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Regulatory officials in the European Union seem to be ignorant of the Rule of Holes: When you're in a hole, stop digging. Repeated analyzes over two decades have documented Europe's lack of competitiveness in biotechnology, but last week, by formally ratifying the United Nations-sponsored Cartagena Protocol on Biosafety, the EU yet again has embraced an oversight regime that wrongly and excessively regulates the international movement and testing of safe, precisely crafted products, while exempting more problematic ones. This is not the road to either commercial success or consumer protection.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Two and a half years ago, when the agreement commonly known as the Biosafety Protocol was negotiated in Montreal, it was heralded as a landmark of global cooperation. The Protocol requires ratifying countries to establish rigid, stringent controls over nearly every aspect of research and development on GM crops, animals and microorganisms. As a result of mandated - and gratuitous - case by case regulatory review, corruption and red tape will dog these products, from the cultivation of the first seed to their appearance on consumers' tables.
The Protocol is the culmination of an effort begun in 1993, when few people had ever even heard of GM, and when no GM crops had yet been cultivated commercially. The unwisdom of the effort was obvious from the start. A scientific panel established by the UN Environment Program earlier that year to review the need for such an agreement advised that this sort of "protocol would, for no clear purpose: divert scientific and administrative resources from higher priority needs; and delay the diffusion of techniques beneficial to biological diversity, and essential to the progress of human health and sustainable agriculture."
Nevertheless, politicians saw biotechnology regulation itself as a growth industry -- with themselves as the "entrepreneurs" -- and were intent upon negotiating an agreement, even in the absence of a demonstrable need for one, and knowing its palpable disadvantages. Thus, the Biosafety Protocol was never contemplated as a useful, risk-based regulatory apparatus, but as cynical justification for new governmental mandates, bigger regulatory budgets and expanded empires.
Since the methods of gene-splicing were pioneered in 1973, dozens of major scientific organizations -- including the U.K.'s Royal Society, World Health Organization, American Medical Association and the U.S. National Academy of Sciences - have investigated potential risks of GM organisms and reached remarkably congruent conclusions: The process of genetic modification is not inherently risky; genetically modified organisms do not pose new or unique risks compared to unmodified organisms or organisms modified in more conventional ways; and in fact, GM organisms are more precisely crafted and predictable than other organisms.
Over time, and relying upon vast experience with a wide array of techniques for the modification of plants and animals, scientists, breeders and farmers have developed methods for keeping unsafe products off the market.
Still, supporters of the Biosafety Protocol (the EU was the 22nd entity to ratify, almost halfway to the 50 needed for it to take effect) have argued an additional layer of formal, pre-marketing (and even pre-testing) government regulation must be introduced to detect unanticipated problems. But they offer no explanation for limiting oversight to superior GM techniques, and for ignoring the arguably greater risks of conventional plant breeding and the introduction of exotic species into new environments.
The reality is that not a single plant, animal, or micro-organism modified with conventional techniques could meet the standards of the new biotech regulations. This bizarre dichotomy reveals that the motivation behind the crafting of the Biosafety Protocol is no more than politics and self-aggrandizement.
Rich-poor politics also explains why, more than two years after the agreement was supposedly finalized, there is still considerable squabbling about how it will actually be implemented. For example, GM pharmaceuticals were excluded from the document finalized in Montreal, because pharmaceuticals are already regulated by another multilateral agreement. Now, several less-developed countries want to bring them back under the Protocol's regulatory framework so they will have extortionate financial leverage over European and North American drug manufacturers.
Perhaps the most problematic issue is how the Protocol's call for a "precautionary approach" to regulatory standard-setting should be interpreted. Although the large agricultural exporting countries specifically opposed including the words "precautionary principle" in the final text, the European Union now argues for a strong reading of the precautionary language that would give it leeway to ban imports on the basis of no more than the most conjectural speculation about potential health or environmental risks.
Although numerous critiques of the so-called precautionary principle, which is not a principle at all but a kind of blanket justification for arbitrarily opposing disfavoured technologies and products, have been promulgated, its shortcomings are nowhere more evident than in GM regulation. This bogus principle has been invoked repeatedly to support unwarranted restrictions on some of the safest, most intensively studied food products in human history, and in a way that reflects that the goal is protectionism, not consumerism: In order not to disadvantage the one relatively active food-biotech sector in Europe, for example, the EU has exempted from its regulatory burden European cheeses, wines, and beers made with GM enzymes.
In the interest of human rights, economic justice and free markets, we need global regulatory policies that make scientific and common sense and that lead to greater productivity and consumer choice. But by creating inconsistent and bizarre regulation, EU politicians (abetted by their cronies at the UN) have diverted the attention of regulators and the public from more significant sources of risk, discouraged research and development, and in effect imposed a huge punitive tax on any products that do emerge from the compromised development pipeline.
The only winners from such wrong-headed regulation will be government regulators, who will enjoy additional power and resources, and anti-science extremists, who will have succeeded in erecting yet another barrier to GM technology. The losers will be consumers everywhere that the Biosafety Protocol is in effect, who systematically will be denied access to safer, more nutritious and affordable products.