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PERSPECTIVE article

Front. Bioeng. Biotechnol.

Sec. Biosafety and Biosecurity

Volume 13 - 2025 | doi: 10.3389/fbioe.2025.1689753

This article is part of the Research TopicSynthetic Nucleic Acid Technology: The Biosecurity LandscapeView all articles

Why Implementation Gaps Could Undermine Synthetic Nucleic Acid Oversight

Provisionally accepted
David  R. GillumDavid R. Gillum1*Rebecca  MoritzRebecca Moritz2
  • 1University of Nevada, Reno, Reno, United States
  • 2Tutela Strategies, LLC, Reno, United States

The final, formatted version of the article will be published soon.

Introduction U.S. biosecurity policy has shifted from organism-level controls to sequence-level governance of synthetic nucleic acids in response to genome synthesis risks, AI-assisted design, and globalized DNA/RNA manufacturing. While intended to strengthen safety, this shift risks overburdening under-resourced institutions and creating oversight that looks thorough but adds little protection. This study examines the widening "implementation gap" between policy ambition and operational capacity. Methods Drawing on practitioner experience and current literature, we analyzed policy frameworks, institutional practices, and case examples to identify structural challenges in sequence-level oversight. Particular attention was given to how definitions, regulatory triggers, and institutional resources interact in practice, creating gaps between intent and capacity. This mixed approach captured oversight design and implementation realities across diverse settings. Results We found three core obstacles: ambiguous definitions of sequences of concern, fragmented and overlapping regulatory triggers, and underdeveloped screening and review capacity. Ambiguity generates uncertainty about what to flag, while fragmented rules add redundancies without clarifying responsibility. Limited resources further constrain oversight. These weaknesses produce overinclusive surveillance, inconsistent screening, unmanaged legacy inventories, and a lack of shared reference tools—straining resources without proportional security benefits. Discussion Aligning oversight with capacity is essential to avoid brittle systems with limited benefit. We propose seven reforms: functional risk tiering, federal investment in biosafety infrastructure, pilots and real-world testing, institutional certification, adaptive governance, pragmatic global harmonization, and coupling screening with operational safeguards. Embedding implementer perspectives and calibrating oversight to realistic capacities will help ensure credible, resilient, and effective biosecurity in the synthetic nucleic acid era.

Keywords: synthetic nucleic acids, biosecurity policy, Sequence screening, Implementation gap, Institutional capacity

Received: 20 Aug 2025; Accepted: 29 Sep 2025.

Copyright: © 2025 Gillum and Moritz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: David R. Gillum, david.gillum@gmail.com

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