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Risk assessment studies as per decision CP-9/13

In decision CP-9/13, Parties requested the Executive Secretary to commission a study informing the application of annex I of the decision to (i) living modified organisms containing engineered gene drives and (ii) living modified fish, and present it to the open-ended online forum and Ad Hoc Technical Expert Group on Risk Assessment and Risk Management.

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 are presented here below. In addition, a table showing the changes made to each of the studies is also provided.


Study on engineered gene drives


Study on living modified fish


Table on engineered gene drives


Table on living modified fish



Annex I of decision CP-9/13:

Identification and prioritization of specific issues of risk assessment of living modified organisms that may warrant consideration

The process for recommending specific issues of risk assessment for consideration by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety should include a structured analysis to evaluate whether the specific issues fulfil the following criteria:
  1. They are identified by Parties as priorities, taking into account the challenges to risk assessment, particularly for developing country Parties and countries with economies in transition;
  2. They fall within the scope and objective of the Cartagena Protocol;
  3. They pose challenges to existing risk assessment frameworks, guidance and methodologies, for example, if the issue at hand has been assessed with existing risk assessment frameworks but poses specific technical or methodological challenges that require further attention;
  4. The challenges in addressing the specific issue are clearly described;

    and considering, inter alia:
  5. The specific issues concerning living modified organisms that:
    1. Have the potential to cause adverse effects on biodiversity, in particular those that are serious or irreversible, taking into account the urgent need to protect specific aspects of biodiversity, such as an endemic/rare species or a unique habitat or ecosystem, taking into account risks to human health and the value of biological diversity to indigenous peoples and local communities;
    2. May be introduced into the environment either deliberately or accidentally;
    3. Have the potential to disseminate across national borders;
    4. Are already, or are likely to be, commercialized or in use somewhere in the world;

and consider a stock-taking exercise to determine if resources on similar issues have been developed by national, regional and international bodies and, if so, whether such resources may be revised or adapted to the objective of the Cartagena Protocol, as appropriate.