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

Draft report of the Online Forum

This discussion will be held between 2 and 10 November 2016 (at 1:00 a.m. GMT)

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.

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).

In this discussion, forum participants are invited to comment on the background document, which was prepared by the Secretariat on the basis of online discussions under this forum and under the forum on synthetic biology, with input from members of a subgroup of the AHTEG.

The task during this discussion is to either support, or not, each of the considerations in the document based on scientific arguments. Identifying concrete examples of current and foreseeable LMOs that present novel and specific challenges to the general principles and methodology of risk assessment will be most helpful. Proposals for revisions to the text are also welcome.

Background document for this discussion:

Possible considerations RA of LMOs developed through synthetic biology (Doc 1 Secretariat Synbio RARM)

Further information:

Online Forum on Synthetic Biology

Report of the AHTEG on Synthetic Biology (Doc2 AHTEG Synbio)

Submission of views, relevant guidance and sources of information on risk assessment of organisms developed through synthetic biology

Discussions will be held between 9 – 23 May 2016
Discussions open and close at 1:00 a.m. GMT

The focus of this discussion is to gather views, information and sources of information or references on risk assessment of organisms developed through synthetic biology.

Please use this space to gather views on how an annotated outline for guidance on risk assessment of organisms developed through synthetic biology in accordance with the Cartagena Protocol would look like. This outline will be submitted to the COP-MOP at its meeting in December 2016, and the Parties will decide whether or not this guidance is needed and, if so, how it could be developed.

Please note that the focus of this discussion is NOT whether additional guidance on risk assessment of organisms of synthetic biology is needed.

Resources:

Online Portal on Synthetic Biology

SBSTTA-20 recommendations on synthetic biology (unedited draft)

Moderator's summary of the discussion:

Moderator's summary

Feedback on the proposed revisions to the Guidance

This discussion will be held between 25 April - 9 May 2016
Note: Discussions open and close at 1:00 a.m. GMT

During this discussion, participants of the Online Forum are invited to review and provide feedback on the most recent revisions to the Guidance (comments should be limited to the new revisions which are marked as “track changes”). The background document for this discussion, which is available for download in the box to the right), is a draft revised Guidance resulting from the work of the AHTEG sub-Group on the outstanding comments from the testing of the Guidance and text boxes on four topics chosen by the AHTEG to be incorporated into the Guidance.

Feedback on the draft outline for further guidance on risk assessment of LM fish

This discussion will be held between 11 - 25 April 2016
Note: Discussions open and close at 1:00 a.m. GMT

Following an earlier discussion to gather views, information and references on risk assessment of LM fish (see below), a group of volunteer AHTEG members drafted an outline for the development of further guidance on this topic for consideration by the COP-MOP at its meeting in December 2016.

The draft outline will serve as the basis for an online discussion of the Online Forum to be held from 11 to 25 April. Members of the Online Forum are invited to provide feedback on the draft outline with a view to helping the AHTEG improve the outline before submitting it to the COP-MOP. The discussion may focus on the structure of the outline but, most importantly, feedback is sought on issues that are unique or particularly relevant to the risk assessment of LM fish are whether these issues are adequately covered in the draft outline.

It is recalled that the Parties will decide whether or not further guidance on this topic is needed and, if so, what form it would take and how it could be developed.

Background document for this discussion:

Draft outline - Risk assessment of LM fish

Submission of views, relevant guidance and sources of information on risk assessment of LM fish

Discussions will be held between 22 February - 7 March 2016
Discussions open and close at 1:00 a.m. GMT

The focus of this discussion is to gather views, information and sources of information or references on risk assessment of living modified fish.

Please use this space to gather views on how an annotated outline for standalone guidance on risk assessment of LM fish in accordance with the Cartagena Protocol would look like. This outline will be submitted to the COP-MOP at its meeting in December 2016, and the Parties will decide whether or not this guidance is needed and, if so, how it could be developed.

Please note that the focus of this discussion is NOT whether additional guidance on risk assessment of LM fish is needed.

Resources:

Previous online discussion on risk assessment of LM fish

Gathering views, relevant guidance and sources of information

Discussions will be held between 1 – 15 February 2016
Discussions open and close at 1:00 a.m. GMT

The objective of this discussion is to gather views, relevant guidance and sources of information on:

• “LMOs introduced in centres of origin and genetic diversity” and “LMOs intended for introduction into unmanaged ecosystems” (the two topics will be addressed together);
• “LMOs created through use of dsRNA techniques, engineered to produce dsRNA or dsRNA” and “LMOs containing RNAi” (the two topics will be addressed together);
• “Integrating human health into the environmental risk assessment” taking into account the topics “Nutritionally altered living modified plants” and “LMOs that produce pharmaceutical products”, as appropriate;
• “Synergistic impacts of different herbicides that are part of the technology package that accompanies certain LMOs”.

As mandated in decision BS-VII/12, the AHTEG considered, during its meeting in November 2015, how topics for further guidance could be taken into account during the revision of the Guidance on Risk Assessment of LMOs. The AHTEG agreed that the four topics shown above could be incorporated into the existing Guidance, by creating text boxes or adding text, as appropriate, in the "Roadmap for Risk Assessment of LMOs" (Part I of the Guidance).

Information documents:

Guidance on Risk Assessment of LMOs

Report of the AHTEG meeting

Feedback on the general issues identified by the AHTEG Sub-Group that may be incorporated or improved in Guidance

Discussions will be held between 27 April – 11 May 2015
Discussions open and close at 1:00 a.m. GMT

In decision BS-V/12, the Parties to the Cartagena Protocol on Biosafety, among other things, invited Parties, other Governments and relevant organizations to test the Guidance on Risk Assessment of Living Modified Organisms (LMOs) in actual cases of risk assessment. The testing of the Guidance took place between June and December 2013 and the results are compiled here.

In decision BS-VII/12, the Parties to the Cartagena Protocol mandated Online Forum and AHTEG on Risk Assessment and Risk Management to revise and improve the Guidance on the basis of the comments provided during the testing referred to above.

In accordance with decision BS-VII/12, and to facilitate the revision of the Guidance, a tentative calendar of activities was developed for the biennium 2014-2016. Some of the planned activities have already taken place, including:

• Grouping of the original comments provided through the testing of the Guidance into matrices by the Secretariat (5 – 31 January 2015);
• An online discussion of the AHTEG on “Feedback on the grouping of comments done by the Secretariat and way forward” (16 February – 2 March 2015; see the outcomes of that discussion);
• Two online discussions of the AHTEG Sub-Group on “Reviewing the grouping of comments done by the Secretariat and revising it as needed” (9 – 23 March 2015) and “Identifying which general issues highlighted in the testing of the Guidance may be incorporated or improved upon, as well as whether or not any of the topics prioritized by the previous AHTEG for additional guidance could also be incorporated during the revision process” (30 March – 13 April 2015; see the outcomes of those discussions).

During the discussions above, the AHTEG and its Sub-Group reviewed the grouping of comments provided through the testing of the Guidance, and identified which general issues highlighted in the testing of the Guidance may be incorporated or improved upon, as well as whether or not any of the topics prioritized by the previous AHTEG for additional guidance could also be incorporated during the revision process.

The next step in the process, in accordance with the calendar of activities, is a joint discussion of the Open-ended Online Forum and the AHTEG to take stock of what has been done so far since the last meeting of the Parties to the Protocol, and to provide feedback on the general issues identified by the AHTEG Sub-Group that may be incorporated or improved during the revision of the Guidance.

The background materials for the discussion are available for download to the right-hand box.

This discussion will take place from 27 April to 11 May 2015 (the discussion will open and close at 1:00a.m. GMT on the dates indicated).

Background documents for this discussion:

Streamlining of general issues from the testing of the Guidance (by AHTEG Sub-Group)

Consideration of topics to be incorporated in the Guidance (by AHTEG Sub-group)

Information documents:

Grouped comments - revised (by AHTEG Sub-group)

Guidance on Risk Assessment of LMOs