Biosafety Manual PDF - Lawrence Berkeley National Laboratory

Biosafety Manual
IBC-approved version (May 18, 2010)
• Inactive means the material is not capable of acting or reacting normally. For example,
infectious proteins (i.e., prions) may be inactivated by chemical destruction.
• Decontaminated means the material has been treated (e.g., sterilized or disinfected) so
that biological contaminants or components have been reduced or inactivated to an
acceptable level to reduce or eliminate the possibility of transmission of pathogens to
undesired hosts. For example, fresh human bones may be decontaminated internally by
radiation.
Biological material and agent hazards are further covered in Section 3.3 as follows:
• The risk group (RG) classification system used to categorize agents and materials
based on the risk of disease in humans (see Section 3.3.1 below)
• Biological risks and concerns related to the following categories of biological materials
and agents:
o Pathogenic agents and toxins (see Section 3.3.2 below)
o U.S. Department of Agriculture (USDA)-regulated materials, organisms, and
agents (see Section 3.3.3 below)
o Bloodborne pathogens and human materials (see Section 3.3.4 below)
o Recombinant materials, organisms, and agents (see Section 3.3.5 below)
o Animals (see Section 3.3.6 below)
3.3.1 Risk Group Classification
The principal hazardous characteristics of the agents that are present, or may be present in the
biological material, must be considered while completing the initial risk assessment. This
consideration includes an assessment of the agent’s capability to infect and cause disease in a
susceptible human or other host, the severity of disease, and the availability of preventive
measures and effective treatments. To facilitate this assessment process, the World Health
Organization (WHO) and NIH established an agent risk group (RG) classification for
laboratories. This RG classification system, which was also adopted by the CDC, describes four
general RGs based on the hazardous characteristics of agents, and the transmission route of
natural disease in humans.
LBNL uses the four RG levels and definitions provided in Appendix B of the U.S.-based NIH
Guidelines (see Table 2 below). As shown in Table 2, a higher RG level indicates a higher risk
for disease in humans. Assignments of RGs to specific agents may be found in various sources,
including:
• Appendix B, Section B.2, of this manual: Provides a list of human pathogens and their
RG designations as excerpted from Appendix B of the NIH Guidelines (Classification of
Human Etiologic Agents on the Basis of Hazard)
• The American Biological Safety Association (ABSA) Risk Group Database
Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version.
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