1. Seventh meeting of the the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 7)

29 September - 3 October 2014

Pyeongchang, Republic of Korea

In decision BS-VII, the COP-MOP invited s Parties to submit (a) information on their needs and priorities for further guidance on specific topics of risk assessment of living modified organisms, and (b) existing guidance on specific topics of risk assessment of living modified organisms. Further, the COP-MOP extended the AHTEG to revise and improve the guidance on risk assessment, taking into account the topics prioritized by the AHTEG, on the basis of the needs indicated by the Parties with a view to moving towards operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes, for the development of further guidance. Furthermore, the COP-MOP agreed to consider, at its eighth meeting, the need for the development of further guidance on topics prioritized on the basis of the needs indicated by the Parties with a view to moving towards operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes.

For full text: Decision BS-VII

2. Ad Hoc Technical Expert Group on Risk Assessment and Risk Management

16 - 20 November 2015

Brasilia, Brazil

Thus, in response to decision BS-VII/12, the AHTEG held its first face-to-face meeting during the intersessional period in Brasilia from 16 to 20 November 2015. At that meeting, on the basis of the work done by its subgroup, the AHTEG considered the substantive proposals for changes to the Guidance, as provided through the testing process and accepted, modified or rejected the proposals, with the necessary justification, as appropriate. 

Also at its meeting in Brasilia, the AHTEG decided to recommend to COP-MOP the development of additional guidance on “risk assessment of LM fish” and “risk assessment of LMOs produced through synthetic biology” and to prepare outlines on the two topics for COP-MOP in order to facilitate its consideration and further development of the topics as separate guidance. 

For full text: Outcome report, Meeting Documents.

3. Ad Hoc Technical Expert Group on Risk Assessment and Risk Management

25 - 29 July 2016

Mexico City, Mexico

To finalize the process as described in decision BS-VII/12, the AHTEG on Risk Assessment and Risk Management held its second face-to- face meeting during the intersessional period in Mexico City, from 25 to 29 July 2016. 

AHTEG members to formulate their recommendations, including future actions on risk assessment and risk management, for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its eighth meeting. 

The “draft outline on the risk assessment of living modified fish”, contained in annex III, is the outcome of the work of the Subgroup of the AHTEG, in consultation with the Secretariat and taking into account input from the “Open-ended Online Forum” and AHTEG, in response to decision BS-VII/12. The resulting outline guidance on the “risk assessment of living modified fish” is to facilitate the consideration of the development of guidance on this topic by the COP-MOP. 

For full text: Outcome report, Meeting Documents.

4. 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. 

5. 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.

6. 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 LMOs containing engineered gene drives and a second on living modified fish.

The study was prepared by Mr. Jeremy Sweet (JT Environmental Consultants Ltd.) with scientific advice from Mr. Fredrik L Sundström (University of Uppsala).

The LM fish referred to in the study were from the classes Agnatha (jawless fish), Chondrichthyes (cartilaginous fish) and Osteichthyes (bony fish). Other marine and aquatic species of crustaceae and molluscs, such as bivalves and snails, were not included in this study. Fish cell culture transgenesis was not considered in this report as it does not result in whole living fish.

Final study: Study

8. Open-Ended Online Forum on Risk Assessment 

20 January - 1 February 2020

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

9. 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 (AHTEG) 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 meeting, Mr. Jeremy Sweet of JT Environmental Consultants made a presentation on the study. He provided a brief overview of the status of genetic modification of fish. He noted that two categories of living modified fish had been commercialized to date: ornamental fish and fish for food consumption. He described the methods used to gather information for the study’s analysis of the issue of living modified fish against decision CP-9/13, annex I. He then summarized the results of that analysis, according to the criteria in annex I, as well as the stock-taking exercise of resources on similar issues. Following the presentation, the experts had the opportunity to ask questions on the study. 

As requested in paragraph (a) of its terms of reference, the AHTEG reviewed the study informing the application of decision CP-9/13, annex I, to living modified fish 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 (BCH) that were then summarized by the Chair during the subsequent live session of the meeting in order to inform the AHTEG’s analysis. In line with its mandate, the AHTEG did not revise the study. Further, according to paragraph (c) of its terms of reference, the AHTEG deliberated on the need for guidance to be developed on risk assessment of living modified fish. In those discussions, the AHTEG also considered the information in CBD/CP/RA/AHTEG/2020/1/2, section II A. 21. The outcomes of the deliberations are presented in annex I. 
 

Final study: Study

For full text: Outcome report, Meeting Documents.

10. 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 4, it also noted the range of perspectives on the need for the development of guidance on risk assessment of living modified fish and decided not to proceed, at this stage, with the development of additional voluntary guidance materials on risk assessment regarding living modified fish, and encourages Parties and invites other Governments and relevant organizations to promote international cooperation, information sharing and capacity-building on risk assessment of living modified fish, and to make use of existing guidance materials, with a view to considering further guidance on living modified fish at its eleventh meeting, subject to the provisions of annex I to decision CP-9/13.

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 texts:  Decision CP-10/10, Meeting Documents.