Report of the World Health Organization (WHO) Biosafety and Biosecurity Inspection Team of the Variola Virus Maximum Containment Laboratories to the Centers for Disease Control and Prevention (CDC): Atlanta, Georgia, United States of America, 2-6 May 2022
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World Health Organization
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[11] p.
Maintaining stringent biosafety and biosecurity standards for variola virus repositories remains a critical requirement to safeguard global health following the eradication of smallpox. This report presents the findings of a World Health Organization inspection conducted in May 2022 at the variola virus maximum containment laboratories at the Centers for Disease Control and Prevention in the United States of America, one of the two WHO-authorized repositories, in accordance with the biennial mandate established by the World Health Assembly. The document outlines the inspection scope, methodology and evaluation framework applied across key areas of biological risk management, including facility infrastructure, supporting engineering systems, decontamination processes, long-term specimen storage and associated healthcare facilities such as the isolation hospital. It examines institutional practices through facility inspection, documentation review and engagement with staff, while assessing progress since the previous inspection and the status of earlier findings. Findings are categorized using a structured system distinguishing observations and priority levels, supporting a risk-based assessment. The results indicate that many previously identified issues have been addressed, with no major findings requiring immediate corrective action. Overall, the laboratories were found to comply with international biosafety and biosecurity standards, while targeted recommendations are provided to support continued improvement and the development of a follow-up action plan.
Maintaining stringent biosafety and biosecurity standards for variola virus repositories remains a critical requirement to safeguard global health following the eradication of smallpox. This report presents the findings of a World Health Organization inspection conducted in May 2022 at the variola virus maximum containment laboratories at the Centers for Disease Control and Prevention in the United States of America, one of the two WHO-authorized repositories, in accordance with the biennial mandate established by the World Health Assembly. The document outlines the inspection scope, methodology and evaluation framework applied across key areas of biological risk management, including facility infrastructure, supporting engineering systems, decontamination processes, long-term specimen storage and associated healthcare facilities such as the isolation hospital. It examines institutional practices through facility inspection, documentation review and engagement with staff, while assessing progress since the previous inspection and the status of earlier findings. Findings are categorized using a structured system distinguishing observations and priority levels, supporting a risk-based assessment. The results indicate that many previously identified issues have been addressed, with no major findings requiring immediate corrective action. Overall, the laboratories were found to comply with international biosafety and biosecurity standards, while targeted recommendations are provided to support continued improvement and the development of a follow-up action plan.