Flowchart ("Roadmap") for risk assessment: the necessary steps to conduct risk assessment according to Annex III of the Protocol
by Hans Bergmans, National Institute of Public Health and the Environment (RIVM), Bilthoven, Netherlands. E-mail: [email protected]
In accordance with Annex III of the Protocol, risk assessment has to be performed in a scientifically sound manner, following a sequence of steps and taking into account the relevant scientific information on a number of points to consider. The methodology reflected in Annex III is not developed ‘de novo’ but rather based on the experience of over 20 years of risk assessment and on the general principles as laid down in international documents such as the 1986 OECD
Recombinant DNA Safety Recommendations and the 1995 UNEP
International Guidelines for Safety in Modern Biotechnology.
With a view to strengthening and promoting capacity building for risk assessment as well as contributing to international harmonization, the COP-MOP decision BS-IV/11 calls for the development of “a ‘roadmap’, such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol and, for each of these steps, provide examples of relevant guidance documents”.
This further elaboration of the
Annex III of the Protocol is aimed at integrating the “Points to consider” (paragraph 9) into the steps of the risk assessment process as established (paragraph 8) by listing the former that may be relevant in the different steps, based on the existing experience with the methodology of risk assessment, whereby some points to consider have been clarified or made more explicit.
It is hoped that once the information has been integrated, the resulting flowchart will contribute to retrieving information that could be useful at the different steps and stages in the process of the risk assessment. The “Points to consider” in each step are in fact the ‘crossroads’ on the road map for risk assessment, where the available information that may be relevant to each of the ‘crossroads’ can be found. The flowchart may be used in mining data from literature databases and could help users to retrieve these data for use in their particular circumstances and cases. As the Protocol explains, the required information may vary in nature and level of detail on case-by-case basis, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.
The purpose of the Discussion Group “Flowchart (‘Roadmap’) for risk assessment: the necessary steps to conduct risk assessment according to Annex III of the Protocol” is to collect views on how to enhance the integration of paragraph 9 of Annex III into paragraph 8, that would be taken into account by the AHTEG in the further development of this integration.
Furthermore, in this process, views and examples will be collected on how to use the flowchart as a help for information retrieval.
Return to the
discussion page.
