As we begin a new millennium, we are engaged in an important debate at the national and international levels concerning the role precaution should play in guiding policy decisions. Whether and how the "Precautionary Principle" should be applied in food safety risk analysis is being debated by the Codex Alimentarius Commission (a United Nations body that sets international food safety standards), and the outcome is by no means clear yet. This food safety discussion reflects a broader trend in societies, as we grapple with the need to find a better balance between reaping the benefits of technology and innovation on one hand, and avoiding or minimizing the risk of unacceptable adverse side-effects of technological progress on the other.

Even at its simplest, as a dispute over new technology introductions at the national level, this social dialogue is very complex, involving both scientific debates and conflicts between competing societal goals. At the international level, complexity increases, as different countries, with different cultures and at different stages of technological and economic development, tend to have very different perspectives on how to strike the right balance between "progress" and "precaution."

The last half of the 20th century has been an era of unprecedented economic progress, driven largely by technological innovation. The pace of change is not slowing; indeed, it may be accelerating, in response to burgeoning global market forces and exponential growth in scientific information. One of the strongest areas of science and investment as we open the 21st century is the so-called "biotechnology revolution."

The scientific and technological innovations of the past 50 years, many of which involved advances in chemistry, have improved life immeasurably for most people, at least in the developed countries. We live much longer, and the quality of our lives is better in countless ways. Most people would agree that the benefits to humanity of this half-century of technological progress probably vastly outweigh whatever harm has been done to human health and the environment by the same innovations.

Nevertheless, many thoughtful observers note that some new chemicals, and the ways we produce and use them, have contributed to human diseases and have adversely affected ecosystems, sometimes in unarguably harmful ways, and perhaps more often, in subtler ways about whose ultimate consequences we are not yet fully certain. Often, these adverse effects were not foreseen when the technology was introduced. As the scientific evidence developed documenting risks, intense controversies ensued, as those concerned mostly about risks were challenged by those with an economic interest in the risk-generating technologies and activities.

Experience with the unanticipated adverse effects of new chemicals over the past half-century has led to growing support for application of the so-called "Precautionary Principle." The precautionary approach calls for developing better mechanisms for anticipating adverse side-effects of new technologies, and for reviewing technologies more thoroughly, exploring alternative ways for reaping benefits while minimizing adverse collateral effects, before any major innovation is widely adopted.

Historically, at least in Western societies, such decisions have been left to market forces. Innovators develop and offer for sale products they believe are better in some important way, and if capital investors and buyers agree, the technology spreads. Governments oversee the process and may regulate the introduction of technologies to some extent, but in free-market societies, most legal and regulatory institutions are heavily biased in the direction of permitting new products to enter the market, assessing risks retrospectively, and demanding persuasive scientific evidence of harm before restricting the use of a product.

This system has fostered innovation, but it has also rewarded ignorance. According to a study done several years ago by the U.S. National Research Council, about 80,000 high-volume chemicals are produced in the U.S., and adequate toxicological data exist for less than 5 percent of them. Today, a definition of "adequate" data would undoubtedly include an assessment of effects on the developing nervous, endocrine and immune systems, and very few chemicals have been tested for these effects. Data on effects of single substances cannot predict the interactive effects of the multiple chemicals to which people are routinely exposed. Efforts to assess the potential effects of chemicals on critical human developmental processes are thus constrained severely by limitations of science. Assessment methods for other hazards associated with foods, such as microbiological contaminants and genetically modified crops, are less robustly developed than those for chemicals. It is therefore sometimes impossible, using available risk assessment tools, to be reasonably certain that foods are "safe."

When dealing with food safety, legislation and regulatory philosophies in most Western, developed countries have traditionally had a large, inherently precautionary component. Most national governments, for example, require toxicity testing of food additives to ensure that they are safe, before they are permitted to be used in foods. Food plays a central role in our health and in our cultures, and most societies agree that more caution should be applied to food safety than is required for most other materials.

The current approach to food safety also relies heavily on the use of risk assessment and on decisions based on "science." A consensus has grown that this approach has sometimes failed to adequately prevent serious food safety problems. The bovine spongiform encephalopathy (BSE) outbreak in the United Kingdom, and contamination of foods with dioxins, a problem in many countries, are recent examples of failures of the risk-assessment-based food safety paradigm. Such problems, coupled with growing awareness in all sectors of some inherent limitations of risk assessment, have stimulated interest in applying the "Precautionary Principle" more explicitly in food safety risk analysis.

Seen properly, precaution is not an alternative to scientific risk assessment, but rather an extension and expansion of science in risk assessment. I have coined a term, precautionary risk assessment, to emphasize the strong link between precaution and science. The essence of precautionary risk assess-ment is to treat scientific questions scientifically. Often, in food safety risk analysis, science is used politically. Risk assessments are narrowly focused on questions where ample scientific data exist, and seem designed to show that risks are "acceptable." A precautionary risk assessment takes a broader approach, defining a full array of risk-related questions needing answers. The assessment then looks rigorously at such issues as how much data exist about a given risk, which questions cannot be adequately answered with the available data, the possible consequences of being unable to answer certain questions (i.e., the risks of ignorance), the knowledge gaps that need to be filled to get better answers, and whether available scientific methods can answer all the important risk questions.

This precautionary approach to risk assessment provides a better basis for decisions as to whether we should proceed to adopt a technology that has risks of unknown magnitude, or whether we should take more time and try to find alternative ways to benefit from the technology while avoiding the risks, before a new technology has been widely adopted.

Two current food safety concerns illustrate the need for more precautionary approaches to risk assessment:

Environmental contaminants. While chemicals that are deliberately added to foods generally are rigorously assessed for safety, many other economically important chemicals are dispersed in the environment, and contaminate our foods, often at very low levels. A British journalist named Lucy Johnston received wide publicity earlier this year, when she had a sample of her body fat analyzed for chemicals, and wrote about what the tests found. Hundreds of different pollutants, most of them pesticides, were detected in her tissue. Analysts who have tested larger populations this way report that more than 500 industrial chemicals are commonly found in the average person's body fat. And those represent only those chemicals that are readily detected by available analytical screening methods; they are but the tip of the iceberg.

Our diet is a source of many environmental contaminants. The cumulative health risks posed by the chemicals in our foods are largely unknown, and perhaps unknowable. Most dietary residues have not been tested adequately for toxic effects, especially for effects on developmental processes that many toxicologists now think are most sensitive low-dose damage. If our health is being adversely affected by chemical contaminants, it will be very difficult to measure the effects with existing scientific methods. Animal test data on single substances can't replicate uneven exposure to mixtures of chemicals that people encounter. Studies of human disease patterns can't sort out all the confounding variables, and there are no suitable unexposed populations to serve as "controls" for such studies. In short, in trying to learn whether pollutants in our foods are harming us, we are limited by the boundaries of current scientific knowledge.

When faced with unanswerable questions of such magnitude, many people respond with what psychologists call "denial," or refusal to acknowledge the problem. One classic form of denial is to assert that no harm is occurring, since none has been scientifically demonstrated. Another popular response is to claim that exposures to chemicals known to be harmful at high doses are invariably safe at low doses. Both of these commonplace assertions rest on heuristics-that is, familiar, everyday strategies for understanding daily experience-not on scientific reasoning.

I believe that the risk perceptions of scientists as well as non-scientists are often colored by a deep-seated belief that something that our senses cannot detect could not be harmful. Many people, including many scientists, seem convinced that "low-level" exposure to chemicals must be safe, and define "low level" approximately by the concentrations that are quantifiable with current analytical methods. Over the years, I have been assured by many sincere people that one part per million of this or one part per billion of that cannot possibly be harmful, it's just too small an exposure to be significant.

That attitude is in fact thoroughly non-scientific; it is based on intuition and perhaps faith, but not on rigorous examination of scientific data. A scientific perspective on this question might consider the fact that the appropriate unit of chemical exposure, in terms of biological activity, is a molecule, rather than a part per billion. (Toxic effects occur, after all, at the molecular level.)

To apply this scientific perspective, let us look at an example. Baby bottles made of polycarbonate plastic can release traces of bisphenol-A, a chemical with estrogen-like effects, into liquids they contain. If the bottle holds infant formula, a baby might be continuously exposed to a hormonally active agent at concentrations around 1 part per billion.

Some (including the manufacturers of polycarbonate bottles) have asserted that 1 ppb of bisphenol-A is too low an exposure to have biological effects. But what is the science behind this statement? There are no data on effects of bisphenol-A on human babies. Some animal tests have reported adverse effects of fetal exposure on the developing reproductive system, but the data are not definitive yet, and have been hotly disputed by the industry.

Simple chemistry offers another perspective on the question. Using basic, undisputed facts-the molecular weight of bisphenol-A, Avogadro's number, and the volume of a baby bottle-one can easily calculate that a 200 ml bottle of fluid contaminated with 1 ppb of bisphenol-A contains roughly 500 trillion (that is, 500,000,000,000,000, or 5 x 1014), molecules of bisphenol-A.

There could hardly be more contrast in these two perspectives. One, based on firm conviction but no data, asserts that there is no effect of bisphenol-A in baby bottles, because none has been observed scientifically and because one part per billion of BPA is "too low" an exposure level to have biological effects. The other, based on simple, undisputed scientific facts, notes that polycarbonate bottles can expose babies to unimaginably large numbers of molecules of an estrogen-like chemical, several times a day. We must ask, on what basis can we presume that such exposure has no biological effects? What if "low-level" exposure is not intrinsically "safe;" what if, instead, our inability to measure effects has created an illusion of safety?

In short, a precautionary risk assessment in this case would emphasize not the lack of concrete data showing harm in babies exposed to 1 ppb of BPA in their formula, but rather would recognize that 1 ppb is not necessarily a "low" exposure. It would assess the difficulties of knowing whether or not the quadrillions of molecules a baby ingests daily have any harmful effects on the tiny consumer's developing systems.

Genetically modified foods. The "biotechnology revolution" will probably expand and accelerate over coming decades, especially if the developers of GM crops can begin to deliver the promised but to date largely unachieved benefits of genetic engineering, in terms of more abundant and sustainable food production, and healthier and more appealing foods.

And yet, at this early stage many observers, including many in the consumer movement, are deeply concerned that risks associated with biotechnology are not adequately understood, and that the rush to commercialize GM crops almost guarantees that if evidence should ultimately emerge of damage done by these crops, it will then be too late to reverse it.

In particular, genetic modifications designed to enhance crops' resistance to pests seem likely to pose risks similar in many ways to those of chemical pesticides. The benefits of chemical pest control sped widespread adoption of the new technology, while the negative side-human health hazards and ecological effects that made pest control more difficult and harmed non-pest wildlife-were documented only gradually, over decades. Many who recall that experience would prefer not to see it repeated with GM crops.

Scientific humility also suggests that we don't yet know enough about the nature of genetically modified organisms to be sure how they will behave in natural ecosystems. Nor do we understand how ecosystems work fully enough to be sure how introduction of genetically modified organisms, and over time, combinations of many modified organisms, will affect the health and the stability of our natural life-support systems. Consumers, who up to this point have derived few direct benefits from genetically modified crops, are generally open-minded about the technology, anticipating benefits, but also interested in ensuring that safety questions are carefully answered.

From the standpoint of policy, societies have an opportunity to learn from experience with chemicals, and to take another approach with genetically modified crops. The alternative approach would exercise more caution at the outset, take a more precautionary approach to risk assessment, and give more weight to the need to avoid future harm, without abandoning the many potential benefits food biotechnology has to offer.

Some of the most important food safety issues of the day cannot be resolved by relying on scientific data and traditional risk assessment methods. As our understanding of risk advances, we have learned that many questions about food-related risks cannot be answered with current knowledge. Precaution, sensibly applied, is one useful tool for making decisions of this nature.

A precautionary approach does not reject science and risk assessment. More accurately, it requires an even more rigorous use of science. It pays greater attention to what science does not know, and to the possible consequences of knowledge gaps, when assessing risks.

The growing emphasis on precaution also implies a shift in philosophy on some long-standing conflicts in societal values. One involves the concept of "burden of proof." For decades, new technologies have been presumed safe until proven harmful. Today, there is a growing tendency to place a greater burden on proponents of a new technology, to demand that risk questions be better identified and addressed, before innovations are widely adopted. This reflects social learning from past mistakes, and a greater sense of equity-an assertion that consumers, and future generations, have the right not to have risks imposed upon them without more discussion of who is benefiting, and of how much risk is acceptable.

The precautionary approach also implies a greater role for government, and less reliance on unbridled market forces, to chart the course of technology. It requires a conscious effort to look for alternative solutions to food-related technical problems, and to choose options with the best risk/benefit ratios. Attempts to "control" technology risk stifling innovation, and governments will proceed cautiously, seeking the right balance. But a better balance must be found than has prevailed for the past 50 years.

The international health community is now moving towards expanding use of precaution. I believe that this is the right direction, and that the trend will continue. I think most consumers would like to avoid repeating the history of chemical innovations, as the biotechnology revolution unfurls. We need to learn from our experience with chemicals, by reflecting objectively on what we still do not know about potential harm to our health and our planet from the myriad contaminants in our foods and our bodies. It is too late to "call back" dispersed chemicals, but not too late to prevent the release of potentially harmful transgenic organisms. Undoubtedly, we can do a better job of understanding what we need to know, and of gathering data to inform our decisions, before we release thousands of new organisms into the global environment.

Adopting a more precautionary approach to risk assessment will not be easy. In the Codex debate, simply defining the terms clearly enough to permit a trans-national, trans-cultural dialogue on this topic has proven exceedingly difficult. Sorting out science and value trade-offs is complicated enough, and in the international arena, national interests in promoting trade, private sector resistance to restrictions on markets, and other political factors have all confounded efforts to improve food safety risk analysis.

We also must recognize that the "right" balance point will differ for different societies, and that a developing country may choose to pursue the benefits of rapid economic growth, and be less precautionary about risks than a wealthy nation with mature technologies might prefer. An international consensus on the "right" amount of precaution may be nearly impossible to find.

As difficult as it will be to achieve, a more precautionary approach to risk assessment is essential to meet the food safety challenges of the 21st century, and I have faith that all involved will continue to pursue this critical goal.

1. Groth, E. (2000) Science, Precaution and Food Safety: How Can We Do Better? A discussion paper for the U.S. Codex Delegation. Yonkers, New York: Consumers Union of U.S., Inc. Available on the Internet at: http://www.consumersunion.org/food/codexcpi200.htm

2. Raffensperger, C. and J. Tickner, Editors (1999), Protecting Public Health & the Environment: Implementing the Precautionary Principle. Washington, D.C.: Island Press.

3. Stirling, A. (1999), On Science and Precaution in the Management of Technological Risk. Final report of a project for the European Commission Forward Studies Unit. University of Sussex, U.K., May 1999.

4. Commission of the European Communities (2000), Communication from the Commission on the Precautionary Principle. CEC COM (2000) 1. Brussels, 2 February, 2000. Available on the Internet at: http://europa.eu.int/comm/off/com/health_consumer/precaution.htm

5. United States Food and Drug Administration and United States Department of Agriculture (2000), Precaution in U.S. Food Safety Decision Making. Annex II to the United States' National Food Safety System Paper for the OECD. Available on the Internet at: http://www.foodsafety.gov/~fsg/fssyst4.html

6. Somogyi, A. (1999), Assuring Science-Based Decisions-Determining the Appropriate Level of Protection: Threshold of Regulations/Implementation. Paper presented at the Food and Agriculture Organization Conference on International Food Trade Beyond 2000: Science-Based Decisions, Harmonization, Equivalence and Mutual Recognition. Melbourne, Australia, 11-15 October 1999.

7. Somogyi, A. (1999), The Value of Science in Economical and Societal Progress and in Regulatory Decisions: A cis-Atlantic View. Paper presented at a Joint COMISA/ FEDESA seminar, "Science and Decision-Making, Risk And Precaution, Consumer Protection and Economical Progress: Contradictions?," Brussels, December 1999.

8. National Research Council (1993), Pesticides in the Diets of Infants and Children. Washington, D.C.: National Academy Press.

9. National Research Council (1999), Hormonally Active Agents in the Environment. Washington, D.C.: National Academy Press.

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