Safety Management of the Crop Produced by New Breeding Techniques

doi:10.19586/j.2095-2341.2021.0147

Current Biotechnology ›› 2022, Vol. 12 ›› Issue (2): 198-204.DOI: 10.19586/j.2095-2341.2021.0147

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Safety Management of the Crop Produced by New Breeding Techniques

Yaohui HUANG¹(), Yijie WANG², Litao YANG², Yue JIAO¹(), Zhongwen FU¹()

^1.Development Center for Science and Technology，Ministry of Agriculture and Rural Affairs，Beijing 100176，China
^2.School of Sciences and Biotechnology，Shanghai Jiao Tong University，Shanghai 200240，China

Received:2021-09-01 Accepted:2021-10-28 Online:2022-03-25 Published:2022-03-25
Contact: Yue JIAO,Zhongwen FU

生物育种新技术作物的安全管理

黄耀辉¹(), 王艺洁², 杨立桃², 焦悦¹(), 付仲文¹()

^1.农业农村部科技发展中心，北京 100176
^2.上海交通大学生命科学技术学院，上海 200240

通讯作者: 焦悦,付仲文
作者简介:黄耀辉 E-mail: huangyaohui@agri.gov.cn
基金资助:
国家转基因生物新品种培育科技重大专项(2016ZX08012003)

Abstract

Abstract:

New breeding techniques （NBTs） refers to a class of new techniques for molecular breeding based on molecular biology tools， which can produce new powerful traits for crops in a short period and promote the development of new crop varieties， such as gene editing technology， RNA interference （RNAi） technology， cisgenesis technology， etc. These new technologies are currently being widely used in global agricultural breeding， and some new crop varieties have been approved for commercial production. However， the world has not yet reached a consensus on the safety and safety management of new crop varieties produced by new biological breeding technologies， and different safety regulation ideas， which may limit the process of development and commercial application of new crop varieties. At this stage， policies and guiding documents on the safety and supervision of NBTs crops form major developed countries around the world were reviewed in this paper， which was expected provide reference for the safety management and regulation polices of NBTs crops to our country.

Key words: new breeding techniques （NBTs）, gene editing, RNAi, cisgenesis

摘要：

生物育种新技术（new breeding techniques，NBTs）是指基于分子生物学工具进行作物分子育种的一类新技术，可以短期内使作物产生新的有利性状，促进作物新品种的开发，如基因编辑技术、RNA干扰（RNA interference，RNAi）技术、同源转基因技术等。这些新技术目前正在全球农业育种中广泛应用，并且已有部分作物新品种获准商业化生产。然而，针对生物育种新技术产生的作物新品种的安全性和安全管理政策，全球尚未达成统一共识，对其安全监管的思考也不尽相同，限制了这些作物新品种的研发和商业化应用进程。综述了现阶段全球主要发达国家对于生物育种新技术作物的安全性和监管方面实施的管理政策和法规，以期对我国生物育种新技术作物的安全性管理政策的制定提供一定的借鉴。

关键词: 育种新技术, 基因编辑, RNAi, 同源转基因

CLC Number:

S330

Yaohui HUANG, Yijie WANG, Litao YANG, Yue JIAO, Zhongwen FU. Safety Management of the Crop Produced by New Breeding Techniques[J]. Current Biotechnology, 2022, 12(2): 198-204.

黄耀辉, 王艺洁, 杨立桃, 焦悦, 付仲文. 生物育种新技术作物的安全管理[J]. 生物技术进展, 2022, 12(2): 198-204.

Figures/Tables 1

References 38

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国家	监管法律或指令	监管方式
阿根廷	Resolucion 173/2015	个案分析 SDN⁃1和SDN⁃2不视为转基因产品，SDN⁃3视为转基因产品进行监管
智利	Resolucion 1523/2001，2017	个案分析，源于阿根廷
巴西	Normativa 16，2018	个案分析，源于阿根廷
哥伦比亚	Resolucion 29299，2018	个案分析，源于阿根廷
澳大利亚	《基因技术协定》	基于过程分析
澳大利亚	FSANZ专家咨询	SDN⁃3和转基因嫁接的产品视为转基因产品；ODM和SDN⁃1及它们衍生的产品不应视为转基因产品
新西兰	CPB FSANZ专家咨询	基于过程分析，同澳大利亚
欧盟	法规（EU）503/2013 指令（EU）2018/350（对指令2001/18 / EC的修订）	基于过程分析对于遗传信息以非自然方式发生改变的均视为转基因作物，按照转基因作物的程序监管
美国	《SECURE》	个案分析
加拿大	Plant Protection Act	个案分析判断是否为PNT植物，并根据性状变异程度监管
日本	《基因编辑食品和食品添加剂安全处理指南》《基因编辑饲料和饲料添加剂安全处理指南》	个案分析不论是否能检测到外来核苷酸，任何在宿主基因组中具有外来核苷酸的活生物体都应受到监管

国家	监管法律或指令	监管方式
阿根廷	Resolucion 173/2015	个案分析 SDN⁃1和SDN⁃2不视为转基因产品，SDN⁃3视为转基因产品进行监管
智利	Resolucion 1523/2001，2017	个案分析，源于阿根廷
巴西	Normativa 16，2018	个案分析，源于阿根廷
哥伦比亚	Resolucion 29299，2018	个案分析，源于阿根廷
澳大利亚	《基因技术协定》	基于过程分析
澳大利亚	FSANZ专家咨询	SDN⁃3和转基因嫁接的产品视为转基因产品；ODM和SDN⁃1及它们衍生的产品不应视为转基因产品
新西兰	CPB FSANZ专家咨询	基于过程分析，同澳大利亚
欧盟	法规（EU）503/2013 指令（EU）2018/350（对指令2001/18 / EC的修订）	基于过程分析对于遗传信息以非自然方式发生改变的均视为转基因作物，按照转基因作物的程序监管
美国	《SECURE》	个案分析
加拿大	Plant Protection Act	个案分析判断是否为PNT植物，并根据性状变异程度监管
日本	《基因编辑食品和食品添加剂安全处理指南》《基因编辑饲料和饲料添加剂安全处理指南》	个案分析不论是否能检测到外来核苷酸，任何在宿主基因组中具有外来核苷酸的活生物体都应受到监管

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Safety Management of the Crop Produced by New Breeding Techniques

生物育种新技术作物的安全管理

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