Sub-working Group on the Roadmap for Risk Assessment

POSTED ON BEHALF OF DAVID HERON

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Dear Hans,

First, let me congratulate you on your outstanding stamina over many months.  The Roadmap has improved greatly, in no small measure to your efforts.  I think that there are still some issues that need further attention, and I have tried to summarize the general ideas in this email, with more specific suggestions included as comments and track changes in the attached document.  It's been a challenge to get all of the suggestions to track changes incorporated, so I hope my list below can serve as a useful guide when I have not marked specific text.  I know you will find a way to make these suggestions best fit with the overall text of the Roadmap.

Please excuse the odd formatting below:

AHTEG_Roadmap_notes14March2010_DH

Roadmap comments (specific text suggestions added as track changes to 07March draft):

1.        Simplify the text overall, remove redundant text, replace jargon, avoid overly academic tone
2.        Provide context on how the document was developed
2.1.        Who were the members of the AHTEG and what written qualifications did the Secretariat use to select them from all nominees (CVs or other written qualifications should be made available in the document or online so the  public can evaluate the expertise the AHTEG could provide in the development of the Roadmap)
2.2.        State how the alternative/dissenting views on ideas in the Roadmap are noted in the text
2.3.        State whether the Roadmap text reflects consensus of all members of the AHTEG or is a “paper of the chair” (Chairperson considered all input but made the final decision about what was to be included, excluded, and the way the document is organized).  Advantage of ownership by the “chair” is that there is no need to state, point by point, which ideas were predominant, which were minority. This was the approach used in the draft last summer, but the current draft no longer describes this as the approach used in drafting.
3.        Keep the scope of the Roadmap restricted to risk assessment
3.1.        Remove text dealing with decision making, precaution, or other aspects of the Protocol. 
3.2.        Make simple, clear statement at the outset of the Roadmap that says that the Roadmap was developed to help people to conduct a risk assessment as consistent with the Protocol (specifically Annex III of the Protocol).
3.3.        Because the AHTEG members were not chosen for expertise in areas of the Protocol outside risk assessment, it is not appropriate for them to digress beyond their expertise and the charge that they have been given from the decision of the Parties.
4.        Acknowledge previous experience around the world in doing environmental risk assessments (not necessarily tied to the Cartagena Protocol, but done under national legal systems).  The Roadmap seeks to acknowledge this experience and offer insights learned over more than 20 years
4.1.        RAs for confined releases since 1987
4.2.        RAs for unconfined releases since 1992
4.3.        For some LMOs RAs have been done by many countries
5.        Roadmap, like Annex III, is used for variety of environmental releases of LMOs
5.1.        Different types of organisms (although most of our experience to date with conducting environmental risk assessments of LMOs in support of governmental regulatory procedures has been in the area of LM plants
6.        Decide whether the release is intended to be confined (less environmental exposure in space and time) or unconfined (greater environmental exposure in space and time
6.1.        Note that confinement approaches can be physical, biological, or temporal
6.2.        In general, far less information is needed for environmental release that are confined than for releases that are unconfined
6.2.1.        (Countries with experience in risk assessments have found that failure to take this into account may place unnecessary requirements for information that will be prohibitive for conducting small-scale, confined environmental releases that are of limited duration). 
7.        Our experience with environmental risk assessments for non-LMOs is typically used in the approaches to evaluating LMOs.  This is a valuable resource when identifying the right people with technical expertise in the biology of the organism as well as the types of environmental interactions that organism has. 
8.        Discussion on “uncertainty analysis” is overly academic, not appropriate for Roadmap
8.1.        The preferred option is to remove this entirely from the Roadmap (not appropriate or helpful)
8.2.        If people insist on keeping a discussion of uncertainty analysis in the text, there should be a clear statement that if uncertainty analysis is done for the potential risks of the LMO, this analysis can only be relevant if a similar uncertainty analysis is done for the existing situation (e.g, the non-LMO parental organism).  Balanced analysis is needed if there is to be a meaningful comparison.  Most people will find that there is just as much uncertainty about the existing situation as the proposed environmental release of the LMO, so the whole issue of uncertainty analysis as presented in the March 7 version of the Roadmap is not really helpful for most risk assessors.
9.        Provide the missing or correct references necessary for the text (these seem to have disappeared in current versions)
9.1.        Double check references in Hans’ version with those on AHTEG web pages (some references seem to be only in one location)
9.2.        Correct citation for precautionary approach should be the Rio Declaration or Convention, not an EC document that is cited on the AHTEG web page link.
9.3.        Add references for the existing guidance documents for environmental risk assessment of GE organisms
9.3.1.        OECD “Blue Book”
9.3.2.        OECD “Scale up” (this is especially important to cite this document and other existing documents at the outset of the Roadmap so the reader knows that the AHTEG is aware of how the Roadmap is intended to augment guidance documents that already are in existence
9.3.3.        Canadian guidance documents have info and have been largely practical in implementation
9.3.4.        Australian and/or NZ guidance documents for assessments, types of information that is appropriate and practical depending upon the type of LMO and whether the release is confined or unconfined.
10.        Revise Flowchart
10.1.        Current version is too complicated and hard to follow
10.2.        It should mimic the Roadmap with the
10.2.1.        same terminology (current version does not)
10.2.2.        same scope (e.g., eliminate box for “phase 4” decision making, etc. since it’s not risk assessment)
10.2.3.        Phase I is likewise not within the scope of risk assessment; it’s text also implies extra requirements that are not part of Annex III
10.3.        Add key elements overarching the steps of Annex III
10.3.1.        Ascertain if the release of LMO is intended to be Confined or Unconfined (this is essential for the risk assessors, but is not noted in the flowchart
10.3.2.        Gather appropriate people with expertise in the species (e.g., experts in mosquitoes if the LMO is a LM mosquito, experts in maize if the LMO is LM maize). 

Hans, I'm looking forward to our further discussions in Slovenia.  If you have any questions about my suggestions or comments before then, please do not hesitate to contact me.

Thanks very much,

Dave