Risk Assessment

Risk assessment is inherently the most critical component of biosafety implementation. Those who make determinations of the relative safety of a biotechnology product and its use will be well served to master an understanding of the approaches that have been used for assessment of environmental risk and the reality of what an assessment may or may not do. With some grasp of the basics, better choices of personnel, education, and training needs may be brought to the formation of biosafety committees and their implementation of regulations or laws.

To fully understand the concepts of risk assessment, it is necessary to have some comprehension of what it is and, as importantly, what it is not. A number of definitions have been offered. Each assumes a basis in or reliance on scientific information. In the broader view, risk assessment is a means for dealing with uncertainties and incomplete data in order that decisions may be made in full consideration of potential consequences. It is influenced by policy choices, individual experience, and public reaction.

Methodology for Biotechnology Risk Assessment

A generally accepted methodology for biotechnology risk assessment has been outlined in several easily accessible documents including the UNEP International Technical Guidelines for Safety in Biotechnology3, the Cartagena Protocol4, and EC Directive 2001/18/EEC5. Each of these include the following steps that, together, identify potential impacts and assess the risks:

1. Identify potential adverse effects on human health and/or the environment

2. Estimate the likelihood of these adverse effects being realized

3. Evaluate the consequences should the identified effects be realized (the risk)

4. Consider appropriate risk-management strategies

5. Estimate the overall potential environmental impact, including a consideration of potential impacts that may be beneficial to human health or the environment

At any point, more data may be needed to arrive at a final recommendation about whether the

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