The determination of what is safe in foods and drugs has a long and torturous history in most civilizations and especially in modern times. I am sure you all recall that in ancient times, kings and other nobles had food tasters to determine whether some members of their courts wished to increase their suffering by poisoning them via substances added to foods. In more modern times, the origin of the Food and Drug Administration (FDA) can be laid at the doorstep of unscrupulous food manufacturers who added preservatives to foods to prolong shelf life. No matter to the sellers that some of these "preservatives", such as borax, proved to be fatal additions to the foods. Similarly, patent medicines that cured cancer, heart disease, syphilis, and a host of other diseases of mankind are now recognized for what they really are, products of overzealous marketing. Unfortunately, many of these are still around. For example, the newly developed drug for impotence, Viagra, has already been copied and several unproven products such as Veagra have reached the marketplace without evaluation of benefit or safety.

But what is the harm in marketing a product that is probably safe but has little or no benefit? Is this a panetic question? Who gets hurt if they consume a food with empty calories or a drug that is ineffective? Where is the suffering except in the pocketbook? Is this issue ripe for analysis? Is the topic of food and drug safety decision-making a subject worthy of inclusion in the interdisciplinary, inter-professional research effort concerning the infliction and alleviation of suffering? It certainly fits the model as a very complex issue with layers of trade-offs. Thus I’d like to explore this issue and elicit some spirited discussion.

As Ralph Widner pointed out, even while producing considerable suffering on my part when he asked me to speak on this subject, many political decisions involve the imposition of some degree of suffering on one group in order to benefit another. Ralph’s thesis is derived from the powerful book by Harold Lasswell who characterized politics as the art of deciding "who gets what, when, and how".

Applied to the issue of food and drug safety, if we determine by some means that something is safe and something else is not safe, who is going to benefit and who is going to suffer? If those who benefit are not satisfied with the benefit, what will they do that may heighten further suffering? If those who suffer are sufficiently distressed, what further suffering might they induce? For sure in the modern world, food and drug safety has international implications. Consider the following.

1. Most of the fresh fruits and vegetables available all year in the US are grown outside the US.

2. What we will not accept because of adulteration, filth or pesticide residues is dumped on the world market and ends up in third world countries.

3. Israel is one of the world’s major producers and exporters of chicken. Why? Because they use irradiation for sanitation and prolonging shelf life. But in the US there is concern about the health effects of food irradiation, and labeling requires that irradiated foods be labeled as irradiated. Not so in Israel, so we import it from Israel.

4. If you like lamb, a good portion of it comes frozen from New Zealand.

5. More and more, the research on and development of drugs involves testing and clinical studies in countries other than the US. Indeed, many of the drug manufacturing companies are international rather than wholly owned US companies.

These are but a few examples of the complexities of the world food supply and market as well as the trade-offs which have little scientific basis, but lots of political and economic bases. In order to obtain some reasonable understanding of the complexity and trade-offs in this topic of food and drug safety decisions, it is best that we limit our scope to something manageable. Consequently, I will take the prerogative of discussing a more defined topic which I may know something about, the process of decision making in food safety.

I’m sure you are aware that there is a fundamental difference between a food and a drug. Under current law a food is defined as "1) articles used for food and drink for man or other animals; 2) chewing gum, and 3) articles used for components of any such article". Foods provide nutrients, taste, and/or aroma; they are inherently safe. This latter point is extremely important. Food by definition is safe and supplies nutrients necessary for normal growth, development and maintenance of health. Drugs, on the other hand, do not support normal growth, development and maintain health. Rather, they are designed and used to restore normal health by eliminating causes of deviations from normal health or to provide the body with time to combat diseases or disorders by physiological, immunological, or other inherent biological defense mechanisms. Drugs may not be safe for certain persons; but this is accepted because drugs have specific uses by certain persons who need them.

So much for drugs. Let us turn our attention to food safety. How has the issue of food safety been dealt with in the past and present?

- Food tasters insured the health of the king.

- Unsafe plant foods either were eliminated from diets by death or by trial and error.

- Safety of food was the responsibility of the food preparer and to some extent still is.

- But increasingly, society has turned to government as the "food policeman or gatekeeper". Today, in this country, we rely on the Federal government, primarily the FDA and state agencies, as the decision maker in matters of food safety. But food is inherently safe as long as there are no data to show that the food is "ordinarily injurious to health". So if its a food you can market it as such. No issue of safety is involved unless you market something that is either not considered a common food or has been shown to be "ordinarily injurious to health".

Who decides what is safe? This is the first of a vast array of complexities.

- If it is a food, it is safe unless FDA proves it is ordinarily injurious to health.

- If it is a food additive, the manufacturer must show by experience or scientific testing that it is safe under expected conditions of use.

- If it is a food color, it must meet certain manufacturing standards as to chemical identity.

- If it is a food flavor, then FDA defers to the Favor Extract Manufacturers Expert Panel.

- If it is a dietary supplement, then it is safe unless FDA proves it is not

- Finally, if it has been in use for a long time and there are no reports of adverse health effects, then it’s Generally Recognized As Safe (GRAS). Who decides GRAS? Up until this year, users and manufacturers had to petition FDA and show evidence of safety. But soon, manufacturers can self-affirm GRAS and FDA is in the position of proving the contrary.

What is the result of this complexity? Who decides safety? Mostly panels of knowledgeable scientists working for universities, manufacturers, trade associations, and for FDA.

What happens if there is a disagreement? Who then is the final arbiter? Why the courts of course, not scientists. So now we have a clue as to how politics enters the arena of food safety. The Federal Food, Drug, and Cosmetic Act does place the burden of establishing safety of food additives on the manufacturer; but the burden of proving otherwise rests with the FDA. And after extensive research and study of a problem, where does the FDA have to go with its scientific evidence to prove something is unsafe? To the courts of course.

My point should be clear. What should be a common sense decision or one based on scientific knowledge by informed and educated citizens has increasingly moved into the judicial system where the decision may be based more on legal precedents rather than common sense or weight of scientific evidence. In such situations, where an either/or decision is made by an institutionalized entity that is not directly affected either way, someone wins and someone loses; someone has less suffering and others end up with more suffering. But Harold Saunders offered a slightly different perspective in his concept of "connection". What was a personal or family, or village decision about what foods are safe evolved into a decision made on the basis of science, one step removed. Now we see a second step of removal, science is not enough and we need the courts to decide. The connection to the citizens becomes more and more tenuous. Perhaps the more logical approach of paneticists should be to alert citizens to the complexities and trade-offs in any food safety disagreements.

However, there is a higher level of complexity. Worldwide, the regulatory mechanisms of governments for establishing food safety are not exactly harmonious. The best example is in our own backyard. One red food coloring approved for use in the US is banned in Canada as a possible carcinogen. However, another red food color, approved for use in foods in Canada, is prohibited in the US because it may be a carcinogen.

There are three aspects of this panetic complexity that I would like to pursue with you today. First is the basic principle of food ingredient safety. The second is the recent "food safety initiative" proposed by President Clinton and now a major effort of your Federal Government. Third, and most important, is the topic of whether food safety is amenable to panetic research.

Let me just outline the first two, as they are background to the primary question of whether we might suggest, or demand that food safety is a most worthy issue for an international panetic research project.

First, the guiding principle of safety decisions related to foods and substances added to foods is the regulatory concept of "ordinarily not injurious to health" and "reasonable certainty of no harm". As senior or aspiring paneticists, I would ask you to consider:

1. What is ordinarily?

2. What is injurious to health?

3. What is reasonable certainty?

4. How do you define "no harm"?

The second matter is the recently enacted and implemented initiative on food safety. This initiative was a result of several recent outbreaks of food illnesses in the US: Escherichia coli 0157:H7 in meat and apple juice, Salmonella in eggs and on vegetables, Cyclospora on fruit, Cryptosporidium in potable water supplies, and hepatitis A in frozen strawberries. On March 4, 1998, President Clinton announced, "Food safety is a part of the basic contract between American consumers and their government. Any food that doesn’t meet our clear and strict standards shouldn’t make it into the United States. It’s just that simple." Sorry, its not that simple.

The food safety initiative called "Food Safety from Farm to Table" commits $43 million dollars this fiscal year to:

1. Enhance FDA oversight for imported foods.

2. Improve agricultural and manufacturing processes.

3. Build on a strong record of accomplishment, which includes

- a FY 99 budget increase of $101 million

- implementation of the Food Safety from Farm to Table program

- modifying the Safe Drinking Water Act of 1996 to eliminate dangerous organisms and to tell the public if contaminants are present

- new regulations on meat and poultry inspections

Now let us turn our attention to the possible investigation of food safety decision-making as an example of panetic analysis. Clearly, decisions on food safety and implementation of the food safety initiative include "arbitrary or unenlightened exercise of political and economic power". And for sure, if we were to suggest that food safety be a topic for investigation, we would face considerable resistance. Perhaps the topic is too large for the panetic quantification proposed by Widner, based on pioneering efforts to establish a methodology that can help decision-makers assess objectively the "humane" consequences ( in terms of alleviation or infliction of human suffering) of the various choices they may make.

Let us look at Widner’s four conditions that underlie political application of any methodology for decision making.

First, the climate of public opinion must be supportive, or at least not antagonistic.

- The US public has in the past supported food safety, except where it interferes with its "freedom to choose", e.g., dietary supplements.

- The food safety initiative sounds good for US citizens, but what of the effects worldwide?

Second, the basic characteristics of the process must be familiar enough that they are understandable and acceptable to the public.

-There are some positive signs here but not as many as needed.

Third, institutional capacity and purpose to apply Panetic Analysis must exist somewhere within governments.

- Perhaps it is, but in the US it is submerged within the FDA, CDC, EPA, UDSA, state and local health departments, NIH, and others. The spirit may be willing but institutional barriers are quite high.

Fourth, the methods for Panetic Analysis must be far enough along, and rigorous enough in their development to make political and governmental application convenient and practical.

- Here we are in deep trouble for several reasons.

1. My overview of some of the complexities and trade-offs is quite superficial and probably with some thought the topic could be better understood as even more complex.

2. How about the challenge of foreseeability? The history of food safety decision-making is instructive in that with few exceptions, the several systems of many governments around the world do work most of the time. Outbreaks of illnesses can almost always be traced to lack of vigilance, cutting corners, and/or ignorance. The food safety initiative affords an excellent opportunity for collecting data on what might occur in this country and abroad. Unfortunately, this dimension of data collection, analysis, and application to future problems is only mentioned in passing.

3. How about the challenge of time limits? As discussed yesterday, time is always a problem for decision-makers as in the present, decisions are needed yesterday. In the future, if and when more food safety issues arise, more decisions will be needed "in time". If the time line for a decision is not met, no decision occurs, and no decision may result in as much and perhaps even more human suffering than a wrong decision might have produced.

4. Certainly, conflicting perceptions and values abound here. Widner suggests that on issues of public health and public safety, the panetic equation can be applied in a reasonably straightforward manner. (There’s that word "reasonable" again). Let me explain, using the food safety initiative as an example. Let us suppose that the US government does develop guidance for growing, processing, shipping, and marketing fruits and vegetables that insures that this produce is more safe for human consumption. But let us suppose also that the guidance standards are say 25% more stringent that those that exist now. What might be the consequences?

- Most probably the 6.5 to 33 illnesses per year and 9,000 deaths per year from food borne pathogens would decrease. Hospital stays would be reduced from the estimated $3 billion/year and the costs of food borne illnesses would drop below $5.6 billion/year.

- But consider the possibility that 10-20% of the US farmers could not meet these standards. What happens to them, their families, and their purchasing power

- Suppose the shipping guidance results in produce needing to be shipped only by truck and air? What happens to the railroads and those whose livelihood depends on railroads? This is probably an instructive example since we know what happened to the railroads after the 2nd World War up to now.

- Consider what might happen if all the US producers did meet the new guidelines, but a significance percentage of Mexican, Central American, and South American producers could not. What are the long term consequences on the world’s economy? Of course, one should also expect that meeting the new guidelines would require price increases in the US. What would that do to the purchases of fruits and vegetables and the health of US children?

My point is that panetic analysis of issues in public health and safety are indeed complex and application of such analysis is not so straightforward. Thus Dr. Saunders’ idea of less emphasis on quantification and more effort to make connections that provide a basis for the body politic to buy in may have merit here, and in other similar circumstances too.

So where are we? Is the issue of food and possibly drug safety amenable to panetic analysis? The picture is not as bleak as I have painted it. Perhaps I have been too eager to identify complexities and their inherent result, trade-offs. Certainly, development of panetic tables which include both direct and indirect consequences of decisions in the arena of food safety decision-making would be a good place to start. Perhaps this effort could be a way to raise the awareness of the body politic.

Could we do this on an international basis? Probably, its a bit early to try as the climate, even in this country, has not yet reached the point where the public realizes that the food supplies of the world are very complex and interdependent -- on weather, political, economic, and cultural aspects of most of the world’s food producing regions. Education of the US public is a worthy goal.

In the area of food safety, as in other issues of common welfare, governments are perhaps a major barrier to alleviation of suffering that is due to an unsafe food supply. Right now, the purpose within our own government is lacking, but our system of government does have the necessary capacity to undertake such panetic analyses. In the near future, it should be our responsibility to make both citizens and decision-makers more familiar with the methodology of panetic analysis. What better way than to dissect the complexities of food safety and develop sound panetic tables for analysis along with efforts to make the public recognize the connections with their best interests. If these were done on the same or similar topics for several countries, a comparative basis for further work would be established.

The trick of course, will be to pick topics that would arouse the interest and understanding of citizens in several countries, and, at the same time, be amenable to comparative analysis. Perhaps, we can start the discussion with this aspect of furthering the application and utility of panetics in understanding and alleviating human suffering that is a component of the world’s ability to provide a safe and adequate food supply for the population of the world.