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巴西基因编辑生物监管框架的最新情况:巴西农业综合企业的一场分子革命

Updates on the Regulatory Framework of Edited Organisms in Brazil: A Molecular Revolution in Brazilian Agribusiness.

作者信息

da Cunha Nicolau B, Silva Junior Jaim J da, Araújo Amanda M M, de Souza Ludmila R, Leite Michel L, Medina Gabriel da S, Rodriguez Gustavo R, Dos Anjos Renan M, Rodrigues Júlio C M, Costa Fabrício F, Dias Simoni C, Rech Elíbio L, Vianna Giovanni R

机构信息

Faculty of Agronomy and Veterinary Medicine (FAV), Campus Darcy Ribeiro, University of Brasilia (UnB), Brasília 70910-970, DF, Brazil.

Post-Graduation in Agronomy Program (PPGA), Campus Darcy Ribeiro, University of Brasilia (UnB), Brasília 70910-970, DF, Brazil.

出版信息

Genes (Basel). 2025 Apr 30;16(5):553. doi: 10.3390/genes16050553.

Abstract

Genome editing technologies have revolutionized the production of microorganisms, plants, and animals with phenotypes of interest to agriculture. Editing previously sequenced genomes allows for the punctual, discreet, precise, and accurate alteration of DNA for genetic analysis, genotyping, and phenotyping, as well as the production of edited organisms for academic and industrial purposes, among many other objectives. In this context, genome editing technologies have been causing a revolution in Brazilian agriculture. Thanks to the publication of Normative Resolution No. 16 (in Portuguese Resolução Normativa No. 16-RN16) in 2018, Brazilian regulatory authorities have adapted to the new genetic manipulation technologies available to the scientific community. This review aims to describe the effects of updates to the regulatory framework for edited organisms in Brazil and to point out their impacts on research and development of emerging technologies in the Brazilian agricultural sector. The implementation of RN16 rationalized the regulatory aspects regarding the production, manipulation, exploration and commercial release of edited organisms and led to the faster, cheaper and safer obtaining of edited technologies, which are more productive and better adapted to different environmental conditions in Brazil.

摘要

基因组编辑技术彻底改变了具有农业相关表型的微生物、植物和动物的生产方式。对先前测序的基因组进行编辑,能够对DNA进行准时、审慎、精确且准确的改变,以用于遗传分析、基因分型和表型分析,以及出于学术和工业目的等诸多目标来生产编辑后的生物体。在此背景下,基因组编辑技术正在巴西农业领域引发一场革命。得益于2018年第16号规范性决议(葡萄牙语为Resolução Normativa No. 16 - RN16)的发布,巴西监管当局已适应科学界可用的新基因操作技术。本综述旨在描述巴西编辑后生物体监管框架更新的影响,并指出其对巴西农业部门新兴技术研发的影响。第16号规范性决议的实施使编辑后生物体的生产、操作、开发和商业释放等监管方面合理化,并实现了更快、更廉价且更安全地获取编辑技术,这些技术具有更高的生产力,且更能适应巴西不同的环境条件。

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