the ethical dimensions of acceptable risk in food safety

The Ethical Dimensions of Acceptable Risk in Food Safety

Deborah Johnson, Ph.D.

DEBORAH G. JOHNSON is an Associate Professor of Phi- losophy in the Department of Science and Technology Studies at Rensselaer Polytechnic Institute. She has pub- lished articles on a broad range of topics in applied ethics. She is the author of Computer Ethics (Prentice-Hall, 1985) and is completing a term as co-editor of the Business & Professional Ethics Journal

Introduct ion The focus of this paper is on ethical issues

surrounding food additives. In particular, the aim is to uncover the ethical pr inciples that are relevant to decisions about food safety. How much risk should there be in our food supply? What level of risk is acceptable? Acceptable risk decisions are sometimes made for the wrong reasons. Nevertheless, it is difficult to criticize such decisions, let alone improve upon them, without first identifying the moral rules or principles that should be used to guide them.

Acceptable risk decisions have moral import because they affect the likelihood of people being harmed, and because they affect the autonomy of individuals. Physical harm is of great significance from a moral point of view because it threatens the very existence and bodily integ- rity of human beings. Individual autonomy is important not jus t because it happens to be val- ued in our society, but because we have a prima facie moral right to control our own lives.

I should point out that although we can spec- ify the kind of harm that is at stake in food safety (i.e., harm to the body), the moral situation is complex for at least two important reasons. First, individual consumers are often not actually harmed by an unsafe food or food additive, but ra ther are put at risk. The kind of information that we have about a food or food additive is typically statistical in nature, telling us only that a few people who eat the food may

be hurt, and most others will not be. This raises the difficult moral question: is a person "in- jured" when they are simply placed at risk, even though the adverse effect does not occur? Sec- ond, the risk associated with foods or food additives may affect some types of consumers more than others, e.g., children, pregnant women, diabetics.

Food safety decisions are further complicated by the fact that we can never know for sure that something is safe. When there is some evidence of a potential deleterious effect, the most that research can establish is that the available evidence does not indicate that the food or food additive is unsafe. Thus, food safety policy either implicitly or explicitly establishes what "acceptable risk" is. The decision to withhold or not to withhold something from the market, or to restrict or not to restrict its use, embodies a judgment (often implicit) that either the risk is small enough to be acceptable or large enough to be unacceptable.

In this paper a quanti tat ive value of risk which will always be acceptable, such as one in one million chance of gett ing cancer, will not be sought. Whether or not it is ever possible to find such a value or demonstrate its acceptability is highly controversial. Such numbers are more likely to be arrived at pragmatically, and rarely on moral grounds.

This paper has two parts. The first examines the moral character of food safety decisions. The

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second discusses three case studies and general principles that might be used in making food safety decisions.

I. The Moral/Political Context

The Parties Involved The parties involved in food safety decisions

are numerous and their relationships complex. Most important are individual consumers who purchase and eat food. Typically, we think of the consumer as someone who buys their own food, prepares it, and eats it, but many consumers do not fit this model. Many, that is, consume food already selected and prepared, in restaurants or institutions such as hospitals and schools. Then come the producers and vendors of the food. While there are actually a number of different ways that individuals or companies may be involved here, e.g., farmers, processors, distribu- tors, vendors, they will be lumped together here as "producers" of food. Similarly, a number of different parts of the government may get involved, e.g., the congress, FDA, USDA, the courts, but again they will be lumped together as the "government" Thus, for our purposes the parties involved in food safety decisions are consumers of food, producers of food, and government.

The Fundamental Relationship The fundamental relationship is that between

consumers and producers. The relationship is one of exchange. Consumers offer money in exchange for food and vice versa. The government is, in a sense, an intermediary in this relationship. It regulates the relationship both by re- stricting what can be exchanged and by creating and enforcing legal rights and responsibilities in the exchange.

Conditions o f Valid Consent The relationship between consumer and pro-

ducer is a contractual relationship in its sim- plest form. From a moral point of view contractual relationships are acceptable when both parties consent to enter into the contract, i.e., they consent to the terms of the contract. If one of the parties does not consent, then there is no contract. Furthermore, consent has to be more than jus t ut ter ing the words "I agree", for that one might do because someone is holding a gun to his head or in complete ignorance of the terms. For consent to be valid, certain conditions must be met. The consent must be (1) competent, (2) informed, and (3) freely given. Let us examine each of these conditions.

The first condition, that the consent be competent, specifies that the person making the contract have the cognitive capacities to understand what is going on. Generally this rules out children and those who are mentally disabled from making contracts. Clearly this applies to food as well as many other things. Children, at least small children, and the mentally disabled are not able to understand the risks that may be involved in certain foods. They are not able to protect their own interests.

The competency requirement specifies a min- imal cognitive capacity. The information requirement specifies that to give a valid consent to enter into a contractual relationship an individual must exercise their competency and come to understand what the terms of the contract are and what the consequences are likely to be. A person can fail to meet this requirement either because information is withheld from him by the other par ty or simply because he does not have the skill or expertise necessary to understand. So, for example, if I agree to buy certain products believing that they have certain characteristics but the seller fails to inform me about the real characteristics of the products, then I have not given a valid consent to enter into the contractual transaction. Similarly, if I am accu- rately informed about the characteristics of the products that I will purchase but I have not been told what the likely and possibly permanent, harmful effects will be from use of these products, then I have not given an informed consent. We will see in a moment tha t this requirement imposes an obligation on producers of food to provide information to consumers and it raises questions about the ordinary consumer's capacity to understand the risks involved in consum- ing certain foods.

If I make an agreement with you because you are holding a gun to my head or holding my family hostage, then, my agreement is not valid. The third condition of valid consent specifies that consent must be freely given. Admittedly food choices are rarely coerced in the strongest sense of "coercion" but in a moment we will see that serious questions can be raised about how cost and availability may affect the choice of foods, particularly for those who are poor or in- stitutionalized.

In theory, then, exchanges between consumers and producers will be morally acceptable if both parties consent to the terms of the exchange and if their consents are competent, informed and freely given.

Government Involvement Now, the government might have a number of

roles in this contractual relationship. It might,

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Johnson: The Ethical Dimension of Acceptable Risk in Food Safety

for example, have the role of insuring that the consent of each party is valid. Or, it might act on behalf of consumers giving and withholding their consent for them. Or, it might serve as an enforcer of the terms of the contract, after the fact, when both parties have given a valid consent. If we were confident that exchanges between consumers and producers met or could meet the requirements of a valid consent, then the only legitimate role for the government would be in insuring that the terms of the contract agreed to were fulfilled. If, that is, we were confident that consumers could make competent, informed and free decisions about what foods to buy and eat, then it would be wrong for the government to interfere in such choices. As things stand now the government interferes after the fact to insure that the terms are fulfilled but it also does more. It insures the terms of the contract by enforcing the rules that consumers must pay, and producers must supply what is designated on the label of their product. If either par ty fails to do what is required, they may be sued and may lose the suit. The government's involvement here serves as an incentive for both consumers and producers to live up to the terms of the contract and in this way, the government facilitates or, at least, makes less risky, the formation of this kind of contractual relationship.

Still, the government does more. It actually defines the terms of the contract and in doing this, in effect at least, represents the consumer's consent. This activity is justified essentially on grounds that the typical consumer cannot give an informed or free consent.

The government's role in defining the terms of the contract needs to be justified because in the absence of such a justification, one's moral right to control one's life would entitle one to make whatever contracts one wants. Food safety could, then, be worked out in the market. In theory people would not buy food that was unsafe and, consequently, producers would produce safe food. This sounds good but in reality, it does not quite work this way (as we will see in a moment). Indeed, the government via food safety policy, specifies that there are certain things for which individuals cannot make a contract. I might be willing to buy meat produced with DES or soft drinks with cyclamate, but reg- ulations prohibit those things from entering the arena of exchange. As well, the government specifies the risk level of the foods that may be purchased. This is intended to insure that the exchanges between consumers and producers will be within a certain range of risk. So the question is, is this form of government involvement justified?

The Just i f icat ion for Government Invo lvement

The justification of this form of government involvement is found in examining the problems which arise over valid consent. That is, when we look carefully into the reali ty of food transactions, we find strong reasons to suspect that consumers cannot give a valid consent.

Competence Already it has been suggested that there are

segments of our population that do not have the competence to make food choices, i.e., the mentally disabled and children. Still, these consumers of food can have their interests represented by their parents or guardians. Those who eat in institutions can be protected by regulating the food-providing facilities of these institutions rather than food producers. In fact, our government does this. Thus, the lack of competence in these segments of our population does not by itself just ify government interference which re- stricts what can and can't enter the marketplace.

Information Problems arise, first, when it comes to "in-

formed consent." It has already been argued that when individuals enter into a contractual relationship, each person must be informed about matters that are relevant to the decision to make the contract. They must know what they are agreeing to. This does not mean that each party must tell absolutely everything they know (this would be impossible and counter-produc- tive), but it does mean that each must tell what they know to be relevant to the decision of the other. Risks of bodily harm and the likely mag- nitude of the risk from consumption of a food are clearly relevant to consumers. If the consumer is not informed about the risks of using a food product before buying it, it is as if the consumer is making an agreement without knowing the terms. The consumer supplies money without knowing what he or she will get in the way of risk.

Assuming no government involvement what- soever, how can we be sure that producers will supply the relevant information? How can we be sure that they will create the information, i.e., do appropriate testing? Indeed, there is an incentive for producers no t to provide this information. The information may discourage people from buying the product. There is also an incentive not to do testing. It is expensive and may make the food more expensive and, thus, less competitive. Yet, producers of food are in the best position to be able to determine and control the risk. This provides the justification for gov-

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ernment regulation which requires food producers to create and provide information for consumers.

When government policies do this, however, they are not interfering with the individual's right to make contracts. They are only insuring that it is possible for individuals to give a valid consent. Such policies are not paternalistic. They merely facilitate individuals in making decisions for themselves. They do not take away choice.

Unfortunately, however, there is no guarantee that consumers will in fact read the information before they make a purchase. That is, information requirements do not insure that consent will be valid. So, the question becomes, can more government involvement be justified?

Before answering this question, let me point out that while information policies do not interfere with consumer autonomy, they do interfere with the autonomy of the producers of food, and some might argue that this is wrong. The appropriate reply is, however, tha t one's right to autonomy only extends to activities which do not threaten to harm others. If the producers of food create food that threatens bodily harm to those who purchase and consume it, their activity is not self-regarding. Their autonomy can be limited. Interference in such activity is justified.

The problem is that even when the government insures tha t information about food is cre- ated and made available, it is unrealistic to sup- pose that consumers actually make use of it. Can consumers understand the information or est imate the risk? The answer seems to be "no".

This is not the typical case where government interference is justified. The more typical case involves protecting individuals who are incom- petent. When it comes to food safety, however, the case for government protection cannot be made on the basis of innate inability. Most individuals are capable of being informed about food, or at least, are capable of being brought to a level of education where they could understand. In principle, that is, consumers can make informed decisions. The problem is that ordinary consumers, though capable in principle, do not in fact have the technical expertise necessary to unders tand food safety, and do not have the t ime or energy to become experts. This is not a mat ter of choice, at least not in any simple sense. It is not jus t that individuals don't want to take the t ime and devote the energy. Rather, it has to do with the technically complex character of food risks and the vast array of decisions requiring a typical consumer's attention. To be well informed about every consumer choice in our society is a practical impossibility. Jus t

think what it now takes to be modestly informed about what car to buy, about household pollu- tants to avoid, about the water we drink and the air we breathe, about what forms of transporta- tion are safe, etc.

Given this situation it is prudent for consumers to have government agencies make policy decisions which do more than simply insure that the consumer has information. Government interference which prevents certain foods or food additives from entering the marketplace or which restrict availability of certain foods helps consumers in their negotiations with producers. Indeed, since consumers cannot give an informed consent, that government involvement is what makes producer-consumer transactions morally acceptable.

There is another reason why such government involvement is beneficial which is also related to the informed consent requirement. Not only is the information about food and food safety technical and voluminous, often the information is so uncertain, tha t it may do more harm than good when it is given to consumers. This is suggested by several of our case studies and will be discussed later. It is not an argument for keeping information about safety secret, but rather an argument for putt ing the burden of synthe- sizing food safety information where it can best be borne.

Coercion The second condition of a valid consent is that

the person agree voluntarily, e.g., to purchase a food. Here also there is reason to believe that government involvement may be justified. On the face of it, perhaps it would seem that consumers voluntari ly choose the foods they buy. Food producers do not and cannot force consumers to buy. However, on closer inspection the reality is a little more complex. First, consumers have no choice when there is a monopoly. When government interferes to prevent monopoly, they are, thus, insuring that consumers have a choice. Second, and perhaps more important, there are varying degrees of choice. How much of a choice one has will be affected by the variety of foods available, the variety of brands of a par- t icular food, how much each costs, how conve- nient each kind of food is to purchase, store, etc.

It would be difficult to argue that consumers are "coerced" into buying a particular food product. This would imply some sort of threat at- tached to their not buying. Nevertheless, food choices seem to be pressured in varying degrees by availability, price and even advertising. It is probably true to say that the rich have access to a larger variety of foods. This is not immoral in

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itself, but if it turned out that the rich have access to safer or even healthier foods, that would be an unjust and morally unacceptable situation.

The case here for government involvement is strong, then, when it comes to anti-monopoly behavior though this is not unique to food policy. This line of argument also suggests that poor people may be pressured by their poverty into buying foods which are unsafe. Their choices may look voluntary, but if they had more money, they would not take the risk. In some sense their poverty may disqualify them from giving a valid consent. Keeping unsafe foods off the market , thus, protects people against the eco- nomic pressures to buy them.

This argument is, perhaps, less convincing than the argument based on information, because there is no evidence indicating that more expensive foods are generally less risky than less expensive foods. However, it is enlightening in that it is a further indication that food safety can not be worked out in the marketplace alone. In the marketplace the rich may express a willingness to pay more for less risk, while the poor express a willingness to pay less and take more risk. This will give us a very distorted view of what people "want" or "need" or find "acceptable ."

Government Protect ion We have, then, two arguments for government

interference in the relationship between consumers and producers when it comes to food. Both arguments suggest that consumers, while capable in principle of giving a valid consent to buy particular foods, will not in reali ty have the information and may not have the freedom to give a valid consent to buy foods. While the first argument is stronger than the second, both argue for some form of protection by government.

Another argument that has been used to jus- tify government involvement in food safety and the resulting reduction in consumer choice, is based on the idea that food consumption is not only self-regarding. Since the food we eat affects our heal th and ul t imately our use of medical services and since the government ul t imately pays the medical bills of many people, the government has a right to control what we eat. (Schultz suggests this argument in his paper on saccharin.)

This argument is interesting though it would not be powerful on its own. Yes, the government indirectly pays the price for our health, and the quali ty of the food supply affects health. Still, our society need not set things up this way. If, indeed, we were confident that people could

make informed and voluntary food decisions, then we might be willing to pay the price in our medical care policies or we might simply reject the idea of national heal th care. The point is that if we really believed that we didn't need government protection, then we wouldn't toler- ate government interference on grounds that it ul t imately pays the price.

The arguments in favor of government involvement, an involvement that goes beyond insuring information, are not exactly arguments for paternalism. Paternalist ic behavior is generally understood to be behavior which goes against the immediate desires of the person being protected. When someone acts paternal- istically, they act to benefit another, even though the other does not recognize the action as beneficial. For some, food safety policy may well have this characteristic, for others it clearly does not. Disagreements usually arise not over the involvement of government but ra ther over a decision on a part icular food or food additive. Still, while government involvement here is not paternalistic, it may be helpful to consider a classic example of paternalism to see what the government's role in food safety should be. An incident from The Odyssey is often used to give the model of paternalistic behavior. Odysseus has learned that during the night his boat will travel through an area where he will hear music that will m a k e him want to do certain things which he does not want to do. He orders his crew to bind him and instructs them not to untie him, even if he orders them to do so during the night. Similarly the government agencies are empow- ered (though not by an explicit act of each individual) to make decisions which will prohibit individuals from doing things which they may actually want to do at some time but which they would not do if they had adequate information and freedom. Ignorance and the pressures of the marketplace are powerful.

The government has a responsibility, then, to act in the interest of consumers by making policy decisions which consumers would make in- dividually for themselves if they had the appropriate information and no pressure. It must see itself much as Odysseus' crew and must not waver in its allegiance. This means behaving in a way such that it, on the one hand, does not simply give in to public demand and, on the other hand, does not violate the public trust.

II. Case Studies This justification of government involvement

in food safety will provide the basis for understanding the sort of principles that government agencies should use in making food safety deci-

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sions. A discussion of three case studies both test the above analysis and provide the context for drawing out its implications.

Acceptable Risk The question is, what is acceptable risk? Or,

how should the government make acceptable risk decisions? That is, morally what is the right thing for a government agency or even Congress to do when faced with complex and unclear evidence about the safety of a food or food additive? This question is, of course, nearly impossible to answer in such general form. For one thing, there are really a series of questions about different stages in the decision making process. How should we decide which foods to spend our limited resources investigating? What scientific tools should we use to measure risk? Once the measures of risk are in, where should we draw the line? And what types of policies should we adopt? Clearly, the answer to any one of these questions affects the risks tha t consumers actually bear.

Not only is the acceptable risk question too general in the sense tha t an answer must take into account the various stages in decision making, it is also too general to yield a useful or informative answer. For example, the simple and not incorrect answer might be that decision makers should do the best they can to protect the heal th and safety of consumers while at the same time balancing heal th and safety against other values, e.g., cost of food, individual choice, etc. It is tempting to say tha t having a safe food supply is something which should not be balanced against anything else because food is so fundamental to human beings. Nevertheless, the case studies suggest tha t it is unrealistic to insist on this. For one thing, there is no way to establish tha t a food is safe. The evidence is almost always too complex and uncertain. For another, we can not simply opt for being as conservative as possible since this may have other kinds of costs e.g., taking choice away from consumers, increasing cost and availability of food, etc.

Though the question about acceptable risk is difficult to answer in its general form, we might make some headway by examining several possible principles which are sometimes profferred for use in food safety policy. In the end, two of the three do not hold up but the reasons they do and don't hold up are il luminating. These are the possible candidates.

1. Food safety decisions should be based on scientific evidence. When there is no evidence of a deleterious effect, the food should be kept on the market. [Jukes sug-

.

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gests something like this in his paper on DES.] Risk-benefit analysis should be used. When the benefits outweigh the risks, the food should be kept on the market. The policy with the least restrictive form (least restrictive of individual choice) should always be adopted.

Value Laden Decisions The first principle may well be one that many

scientists implicitly endorse, believing that such decisions can and should be scientific and, there- fore, value neutral. Unfortunately such decisions are not and should not be value neutral.

Nothing in the previous analysis suggests tha t government decisions can or should be value neutral. The analysis does suggest that decisions be made which are in the best interest of consumers, and this, in itself, means that the decisions will not be neutral. Consumer interests are values.

Actually there are several different ways in which food safety decisions are value decisions. Also, scientific evidence by itself can not tell us what to do about a food. Scientific research in the food safety area most often leads to statistical s tatements about the response of certain an- imals to certain quantities of a substance. Ex- trapolations are made for humans on the basis of these numbers. Even if the extrapolations were reliable (and no one ever knows for sure tha t they are), they do not tell us w h a t to do about the food or food additive. Science can only tell us what the probability is of something hap- pening or how much of a substance is present, etc. From this information we may be able to state a measure of risk for humans who consume the food. Still, this does not tell us whether or not the food should be banned, restricted, or freely marketed. To make such a judgment we have to judge whether the risk is "acceptable" And, what is "acceptable risk" seems to depend on an array of factors including the alternative foods or food additives in the same category, their cost, availability, risks; other natural risks in the environment; the cultural significance of the food; the benefits of the food; etc.

The best i l lustration of this point is found in Jukes's paper. Jukes tries repeatedly to make the point tha t DES should not have been banned. He does this by arguing over the scientific theory used in the DES case and the evidence. He claims tha t these were misunder- stood. Thus, in the final pages of his paper he concludes.

My viewpoint is tha t Claus and Bolander (30) are correct and tha t the threshhold

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principle is a law of nature that includes genetic toxicity and carcinogenesis, and applies to estrogens, including DES. This con- clusion is on scientific rather than ethical grounds. Identification of a no-effect level may be difficult, but it should be possible. 1

He is t rying to make his case for DES on grounds that there are levels or should be levels at which DES will not have an effect on humans. The interesting thing is that his real disagree- ment with the decision on DES comes out in a later paragraph.

"Erring on the side of safety" is an unacceptable subst i tute for the evaluation of en- vironmental carcinogens with respect to the comparative risk that each presents. I shall eschew any mention of benefit in the context of a discussion of carcinogenicity. In the case of DES in the production of beef I do not perceive the existence of a carcinogenic risk. 2

FDA, and the Delaney clause, have taken a position on carcinogenic residues which Jukes be- lieves to be too conservative. Yet his arguments do not show that it is irrational to protect ourselves against even an infinitesimally small risk. In other words, he has tried to use scientific theory and evidence to criticize a policy which incorporates a value (disvalue of carcinogenicity).

In any case, while food safety decisions could not be value neutral even if we wanted them to be, we would never want them to be. The pur- pose of the government agencies is not to be value neutral, but rather to see to it that certain things which we value, namely health and safety, are realized. The difficulty that agencies have in making food safety decisions is not in trying to be neutral but ra ther in trying to bal- ance a variety of sometimes conflicting values. Two of the most predominant are protection against bodily harm and individual autonomy. Each of the cases that we looked at, implicitly or explicitly, struggled with balancing these two goods. The debate over saccharin probably dealt with it most explicitly. The final outcome balanced individual choice against potential harm by allowing saccharin to be used in soft drinks and requiring warning labels on the containers.

Other values are somewhat more buried in the case studies, sometimes they are buried jus t because they are so obvious or accepted. In the lead case, for example, the fact that the industry chose first to reduce lead levels in infant foods clearly reflects the special value or importance we place on children. Even acknowledging that damage to children from lead may be more se- vere and permanent, there is a moral tone to the

industry's choice to at tend to infant food first. This is i l lustrative of the more general point that the choice of which foods to scrutinize is a value laden choice in that it involves assump- tions about which kinds of risks are most serious and/or which populations most important.

People seem reluctant to admit this point about the value ladenness of food safety decisions, perhaps, because there is a fear that if we admit that such decisions are necessarily value laden, this might imply that it is all right for government agencies and their employees to use their own personal values in decision making. But, this does not follow. The kind of values that are at stake and should be taken into account in food safety are more basic, and common to all, e.g., protection against bodily harm, autonomy. Indeed, it is because we value individual autonomy, that we are reluctant to let government representat ives make decisions which impose their personal values on others.

Another difficulty is deciding how different and conflicting values should be balanced. What sort of values may tip the scales towards tolerating risk? Should individual choice always be protected no mat ter what the risk? In any case, it is clear that the first proposed principle cannot be accepted. Food safety decisions are and should be value laden.

Needs and Benefits The second principle advocates the use of risk-

benefit analysis. This was alluded to by several of the authors in this collection and is proposed in reaction to the reluctance of several government agencies to make use of it. Nevertheless risk-benefit analysis seems to be used implicitly even if not explicitly. To see this a short tangent will be necessary.

The argument for government involvement in food safety says, in essence, tha t the government should protect us from ourselves and others who might take advantage of us. Still, there is an aspect to this which has hardly been men- tioned, and that is the uniqueness of food. If we had been talking about government involvement in hang gliding or mountain climbing, the analysis would have been very different. Even if it had been about cars or computers, the analysis would have been different. In these cases the argument for government involvement would have been weaker, though perhaps still plau- sible. Food is special because we need it to exist. We cannot live without it. We can live and have reasonably satisfying lives without hang gliding, mountain climbing, computers, and even cars. If we have a moral right to food it is because we have an essential need for food.

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Recognition of our need for food is implicitly at the foundation of every food policy decision and in this sense alone a kind of risk-benefit balancing is inherent. This balancing is, however, complicated by the fact tha t the need to be fulfilled or achieved is complex. That is, from a biological or physiological point of view, what we need is extremely complex. We need a certain quant i ty of food and a variety of types of nutri- ents, vitamins, protein, minerals, etc. The biological requirements can be fulfilled in an infi- nite number of different ways, i.e., a variety of foods and food combinations. Thus, our biological needs do not necessitate that any one particular food be available.

Even if we assume that people have a right to food (and Shue gives us strong arguments to do more than assume this), it can not be a right to abundant , cheap, or even "safe" food. The last seems most arguable, but since there is no ab- solute meaning to "safe" at most we can say that individuals have a right to a "reasonably safe" food supply. And, even if the right was a right to abundant and cheap food, it would not follow that all foods must be abundant and cheap. The point is tha t even though food is special because we have such a fundamental need for it, this has little significance when it comes to part icular foods, for no particular food is needed per se. This means that when it comes to doing the implicit risk-benefit (need) analysis for part icular foods, the scales are heavily tipped against risk. Why take a risk when you can get the benefit (fulfill the need) in some other way?

Of course, all three of the case studies focused on food additives and only indirectly on the foods to which they are added. Food additives are not needed. Rather they are desirable because of something they do to the food, e.g., make it taste or look better, make it less caloric, store longer, etc.

Rodricks points out that the FDA rejected the use of risk-benefit analysis in their decision on DES and yet risk-benefit analysis seems to be imbedded. It is hard even to place the debate and decision in a context without asking why growth hormones would be considered for use. The answer, of course, is that they are desirable. They are desirable to farmers who raise sheep and cattle because they increase the efficiency of production. More meat can be produced in a shorter period of time with less feed and there- fore less cost. If there were no risks involved in using DES, it would be purely beneficial.

Thus, need and benefit do play a very important role in all these decisions. But, it seems that the scale is tipped or should be tipped against most part icular foods simply because

most of our needs can be fulfilled in such a variety of ways that no particular food is needed. It is no surprise, then, that in both the saccharin and the DES case, the FDA decision was to ban. (In the saccharin case, of course, the initial FDA decision to ban was overturned by Congress.)

The hard and perhaps most interesting question has to do with the kind of need or benefit that policy makers should take into account. That is, when we move beyond the biological level and begin to focus on psychological needs or cultural attitudes. Here the protective role of government is tested, for often consumers express strong desires for additives which are not good for them.

The DES case il lustrates the subtle role of cultural values in the sense that we do not need meat to survive or even to be healthy. Clearly, however, in our culture meat is an important part of our diet. In the case of something like saccharin, the situation is also complex. People do not need saccharin. They want it to reduce caloric intake and still have their food taste sweet. Even for diabetics, saccharin was something which made food taste better, increasing the at tractiveness of various foods, and increasing the diabetics options, but saccharin could hardly have been called a necessity (even when it was the only available nonsugar sweetener).

The saccharin case is most interesting because it poses for us in a very clear form the dilemma of an agency that is acting as a protec- tor. Should it succumb to the demands of consumers, implementing their choices? Should it give weight to culturally perceived needs and culturally determined tastes rather than just biological needs? Should it do what it perceives to be best for consumers even though they will not recognize this? Odysseus' men, no doubt, be- gan to wonder what they should do when during the night Odysseus pleaded with them to untie him and argued that he had made a mistake when he gave the original orders. What seems clear from my above analysis is that government agencies do not have an obligation to give in to the claims of consumers. Indeed, doing so may be a violation of duty. However, this is not to say that agencies should totally disregard the arguments made by consumers or even lobby- ists. The arguments are extremely informative for understanding what is really at stake, e.g., the real benefits of the food or food additive. Nevertheless, after listening to the arguments government agencies must act to protect the real interests of consumers and this may not be their perceived interests.

The role that risk-benefit analysis played in the lead case is very different in contrast to sac-

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charin and DES because no one wants lead in their food. The case for tolerating lead is never made very explicit, but clearly it is tied to cost and viabili ty of alternatives that make food widely available and storable over time.

Risk-benefit analysis will implicitly, if not explicitly, be used by food safety decision makers. This is not necessarily bad if the benefits and needs being balanced against risk are ade- quately represented. Needs are different than benefits and should be given more weight, but in either case it should be real need and real benefit ra ther than perceived need and benefit that come onto the scales. If it is done this way the scales will be heavily tipped against risk, for with food the needs can always be fulfilled in a variety of ways. So, the second possible principle, that risk-benefit analysis should be used, is not rejected. Indeed, it seems it will be used implicitly if not explicitly.

Least Restrictive Alternative Given the moral importance of individual au-

tonomy, it seems reasonable to suggest that government agencies should adopt policies that restrict individual choice as little as possible. This is a s trategy which might be suggested by the saccharin case, for in the end what was aimed at was that saccharin be banned from soft drinks but sold as an over the counter drug. In this way, people were protected in some way but not prohibited from use of saccharin. It takes more effort to get it over the counter and add it

to food. Still, this is less restrictive than an ab- solute ban.

Of course, one could argue that this is more restrictive than allowing saccharin in soft drinks but put t ing a warning on the can. The point is tha t there are a range of strategies that can be adopted once a substance has been iden- tified as dangerous. These strategies discourage consumption to varying degrees.

While the principle of opting for the least restrictive policy is attractive, it can not be en- dorsed for the very reasons that justified government interference in the first place, i.e., that consumers are not capable of understanding the risks involved in certain foods. Thus, in many cases it will be bet ter simply to take the choice out of their hands.

The least restrictive alternative might also be thought of as a good strategy for dealing with the producers of food. In this regard it might be argued that voluntary action on the part of industry is bet ter than regulation. The lead case suggests this but it is hard to generalize from it. It is not clear that voluntary measures will always be bet ter and, of course, it is not clear that voluntary measures will be forthcoming.

Notes

1. p. 58--The Institute for Consumer Policy Research, Con- ference Papers: Ethics and Values in Food Safety Regula- tion. May, 1984.

2. p. 59.

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the ethical dimensions of acceptable risk in food safety

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