Dear participants to the Open-ended Online Forum and AHTEG,

I am pleased to announce the opening of the online discussion on "Exchange of experiences from the testing of the Guidance on Risk Assessment of LMOs" at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml.

In this discussion, you are invited to share views on the ongoing testing of the overall utility and applicability of the draft revised “Guidance on Risk Assessment of LMOs” (dated 15 September 2011; available though the link above) by:

a) Submitting the results of your own testing (please fill out and upload the questionnaire available in the link above);

b) Providing comments on the testing results already submitted (available at http://bch.cbd.int/onlineconferences/ra_guidance/testing.shtml); and

c) Sharing experiences relevant to the testing of the Guidance.

This online discussion will take place for 5 days only and will close on 3 December 2011 (1:00 a.m. GMT), while the deadline for submission of testing results is 15 December 2011.

Please do not hesitate to contact me (manoela.miranda@cbd.int) if you have any question.

Thank you and best regards,

Manoela

POSTED ON BEHALF OF PIET VAN DER MEER

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Please find attached the results of testing conducted by the PRRI Working group on Risk Assessment of the draft guidance on risk assessment of living modified organisms, part I (“the Roadmap”) relating to Step 1 through Step 3. 

While PRRI anticipates submitting additional results prior to the December 15 deadline, we submit these comments now, so that they can be taken into account in the current online forum. 

To avoid confusion, the additional testing results will not address the Steps 1 through 3 of the roadmap.

Yours sincerely


Em. Prof. Marc baron van Montagu, Chairman of the Public Research and Regulation Initiative

Dear Participants,
Please find attached the results of testing conducted by the PRRI Working group on Risk Assessment of the draft guidance on risk assessment of living modified organisms, now including part II.
In addition, PRRI Working Group on RA of LMOs believe that several terms in the glossary need to be better worked on. Unfortunately, it seems that the input is limited to a very small number of characters and not even the most relevant clarifications had space to be added.
One such example, is the definition of "Introgression" lines 1446-1447, it is important to mention that key to introgression is that a trait stays in the receiving population for a sustained period of time (See Ellstrand). For Risk assessment, lines 1477-1480, it is better to copy the definition the definition of Annex III.  And several other examples.
warm regards,
Lucia

dear all,
I'm having problems to attach the document, therefore I'll send to the Secretariat.
best regards,
Lucia

Thanks very much for the opportunity to comment.

With regard to the analysis of the testing I found the compilation quite confusing and with the aggregation of the results, I am not sure if this was a true reflection of the range of experiences. 

My major concern is that the evaluation of the Roadmap by an inexperienced risk assessor will skew the outcomes since they have no context for comparison.  In the absence of any kind of comparator, near isogenic or not, it is difficult to provide a useful evaluation, other than to say that it may be better than nothing, which is hardly helpful.  

The experienced evaluators in my own group who routinely conduct risk assessments on the commercial release of transgenic plants were very much of the view that guidance was confusing and more likely to lead an inexperienced risk assessor down unhelpful and time consuming avenues since in many cases the connection between potential harms and probable pathways to harm are unclear or unexplained.  To me, the link between protection goals and assessment endpoints is still not well developed and this step is key in the problem formulation phase of the risk assessment.  Data review exercises without clear goals can only add to uncertainty and diminish the value of the risk assessment.

In Canada, we feel the Roadmap still requires substantial work before it is a useful tool for inexperienced risk assessors of products of biotechnology.  The additional effort is required to improve the readability, standardize the language and concepts and clarify the process.