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生物技术行政命令为农业中基因工程微生物的监管改革和社会接受打开了大门。

Biotechnology executive order opens door for regulatory reform and social acceptance of genetically engineered microbes in agriculture.

机构信息

Department of Plant and Microbial Biology, North Carolina State University, Raleigh, NC, USA.

Genetic Engineering and Society Center, North Carolina State University, Raleigh, NC, USA.

出版信息

GM Crops Food. 2024 Dec 31;15(1):248-261. doi: 10.1080/21645698.2024.2381294. Epub 2024 Jul 27.

Abstract

In the United States, regulatory review of genetically engineered microbes for agriculture falls under the Coordinated Framework for the Regulation of Biotechnology (CFRB). However, the lack of a centralized regulatory pathway and multiple oversight authorities can lead to uncertainty in regulatory review. Using three microbial-based technologies for agriculture as illustrative examples, this commentary identifies the weaknesses and challenges associated with the CFRB by assessing the current system and proposed changes to the system under a multi criteria decision analysis framework. In addition, it discusses opportunities for regulatory reform to improve clarity, efficiency, and public acceptance of genetically engineered microbes in agriculture under the CHIPS and Science Act and the 2022 Executive Order on the Bioeconomy.

摘要

在美国,农业用基因工程微生物的监管审查属于生物技术监管协调框架(CFRB)的范畴。然而,缺乏集中的监管途径和多个监督机构可能会导致监管审查的不确定性。本文使用农业用三种基于微生物的技术作为说明性示例,通过在多标准决策分析框架下评估现行制度和对制度的拟议改革,确定了 CFRB 的弱点和挑战。此外,本文还讨论了在 CHIPS 和科学法案以及 2022 年关于生物经济的行政命令下,进行监管改革以提高公众对农业用基因工程微生物的接受度、清晰度和效率的机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/349e/11285237/db6994ad8eed/KGMC_A_2381294_F0001_OC.jpg

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