title: The Regulatory Status of Genome-edited Crops.
abstract: 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.
authors.affiliation: Department of Agronomy, Iowa State University, Ames, IA, USA.|Biosafety Institute for Genetically Modified Agricultural Products, Iowa State University, Ames, IA, USA.|Crop Bioengineering Consortium, Iowa State University, Ames, IA, USA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Wolt
authors.affiliation: Department of Agronomy, Iowa State University, Ames, IA, USA.|Crop Bioengineering Consortium, Iowa State University, Ames, IA, USA.
authors.forename: Kan
authors.initials: K
authors.lastname: Wang
authors.affiliation: Crop Bioengineering Consortium, Iowa State University, Ames, IA, USA.|Department of Genetics, Development, and Cell Biology, Iowa State University, Ames, IA, USA.
authors.forename: Bing
authors.initials: B
authors.lastname: Yang
mesh_terms: D018556:Crops, Agricultural / Q000191:economics / Q000235:genetics*; D000072669:Gene Editing / Q000331:legislation & jurisprudence* / Q000379:methods*; D018745:Genome, Plant; D023281:Genomics; D012926:Social Control, Formal
keywords: CRISPR/Cas9; TALEN; engineered nucleases; homology-directed repair; site-directed nucleases; site-specific mutagenesis