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Development of the Roadmap for Risk Assessment

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The objective of this Discussion Group is to provide input to the AHTEG Sub-working Group (SWG) for the development of a roadmap for risk assessment. For more information on the work of the AHTEG and its SWGs, please follow this link.

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Contents

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Introduction to the work of the SWG

In decision BS/IV 11 of COP-MOP/4, the Parties to the Protocol established an Ad Hoc Technical Expert Group (AHTEG), that was tasked, inter alia, with the mandate to “develop 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”.

The AHTEG will be conducted in two sessions. In the first session, which took place from 20 – 24 April 2009, an initial draft of the roadmap was prepared (see Annex I in the report of the AHTEG). This initial draft will be developed further during the period until the second session of the AHTEG, in April 2010. In the second session, the roadmap will be finalized for the effective use of information and guidance documents on risk assessment.

In its first session, the AHTEG has established an Sub-Working Group (SWG), consisting of those members of the AHTEG that were interested in further developing the Roadmap. The AHTEG elected Hans Bergmans (NL) as chair of the SWG.

The first step in the development has been a commenting period for the members of the SWG, in which texts were provided for a number of places where there were open spaces in the initial draft. At the same time, the members of the SWG also contributed many other comments and suggestions. These comments have been combined in an advance draft of the Roadmap, that will now be open for general discussion on the Online Forum that has been announced for 22 June – 6 July 2009.

Aim of the Roadmap for risk assessment and risk management, in accordance with Annex III of the Cartagena Protocol on Biosafety

Paragraphs 8 and 9 of Annex III of the Protocol provide a description of the risk assessment process and points to be considered in the process. The Annex does however not describe how the steps described in paragraph 8 are to be linked to the points to consider in paragraph 9. In general, the structured approach that is required for risk assessment is not detailed in Annex III.

The Roadmap aims to provide the description of such a structured approach, based on Annex III. It describes rationales for the steps in paragraph 8, and the interrelationship between the steps. It then lists points to consider for each step, and provides explanations where necessary. The Roadmap starts with general considerations and overarching issues, that should be taken into account during the entire risk assessment process.

The Roadmap applies to risk assessment of all types of LMOs and applications within the scope of the Protocol. It is meant to be useful, inter alia, in developing capacity in countries where a risk assessment framework is not yet available.

The Roadmap is also meant to provide a framework for risk assessment information. A general need is felt for a better organization of the information that is available on risk assessment of LMOs within the context of Annex III. The BIRC contains some 200 information and guidance documents, but it would be helpful if these documents were organized on basis of the step in risk assessment where they provide information on. Examples are: documents on biological characteristics of recipient organisms, on traits introduced into LMOs, on how to characterize receiving environments, etc.

The Roadmap could be used as a frame of reference for these documents, assigning documents a place in the framework of the Roadmap where they fit. This would be straightforward for documents on biological characteristics of one organism, or on characteristics of a certain trait. There may also be guidelines that cover a broader area, and these could be assigned to different places in the Roadmap.

The present version of the Roadmap provides a few examples of documents providing supplementary information, as examples. These lists should be further developed for the effective use of information and guidance documents on risk assessment.

The ‘advance draft of the Roadmap’

The present ‘advance draft’ provides a rather developed version of the Roadmap, but it is far from finalized. More reflection and discussions are needed to see whether it meets the aims of elucidating the process of LMO risk assessment under the Protocol, and providing a framework for the use for guidance documents.

While compiling the comments from the members of the SWG also a number of discussion items became clear, where there are differences of opinion, or where more reflection is needed. These discussion items have been taken on board at the end of the document, and are referred to by footnotes in the document. These items are for discussion in the next step: the general discussion in the Online Discussion Forum, mentioned above.

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Advance draft of the Roadmap

This 'advance draft' was prepared by the SWG and provides the basis for discussions.

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Guiding questions

The following questions were prepared by the Chair of the SWG to assist the discussions on this topic.

  • Does the Roadmap provide a clear description of the risk assessment process in the context of Annex III?; do you have suggestions for improvement?
  • Is the Roadmap useful for you, to improve your grasp on the LMO risk assessment process, and for capacity building purposes; do you have suggestions for improvement?
  • Could you consider the discussion items that are referred in several footnotes in the document, and that are listed at the end of the document, and provide us with your points of view and reflections on these items? Your textual comments and comments on content, e.g. items or considerations that are missing, as well as further discussion items that you feel should be considered, are very much appreciated.
  • Do you see value in the Roadmap as a structure for the effective use of information and guidance documents on risk assessment, as explained above; do you have suggestions for improvement?
  • Could you please provide us with more examples of information documents, and indicate where in the Roadmap they should be assigned?

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