Risk Governance

Pre-Assessment

The pre-assessment phase has the purpose of providing a structured definition of the problem and how it may be handled. Pre-assessment forms the baseline for how a risk is assessed, evaluated, and managed from the different stakeholder perspectives. IRGC identified two major frames of nanotechnology products and production processes::

Risk appraisal comprises both a risk assessment—a scientific assessment of the risk's factual, physical, and measurable characteristics including the probability of it happening—and a concern assessment—a systematic analysis of the associations and perceived consequences. The concern assessment seeks to establish the public's concerns and perceptions and the likely social response to the risk. In the field of nanotechnologies both knowledge about risk assessment and public attitudes about the acceptability of nanotechnology applications are in constant development and interaction. Therefore, risk appraisal will remain an ongoing challenge.

Characterization and Evaluation

Risk decision makers and regulators have the task of making a judgment about the balance between the potential negative and positive impacts. There are an enormous number of existing and anticipated nanomaterials and nanostructures as well as potential applications. [Page 677]It is therefore not possible to make a single judgment for nanotechnology as a whole. Currently, it is necessary to look at each application, to collect what is known about the impacts and then to make a judgment of acceptability or tolerability on a case-by-case basis. The issue of the difficult characterization implies further consequences for the application of regulation.

Risk Management, Regulation, and Self-Regulation

Risk management includes the generation, assessment, evaluation and selection of appropriate risk reduction options as well as implementing the selected measures, monitoring their effectiveness and reviewing the decision if necessary. Notwithstanding the public debate on the benefits and risks of all the various applications of nanotechnology, companies developing or marketing products based on nanotechnologies or including nanomaterials are legally obliged to guarantee that their products are safe and that they do not cause any harm to humans, animals or the environment. In a situation in which risk assessment protocols are in the stage of development and potential societal impacts are still uncertain there is a need for promulgating internationally binding guidelines for a responsible and precautionary risk management.

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