Abstract
The identification of risks associated with novel agricultural products of plant origin obtained via genome editing is an important aspect of genetic engineering. An extensive discussion is currently ongoing worldwide to clarify the similarities and differences between the “old” risks of “classic” GM plants and the “new” ones associated with genome editing, the lack of existing methods for identification and assessment of new risks. We propose here the concept of “safe by design” as applied to protection that is a new interesting tool that introduces good known standards of safety into plant bioengineering. This approach states that design options are identified to minimize or prevent risks and off-target of genome editing at the concept stage. The correlation between experimentally determined and in silico predicted off-target gRNA activity is a major challenge in the CRISPR system application. Today the most studies are focused on efficiency of gRNA design, while we pay attention specifically to the bioinformatics search and study of potential promoters, as the potential risk associates with a possible unplanned change in the transcriptional activity of promoters. We conveyed these strategies in the form of a risk assessment framework for regulation of new genetic technologies.
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