Centre for Research in Biotechnology for Agriculture (CEBAR), Level 3, Research Management and Innovation Complex, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia.
Faculty of Science, Institute of Biological Sciences, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia.
Plant Cell Rep. 2019 Dec;38(12):1449-1463. doi: 10.1007/s00299-019-02446-6. Epub 2019 Jul 26.
Recent developments in modern biotechnology such as the use of RNA interference (RNAi) have broadened the scope of crop genetic modification. RNAi strategies have led to significant achievements in crop protection against biotic and abiotic stresses, modification of plant traits, and yield improvement. As RNAi-derived varieties of crops become more useful in the field, it is important to examine the capacity of current regulatory systems to deal with such varieties, and to determine if changes are needed to improve the existing frameworks. We review the biosafety frameworks from the perspective of developing countries that are increasingly involved in modern biotechnology research, including RNAi applications, and make some recommendations. Malaysia and India have approved laws regulating living modified organisms and products thereof, highlighting that the use of any genetically modified step requires regulatory scrutiny. In view of production methods for exogenously applied double-stranded RNAs and potential risks from the resulting double-stranded RNA-based products, we argue that a process-based system may be inappropriate for the non-transformative RNAi technology. We here propose that the current legislation needs rewording to take account of the non-transgenic RNAi technology, and discuss the best alternative for regulatory systems in India and Malaysia in comparison with the existing frameworks in other countries.
近年来现代生物技术的发展，如 RNA 干扰（RNAi）的应用，拓宽了作物遗传改良的范围。RNAi 策略在作物的生物和非生物胁迫防护、植物性状的修饰和产量提高方面取得了重大成果。随着基于 RNAi 的作物品种在实际应用中变得更加有用，重要的是要检查当前监管体系处理此类品种的能力，并确定是否需要进行更改以改进现有的框架。我们从越来越多地参与现代生物技术研究（包括 RNAi 应用）的发展中国家的角度审查了生物安全框架，并提出了一些建议。马来西亚和印度已经批准了规范活体改性生物体及其产物的法律，这突出表明任何基因修饰步骤的使用都需要进行监管审查。鉴于外源性双链 RNA 的生产方法和由此产生的双链 RNA 产品的潜在风险，我们认为基于过程的系统可能不适合非转化 RNAi 技术。我们在这里提出，需要重新措辞现行立法，以考虑非转基因 RNAi 技术，并讨论印度和马来西亚的最佳监管系统替代方案，以及与其他国家现有框架的比较。
