Regulatory framework of genome editing in Brazil and worldwide.
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The regulation of the use of products obtained through genome-editing techniques has been the subject of great debate worldwide. Currently, the discussions are mainly focused on whether products obtained by different strategies of site-directed nucleases (SDN) should or not be classified as Genetically Modified Organisms (GMOs). In the SDN-1 application, the natural DNA cell repair pathway (Non-Homologous End-Joining - NHEJ) is explored to introduce simple random mutations (substitutions, insertions, and deletions) by systems such as CRISPR-Cas, TALENs, or Zinc Fingers Nucleases, which cause silencing of the gene product after breaking DNA (by Double-Strand Break - DSB). In the SDN-2 approach, a template DNA is also used to introduce a change in the sequence of nitrogen bases (A, C, G, T) at the target site where the DSB occurred, exploring another natural repair system directed by a DNA fragment from the same species (Homology-Directed Repair - HDR). In the SDN-3 approach, both NHEJ and HDR can be explored to insert one or more DNA fragments with sequences necessary for the expression of a gene (promoter, coding, and terminator region) at a specific location in the genome. In the following topics, questions related to genome editing regulation in different countries are discussed in detail.
Palabras clave
Biotecnologia, DNA, Engenharia Genética, Genética Vegetal, Legislação, Biotechnology, Genetic engineering, Genetically modified organisms, Plant genetics
