- The Washington Times - Friday, March 30, 2001

Eleven senators from both parties have asked the president to create a "biotechnology coordinator" who would ensure that policy at a veritable alphabet soup of government agencies is consistent and sensible. But dogs bark, cows moo and regulators regulate, and the Bush administration will have a difficult time crafting and implementing needed regulatory reform. A biotech coordinator would have to be part diplomat and part Lord High Executioner.
Current federal regulatory policy is relentlessly negative toward biotechnology. The FDA last year repudiated its 20-year commitment not to discriminate against gene-spliced products, by abandoning its 8-year-old policy on new plant varieties which applied irrespective of whether the plant arose from gene-splicing or "conventional" genetic engineering methods. The agency now requires that all gene-spliced foods come to the agency for pre-market review.
Characteristically, the EPA has been the worst of all. The agencys oversight is flagrantly unscientific and discriminatory, focusing on the most precise and predictable techniques of biotechnology while ignoring genuinely hazardous products. A regulation under the Toxic Substances Control Act that regulates products made with the most precise techniques of the new biotechnology has halted critical research into gene-spliced microorganisms that might be used to clean up oil spills and toxic wastes.
In addition, EPA issued a regulation rammed through in the last hours of the Clinton administration that would require the review of the testing of gene-spliced crop and garden plants that have been modified for enhanced pest- or disease-resistance. These genetically improved plants, such as corn, cotton, wheat and marigolds, would be subjected to the same sort of lengthy, hugely expensive review as chemical pesticides. EPAs policy is so potentially damaging and outside scientific norms that it has galvanized the scientific community: Eleven major scientific societies representing more than 80,000 biologists and food professionals published a report warning that the EPA policy would discourage the development of new pest-resistant crops and prolong and increase the use of synthetic chemical pesticides.
The government has been busy creating mischief internationally as well. The "Cartagena Biosafety Protocol," finalized last year under the auspices of the United Nations Convention on Biological Diversity (CBD), established a global scheme for regulation of biotechnology products. It embraces the bogus "precautionary principle," which holds that every new technology should be proven absolutely safe before it can be used. This erects an almost insurmountable barrier against new products because nothing can be proved totally safe.
The protocol will hobble the work of academic researchers and small, innovative companies, ultimately delaying or denying the benefits of the "gene revolution" to much of the world. U.S. government negotiators collaborated aggressively in crafting these unscientific and illogical regulations, in spite of the Senates explicit unwillingness to ratify the CBD itself.
Similarly, with full U.S. support and collaboration, three panels of the Codex Alimentarius Commission, the United Nations agency concerned with international food standards, are now 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 all but a handful from having a fair chance to compete in the marketplace.
The flawed Cartagena Protocol and Codex rules are worrisome for two reasons. First, they legitimatize the flawed precautionary principle, offering cover to incompetent, overzealous or corrupt regulators who wish to obstruct research and development or to create trade barriers to certain products. Second, once this United Nations-based international oversight becomes established and regulators taste unaccustomed (and unwarranted) power, there is little likelihood that the regulations will be rolled back or eliminated.
Even with good intentions, the Bush administration will find it difficult to rationalize this public policy chaos. The new secretary of agriculture, Ann Veneman, has spoken of the importance of agbiotech, but her praise of agbiotech "products that make farmers more productive and consumers more healthy and satisfied" falls far short of a commitment to bring about needed regulatory reform.
EPA Administrator Christie Whitman will find biotech issues arcane, but will get little constructive help from her deputy, Linda Fisher, who actually crafted many of the agencys flawed biotech policies during the previous Bush administration. She and the EPA career staff have defended wrong-headed policies like a dog with a favorite bone.
The international miasma may be the most difficult problem of all. It should be met uncompromisingly. The Bush administrations mantra should be that good science trumps everything else; that arbitrary, capricious, unscientific policies will not be tolerated whether they originate in Brussels, Washington or U.N. headquarters.
There are plenty of empirical data and scientific theory to support regulatory policies that focus on the actual risks of products, instead of merely on the use of certain in this case, superior techniques. What we need now is the political will to insist on them.

Henry Miller is a fellow at the Hoover Institution and the Competitive Enterprise Institute. He is the author of "Policy Controversy in Biotechnology: An Insider's View."


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