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Risky creatures: Institutional species boundary change in biotechnology regulation

Novel biotechnologies present acute difficulties to regulation for the very reason that they traverse the boundaries between existing regulatory authorities, their terms of reference, their disciplinary capabilities, and so on. To this extent, they are hybrid phenomena, difficult to categorise and a source of acute uncertainty. Moreover, most biotechnologies confuse and trouble the distinctions between different species. These species disruptions are particularly evident in transpecies transplantation, an illustrative case that we address in detail throughout this paper. From time to time, questions about the safety of such hybrid risks have inspired the establishment of equally hybrid regulatory agencies. Such 'institutional hybrids' are 'risky creatures' and are therefore important objects of social science critique if we are to understand whether or not they have successfully traversed otherwise dangerous gaps in risk regulation. To illustrate these processes of institutional species boundary change, we draw on two examples in the regulation of xenotransplantation. The first examines the establishment of a specific institutional hybrid body for regulating transpecies transplantation, and especially, the scope and limitations of its hybridity. In this way it becomes possible to see how biotechnology is carved up and distributed between various arms of regulation. Second, we document important changes in the definition of xenotransplantation, illustrating the acute difficulties faced by hybrid regulatory institutions in determining what developments they should and should not be regulating.