Background - Second session
In decision CP-10/10, the Conference of the Parties serving as a meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) agreed to develop additional voluntary guidance materials to support case-by-case risk assessment of living modified organisms (LMOs) containing engineered gene drives in accordance with Annex III of the Cartagena Protocol. The COP-MOP decided that this material should have a special focus on engineered gene drive mosquitoes taking into account the current experience with the organism, the type of gene drive and specific issues of risk assessment, identified in annex I of decision CP-9/13, including existing reports, general considerations of LMOs containing engineered gene drives and existing national and regional risk assessment experiences. The decision also established an Ad Hoc Technical Expert Group (AHTEG) and requested the convening of the Online Forum on Risk Assessment and Risk Management to contribute to this process. The Subsidiary Body on Scientific, Technical and Technological Advice will consider the draft prepared by the AHTEG.
To support the development of the additional voluntary guidance materials, the COP-MOP requested the Executive Secretary to commission the preparation of a detailed outline of the additional guidance materials on risk assessment of living modified organisms containing engineered gene drives, which would be reviewed by the online forum and serve as a base for the work of the AHTEG.
In response to this, the Secretariat commissioned the International Centre for Genetic Engineering and Biotechnology (ICGEB) to draft this detailed outline. In addition, the Secretariat convened the Open-ended Online Forum on Risk Assessment (from 10 to 25 April 2023) to provide inputs which were taken into consideration in the drafting of this outline. Thus, the Secretariat is convening the Online Forum on Risk Assessment and Risk Management for an additional round of discussions to review this draft outline and support the development of a final detailed draft to support the work of the AHTEG. A preliminary summary of the first round of discussions and the draft outline have been made available below. As a kind reminder, the draft outline is not for citation purposes.
Background document(s):
- Draft outline of the Additional voluntary guidance materials
- Advanced draft - summary of OEOF - first discussions
- Advanced draft - Synthesis of submissions on risk assessment of LMOs-EGD
The second session of the online forum will open at 12:00 (noon) EDT on Monday, 21 August 2023.
The second session of the online forum will now close at 17:00 (5:00 pm) EDT on Wednesday, 30 August 2023.
The forum will be moderated by: Dr. Luciana Ambrozevicius from Brazil.
Suggestions on the detailed outline of the additional voluntary guidance materials to support the case-by-case risk assessment of living modified organisms containing engineered gene drives.
In decision CP-10/10, the COP-MOP agreed that a specific focus of the additional voluntary guidance materials should take into account, among others, general considerations of living modified organisms containing engineered gene drives and have a specific focus on engineered gene drive mosquitoes. Thus, the detailed outline has been produced with two sections, Part A Risk Assessment of living modified organisms containing engineered gene drives and Part B Risk assessment of a living modified Anopheles mosquito containing an engineered gene drive for malaria control. To focus the discussions, participants are requested to provide feedback on the following sections.
- Part A, sections 1 to 3
- Part A, sections 4 to 6
- Part B, sections 7 to 9
- Part B, sections 10 to 13
When providing an intervention, participants are requested to provide the section, page number and line number to indicate the location of the intervention and to be as specific as possible. When posting this information, participants are requested to provide their source of information, indicating if it is coming from a publication, their own work, or other type of source. When sharing publications, it is kindly requested that the URL and DOI links be provided.
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Table of Contents
Moderator Announcements
My name is Luciana Ambrozevicius, I am an agronomist with a Ph.D. in Genetics and Plant Breeding currently working in the Brazilian Ministry of Agriculture and Livestock with extensive experience on risk assessment and risk management including as a former member in the Biosafety National Technical Commission, a member of the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management and a former member of the AHTEG on Synthetic Biology.
It is a pleasure to moderate discussions for a second time. This online forum will be collecting views on draft outline of the additional voluntary guidelines for the risk assessment of living modified organisms containing engineered gene drives, which will be further developed by the AHTEG later in the year. The draft outline represents an overall structure that is being proposed for the additional voluntary guidance materials. I encourage you to comment on the structure of the draft outline, suggest elements that should be included or further elaborated on under the various sections of the draft outline and provide information on points that could be missing. These will be taken into account for the final draft that will be made available for the AHTEG.
The draft outline, the summary of the first round of discussions of this forum and the synthesis of the submissions have been made available under the Background section of this page and added as attachments to these moderator messages.
We have divided the topics of this forum by the sections of the report to focus the discussions and facilitate providing feedback. When planning your intervention, I would like to kindly ask you to use the line numbers and be concise. Please note that if you would like to respond to a post, I encourage you to reply directly to that post. In addition, when posting information, kindly provide the URL, the DOI or use the attachment function, please.
As a kind reminder, discussions will close on 17:00 (5pm) EDT on Wednesday, 30 August 2023.
Your points of view and feedback will be much appreciated. I hope that we can have a productive dialogue that will support the development of these additional voluntary guidance materials.
I thank you for your participation in this forum, and I look forward to an interesting discussion.
Sincere regards,
Luciana Pimenta Ambrozevicius
Participants registered to the Forum must sign-in using a CBD account to post messages. Please answer the following questions in their corresponding thread below:
Topics:
Topic 1: Part A, sections 1 to 3
Topic 2: Part A, sections 4 to 6
Topic 3: Part B, sections 7 to 9
Topic 4: Part B, sections 10 to 13
Please note the attached draft outline of the additional voluntary guidance materials:
Topic 1: Part A, sections 1 to 3
1. Objective and scope of these additional voluntary guidance materials
2. Introduction
3. Overarching issues in the risk assessment process on EGD-LMOs
Participants are requested to follow the forum guidelines:
1. Briefly introduce themselves when posting their first message, including their name, country and institutional affiliation.
2. Keep their messages short, concise and focused.
3. Ensure that the messages are relevant to the topic/question being discussed.
4. Make sure that the text or files attached do not contain viruses, corrupted files or any other similar file deficiencies.
5. Be respectful of others’ points of views.
Topic 2: Part A, sections 4 to 6
4. Planning phase of the risk assessment of EGD-LMOs
5. Conducting the risk assessment
6. Related issues
Participants are requested to follow the forum guidelines:
1. Briefly introduce themselves when posting their first message, including their name, country and institutional affiliation.
2. Keep their messages short, concise and focused.
3. Ensure that the messages are relevant to the topic/question being discussed.
4. Make sure that the text or files attached do not contain viruses, corrupted files or any other similar file deficiencies.
5. Be respectful of others’ points of views.
Topic 3: Part B, sections 7 to 9
7. Introduction
8. Objective and scope
9. Planning phase of the risk assessment of EGD in Anopheles
Participants are requested to follow the forum guidelines:
1. Briefly introduce themselves when posting their first message, including their name, country and institutional affiliation.
2. Keep their messages short, concise and focused.
3. Ensure that the messages are relevant to the topic/question being discussed.
4. Make sure that the text or files attached do not contain viruses, corrupted files or any other similar file deficiencies.
5. Be respectful of others’ points of views.
Topic 4: Part B, sections 10 to 13
10. Conducting the risk assessment of EGD-LM Anopheles
11. Monitoring EGD-LM Anopheles released in the environment
12. Related issues
13. References
Participants are requested to follow the forum guidelines:
1. Briefly introduce themselves when posting their first message, including their name, country and institutional affiliation.
2. Keep their messages short, concise and focused.
3. Ensure that the messages are relevant to the topic/question being discussed.
4. Make sure that the text or files attached do not contain viruses, corrupted files or any other similar file deficiencies.
5. Be respectful of others’ points of views.
