U.S. drops the biotech ball
(San Jose Mercury News) Posted at 1:43 p.m. PDT Wednesday, April 21, 1999
BY HENRY I. MILLER
President Clinton delivered a ''foreign policy State of the Union'' speech not long ago in which he touted his administration's achievements in foreign affairs.
Among them, he said, were policies that brought ''increasing knowledge and larger trade,'' control of ''global environmental crises'' and ''globalization.''
Illustrating the disconnect between Clinton's rhetoric and his policies, however, just a few days earlier U.S. negotiators had been disingenuously negotiating biotechnology regulations in Cartagena, Colombia. Led by the United States, a small bloc rejected proposed regulations that are advocated by more than 130 countries. (The talks were held under the mandate of the 1992 U.N. Convention on Biological Diversity, which the Clinton administration has strongly supported since its inception.)
What happened in Cartagena was a mixed blessing. On the plus side of the ledger, the bloc's action was an excellent development as the regulations under consideration are unscientific, anti-innovative and anti-competitive.
Embodied in a U.N. protocol, they would govern testing and trading of genetically modified organisms -- activities that may sound worrisome but are actually of negligible risk.
If put in place, the rules would be catastrophic for international research on ways to enhance agricultural productivity. Over time, curbing this work would harm both consumers and the environment.
On the minus side of the ledger, the U.S.-led group, which includes Canada, Australia, Chile, Argentina and Uruguay, won only a temporary victory at the Cartagena negotiations. Worse, U.S. negotiators did the right thing for the wrong reasons and now find themselves in an untenable situation.
Although they could have argued persuasively that the proposed regulations lack scientific and common sense, their arguments -- calculated to protect large agribusiness interests -- instead focused exclusively on trade considerations.
Their position is undermined by the fact that the U.S.' own biotech regulatory policies, as well as the proposed U.N. regulations, conflict with scientific consensus. That's a violation of the General Agreement on Tariffs and Trade, which governs world trade.
To put the debate in perspective, it's time for a quick visit to the Biotech 101 classroom.
Biotechnology is the application of precise, state-of-the art genetic techniques, primarily ''gene-splicing,'' to improve the genetics of animals, microorganisms and plants.
Biotech can make fruits and vegetables more resistant to pests and diseases, increase their yield and boost their nutritional value.
Last year, gene-spliced plants were cultivated on more than 80 million acres worldwide, about three-quarters of them in the United States.
How should these products be regulated? The vast majority of scientists agree that this new biotechnology is merely an extension, or refinement, of less precise and less predictable techniques that have long been used for genetic modification.
For example, long before the advent of gene-splicing, plant breeders performed hybridizations in which genes (and even whole chromosomes) were moved from one species or genus to another, across natural breeding barriers.
These ''wide crosses'' have yielded a large number of genetically improved plant varieties, including potatoes, tomatoes, wheat, corn, oats and pumpkins that Europeans and Americans consume routinely and safely.
It is noteworthy that governments generally require no pre-market regulation of these products, from the first field test to the consumer's plate.
This efficient, laissez-faire situation would change under the proposed U.N. regulations -- but only for products improved with the most precise and sophisticated techniques.
The scope of the regulations would conflict with one of the basic principles of regulation -- that the degree of oversight should be commensurate with risk.
In other words, case-by-case review is appropriate only when a product poses potential safety concerns -- an organism with known toxicity, for example, or a plant pest or environmental nuisance.
The United Nations' wrongheaded and unscientific regulatory proposals would make gene-spliced organisms artificially expensive to test, produce and use around the world.
Experience in the United States has shown that the costs of field-testing such plants would increase tenfold to twentyfold, compared with the costs of testing plants with identical properties but modified with older, less precise techniques.
The delegates at Cartagena agreed to suspend the talks and resume them at some unspecified time before May of next year.
During that time, the deliberations will continue to be based on politics, expediency and perceived narrow self-interest rather than on scientific principles, actual product risk and the public interest.
What will surely emerge is a package that is less objectionable to the United States, its allies and big agribusiness but that remains devoid of scientific and common sense.
President Clinton claims that the United States has pursued an enlightened foreign policy that encourages international trade, environmental protection and globalization, but his administration's positions on biotechnology regulation during the past seven years have shown no sign of it.
The United States should have insisted that regulations focused solely on gene-spliced organisms are unscientific and violate GATT, and declared that any U.N. agency or program associated with such a regulatory regime, directly or indirectly, is ineligible to receive money from U.S. dues.
Dr. Henry I. Miller is a senior research fellow at Stanford University's Hoover Institution and the author of ''Policy Controversy in Biotechnology: An Insider's View'' (Academic Press). He is also a former official in the Food and Drug Administration.
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