Biotech Rules Are Missing

THE biotechnology industry has entered the 1990s with one of its main needs unmet. After more than a decade of discussion, there still is no settled regulatory system that enables those who want to develop, test, and market novel products to know legally where they stand. Participants in the biosafety symposium held in February by the United States Agency for International Development noted that there isn't even international agreement on how to develop such regulations.

In the US, the long-awaited Department of Agriculture regulatory scheme for genetically engineered organisms still is not fully in place. The USDA issued guidelines ``intended to aid researchers and institutions in the design of safe experiments'' on Feb. 1. But a plan to implement those guidelines is yet to come.

Meanwhile, the President's Council on Competitiveness is urging federal agencies not to overregulate products just because they are produced by bioengineering. This does not help agencies deal with products whose very nature is in doubt. The Food and Drug Administration, for example, is unsure about the new so-called antisense compounds. These enter living cells and act in a natural manner to alter or inhibit certain cell functions. Should they be classed as biologicals (natural compounds) or drugs (syn thetic chemicals)?

One of the most portentous of cutting-edge biotechnologies - applied molecular evolution - may increase the confusion. Enzymes work by fitting neatly into receptor structures on other molecules as one piece of a jigsaw puzzle fits another. The new technology enables biochemists to mix a brew of randomly constructed molecules and select those that have the right shape for specific jobs. These molecules can then be further improved, with the best again being selected.

Within the decade, this technology could produce a host of powerful new chemicals that regulators will have to classify and assess for risk.