Sub-working Group on the Roadmap for Risk Assessment

POSTED ON BEHALF OF PAUL KEESE

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Dear Hans

My sincere apologies for this tardy response, but I would like to applaud you for all of your sterling efforts at casting pearls before us (or is it more the making of silk purses?). So far, the Roadmap is certainly proving to be a ‘living document’ with continual improvement over remarkably short time frames.

Just a few comments.

General comments

    * As this is not a consensus document, but one that is from the Chair, it would be better to acknowledge this fact up front.
    * We seem to have lost, or watered down, the primary goal of this document being useful for less experienced risk evaluators or where risk assessment methodology is still under development.
    * There is still insufficient guidance on paragraphs 6 and 7 of Annex III, which is of particular significance for differentiating requirements for field trials vs commercial releases of LM plants. More clarification could be useful here.
    * It would seem preferable to use international guidelines wherever possible, or experience from risk assessments from currently approved LMOs, rather than create standards de novo in areas that remain contentious as to their meaning and treatment, eg data quality and uncertainty.
    * There should be a caveat placed on step 5. By all other international standards regarding risk assessment, step 5 is part of risk management, not risk assessment, and therefore subject to policy and decision-making settings rather than scientific standards.
    * The flowchart is overly complicated, difficult to follow connecting arrows, does not distinguish clearly between the risk assessment and external issues (eg phase IV) and would suggest combining phase I and II in a simple way, as I am somewhat uncomfortable with a notion of a phase prior to planning. See attached figure for a simplified alternative for your consideration.


Specific comments

    * Line 19, except for HGT, this document relies almost exclusively on experience with a couple of traits in a few plant species, not really much on LM micro-organisms.
    * Line 61, it is not so much about ‘increase the confidence’, but reserving more detailed consideration of those risks that are considered more important.
    * Lines 93-103, would be better replaced by the WHO 2008 criteria as the starting point. The overuse of the word scientific in its current form is misleading (there are no “scientifically robust standards” for data quality. In reality, as regulators we consider all of the information that is available, including much useful technical information, as well as scientifically dubious information. It is more a matter of being transparent in our judgement of the value we attach to that data).
    * Lines 118-133, provide excessive discussion of uncertainty in ways that have not been used for risk assessments of currently approved LMOs. It also includes confusing notions about uncertainty. Risk is about uncertainty and the risk assessment as outlined by steps 1-5 is already a systematic analysis of uncertainty. The type of uncertainty described in lines 118-133 is more a second order uncertainty consideration, but done in an idiosyncratic manner. For example, the primary reason why uncertainty may not be reduced by additional data is due to the nature of the uncertainty (eg variability or descriptive [linguistic] uncertainty), which can be better characterised or specified but is immune to uncertainty reduction by more data. Take for example Mendel’s 3:1 segregation ratio that characterises the uncertainty of dominant vs recessive phenotypes in the progeny from reassortment of heterozygous alleles. It cannot be reduced, no matter how many progeny are examined.


I look forward to meeting you and all of the others soon.

Best wishes
Paul