title: Challenges and Practices in Building and Implementing Biosafety and Biosecurity Programs to Enable Basic and Translational Research with Select Agents.
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.
authors.affiliation: Department of Microbiology and Immunology, University of Louisville, KY, USA ; Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases, University of Louisville, KY, USA.
authors.forename: Colleen B
authors.initials: CB
authors.lastname: Jonsson
authors.affiliation: Center for Vaccine Research, Regional Biocontainment Laboratory, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA ; Department of Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Kelly Stefano
authors.initials: KS
authors.lastname: Cole
authors.affiliation: Tulane National Primate Research Center, Regional Biosafety Laboratory, Covington, LA, USA ; Division of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA.
authors.forename: Chad J
authors.initials: CJ
authors.lastname: Roy
authors.affiliation: Public Health Research Institute and UMDNJ Regional Biocontainment Laboratory, New Jersey Medical School-UMDNJ, Newark, NJ, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Perlin
authors.affiliation: Department of Microbiology and Immunology, University of Tennessee, Memphis, TN, USA.
authors.forename: Gerald
authors.initials: G
authors.lastname: Byrne