Reprinted with permission by the Washington Legal Foundation. For more information, please see www.wlf.org.
Agricultural biotechnology is under attack around the world by activists and government officials who see regulation as a growth industry. Opponents of the technology raise the specter of various potential threats to the environment and human health — assertions that are supported by neither the weight of evidence nor the judgments of the scientific community. Nevertheless, anti‑biotech campaigners represent a growing political force. They advocate new legal standards for the evaluation of new technologies, which threaten technological progress and deny its benefits to consumers.
A Gap Between Science and Regulation. The discovery of gene‑splicing (recombinant DNA) techniques some thirty years ago was heralded as a signal advance for the future of medicine, agriculture and other applications. Foods and pharmaceuticals developed with this new biotechnology have been available in the U.S. for nearly two decades. During that time, a wide consensus has grown in the scientific community that because gene‑splicing is more precise and predictable than older techniques of genetic modification — such as selection and cross‑breeding — it is at least as safe. In its highly regarded 1987 report, the National Academy of Sciences concluded that “the risks associated with the introduction of [gene‑spliced] organisms are the same in kind as those associated with unmodified organisms and organisms modified by other methods.” It also found that judgments about safety should be based upon the specific characteristics of each individual product, not upon the methods used to develop it. In subsequent reports released in 1989 and in April of this year, the NAS reiterated its support for those earlier findings.
Nevertheless, the United States and many foreign nations have developed regulatory systems that single out gene‑spliced products for heightened scrutiny and discriminatory treatment, regardless of the level of risk individual products pose. In the United States, Environmental Protection Agency regulations have unnecessarily inflated the costs of developing of gene‑spliced plants and microorganisms and have stifled much commercial and, especially university‑based research. They have all but destroyed the once‑promising development of “biorational” microbial pesticides and of gene‑spliced microbes for remediation of toxic wastes, by making it vastly more difficult and expensive to test new products outside laboratories and greenhouses. U.S. Department of Agriculture regulations, which have admittedly been less stifling, are similarly biased against gene‑spliced products. Among domestic regulatory bodies, only the Food and Drug Administration (FDA) once stood as a counter to this general trend. Though forces within the FDA have at times been antagonistic to biotechnology, the agency’s official policy has tended to treat gene‑spliced foods cautiously but fairly. Unfortunately, the FDA recently announced a change in policy that will begin treating gene‑spliced foods in A discriminatory fashion.
Internationally, the regulatory situation is even worse. Regulations developed by many foreign countries and various agencies of the United Nations single out gene‑splicing for at least heightened scrutiny, and sometimes bans and moratoria. These rules are frequently rationalized on the basis of the unscientific “precautionary principle,” which states that regulatory action ought to be taken to avoid a risk even when there is incomplete scientific evidence as to its magnitude or potential impacts. In practice, it has been interpreted to mean that a technology should not be used unless and until it has been shown to be absolutely safe. This means that the usual burden of proof is reversed. New technologies are thus assumed to be guilty until their innocence can be proven to a standard demanded by their critics — in most cases, a practical impossibility. Dr. Elizabeth M. Whelan, president of the American Council on Science and Health, aptly sums up the shortcomings of the precautionary principle:
First, it always assumes worst‑case scenarios. Second, it distracts consumers and policy makers alike from the known and proven threats to human health. And third, it assumes no health detriment from the proposed regulations and restrictions. By that I mean that the precautionary principle overlooks the possibility that real public health risks can be associated with [expending resources on] eliminating minuscule, hypothetical risks.
When applied to agricultural and food biotechnology, the precautionary principle focuses solely on the possibility that new products may pose theoretical risks. But this standard ignores the very real, existing risks that could be mitigated or eliminated by those products. Applying the precautionary principle in this way often results in increasing — not decreasing — overall risk. For example, if the precautionary principle had been applied decades ago to innovations like polio vaccines and antibiotics, regulators might have prevented occasionally serious, and sometimes fatal, side effects by delaying or denying approval of those products, but that precaution would have come at the expense of millions of lives lost to infectious diseases.
Using the precautionary principle as justification, half a dozen UN programs and agencies have targeted biotechnology with a sweeping array of burdensome new regulations. The UN’s major regulatory initiatives relating to biotechnology are contained within the Cartagena Protocol on Biosafety, finalized at a meeting in Montreal in January 2000. The goal of these regulations is ostensibly to ensure that the development and use of gene‑spliced organisms are undertaken in a manner that prevents or reduces the risks to biological diversity and human health. But even a cursory examination of the protocol shows that the agreement has less to do with legitimate concerns about public health and the environment, and more to do with trade protectionism and pandering to anti‑technology ideology. In the name of enhancing biodiversity and habitat conservation, the biosafety protocol establishes the framework for a precautionary regulatory regime over nearly all international shipments of gene‑spliced agricultural products.
In Europe, the precautionary principle is becoming an ever more popular excuse to limit the introduction of new technologies. In February 2000, just days after the biosafety protocol was finalized, the German government decided capriciously to block the commercial‑scale cultivation of a gene‑spliced corn variety by the biotechnology company Novartis. This action came one day before the new variety was expected to be approved for commercial use by the Ministry of Agriculture, which specifically cited the need to respect the precautionary principle and called for more research into the crop plant’s potential hazards.
Ironically, many of the products of the new biotechnology would offer environmental benefits, such as crop plants that have greater yields and require less agricultural chemicals, biological alternatives to chemical pesticides, and various biological methods of cleaning up toxic wastes and purifying water. But as a result of the excessive new rules, researchers around the world will see their regulatory expenses skyrocket and their potential markets shrink. What will expand are opportunities for corruption among regulatory officials because application of the precautionary principle essentially gives regulators carte blanche to require as much or as little testing as they see fit. The precautionary principle’s great appeal to regulators stems precisely from its ambiguity and arbitrariness.
Furthermore, the precautionary principle provides ample opportunity for protectionism‑minded politicians to thwart competition and extract concessions from biotech researchers. While its proponents publicly argue that the precautionary principle should not be used as a disguised form of protectionism, there is no clearly defined evidentiary standard that could be used to satisfy demands for an assurance of “safety.” Nor is there any procedural safeguard in the biosafety protocol — or any other document that incorporates the precautionary principle — that would serve to mitigate such disguised protectionism. Under this new standard of evidence, which European officials have warmly embraced and implemented, regulatory bodies are free arbitrarily to withhold approvals indefinitely.
Growing Threat to Science‑Based Regulation. These unsavory developments leave only the World Trade Organization (WTO) as a defense against protectionism and corrupt regulators restricting trade. Historically, the WTO has been one of the few international defenders of scientifically‑sound risk regulation. It should come as no surprise, therefore, that the mechanisms under which the WTO evaluates human health and environmental safety regulations are also under assault. In order to make the world safe for the deployment of the precautionary principle against free trade, anti‑technology activists are trying to undermine the WTO by writing the precautionary principle into another set of international food safety standards drafted by the Codex Alimentarius Commission, a joint program of the UN’s World Health Organization and Food and Agriculture Organization. Parties to the Codex are not directly bound by its regulatory guidelines, but the WTO tends to defer to Codex principles for guidance on acceptable regulatory decisions. Therefore, Codex measures have a great influence on international trade.
Recently, the Codex Alimentarius Commission established a working group specifically to consider the need for special rules related to biotechnology and food. The first meeting, held in March 2000, began auspiciously, with Codex Chairman (and U.S. Department of Agriculture official) Thomas J. Billy, defending biotechnology and arguing that the risk‑based characteristics of a new product are the most important determinant of the necessary level of scrutiny, not the production techniques used. Unfortunately, this scientific approach was not heard from again. Instead, the group moved deliberately toward circumscribing only food products made with gene‑splicing for various Draconian and even bizarre regulatory procedures and requirements without objection from the U.S. delegation. The creation of obstacles was, of course, exactly the agenda of many of those assembled. Motivations vary: The Europeans want to stop gene‑spliced products because they’re mostly made by American companies, and the radical environmental activists (who are permitted to participate in Codex meetings) are ideologically opposed to new technology. Their opposition to biotechnology was nothing new.
The reasons for the lack of objection or direction from the us delegation was apparently domestic politics – namely, an imminent change in the United States’ own policy. The FDA announced in May a new policy that reverses both its scientific approach to food regulation, and a twenty‑year old commitment not to discriminate against biotechnology‑derived foods and pharmaceuticals. Thousands of biotech foods in U.S. supermarkets have been regulated under the FDA’s 1992 policy on products from “new plant varieties,” which defined certain potentially hazardous characteristics of new foods that, if present, required greater scrutiny by the agency, and which could have resulted in additional testing and labeling, or banishment from commerce. But this policy applied irrespective of whether the plant arose by gene‑splicing or conventional methods of genetic modification. Thus, the agency’s approach conformed with the scientific consensus on gene‑spliced foods and with the fundamental principle that the degree of scrutiny should be commensurate with risk. The FDA’S recent reversal in policy, however, singles out gene‑spliced foods for the sort of discriminatory oversight that the agency once opposed. The impending change in domestic regulatory policy tied the U.S. delegation’s hands at the Codex meeting and will continue to do so in other important international forums.
High Cost of the New Regulatory Burdens. Excessive international regulation imposes significant burdens on trade in gene‑spliced foods. Its greatest effect, however, will be to slow dramatically the pace of technological progress in the impoverished regions around the world most in need of lower‑input, more robust and nutritious crop plants. Agricultural biotechnology is particularly vulnerable, because the required case‑by‑case regulatory review removes an important tool of crop breeders: the ability to test large numbers of new varieties in field trials readily and rapidly. In traditional plant breeding, an individual breeder of corn, soybean, wheat, or potato commonly tests tens of thousands of distinct new genetic variants each year. But the protocol’s stultifying regulation will prevent this level of research activity for genetic variants developed with the newest and most precise techniques.
Ill‑conceived public policy already has exacted a high price. The inflated costs of research and development make it harder for academic and charitable institutions to sponsor research targeted at poor subsistence farmers and consumers. Agricultural biotechnology, touted in the 1970s as promising to increase food productivity in the developing world, has increasingly become a boutique technology applied primarily to large commodity crops, and focused on making high‑value‑added products useful mainly to farmers in industrialized countries. Furthermore, many small agricultural biotechnology companies have failed under the weight of burdensome regulation. Many more have had to merge with large firms in order to remain competitive. In contrast to the biopharmaceutical sector, there are actually fewer agricultural biotech companies in the United States now than a decade ago. The result of such consolidation is reduced competition and innovation. Ultimately, consumers will pay inflated prices for overregulated products and higher taxes to support bloated bureaucracies, and they will have fewer options in the marketplace.
Myopic regulatory decisions have real costs for citizens of the U.S. and other nations. It is these citizens who continue to underwrite both the direct and indirect expenses of ultimate compliance with the new regulations. And in the longer term, the added expense of unnecessary regulations will serve as a potent disincentive to research and development, especially on the kinds of low value‑added products used in agriculture in general and subsistence farming in particular. The result will be that many countries will become no more than hungry spectators to the revolution in agricultural biotechnology.
More than one billion people in the world now live on less than a dollar a day, and hundreds of millions are severely malnourished. By increasing the efficiency of agriculture and food production in myriad ways, gene‑spliced products can significantly increase the availability and nutritional value of foods and reduce their cost. But the application of the precautionary principle will stall progress and exact a substantial human toll. The huge stakes — both in human and commercial terms — demand that regulators instead create scientifically sound, risk‑based frameworks for the regulation of biotechnology.
Henry I. Miller is a Senior Research Fellow at Stanford University’s Hoover Institution, and from 1989 to 1994 he served as director of the U.S. Food and Drug Administration’s Office of Biotechnology. Gregory Conko is Director of Food Safety Policy at the Competitive Enterprise Institute in Washington, D.C.
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