Characterization of Departures from Regulatory Requirements Identified During Inspections Conducted by the US Federal...

We studied departures from regulatory requirements identified on US Federal Select Agent Program (FSAP) inspections to increase transparency regarding biosafety and security risk at FSAP-regulated entities and identify areas for programmatic improvement. Regulatory departures from inspections led by Centers for Disease Control and Prevention inspectors during 2014-15 were grouped into "biosafety," "security," and "other" observation categories and assigned a risk level and score reflecting perceived severity. The resulting 2,267 biosafety (n = 1,153) and security (n = 1,114) observations from 296 inspections were analyzed by frequency and risk across entity and inspection characteristics. The greatest proportion of biosafety observations involved equipment and facilities (28%), and the greatest proportion of security observations involved access restrictions (33%). The greatest proportion of higher-risk observations for biosafety were containment issues and for security were inventory discrepancies. Commercial entities had the highest median cumulative risk score per inspection (17), followed by private (13), academic (10), federal government (10), and nonfederal government (8). Maximum containment (BSL-4) inspections had higher median biosafety risk per inspection (13) than other inspections (5) and lower security risk (0 vs 4). Unannounced inspections had proportionally more upper risk level observations than announced (biosafety, 21% vs 12%; security, 18% vs 7%). Possessors of select agents had higher median biosafety risk per inspection (6) than nonpossessors (4) and more upper risk level security observations (10% vs 0%). Programmatic changes to balance resources according to entity risk may strengthen FSAP oversight. Varying inspection methods by select agent possession and entity type, and conducting more unannounced inspections, may be beneficial.