Department of Biology
Assessment considerations
- A case by case assessment is recommended involving a tiered strategic approach
- In the first instance, the use of CRISPR-Cas9 for genome editing in the vast majority of situations, will NOT require system configurations that could lead to gene drive
- System configurations that WOULD raise concerns include:
- Co-location of the gene encoding CRISPR-Cas9 with the targeting sequence (guide RNA) in a single heritable unit
- Designs in which the Cas9 gene and/or guide RNA are expected to insert into the target sequence (“homing” behaviour)
- Secondly, where one of the factors above is required, “non-autonomous” configurations should be considered where the potential for super-Mendelian inheritance is lost in subsequent generations (e.g. due to segregation of system components)
- Finally, if alternatives cannot be used, and autonomous systems are planned, additional containment and control measures may be required
- These will vary depending on the specific species, applications and circumstances, but are likely to be enhanced compared to otherwise-similar GMOs of the same species that lack potential synthetic selfish DNA elements.
This step wise and case by case approach is advocated in recent publications in Science.