ABSTRACT

This chapter explains the National Research Council (NRC) also recommended the creation of a National Science Advisory Board for Biodefense. The NRC recommended the extension of biosafety measures to cover "experiments of concern" in addition to specified pathogens. Thus, the guidelines constitute a general standard of practice and care for biosafety risk assessment and management in the area of recombinant deoxyribonucleic acid research and commercialization. Synthetic biology research and commercialization raises three major policy issues: safety; bioterrorism; and the creation of "unfair" monopolies based on intellectual property rights. Furthermore, the existing United States (U.S) regulatory framework could deal with any potential risks associated with biotechnology products likely to be developed, at least in the foreseeable future. Federal regulators in the U.S have little experience with the potential risks posed by the possible impact and/or evolution of genetically engineered microorganisms intended for use outside the laboratory.