Existing guidelines are adequate for evaluating risks associated with gene-drive modified insects, but further guidance is needed for some areas, most notably for environmental risk assessments, according to an opinion of the EU’s food safety agency (EFSA).
After being mandated by the European Commission, EFSA’s experts on genetically modified organisms (GMOs) published the scientific opinion related to engineered gene drives on Thursday (12 November), specifically focusing on gene drive modified disease-transmitting insects, primarily mosquitoes.
The evaluation was requested to explore the issue ahead of the consideration of any possible applications of the technology and is also designed to support the EU in discussions on the biosafety of GMOs in international fora such as the United Nations.
It found that while existing guidelines are sufficient for evaluating risks associated with technology, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring.
Synthetic gene drives are a new form of genetic engineering, created via the genetic engineering method CRISPR/CAS9, and are intended to permanently modify or eradicate populations, or even whole species, in the wild.
The idea of gene drive technology is to force the inheritance of detrimental genetic traits. In this way, scientists hope to reprogramme or eradicate species such as disease-carrying insects and invasive species.
This is a key distinction between gene-drive organisms (GDOs) and genetically modified organisms (GMOs), which are explicitly designed to contain the spread of modified traits.
Scientists say that gene drive technology could play a key role in suppressing or modifying mosquito populations, thus potentially eradicating the life-threatening diseases they carry, such as malaria.
Recently, Imperial College London created a modification that was able to eliminate populations of malaria-carrying mosquitoes in lab experiments, funded by the Bill & Melinda Gates Foundation under the Target Malaria project.
The technology is also being explored to control agricultural pests, eradicate invasive species, and rescue endangered species, with research rapidly evolving in this area.
However, the report acknowledges there is concern that this emerging technology may have “possible and irreversible side effects”.
While Mareike Imken of the German association Save our Seeds welcomed EFSA’s conclusion that existing guidelines for genetically engineered insects are insufficient for undertaking environmental risk assessments, she raised concerns that the report failed to acknowledge other key issues.
“EFSA does not acknowledge a key challenge for the risk assessment and monitoring of genetically engineered gene drive organisms – so-called next-generation effects,” she highlighted.
These next-generation effects would encompass unintended changes to the biological characteristics in the offspring of GDOs, which she said would “likely happen due to the repeated and uncontrollable process of genetic engineering that gene drives set in motion in nature”.
“The likely impossibility to model and predict next-generation-effects, as already observed in the offspring of genetically engineered plants, calls for the establishment of cut-off-criteria for risk assessment”.
She added that decision-making about this technology needs to be informed by more than risk assessment, stressing that there is an “urgent need for a broader political debate and processes for participatory and inclusive societal deliberation around the desirability, costs and benefits of this technology”.
[Edited by Zoran Radosavljevic]