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 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. (shrink)

Substantial equivalence has beenintroduced to assess novel foods, includinggenetically modified food, by means ofcomparison with traditional food. Besides anumber of objections concerning its scientificvalidity for risk assessment, the maindifficulty with SE is that it implies that foodcan be qualified on a purely substantial basis.SE embodies the assumption that only reductivescientific arguments are legitimate fordecision-making in public policy due to theemphasis on legal issues. However, the surge ofthe food debate clearly shows that thistechnocratic model is not accepted anymore. Food is more (...) than physico-chemical substanceand encompasses values such as quality andethics. These values are legitimate in theirown right and require that new democraticprocesses are set up for transverse,transdisciplinary assessment in partnershipwith society. The notion of equivalence canprovide a reference scale in which to examinethe various legitimate factors involved:substance, quality, and ethics. QE requires that newqualitative methods of evaluation that are notbased on reductive principles are developed. EEcan provide a basis for the development of anEthical Assurance as a counterpart of QualityAssurance in the food sector. In France, asecond circle of expertise is being set up toaddress the social issues in food public policybeside classical risk assessment by the firstcircle of expertise. Since ethics is likely tobecome an organizing principle of the secondcircle, the equivalence ethical framework canprove instrumental in this context. (shrink)