Feedback on the draft report of the Online Forum

This discussion will be held from 16 to 21 June 2014 (at 1:00 a.m. GMT).

In accordance with the terms of reference for the Online Forum, as set out in the annex to decision BS-VI/12, a report summarizing its activities, outcomes and recommendations shall be submitted for consideration of the COP-MOP at its seventh meeting.

To fulfill this request, participants the Online Forum are invited to consider and provide feedback on a draft report prepared by the Secretariat (see under "background document for this discussion").

This discussion will take place from 16 to 21 June 2014. As for previous discussions, kindly note that the opening and closing times of the discussion is 1:00 a.m. GMT (i.e. the discussion will close on the night of Friday, 20 June for countries west of the Greenwich meridian).

Other Matters

This discussion will be held from 5 to 12 May 2014 (at 1:00 a.m. GMT).

Analysis of the results gathered from the testing and possible improvements to the Guidance

This discussion will be held from 21 April to 5 May 2014 (at 1:00 a.m. GMT).

In their decision BS-VI/12, the Parties requested the Executive Secretary to:

(a) Develop appropriate tools to structure and focus the testing of the Guidance;

(b) Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms; and

(c) Provide a report on possible improvements to the Guidance for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its seventh meeting.

Further in decision BS-VI/12, the Parties mandated the Open-Ended Online Forum and AHTEG to "provide input, inter alia, to assist the Executive Secretary in his task to structure and focus the process of testing the Guidance, and in the analysis of the results gathered from the testing".

The testing of the Guidance in actual cases of risk assessment took place between June 2013 and 31 March 2014. A total of 55 submissions were made (42 by Parties, 3 by other Governments and 10 by organizations). Individual submissions and suggestions for improvements are available at http://bch.cbd.int/protocol/testing_guidance_RA.shtml. Moreover, a draft analysis of the results was prepared by the Secretariat to assist in the discussion.

On the basis of the background materials for this discussion, participants of the Online Forum are invited to provide input to the analysis of the results gathered from the testing with a view to assisting the Secretariat in preparing a report for consideration of the Parties. This input may include:

i) General feedback about the results of the testing;

ii) Comments on the improvements to the Guidance as per submissions received during the testing;

iii) Suggestions of possible mechanisms through which the Guidance could be improved.

This online discussion will open on 21 April 2014 and will close on 5 May 2014 at 1:00 a.m. GMT.

Background materials for this discussion:

Analysis of the results of the testing of the Guidance on Risk Assessment of LMOs

Suggestions for improvements to the Guidance as per submissions

Results of the testing of the Guidance on Risk Assessment of LMOs

Alignment of the Guidance and training manual – Comments on the draft online package

This discussion will be held from 31 March to 14 April 2014 (at 1:00 a.m. GMT).

The objective of this discussion is to provide recommendations to the AHTEG on possible improvements to the draft of an online package aligning the Manual on Risk Assessment of LMOs and the Guidance (i.e. the Roadmap).

Background documents to assist and guide the discussion consist of a document in MS Word format containing an alignment of the texts of the Manual (left column) and Roadmap (right column), as well as a PowerPoint presentation containing a draft concept of an online package aligning the two documents in a graphic format. Each page of the Word document corresponds to a slide in the PowerPoint presentation.

Participants are invited to review the background documents and provide suggestions on how to improve the alignment of the text of the Manual in relation to the text of the Roadmap, and the graphics of the draft concept of the aligned package. Participants are also invited to provide general recommendations to the AHTEG regarding the development of a package that aligns the Guidance and the Manual.

Recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment

This discussion will be held from 24 February to 10 March 2014 (at 1:00 a.m. GMT).

In decision BS-VI/12, the Parties mandated the open-ended online forum and the AHTEG to work together with a view to developing and achieving, among other things, a “recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes”.

In preparation for the face-to-face meeting of the AHTEG to be held from 2 to 6 June 2014 in Bonn, Germany and with the view of moving toward the operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes (see under resources for this discussion for ease of reference), participants of the open-ended online forum are invited to provide a concrete recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment. In particular, taking into account the priorities and needs indicated by the Parties, and cognizant of the diverging views posted in an earlier online discussion on this topic, participants are invited to provide their views on the following:

• What process and timeframe could be put in place for the development of such guidance?
• Which topics from among those identified by the AHTEG and the open-ended online forum (see under resources for this discussion) could be prioritized for the development of guidance? Please indicate up to a maximum of 3 topics.

Background documents for this discussion:

Lists of topics identified by the Online Forum and AHTEG for the development of further guidance

Operational objectives 1.3 and 1.4 of the Strategic Plan

Further resources for this discussion:

• Recommendations regarding the development of additional guidance on specific topics and annex IV to the “Final Report of the AHTEG on RA & RM”
• Online discussion on the development of further guidance on new topics of RA & RM, in particular the closing summary of the moderator
• Submissions on the identification of LMOs or specific traits that may have adverse effects (...)

Final improvements to the alignment for submission to the AHTEG

This discussion will be held from 12 to 23 December 2013 (at 1:00 a.m. GMT).

Message from the Moderator:

Participants of the Online Forum are invited to one last round of discussion before submitting the revised Manual to the AHTEG. In this discussion, you are invited to provide comments, if any, regarding the last revisions in the Manual. If you have any suggestion for improving the last revisions, I kindly ask you to be concise and provide concrete text proposals.

The discussion is now open and will close on 23 December at 1:00am GMT.

As for the way forward with regard to the alignment, the Secretariat indicated that they will prepare a draft online package aligning the Guidance and Manual on the basis of earlier inputs from the Online Forum on how this could be done. In March 2014, the Online Forum will discuss and provide input to the draft online package.

Best regards,

Lucette

Background documents for this discussion:

Revised Manual, "clean" version (11 Dec 2013)

Guidance on Risk Assessment of LMOs

Further resources for this discussion:

Revised Manual, "track changes" version (11 Dec 2013)

Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)

This discussion will be held between 4 and 18 November 2013.
Discussions open and close at 1:00 a.m. GMT

This round of discussion will focus on further aligning the “Training Manual on Risk Assessment of LMOs” (all modules) and the “Guidance on Risk Assessment of LMOs”.

As a basis for this discussion, a revised version of the “Manual on Risk Assessment of LMOs” was prepared by the Secretariat in consultation with the Moderator of this topic and the Chair of the AHTEG. The revised Manual is available for download on this page ( http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml). Please note that the “clean” version is the working document, whereas the “track changes” version is being provided for reference only.

In revising the Manual, all comments posted in previous discussions were taking into account vis-à-vis the mandate given by the COP-MOP (i.e. to develop a package that aligns the Manual and Guidance). As such, it is noted that, while many excellent suggestions were made by the participants of the Forum during the past rounds of discussion, the scope of the revision of the Manual had to limited to changes that (i) were proposed in the online forum and (ii) improve the alignment with the Guidance, or correct a mistake (e.g. typos, wrong reference, etc).

Forum participants are invited to provide feedback on the revised Training Manual on Risk Assessment (revised on 28 October 2013, "clean version") and make concrete text proposals to further improve the alignment with the Guidance.

This discussion will start on 4 November and will remain open until the 18 November 2013 at 1:00 a.m. GMT.

Background documents for this discussion:

Revised "Training Manual on Risk Assessment of LMOs", "clean" version (28 Oct 2013)

Guidance on Risk Assessment of LMOs

Further resources for this discussion:

Revised "Training Manual on Risk Assessment of LMOs", "track changes" version (28 Oct 2013)

Alignment of the Guidance and Training Manual – Module 3

This discussion will be held between 16 and 30 September 2013.
Discussions open and close at 1:00 a.m. GMT

This round of discussion will focus on the alignment of module 3 of the “Training Manual on Risk Assessment of LMOs” and the “Guidance on Risk Assessment of LMOs”.

To assist in this discussion, the Secretariat revised the Training Manual to reflect the proposed restructuring for better alignment with the Guidance (for more information on the restructuring, see the discussion held from 17 to 22 July 2013, below).

The Guidance and two versions of the revised Training Manual are available for download, i.e. one clean version that will form the basis of this discussion (under background documents), and one version with tracked changes for reference purposes (under further resources). It is noted that in addition to moving entire sections in a way that reflects the restructuring as per the last discussion, the revised Training Manual contains some editorial and formatting changes as well as a few changes in response to specific comments made during earlier online discussions.

In this discussion, participants are invited to perform a thorough analysis of the text of “Module 3” of the Training Manual and the relevant sections of the Guidance on Risk Assessment, in particular the “Roadmap”, and provide concrete suggestions on how these texts can be better aligned. Most importantly, participants are invited to indicate if there are any inconsistencies between the concepts in Module 3 of the Manual and the Guidance, and provide concrete recommendations on how to harmonize these concepts to improve the consistency between the two documents. In doing so, it is strongly recommended that the concrete recommendations be accompanied by line numbers indicating the location of the specific text in the Manual and the Guidance, taking into account that any suggestions for improvements to the Guidance will be forwarded for the consideration of the COP-MOP.

This discussion will start on 16 September and will remain open until the 30 September 2013 at 1:00 a.m. GMT.

Background documents for this discussion:

Revised "Training Manual on Risk Assessment of LMOs"

Guidance on Risk Assessment of LMOs

Further resources for this discussion:

Revised "Training Manual on Risk Assessment of LMOs", track changes

Clarification on the proposed restructuring of the Manual on Risk Assessment of LMOs

This discussion was held between 17 and 22 July 2013.

Following a suggestion made during the previous round of discussion to restructure the Manual, as appropriate, so that for corresponding sections the wording of the headings of and their order would be similar or at least closer to those of the Guidance, the Secretariat prepared a draft on how the Manual could be restructured for better alignment with the Guidance. This draft restructuring was achieved by renaming and reordering some of the Manual’s sections. It is noted that no concepts were introduced or removed from the Manual. Moreover, the structure of the Guidance remains unchanged. A comparison between the current contents of the Guidance and Manual is also available for your ease of reference.

With a view to building a foundation in preparation for the next discussion on the newly restructured Module 3 of the Manual, the present discussion will be open for 5 days, till 22 July. This will enable participants to familiarize themselves with the proposed draft restructuring of the Manual and, at the same time, provide an opportunity to those seeking clarification to put forward questions to the Secretariat on how the proposed draft restructuring of the Manual was performed and what changes were made.

Development of a package that aligns the "Guidance on Risk Assessment of Living Modified Organisms" (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms”

Discussions will be held between 30 June - 14 July 2013
Discussions open and close at 1:00 a.m. GMT

In their decision BS-VI/12, the Parties mandated the Open-Ended Online Forum and AHTEG to “coordinate, in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms” in a coherent and complementary manner, for further consideration of the Parties, with the clear understanding that the Guidance is still being tested”.

This round of discussion will focus on the alignment of modules 1 and 2 of the Training Manual and the Guidance. To assist in this discussion, the Secretariat has prepared an initial comparison between the first two modules of the Manual and the relevant sections of the Guidance.

In addition to discussing the content of the alignment between modules 1 and 2 of the Training Manual and the Guidance, participants are invited to consider a way forward by which the alignment between the Manual and the Guidance may be done.

This discussion will take place from 30th June and remain open until the 14th July 2013 at 1a.m. GMT.

Background document for this discussion:

Draft comparative alignment - Modules 1 & 2

Development of a package that aligns the "Guidance on Risk Assessment of Living Modified Organisms" (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms”

Discussions were held between 27 May - 9 June 2013
Discussions open and close at 1:00 a.m. GMT

In their decision BS-VI/12, the Parties mandated the Open-Ended Online Forum and AHTEG to “coordinate, in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms” in a coherent and complementary manner, for further consideration of the Parties, with the clear understanding that the Guidance is still being tested”.

Forum participants were invited to share their views on ways forward to develop this package in an online discussion held on 3-14 December 2012. Among the proposals put forward by the participants, there was emerging agreement that the two documents should not be merged but remain independent and their contents could be aligned. Furthermore, there was agreement amongst Forum participants that the use of terms between the two documents, with preference given to the terms in the Guidance, needs to be consistent in such a way that they share the same meaning in both documents.

To achieve an alignment as envisioned by the Forum participants, the way forward would entail a thorough analysis of the text of each document and preforming an initial alignment between sections and concepts that correspond between the Guidance and the Manual. This would also ensure the two texts are in line with the Protocol and Annex III and the presence of consistent conceptual thinking within the documents, the importance of which was highlighted in the discussion amongst the participants.

This round of discussion will focus on the alignment of the terminology between the Guidance and the Manual. To assist in the discussion, the Secretariat performed an initial comparison between the terminology in the “Use of Terms” section of the Guidance and the corresponding definition and/or use of the term in the Manual. Explanatory notes are also presented to highlight any conceptual differences in the way each term is used in the Guidance and Manual.

Participants are invited to provide comments and suggestions regarding the draft terminology alignment between the Guidance and Manual, including any additional terms that could be included in the comparative alignment and comments on the explanatory notes. Participants are also invited to provide recommendations for consideration by the COP-MOP on how to improve the consistency between the terms in the Guidance and Manual.

This discussion will take place from 27 May to 9 June 2013.

Background document for this discussion:

Draft terminology alignment

Further resources for this discussion:

Guidance on Risk Assessment of LMOs

Training Manual on Risk Assessment of LMOs

In their decision BS-VI/12, the Parties requested the Executive Secretary to:

(a) Develop appropriate tools to structure and focus the testing of the Guidance;

(b) Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms; and

(c) Provide a report on possible improvements to the Guidance for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its seventh meeting.

Further in decision BS-VI/12, the Parties mandated the Open-Ended Online Forum and AHTEG to "provide input, inter alia, to assist the Executive Secretary is his task to structure and focus the process of testing the Guidance, and in the analysis of the results gathered from the testing".

Accordingly, the Secretariat has developed a draft concept note and a draft questionnaire on the basis of previous discussions with a view to structuring and focusing the testing of the Guidance. It is noted that the draft concept note is intended as a discussion document, which will be used as the basis for developing more detailed instructions to assist those who will test the Guidance.

Participants of the Online Forum are invited to provide feedback on the draft concept note and draft questionnaire through this online discussion between 8-21 April 2013.

In Paragraph 1(c) to the annex to their decision BS-VI/12, the Parties requested the Open-ended Online Forum and AHTEG to “Consider the development of guidance on new topics of risk assessment and risk management, selected on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment.”

Participants are invited to discuss their views on the development of new guidance.

Below are some suggested points for discussion:

1. The need by Parties for guidance on new topics of risk assessment and risk management;
2. If such a need exists which topics should be considered.

In their decision BS-VI/12, regarding Further guidance on specific aspects of risk assessment, paragraph 5(a) the Parties requested the Executive Secretary to “Develop appropriate tools to structure and focus the testing of the Guidance”.

Furthermore the the Parties requested the Open-Ended Online Forum, as per Decision BS-VI/12, paragraph 1(a) of the annex to "provide input, inter alia, to assist the Executive Secretary is his task to structure and focus the process of testing the Guidance, and in the analysis of the results gathered from the testing".

We would therefore like to invite participants to put forward ideas on possible tools that can be used to conduct the testing with the view to work towards gathering data from actual cases of Risk Assessment as outlined in BS-VI/12, paragraphs 1(b) and 3.

Below are some suggested points for discussion:

1. What tools can be used to conduct testing in actual cases of risk assessment?
2. How can these tools be structured and presented in order to gather the most pertinent information?

Topic 1: Development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms”

Discussions were held between 3-14 December 2012

In their decision BS-VI/12 regarding activities relating to Capacity-building in risk assessment and risk management, the Parties requested the Open–Ended Online Forum and AHTEG to coordinate, in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms” in a coherent and complementary manner, for further consideration of the Parties, with the clear understanding that the Guidance is still being tested.

Participants are invited to propose ideas for the co-ordination of the process of the development of the advanced educational package.

Below are some suggested points for discussion:

1. What recommendations do you have regarding the most suitable approach for this task?

2. Which of the two documents would you suggest to use as the basis to reach the desired outcome?