Regulatory Assessment of Off-Target Changes and Spurious DNA Insertions in Gene-Edited Organisms for Agri-Food Use

Abstract

Worldwide, an increasing number of regulatory systems have begun to consider applications for the authorization of activities involving gene-edited organisms for agri-food use. Although a handful of countries have made advances in establishing regulatory criteria and gathering practical experience in this regard, there is still a general need for regulatory cooperation concerning capacity building and development of harmonized criteria. Consequently, many biotechnology regulators need to quickly become more acquainted with the numerous technological possibilities enclosed under the concept of "gene editing", and to incorporate criteria for their regulatory assessment. This article contains a simplified introduction to the state of the art in genome editing, described from a regulatory perspective. In particular, two issues of higher practical importance are covered in detail, namely, off-target effects and unintended DNA insertions. The detailed review of current evidence regarding those issues serves as the basis for proposing concrete regulatory criteria to address them. doi: 10.21423/jrs-v09i1lema