Biotechnology

Pursuant to a congressional request, GAO assessed institutional biosafety committees' implementation of the federal guidelines applicable to the environmental release of genetically engineered organisms, focusing on their: (1) membership composition; (2) functions and activities; (3) implementation of the National Institutes of Health (NIH) guidelines for research involving recombinant deoxyribonucleic acid (DNA) molecules; and (4) role in federal regulation of genetically engineered organisms.

GAO found that: (1) members with genetic engineering backgrounds dominated the committees; (2) committee functions and activities varied, with 60 percent exclusively reviewing recombinant DNA research, 23 percent reviewing DNA research proposals at least half of their time and overseeing research on infectious diseases, hazardous chemicals, or radioactive materials, and 17 percent devoting less than half their time reviewing DNA research; and (3) both public- and private-sector biosafety committees generally complied with NIH guidelines. GAO also found that, while committees understood their relationship with NIH, their relationship with other federal agencies in reviewing proposals was less clear. In addition, GAO found that a recent incident involving genetic experimentation illustrated problems with: (1) university policies regarding the NIH guidelines; (2) committee awareness of research activities; (3) the definition of what constitutes a deliberate release of genetically engineered organisms; (4) guideline enforcement; and (5) the relationship between committees and federal agencies.