Abstract
Modern biotechniques such as RNA interference (RNAi) and CRISPR have played a crucial role in crop improvement, medicine, and biotechnology. Nevertheless, the success of these systems is associated with regulation of the final product and low toxicity rate. For example, genetically modified (GM) crops are often subjected to strict risk, toxicity, and biosafety assessments. Keeping in view the risk associated with the product of modern techniques, the regulatory process varies across different jurisdictions and is mainly focused on process- or end-product-based. European Union (EU) and New Zealand regulate GM products through the process-based system. In process-based regulations, crops regulated as genetically modified organisms (GMOs) pass through regulatory checks and are labeled as GMOs. This regulatory framework requires heavy investment and is time-consuming. In contrast, the United States, Canada, China, and some countries of EU follow end product–based regulatory framework. In this case, if the product is transgene-free then it will be labeled as non-GMO. The end of product-based regulations is relatively cost-effective and time-saving. Additionally, the bioengineered products are passed through different risk assessment studies that vary from in silico studies using different bioinformatics tools to in vitro studies in labs by feeding animals and observing their harmful effects. Similarly, these crops are also monitored for their possible harmful effects on nontarget organisms before commercialization. Thus in this chapter, we have provided a brief overview of different regulatory frameworks regarding RNAi and CRISPR systems in various jurisdictions, that is, the United States, Canada, EU, China, Pakistan, Australia, Brazil, Argentina, Chile, New Zealand, and Japan. We also discussed risk assessment and toxicity related to CRISPR- and RNAi-based crops for food and feed, and environment. In the end, an outlook is given for improvement of a regulatory framework and risk assessment procedures.
Published Version
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