REGULATION:
The U.N., Biotechnology, and the Poorest of the Poor

By Henry I. Miller and Gregory Conko

How the U.N.’s systematic sacrifice of science, technology, and sound public policy to its own bureaucratic self-interest obstructs technological innovation and hurts the poorest of the poor. By Henry I. Miller and Gregory Conko.

The United Nations is best known for its peacekeeping efforts, but it is also involved in myriad other activities, from promoting human rights and the health of children to preserving rain forests and preventing desertification. Many in the scientific and public health communities, however, find it disturbing that respect for well-recognized principles of science and regulation appears to be an alien concept to many U.N. policymakers, whose deliberations frequently are unduly influenced by radical activists.

The U.N.’s systematic sacrifice of science, technology, and sound public policy to its own bureaucratic self-interest obstructs technological innovation that could help the poorest of the poor. In particular, the U.N.’s involvement in the excessive, unscientific regulation of biotechnology—also known as gene-splicing, or genetic modification (GM)—slows the progress of essential agricultural research and development and promotes environmental damage. Ultimately, such regulation will prevent the diffusion of the technology to less-developed countries and thereby prolong famine and water shortages for millions in those countries, as well as hasten the destruction of valuable ecosystems as low-productivity farmers are forced to increase the amount of acreage under cultivation.

During the past decade, delegates to the U.N.-sponsored Convention on Biological Diversity negotiated a “biosafety protocol” to regulate the international movement of gene-spliced organisms. A travesty of sound science, it is based on the bogus “precautionary principle,” which dictates that every new product or technology—including, in this case, a clear improvement over less-precise technologies—must be proven completely safe before it can be used.

An ounce of prevention is certainly desirable, but because nothing can be proved totally safe—at least, not to the standard demanded by many activists and regulators—the precautionary principle has become a self-defeating impediment to the development of new products. Precautionary regulation shifts the burden of proof from the regulator, who previously had to demonstrate that a new technology was likely to cause some harm, to the innovator, who now must demonstrate that the technology will not cause harm under any circumstances.

This shift is ominous because it frees regulatory bodies to require any amount and kind of testing that they wish. Rather than creating a uniform, predictable, and scientifically sound framework for effectively managing legitimate risks, the U.N.’s biosafety protocol establishes an ill-defined global regulatory process that encourages overly risk-averse, incompetent, or corrupt regulators to hide behind the precautionary principle—and provides cover to politicians bent on protectionism—in delaying or deferring approvals.

Examples include a six-year-long moratorium on approvals of gene-spliced plants throughout Europe and the rejection of badly needed food aid by several African countries—only because it contains the same (superior) gene-spliced varieties of grain consumed routinely in North America.

Other U.N. agencies have gotten into the act. In 2003 the Codex Alimentarius Commission, the joint food standards program of the U.N.’s World Health Organization and its Food and Agriculture Organization, singled out food products made with gene-splicing techniques for draconian and even bizarre regulatory procedures and restrictions—regulatory requirements that cannot be met by conventionally produced foods, which are made with less precise and predictable technology. These deliberations were heavily influenced by the European Union and individual European countries (which increasingly are trying to make the precautionary principle a tenet of law and practice) and by anti-technology activists, who were permitted full participation.

The U.N.’s approach to biotechnology regulation ignores a fundamental principle of any regulatory regime: that the degree of regulatory scrutiny must be commensurate with the perceived risk. On the contrary, the U.N.’s preoccupation with gene-spliced crops and foods gives rise to regulation in which the degree of oversight is inversely proportional to risk.

Overly burdensome standards for gene-spliced foods are ominous not only because of their direct effects on research and development but also because they will keep beneficial new crop plants out of the hands of the resource-poor farmers in less-developed countries who need them most. Scientists worldwide agree that gene-splicing is merely a refinement, or improvement, of less-precise and less-predictable genetic techniques that have been used for centuries and thus is an exquisite tool that can help to develop plants with higher yields and innovative traits. Thousands of greenhouse and field studies, as well as widespread commercialization in a half-dozen advanced countries, have documented that the risks of gene-spliced plants and foods are minimal, that their benefits are palpable, and that their future potential is extraordinary. Globally, the adoption of gene-spliced crops annually reduces pesticide use by tens of millions of pounds and saves millions of tons of topsoil from erosion.

In less-developed countries such as China and South Africa, the few available gene-spliced plant varieties have already increased crop yields, raised the incomes of resource-poor farmers, and reduced occupational exposure to (and poisonings from) chemical pesticides. Wider adoption and diffusion of gene-spliced crops could improve human nutrition, reduce the amount of land and water needed to produce food, and spare ecosystems from fragmentation and development. But these advances are being drastically limited by the unscientific, hugely burdensome, U.N.-based regulatory regimes.

The precautionary principle–driven standards and regulations the U.N. defends actually harm the environment and public health, stifling the development of environmentally friendly innovations that can increase agricultural productivity, help clean up toxic wastes, conserve water, supplant agricultural chemicals, and reduce the contamination of grain by fungal toxins.

Many U.N. experts themselves warn that the greatest single threat to the planet’s environment comes from the world’s burgeoning population and the resulting need for ever more land to be devoted to food production. Ironically, at least four of the eight Millennium Development Goals for the next decade that were announced with great fanfare recently by the U.N.—for example, to “eradicate extreme hunger and poverty . . . reduce child mortality . . . reduce HIV/AIDS, malaria, and other infectious diseases . . . [and] ensure environmental sustainability”—will require broadly available and widely used techniques and products of gene-splicing. But the regulatory regimes promoted by various U.N. agencies and projects vastly inflate the costs of gene-splicing R&D, reduce the number of products that can be pursued, and ultimately deny less-developed countries precisely the kind of technology they need.

How do such travesties of regulation arise? Through a kind of “emperor’s new clothes” process in which self-interested participants move a flawed proposal step by step through the approval process, all the while pretending that it makes sense. But, like elections held in totalitarian countries, although the process appears to be transparent, it is corrupt. The U.N. uses coercion to induce countries to sign on to agreements to regulate gene-splicing excessively, such as the Cartagena Protocol and the Codex standards. For example, the United Nations Environment Program has distributed scores of millions of dollars to help developing countries set up infrastructure for “building capacity for assessing risks, establishing adequate information systems and developing expert human resources in the field of biosafety.”

But as Harvard’s Calestous Juma has said, introducing regulation without promoting the development of technology is like offering swimming lessons to inhabitants of the Sahara Desert. The UNEP program’s “capacity building” applies only to creating apparatuses for the regulation of gene-spliced products, and many of the countries for which the project is intended lack virtually any regulation of acknowledged high-risk activities, such as public transport and dangerous occupations, and their expenditures on public health are woefully inadequate. It is not unusual in poor tropical countries, for example, to observe pre-teens performing welding or using dangerous machinery, with no protective gear and wearing only shorts or a loincloth. Malaria, schistosomiasis, and bacterial and viral diseases that have been all but eradicated from industrialized countries remain epidemic in many underdeveloped nations. Surely the U.N.’s largesse would be spent much more productively if it were allocated to address any of these more important problems.

The UNEP’s bribing of countries to induce them to ratify flagrantly flawed regulations offers a Faustian bargain to less-developed nations. They receive small grants up front, but in the long term, unscientific, excessive regulation of this promising new technology—and the resulting uncertainty among innovators about their ability to conduct research and market products—ensures that the biotechnology revolution will all but pass them by. Such strategies—on which the U.N. bureaucrats publicly congratulate themselves—are outrageous.

Defenders of the U.N. note that the body itself includes institutions that actually employ and promote gene-splicing in their work, and that opinions and policies within the organization are far from homogenous and do encompass advocacy for more scientific public policy. One former senior U.N. official maintains that “there are more sections of the U.N. that are supportive of biotech than those who are opposed.” “The problem is,” he believes, “that those [organizations] that are opposed have also been populated by activist tendencies and so their voice is much louder.”

There are, to be sure, U.N. agencies such as the Food and Agriculture Organization that harbor more supporters than critics. From time to time the FAO even issues reports acknowledging biotechnology’s great potential for addressing both food security and environmental degradation. And the U.N. Development Program’s 2001 Human Development Report concluded that plant biotechnology could be a “breakthrough technology for developing countries” and laments the “opposition to yield-enhancing [gene-spliced] crops in industrial countries with food surpluses.”

However, although there are many competent scientists and well-meaning advisers within the U.N., their marginalization within many agencies and programs illustrates just how perverse and corrupt the U.N.’s policymaking has become. Despite the fact that many within the U.N. share the overwhelming consensus of the scientific community that gene-splicing is a safer way to modify plants than conventional breeding, extremism and political considerations continue to hold sway: One need look no further than the Cartagena Protocol and the Codex standards, which are not merely imperfect but absurd.

It is not difficult to see how this has occurred. As Wellesley College political scientist Robert Paarlberg has noted, the European Union and many individual European nations have threatened to withhold funding from U.N. bodies that use or publicly support crop biotechnology. To get their way, the Europeans, who for decades have been intractable opponents of a rational, scientific approach to gene-splicing, also have waged military-like campaigns during the negotiation of treaties and other agreements. And although the U.S. government has at times withheld financial support to protest anti-social policies at the U.N., U.S. representatives have done little to stop—and at times have even helped to promote—these unscientific biotechnology policies.

Whatever differences of opinion may exist within the U.N., its policies are cynical and flawed and their impacts horrific. Morally, they are no different from permitting the construction of an unsafe dam or knowingly administering a contaminated vaccine. Countless people will suffer and die needlessly as a result of the arbitrary, unscientific restrictions that prevent us from helping the poor to help themselves. As long as the U.N.’s senior officials persist in adopting anti-social policies, and in being unaccountable, they will deserve the opprobrium that they have lately received.

Available from the Hoover Press is To America’s Health: A Proposal to Reform the Food and Drug Administration, by Henry I. Miller. To order, call 800.935.2882 or visit www.hooverpress.org.

Henry I. Miller, M.S., M.D., is a research fellow at the Hoover Institution, where his research focuses on public policy toward science and technology. It encompasses a number of areas, including pharmaceutical development, the new biotechnology, models for regulatory reform, and the emergence of new viral diseases.