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As one of the nation's largest and richest trade associations holds its annual meeting in <?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />San Francisco this week, it is worth noting that all is not coming up genetically engineered roses for the biotech industry. Although the biopharmaceutical sector is for the most part robust, biotechnology applied to agriculture, food production, and environmental problems has a long row to hoe. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Many of biotech's travails can be traced back to two decades of unwise strategic decisions by individual companies and by the trade association itself—the Biotechnology Industry Organization.
Long before the first gene-spliced plants were ready for commercialization, a few agrochemical and biotechnology companies, led by Monsanto and Calgene and supported by BIO (and its precursors), approached policy-makers in the Reagan administration in the mid-1980s and asked that the Environmental Protection Agency, Department of Agriculture and Food and Drug Administration create a regulatory framework specific to gene-spliced products.
The policies recommended by the biotechnology industry, predicated on the myth that there is something fundamentally novel and worrisome about gene- splicing techniques, were far more restrictive than could be justified on scientific grounds and often even more burdensome than proposals by regulators.
Ostensibly, the goal of these policies was to placate anti-biotech activists and provide reassurance to consumers that regulators had evaluated and cleared gene-spliced products, but the real motives were less benign. Industry representatives have admitted after the fact that the companies wanted excessive regulatory requirements to make biotech R&D too expensive for possible competitors such as start-ups and seed companies; in other words, regulatory expenses and delays would serve as a market-entry barrier.
The USDA and EPA in particular were glad to oblige industry, with draconian policies that focused specifically on and discriminated against plants and microorganisms crafted through gene splicing. As a result, a field trial on a gene-spliced organism today costs 10 to 20 times as much as the same trial with a plant that has virtually identical traits, but that has been modified with less precise and predictable conventional techniques.
This strategy of the biotechnology industry has backfired horribly. Unrealistic and unnecessary regulatory requirements have created the foundation for various kinds of pseudo-crises that are precipitated whenever inconsequential transgressions of the overly stringent rules occur, and also for a variety of nonevents that, nevertheless, have been public-relations debacles: For example, the alleged killing of Monarch butterflies by pollen from gene-spliced corn and supposed "contamination" of native corn varieties in Mexico. The public imagination seems to have been captured by the apparent newness and uniqueness of gene-splicing, although with the exception of fish, wild berries, wild mushrooms and game, all the grains, fruits, vegetables and animals in our diets have been genetically improved in some way. Gene-splicing is an extension, or refinement, of less precise and predictable techniques.
All of this has given rise to a disastrous domino effect. In March, Mendocino County voters passed a referendum that prohibits any cultivation of gene-spliced organisms. In May, Monsanto announced that it was shelving plans to sell a gene-spliced wheat variety, attributing the decision to changed market conditions. That decision, however, was forced upon the company by the reluctance of farmers to plant the variety and of food processors to use it as an ingredient, factors that are directly related to the over-regulation of the new biotechnology in important export markets.
Monsanto also announced last month that it has abandoned plans to introduce its gene-spliced canola into Australia, following consumer skepticism and environmental concerns. Other companies have acknowledged giving up plans to work on certain applications of the technology because of excessive regulations.
After receiving tentative approval from the British government for a gene- spliced variety of corn, Bayer CropScience decided not to sell it because additional regulatory hurdles would delay commercialization for several years.
The anti-biotech activists have been right about one thing: The ag- biotech industry did create a Frankenstein's monster—a regulatory one of its own making.