- Is the current novel "SARS-like" coronavirus considered a select agent?
- I have inactivated SARS-CoV genomic material by irradiation. Is the genomic material still regulated after inactivation?
- What is the appropriate biosafety level for work with SARS-CoV?
The intent of the addition of Severe acute respiratory syndrome coronavirus (SARS-CoV) to the select agent and toxin list was to capture the SARS-CoV that caused the world wide outbreak in 2002-2003. The SARS-CoV that caused the outbreak in 2002-2003 and any derivative strains made from it are regulated. At this time the Federal Select Agent Program does not intend to regulate the current novel SARS-like coronavirus.
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With regard to SARS-CoV genomic material, if the irradiation inactivates the genomic material such that it is no longer capable of producing infectious forms of SARS then it is excluded from the select agent regulations. If a Principal Investigator has separate fragments of SARS-CoV RNA, the individual fragments are not regulated if they cannot produce infectious forms of SARS. Please refer to the guidance on synthetic genomics at http://www.selectagents.gov/SyntheticGenomics.html for additional information.
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The Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Ed, recommends the following for work with SARS-CoV:
- The following procedures may be conducted in the BSL-2 setting:
- pathologic examination and processing of formalin-fixed or otherwise inactivated tissues,
- molecular analysis of extracted nucleic acid preparations,
- electron microscopic studies with glutaraldehyde-fixed grids,
- routine examination of bacterial and fungal cultures,
- routine staining and microscopic analysis of fixed smears, and
- final packaging of specimens for transport to diagnostic laboratories for additional testing (specimens should already be in a sealed, decontaminated primary container).
- Activities involving manipulation of untreated specimens should be performed in BSL-2 facilities following BSL-3 practices. In the rare event that a procedure or process involving untreated specimens cannot be conducted in a BSC, gloves, gown, eye protection, and respiratory protection (acceptable methods of respiratory protection include: a properly fit-tested, National Institute for Occupational Safety and Health [NIOSH]-approved filter respirator [N-95 or higher level] or a PAPR equipped with HEPA filters) should be used. All personnel who use respiratory protective devices should be enrolled in an appropriately constituted respiratory protection program. [ The entity's biosafety plan should be site specific and based on a risk assessment.]
- SARS-CoV propagation in cell culture and the initial characterization of viral agents recovered in cultures of SARS specimens must be performed in a BSL-3 facility using BSL-3 practices and procedures. Risk assessment may dictate the additional use of respiratory protection.
- Inoculation of animals for potential recovery of SARS-CoV from SARS samples, research studies, and protocols involving animal inoculation for characterization of putative SARS agents must be performed in ABSL-3 facilities using ABSL-3 work practices. Respiratory protection should be used as warranted by risk assessment.
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