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By Root 1204 0

The FDA uses this approach for food additives characterized as “generally recognized as safe” (GRAS) and also, with some modifications, for genetically engineered foods. If problems occur, the agency deals with them after the foods are marketed. This approach requires neither premarket testing nor labeling; it is based on a standard that requires food manufacturers to demonstrate “reasonable certainty of no harm.” This standard, which translates as “safe enough to be acceptable,” leaves plenty of room for subjective opinion and judgment.

An alternative approach is one that has come to be known as the principle of precautionary action, or the “precautionary principle.” This principle, which emerged in Europe as a guideline for environmental protection, can be summarized as “look before you leap,” meaning test the products first, then introduce them into the marketplace. Although this approach may seem so sensible as to be politically neutral, it is nothing of the kind. As the European Commission explains:

Decision-makers are constantly faced with the dilemma of balancing the freedom and rights of individuals, industry and organizations with the need to reduce the risk of adverse effects to the environment or to health. . . . Whether or not to invoke the Precautionary Principle is a decision exercised where scientific information is insufficient, inconclusive, or uncertain and where there are indications that the possible effects on the environment or human, animal or plant health may be potentially dangerous and inconsistent with the chosen level of protection. . . . The appropriate response in a given situation is thus the result of a political decision, a function of the risk level that is “acceptable” to the society on which the risk is imposed.31

In practice, invocation of the precautionary principle can be used to require companies to demonstrate that foods are safe before they are marketed. As we have seen, the EPA followed this principle to some extent when it ruled that StarLink could not enter the human food supply. On the basis of such precautions, the European Union banned American and Canadian beef from cattle treated with growth hormones and delayed introduction of genetically modified crops. Thus, the precautionary principle has implications for international trade as well as domestic food policy and has become a major rallying point for advocates who favor environmental protection or oppose food biotechnology.32 In January 1998, for example, a group of such advocates met in Wingspread, Wisconsin, to formulate what is now known as the Wingspread statement on the precautionary principle: “When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context, the proponent of the activity, rather than the public, should bear the burden of protection.”33

As a result of such advocacy, international agreements increasingly incorporate the precautionary principle in policy statements. For example, European and United States experts on food biotechnology issued a joint statement in 2000 saying, “When substantive uncertainties prevent accurate risk assessment, governments should act protectively on the side of safety.”34 Even so mild a statement suggests that companies will have to do more to demonstrate safety in advance. But because testing can never prove that a food is perfectly safe, public willingness to accept a new food depends on how well it meets the value concerns summarized in table 2. If a food ranks high in dread and outrage, it will never appear safe enough, no matter how much effort goes into attempts to prove it harmless.

In their frustration with dread-and-outrage factors, industry leaders and their supporters argue that no matter what they do, they will never be able to satisfy opponents. Instead, they argue, the true purpose of the precautionary principle is to inhibit business. Elizabeth Whelan, who directs the industry-sponsored American Council