Table 3 Gene- edited crop regulation status on the basis of SDN
From: Challenges and Perspectives in Homology-Directed Gene Targeting in Monocot Plants
Category | EFSA-2012 Definition | The major contents of Regulation | |||
|---|---|---|---|---|---|
USA | Japan | Australia | EU | ||
SDN-1 | After 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 mechanism | Excluded from regulation if the resulting plants are free of DNA from “plant pests” such as viruses or bacteria | When 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 regulation | Regulated as GMO(s) |
SDN-2 | Systematically 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 regulated | Regulated as GMO(s) | ||
SDN-3 | Forms 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 regulated | Regulated as GMO(s) | ||
Effective date | 28 March 2018 | 27 March 2019 | 8 October 2019 | 25 July 2018 | |