Review Article
Challenges and Practices in Building and Implementing Biosafety and Biosecurity Programs to Enable Basic and Translational Research with Select Agents
Colleen B. Jonsson1,2, Kelly Stefano Cole3,4, Chad J. Roy5,6, David S. Perlin7, Gerald Byrne8 and members of the RBL-NBL Directors Network
1Department of Microbiology and Immunology, University of Louisville, KY, USA
2Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases, University of Louisville, KY, USA
3Center for Vaccine Research, Regional Biocontainment Laboratory, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
4Department of Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
5Tulane National Primate Research Center, Regional Biosafety Laboratory, Covington, LA, USA
6Division of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA
7Public Health Research Institute and UMDNJ Regional Biocontainment Laboratory, New Jersey Medical School-UMDNJ, Newark, NJ, USA
8Department of Microbiology and Immunology, University of Tennessee, Memphis, TN, USA
- *Corresponding Author:
- Colleen B. Jonsson
Professor of Microbiology
Department of Microbiology and Immunology and Director
Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases
University of Louisville
Clinical and Translational Research Building 505 South Hancock Avenue
Louisville, KY 40202, USA
Tel: 502-852-5773; 502-413-1177
E-mail: cbjons01@louisville.edu
Received Date: January 15, 2013; Accepted Date: April 25, 2013; Published Date: April 29, 2013
Citation: Jonsson CB, Cole KS, Roy CJ, Perlin DS, Byrne G, et al. (2013) Challenges and Practices in Building and Implementing Biosafety and Biosecurity Programs to Enable Basic and Translational Research with Select Agents. J Bioterr Biodef S3:015. doi:10.4172/2157-2526.S3-015
Copyright: © 2013 Jonsson CB, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Select agent research in the United States must meet federally-mandated biological surety guidelines and rules which are comprised of two main components: biosecurity and biosafety. Biosecurity is the process employed for ensuring biological agents are properly safeguarded against theft, loss, diversion, unauthorized access or use/release. Biosafety is those processes that ensure that operations with such agents are conducted in a safe, secure and reliable manner. As such, a biological surety program is generally concerned with biological agents that present high risk for adverse medical and/or agricultural consequences upon release outside of proper containment. The U.S. Regional and National Biocontainment Laboratories (RBL, NBL) represent expertise in this type of research, and are actively engaged in the development of programs to address these critical needs and federal requirements. While this comprises an ongoing activity for the RBLs, NBLs and other facilities that handle select agents as new guidelines and regulations are implemented, the present article is written with the goal of presenting a simplified yet comprehensive review of these requirements. Herein, we discuss the requirements and the various activities that the RBL/NBL programs have implemented to achieve these metrics set forth by various agencies within the U.S. Federal government.
