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Published in Nature Biotechnology<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
April 2001 Volume 19 Number 4 pp 302 - 303
Remember the admonition not to believe a bureaucrat who claims that "I'm from the government and I'm here to help you"? Well, government regulators now have a more subtle, updated version of that assertion: a wolf in sheep's clothing called the "precautionary principle". It has already laid waste to several industries and boasts a body count in the tens of thousands. It is now being used to cripple public sector and academic researchers as well as the biotechnology industry.
Although a widely accepted 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, although there may be incomplete scientific evidence as to their potential significance. Several European countries have used the precautionary principle to justify paralyzing restrictions on agricultural and food biotechnology, and the European Commission (EC) has invoked it to justify a moratorium on the approval of new recombinant DNA-modified products1.
Use of the precautionary principle is sometimes represented as "erring on the side of safety". But we believe the way it is typically applied to research and development and to commercial products can actually increase risk.
Potential risks should be taken into consideration before proceeding with any new activity or product, whether it is the choice of site for a power station or the introduction of a new drug into the pharmacy. But advocates of the precautionary principle focus primarily on the possibility that technologies could pose unique, extreme, or unmanageable risks. What is missing from the precautionary calculus is an acknowledgment that even when technologies introduce new risks, most confer net benefits; that is, their use reduces many other, far more serious hazards. Examples include blood transfusions, magnetic resonance imaging (MRI) scans, and automobile air bags, all of which offer immense benefits and only minimal risk.
The real danger of the precautionary principle is that it distracts consumers and policymakers from known, significant threats to human health and often diverts limited public health resources from those genuine and far greater risks. Consider, for example, the environmental movement's misguided crusade to rid society of all chlorinated compounds.
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. That decision contributed to the acceleration and spread of Latin America's 1991-1996 cholera epidemic, which afflicted more than 1.3 million people and killed at least 11,0002.
Anti-chlorine campaigners more recently have turned their attacks to phthalates, liquid organic compounds added to certain plastics to make them softer. These soft plastics are used for important medical devices, particularly fluid containers, blood bags, tubing, and gloves; children's toys, such as teething rings and rattlers; and household and industrial items, such as wire coating and flooring. Waving the banner of the precautionary principle, activists claim that phthalates could have numerous adverse health effects-even in the face of significant scientific evidence to the contrary3. Governments have taken these unsupported claims seriously, and several formal and informal bans have been implemented around the world. Industry has been stymied, consumers denied product choices, and doctors and their patients deprived of lifesaving tools.
During the past few years, skeptics began more intensively to scrutinize the precautionary principle. In response to those assessments, the EC, a prominent user and abuser of the precautionary principle, last year published a formal communication to promote the legitimacy of the concept4. The EC resolved that, under its auspices, precautionary restrictions would be "proportional to the chosen level of protection," "non-discriminatory in their application," and "consistent with other similar measures." The commission also avowed that EC decision makers would carefully weigh "potential benefits and costs." But all of these stipulations have been flagrantly ignored or abused in the commission's regulatory approach to recombinant DNA-modified-or in their argot, "genetically modified" (GM)-foods.
Dozens of scientific bodies, including the UK's Royal Society, the US National Academy of Sciences, the World Health Organization, and the American Medical Association have analyzed the oversight that is appropriate for gene-spliced organisms and arrived at remarkably congruent conclusions: The newer molecular techniques for genetic improvement are an extension, or refinement, of earlier, far less precise ones; adding genes to plants or microorganisms does not make them less safe either to the environment or to eat; the risks associated with recombinant DNA-modified organisms are the same in kind as those associated with conventionally modified organisms; and regulation should be based upon the risk-related characteristics of individual products, regardless of the techniques used in their development.
Notwithstanding the EC's promises that the precautionary principle would not be abused, regulators treat recombinant DNA-modified plants and microorganisms in a discriminatory and inconsistent fashion, and without proportionality to risk. Both the fact and degree of regulation turn on the use of certain production methods-that is, on whether recombinant DNA techniques have been used-regardless of the level of risk posed by individual products.
For example, recombinant herbicide-tolerant crop plants, such as soybeans and canola, are subject to lengthy, hugely expensive mandatory testing and pre-market evaluation, whereas plants with virtually identical properties but developed with older, less precise genetic techniques are exempt from such requirements. In the United States, Department of Agriculture requirements for paperwork and field trial design make field trials with gene-spliced organisms 10-20 times more expensive than the same experiments with virtually identical organisms that have been modified with conventional genetic techniques5.
The real-world impacts of this wholly disproportionate approach are instructive. If a student doing a school biology project takes a packet of "conventional," but genetically improved, tomato or pea seeds to be irradiated at the local hospital and plants them in his backyard in order to investigate interesting mutants, he need not seek approval from any local, national, or international authority. However, if the seeds have been modified by the addition of one or a few genes by recombinant DNA techniques, this would-be researcher (or equivalent highly skilled agricultural scientists) faces a mountain of bureaucratic paperwork and expense.
Not only does this discrimination flaunt the scientific consensus about the essential continuity between the traditional and molecular genetic improvement of plants, but it also ignores the fact that recombinant DNA technology is more precise and predictable and the modifications far better characterized than with other techniques. Logical application of the precautionary principle to situations of scientific uncertainty would dictate that greater precaution apply to the cruder, less precise, less predictable "conventional" forms of genetic modification. Instead, by torturing the precautionary principle, regulators have chosen to set the burden of proof far higher for recombinant DNA technology than for conventional plant breeding. And, as the EC's moratorium on new product approvals demonstrates, even when that extraordinary burden of proof is met through unprecedented amounts of testing and evaluation, regulators frequently declare themselves unsatisfied.
Remarkably, although the EC characterized its communication on the precautionary principle as an attempt to impart greater consistency and clarity, it specifically declined to define the principle, adding naively that "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 even individual regulators.
As it is being applied, the precautionary principle provides neither evidentiary standards for "safety" nor procedural criteria for obtaining regulatory approval, no matter how much evidence has been accumulated. 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.
In spite of the assurance of the European Union and other advocates of precautionary regulation to the contrary, regulators of biotechnology applied to agriculture and food production seldom consider the potential risk-reducing benefits of new technologies. For example, the use of recombinant DNA-modified plants with enhanced pest or disease resistance has reduced farmers' use of chemical pesticides, reducing runoff into waterways, and the exposure of workers who manufacture, transport, and apply these chemicals. It has also permitted farmers to more widely adopt environment-friendly, no-till farming practices. And recently developed rice varieties enhanced with pro-vitamin A and iron could drastically improve the health of hundreds of millions of the malnourished in developing countries. These are the kinds of tangible environmental and health benefits that have been given little or no weight in precautionary risk calculations.
But benefits aside, the safety of this new technology is not really in doubt. Both theoretical and empirical evidence shows the extraordinary predictability and safety of gene-spliced organisms. Recombinant DNA-modified plants are now grown worldwide on more than 100 million acres annually, and more than 60% of processed foods in the United States contain ingredients derived from recombinant organisms. There has not been a single mishap resulting in injury to a single person.
For anti-biotechnology activists, the deeper issue is not really safety at all. Often, the controversies over the testing and use of gene-spliced organisms-and in particular, the metastasis of the precautionary principle-stem from a social vision that is not just strongly anti-technology, but one that poses serious challenges to academic, individual, and corporate freedom.
In the western democratic societies, we enjoy long traditions of relatively unfettered scientific research, except in the very few cases where bona-fide safety issues are raised. (An example with contemporary relevance is the ban on research using live foot-and-mouth disease virus in the mainland United States.) Traditionally, we shrink from permitting small, authoritarian minorities to dictate our social agenda, including what kinds of research are permissible and which technologies and products should be available in the marketplace. Thus, for remarkably well-behaved recombinant DNA technology, a refinement of earlier techniques, it is beside the point whether the purpose of investigating a new plant variety or microorganism is to test a scientific hypothesis or a marker gene, to produce a more elegant rose, to offer a marginal improvement for purposes of downstream processing, or to improve the lot of malnourished children.
It is precisely the anti-technology nature of the precautionary principle that makes it the darling of many non-governmental organizations. Greenpeace, one of the principal advocates of the precautionary principle, wrote in its 1999 Internal Revenue Service filings that the organization's goal is not the prudent, safe use of recombinant DNA-derived foods or even their labeling; rather, they demand nothing less than these products' "complete elimination [from] the food supply and the environment."6 Many of these groups do not merely proselytize for illogical and stultifying regulation or outright bans on product testing and commercialization; they advocate and carry out vandalism of field trials.
Carolyn Raffensperger, executive director of the Science and Environmental Health Network, a consortium of radical groups, asserts that the precautionary principle "is in the hands of the people," as illustrated, according to her, by violent demonstrations against economic globalization, such as those in Seattle at the 1999 meeting of the World Trade Organization7. "This is [about] how they want to live their lives," says Raffensperger.
In our view, it's really about how a small, vocal, violent group of radicals wants to dictate to the rest of us how we should live our lives. In other words, the issue here is freedom and its infringement by ideologues who disapprove, on principle, of a certain technology. But bullies should not be permitted to use untruths, conspiracy, and violence to oppose legitimate research into technologies that can improve our safety and well-being. We should no longer allow extremists to dictate the terms of the debate.
1.Hodgson, J. Nature Biotechnol. 18, 918-919 (2000). 2.Anderson, C. Nature 354, 255 (1991). | PubMed | 3.Durodié, W. Poisonous Propaganda: Global Echoes of an Anti-Vinyl Agenda (Washington DC: Competitive Enterprise Institute, 2000). 4.European Commission. Communication From the Commission on the Precautionary Principle (Brussels: February 2, COM 1, 2000). 5.Huttner, S.L., Miller, H.I. & Lemaux, P.G. US
Biotechnology: Status and Prospects. Technological Forecasting and Social Change 50, 25-39 (1995). 6.Greenpeace. 1999 Federal Income Tax Filing with the U.S. Internal Revenue Service: IRS Form 990, Part III, Statement of Program Service Accomplishments, "Genetic Engineering." 7.Appell, D. Sci. Am. 284, 18-19 (2001).
Henry I. Miller (e-mail: firstname.lastname@example.org ) is a fellow at the Hoover Institution, Stanford, CA, 94305 and the author of Policy Controversy in Biotechnology: An Insider's View. Gregory Conko (e-mail: email@example.com ) is director of food safety policy at the Competitive Enterprise Institute, Washington, DC 20036.
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