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Ms. Luciana Pimenta Ambrozevicius, Brazil #11769
Welcome to the second round of discussions of the Online Forum on Risk Assessment and Risk Management!

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:
Mr Austein McLoughlin, Secretariat of the Convention on Biological Diversity #11800
Dear Participants of the Open-Ended Online Forum on Risk Assessment and Risk Management,

To provide an opportunity for greater participation and continue the active contributions, the Secretariat would like to extend this online forum until 17:00 (Montreal time) on Wednesday 30 August 2023.

Thank you for your activity on the online forum. We look forward to your continued participation and contributions.

Best regards,

The Secretariat.
Mr Austein McLoughlin, Secretariat of the Convention on Biological Diversity #11827
Posted on behalf of Dr. Luciana Pimenta Ambrozevicius, Brazil

Dear participants,

Thank you for your participation in this online forum and all the valuable contributions!

With the Decision VIII-12 the Parties "Takes note of the voluntary guidance on RA and RM” and established a new process for the development of further guidance. The voluntary guidelines for the RA of LMO containing gene drive is the first attempt to have a new constructive process based on the priorities of the Parties. Thus, your participation in this online forum is very important to provide elements to the final draft that will be considered by the AHTEG at their meeting in November.

In this way I encourage your participation in the next few days of the online forum. I also present some general and specific questions, based on the previous discussions and some points raised by the participants, that could further stimulate your feedback:

- Is the proposed format useful, with Part A containing the steps for RA of LMOS containing engineered gene drive and Part B presenting a case study?

- Considering the mandate from decision CP-10/10 with the special focus on engineered gene drive mosquitoes and the existence of international guidelines such as the WHO Guidance Framework for Testing Genetically Modified Mosquitoes, are the draft outline covering aspects related with the three objectives of the Convention and not duplicating the work?

- If the temporal and spatial dimensions of LMOs containing gene drive are important aspects during risk assessment of this organism, are those being adequately captured with the proposed items?

Section 1 to 3:
- Is there any aspect of uncertainty in the case of engineered gene drive LMOs that is different from other LMOs? What is the role of modeling, a tier-based testing approach and other tools to reduce uncertainty?

Section 4 to 6:
- Considering the importance of problem formulation step, is the proposed approach focusing on items that are novel for LMOs containing gene drive?

- How the appropriate comparators (LMOs that do not contain GD, other disease vector control strategy etc) could be chosen in the case of engineered gene drive LMOs, specifically for gene drive mosquitoes?

Section 7 to 9:
- In the case where the organism is part of a species complex where not all the species are relevant, how to define the ‘target organism’? Should the definition be restricted to those which are vectors to humans? 

Section 10 to 13:
- How to engage actors with broad expertise in the problem formulation stage for ERAs of engineered gene drive applications? What are the best practices to be included in the RA guidance that could inform the process?

Thank you.

Best regards,
Luciana P. Ambrozevicius
Mr Austein McLoughlin, Secretariat of the Convention on Biological Diversity #11877
--- Posted on behalf of Dr. Luciana Pimenta Ambrozevicius, Brazil ---

Dear forum participants,

The second session of the Open-Ended Online Forum for Risk Assessment and Risk Management is now closed.

I would like to thank the ICGEB for drafting the outline and thank you for your activity on this forum.

Your valuable comments on the structure of the draft outline, elements that should be included or further elaborated on and information on points that could be missing will surely guide the process moving forward and have been captured by the Secretariat. This review of the draft outline will support the development of a final detailed draft, which will be the basis of the work of the AHTEG at their meeting in November in Montreal.

Best regards,

Luciana