Genome editing and gene drive: potential applications and risks

(Updated 10 May 2016 18:46 UTC -3:00, with new references on gene drive as suggested by Kevin Esvelt)

The discovery of a genome editing system in bacteria and its use for editing genomes of many organisms is transforming the way biotechnology is done. Likewise, the use of the gene drives (a form of stimulating biased inheritance of particular genes to alter entire populations) opens up new applications for the control of pests and invertebrate vectors or hosts, whenever they have a short life cycle. But the knowledge of the two techniques is far from being widespread and sufficient, even among geneticists.

In parallel with the rapid development of genome editing and gene drives, regulatory issues arise questioning the applicability of risk assessment procedures, as originally established for GMOs, and legal issues, such as the inclusion of this or that product in the regulatory framework of each country, regulatory asynchrony, the ethical issues involved, etc.

Any meaningful discussion of these issues must be grounded in updated and quality information. We therefore collected and offer the reader a set of selected references that may be helpful in understanding both new technologies and in establishing the applicability and eventual limits of present risk assessment rules of new genome-edited or gene drive products.

We split a little arbitrarily texts in three subsets, the first devoted to the issue of genome editing by the CRISPR/Cas9 system, the second to gene drives and the third for risk assessments available for the GM Aedes aegypti previously evaluated by CTNBio in Brazil and considered safe for commercial use in 2014. The latter references also include general considerations on GM mosquitoes and emphasize the importance of new tools in vector control, particularly in mosquito-borne diseases.

The texts whose links follow below can be of various kinds: scientific articles, technical reports, reviews written by scientists, reviews written by activists, conference presentations, etc. Many are available to the general public. Texts marked with a star are suitable for a first approach to the subject. The search for texts was not exhaustive and therefore we know that there may be relevant texts that are not listed below. So over the next few months, other texts may be added, appropriately highlighted as new.

Finally, we remind the reader that national regulatory frameworks should not regulate a technology, but their products. In fact, each product carries its risks and benefits, even if produced by the same technology. The serious mistake many countries committed regulating the technology, rather than the product, should not be repeated again. We also recall that the risk assessment conceptual basis, as established for GMOs, probably will suffice for a careful and responsible risk assessment of products arising from any other technology, especially the CRISPR system / Cas9.

The Research Team from TargetDNA Biotechnology Solutions (


Selected texts on genome editing issues

Texts describing the technology and general issues

  • Bhaya D, Davison M, Barrangou R, 2011. CRISPR-Cas Systems in Bacteria and Archaea: Versatile small RNAs for adaptive defense and regulation. Annu. Rev. Genet. 45:273–97.
  • Anonymous, 2016. CRISPR/Cas9 Guide.
  • Medina-Aparicio L, Rebollar-Flores JE, Gallego-Hernández AL, Vázquez A, Olvera L, Gutiérrez-Ríos RM, Calva E, Hernández-Lucas I, 2011. The CRISPR/Cas Immune System Is an Operon Regulated by LeuO, H-NS, and Leucine-Responsive Regulatory Protein in Salmonella enterica Serovar Typhi. J. Bacteriol. 193(10): 2396-2407.
  • important-green Ran FA, Hsu PD, JWright J, Agarwala V, Scott DA, Zhang F, 2013. Genome engineering using the CRISPR-Cas9 system. Nature Protocols 8(11): 2281-2308   doi:10.1038/nprot.2013.143.

Texts on regulatory and ethical issues (risk assessment, risk analysis, legal framework, etc.)

Selected texts on gene drive issues

Texts describing the technology and general issues

Texts on regulatory and ethical issues (risk assessment, risk analysis, legal framework, etc.)

Selected texts on OX513A Aedes aegypti risk assessment and general issues on GM insects

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