Biosafety Manual PDF - Lawrence Berkeley National Laboratory

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Biosafety Manual IBC-approved version (May 18, 2010) Table 4 Materials Regulated by USDA-APHIS APHIS Branch Plant Protection and Quarantine (PPQ) Veterinary Services (VS) Biotechnology Regulatory Services (BRS) Agricultural Select Agent Program Examples of USDA-APHIS-Regulated Materials, Organisms, and Agents Plant pests such as soil, plant pathogens, plants, plant products, weeds, insects, mollusks, and nematodes Material, organisms, vectors, animal pathogens, animal products, cell cultures and their products, live animals, semen, embryos, and veterinary biologics (e.g., vaccines, antibodies, and diagnostic kits) that may harm animal health Certain genetically engineered organisms that may pose a plant pest risk, including organisms that are plants, insects, or microbes Animal and plant pathogens that are select agents 3.3.4 Bloodborne Pathogens and Human Materials The federal OSHA Bloodborne Pathogens Standard has comprehensive requirements for workers who are or may be exposed to BBPs or designated materials assumed to contain BBPs. LBNL uses the term “BBP materials” to describe the pathogens and materials covered by the OSHA standard. These BBP materials are summarized in Table 5 and discussed in the next paragraph. BMBL guidelines for working with human and mammalian cells and tissues are also discussed below. Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 22
Biosafety Manual IBC-approved version (May 18, 2010) Table 5 Materials Covered by the OSHA Bloodborne Pathogens Standard* • Bloodborne pathogens such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) • Human blood: includes blood, blood components, and products made from human blood • Other potentially infectious materials (OPIM): o Unfixed human tissue or organ (other than intact skin) from a living or dead human o Primary human tissue cultures. These cultures are explants of living human tissue placed in a medium for tissue culture. o Primary human cell strains.** These cell strains are propagated in vitro from primary explants of human tissue or body fluids that have a finite lifetime (i.e., nontransformed) in tissue culture for 20 to 70 passages. o Established human cell lines.** These cell lines are immortalized cells that have been transformed by spontaneous mutation or natural or laboratory infection with an immortalizating agent, and then propagated or passed many times (e.g., in vitro or in animals such as mice). o Human body fluids. Fluids that are assumed to be potentially infectious include semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids. Some human secretions that do not contain visible blood are not considered OPIM (e.g., urine, feces, vomit, tears, sweat, sputum, nasal secretions, and saliva). o HIV or HBV infected materials. HIV-containing cell or tissue cultures, organ cultures, and HIVor HBV-containing culture medium or other solutions; and blood, organs, or other tissues from humans or experimental animals infected with HIV or HBV Table Footnotes: * Text taken from OSHA Bloodborne Pathogen Standard 29 CFR 1910.1030 and the OSHA Standard Interpretation on Applicability of 1910.1030 to Establish Human Cell Lines. ** Most primary human cell strains and established human cell lines at LBNL (e.g., American Type Culture Collection cell lines) are OPIM as required by the OSHA Standard Interpretation on such cells. If the researcher does not want to consider the cells OPIM, the cells must be “characterized.” Characterization must include documented screening of the cell lines or strains for viruses specified as BBPs in the OSHA standard, including human immunodeficiency viruses, hepatitis viruses, and herpes viruses (e.g., Epstein-Barr virus) if the cells are capable of propagating such viruses. Documentation that the cell line in culture is free of BBPs must be reviewed and approved by the Biosafety Officer and the Institutional Biosafety Committee. BBPs are infectious agents capable of causing human disease, and are transmitted through human blood and tissues. Examples include HBV and HIV. According to the OSHA Bloodborne Pathogens Standard, materials that are regulated based on their potential to contain BBPs include human blood, human blood components, products made from human blood, and OPIM listed in Table 5. LBNL uses the term BBP materials to describe all of these materials covered by the OSHA standard. Dried blood and some human secretions (e.g., urine, feces, vomit, tears, sweat, sputum, nasal secretions, and saliva) that do not contain visible blood are not considered OPIM even though they may contain other types of infectious agents or present health concerns. Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 23
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