Getting Ahead of Challenges in the Risk Assessment and Management of GM Viruses

TWN Info Service on Biodiversity/TK and Biosafety
25 April 2024
Third World Network


Dear Friends and Colleagues,

Getting Ahead of Challenges in the Risk Assessment and Management of GM Viruses

This study aims to provide additional information for regulatory agencies concerning the types of GM virus applications that are being developed for use in the environment and for purposes that may interfere with nature conservation efforts. The horizon scan described in the study and the analysis of several examples of GM virus applications indicate that a number of significant challenges exist at present regarding the risk assessment and risk management of GM virus applications.

To increase the necessary preparedness, further horizon-scanning activities to identify emerging GM virus applications are deemed necessary. The existing guidance for risk assessment also needs to be updated to include GM viruses. GM virus applications are for different purposes and subject to different regulations. Thus, it is important that the guidance that is available in different regulatory areas is reviewed and consolidated for easier accessibility and coordination of risk assessment requirements.

No established concepts currently exist regarding the post-market environmental monitoring of GM virus applications in the EU. Due to their high potential for survival and spreading as well as their ability to quickly mutate and evolve, robust monitoring approaches should be developed in the near future based on experience with recently established virus-surveillance approaches.

Parties to the Convention on Biological Diversity (CBD) will be discussing some of these issues in relation to the agenda item on synthetic biology, at their upcoming subsidiary body meetings in Nairobi in May (SBSSTA-26). It is paramount that the horizon scanning, monitoring and assessment process established by Parties continues so that the countries are equipped to deal with emerging biotechnological applications such as GM viruses.

With best wishes,
Third World Network



by Michael F. Eckerstorfer et al.
International Journal of Molecular Sciences 2024,25(3), 1507
25 January 2024


The release of novel genetically modified (GM) virus applications into the environment for agricultural, veterinary, and nature-conservation purposes poses a number of significant challenges for risk assessors and regulatory authorities. Continuous efforts to scan the horizon for emerging applications are needed to gain an overview of new GM virus applications. In addition, appropriate approaches for risk assessment and management have to be developed. These approaches need to address pertinent challenges, in particular with regard to the environmental release of GM virus applications with a high probability for transmission and spreading, including transboundary movements and a high potential to result in adverse environmental effects. However, the current preparedness at the EU and international level to assess such GM virus application is limited. This study addresses some of the challenges associated with the current situation, firstly, by conducting a horizon scan to identify emerging GM virus applications with relevance for the environment. Secondly, outstanding issues regarding the environmental risk assessment (ERA) of GM virus applications are identified based on an evaluation of case study examples. Specifically, the limited scientific information available for the ERA of some applications and the lack of detailed and appropriate guidance for ERA are discussed. Furthermore, considerations are provided for future work that is needed to establish adequate risk assessment and management approaches.

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