European Biotechnology Regulation: Framing the Risk Assessment of a Herbicide-Tolerant Crop

As products of the "new biotechnology," genetically modified organisms have provoked a wide-ranging risk debate on potential harm, especially from herbicide-tolerant crops. In response to this legitimacy problem, the European Community adopted precautionary legislation, which left open the definition of environmental harm. When the U.K. proposed Europe-wide market approval of a herbicide-tolerant oilseed rape (canola), the proposal encountered dissent from some countries and environmentalisi groups. Further debate on normative judgments became necessary to implement the precaution- ary legislation. In dispute were several regulatory boundaries-of administrative re- sponsibility, causality, acceptability, and evidence. The boundary disputes expressed divergent framings of biotechnological risk, each with its implicit model of the socionatu- ral order In this way, the disputes can illuminate the sorts of risk framings that have already become embedded and standardized in other regulatory sectors

Recasting "substantial equivalence": transatlantic governance of GM food

When intense public controversy erupted around agricultural biotechnology in the late 1990s, critics found opportunities to challenge risk assessment criteria and test methods for genetically modified (GM) products. In relation to GM food, they criticized the concept of substantial equivalence, which European Union and United States regulators had adopted as the basis for a harmonized, science-based approach to risk assessment. Competing policy agendas framed scientific uncertainty in different ways. Substantial equivalence was contested and eventually recast to accommodate some criticisms. To explain how the concept changed, this article links two analytical perspectives. Regulatory-science perspectives illuminate how the scientification of politics and politicization of science led to shifts in the boundary between science and policy. Governance perspectives illuminate how the collective problem for policy was redefined to provide a new common ground for some stakeholders. Overall, substantial equivalence was recast to govern the social conflict and address legitimacy problems of regulatory procedures