Sub-working Group on the Roadmap for Risk Assessment

Dear Colleagues,

Thank you for the opportunity to provide input.  The Road Map has certainly undergone a number of useful additions and the rich discussion has provided an interesting opportunity to exchange ideas.  The document in its current form will provide a useful basis for further refinement.  The Road Map has strongest value in the areas where it is most focussed on its original purpose of providing expanded guidance for Annex 3.  In the area where it strays from this purpose to become a discussion document on certain aspects of risk assessment, that utility is lost and the utility of the Road Map suffers as a consequence.  I have made changes to the Road Map in track changes and my general comments are as follows:

• The section on uncertainty adds confusion to the process since it does not provide guidance but rather wide ranging discussion. There is also the implication here that there are standard methodologies for uncertainty analysis for environmental risk assessment rather than intense discussion amongst expert risk assessment practioners.  The original guidance in Annex 3 on uncertainty is useful to a risk assessor and sufficient.

• The section on method verification is prescriptive and misleading by suggesting that there are recognized standards that can be referenced for data quality and standard operating procedures for data collection that can be applied to information supplied for an environmental risk assessment.  The original guidance on providing verifiable scientifically sound data is sufficient and recognizes that the risk assessment will be conducted by a scientist capable of applying their own professional standards.

• The section on molecular characterization is extensive and suggests analysis that are not generally agreed practice for an environmental risk assessment of an LMO.  In practice, the confounding effects of genome variability, mutations that arise for plant breeding, and environmental variability are recognized as confounding factors to any predictive value of an extensive genomic analysis and risk assessors rely heavily on the phenotypic analysis of the LMO.  The balance between the genomic and phenotypic analysis should be captured in this section as well.

• The entire section on decision making should be removed.  This falls outside of the context of the Road Map and the collective expertise for which experts were chosen for the AHTEG.

• The flow chart is an excellent addition to the document since it provides a graphical representation of the logic of the Road Map and how that relates to the conduct of an environmental risk assessment of an LMO.  With that in mind the boxes should align with the sections of the Road Map and the explanatory text removed and links to the relevant sections provided in the boxes.  This should enhance clarity and readability and ensure that the flow chart is consistent with the Road Map document.

I hope these comments are clear and I look forward to continuing our discussions at the face to face meeting and to sharing some of the reactions to the Road Map that I have received from expert groups in the European Plant Protection Organization and the IPPC. 

Best regards,
Phil