A report of the considerations of the overarching issue of uncertainty. This is to reflect the inherent uncertainty that exists when conducting a risk assessment due to, as previously mentioned, (i) lack of information, (ii) incomplete knowledge, and (iii) biological or experimental variability.

As seen in the previous module (Module 3, section 5), uncertainty is an inherent component of any risk assessment, and should be considered in a systematic manner at each step of the risk assessment process. Nevertheless, at the end of the risk assessment, uncertainties may still remain with regard to one or more specific steps in the process or about the likelihood or consequences of the potential adverse effects.

Annex III of the Protocol addresses this matter by requiring that “Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment”.