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Testing of the Roadmap for Risk Assessment

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Your input is asked for the discussion on how to create links between the Roadmap and guidance documents in the BIRC [#1531]
In several places in the version of the Roadmap of 8 November 2009, it is announced that at a later stage of development of the Roadmap, examples of supporting guidance material will be provided (see lines 186, 221, 240, 259, 294). It is envisaged that this will be done in the form of links to guidance documents that are available in the Biosafety Information Resource Center (BIRC) of the BCH.
Links to guidance documents may be provided not only in the places where this has been indicated. They may be provided for any step or any topic in the Roadmap, for which guidance is useful and available.
This is seen as one of the important functions of the Roadmap: next to providing a structured approach to the risk assessment process in accordance with Annex III of the Protocol, the Roadmap will also help risk assessors by to pointing at available guidance documents on risk assessment that may be helpful.

Although the idea of making connections between steps and topics in the Roadmap and available guidance documents is attractive, it is not straightforward to put the idea into practice.
Questions that arise are, for instance:
- How to select relevant documents from the BIRC, and how to allocate relevant guidance documents to the topics in the Roadmap?
- What are the criteria for guidance documents that can be referenced in the Roadmap? They should be relevant for environmental risk assessment and non-trivial, but what other quality criteria should be met?
- Who is responsible for the selection and the allocation? (For instance: a steering committee of some kind could take care of this, if clear criteria can be made for the selection and allocation.)
- The references should also be kept up-to-date. At what time interval should this be done?
- May links be provided to other sources than the BIRC (this may pose problems with continuity; links to the BIRC can be assumed to be stable, but how about links to other URLs?). Or should all guidance documents be available on the BIRC in principle?
- You are invited to add your questions to this list.

Please provide us with your comments to the above questions.
The development of the mechanisms by which the links between the Roadmap and the BIRC will be made, will be further discussed in the second session of the AHTEG.
Your input into this discussion is very much appreciated!
posted on 2009-12-09 20:36 UTC by Hans Bergmans, Netherlands
 
RE: Your input is asked for the discussion on how to create links between the Roadmap and guidance documents in the BIRC [#1532]
I agree with Hans that at a later stage in the development of the road map (maybe now or after the next MOP, appropriate supporting guidance material be provided. This will help strengthen the utility and applicability of the road map in different situations. Moreover, the road map is a compressed framework for carrying out risk assesment in accordance with annex III. The details can be in the form of links.

However, the guidance documents should be relevant, factual and current. For them to be current, it means mechanisms have to be found for regular updating. The identification and allocation of guidance documents to specific topics on the road map requires wisdom to sift through a variety of sources and zero in on those which add value to the risk assessment process.

As to who should be involved in this process, I think a non-partisan, all inclusive stakeholder grouping should carry out this noble work. Whether this is a steering committee or any other credable structure makes no difference to me.

Abisai Mafa, Zimbabwe
posted on 2009-12-10 06:46 UTC by Mr. Abisai Mafa, Biosafety Board of Zimbabwe
 
RE: Your input is asked for the discussion on how to create links between the Roadmap and guidance documents in the BIRC [#1550]
I fully agree with Abisai and Hans that it is crucial to maintain  a set of guidance explicitely linked with the roadmap but independant from it and easily accessible.

This set of guidance will allow to design the roadmap according to its initial objective. In the same way a city-tripper use a guide book and a city-map, the risk assessor starting his travel throughout the risk assessment land will have the set of guidance and the roadmao as available tools.

The source of documents can be documents produced by recognised international institutions like
- OECD consensus documents produced by the Working Group on Harmonization of Regulatory Oversight.
- Publications of the International Society for Biosafety Research (ISBR), ILSI CERA etc.
- ICGEB and CGIAR could also provide useful sources and tools.
- The publications of regional and national agencies (USDA/APHIS, CFIA, EFSA, OGTR etc.) might also serve as references while distinguishing from the international publications.

It is also of utmost importance that this information is current and accurate. I support the idea of setting up an independant board of reviewers, representative of involved stakeholders (governments and practitioners) with the administrative support of the Secretariat.
posted on 2009-12-13 10:24 UTC by Jean-Francois Sarrazin, Bayer Cropscience NV
 
RE: Your input is asked for the discussion on how to create links between the Roadmap and guidance documents in the BIRC [#1552]
I agree about the need and usefulness of guidance documents from other international bodies linked to the roadmap but to create another review board within the CBD? I think that is redundant. What I think is more productive is a regular meeting among regulators from various countries to share their experiences and insights to be sponsored by the Secretariat. All of us are really new to this experience and as we are faced with the situation in our countries we may react differently and have our own reasons to have done so.
posted on 2009-12-13 13:49 UTC by Saturnina Halos, Philippines
 
RE: Your input is asked for the discussion on how to create links between the Roadmap and guidance documents in the BIRC [#1554]
Please do not overlook one of the most relevant sets of documents, the Principles and the Guidelines produced by the Codex Alimentarius' Ad Hoc Task Force on Foods from Modern Biotechnology, chaired by Dr Yoshikura, which are easily applicable to non-food LMOs as well.
posted on 2009-12-13 19:48 UTC by Professor Philip L. Bereano, Washington Biotechnology Action Council