The White House has approved a federal committee to coordinate the government's handling of biotechnology issues but has cut its planned powers after objections from biotechnology companies and some federal officials.
For at least a decade, government, industry and others have called for more coordination of biotechnology policy, regulations and research. These matters now reside, theoretically at least, in five or six federal agencies.
Companies are often uncertain whether their products fall under the jurisdiction of the Environmental Protection Agency, the Agriculture Department, the National Institutes of Health, the Food and Drug Administration or a combination of agencies.
The debate has sometimes been bitter. There have been several court cases over how the government should handle products of the new biological methods, loosely called "genetic engineering."
Over the last decade, different agencies have responded differently.
The FDA has handled new products without regard to whether genetic engineering was used in production.
The NIH has committed much work to examining the new technologies and whether newly created organisms may have harmful effects.
The EPA began regulating biotechnology products years after the others but now is working on ways to test the risks of these products.
The Agriculture Department is considering what regulatory role it should take but contends that some engineered plants are under its jurisdiction.
The new panel will be called the Biotechnology Science Coordinating Committee (BSCC). Originally, the committee was intended to oversee the work of all the regulatory agencies, reviewing abstracts of applications before acting on them.
But after strong objections from industry, that provision was modified.
Alan Goldhammer, spokesman for the Industrial Biotechnology Association, said companies were concerned that the board would have power to review agency actions -- adding a hurdle to the regulatory process.
The new board will report, in theory, to a higher committee, the Federal Coordinating Council for Science, Engineering and Technology, and ultimately to George A. Keyworth II, the president's science adviser and head of the White House Office of Science and Technology Policy.
It is not clear how much direction, in practice, will come from Keyworth or his staff.
The seven members of the BSCC are high-ranking representatives of the five key agencies dealing with biotechnology: the NIH, the EPA, the National Science Foundation, the FDA and Agriculture.
David T. Kingsbury, the National Science Foundation's assistant director for biological, behavioral and social sciences, will be the board's first chairman. Kingsbury and Robert Rabin of the White House science office outlined the key elements of the BSCC's new job:
*Developing consistency in regulatory procedures.
*Developing consistency of scientific information used to assess the risks of biotechnology products.
*Sharing information and developing a consensus among agency leaders on important issues.
*Naming important gaps in knowledge needed to assess risk.
*Helping resolve questions of jurisdiction -- which agency should regulate which products, from designed microbes to modified mammals.
Each agency on the board will designate a committee to handle biotechnology issues. BSCC members will lead those committees. Therefore, agency officials will dominate committee action.
"It's going to be a consensus body," Kingsbury said. "We are not going to spend our time looking over agency shoulders and saying, 'You made a mistake in releasing something, and we'll have to bring it back.' "
Some, including FDA officials, have questioned whether the board is needed. Industry representative Goldhammer said the BSCC is likely to fade away eventually but that it can be a useful coordinating body while the government confronts new biotechnology products.
The designated officials on the new committee, in addition to Kingsbury, are the directors of the NIH and the FDA; two assistant secretaries in the Agriculture Department, one for science and education and one for marketing and inspection services; and two EPA officials, the assistant administrator for pesticides and toxic substances and the assistant administrator for research and development.