Institutions and science in the authorization of GMO releases in the European Union (1990-2007): The false promise of proceduralism.

This thesis examines the development and operation of the EU's legislative framework on the deliberate releases of GMO products as a case study of social regulation operating within a predominantly technical framework. The examination of the founding and implementation of this particular licensing framework has allowed for a reconsideration of the normative power of EU institutional structures in affecting the design and the outcomes of the application of the relevant authorization provisions. It is argued that in the case of the EU agricultural biotechnology framework, the particular institutional settings created for the formulation and interpretation of its provisions have been of decisive importance in elaborating a proceduralised 'science-based' prior authorization scheme as the preferred framework for granting commercial permits. It is further argued that the particular risk assessment and management practices have 'captured' the operation of this framework, perpetuating its self-referential character, and have as a result undermined the acceptability of the correspondent authorization decisions. The analysis and findings are based on documentary analysis and semi-structured interviews with regulators, risk assessors, public interest groups and biotechnology experts at the national and European levels. More precisely, the thesis argues that contrary to its defined objectives, the apparently proceduralised model of Community regulation, based on a decentralized and open-ended risk analysis structure, is in fact limited in accommodating 'alternative' conceptualisations of what constitutes 'acceptable risk' in the field of genetic engineering. The examination of the operation of the Deliberate Release regime has exposed a twofold misrepresentation regarding the apparently pluralistic and reflexive prior authorization control. Firstly, whereas the proceduralised framework has been destined to offer an all-embracing deliberation structure, the authorization decisions are exclusively based on EFSA opinions as the sole form of acceptable evidence. This practice has limited both the actors participating in the process and the range of factors considered. Secondly, the examination of the risk assessment practice demonstrates a dilution of the objective character of the conclusions reached in the context of the science-based licensing framework. The introduced proceduralisation paradigm is underdeveloped and lacks sufficient guarantees to ensure the consideration of all relevant viewpoints. It is concluded that, consequently, the non-hierarchical and open-ended structure suggested by this administrative model, leaves space that was destined for deliberation and reflection to be captured, in normative terms, by dominant institutional practices