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The Seed Industry in the Era of Genome Editing: Safety Assessment, Regulatory Governance, and Commercialization Challenges
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Seyed Sajad Sohrabi *   |
| Lorestan University |
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Abstract: (265 Views) |
Genome editing and New Breeding Techniques (NBTs) offer promising avenues to enhance productivity, sustainability, and climate resilience in agricultural systems. However, the commercialization of these technologies in the absence of a coherent governance framework may be accompanied by biosafety, legal, economic, and social challenges. This study aimed to analyze the scientific and regulatory developments of plant genome editing in the seed industry and propose a tiered, science-based, and case-by-case risk governance model. Conducting an analytical-integrative review, this study systematically examined scientific, regulatory, and policy evidence regarding biosafety, off-target mutations, gene flow, food and feed safety assessments, intellectual property rights (IPRs), market concentration, and public acceptance. The findings revealed that the safety evaluation of genome-edited products—while adhering to fundamental risk assessment principles—must be conducted based on the molecular nature of the genetic alteration, trait functionality, exposure levels, and plausible hazard hypotheses, rather than relying solely on the enabling tool. Furthermore, global regulatory trajectories are increasingly shifting toward differentiated, multi-tiered systems; hence, international regulatory disharmony significantly impacts global trade, supply-chain traceability, and R&D investment. From a policy perspective, tailored solutions for developing nations—particularly Iran—include establishing clear statutory definitions, tiered assessment frameworks, a national event registry, and a specialized IPR desk. Ultimately, the responsible deployment of genome editing to foster food security hinges on establishing a smart governance framework; one that, while strictly adhering to biosafety imperatives, aligns regulatory processes with scientific evidence and the actual level of risk.
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| Keywords: Genome Editing, New Breeding Techniques (NBTs), Seed, Governance, Risk Assessment, Iran |
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Full-Text [PDF 1745 kb]
(154 Downloads)
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Type of Study: Review |
Subject:
Special
Received: 2025/12/25 | Accepted: 2026/03/7 | Published: 2026/09/22
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