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