Safety, Security, and Policy Perspectives for Genome-Edited Crops.

Genome editing has rapidly emerged as a leading technology for crop improvement. The ability to precisely edit plant genomes affords significant opportunities for both discovery of gene function and for the identification and development of useful crop traits. As with any new technical innovation, regulators and the public seek assurances concerning the safety and benefits of the processes used and the resulting products. Governance and regulatory decision making involves robust standards of evidence extending from the laboratory to the post commercial marketplace. Therefore, the research community and developers of genome-edited crops must anticipate significant engagement and investment to address questions of regulators and civil society. Genome editing entails a continuum of approaches extending from point mutations to transgene insertions. Thus, clarity is required by scientists and product developers in describing - in a given instance - the specific approach used, the benefit derived, product characteristics, product safety and underlying uncertainties. Key initial considerations for crops bioengineered through genome editing relate to target specificity, the potential for mismatched edits, unanticipated downstream effects of off-target mutations, and assurance that genome editing reagents do not occur in finished products. Once broader questions of the genome editing process, its specificity and integrity have been subject to scientific and public discourse, regulatory considerations for genome edited crops and derived products should focus on phenotypic attributes of the crop and safety of the derived products rather than on the genome editing process per se. Research governance models are needed that reduce regulatory burden for genome edited crops and other genome bioengineering technologies, so that the benefits of these technologies may be fully realized.