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

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Gene editing (GEd) regulation faces challenges due to ambiguity in international biosafety protocols. This study suggests a hybrid approach, blending the Precautionary Principle with a flexible Principle-Based Approach for adaptive governance of emerging genetic technologies.

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Area of Science:

  • Agricultural biotechnology
  • Biosafety regulations
  • Genetic technologies

Background:

  • Gene editing (GEd) technologies are advancing rapidly in agriculture.
  • Existing biosafety protocols, like the Cartagena Protocol on Biosafety (CPB), were designed for genetically modified organisms (GMOs) and lack clarity for GEd.
  • Regulatory uncertainty hinders innovation and product development in agricultural biotechnology.

Purpose of the Study:

  • To critically examine the role of the Precautionary Principle (PP) in governing emerging genetic technologies.
  • To analyze the challenges posed by the interpretation of the PP, particularly in the European Union.
  • To contrast the Precautionary Principle (PP) with a Principle-Based Approach (PBA) for adaptive governance.

Main Methods:

  • Review of global regulatory trends concerning gene editing technologies.
  • Critical examination of the theoretical and practical implications of the Precautionary Principle (PP) and Principle-Based Approach (PBA).
  • Analysis of jurisdictional challenges in regulating emerging genetic technologies.

Main Results:

  • The Precautionary Principle (PP), while foundational to the CPB, can create regulatory barriers that delay beneficial technologies.
  • A Principle-Based Approach (PBA) offers a more adaptive framework, allowing flexibility with scientific advancements.
  • Global regulatory landscapes present significant jurisdictional challenges for GEd governance.

Conclusions:

  • Current regulatory frameworks struggle to accommodate the rapid advancements in gene editing.
  • A shift towards more adaptive governance models is necessary for emerging genetic technologies.
  • Policy recommendations advocate for a hybrid model that integrates the Precautionary Principle with the flexibility of a Principle-Based Approach.