MINI REVIEW article
Front. Bioeng. Biotechnol.
Sec. Biosafety and Biosecurity
Volume 13 - 2025 | doi: 10.3389/fbioe.2025.1702481
This article is part of the Research TopicThe Future of Agricultural Biosafety RegulationsView all 11 articles
A Call for Congressional Action: Revisiting the U.S. Coordinated Framework for the Regulation of Biotechnology
Provisionally accepted
- 1Georgetown University, Washington, United States
- 2Novonesis A/S, Bagsværd, Denmark
- 3Breakthrough Institute, Oakland, United States
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Since the 1986 release of the Coordinated Framework for the Regulation of Biotechnology almost 40 years ago, there have been two whole of government updates that made only minor changes, while new regulations and guidance from individual agencies have made more substantial alterations. Despite scientific advances and the emergence of products that fall outside the purview of legacy statutes, repeated calls for substantive changes have gone largely unanswered. We expand upon the NSCEB's most important recommendations for improvements to the Coordinated Framework. We recommend that Congress create an NBCO and direct it to create a centralized application submission portal; conduct horizon scanning for future products of biotechnology; streamline regulations for familiar products and exempt low-risk products; and improve organizational structure, staff training, and interagency exchange.
Keywords: Biotechnology, CRISPR, innovation, Coordinated Framework, Agriculture, national security, GMO, gene editing
Received: 10 Sep 2025; Accepted: 09 Oct 2025.
Copyright: © 2025 Buchman and Kovak. 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:
Leah Buchman, lebu@novonesis.com
Emma Kovak, ekovak@thebreakthrough.org
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.