Biosafety Manual PDF - Lawrence Berkeley National Laboratory

Biosafety Manual
IBC-approved version (May 18, 2010)
Biohazard label is a sign that is predominately fluorescent orange or orange-red and contains a
biohazard symbol and the word “Biohazard” in a contrasting color.
Biohazardous is an adjective used to describe biological materials that present potential
detrimental risk to the health of humans or other organisms, either directly through infection or
indirectly through damage to the environment.
Biohazardous waste is waste that requires inactivation (i.e., decontamination) in an approved
manner prior to disposal, but is not regulated by the California Department of Health Services as
regulated medical waste. See PUB-3095, Medical and Biohazardous Waste Generator
Guidelines, for additional information.
Biological agent or agent is a very specific biological organism or material that is often directly
responsible for producing an effect (e.g., disease). Agent examples include a microorganism
(e.g., bacterium, fungus, or parasite), virus, prion, or biological toxin.
Biological etiologic agent is an agent of biological origin (e.g., bacterium, fungus, parasite,
virus, etc.) that causes disease in humans (i.e., pathogenic to humans).
Biological materials are a broad range of organisms, cells, viruses, and other materials of
biological origin that pose differing levels of risks to plants, animals, or humans.
Biological products are materials that are regulated by Department of Transportation (DOT)
and International Air Transport Association (IATA) for shipping that are derived from living
organisms and manufactured for use in the prevention, diagnosis, treatment, or cure of disease
in humans or animals and are certified by the USDA, Food and Drug Administration (FDA), or
other national authority. Examples of biological products include certain viruses, therapeutic
serums, toxins, antitoxins, vaccines, blood, and blood products.
Biological toxin, biotoxin, or toxin. See toxin.
Biological Use Application is the form completed by a prinicipal investigator (PI) or supervisor
and submitted to the Environment, Health, and Safety (EH&S) biosafety office for review,
approval, and authorization by a Biosafety Officer, the Institutional Biosafety Committee (IBC),
or line management. Authorized applications result in a Biological Use Authorization (BUA),
Biological Use Registration (BUR), or Biological Use Notification (BUN).
Biological Use Authorization (BUA) is a type of LBNL formal biosafety authorization for work
involving Risk Group (RG) 2 or higher biological materials, Biosafety Level (BL) 2 used for
safety, or a regulatory permit or registration.
Biological Use Notification (BUN) is a type of LBNL biosafety authorization for work involving
RG1 biological materials, including work with National Institutes of Health (NIH)-exempt
recombinant DNA molecules.
Biological Use Registration (BUR) is a type of LBNL biosafety authorization for work involving
RG1 work with recombinant DNA molecules and organisms or viruses containing recombinant
DNA molecules.
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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