Deliberate Release of Genetically Engineered Organisms in the Environment

Abstract

When recombinant DNA technology was first developed, it was limited to basic research laboratories performing primarily biomedical research. As most biomedical research in the United States is funded by the National Institutes of Health (NIH), the 1976 NIH Guidelines for Research Involving Recombinant DNA Molecules [1] adequately covered all Government funded research. Other research institutions and most industries performing recombinant DNA research voluntarily agreed to abide by the NIH Guidelines. This voluntary control continued to work well without established regulations until recombinant DNA research moved from the public to the private sector, where it was expanded to include other biotechnical advances such as hyubridoma research; the large-scale production of new drugs, hormones, chemicals, enzymes, diagnostic and detection devices; as well as novel process technology. Scientists were no longer experimenting with small 10-liter quantities; large scale fermentation processes were required. In agriculture and in industrial areas, research started to move from the laboratory into the open field. The NIH Guidelines could no longer cover this rapid growth. The intervention of the regulatory agencies became necessary as products moved from the laboratory to the market place.