Establishing a national biosafety and biosecurity agency for the United States

The rapid advancement of biological research and biotechnology requires a novel and robust regulatory agency to ensure uniform biosafety and biosecurity governance in the United States. The current fragmented regulatory landscape needs to be refocused to address the complexities of modern biological...

Full description

Saved in:
Bibliographic Details
Main Authors: David R. Gillum, Rebecca Moritz, Gregory D. Koblentz
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-10-01
Series:Frontiers in Bioengineering and Biotechnology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fbioe.2024.1474120/full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850190623902007296
author David R. Gillum
David R. Gillum
David R. Gillum
Rebecca Moritz
Rebecca Moritz
Gregory D. Koblentz
author_facet David R. Gillum
David R. Gillum
David R. Gillum
Rebecca Moritz
Rebecca Moritz
Gregory D. Koblentz
author_sort David R. Gillum
collection DOAJ
description The rapid advancement of biological research and biotechnology requires a novel and robust regulatory agency to ensure uniform biosafety and biosecurity governance in the United States. The current fragmented regulatory landscape needs to be refocused to address the complexities of modern biological research, including risks associated with accidental, inadvertent, and deliberate biological incidents. An independent government agency, which we call the National Biosafety and Biosecurity Agency (NBBA), that is devoted to biosafety and biosecurity could effectively address these challenges. The NBBA would consolidate various regulatory functions, streamline processes, and enhance oversight. This oversight would encompass life sciences research in the United States, regardless of the source of funding or level of classification. The agency could also contribute to the bioeconomy by streamlining requirements to safeguard public health and the environment while fostering scientific and commercial progress. The proposed agency would govern high-risk biological pathogens, manage the Federal Select Agent Program, enforce policies related to dual use research of concern, pathogens with enhanced pandemic potential, and nucleic acid synthesis screening, administer regulations on the use and care of laboratory animals, as well as regulate other relevant biosafety and biosecurity activities. The goal would be to provide one-stop shopping for the biomedical research and biotechnology sectors subject to oversight by the Federal government. To ensure leadership in global biosafety and biosecurity, the agency’s mission would include international collaboration, applied research, education, workforce development, and coordination with national security initiatives. Creating an agency like the NBBA will be politically challenging but presenting a comprehensive vision and engaging stakeholders early and frequently, and being transparent in the process, will be essential for garnering support. Creating a unified biosafety and biosecurity governance system in the United States will ensure the safe and secure advancement of biological research while sustaining innovation and maintaining international competitiveness.
format Article
id doaj-art-e4fbfc17782849aab45b056e77b54943
institution OA Journals
issn 2296-4185
language English
publishDate 2024-10-01
publisher Frontiers Media S.A.
record_format Article
series Frontiers in Bioengineering and Biotechnology
spelling doaj-art-e4fbfc17782849aab45b056e77b549432025-08-20T02:15:12ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852024-10-011210.3389/fbioe.2024.14741201474120Establishing a national biosafety and biosecurity agency for the United StatesDavid R. Gillum0David R. Gillum1David R. Gillum2Rebecca Moritz3Rebecca Moritz4Gregory D. Koblentz5Research and Innovation, University of Nevada, Reno, NV, United StatesSchool for the Future of Innovation and Society, Arizona State University, Tempe, AZ, United StatesTutela Strategies, LLC, Reno, NV, United StatesTutela Strategies, LLC, Reno, NV, United StatesOffice of the Vice President for Research, Colorado State University, Fort Collins, CO, United StatesSchar School of Policy and Government, George Mason University, Arlington, VA, United StatesThe rapid advancement of biological research and biotechnology requires a novel and robust regulatory agency to ensure uniform biosafety and biosecurity governance in the United States. The current fragmented regulatory landscape needs to be refocused to address the complexities of modern biological research, including risks associated with accidental, inadvertent, and deliberate biological incidents. An independent government agency, which we call the National Biosafety and Biosecurity Agency (NBBA), that is devoted to biosafety and biosecurity could effectively address these challenges. The NBBA would consolidate various regulatory functions, streamline processes, and enhance oversight. This oversight would encompass life sciences research in the United States, regardless of the source of funding or level of classification. The agency could also contribute to the bioeconomy by streamlining requirements to safeguard public health and the environment while fostering scientific and commercial progress. The proposed agency would govern high-risk biological pathogens, manage the Federal Select Agent Program, enforce policies related to dual use research of concern, pathogens with enhanced pandemic potential, and nucleic acid synthesis screening, administer regulations on the use and care of laboratory animals, as well as regulate other relevant biosafety and biosecurity activities. The goal would be to provide one-stop shopping for the biomedical research and biotechnology sectors subject to oversight by the Federal government. To ensure leadership in global biosafety and biosecurity, the agency’s mission would include international collaboration, applied research, education, workforce development, and coordination with national security initiatives. Creating an agency like the NBBA will be politically challenging but presenting a comprehensive vision and engaging stakeholders early and frequently, and being transparent in the process, will be essential for garnering support. Creating a unified biosafety and biosecurity governance system in the United States will ensure the safe and secure advancement of biological research while sustaining innovation and maintaining international competitiveness.https://www.frontiersin.org/articles/10.3389/fbioe.2024.1474120/fullbiosafetybiosecuritylegislationbiotechnology regulationincident responseunified biosafety agency
spellingShingle David R. Gillum
David R. Gillum
David R. Gillum
Rebecca Moritz
Rebecca Moritz
Gregory D. Koblentz
Establishing a national biosafety and biosecurity agency for the United States
Frontiers in Bioengineering and Biotechnology
biosafety
biosecurity
legislation
biotechnology regulation
incident response
unified biosafety agency
title Establishing a national biosafety and biosecurity agency for the United States
title_full Establishing a national biosafety and biosecurity agency for the United States
title_fullStr Establishing a national biosafety and biosecurity agency for the United States
title_full_unstemmed Establishing a national biosafety and biosecurity agency for the United States
title_short Establishing a national biosafety and biosecurity agency for the United States
title_sort establishing a national biosafety and biosecurity agency for the united states
topic biosafety
biosecurity
legislation
biotechnology regulation
incident response
unified biosafety agency
url https://www.frontiersin.org/articles/10.3389/fbioe.2024.1474120/full
work_keys_str_mv AT davidrgillum establishinganationalbiosafetyandbiosecurityagencyfortheunitedstates
AT davidrgillum establishinganationalbiosafetyandbiosecurityagencyfortheunitedstates
AT davidrgillum establishinganationalbiosafetyandbiosecurityagencyfortheunitedstates
AT rebeccamoritz establishinganationalbiosafetyandbiosecurityagencyfortheunitedstates
AT rebeccamoritz establishinganationalbiosafetyandbiosecurityagencyfortheunitedstates
AT gregorydkoblentz establishinganationalbiosafetyandbiosecurityagencyfortheunitedstates