Confidence in Other Industry Sectors Growing

"'Biotechnology' is a terrible term," says David Kingsbury of the National Science Foundation, who has been chairing the federal-wide effort to coordinate biotechnology regulations and guidelines (1). Although definitions of biotechnology have changed often during recent years, the word's meaning has seldom proved a serious stumbling block However, in 1986, federal officials renewed the debate over how best to define the term because of a troublesome dilemma they find themselves facing. Indeed, even their reluctance to close this long-lived debate suggests a useful purpose is being served by keeping the definition of biotechnology from becoming too precise. The dilemma over biotechnology arises because of the dual missions of research and regulation for which so many federal agencies are responsible. As interest in biotechnology grew rapidly during the past 5 to 10 years, members of Congress have pressed agency officials to show they were giving proper support to this emerging enterprise. Although its growth in the private sector has been fast and enormous, no one questions the impetus stemmed from federally sponsored research-originally, largely from basic biomedical research underwritten by the National Institutes of Health (NIH). Other agencies have been urged to join in supporting biotechnology and, wherever possible, to induce researchers whom they fund to modernize their own efforts by adopting its powerful tools. Following that path has not proved a straightforward assignment, however. Because many of the same federal agencies also share a responsibility for regulating biotechnology research and its products, agency officials often find themselves faced with two very different agendas on the same topic. In particular, techniques used widely within biotechnology, especially manipulations involving recombinant DNA techniques, have come under close regulatory scrutiny. Although this attention has been deemed critical for ensuring both public confidence and safety, it tends to slow progress. Some federal officials now are increasingly worried that the biotechnology regulatory net may be opening too widely. In the rush to redirect and reclassifY agency research efforts, making them better attuned to biotechnology's promise, the scope of regulation may also have been inadvertently broadened too much.