ABSTRACT

During the 1970s in the United States, public concern about the safety of conducting experiments with recombinant DNA under conditions of adequate laboratory containment led to the issuance of the "National Institutes of Health Guidelines for Research Involving Wecombinai~t DNA cuies" (NIH Guidelines, 1979; current version, 1998). Public concern was again elicited in the 1980s, this time by proposals to test and use genetically engineered organisms in the environment. The U.S. Congress and the executive branch were then stimulated to reexamine the issues surrounding widespread commercial development of the products of biotechnology. The issues ranged from speculation about the long-term ecological effects of environmental releases of genetically engineered organisms, to concerns that unwarranted restraints on the biotechnology industry would deprive the American public of the benefits of the new technology. Hn addition, the NIH Guidelines, which were originally written for NHH grantees doing biomedical research in the laboratory. were

proving inadequate for testing in the enviroarnent a broad s ectrum of genetically engineered organisms and potential commercial products.