Transgenic, cisgenic and novel plant products: Challenges in regulation and safety assessment

Plant science has made considerable progress in developing new biotechnology-based plant breeding techniques to alter genetic and epigenetic factors. In this chapter, we will discuss novel plant products (NPPs) obtained by cisgenesis, intragenesis and genome engineering using site-specific nucleases and gene-targeting oligonucleotides. Among these, zinc finger nucleases, transcription activator-like effector nucleases and clustered, regularly interspaced, short palindromic repeats-associated Cas9 nucleases. Reverse breeding methods and backcrossing of the engineered plants with natural varieties has provided improved plants and fruit trees devoid of transgenes and cisgenes. There is an increasing higher public acceptance of the NPPs devoid of virus sequences and antibiotic genes, and containing only genetic material derived from the species itself or from closely related species. An overview is presented on the differences between regulation and regulatory bodies in various countries, with a need for harmonization in the ruling and in definition differences between modified and non-modified plant genomes.