The precautionary principle often materializes as a justification for excluding biotechnology products from the marketplace. For instance, the German government used the precautionary principle as the rationale for banning the commercial-scale cultivation of Bt corn by Novartis, and the European Union cited the precautionary principle as the reason for delaying approval of genetically engineered crops for sale in European markets. On an international level, the precautionary principle appears, implicitly or explicitly, in various charters, declarations, and treaties.

The conceptual core of the precautionary principle seems to be that precautions should be taken, even if a cause-and-effect relationship between an activity and harm to the environment (or to human health) has yet to be established scientifically. An underlying mandate of the precautionary principle is that, in the face of scientific uncertainty, a party should refrain from actions that might harm the environment, and that those who oppose this prohibition have the burden of proof for assuring the safety of the proposed action.

A significant problem in implementing the precautionary principle as a policy tool arises from the extreme variability in its interpretation, with approaches ranging from eco-centric and risk-averse to utilitarian and risk-taking. In addition, a basic, unresolved question about the precautionary principle concerns the amount of evidence (or lack thereof) needed to invoke it. Should evidence of "likely harm" or "serious or irreversible harm" trigger the principle? As one observer notes, the precautionary principle has deviated from a strong mandate for precautionary action toward a universal sentiment, with little guidance on practical implementation.

Earlier this year, the Commission of the European Communities issued a report outlining its approach for implementing the precautionary principle. In the Commission's view, precautionary measures should be nondiscriminatory in application, consistent with measures taken under similar circumstances, subject to cost-benefit analyses, and reviewed in light of new scientific evidence.

Certain current manifestations of the precautionary principle present a challenge to a scientifically based process of risk assessment. The European Commission's approach, which expressly blends precautionary measures with scientific analysis, may well lay a foundation for the future development of a generally acceptable view of the precautionary principle. It is unclear, however, whether any particular formulation of the precautionary principle, no matter how balanced and well reasoned, could become embraced as an international standard.

One of the prerequisites for effective implementation of a treaty that includes a precautionary principle directive is the definitive interpretation of the principle in terms of practical measures. Without such interpretation, the principle would remain as a token statement of belief. However, the perception of risk, the very trigger for invoking the precautionary principle, varies between populations of various countries, and between groups within a particular country. To take one example, several studies indicate that qualitative factors of risk, other than the magnitude of the probability of an adverse outcome, influence consumer acceptance of foods produced using biotechnology.

Consequently, an implementation of the precautionary principle can only be practicable when stakeholders collaborate at the national level to make a decision in a particular context. This process requires an identification of those levels of damage deemed tolerable to that society. In other words, the precautionary principle will be put into practice according to predominant national values. Since the presumption of the precautionary approach is that a precautionary action must be taken despite a lack of full scientific information, policy decisions will be based, predominantly, upon ethical, moral, or political grounds. As the European Commission notes, establishing an acceptable level of risk for society is a political responsibility.

One reason for the popularity of the precautionary principle is that it reflects the current mood of distrust of technologies perceived to be risky and forced on a naive public by commercial interests aligned with governments. Both the European Commission and U.S. officials contend that decision- making procedures should be transparent and should involve all interested parties. A process that treats uncertainty in an open manner, rather than dismissing or downplaying it, may begin to address concerns that fuel the popularity of the precautionary principle. In the long run, dealing with the underlying apprehensions that have fostered the precautionary principle may be more practical than attempting to devise a formulation intended to fit all nations.

(1) Excerpted and revised from Jones, P. B. C. (2000). "The Precautionary Principle: Legal Doctrine or Rorschach Inkblot Test?" Information Systems for Biotechnology News Report.

References

Commission of the European Communities. (2000). Communication from the Commission on the Precautionary Principle.

Knoppers B.M. and A. Mathios (eds.). (1998). Biotechnology and the Consumer. Dordrecht, the Netherlands: Kluwer Academic Publishers.

Raffensperger C. and J. Tickner (eds.). (1999). Protecting Public Health and the Environment: Implementing the Precautionary Principle. Washington, D.C., USA: Island Press, Inc.

VanderZwaag, D. (1997). CEPA and the precautionary principle/approach.

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