Non-safety Assessments of Genome-Edited Organisms: Should They be Included in Regulation?
Non-safety Assessments of Genome-Edited Organisms: Should They be Included in Regulation?
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DOI：
10.1007/s11948-020-00222-4
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发表时间：
2020-10
影响因子：
3.7
通讯作者：
Myhr AI
中科院分区：
文献类型：
--
作者：
Myskja BK;Myhr AI
本文提出并评价了支持以下观点的论点：食品或饲料用基因组编辑生物的批准程序应包括对社会、伦理和环境问题的广泛评估；即所谓的非安全性评估。分析的核心是《挪威基因技术法》的要求，即在监管机构批准新产品之前，应评估转基因生物的可持续性、伦理和社会影响。本文概述了这一要求在监管实践中的实施情况，证明了这种评估是可行和合理的。即使在基因组编辑的生物体被认为在风险方面与未修饰的生物体相当的情况下，这项技术除了社会益处外，可能还会产生负面影响，需要对该法要求的那种进行评估。主要原因是基因组编辑技术的颠覆性，因为它们有潜力在农业和水产养殖中提供新颖的开创性解决方案，并结合专利制度形成的经济框架。从生物和文化上讲，食品是美好生活的基础，这就需要比其他行业更严格的评估程序，至少在挪威这样有着国家控制农产品市场和育种项目的强大传统的国家是这样。
This article presents and evaluates arguments supporting that an approval procedure for genome-edited organisms for food or feed should include a broad assessment of societal, ethical and environmental concerns; so-called non-safety assessment. The core of analysis is the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a genetically modified organism should be assessed prior to regulatory approval of the novel products. The article gives an overview how this requirement has been implemented in the regulatory practice, demonstrating that such assessment is feasible and justified. Even in situations where genome-edited organisms are considered comparable to non-modified organisms in terms of risk, the technology may have—in addition to social benefits—negative impacts that warrant assessments of the kind required in the Act. The main reason is the disruptive character of the genome editing technologies due to their potential for novel, ground-breaking solutions in agriculture and aquaculture combined with the economic framework shaped by the patent system. Food is fundamental for a good life, biologically and culturally, which warrants stricter assessment procedures than what is required for other industries, at least in countries like Norway with a strong tradition for national control over agricultural markets and breeding programs.
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影响因子：
2.8
作者：
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通讯作者：
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DOI：
10.1080/21645698.2015.1134405
发表时间：
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影响因子：
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作者：
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