Regulatory aspects of genome-edited crops

Abstract

Genome editing with engineered nucleases (GEEN) is a highly efficient means of generating useful traits in crops. The application of GEEN for multiple traits and crops is resulting in products that are already entering the marketplace. Genome editing represents diverse and robust techniques targeting highly specific genome locations to cause double-strand breaks and subsequent repair by homologous and non-homologous mechanisms. Genome edits range from simple random insertions or deletions to template additions to stacking of multiple transgenes at a specific locus. Consequently, it is not easy to generalize the regulatory view of genome editing for crop improvement since a case-specific consideration is necessary which, in many regulatory regimes, encompasses the process used and the genome edit achieved in addition to the phenotype derived. Key process considerations for regulators of a GEEN-derived product are the nature of the edit, specificity, the source of the editing machinery, and post-editing trait segregation. These considerations along with the nature of the derived trait and performance of the crop phenotype inform the safety and benefit of a given GEEN product. The view of regulators toward a particular genome-edited crop is driven by the degree that regulatory statutes are product-versus process-focused and will be shaped by emerging scientific and public views of genome-editing technology. In order that the public will not confuse genome-edited crops with genetically modified organisms (GMOs), scientists and regulators alike need to carefully frame and communicate GEEN techniques in terms of the specific process used and the benefits derived through development of useful crop traits.