The last two decades have been the best of times and the worst of times for biotechnology applied to agriculture and food production - stunning scientifically, dismal politically. In particular in Europe where there is widespread public and political opposition to importing gene- spliced, or "genetically modified" (GM), seeds; vandalisation of field trials; suspension of regulatory approvals; labelling to identify GM foods and even their banishment by major supermarket chains. Overregulation The cause of much of this adversity is ill-conceived public policy - in particular overregulation that singles out and discriminates against a superior new technology. Ironically, the big agribusiness companies,especially Monsanto, have no one to blame but themselves. By insisting for years that their own gene-spliced crop plants and the foods derived fromthem merited extraordinary government oversight, agricultural biotech companies elicited regulation that lessened competition and slowed the flow of products through the development pipeline. (This strategy also played into activists' scare scenarios, discouraging public acceptance of the new products.) Biotech giants drove restrictive legislation In the early 1980s a few major agrochemical-biotechnology companies led by Monsanto approached senior policy makers in the administration of PresidentRonald Reagan and requested more restrictive regulation, primarily from the Environmental Protection Agency (EPA), than could be justified on scientific grounds. Their motive was clear: to use regulation as a market entry barrier to competitors - in particular, seed companies and biotech startups - that were less able to bear the high costs of unnecessary regulation. Smaller companies struggle They achieved their short-term goal. The US Department of Agriculture, Food and Drug Administration and (especially) Environmental ProtectionAgency promulgated new policies that focused specifically on and discriminated against plants and microorganisms crafted with gene- splicing techniques. The regulatory policies put federal bureaucrats in the middleof virtually all field trials of GM plants during the past fifteen years. The cost of field-testing GM plantsskyrocketed to as much as twenty-fold higher than for virtually identical plants crafted with older, less precise genetic techniques. Limited R&D resources were siphoned away from productive research to paperwork and gratuitous field test requirements. Added production costs were a particular disadvantage to products in this competitive, low profit-margin market. Many seed companies and entrepreneurial biotech companies failed to compete successfully on this tilted playing field, and subsequently many were bought at a fraction of their true value by Monsanto, Novartis and Dupont. During one period of only 18 months Monsantobought Agracetus, Ecogen, and Calgene. Few of the agbiotech companies launched in the 1980s exist today - in contrast to biopharmaceutical companies, whose numbers have increased steadily for a quarter century. Tight rules lead to suspicions The overregulation that they engineered has fed theanti-biotechnology mythology that in turn influenced the views of consumers and emboldened regulators, particularly in Europe and Japan. The industry as a whole must share the blame for this strategy. Its monolithic trade association, the Washington DC-based Biotechnology Industry Organisation (BIO), has lobbied tirelessly for overregulation inthe United States and internationally for more than a decade. UN protocol" > In the international arena, Monsanto and BIO have lobbied for United Nations-based regulation of biotechnology. One result has been the disastrous Cartagena biosafety protocol, finalised in January 2000 under theauspices of the 1992 United Nations' Convention on Biological Diversity. These regulations introduce a global scheme for regulation of biotech products that violates a cardinal principal of regulation - namely, that the degree of scrutiny should be commensurate with risk. Under this unscientific and Draconian regulatory regime, no biologist, plant breeder or farmer will be allowed to grow and test a GM crop or garden plant - nomatter how small the test-plot - without prior, case by case approval from the UN-sanctioned bio-police. (With rare exceptions, plants crafted with more primitive, less precise genetic techniques will continue to be subject to no government scrutiny at all, from the first tests in the field to the consumer's plate.) Paperwork, red tape and corruption will dog the process from beginning to end, from the first seed to the store shelves, around theworld, and the regulations offer national regulators cover for decisions based only on protectionist considerations. Biotech and Codex Monsanto and BIO have likewise supported and participated in the work of no fewer than three panels of the Codex Alimentarius Commission, the UnitedNations agency concerned with international food standards. These groups are working toward holding biotech-derived food and food ingredients to standards that are unscientific, far beyond those that any other products can or should meet, and that will prevent their competing successfully in the marketplace. Regulation slows progress Agricultural biotechnology holds tremendous potential benefits for the world's consumers and farmers. Products will continue to emerge in the marketplace, but at a low rate because of regulatory barriers. Under current circumstances, the commercialisation of agbiotech products will be limited primarily to commodity crops grown at vast scale, at the expense of opportunities to improve important small-acreage crops. Forexample, innovation will seldom target improvement of the genetics of environmentally-threatened but low-value-added species such as trees, or of subsistence crops such as millet, cassava and yams. The potential market for GM plants and foods derived from them is being undermined and distorted by overregulation and public antagonism. Ironically, both are the industry's own Frankensteinian creation.
Dr Henry Miller is an academic researcher and regulatory consultant. From 1979-1994 he was an official at the US Food and Drug Administration. From 1989-1994 he was the founding director of the FDA's Office of Biotechnology. Mr. Miller is currently Senior research fellow at Stanford University.