European Affairs

Although a standard definition of the principle does not exist, its thrust is that regulatory measures should prevent or restrict actions that raise even conjectural threats of harm to human health or the environment, even when there may be incomplete scientific evidence as to their potential significance.

This is sometimes represented as "erring on the side of safety." But applying the precautionary principle in too doctrinaire a way can erode the value of scientific risk analysis and actually increase risk.

Caution has much to recommend it, of course, and few would dispute that potential risks should be taken into consideration before proceeding with any new activity or product, whether it is the introduction of synthetic chemicals into the environment or a new drug into the pharmacy.

Advocates of the precautionary principle, however, focus mainly on the possibility that technologies could pose unique, extreme, or unmanageable risks. By doing so, they ignore that we already live in a world replete with risks - risks that must also be assessed, compared and managed.

For example, we tolerate moderate risks from fire trucks - which speed noisily through busy streets, emit toxic emissions into the air, and make use of chemical foams - because we judge the potential risks of fires to be much higher.

Putting it another way, what is missing from the precautionary principle is an acknowledgment that many technologies confer net benefits, even when they introduce new risks - that is, their use reduces many other, far more serious hazards. Examples include blood transfusions, x-rays, and automobile seat belts, all of which offer immense benefits and only minimal risk.

Perhaps it is human nature to fear the novel and to find comfort in the status quo, especially if the technology is arcane (e.g., nuclear fission) or perceived to be "tampering with nature" (genetic modification). Whatever the cause, governments are predisposed to over-regulate what is believed to be new or mysterious. Moreover, in industrialized societies, exposure to harmful products is widely publicized and condemned, while the opportunity costs of excessive restrictions go unnoticed. This creates an asymmetrical incentive structure in which governments are compelled to address the readily apparent harms from new products, while being free to discount the hidden risk reducing properties of unused technologies.

This problem is compounded in public policy, where majorities make binding, all or nothing decisions that leave little room for individual choice about which risks to assume voluntarily. The result is a lopsided decisionmaking process that is inherently biased against change and therefore against innovation.

Dr. Elizabeth Whelan of the American Council on Science and Health has observed that the precautionary principle "distracts consumers and policy-makers from known and proven threats to human health and ignores the fact that new regulations and restrictions may divert limited public health resources from genuine and far greater risks."

Consider, for example, the environmental movement's crusade to rid society of chlorinated compounds, which has extended even to opposing the chlorination of drinking water. By the late 1980s, environmental activists were attempting to convince water authorities around the world of the possibility that carcinogenic byproducts of chlorination made drinking water a potential cancer risk. Peruvian officials caught in a budget crisis used this supposed threat to public health as a justification to stop chlorinating much of their country's drinking water. According to infectious disease specialists, that decision to be "better safe than sorry" contributed to the acceleration and spread of Latin America's 1991-1996 cholera epidemic, which af§icted more than 1.3 million people and killed at least 11,000.

On its face, the precautionary principle seems innocuous enough - perhaps even to make sense. After all, one might think that a paradigm intended to restrict activities that pose potential threats to human health or the environment could be used to compel the adoption of a given technology just as easily as it could compel the interdiction of one. But, in practice the precautionary principle is invariably used as a rationale for restricting activities or products.

Bioethicist Gary Comstock and others have argued that, because it is not clear what the language of the precautionary principle actually requires of risk managers, "defenders of the principle should explain why its implications are not incoherent."

The European Commission sought to do just that in February 2000 when it issued a formal communication on use of the precautionary principle. Remarkably, in this attempt to impart greater clarity, the Commission specifically declined to define the principle, adding naively "it would be wrong to conclude that the absence of a definition has to lead to legal uncertainty."

Although reliance on regulatory agencies and courts to define and elaborate statutory policy is not unusual, this reluctance to define what purports to be a fundamental principle makes confusion and mischief inevitable, leaving innovators' legal rights and regulators' legal obligations subject to the wholly subjective and sometimes nefarious judgment of governments (or individual regulators).

As it is actually being applied, the precautionary principle provides no apparent evidentiary standards for "safety," and no procedural criteria for obtaining regulatory approval, no matter how much evidence has been accumulated. The precautionary principle allows overcautious, incompetent, corrupt, or politically motivated regulators to require any amount and kind of testing they wish, arbitrarily withholding or deferring approvals indefinitely.

In effect, regulators are given carte blanche to decide what is "unsafe" and what is "safe enough," with no means to ensure that their decisions actually reduce overall risk or that they make any sense at all. Contrary to the claims of its supporters, the precautionary principle tends to make governments less accountable, not more so, because its lack of definition allows regulators to justify any decision.

Publicly, advocates argue that the precautionary principle should not be invoked capriciously - such as using it in a futile attempt to attain zero risk or as a cover for hidden protectionism. But the precautionary principle's vagueness and its failure to require the comparison of competing risks permit - even encourage - its being used in exactly that way.

In the chlorinated drinking water case described above, for example, we cannot know for certain whether the Peruvian health officials were legitimately motivated by a concern for public health, or whether the potential chlorine cancer link was simply a convenient excuse to spend less money on sanitation.

If the first is true, they are guilty of incompetence; if the second, negligence bordering on the criminal. Either way, the decision was bereft of science - without proper consideration of the risk reducing properties of water chlorination.

Hoping to de§ect such criticism of the precautionary principle, the European Commission's communication stipulated that regulatory measures taken under its auspices should be "proportional," "nondiscriminatory," and "consistent"; that decisionmakers should carefully weigh "potential benefits and costs"; and that decisions should be "subject to review in the light of new scientific data."

David Byrne, the Commissioner responsible for health policy, repeated all these points in his contribution to the Spring 2000 issue of European Affairs, asking, "How could a Commissioner for Health and Consumer Protection reject or ignore well founded, independent scientific advice in relation to food safety?"

Mr. Byrne should know. The ongoing dispute between the Commission and the United States and Canada over restrictions on hormone-treated beef cattle is a case in which the Commission is doing just that. The Commission argues that the precautionary principle permits the restriction of imports of U.S. and Canadian beef from cattle treated with certain growth hormones.

A scientific committee assembled by a World Trade Organization dispute resolution panel found that even the scientific studies cited by the Commission in its own defense did not indicate a safety risk when the hormones in question were used in accordance with good animal husbandry practices.

Nevertheless, the Commission continues to enforce restrictions on hormone-treated beef, a blatantly unscientific and protectionist policy that belies the Commission's protestations that the precautionary principle will not be abused.

Another example of abuse pertains to the Commission's commitment to apply the precautionary principle in a nondiscriminatory manner - an easy promise to make, but one frequently broken. The most egregious example is surely the Commission's regulatory approach to gene-spliced, or genetically modified (GM), foods.

The results of scientific investigations into the risk inherent in gene-splicing are unequivocal. Dozens of scientific bodies, including the UK's Royal Society, the U.S. National Academy of Sciences, the World Health Organization and the American Medical Association, have performed analyses of the oversight that is appropriate for GM organisms (GMOs), with remarkable congruence in their conclusions:

  • The newer molecular techniques for genetic improvement are an extension, or refinement, of earlier, far less precise ones;
  • Adding genes to plants does not make them less safe either to the environment or to eat;
  • The risks associated with GMOs are the same in kind as those associated with unmodified and conventionally-modified organisms; and
  • Regulation should be based upon the risk-related characteristics of individual products, regardless of the techniques used in their development.

Nevertheless, virtually all domestic and international regulators treat gene-spliced plants and microorganisms in a discriminatory fashion. The fact and degree of regulation are determined solely by the production methods.

For example, GM herbicide-tolerant crop plants such as soya and rapeseed are subject to lengthy, hugely expensive mandatory testing and premarket evaluation, while plants with similar properties, but developed with selection, hybridization, or induced mutation techniques, are exempt from such requirements.

Above and beyond even these extraordinary regulatory requirements, the European Commission has imposed a de facto moratorium on new GM product approvals, the rationale for which is the precautionary principle. Yet far less is known about the biological basis for the herbicide tolerance trait in conventional varieties, and their potential impacts on human health or the environment, than is known about the gene spliced varieties.

Other examples of scientifically unjustifiable GMO regulation based on the precautionary principle can be found at the national level all around the world, particularly in Western Europe. A few examples:

  • Since 1997, Austria and Luxembourg have enforced a ban on certain GM maize varieties that have been approved by the Commission for cultivation throughout the European Union.
  • In 1998, the highest French court suspended commercialization of three GM maize varieties, although the French government had supported approval for those varieties at the EU level just two years earlier.
  • In November 1999, the UK government announced a moratorium on commercial growth of GM crops, pending a three-year program of farm-scale evaluations to assess environmental impacts. But due to poor security provided to farmers participating in these trials, anti-GM activists routinely destroy GM test crops, and many farmers are dropping out of the program.
  • In February 2000, Germany rescinded the license for field-testing a GM maize variety against the recommendation of the German Central Commission for Biological Safety. This decision was made a single day before the agriculture ministry was due to approve the variety for commercial cultivation. In August 2000, the Italian government suspended the commercialization of four GM maize varieties because of alleged concerns about potential health risks, even though a report from the Italian National Institute of Health found that "there is no reason to believe that a risk for human or animal health could ensue from the consumption of products derived from the GM plants in question."
  • In perhaps the most egregious and preposterous recent case, since July 2000 the Italian agriculture ministry has declined even to permit field trials to test the safety of GM plants.

The burden of proof has been set much higher for GM technology than for conventional plant breeding. And as these cases show, even when that burden of proof is met, regulators frequently remain unsatisfied.

Even in major agricultural exporting nations such as Australia, Canada, and the United States - which are sometimes derided by Europeans as embracing agricultural technologies with reckless abandon - precautionary regulation has resulted in unscientific, discriminatory policies that inhibit development of new products, waste resources, threaten agricultural research, and restrict consumer choice.

Nevertheless, widespread use of modern agricultural practices in those countries, including widespread cultivation of GM plants, has allowed productivity to soar. Perhaps more important from an environmental perspective, the tremendous productivity improvements of the Green Revolution and Gene Revolution have allowed more food to be produced on less land, saving millions of hectares of wildlife habitat and protecting biodiversity.

Moreover, the use of gene-spliced plants with enhanced pest- or disease-resistance has reduced farmers' need to use chemical pesticides, reducing runoff into waterways and the exposure of workers who manufacture, transport and apply these chemicals. These are the types of tangible environmental and health benefits that invariably are given little or no weight in precautionary risk calculations.

Any regulatory framework that hopes to achieve net risk reduction and promote overall social benefit must recognize that whilst there are risks in testing and using a new product or technology, there may also be risks in slowing or preventing its appearance - and that the degree of oversight should be commensurate with risk.

As it is being applied, however, the precautionary principle meets neither of these conditions. It increases societal risks, and eventually will also increase public cynicism about the motives and performance of government.


This article was published in European Affairs: Volume number II, Issue number II in the Spring of 2001.