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Regulating Biotechnology

PRESIDENT Bush's announcement of "major new ground rules for regulation of biotechnology" is a step in the right direction. But the regulatory issues still are not fully resolved.

The White House announcement is a statement of policy, not a detailed set of rules. These will have to be developed by the Department of Agriculture, the Environmental Protection Agency, or the Food and Drug Administration, depending on the types of products involved.

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Still, as a policy statement, it puts the regulatory emphasis where it belongs. It states that novel organisms should be regulated according to their characteristics and use, not by the means that produce them. It aptly notes that "although the new biotechnology processes can be used to produce risky organisms, so can traditional techniques."

This is the emphasis that the National Academy of Sciences has recommended. The regulatory agencies themselves have also been moving in that direction.

The administration's policy aims to ease needlessly burdensome rules for the rapidly emerging biotechnology industry. It may, indeed, do so. But it also addresses a risk that escapes current regulations. As the policy statement notes, traditional breeding techniques can also produce risky organisms. Yet those organisms currently escape the detailed safety scrutiny given the products of the "genetic engineer."

Modern molecular biology has greatly enhanced "traditional" breeding. Both the genetic engineer and the modern breeder use the same biochemical methods to identify genes associated with desirable plant or animal traits. The genetic engineer then introduces these genes directly into the molecules that carry an organism's genetic instructions while the breeder uses traditional crossbreeding to move such genes from one organism to another. It makes little sense to tightly regulate the former and not the lat ter.

If small genetic changes produced by breeding are not considered abnormally risky, why should equally small changes produced by genetic engineering be any more threatening? Likewise, introduction of a truly novel organism should be tightly controlled however that organism is produced.

Many of the new organisms - plants, farm animals, or microbes - fall into the slight-change, low-risk category. Regulations based on the new policy should smooth the way to bring them into use. This would free regulatory resources to focus more sharply on the truly novel cases.

The responsible agencies should act on the new policy and put biotechnology regulation on this rational basis.

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