Broad political debate

Political consensus on PP/Treaty basis

Invocation of PP : scientific uncertainty/threat of adverse effects (two trigger off factors)

« act rather than not to act »

Invoking the PP, implies a delicate interplay between

the choice of possible normative standards of acceptability

and

scientific assessments whether such standards would be violated without regulatory measures

Relevance of uncertainties and available knowledgeScience-policy interface/Risk management

Identification of state of affairs in affairs in science/normative qualification of uncertainties

Lack of knowledge/scientific controversy : application of PP

Normative qualification of available information. Relating the quality of available information to « degree of seriousness »

Knowledge assessment

• Normative qualification of available knowledge• Normative qualification of knowledge gaps and

“need to knows”• Relating the quality of the knowledge(or an

assessment of particular uncertainties to the seriousness threats/oppertunities/challenges

• Knowledge assessment relates to place of knowledge production and knowledge procurement among institutions and actors

Non-directional cycle of deliberative normative policy filters

Knowledge-assessment

Where, following an assessment of available scientific information, there is reasonable concern for the possibility of adverse effects but scientific uncertainty persists, provisional risk management measures based on a broad cost/benefit analysis whereby priority will be given to human health and the environment, necessary to ensure the chosen high level of protection in the Community and proportionate to this level of protection, may be adopted, pending further scientific information for a more comprehensive risk assessment, without having to wait until the reality and seriousness of those adverse effects become fully apparent (Von Schomberg et al, Implementing the PP, Edgar Elgar, 2006).

Regulation 1331/2008 on assessment of food enzymes/additives/flavourings

“It is recognised (...) scientific risk assessment alone cannot provide all the information on which a Risk Management decision should be made, and (...)Other legitimate factors (....) may be taken into account including societal, economic, traditional, ethical and environmental factors and the feasibility of controls

Limits to implementation

• Case for case assessment necessary but impossible?•Costs of risk assessments: 249 million-1,2 billion for 190 available nanomaterials(34-53 years to implement(Choi,J et al 2009)•Constaints on testing (EU cosmetics, no animal tests)

OR EVENTUALLYApplying PP: No “feasibility of control” , thus.....

European CommissionResearch DG

Governance and Ethics

Dr. Dr.phil. Rene von Schomberg.

Publications:on Governance and Ethics of emerging technologies, foresight and precaution: Rene.vonschomberg@ec.europa.euhttp://ec.europa.eu/research/science-society