EU Policy-Making on GMOs by Mihalis Kritikos

Author:Mihalis Kritikos
Language: eng
Format: epub
Publisher: Palgrave Macmillan UK, London

5.2 Risk Assessment and the Prior Authorisation Practice: Space for Non-scientific Factors?

The consideration of non-scientific factors or of those factors that do not derive from non-expert sources in the risk assessment procedure of the 2001/18 licensing framework will now be examined. This section demonstrates that major aspects of the genetic engineering issue go unnoticed, are neglected, undercommunicated, or instrumentalised because problems are only addressed from the point of view of the established notification requirements of a technical character. The section also highlights how the deployment of a particular expert-oriented risk assessment and management practice has prevented the pertinent regulatory debate from considering a range of other non-scientific contextual issues and has in fact trivialised their legislative weight.

More concretely, the examination of the risk assessment practice evidences that the GMO Panel has either not responded or rejected all those public comments that have been submitted to the SNIF database 39 and has made no particular reflection with regard to the respective non-technical concerns. Although this risk assessment practice might seem compatible with the technical character of the established notification and risk assessment requirements of the deliberate release framework, the realm of EFSA ’s competences, the composition of its GMO Panel, and the rationale behind the institutionalisation of the stage of risk assessment, is evidence that EFSA ’s approach to those concerns and challenges that have become associated with the commercialisation of plant biotechnology fails to meet the all-encompassing and inclusive requirements of this proceduralised framework. As it is further shown, the Commission has chosen to found its authorisation proposals and decisions exclusively upon EFSA ’s opinions and not to take into account the—as noted in the Directive—ethical and socio-economic aspects of agricultural biotechnology, narrowing, in this way, not only the frame of its risk management duties, but also the scope of the established risk analysis framework.

The examination of the relevant risk assessment practice indicates a major contradiction in the Commission’s regulatory approach towards the risks and the effects of genetic engineering. On the one hand, the Commission has initiated the creation of an authorisation framework that should operate via the fulfillment of a series of procedural duties, which offer various opportunities for the participation of actors with multiple interests. On the other, the operation of this framework as such indicates a sole emphasis on the scientific dimension of the risk assessment framework and the Commission’s persistence on grounding its arguments upon the opinions of the EFSA GMO Panel. The contradiction found between its intentions and the actual implementation is indicative of its preference for measurable and quantifiable forms of argumentation in the field of risk regulation.

The prevalence of ‘scientific argumentation’ as a source of ‘objective’ and ‘reliable’ input into the release framework can be seen in the marginalisation of non-scientific factors (lay views, public comments, socio-economic considerations) and the operationalisation on behalf of EFSA , as well as of the Commission, of only those provisions of the DRD that relate to the production and assessment of hard scientific facts. EFSA does

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