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Risk assessment is a part of a comprehensive risk governance process. Risk governance is a systematic approach toward coping with risks under participation of all relevant actors—government, companies, the scientific community, nongovernmental organizations (NGOs), and the general public. Risk assessment is a tool for gaining knowledge about risks. It aims to identify and explore the type, intensity, and likelihood of the consequences related to an activity or event.

In the field of nanotechnology, risk assessment is difficult, due to the fact that there is no clear definition of nanotechnology. It is still unclear which research and development activities produce new technological phenomena that are related to unknown impacts, and therefore deserves a carefully performed risk assessment. At present there is a certain consensus that there is demand for a risk assessment of engineered nanomaterials, especially synthetic nanoparticles. In this respect, the exposure rate of a person or the environment is an important aspect in assessing risks related to nanoparticles.

Risk Identification

Risk denotes a concept that combines a specific adverse or harmful outcome of an action with the possibility of occurrence of this outcome. Risk identification will start with an analysis of what major societal actors (government, companies, the scientific community, NGOs, and the general public) define as areas of concern or impact that they regard as risks.

There are two main obstacles in identifying possible hazards. The first is connected to the limitation of knowledge. In many cases the possible impacts (for instance, of new technologies) are simply not known. Experience from the past can be used to construct scenarios that illustrate potential hazards related to the application of the new technology. But it is not possible to anticipate all potential scenarios.

The second is based upon the classification of an outcome as an undesired consequence. There is no disagreement that any threat toward health and prosperity to a person is adverse. But there exists a considerable personal and cultural disagreement about the assignment of an event as something that could have been avoided, and which has to be object of a risk assessment.

What is perceived as risky could vary considerably from person to person, but also depending on scientific evidence. Whether a certain consequence of an action is perceived as a risk or not depends highly on the existing knowledge and on the belief of its controllability.

These aspects are objective of concern assessment and the investigations of risk perception.

Risk Evaluation

Risks are characterized by the extent of damage, the probability of its occurrence, and the extent of its uncertainty. In case of release of chemical agents or nanoparticles, the exposure rate and reversibility are other additional important aspects. With the help of these characteristics, societal (value-based) balancing of benefits and risks (including societal needs, contribution to quality of life, contribution to sustainability, potential of substitution and compensation, policy imperatives) are performed. The result is a judgment whether a risk is acceptable, tolerable, unacceptable, or not defined. Stakeholders play an important role in this process.

Related to nanotechnology, risk assessment is confronted with additional problems. Due to the broad definition of nanotechnology, it is unclear which technical developments should be the object of a risk assessment. It is obvious that a risk assessment of nanotechnology in general does not make sense.

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