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Table 3 Gene- edited crop regulation status on the basis of SDN

From: Challenges and Perspectives in Homology-Directed Gene Targeting in Monocot Plants

CategoryEFSA-2012 DefinitionThe major contents of Regulation
SDN-1After the intended site-specific cleavage of the DNA in the genome, random mutation (base substitution, insertion, or deletion) occurring for one or a few bases as a natural repair mechanismExcluded from regulation if the resulting plants are free of DNA from “plant pests” such as viruses or bacteriaWhen there are no transgenic genes and/or fragments of transgenic genes in the final product, however, the genome edited foods will not be considered to be foods derived from recombinant DNA technology, as long as, the DNA double-strand break induced by engineered restriction enzyme and following repair (i.e., mutation) is: a) base-pair deletion; b) substitution; c) naturally occurring gene deletion; and/or, d) concomitant insertion (mutation) of one to several base pairs.Excluded from regulationRegulated as GMO(s)
SDN-2Systematically induces mutation for one or a few bases by artificially synthesizing a short DNA fragment (template) that is homologous to the target base sequence and introducing it along with an artificial restriction enzyme at the time of cleaving.Explicitly regulatedRegulated as GMO(s)
SDN-3Forms a special DNA fragment at a specific domain on the genome by introducing a long DNA fragment containing a gene of several thousand base pairs not originating from compatible same or related varieties (transgene) in a form sandwiched by sequences homologous to the target sequence.Explicitly regulatedRegulated as GMO(s)
Effective date28 March 201827 March 20198 October 201925 July 2018