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The precautionary principle: an 'unprincipled' approach to biotechnology regulation

A tenet of administrative law, particularly in the United States, is that regulators must base their decisions on 'intelligible principles' to provide consistency, predictability, transparency and accountability. The precautionary principle, which purports to provide a new decision rule for making environmental decisions under conditions of uncertainty, fails to provide such an intelligible principle for making decisions. The precautionary principle is ambiguous on the use of the two major criteria currently used to make environmental decisions - significant risk and cost-benefit balancing - yet offers no new specific decision criteria in their place. The second fundamental problem with the precautionary principle is that it is based on the unsubstantiated premise that the current regulatory system is insufficiently protective. The current system already tends to err on the side of the safety, as it should, but the relevant question is just how precautious should we be? As illustrated by the example of genetically modified organisms, the prudent level of precaution depends on factors such as the magnitude, distribution and uncertainty of risks, the extent of exposure, and the trade-offs and lost benefits in foregoing the risk. These are precisely the factors that are considered under the current risk-based approach, which the precautionary principle seeks to replace.