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“Science-based regulation should never be misunderstood to mean science converted, at its face value, into regulation.” Hence, regulation based entirely on ‘sound’ science, as the United States urges its trading partners to adopt, is only theoretically possible. The values of a society will ultimately affect the outcome of science-based risk assessment. The origin of facts is contingent on what the society deems is most important for research, how it is researched, and which of the research matters in the final assessment. The interpretation of facts will be determined by regulatory institutions, official expertise, economic models, and assumptions on what constitutes a desirable society. The risk assessment methodologies and risk management approaches of the United States and the European Union towards genetically modified foods demonstrate this truth, and this situation will be explored as a case study of science – based regulation. In science lies the facts, but the origin and interpretation of the facts cannot be separated from political, social, and cultural influences.
The European Union and the United States have different risk assessment and management policies which arise from political and socioeconomic differences within these two societies. From a political and cultural standpoint, the clout of strong consumer unions and farmers in the European Union and similar pull from the industrial sector in the United States cannot be separated from the decision-making process. Socially, we find that risk perception between the two societies is quite different. American society exhibits consumer acceptance and the European Union exhibits consumer recalcitrance towards GM-foods.
More importantly, the differing philosophies in risk assessment are structured so that either entity can have their risk assessments arrive at their desired outcomes. The United States insists that risk assessment of genetically modified foods be based on ‘sound’ science and rules. Though the European Union does not directly counter this position, it did recently make clear in The EU Communiqué on the Precautionary Principle that it would reserve its sovereign right to exercise the precautionary principle when the known facts surrounding the risks of a particular GM-food were not enough to establish the food as safe for human consumption.
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Discussion surrounding the Precautionary Principle and ‘substantial equivalence’ embodies the most heated debate in agricultural trade today. This discussion has brought the feud into the global arena. It has appeared in successive rounds of talks within the World Trade Organization and the United Nations. The evolving debate between the two entities presents itself as a good case study for the exploration of the influences on the outcomes of risk assessment, and the impossible demands that are asked of science in doing this.
The case study
Both European and American society have expressed concerns about the safety of the production, transfer, and consumption of GM-foods. From an environmentalist’s perspective, the release of GM-organisms and foods into the environment poses the potential risk of disrupting an ecosystem’s equilibrium. A GM-livestock or a GM-crop introduced into an ecosystem becomes a new factor into its stochastic calculus. Any number of present variables can influence the outcome of the actual damage that may result from the introduction. Because the ecosystem is essentially chaotic, the effects of introducing a novel GM-organism can range from benign to dramatically destructive. The risk is that dramatically destructive results will occur.
For human consumption and health, the risks do not lie in the chaos but rather introducing new foods with incomplete knowledge. The first aspect that is not entirely understood is the effect of inserted genes on the metabolic processes of an organism. When a gene is inserted into the DNA of a particular organism, the organism’s internucleic machinery will transcribe this new gene as it transcribes the rest of the DNA into proteins. Proteins are long strands of amino acids that fold in special ways as commanded by the negative and positive charges of amino acids. These proteins interact with their environment and each other to change the folding and consequently the protein structure, which is key to protein function. If one is unable to predict how the proteins produced by the new gene will interact with the proteins produced by the organism’s initial DNA, then one is unable to say whether the metabolic interactions between the transferred gene or genes and the host genome may produce toxins or allergens that are threats to human health. Another possible consequence of inserted genes is that they may disrupt a sequence for a crucial enzyme or protein whose importance cannot be known until it is disrupted. If the synthesis of proteins that govern the protein structure of another is disrupted, there could be disruptive ramifications on the metabolic processes of the organism. A second unknown is the effect that the consumption of GM-foods over a long period of time may have on human health. GM-foods may leave residual contaminants that are benign if consumed sparingly, but may have malignant effects after accumulation in one’s system. Another unknown is whether the insertion of promoters – the snipped of DNA placed before the gene that is necessary for the gene to “turn on” – can jump around in the gene and “turn on” genes that cause deleterious effects to the organism or produce toxins. The list of unknowns is indeed immense, as the complexity of the genome and metabolic interactions at the molecular level continues to mystify scientists.
Risk assessment philosophies
If one were to demand that all metabolic processes be known in detail of foods before they can be released into the market, much of the agricultural produce we see in the supermarket today would disappear. Investigation of protein interaction at the molecular level is still a relatively new field, and the only substantiated evidence that attests to food-safety is long-term empirical data. Since the advent of GM-foods is a recent one, long-term empirical data does not exist. Both parties use this presence of incomplete data to their own advantage. The United States and the European Union have radically different philosophies on how to deal with risk assessment given incomplete knowledge. The principles are fundamentally irreconcilable by the very nature of how they account for lack of evidence. For the most part the principles will arrive at very different conclusions in the risk assessment for GM-foods. The US and EU have brought these differences to the negotiating table many times – not just in bilateral discussions, but also in some very important global agreements, such as the Rio Declaration on the Environment, the WTO Convention on Sanitary and Phytosanitary Measures of 1992 and the most recent Cartagena Protocol on Biodiversity drafted in Montreal in January 2000. Within these different negotiations, the European Union has campaigned fervently for the Precautionary Principle to be placed in the draft text of conference documents to protect its right to use the Principle. At the same time the United States has amassed large counter campaigns. This dichotomy was most pronounced at the recent Montreal meeting on the drafting of the Cartagena Protocol on Biosafety, where the struggle between the two conflicting viewpoints dominated the debate into the morning hours of Montreal. The United States finally had to make concessions, but the debate on the authority of the Precautionary Principle is unlikely to stop anytime soon. At a recent G8 Conference in July of 2000 in Okinawa, the leaders affirmed in the proceedings that it would be necessary “to achieve greater consensus on how precaution should be applied to food safety in circumstances where available scientific information is incomplete or contradictory.”
The Precautionary Principle was first formalized in 1982 in the draft text of the United Nations General Assembly World Charter for Nature to insist that strong but unaffirmed of environmental degradation warrants precautionary action if effects were to be irreversible and devastating. In the Rio Declaration of 1992, the principle warranted that when “there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” The principle has been the underlying framework upon which the European Union collectively analyzes the safety of GM-foods for human consumption and the environment. It was first introduced into EC law in the Maastricht Treaty in 1992.
The United States is a harsh critic of the principle in large part because it discriminated against genetically modified crops. First, the Precautionary Principle and the pertaining EU agenda is vaguely defined. After the Communiqué was issued, the USDA composed a list of thirty-seven questions in a position paper issued to the European Union after the EC released the Communiqué on the PP for clarification on different points in the Communiqué. Indeed, as Dr. Catherine Woteki, the Under-Secretary for Food Safety of the U.S. Department of Agriculture, stated, “It is not clear, why, if food safety decisions based on the risk analysis framework are inherently precautionary in nature, that a separate “Precautionary Principle” is needed.
Second, the principle has discriminated against entrance of genetically modified organisms even though many have passed the same stringent food regulations that other conventionally bred crops have had with ease. In the latter part of 2000, Italy banned the importation of four types of GM-corn, despite authorization by the European Union. The Precautionary Principle is a convenient barrier to trade, allowing the Europeans to vainly resuscitate their agricultural sectors. Usage of the principle for these purposes follows the continuing trend of strong history of European protectionism for its farmers. Indeed the US argues that there is sufficient empirical data to appease European anxieties of the “Frankenfoods,’ as they have been referred to in the European press. Within the United States, transgenic crops occupied seventy-one million acres of agricultural farmland in 1999. This widespread cultivation and consumption for over half a decade, the US argues, should provide enough empirical data to assure consumers that the risks remain low. As it stands, the precautionary principle poses an unrealistic burden of proof for safety and discriminates against GM-crops. Certainly, the Precautionary Principle will never be satisfied “as long as the inventive alarmist can think of yet one more hypothesis about a possible risk that has not yet been absolutely proven not to exist.” At odds with the Precautionary Principle are other alternatives, such as that of “substantial equivalence.” Substantial equivalence is the risk assessment philosophy by which the safety of the genetically modified organism is gauged by its degree of similarity to its conventionally bred counterpart. The principle of substantial equivalence is currently one of the risk assessment tools that the FDA uses to evaluate the safety of GM-foods. A joint conferences between the Food and Agricultural Organization (FAO) and the World Health Organization (WHO) endorsed the usage of the principle in the risk assessment of GM-foods. Many foods within the United States have been approved using this principle.
The principle of substantial equivalence, like the Precautionary Principle, is yet another means to use a lack of evidence to justify a particular course of action. Many critics of substantial equivalence would caution that lack of evidence for a hazard does not make a product safe. Substantial equivalence is a means to bypass necessary biological, immunological, and toxicological tests. Furthermore, if genetically modified products merit patents, then they are intrinsically novel and their implications cannot be assessed by examining conventionally counterparts. A study done by the University of Georgia discovered that the popular Monsanto Round-up Ready GM Soya had marked differences across the board than its conventional counterpart – namely, they had lower heights, yields, weights, and the stems cracked and split open in every GM soya bean plant. Unengineered side effects such as these make harder the case for substantial equivalence.
Defining what is a hazard is a decision in the hands of policy-makers. Some hazards are unacceptable to society, even if the risks are low or almost negligible – nuclear meltdown, for example. Other hazards, even at high and prominent levels of risk, are acceptable because society is willing to expose itself to this risk for the benefits that exposure provides. A good example of this are the use of automobiles. Despite thousands of deaths that result from automobile-related activities every year in the United States, society feels that exposing itself to these risks are worth the benefits of automobile transportation. Policy-makers, then, must make decisions upon how society perceives risk. This is a difficult exercise, especially if society is not well-informed about the risks involved. It is a hard undertaking for society to perceive risks in terms of percentages of chances; thus, when an adverse event has the probability of a one-in-a-million chance of occurring, “it is popularly viewed as having a 50-50 chance of occurring.” Indeed it is the perception of risk of his or her constituency that will guide the policy-maker in establishing the desired level of risk.
In this case study between the United States and the European Union, the fact that food is at the heart of the issue significantly complicates the situation. It changes the way that the risks are perceived and society establishes a much lower level of risk tolerance that it does with other risks. These other risks, such as car crashes and lung cancer from cigarettes, are easily recognized by consumers, and assessing the risks of using these goods can be incurred, for the most part, by the consumer himself. Consumers have a choice to become subject to these risks are a result of his or her consumption decisions. With food, consumers have no choice. Everyone must eat. Food-related regulatory decisions have a direct consequence for each and every citizen of any community. It is then the government’s responsibility to ensure that all the food that is available will not endanger human health. The mad cow disease scare in the United Kingdom, Germany, and France illustrates the pandemonium and mistrust of governmental institutions that can arise when harmful foods are not filtered. Furthermore it is more difficult for an individual to assess the risks that may come with food. Their knowledge of its whereabouts before it comes to the supermarket is limited at best. Indeed, the mere act of buying food without an intimate relationship with the seller reveals the high level of trust that people put into the governmental institutions that ensure food safety.
When it comes to GM-foods, public perception between the US and the EU are polar opposites. According to research by MORI for the Department of Trade and Industry in the United Kingdom, only 1 in 100 Britons think that GM-food is good for society. On the other side of the Atlantic, a survey of 1,002 adults in the U.S. by the International Food Information Council said that 63% of adults that were familiar with the word ‘biotechnology’ believed that biotechnology in food would benefit them over the next five years. This sharp rift in sentiment toward the benefits of GM-foods illustrates how British society is less willing to be exposed to the same level of GM-food risk that American society would gladly embrace.
Also, low tolerances in the risk management of GM-food within the European Union is part of an overall agenda to regain society’s trust of government management and approval of all food in general. In the same MORI study it was found that few trusted the government to make scientific decisions on their behalf. Most of this sentiment comes from the events surrounding the mad-cow disease scare within the United Kingdom. For most of the eighties and the early part of the nineties, there was scientific consensus that bovine spongiform encephalopathy, the disease that plagued the cow population of the U.K., could not cross the species barrier and cause Creutzfeld-Jacobs disease in humans. Indeed the British Government had to reverse the position that they had held over a decade as new scientific evidence emerged that linked bovine spongiform encepaholpathy and Creutzfeld-Jacobs disease. The European Union put the island under quarantine, and trust in British government to regulate food safety plummeted. A similar incidence occurred in Belgium, where in May of 1999 the government was blamed for belatedly announcing that dioxins (carcinogens) were present in abnormally high levels in Belgian poultry. Shortly afterward, the Farm and Health Ministers resigned – the food scare is also believed to be one of the main reasons that the incumbent Christian Democrats lost in the next month’s national elections.
Assumptions on what constitutes a desirable society also affects the level of exposure that society is willing to tolerate against certain risks. The European Union works at length to preserve its farming, despite accusations of being protectionist. Many countries within the European Union find the agricultural sector to have “multifunctionality” – the agricultural sector not only serves as a food source but is also valuable because it serves environmental, aesthetic, and cultural purposes. Hence, disrupting the agricultural sector would cause hazards that European society is just not willing to accept. In 1999, OECD countries, the majority of which are European, paid 360 billion USD in agricultural support. Within the United States the revolution of GM-crops has helped many large-scale farmers increase yields and decrease pesticide use, and the biotechnology industry remains a strong influence of American government policy. Indeed the different structure of agriculture within these two societies greatly influences the level of risk that the societies are willing to tolerate towards the introduction of GM-foods. Socially and politically, the U.S. and the E.U. simply have different agricultural values.
As industry remains a strong force within the United States, the consumer unions of the European Union have an especially strong influence on national government policies. Consumer unions within the United States do not have as much as a lobbying presence as those in within the European Union do. It is an impossible task for regulator agencies within the European Union to make decisions regarding food without considering the possible actions of their vigilant consumer groups. Because of recent backlashes of the approval of GM-foods, conventional risk assessments within the Netherlands are now combined with a public appraisal to conclude whether a substance should be used.
Choice of phenomenon to research
Even in the pure scientific exercise of risk assessment, it is unavoidable to introduce elements of value judgment while conducting and evaluating the process of scientific testing. Within the United States, data gained in animal experiments is used to establish “virtual safe doses” (VSD). Virtually safe doses are estimated by taking the predetermined incidence of a disease and then gauging if this number increases after consumption of the food by the tested animals. Foods that do not exceed certain threshold limits of risk as ascertained by animal tests become Generally Recognized as Safe (GRAS). In contrast, the Scientific Committee on Food, the body responsible for scientific assessment of foods for the European Union, does a case-by-case evaluation based on the “weight-of-evidence” concept. Animal tests are given weight in the process of determining the risks posed to human health, but these results are only given partial weight to the risk assessment of the particular product. Weight is also given to comparative toxicokinetic, toxicodynamic and toxicological data. This information is then used to determine the potential ramifications if the food is consumed at large levels, and levels of ADI (acceptable daily intake) are then determined. These methods illustrate the differences between the two entities in the evaluation of scientific data for risk assessment. Though both are based on ‘sound’ science, it appears clear how the difference in method and evaluation can give rise to differences in risk assessment.
The US demands for risk assessments based on “sound” science only begs the question: what is “unsound” science? At first one would respond “unsound” science is one where integrity of the scientific conclusions are influenced by political factors that should not play into the risk equation. Nevertheless, one can observe that even if social and political factors were completely removed from the equation, different methods of compiling and evaluating scientific data will arrive at different conclusions. As seen with the case of ADIs and GRAS, scientific data used in these assessments meet all the criteria of being “sound” but nonetheless deliver different results. Because differences in risk assessment and available data have led to different conclusions, public confidence in the science-based approach has been weakened. Though the science-based approach is decidedly the universal means to assess food quality and safety, it will take significant time for the constituents of the European Union to regain confidence in the food regulatory agencies of their national governments. “Sound” science failed many Britons during the mad-cow disease scare, and instituted quarantines are likely to stay in the institutional memory for years. With such food crises, umbrella policies like the Precautionary Principle are not just requested, but demanded. For the British as well as the rest of the European Union, the right to take precautionary action regarding food safety must override any other considerations.
For the United States, the Precautionary Principle currently stands ill defined and hence gives opportunity for political agendas to influence the findings of “sound” science. Certainly, the Precautionary Principle has been convenient for the current political and socioeconomic situation the European Union faces, such as the Common Agricultural Policy (CAP), the protest of consumer unions, and the need to reestablish confidence in food safety.
Other case studies suggest that risk assessment based on “sound” science is an imperfect strategy for risk management. The speculation regarding the role of CFCs in the possible existence of an ozone hole over the South Pole during the eighties demonstrated that nations will arrive at different risk tolerances when they have differences in the ways that they discount future events (more UV rays entering the atmosphere) in light of present actions (the benefits of using CFCs). Nuclear power plants failed in the United States partly because the U.S. failed to win the confidence of the American people that the risks of nuclear meltdown are small, which has in turn created a NIMBY (not-in-my-backyard) sentiment towards the building of nuclear power plants. Such a sentiment has for the most part, escaped the French community, which has had a relatively successful experience with nuclear power generation. Because of the NIMBY sentiment, American politicians have lacked the political will to build nuclear power plants despite the enormous benefits that they have been proved to reap.
Undeniably, political judgments are the ones that make risk assessment decisions. These political judgments are unavoidable and cannot be separated from the risk assessment process. Science can only go so far as to provide information – it is up to policy – makers to make decisions based on incomplete information. The “sound” science slogan has “tended to restrict and conceal these necessary political judgments” rather than making them an integrated part of the risk assessment process. Furthermore it casts aside scientific uncertainties when these uncertainties should be prioritized and fully explored. The slogan “sound” science has pitted science against politics, when it is essential that science and politics work together to arrive at the sound risk assessments. Science can provide all the facts, but the interpretation of these facts for risk assessment cannot be separated from political and socioeconomic influences.
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