The Regional Biocontainment Lab (RBL) at the University of Tennessee Health Science Center has received a three-year renewal to continue research using select agents from the Centers for Disease Control (CDC), after an unannounced inspection visit.
“Receiving a three-year renewal is a significant achievement, as it demonstrates the CDC was very satisfied with our program management and personnel who work with select agents,” said Jennifer Stabenow, MS, RVT, facility manager of the RBL and Responsible Official for the Select Agent Program at UTHSC. “This will allow our research to continue with certain pathogens in hope of finding new vaccines or treatments for these agents.”
The UTHSC RBL has been approved to work with select agents since it opened in 2010. A renewal of the CDC Select Agent registration means the UTHSC RBL is approved for an additional three years to work with certain select agents. The renewal process can award from one to three years on a registration, and is determined by the CDC’s assessment of the select agent process management at each institution.
A CDC inspection is required for work with a group of pathogens referred to as select agents. These are the viruses, bacteria, and toxins that have been deemed to be a significant threat to either humans, animals, or plants. All laboratories that work with any of the current 65 Select Agents must register with either the Department of Health and Human Services (HHS), overseen by the CDC, or with the Animal and Plant Health Inspection Service (APHIS), overseen by the United States Department of Agriculture (USDA).
The inspection process includes an inspection of the laboratory and support spaces, inventory of all select agents, review of all biosafety, security and incident response documents, training records, and interviews with personnel that work with these agents. These inspections typically include multiple inspectors from the CDC and/or USDA, and last from one to five days, depending on the complexity of the research program.
The UTHSC RBL hopes to grow its program under the leadership of Colleen Jonsson, PhD, an RNA virus expert, who was previously the director of the RBL at the University of Louisville.
The RBL was constructed to support research that requires Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) containment. The facility was built using funds awarded from an RFP from the National Institute of Allergy and Infectious Diseases (NIAID) with a partial match of funds from UTHSC. The goal of RBLs throughout the country is to provide research facilities to study pathogens that require high containment laboratories and to provide overflow capacity for diagnostics in the event of an outbreak in the United States. A total of 13 RBLs were constructed and most became operational from 2007-2010. The NIAID funding required each university to commit to maintaining these facilities for high- containment research capabilities for 20 years.