use of GE foods and crops is who participates in risk analysis and the risk decision-making process. Risk analysis is the integration of science-based risk assessment with inputs from public policy, which integrates science into a wider context of social, cultural, political, and economic determinants. Whereas risk assessment is a highly formalized and detailed process that is carried out by technical experts, risk analysis is characterized as an analyticdeliberative process that seeks input from stakeholders regarding how uncertainty should be addressed. The rationale and importance of engaging in risk analysis have been summarized by Auberson-Huang: Opening the dialogue between precaution and risk with civil society is a move towards a systems approach, where all variables are admitted simultaneously for the characterization, framing, management, and communication of risks. A dialogue between precaution and risk is a dialogue between science and society. In the risk analysis process, good science is considered necessary and indispensable but not sufficient for good risk characterization because risk decisions are ultimately public policy choices. On a societal level, use of a risk analysis approach to inform public policy making could be achieved through use of various deliberative processes: expert panels, citizen juries, stakeholder decision analysis, and deliberative polling. And while participatory approaches to risk analysis and risk decision-making have been used in various parts of the world, for example, Denmark, Norway, the United Kingdom, and Japan, their use in the United States has been limited. In 1996, the NRC Committee on Risk Characterization released a report in which it recommended that federal agencies incorporate iterative interaction between technical analysis and social deliberation when developing health, safety, and environmental regulations. In this framework, there are 3 rationales for including broad participation in risk characterization: normative, substantive, and instrumental. Normative rationale is that governments should obtain the consent of the governed and that citizens have a right to participate meaningfully in public decision making and to be informed about the bases for government decisions. S ubstantive rationale is that participation by people with diverse experiences will provide key information and insights to risk analysis. Instrumental rationale is the premise that broad participation enhances the chances of reducing conflict and increases acceptance and trust in risk decisions made by governments and international bodies. Crucial to this framework is the recursive interplay between analysis and deliberation in reaching some degree of agreement among scientists, governments, and affected and interested social groups over the risks that should be treated as possible hazards. The Scientists' Working Group on Biosafety and the biotechnology "Safety First Initiative," that is, a public-private partnership formed to facilitate the transparent development of proactive safety standards that anticipate and resolve safety issues as far upstream as possible, are two examples of recent projects that have used the NRC risk characterization process to assess the environmental and human health effects of GEOs. Labeling and the Consumer Right to Know Labeling issues span science, public policy, consumer education, and consumer right to know issues. Currently, the FDA does not require labeling of foods derived from bioengineering because it believes that the process used in producing a crop or food is irrelevant as long as the nutritional content remains the same as its nonbioengineered counterpart. In 2001, the FDA proposed guidance to the food industry for voluntary labeling of GE foods. However, without stricter government regulations regarding crosscontamination of GE and non-GE crops, the FDA's guidance is of little value, and food labels such as "biotech free" may prove to be misleading. Also misleading, according to the FDA, is the fact that such phrases could imply that nonbioengineered food is superior to bioengineered food. Hence, the FDA's proposed labeling guidance shifts the burden of responsibility from the companies developing and marketing GE foods onto producers and companies marketing the product, which are typically those

marketing organic foods.In the end,individuals who wish to purchase foods without bioengineered ingredients must purchase the more expensive certified organic alternative. Representative Kucinich(D-OH),who introduced national level legislation to require GE food labeling, first in 1999 and then again in 2002,believes that labeling GE foods is warranted because of the widespread use of genetic engineering in US food production,despite a limited history of use. Confirming this belief are groups such as the BMA,which noted that labeling GE foods could be helpful in tracing any potential health problems should they occur.Zepeda et al reported that the presence of labels on GE foods could reduce consumers'risk perceptions by transforming the perception of risk from one that is involuntary to one that is voluntary.Recent research on consumers'risk perceptions toward GE soybeans found that participants wanted GE foods to be labeled even when they provided consumers with a demonstrated benefit.Many large multinational food companies have established processes that keep GE products separate from non-GE products,particularly if they ship products into the European Union and Japan because these countries already require segregation for labeling purposes.Segregation has been made possible by the use of identity preservation techniques that keep harvested GE crops separate from the point of planting to the point of food processing and,finally,to the point of export Although not infallible,identity preservation products can be tested to ensure that cross-contamination of products has not occurred at some point in the supply chain.Many countries,including member countries of the European Union,Japan,Australia,New Zealand,South Korea,and China,already require GE products to be labeled.Other countries,such as Saudi Arabia and Taiwan,will be implementing mandatory labeling requirements in the near future. As the GE labeling debate continues around the globe,consumer right to know acts are surfacing in the United States as an alternative.Trying to respond to consumer demands without unnecessarily burdening GE food producers and processors,the proposed scheme would require simple disclosure Basically,the act would require registration of all GE food products with a state agency that would maintain a database accessible to consumers.Enforcement mechanisms,administrative and judicial procedures,liabilities,and available defense mechanisms would be included in the act.Advocates of this route believe that this compromise meets the consumer's need to know but does not jeopardize the cost or sales of GE products.Finally,it is argued that a right to know act should be formulated to survive legal hurdles that have blocked state-level labeling legislation thus far. CULTURAL DIFFERENCES IN PUBLIC PERCEPTIONS OF GE FOODS There have been very different reactions to GE foods in the United States compared with other parts of the world,particularly in Europe,and in many developing countries.Differences in public reactions to GE foods are largely the result of moral and ethical concerns that reflect the history,traditions, experiences,beliefs,and values of a diverse citizenship.Understanding such differences in underlying values can aid both US and international policy makers in disseminating information on agricultural biotechnology and GE foods to citizens and other stakeholders in the United States and abroad. Underlying cultural differences in public perceptions of GE foods stem from (1)differences in the cultural significance of food and food production,(2)differing perceptions of nature,(3)the level of trust in regulators,(4)perceptions of science,(5)the quality of citizen engagement,and(6)concern about threats to pluralism.Each of these is explored below in more detail. Cultural Significance of Food One significant difference between Europeans and Americans regarding their attitudes surrounding GE foods relates to the relative cultural significance of food in the lives of Europeans versus Americans. Whereas American national identity is generally not linked to food and food production,the opposite is true in Europe,especially in countries such as France and Italy,where national identity is entwined with

marketing organic foods. In the end, individuals who wish to purchase foods without bioengineered ingredients must purchase the more expensive certified organic alternative. Representative Kucinich (D-OH), who introduced national level legislation to require GE food labeling, first in 1999 and then again in 2002, believes that labeling GE foods is warranted because of the widespread use of genetic engineering in US food production, despite a limited history of use. Confirming this belief are groups such as the BMA, which noted that labeling GE foods could be helpful in tracing any potential health problems should they occur. Zepeda et al reported that the presence of labels on GE foods could reduce consumers' risk perceptions by transforming the perception of risk from one that is involuntary to one that is voluntary. Recent research on consumers' risk perceptions toward GE soybeans found that participants wanted GE foods to be labeled even when they provided consumers with a demonstrated benefit. Many large multinational food companies have established processes that keep GE products separate from non-GE products, particularly if they ship products into the European Union and Japan because these countries already require segregation for labeling purposes. Segregation has been made possible by the use of identity preservation techniques that keep harvested GE crops separate from the point of planting to the point of food processing and, finally, to the point of export. Although not infallible, identity preservation products can be tested to ensure that cross-contamination of products has not occurred at some point in the supply chain. Many countries, including member countries of the European Union, Japan, Australia, New Zealand, South Korea, and China, already require GE products to be labeled. Other countries, such as Saudi Arabia and Taiwan, will be implementing mandatory labeling requirements in the near future. As the GE labeling debate continues around the globe, consumer right to know acts are surfacing in the United States as an alternative. Trying to respond to consumer demands without unnecessarily burdening GE food producers and processors, the proposed scheme would require simple disclosure. Basically, the act would require registration of all GE food products with a state agency that would maintain a database accessible to consumers. Enforcement mechanisms, administrative and judicial procedures, liabilities, and available defense mechanisms would be included in the act. Advocates of this route believe that this compromise meets the consumer's need to know but does not jeopardize the cost or sales of GE products. Finally, it is argued that a right to know act should be formulated to survive legal hurdles that have blocked state-level labeling legislation thus far. CULTURAL DIFFERENCES IN PUBLIC PERCEPTIONS OF GE FOODS There have been very different reactions to GE foods in the United States compared with other parts of the world, particularly in Europe, and in many developing countries. Differences in public reactions to GE foods are largely the result of moral and ethical concerns that reflect the history, traditions, experiences, beliefs, and values of a diverse citizenship. Understanding such differences in underlying values can aid both US and international policy makers in disseminating information on agricultural biotechnology and GE foods to citizens and other stakeholders in the United States and abroad. Underlying cultural differences in public perceptions of GE foods stem from (1) differences in the cultural significance of food and food production, (2) differing perceptions of nature, (3) the level of trust in regulators, (4) perceptions of science, (5) the quality of citizen engagement, and (6) concern about threats to pluralism. Each of these is explored below in more detail. Cultural Significance of Food One significant difference between Europeans and Americans regarding their attitudes surrounding GE foods relates to the relative cultural significance of food in the lives of Europeans versus Americans. Whereas American national identity is generally not linked to food and food production, the opposite is true in Europe, especially in countries such as France and Italy, where national identity is entwined with

particular varieties,quality,and preparations or purity of food.Consequently,the introduction of GE foods is perceived by many Europeans to be a threat to their cultural identity Perceptions of Nature There are different cultural and ethical notions between Europeans and Americans about what constitutes nature and how it is valued.Americans tend to equate nature with wild spaces--hence the practice of preserving large tracts of unsettled land as nature preserves.On the other hand,Europeans share more densely populated land and have access to fewer unaltered landscapes,so there is a broader sense of what counts as nature and what,therefore,should be protected or left unaltered.The importance of wildness also applies to animal welfare issues.In the United States,greater emphasis is placed on protecting wild or endangered animals rather than farm animals.In Europe,there is a broader public debate over issues of animal welfare,including animal husbandry practices. Trust in Regulators Europe and the United States have very different histories of biotechnology regulation and different levels of public trust in government agencies.In a recent survey that evaluated Europeans'and Americans'perceptions of trust surrounding the regulation of biotechnology,Europeans reported placing the highest confidence in international organizations such as the United Nations and the World Health Organization.In contrast,in the United States,most support was reported for US government agencies. including the USDA and the FDA.In Europe,the ability of regulators to act impartially and quickly to protect public health with respect to food safety issues is viewed as deeply suspect.Much of this skepticism is the result of the experience with bovine spongiform encephalopathy(BSE)or "mad cow disease"in the United Kingdom and recent outbreaks of BSE in other countries in Western Europe. Perceptions of Science US and European perceptions on the role of science in society also differ.In the United States,science is seen as a powerful and revered tool.Industry and government tend to rely heavily on scientific data to support or reject concerns articulated by other stakeholders.There is limited tolerance for scientific disagreement because such disagreement is interpreted as meaning that the truth has not been uncovered and that the science is simply not complete.In Europe,there appears to be an understanding that science is a process of debate or a debate in process.This means that it is possible to have legitimate disagreement by reputable scientists and conflicting scientific results.The power of science is,therefore, less absolute.Instead,it is considered a tool to be used in solving a problem.This understanding of the role of science as a process of debate permits a broader range of ethical,social,and cultural factors to be valued more highly in Europe compared to the United States. There are additional cultural factors at play with respect to the role of science in the United States.First, obstacles to progress and scientific freedom are viewed unfavorably.In addition,a significant American sentiment is libertarian,that is,against government regulation or the intrusion of government into the affairs of individuals and private corporations.Thus,a belief in the power of science and a significant libertarian sentiment explain why the United States has insisted that science be halted only if there is "sound scientific evidence"to support public policy decisions.In Europe,there is less confidence placed in the power of science,which has led to the adoption of the precautionary principle as being the dominant standard for progress in the face of scientific uncertainty. Quality of Citizen Engagement

particular varieties, quality, and preparations or purity of food.Consequently, the introduction of GE foods is perceived by many Europeans to be a threat to their cultural identity. Perceptions of Nature There are different cultural and ethical notions between Europeans and Americans about what constitutes nature and how it is valued. Americans tend to equate nature with wild spaces--hence the practice of preserving large tracts of unsettled land as nature preserves. On the other hand, Europeans share more densely populated land and have access to fewer unaltered landscapes, so there is a broader sense of what counts as nature and what, therefore, should be protected or left unaltered. The importance of wildness also applies to animal welfare issues. In the United States, greater emphasis is placed on protecting wild or endangered animals rather than farm animals. In Europe, there is a broader public debate over issues of animal welfare, including animal husbandry practices. Trust in Regulators Europe and the United States have very different histories of biotechnology regulation and different levels of public trust in government agencies. In a recent survey that evaluated Europeans' and Americans' perceptions of trust surrounding the regulation of biotechnology, Europeans reported placing the highest confidence in international organizations such as the United Nations and the World Health Organization. In contrast, in the United States, most support was reported for US government agencies, including the USDA and the FDA. In Europe, the ability of regulators to act impartially and quickly to protect public health with respect to food safety issues is viewed as deeply suspect. Much of this skepticism is the result of the experience with bovine spongiform encephalopathy (BSE) or "mad cow disease" in the United Kingdom and recent outbreaks of BSE in other countries in Western Europe. Perceptions of Science US and European perceptions on the role of science in society also differ. In the United States, science is seen as a powerful and revered tool. Industry and government tend to rely heavily on scientific data to support or reject concerns articulated by other stakeholders. There is limited tolerance for scientific disagreement because such disagreement is interpreted as meaning that the truth has not been uncovered and that the science is simply not complete. In Europe, there appears to be an understanding that science is a process of debate or a debate in process. This means that it is possible to have legitimate disagreement by reputable scientists and conflicting scientific results. The power of science is, therefore, less absolute. Instead, it is considered a tool to be used in solving a problem. This understanding of the role of science as a process of debate permits a broader range of ethical, social, and cultural factors to be valued more highly in Europe compared to the United States. There are additional cultural factors at play with respect to the role of science in the United States. First, obstacles to progress and scientific freedom are viewed unfavorably. In addition, a significant American sentiment is libertarian, that is, against government regulation or the intrusion of government into the affairs of individuals and private corporations. Thus, a belief in the power of science and a significant libertarian sentiment explain why the United States has insisted that science be halted only if there is "sound scientific evidence" to support public policy decisions. In Europe, there is less confidence placed in the power of science, which has led to the adoption of the precautionary principle as being the dominant standard for progress in the face of scientific uncertainty. Quality of Citizen Engagement

In addition to cultural differences,the quality of citizen engagement on GE foods has differed in the European Union and the United States.Whereas Americans are most often addressed in their capacity as consumers,Europeans often separate their roles in society into citizens first and consumers second Countries such as Denmark have a tradition of successful,in-depth citizen engagement on public issues that are perceived to have profound societal effects,including GE foods.These methods of citizen engagement have not been widely explored in the United States,where a dominant philosophy is to rely instead on market regulation,which focuses primarily on allowing individuals to make their value preferences known at the cash register. Concern about Threats to Pluralism With the rise of global markets,the establishment of the WTO,and the increased concentration in power by multinational corporations,many Europeans and citizens of developing countries believe that corporate consolidation in the agricultural food system,including the biotechnology sector,poses a threat to the values of pluralism.A first point of concern is that the trade context in which international discussions on modern agricultural biotechnology occur permits economic and scientific values to be raised almost entirely to the exclusion of other social,cultural,and ethical values.Concerns have also been expressed that the WTO Trade-Related Aspects of Intellectual Property Rights(TRIPS)agreement, which places primacy on the respect for intellectual property rights over other values,will primarily benefit industrialized countries over the welfare of developing countries that serve as stewards to the vast majority of the world's genetic resources.Consequently,the following issues have been implicated in the backlash against the use of modern biotechnology:the morality of bioprospecting,reductions in the world's biodiversity,the destruction of agrarian traditions,cultivating economic dependence on multinational corporations,access to benefits,and global justice. Peasant farmer and indigenous peoples'organizations have expressed concern that developments in modern biotechnology,along with the development of the International Union for the Protection of New Plant Varieties(UPOV),could threaten their food sovereignty,which they believe is a prerequisite to achieving food security.Food sovereignty is the right of peoples to define their own policies and strategies for sustainable production,distribution,and consumption of food with respect for their own cultures and own systems of management of natural resources and rural areas.It is a term that was coined by Via Campesina--an international association of small farmers and peasants from around the globe.A key focus of the food sovereignty movement is strengthening people's political power by working with disadvantaged groups from around the world,including women,to build their organization,negotiation,and advocacy skills.Similarly,the Organization for African Unity (OAU), now the African Union,has developed a model law for the regulation of(1)access to biological resources,(2)community rights,(3)farmers'rights,and(4)plant breeders'rights.The most crucial features include the belief that breeders'rights are subordinate to farmers'rights,the belief that patent protection of any life form is prohibited,and strong support for the role of women.Although the OAU model law is based in provisions of international law(the CBD),it has recently come under challenge from the World Intellectual Property Organization,an organization whose mandate is to promote and protect intellectual property rights(ie,to enforce patent rights)and uphold the UPOV.How such developments will continue to unfold in the future is uncertain. ECONOMIC,SOCIAL,AND ECOLOGICAL SUSTAINABILITY When assessing individual applications of GE to food and agriculture from a food systems perspective, it is important to evaluate their characteristics according to the adherence to the principles of economic, social,and ecological sustainability.Sustainability is defined as "society's ability to shape its economic and social systems so as to maintain both natural resources and human life."Because HT and insect- resistant crops collectively account for the majority of the GE crop acreage planted globally(92%of the

In addition to cultural differences, the quality of citizen engagement on GE foods has differed in the European Union and the United States. Whereas Americans are most often addressed in their capacity as consumers, Europeans often separate their roles in society into citizens first and consumers second. Countries such as Denmark have a tradition of successful, in-depth citizen engagement on public issues that are perceived to have profound societal effects, including GE foods. These methods of citizen engagement have not been widely explored in the United States, where a dominant philosophy is to rely instead on market regulation, which focuses primarily on allowing individuals to make their value preferences known at the cash register. Concern about Threats to Pluralism With the rise of global markets, the establishment of the WTO, and the increased concentration in power by multinational corporations, many Europeans and citizens of developing countries believe that corporate consolidation in the agricultural food system, including the biotechnology sector, poses a threat to the values of pluralism. A first point of concern is that the trade context in which international discussions on modern agricultural biotechnology occur permits economic and scientific values to be raised almost entirely to the exclusion of other social, cultural, and ethical values. Concerns have also been expressed that the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which places primacy on the respect for intellectual property rights over other values, will primarily benefit industrialized countries over the welfare of developing countries that serve as stewards to the vast majority of the world's genetic resources. Consequently, the following issues have been implicated in the backlash against the use of modern biotechnology: the morality of bioprospecting, reductions in the world's biodiversity, the destruction of agrarian traditions, cultivating economic dependence on multinational corporations, access to benefits, and global justice. Peasant farmer and indigenous peoples' organizations have expressed concern that developments in modern biotechnology, along with the development of the International Union for the Protection of New Plant Varieties (UPOV), could threaten their food sovereignty, which they believe is a prerequisite to achieving food security. Food sovereignty is the right of peoples to define their own policies and strategies for sustainable production, distribution, and consumption of food with respect for their own cultures and own systems of management of natural resources and rural areas. It is a term that was coined by Vía Campesina -- an international association of small farmers and peasants from around the globe. A key focus of the food sovereignty movement is strengthening people's political power by working with disadvantaged groups from around the world, including women, to build their organization, negotiation, and advocacy skills. Similarly, the Organization for African Unity (OAU), now the African Union, has developed a model law for the regulation of (1) access to biological resources, (2) community rights, (3) farmers' rights, and (4) plant breeders' rights. The most crucial features include the belief that breeders' rights are subordinate to farmers' rights, the belief that patent protection of any life form is prohibited, and strong support for the role of women. Although the OAU model law is based in provisions of international law (the CBD), it has recently come under challenge from the World Intellectual Property Organization, an organization whose mandate is to promote and protect intellectual property rights (ie, to enforce patent rights) and uphold the UPOV. How such developments will continue to unfold in the future is uncertain. ECONOMIC, SOCIAL, AND ECOLOGICAL SUSTAINABILITY When assessing individual applications of GE to food and agriculture from a food systems perspective, it is important to evaluate their characteristics according to the adherence to the principles of economic, social, and ecological sustainability. Sustainability is defined as "society's ability to shape its economic and social systems so as to maintain both natural resources and human life." Because HT and insectresistant crops collectively account for the majority of the GE crop acreage planted globally (92% of the

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