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. 2016 Feb;14(2):510-8.
doi: 10.1111/pbi.12444. Epub 2015 Aug 7.

The Regulatory Status of Genome-edited Crops

Free PMC article

The Regulatory Status of Genome-edited Crops

Jeffrey D Wolt et al. Plant Biotechnol J. .
Free PMC article

Erratum in

  • Erratum.
    Plant Biotechnol J. 2016 Sep;14(9):1937. doi: 10.1111/pbi.12597. Plant Biotechnol J. 2016. PMID: 27507799 Free PMC article. No abstract available.


Genome editing with engineered nucleases (GEEN) represents a highly specific and efficient tool for crop improvement with the potential to rapidly generate useful novel phenotypes/traits. Genome editing techniques initiate specifically targeted double strand breaks facilitating DNA-repair pathways that lead to base additions or deletions by non-homologous end joining as well as targeted gene replacements or transgene insertions involving homology-directed repair mechanisms. Many of these techniques and the ancillary processes they employ generate phenotypic variation that is indistinguishable from that obtained through natural means or conventional mutagenesis; and therefore, they do not readily fit current definitions of genetically engineered or genetically modified used within most regulatory regimes. Addressing ambiguities regarding the regulatory status of genome editing techniques is critical to their application for development of economically useful crop traits. Continued regulatory focus on the process used, rather than the nature of the novel phenotype developed, results in confusion on the part of regulators, product developers, and the public alike and creates uncertainty as of the use of genome engineering tools for crop improvement.

Keywords: CRISPR/Cas9; TALEN; engineered nucleases; homology-directed repair; site-directed nucleases; site-specific mutagenesis.


Figure 1
Figure 1
Relationship of site‐directed genome approach to the anticipated degree of regulatory scrutiny of the plant phenotype obtained. *Current uses of OMM are analogous to SDN1 in terms of regulatory scrutiny.

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