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Comparative analysis reveals diverse regulatory approaches for agrobiotechnology, highlighting the need for legal harmonization.
This article is devoted to a comprehensive analysis of current trends and challenges in the legal regulation of agrobiotechnology in the context of the global transition from classical transgenesis to site-directed genome editing technologies such as CRISPR-Cas9. The relevance of the study is due to the rapid development of these technologies, which offer new opportunities for food security, climate change adaptation and sustainable agricultural development, but face diverse and often outdated legal regimes. The aim of the work is to identify and systematize key models of legal regulation of the turnover of genetically modified organisms (GMOs) and genomic editing products in countries that are leading producers of agricultural products, as well as features, common features and patterns in the development of legal regulation in this area using the example of the agricultural sector. Based on the comparative legal method, the legal systems of the United States, Canada, Brazil, Argentina, the European Union, China, India, and the Russian Federation in this area have been studied. The analysis made it possible to identify three dominant regulatory approaches: a product-oriented model (USA, Canada), a flexible model stimulating innovation (Brazil, Argentina), and a model based on strict application of the precautionary principle (EU, China, India, Russia). Special attention is paid to the legal status of organisms obtained using genome editing technologies that do not contain foreign DNA. Recent legislative initiatives aimed at differentiating their regulation from classical GMOs, in particular, the new EU Regulation on new Genomic techniques (NGTs), have been investigated. In conclusion, the main trends are summarized, which include the transition from regulating the creation process to evaluating the characteristics of the final product, as well as the formation of simplified procedures for genome editing products. It is revealed that the lack of international harmonization in this area remains the main barrier to the development of innovation. It is concluded that it is necessary to develop a detailed and balanced regulatory framework in Russia that would ensure biosafety without hindering scientific and technological progress in the agricultural sphere.
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Tatiana Vladimirovna Rednikova (2025) studied this question.
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