ISHPSSB 2001 || Quinnipiac University, July 18-22, 2001

Regulatory Science II: GMOs, Uncertainty & Law

This session will explore policy issues concerning biological research. Examples of such issues are the precautionary principle, bioprospecting and biodiversity resource exploration, macro-agro-ecological zoning and development, and transgenic product regulation. Most themes reveal aspects of risk assessment negotiation, regulation debate, political debate on development, international trade, international relations and globalization issues.

Organized by: Marilia Coutinho & Les Levidow

Lino Paula, Leiden University
"Governmental Biotechnology Ethics Policy in the Netherlands"
An empirical study has been carried out to assess how the animal biotechnology issue has been addressed in the Netherlands. Central to the Dutch legal framework is a purely ethical review of animal biotechnology procedures by a national advisory committee. This proces, unique in the world, takes the explicitly legally recognised 'intrinsic value of animal life' as its point of departure. It was hoped that through the work of the committee the position of animals with regard to biotechnology would be clarified and strengthened. Also, government believed that consensus on this issue would thus develop over time. In particular, the interaction between the legal framework and the societal debate on this issue has been explored. The study provided information on the practical constraints on governmental ethical review and decision making. It shows that, although seemingly effective from a governmental point of view, the legal framework has not been able to build consensus. Problem definitions differed between the relevant actor groups, leading to persistently reoccurring objections to governmental decisions. Furthermore, the legal context in which the CAB functioned put constrains on dialogue about the issues raised and on the interaction between government and societal groups.

Keith Culver, University of New Brunswick
"Transgene Flow and International Law: Can Corrective Justice Be Achieved When Genetically Modified Organisms Escape?"
The next revolution in the production of animal protein will occur in the aquaculture of genetically modified (GM) organisms. This kind of aquaculture gives rise to legal and philosophical problems as yet only briefly treated. Popular aquaculture organisms such as salmon are known to escape across national boundaries, causing damage to national fish stocks, regional ecosystem health, and global biodiversity. Use of GM farmed salmon involves different, perhaps increased risk to surrounding environments and wild stocks.
Can corrective justice be achieved under current international regulatory mechanisms for redress of damages suffered in transboundary contexts? I shall argue that the current overlapping regime of national, regional and international regulatory and compensatory frameworks is ineffective for reasons not merely practical but conceptual also. The absence of reliable empirical information regarding the damage done by GM escapee salmon shows that no viable purposes is served by imposition of legal categories onto poorly understood biological phenomena whose existence cannot be neatly compartmentalized into national, regional, or global strategies for regulation and redress. The current system of overlapping regulatory norms of variable normative force must be replaced with what I sketch as a unified multi-lateral treaty on genetically modified organisms.

Les Levidow, Open University, Milton Keynes
"Sound Precaution?: GM Crops Across the Trans-Atlantic Divide"
Genetically modified (GM) products have been largely blocked in Europe. Although the commercial blockage mainly comes from food retailers, Europe has imposed a relatively more stringent regulation and delayed decisions on many products already approved in the USA. According to proponents of GM products, the Precautionary Principle allows politics to supersede science in Europe, by contrast to 'science-based regulation' in the USA. On the contrary, as this paper argues, regulatory decisions can never be based entirely on science. The Precautionary Principle shifts the criteria for scientific evidence; it can be more scientific by asking questions differently. 'Sound science' pre-empts such issues, even disparaging evidence of risk as unsound, thus representing political judgements as science. More stringent norms implicitly promote a different vision of the socio-natural order, e.g. a less intensive agri-environmental model. Sound precaution depends on acknowledging the values which guide risk research and criteria for evidence.

Part I: Intellectual Property

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