I write to identify potential conflict between proposed requirements in 16 VAC 25-220 and recommended public health, occupational health and laboratory biosafety practices.

§50 Requirements for hazards or job tasks classified at “very high” or “high” exposure risk. P. 25 states the following:

6.Use special precautions associated with Biosafety Level 3 (BSL-3), as defined by the U.S. Department of Health and Human Services Publication No. (CDC) 21-1112 “Biosafety in Microbiological and Biomedical Laboratories” (Dec. 2009), which is hereby incorporated by reference, when handling specimens from known or suspected COVID-19 patients or persons

However, CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) (Updated June 5, 2020) indicates routine diagnostic testing of specimens, such as the following activities, can be handled in a BSL-2 laboratory using Standard Precautions:

• Using automated instruments and analyzers
• Processing initial samples
• Staining and microscopic analysis of fixed smears
• Examination of bacterial cultures
• Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues
• Molecular analysis of extracted nucleic acid preparations
• Final packaging of specimens for transport to diagnostic laboratories for additional testing (specimens should already be in a sealed, decontaminated primary container)
• Using inactivated specimens, such as specimens in nucleic acid extraction buffer
• Performing electron microscopic studies with glutaraldehyde-fixed grids.

Virus isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens should only be conducted in a Biosafety Level 3 (BSL-3) laboratory using BSL-3 practices.

Reference to BSL3 in 16 VAC 25-220 is likely intended to align with U.S. public health guidance for experiments/procedures involving SARS-CoV-2; however, the BSL3 statement, as written, may be rigidly (and incorrectly) interpreted to indicate that BSL3 containment is required for the safe handling of all specimens from suspected COVID-19 patients or persons. Clinical, hospital, and research laboratories often utilize BSL2 containment, often with enhancements, to safely handle patient samples in accordance with US DHHS Publication No. 21-1112.  Imposing BSL3 containment for handling human specimens could potentially impede testing capabilities and discovery across the Commonwealth.  

I recommend the referenced statement under §50 Requirements be modified as follows: Use precautions as defined by the U.S. Department of Health and Human Services Publication No. (CDC) 21-1112 “Biosafety in Microbiological and Biomedical Laboratories” (Dec. 2009), which is hereby incorporated by reference, when handling specimens from known or suspected COVID-19 patients or persons.

Thank you for your consideration.  

Tom Leonard, PhD, CSP, CBSP