U.S. Agencies Seek Balance In Biotechnology Rules

WASHINGTON-Government agencies, in their zeal to demonstrate support for biotechnology research, may have unintentionally complicated efforts to regulate the burgeoning field, according to federal officials. "We have opened up a complex regulatory world that need not have been," asserted David Kingsbury of the National Science Foundation. There is a growing "tendency to 'do' all of biology," he added, as conscientious regulators "examine things that have been going on for long periods of time. W

By | October 20, 1986

WASHINGTON-Government agencies, in their zeal to demonstrate support for biotechnology research, may have unintentionally complicated efforts to regulate the burgeoning field, according to federal officials.

"We have opened up a complex regulatory world that need not have been," asserted David Kingsbury of the National Science Foundation. There is a growing "tendency to 'do' all of biology," he added, as conscientious regulators "examine things that have been going on for long periods of time. We may have done ourselves some mischief."

Kingsbury, associate director for biological, behavioral and social sciences at the science foundation, also chairs the committee that is overseeing the federal effort to co ordinate biotechnology regulations and guidelines. He spoke during a one-day workshop last month on public funding of biotechnology research and training convened by the Office of Technology Assessment.

The various agencies involved in supporting biotechnology found themselves in a dilemma as interest in the subject grows. The legacy of the pioneering work sponsored by the National Institutes of Health-upon which private industry has built so successfully-has led other federal agencies to urge their researchers to adopt whenever possible the tools of the new technology. At the same time, most of these agencies are also supposed to regulate biotechnology re search and its products.

The debate on a proper definition of biotechnology also affects policy decisions. The workshop was held shortly after the release of a General Accounting Office report that also focused on federally funded research in the area. The report, requested by Rep. John Dingell (D-Mich.), found that "only a small number" of federally sponsored projects were devoted to assessing the risk from the new . technology. Federal officials, including Kingsbury, worry that any push by Congress to fund more studies on that subject could backfire by jeopardizing the considerable autonomy that agencies have traditionally enjoyed in setting re search priorities.

The workshop revealed the extensive but uneven federal support for biotechnology. NIH estimates that its overall support is as high as $1.8 billion annually, with at least one-third devoted to basic work in the field. Almost one-half of its annual $170 million training budget, moreover, supports young scientists who are learning skills related to the new technology.

Major programs are also being conducted by the National Science Foundation, with a budget of $81 million, and the Department of Agriculture, with a budget of $73 mil lion. Agencies with smaller but significant research programs in the millions of dollars include the Food and Drug Administration, the Environmental Protection Agency, the Department of Energy, the Veterans Administration and the Agency for International Development.

The technology assessment office is also beginning to evaluate state programs. And it is looking into ways that federal money can help the private sector compete with efforts by other countries. Although there was no agreement at the workshop on critical needs in biotechnology, several participants cited bioprocess engineering, the basic biology of higher organisms and technology transfer from the lab bench to marketplace as topics that are worthy of additional support.

Jeffrey Fox is a freelance science writer in Washington.

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