Regulators from around the world were dealt a blow last February when a small group of nations led by the United States rejected a proposed biotechnology regulation advocated by more than 130 countries. The proposed regulation, a UN biosafety protocol (BSP) that would regulate the testing of and trade in gene-spliced organisms, seeds and products derived from them, is unscientific and anti-competitive. In anything resembling its present form, the regulation would be harmful to consumers and the environment and catastrophic for efforts to improve agricultural growth.
Unfortunately, the rejection was only a temporary victory. And since the American delegation argued from an economic rather than a scientific perspective, the U.S. position is undermined by the fact that the United States's own unscientific biotech regulations violate the General Agreement on Tariffs and Trade (GATT). (Under the GATT, regulations that are not science-based are considered to be non-tariff trade barriers.)
There is nothing mysterious about the new biotechnology in question; it is an extension of techniques that have been developed and applied over the centuries. In 1987 the National Academy of Sciences (NAS) concluded that there is no evidence of unique hazards either in the use of gene-splicing techniques or in the movement of genes between unrelated organisms. NAS also proclaimed that the risks associated with the introduction of gene-spliced organisms into the environment are the same as those associated with the introduction of unmodified organisms.
The National Research Council (NRC), the research arm of NAS, concluded in a 1989 report that "no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes," whether in the laboratory, in the field or in large-scale environmental introductions. Such conclusions have clear regulatory implications: gene-spliced organisms, and products derived from them, should be treated no differently from other products or organisms, except where scientific considerations require such treatment.
The use of molecular methods of gene transfer does not, in itself, warrant regulatory action. Governments generally do not require pre-market regulation of new varieties of agricultural plants or microorganisms, except those that are known pests or pathogens or that may harbor agents harmful to plants or animals. Such free-market policies encourage the voluntary testing of new plant varieties by plant breeders, other researchers and manufacturers of food and agricultural products. The proposed UN regulation would introduce Draconian rules — but only for products improved with the most precise and sophisticated techniques.
The biosafety protocol would make gene-spliced organisms more expensive to test, produce and use. Experience in the United States indicates that the costs of field testing such plants would be 10 to 20 times greater than the costs of field testing plants having identical properties but modified with older, less-precise techniques. According to a U.S. Department of Agriculture study, the prices of wheat and coarse grains (corn, barley and sorghum) could increase worldwide by an average of 2 percent and 5.6 percent, respectively, if the UN regulations were fully implemented. Developing countries would be the main victims of the proposed regulation: they would have to spend more for food and would be unable to acquire the new technology.
Paradoxically, almost all developing countries favor restrictive biotech regulation. The environmental regulators in those countries see biotech regulation as a growth industry, and they have been bought off by the promise of resources for "capacity building" (a UN euphemism for bigger regulatory bureaucracies).
Conspicuously absent from the negotiations was any mention by the United States of the scientific deficiencies of the regulation. Why? Because biotech regulation at three U.S. agencies (the Environmental Protection Agency, the Department of Agriculture and the Food and Drug Administration) is similar to the proposed UN regulation: in one way or another, all three agencies focus discriminatory policies on gene-spliced organisms.
The U.S. negotiators were in fact arguing against the very kind of regulation imposed by U.S. government agencies at home. Apparently, the U.S. government really favors discriminatory, excessive regulation — but not where it threatens the interests of major U.S.-based agribusinesses.
When the negotiations resume sometime before May 2000, they will continue to be based on politics, expediency and perceived narrow self-interest rather than on scientific principles, actual risks and the public interest. What will surely emerge is a regulation that is less objectionable to the United States, its allies and big agribusiness but a regulation devoid of scientific and common sense. The result will violate the principle that something that isn't worth doing at all isn't worth doing well.
Instead of lending a hand to the UN effort, the United States should long ago have taken the scientific and moral high ground by insisting that any regulation aimed only at gene-spliced organisms is wholly unacceptable and that any UN agency or program associated with such a regime, directly or indirectly, cannot be funded from U.S. dues.