Eckerstorfer Michael F, Engelhard Margret, Heissenberger Andreas, Simon Samson, Teichmann Hanka
Department Landuse and Biosafety, Environment Agency Austria, Vienna, Austria.
Federal Agency for Nature Conservation, Bonn, Germany.
Front Bioeng Biotechnol. 2019 Feb 19;7:26. doi: 10.3389/fbioe.2019.00026. eCollection 2019.
The development of new genetic modification techniques (nGMs), also referred to as "new (breeding) techniques" in other sources, has raised worldwide discussions regarding their regulation. Different existing regulatory frameworks for genetically modified organisms (GMO) cover nGMs to varying degrees. Coverage of nGMs depends mostly on the regulatory trigger. In general two different trigger systems can be distinguished, taking into account either the process applied during development or the characteristics of the resulting product. A key question is whether regulatory frameworks either based on process- or product-oriented triggers are more advantageous for the regulation of nGM applications. We analyzed regulatory frameworks for GMO from different countries covering both trigger systems with a focus on their applicability to plants developed by various nGMs. The study is based on a literature analysis and qualitative interviews with regulatory experts and risk assessors of GMO in the respective countries. The applied principles of risk assessment are very similar in all investigated countries independent of the applied trigger for regulation. Even though the regulatory trigger is either process- or product-oriented, both triggers systems show features of the respective other in practice. In addition our analysis shows that both trigger systems have a number of generic advantages and disadvantages, but neither system can be regarded as superior at a general level. More decisive for the regulation of organisms or products, especially nGM applications, are the variable criteria and exceptions used to implement the triggers in the different regulatory frameworks. There are discussions and consultations in some countries about whether changes in legislation are necessary to establish a desired level of regulation of nGMs. We identified five strategies for countries that desire to regulate nGM applications for biosafety-ranging from applying existing biosafety frameworks without further amendments to establishing new stand-alone legislation. Due to varying degrees of nGM regulation, international harmonization will supposedly not be achieved in the near future. In the context of international trade, transparency of the regulatory status of individual nGM products is a crucial issue. We therefore propose to introduce an international public registry listing all biotechnology products commercially used in agriculture.
新基因编辑技术（nGMs）的发展，在其他资料中也被称为“新（育种）技术”，引发了全球范围内关于其监管的讨论。现有的不同转基因生物（GMO）监管框架对nGMs的涵盖程度各不相同。nGMs的涵盖情况主要取决于监管触发因素。一般来说，可以区分两种不同的触发系统，一种考虑开发过程中应用的方法，另一种考虑最终产品的特性。一个关键问题是，基于过程或产品导向触发因素的监管框架，对于nGM应用的监管是否更具优势。我们分析了不同国家针对GMO的监管框架，涵盖了两种触发系统，重点关注它们对各种nGM技术培育植物的适用性。该研究基于文献分析以及对各国GMO监管专家和风险评估人员的定性访谈。在所有被调查国家，所应用的风险评估原则非常相似，与所采用的监管触发因素无关。尽管监管触发因素要么是过程导向，要么是产品导向，但在实践中，两种触发系统都呈现出对方的一些特征。此外，我们的分析表明，两种触发系统都有一些共同的优点和缺点，但在总体层面上，没有一种系统可以被认为是更优越的。对于生物体或产品的监管，尤其是nGM应用，更具决定性的是在不同监管框架中用于实施触发因素的可变标准和例外情况。一些国家正在讨论和磋商是否有必要修改立法，以建立理想的nGM监管水平。我们为希望对nGM生物安全应用进行监管的国家确定了五种策略——从无需进一步修订就应用现有的生物安全框架，到制定新的独立立法。由于对nGMs的监管程度不同，短期内预计无法实现国际协调统一。在国际贸易背景下，单个nGM产品监管状况的透明度是一个关键问题。因此，我们建议引入一个国际公共登记册，列出所有在农业中商业使用的生物技术产品。
