Sub-working Group on the Roadmap for Risk Assessment

I truly appreciate all the efforts my AHTEG colleagues, in particular Hans, have put into providing this draft.  I think significant progress has been made and acknowledge the improvements made in this new version of the Roadmap.  I believe these changes significantly improve the Roadmap’s usability.  However, while there have been improvements, I am providing some constructive edits to further improve the document.  These comments and edits may appear numerous, but they are basically focused on trying to simplify the Roadmap and deleting much text that is either confusing, redundant, or distracting to a person viewing this as guidance based on Annex III. 

I have found it helpful to better familiarize myself with existing guidance that is relevant for most Parties.  These include OECD guidance on field trials (1992), ISPM 11 (relevant to all WTO countries) and Codex.  For example, reference to “isogenic” in line 71 is incongruous with Codex guidance on comparative assessment.

You will find suggestions to further improve the Roadmap and make it a valuable guidance document for Parties that would have a need for such guidance are:
1.  We need to be careful not to imply that standards exist when they do not.  Within Overarching issues (starting on line 88), the bullets in lines 94 and 99 have significant flaws by referencing “standards” the both do not exist and are not necessarily required by the Protocol.  The Protocol makes no requirement for “standard practices of scientific evidence gathering”.   Furthermore, there are no widely accepted principles of verifiability and reproducibility.  As such, this section overstates these issues and should be edited to reflect a more accurate description of reality.  Importantly, the reference to verifying that a risk assessment is carried out (lines 102-103) could be misunderstood and result in a barrier to decision making.
2.  I would recommend deleting the much of the current text on uncertainty in the Introduction.  I am concerned that this is distracting from evidence-basd risk assessment. In fact, the reference to applying the Precautionary Approach in this context undermines the science process of risk assessment. Since, there is always uncertainty in a scientific examination the scientific approach is made irrelevant by the inevitable presence of uncertainty.  This reference to Precaution in the context of LMOs is only relevant to decision-making and not the risk assessment.
3.  I feel that the document needs a clear and consensus based definition of cumulative and combinatorial if it plans to use these terms.   As stated in lines 221 and 333, these terms are ambiguous and I really don't think this will be helpful to assessors unfamiliar with the basics of RA.  Also, there is no published guidance to which we could point people for a better explanation. 
4.  I've tried to edit Points to consider sections (e.g., section beginning on line 199) to ensure that the points noted have the appropriate comparative context for risk assessment.  References to rearrangements, deletions, receiving environment should be framed in the context of conventional counterpart if mentioned at all.  Also points (g) (line 238) and (h) (line 243) should be moved to Step 2 as they are part of exposure/likelihood assessment, not hazard identification.
5.  Step 2 needs a section on gene flow assessment, which could be accommodated by moving points (g) and (h) from the previous section to points to consider in Step 2.
6.  Step 3 is missing a very important body of information which are the endpoints from laboratory studies e.g., NOEL’s, NOAEC’s, LD-50’s and % dormant seed.  Explicit recognition of these outcomes that are considered important endpoints in a “consequences” assessment would help the Roadmap. 
7.  Finally, I believe that the “Issues Related to Decision-making Section are not related to decision-making within the context of risk assessment under the protocol.  Rather, they relate to other aspects of ensuring the safe transfer, handling and movement of LMOs.

Thanks again for the active involvement in this important work.

Tom