ABSTRACT

The objective of risk assessment as set out in Annex III of the Cartagena Protocol on Biosafety is to identify and evaluate in scientifically sound manner any adverse effects of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity in receiving environment, taking into account human health. The central role of risk assessment in the biosafety protocol as a basis for informed decisions on the transboundary movement of LMOs was never fundamentally questioned. The protocol also requires the party of import to ensure that a risk assessment is carried out, and it may require the exporter to carry out the risk assessment. Risk assessment is a tool used by authorities to make informed decisions regarding the transboundary movement of living modified organisms. In discussing the development of technical guidance for risk assessment, an inescapable fact is that the concept of risk varies culturally and individually as well as temporally and spatially.