Rethinking gene-edited crop regulation: advancing a Principle-based framework for modern biotechnology governance

Gene editing (GEd) technologies are rapidly transforming agricultural biotechnology; however, their regulatory treatment remains ambiguous under international instruments such as the Cartagena Protocol on Biosafety (CPB), which was originally developed for genetically modified organisms (GMOs). This regulatory uncertainty creates challenges for product developers and regulators. This study critically examines the role of the Precautionary Principle (PP) in governing emerging genetic technologies. While the PP underpins the CPB, its interpretation, particularly in the European Union, has been criticized for creating legal barriers that have delayed the adoption of beneficial technologies. In contrast, a Principle-Based Approach (PBA) provides a more adaptive governance framework, grounded in high-level principles that enable flexibility with evolving scientific evidence. Through a review of global regulatory trends, this study identifies jurisdictional challenges and contrasts the theoretical and practical implications of the PP and PBA. It concludes with policy recommendations advocating a hybrid model integrating precaution and principle-based flexibility.