Human and Non-Human Primate Cells
Work with primary human and non-human primate blood, body fluids and tissues requires a BUA, and related waste is handled as medical waste. Describe what is known about these materials, including
- Cell or tissue types
- Source, i.e., hospital or clinic, tissue bank, collaborator, or commercial vendor
- Whether the materials are known to be infectious for a certain disease indication
- Whether the materials have been screened for common bloodborne pathogens, and which pathogens are included in the panel. Results, when available, are typically provided for a specific lot on the Certificate of Analysis, showing either a "negative" or "positive" specification or result for the assay.
- Whether the materials will be procured with an IRB-approved Human Subjects Research protocol
Register work with well characterized human cell lines with the IBC via the biosafety officer using the standard BUA form.
Use of such cell lines does not require IBC review before work begins.
Well characterized human cell lines are accompanied by a Certificate of Analysis from the vendor indicating that the cells have been screened and found to be negative for, at a minimum, hepatitis B virus, hepatitis C virus, and the human immunodeficiency virus. For established tumor cell lines, human or NHP origin does not intrinsically make them medical waste unless there is information about contamination with pathogens or integration of non-defective pathogenic viral sequences. The California Department of Public Health does not designate well characterized human cell lines as medical waste, and OSHA exempts well characterized cell lines from the Bloodborne Pathogens Standard. Example cell line registration
While cell line vendors and repositories may downgrade containment to biosafety level 1 to simplify shipping, these vendors and repositories are not regulatory agencies or part of Health and Human Services.
BMBL (CDC, NIH) and the OSHA and Cal/OSHA Bloodborne Pathogens Standards maintain that work with human and non-human primate cells is done with biosafety level 2 containment practices.
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