1. Eighth meeting of the the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 8)

4 - 17 December 2016

Cancun, Mexico

At its eighth meeting , in decision CP-VIII/12, the Conference of the Parties serving as the meeting of the Parties to the Protocol (COP-MOP) took note of the voluntary Guidance on Risk Assessment of Living Modified Organisms as the outcome of the Ad Hoc Technical Expert Group with input from the Online Forum; and invited interested Parties, other Governments and relevant organizations to take the Guidance into account as a voluntary tool to assist in conducting risk assessment in accordance with the Cartagena Protocol while acknowledging that other guidance documents and national approaches can also assist in conducting risk assessment in accordance with the Protocol. Further, the COP-MOP invited Parties to submit to the Executive Secretary (a) information on their needs and priorities for further guidance on specific topics of risk assessment of living modified organisms, (b) proposals on criteria, including the technical justification, that may facilitate the selection of topics for the development of further guidance, and (c) views on perceived gaps in existing guidance materials.

For full text: Decision CP-VIII/12, Meeting Documents. 

2. Ninth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 9)

17 - 29 November 2018

Sharm El-Sheikh, Egypt

At its ninth meeting, in decision CP-9/13, the Conference of the Parties serving as the meeting of the Parties to the Protocol (COP-MOP) called for broad international cooperation, knowledge sharing and capacity-building to support, inter alia, Parties in assessing the potential adverse effects on the conservation and sustainable use of biodiversity from living modified fish and other living modified organisms produced through new developments in modern biotechnology, including living modified organisms developed through genome editing and living modified organisms containing engineered gene drives, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences of individual countries in performing risk assessment of such organisms in accordance with annex III of the Cartagena Protocol.

COP-MOP also decided to consider, at its tenth meeting, whether additional guidance materials on risk assessment are needed for (a) living modified organisms containing engineered gene drives, and (b) living modified fish.

It requested the Executive Secretary to commission a study informing the application of annex I to (i) living modified organisms containing engineered gene drives and (ii) living modified fish, to facilitate the process referred to in paragraph 6 above, and present it to the open-ended online forum and Ad Hoc Technical Expert Group on Risk Assessment and Risk Management.

It further decided to establish an Ad Hoc Technical Expert Group on Risk Assessment (AHTEG), composed of experts selected in accordance with the consolidated modus operandi of the Subsidiary Body on Scientific, Technical and Technological Advice, in accordance with the terms of reference contained in annex II of decision CP-10/13.

For full text: Decision CP-9/13, Meeting Documents.

3. Submissions of information on experiences, challenges and needs regarding risk assessment of living modified organisms containing engineered gene drives and living modified fish

1 February - 15 March 2019

In decision CP-9/13, the COP-MOP invited Parties, other Governments, indigenous peoples and local communities, and relevant organizations to submit to the Executive Secretary information relevant to the work of the online forum and the AHTEG. In response to this, the Executive Secretary issued notification 2019-009 (dated 1 February 2019), inviting Parties, other Governments, relevant organizations and indigenous peoples and local communities to submit information related to: (a) experience in undertaking risk assessment of living modified organisms containing engineered gene drives and living modified fish (detailing how and for which cases); or else, lack of experience in doing so; (b) challenges experienced or foreseen in undertaking risk assessment of living modified organisms containing engineered gene drives and living modified fish;  and (c) specific needs (if any) to properly undertake risk assessment of living modified organisms containing engineered gene drives.

The submissions have been made available through the BCH.

For synthesis text: CBD/CP/RA/AHTEG/2020/1/INF/1 

In response to the requests in decision CP-9/13 and with the financial support of the Kingdom of the Netherlands, the Secretariat commissioned two studies: one on living modified organisms containing engineered gene drives and a second on living modified fish.

The study was prepared by Ms. Greet Smets and Mr. Patrick Rüdelsheim (Perseus bvba).

The study was intended to inform the application of annex I to decision CP-9/13 to living modified organisms (LMOs) containing engineered gene drives for the process for recommending and prioritizing specific issues of risk assessment for consideration under the Cartagena Protocol on Biosafety mentioned in paragraph 6 of decision CP-9/13.

Final study: Study

5. Open-Ended Online Forum on Risk Assessment 

 20 January - 1 February 2020

Online

The draft studies were made available for the discussions of the online forum held between 20 January - 1 February 2020. After the online forum all comments and items raised by the forum participants were considered and the studies were modified to reflect the indications that were in scope of the mandate. The final version of the studies is available in “Resources”. 

Website

6. Ad Hoc Technical Expert Group on Risk Assessment 

30 March - 3 April 2020 

Online

The meeting of the Ad Hoc Technical Expert Group on Risk Assessment was held virtually, due to difficulties related to the global pandemic of COVID-19, through a combination of live sessions and discussions through an online forum from 30 March to 3 April 2020. 

During the virtual meeting, Mr. Patrick Rüdelsheim of Perseus made a presentation on the study. He gave a brief description of engineered gene drives as considered in the study, including different categories (suppression drives, replacement drives) and applications to date. He highlighted some considerations for risk assessment of living modified organisms containing engineered gene drives and summarized the study’s analysis against the criteria in annex I as well as the stock-taking exercise. Following the presentation, the experts had the opportunity to ask questions on the study

Pursuant to paragraph (a) of its terms of reference (decision CP-9/13), the Expert Group reviewed the study informing the application of decision CP-9/13, annex I, to living modified organisms containing engineered gene drives and performed an analysis according to annex I, supported by the data in the study. The review was conducted through online discussions on the Biosafety Clearing-House that were then summarized by the chair during the subsequent live session of the meeting in order to inform the analysis by the Expert Group. In line with its mandate, the Expert Group did not revise the study. Further, according to paragraph (c) of its terms of reference, the Expert Group deliberated on the need for guidance to be developed on risk assessment of living modified organisms containing engineered gene drives. In those discussions, the Expert Group also considered the information in CBD/CP/RA/AHTEG/2020/1/2, section II B.
 

Final study: Study

For full text: Outcome report, Meeting Documents.

7. Tenth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 10, Part Two)

7 - 19 December 2022

Montreal, Canada

At its tenth meeting, in decision CP-10/10, the Conference of the Parties serving as the meeting of the Parties to the Protocol (COP-MOP) welcomed the analysis done by the Ad Hoc Technical Expert Group on the topics of (a) living modified organisms containing engineered gene drives and (b) living modified fish pursuant to decision CP-9/13, annex I.

In paragraph 5, it endorsed the recommendation of the Ad Hoc Technical Expert Group that additional voluntary guidance materials to support case-by-case risk assessment of living modified organisms containing engineered gene drives should be developed, and agreed to develop such additional voluntary guidance materials as per the annex to that decision. 

An ad hoc technical expert group on risk assessment was established to develop these materials in accordance with Annex III to the Protocol.  A specific focus of these materials should be engineered gene drive mosquitos taking into account the current experience with the organism, the type of gene drive and specific issues of risk assessment, identified in annex I to decision CP-9/13, including existing reports, general considerations of living modified organisms containing engineered gene drives, and existing national and regional risk assessment experiences.

To facilitate their work, the Executive Secretary was requested  to commission a detailed outline and to convene online discussions of the Open-Ended Online Forum on Risk Assessment to review the detailed outline and support the work of the Ad Hoc Technical Expert Group. Parties, other Governments, indigenous peoples and local communities and relevant organizations were also invited to submit to the Executive Secretary information relevant to the work of the Expert Group.

The same decision further called upon Parties, other Governments and relevant organizations to continue to disseminate information and share experiences, especially through the Biosafety Clearing-House (BCH), that are useful for risk assessments of living modified organisms, including living modified fish and organisms containing engineered gene drives; and requested the Executive Secretary to provide dedicated web pages in the BCH to facilitate easy access and raise awareness of available information that is relevant for risk assessment of living modified organisms, including living modified fish and organisms containing engineered gene drives.

For full text:  Decision CP-10/10, Meeting Documents.

8. Online discussions of the Open-Ended Online Forum on Risk Assessment

10 - 25 April 2023 

Online

In response to the requests in decision CP-10/10, the Secretariat convened the first session of the online forum to collect views on elements to be included in the outline for the additional voluntary guidance materials.

Website 

10. Online discussions of the Open-Ended Online Forum on Risk Assessment

21 - 25 August 2023 

Online

The Secretariat convened an additional round of discussions of the online forum to review the draft outline and support the development of a final detailed draft to support the work of the Ad Hoc Technical Expert Group with the financial support of the Government of Finland.

Website

11. Ad Hoc Technical Expert Group on Risk Assessment

1 - 3 November 2023

27 February - 1 March 2024

Montreal, Canada

The Expert Group met twice, from 1 to 3 November 2023 and from 27 February to 1 March 2024, with financial support from the European Union.  

At its first meeting, the Expert Group agreed to follow a problem formulation approach and also agreed on the structure of the document.

Following the first meeting, the text of the additional voluntary guidance materials were developed using regionally balanced drafting groups.

At its second meeting, it finalized the work on the guidance materials in accordance with its terms of reference found in the annex to decision CP-10/10. 

First meeting of the Expert Group: Meeting documents

Second meeting of the Expert Group: Meeting documents

12. Eleventh meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 11)

21 October - 1 November 2024

Cali, Colombia

Following the meeting of the Ad Hoc Technical Expert Group on Risk Assessment and the Subsidiary Body on Scientific, Technical and Technological Advice (13 - 18 May 2024 in Nairobi, Kenya), the additional voluntary guidance materials to support case-by-case risk assessment of living modified organisms containing engineered gene drives was formally edited. The Conference of the Parties serving as a meeting of the Parties to the Cartagena Protocol will consider these materials at their eleventh meeting in Cali, Colombia.

Website: Meeting documents