Are there specific challenges for risk assessment of gene drive-modified insects?
Typically, risk assessment utilizes a variety of data and information sources, giving them different weight. Data generated using the particular organism (species), modification (engineered trait), and receiving environment will have the highest weight. To date, no gene drive-modified organism has been released into the environment. Experimental data from contained testing in small and large cages will be most informative, along with knowledge of the biology and behavior in nature of the host insect, of related naturally occurring gene drives, and of the environment where the modified insects will be used. Various predictive tools, including mathematical modelling, can provide insights into aspects of the behavior of the gene drive-modified insects upon release, such how time, seasonality, or use of other control measures might affect their spread through the local population of the target organism. Nonetheless, in the initial absence of data on the field performance of engineered gene drives, risk assessment may have to accommodate a range of uncertainties. Some of these may be addressable through specific risk mitigation methods and monitoring. While, several risk assessment experts have published that current risk assessment frameworks are suitable for evaluating gene drive-modified organisms, they also have noted areas where additional guidance would be helpful. Work to provide such guidance is underway in several venues, including the Convention on Biological Diversity and the European Food Safety Authority. This will add to existing internationally accepted risk assessment guidelines.
For more information:
https://www.sciencedirect.com/science/article/abs/pii/S1462901119311098
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6297
https://bch.cbd.int/protocol/risk_assessment/cp-ra-ahteg-2020-01-04-en-2.pdf
https://www.nature.com/articles/s41467-023-37483-z
https://malariajournal.biomedcentral.com/articles/10.1186/s12936-022-04183-w
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4971