REGULATORY OVERSIGHT OF GENETICALLY-ENGINEERED MICROORGANISMS - HAS REGULATION INHIBITED INNOVATION

Using detailed interviews with company representatives and researchers in the field, this paper examines the factors that might account for the slow pace of development of genetically engineered microorganisms (GEMs) intended for environmental release. We specifically analyzed th e role of the regulatory system in shaping innovation, We identified a t least two cases where industry decided to discontinue the developmen t of a genetically engineered microbial product because of concerns ov er regulatory oversight. However, most often industry decisions to con tinue or halt development of GEMs were based on an evaluation of the p articular product's efficacy and potential for profitability. Thus the inability of GEMs to perform up to expectations in the field, rather than the regulatory constraints, appears to be the factor responsible for the slow pace of development.