Activities of the Open-Ended Online Forum (2014-2016)

Dear Forum participants,

As per decision BS-VII/12, the Online Forum shall submit a report to the eighth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol (COP-MOP). Accordingly, the Secretariat has prepared a draft report detailing the activities undertaken by the Online Forum during the last intersessional period. 

In this discussion, forum participants are invited to review the draft report which will be submitted to COP-MOP-8 as an information document.

Please note that the discussion will be open till 10 November 2016 at 1:00 a.m. GMT (which is the night of 9 November in western countries).

Thank you and best regards,
Manoela

Dear Manoella and dear collegues,
I read the draft report of the online forum activities and I felt that the report captures all that happened during this period of very enrichment and fruitfull discussion.
Thanks again to all moderators for their excellent job.
I hope that we can have a succesful negotiation about the RA&RM topic in the COPMOP8.
See you in Cancun.
Alejandra Barrios
Dir. Regulación de Bioseguridad, Biodiversidad y
Recursos Genéticos
SEMARNAT,
México

Dear Manoella and All,

I have read the draft report and wish to congratulate and thank all who actively participated in the Online Forum and the Secretariat who did a great job in coming up with the draft report. Looking back in 2014 and keeping track of the discussions and agreements until 2016, significant strides have been achieved. It has been very informative for making future decisions regarding LMOs. I am in full agreement with the observations of Alejandra.
Again, congratulations!

Franco Gaite Teves
Biorisk Officer and
Head, Microbial Technology and Molecular Genetics Lab
MSU-Iligan Institute of Technology
Philippines

Dear Colleagues,

I have read the report, and it captures the salient features of the earlier discussion on this subject.

Regards,

Hari Sharma

Dear Manoela and All,

I have read the draft report and, as always, you have done a great job. My impression is that this report summarize the important steps of the work and capture discussions and decisions of the group.
Hope to see you all in Cancun in December.
Thank you and best regards, Janne

Dear Manoela and colleagues in the Discussion Forum,
I agree with the sentiments expressed by Ms. Janne Bohnhorst that the report captures the key steps and decisions of the Forum and congratulate the Secretariat for a job well done in capturing the journey from 2014 to date in this discussion forum. I concur that the report accurately captures the expressions made along the way.

Dear Manoella and all,
Thank you very much for the report. It is a very good summary of the work done.
Abrazos para todos,
Elizabeth

POSTED ON BEHALF OF ROGERIO MARCOS MAGALHAES
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Dear Manoela,

I have read this draft report and the document summarize discussions about the question. Great job!

Best regards,

Rogerio M. Magalhaes
Environmental Analyst
Doctor of Sustainable Development
Ministry of Environment
Secretariat of Biodiversity and Forest
Department of Genetic Heritage
55 61 2028 2008

Dear Manoela,

Thank you for providing us with the draft report for review and comment.  I suggest the follow changes be made to more accurately reflect the process and outcomes.  Recommended new text is in [brackets].

Paragraph 15 and Section A of the Annex, the dates must be in error.  The text currently states "27 April to 11 March 2015". 

Paragraph 17, second line states "where it deliberated on each of the substantive and editorial proposals for changes to the guidance" [provided by the subgroup].  Inclusion of "provided by the subgroup should be inserted giving the central role played by the subgroup to select the comments that would be addressed and the manner in which they were treated. 

Paragraph 18, please change "the AHTEG decided" to ["the final report from the AHTEG reflects"].  It would be inaccurate to suggest that the AHTEG made "decisions" on the matters listed.  I especially recall the heated disagreement that was never resolved within the AHTEG on inclusion of paragraph 18(d). 

Paragraph 21, please change "the AHTEG decided to recommend to the COP-MOP the" to ["the report from the AHTEG includes a recommendation to the COP-MOP for the"].  Again, it is inaccurate to communicate that the AHTEG decided because it implies that as a whole the AHTEG came to a decision on the matter of developing additional guidance. 

It is worthy to note that the moderator reports in the Annex (particularly sections B to E) accurately reflect the disagreement that has been ever present since the beginning of the process to develop guidance.  Despite valiant effort of the chair to resolve these differences and reach compromises, many substantive issues have remained unresolved or unaddressed.  I believe report 8/INF/2 should reflect this.

Thanks,
Tom

Dear Manoela,

Thank you for this opportunity to review the draft ‘Report of the open-ended online expert forum on risk assessment and risk management’.  I would suggest the following changes to better reflect the process:

In paragraph 9d, delete the text between *-* and add the text between [-]:

     The Open-ended Online Forum and the AHTEG were subsequently requested to review *all* comments [‘taken on board’ by the subgroup] and suggestions [for changes based on those comments] with a view to having an improved version of the Guidance for consideration by COP-MOP at its eighth meeting.

In paragraph 16: Add the sentence below between [-]:
     In moving forward with its task and taking into account the suggestions made by the Online Forum, the AHTEG and its subgroup undertook further rounds of online discussions to streamline the suggestions for changes provided through the testing and make revisions to improve the Guidance.  [The subgroup decided which comments should be 'taken on board' and proposed substantive and editorial changes in the Guidance based on the comments to be taken on board, and the decisions and justification for comments taken or not taken on board by the subgroup were made available for viewing.]

In paragraph 17: Add the text below between [-]:
      The AHTEG held its first face-to-face meeting in the intersessional period from 16 to 20 November 2015 in Brasilia, Brazil, where it deliberated on each of the substantive and editorial proposals for changes to the Guidance [suggested by the subgroup, for those comments which the subgroup had decided should be 'taken on board']. The proposed changes based [only] on [those] comments provided through the testing of the Guidance [that the subgroup decided should be 'taken on board'] were accepted, modified or rejected, with the necessary justification, as appropriate, taking into account the contribution from the Online Forum. The resulting updated Guidance is contained in annex II of the AHTEG report with a new title: “Guidance on risk assessment of living modified organisms and monitoring in the context of risk assessment”.

In paragraph 19, add the text below between [-]:
     A final round of online discussion focusing on improving the existing Guidance was held by the Online Forum from 25 April to 9 May 2016 with a view of gathering feedback [only] on the [new] proposed changes to the Guidance [suggested by the subgroup after the first face-to-face meeting of the AHTEG] for consideration by the AHTEG at its second face-to-face meeting in the intersessional period. [The Online Forum (including the AHTEG) was invited at this time to make concrete proposals to improve the text of only these latest changes suggested by the subgroup.]  Fifty-five interventions were made during that discussion by 31 participants of the Online Forum [out of 266 registered experts]. A summary of the discussion prepared by the moderator is available in section C of the annex to this report.

I think it is important to make these changes that more accurately reflect the process primarily because concerns were expressed by some during the online forum discussion ‘Feedback on the proposed revisions to the Guidance (25 April – 9 May 2016)’ that there was limited opportunity for forum participants to respond to all of the changes or to discuss whether comments from the testing were adequately addressed.  I believe members of the AHTEG and the Online Forum expected to have this opportunity because the mechanism established by the COP-MOP in the terms of reference for the Online Forum and the AHTEG annexed to decision BS-VII/12 stated in the Methodology Paragraph 1:
     (c) The AHTEG shall streamline the comments by identifying which suggestions may be taken on board and providing justification for those suggestions that may not be taken on board. The AHTEG will also provide concrete text proposals for the suggestions to be taken on board with a justification where the original suggestion was modified;
     (d) The Open ended Online Forum and the AHTEG shall subsequently review all comments and suggestions with a view to having an improved version of the Guidance for consideration by the COPMOP at its eighth meeting.

These concerns were addressed in the Moderator’s summary on ‘Feedback on the proposed revisions to the Guidance (25 April – 9 May 2016) (Part C in the Annex of this draft report) by noting:
     ‘Any participant who wishes to examine, for informational purposes, all the changes made to date to the text of the Guidance is welcome to use the “compare documents” function in Word or ask the Secretariat to do so. Towards the end of the process later this year and similar to what was done in the last intersessional period, the online forum will have an opportunity to consider a draft report of its work which will be forwarded to the COP-MOP. I expect that the Secretariat will reflect the different views in this draft report, both in terms of substance as well as process.’

This offer by the moderator does not adequately address the concerns expressed in the forum, which is not whether there was an opportunity to ‘examine’ all the changes or the responses to the comments by the subgroup, but that there was not an opportunity to discuss or give their expert opinion on these.  I also do not see that the Secretariat reflected the different points of view expressed during this forum discussion in this draft report in terms of substance or process.

This critique is in no way meant to diminish the hard work or expertise of the members of the subgroup or the AHTEG, nor the transparency of this process.  It is more to point out a missed opportunity to consider the input from the broader group of experts.  This seems to go against the purpose of an AHTEG.

Kind regards,
Karen

Dear Manoela and colleagues in the Online Discussion Forum,
I wish to thank all participants for their valuable input into these summaries. I did note though some differences between the summaries. Summaries under Annex A, B, D and E are helpful in putting together the different views of the online participants on the most important points in a well arranged manner. However, summary in Annex C gives a rather broad outlook on general difficulties of the past discussion and challenges of the future. I appreciate this rational appeal to continue working on this difficult task. However, as being a summary I rather would have favored a more concrete and detailed overview on and listing of the key issues and the contents of the divergent arguments to form a helpful working basis for the future. May be this summary can be revised to be more concrete and detailed? In addition, summary in Annex B has a component of evaluation in it as it refers to a past COPMOP decision and criticizes on this basis the views of some discussion members on the suitability of certain topics for a guidance document. Is this really necessary?  I believe the focus here should be on summary of the views and not on evaluation which is rather the task of AHTEG and the parties.
I hope these comments are helpful to you.
Kind regards Werner and colleagues

Werner Schenkel
Unit 403, Federal Office of Consumer Protecion and Food Safety (BVL)
Berlin, Germany

Dear Manoela, dear participants of the forum,
I believe the draft report of the online forum activities adequately covers all difficult discussions that took place during the forum sessions. Therefore I strongly support it. I'd like to use this opportunity to thank everyone for the hard and patient work and exchange of views, which, I hope, will bring us closer to the useful product in the future.
Best wishes
Ruth Rupreht

Dear Manoela and colleagues of the online forum,
I have read the draft report and I´ve found that it summarizes the main steps, discussions and opinions of the group
Thank you
Best
Roberto

Dear Manoela, dear secretariat,
Thank you for providing an elaborate summary of the activities and the exchanged arguments of the online forum.
I would just like to add some comments:
• On page 5, paragraph 21. First line delete the “a” after account.
• In the annex page 12 to 13 chapter E:
o It is not clear if the summary of the moderator summarizes the forum until the end or only some time before as she wrote in paragraph 2.
o The summary -dividing the interventions into pro or contra an extra guideline for synthetic biology by countries- left out the comments Margret and I provided. I know that our comments were late in the process but still valid and should therefore be taken into account. Otherwise it gives the wrong view that German experts where all of the opinion that no specific guidance is needed.

POSTED ON BEHALF OF MARIA MERCEDES ROCA
------------------------
Dear Manoela, dear all,

I thank Manoela and the Secretariat and congratulate the group for their  hard work  in producing this draft document for review and comment, before it is presented  to the MOP8.  I agree with all,  that coming up with a draft document  that captures the areas of consensus, as  well as the split opinions and discrepancies, has not been easy.

After such hard work,  it is understandable that most AHTEG members will want to “move on” and finish the job, especially experts from parties that have other  robust risk assessment methodologies in place and experienced risk assessors who’s countries  will not have to  adopt the  AHTEG Guidance by default.

However hard we have all worked on this document over the years, I don’t feel it is fair to give party delegates and observers the impression that the “AHTEG has agreed or  decided” on several issues that remain contentious, were never properly resolved  and where split opinions between experts  and parties still remain.  Some AGHTEG members feel the Guidance is useful and practical for inexperienced risk assessors  from developing countries and  that the testing showed this, while  many others disagree with this.  Thus I agree with #8181  and # 8182 that some changes to the document are still necessary and invite the group who drafted the final document , to incorporate these  suggested changes  before the final draft is released as an official document.

As a teacher (and a Spanish speaker) I still have serious concerns about using  the Guidance in its present form, and present it to parties to endorse it  as  robust capacity building material and  training tool for risk assessors of Spanish speaking countries.

I happen to be writing this from a preparatory meeting in Costa Rica and I have been invited to address the subject of available resources to conduct an ERA for LMOs for Latin American countries. I have reviewed several available resources and find that our Guidance still needs to be improved by simplifying it, yet we keep adding boxes and more complex  text.

However, I also know one  cannot always go against the current and compromise is often necessary.

It will be a pleasure to see many of you in Cancun.

Dr. Maria Mercedes Roca

Honduras

P.S. My name as moderator for the synthetic biology on-line forum appears as simply as  "Maria Mercedes" , ommitting my surname . Would you kindly amend it ? Many thanks in advance

Dear Secretariat and members of this Forum,

thanks for the hard work in putting together the information and discussion topics in an organized way to be presented in the next COPMOP.

When revising the document I felt not very well "represented" in considerations many of us sent to the Forum; something bothered me and I have to say that the text presented this morning by Maria Mercedes [#8187] clearly expressed my feelings and concerns.

Also, as she mentioned, comments  #8181  and # 8182 proposed some changes to the document, showing that a new reviewed version would be very appreciated and necessary before the final draft is released.

We all know that revising and revising again is stressfull, but in the name of transparency and reliability I feel it is workable and of great importance at this point.

Best regards

Deise Capalbo
Embrapa Environment, Brazil

Dear Manoella and online forum participants:
My personal opinion is that the draft report proposed reflects sufficiently and in a clear manner what was done in the intersessional period from COPMOP7 till now.  I do not favor the changes proposed by Karen Hokanson resulting in making emphasis that the sub-group mechanism was the sole "responsible" of what issues were or were not taken on board for revision, changes, etc.........this is not precise and should not be included.
Kind regards to all,
Francisca

POSTED ON BEHALF OF DAVID A. MBAH
-----------------------------------------
Dear Manoela et al,
Thank you all for bringing the guide to this level. Risk assessment techniques and expertise are evolving and will continue to evolve. The guide is much improvement over what was available from 2004. We can now attempt more detailed RA of GM animals. This is very important for Cameroon whose RA & RM produced in 2004 is undergoing revision under the Cameroon Biosecurity Project(which covers IAS and LMOs). The issue of simplicity(and size/length) is important but not easy to eliminate given the nature of expertise required. This simply means that risk assessors cannot avoid being well- trained/experienced.
David A. Mbah

Dear All,

I join others in thanking those who have worked hard on preparing the draft report, and I appreciate the opportunity to provide feedback on the draft report.

My feedback is given from a similar perspective as that of submission [#8183]:  i.e. to serve the MOP best in its discussions, it is important that the report lists the key points on which there was consensus as well as the key points for which there are significantly diverging views and the arguments provided to substantiate those views. In addition, it is important that the report shows which topics have been discussed in detail and which topics were not, as well as which topics were discussed in ‘plenary’ and which topics were not.

In this respect, I agree with those who feel that the report suggest more consensus then there actually was, and I support the comments in for example the submissions [#8182], [#8187], and [#8188],

I there support the suggestions made that the report be fine-tuned so that it gives the MOP an honest account of where the consensus lies and where the divergence.

Wishing everyone a good remainder of the day !

Piet

Dear Manoela, dear colleagues,
I would like to thank the Secretariat for a great job as always. I think the report is a very good reflection of the work carried out. I join into the comments provided by Elizabeth, Janne, Hari, Ruth and Fran. All the best and see you all in Cancun - very soon.
Marja

POSTED ON BEHALF OF MARTIN BATIC
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Dear Manoela and Colleagues of the online forum,
I have read the draft report of the online forum activities and I believe that the report adequately captures the essence of all that had happened during the last intersessional period of very enriched and fruitful discussions.
Thanks again to the Secretariat and all the moderators for their effort.
With best wishes,
Martin