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- 1University of Nevada, Reno, Reno, United States
- 2Tutela Strategies, LLC, Reno, United States
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
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
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.