Biosafety Manual PDF - Lawrence Berkeley National Laboratory

Biosafety Manual
IBC-approved version (May 18, 2010)
Work with biological materials, like all work at LBNL, must be conducted using the guiding
principles and five core functions of Integrated Safety Management (ISM) (e.g., define scope of
work, analyze hazards, develop and implement controls, perform work within controls, feedback
and continuous improvement) as discussed in PUB-3000, Section 1.4. These core functions are
integrated into the work authorization and control functions summarized above in Table 1.
3.0 Work and Risk Assessment
The work scope must be defined and the hazards and risks must be assessed before work
begins. These work-planning processes are the first two core ISM functions and required by
biosafety standards. Biological work and risks at LBNL are defined using established
institutional assessment and authorization processes, a structured approach as required by the
Department of Energy (DOE), and the standard biosafety risk assessment process defined by
the Centers for Disease Control and Prevention (CDC) and the National Institutes of
Health (NIH). It is a primary responsibility of workers, work leads, and supervisors to ensure
these processes are implemented before work begins.
3.1 LBNL Assessment and Authorization Processes
LBNL uses the following institutional assessment and authorization processes and documents
to define work, identify biological hazards and potential exposures, assess biological risks, and
establish biosafety controls:
• A Job Hazards Analysis (JHA) is prepared for each worker (see PUB-3000, Chapter 32).
• A Subcontractor Job Hazards Analysis and Work Authorization (SJHAWA) is prepared
for each subcontractor, vendor, or guest (see Chapter 31).
• Biosafety Work Authorizations are prepared for work with biological materials in specific
operations or projects. In the case of research involving biological materials, the
Institutional Biosafety Committee (IBC) reviews and approves the definition of work, risk
assessment, and controls as part of the authorization process. See Section 5.1 below
and PUB-3000, Section 26.8, for details.
3.2 Biosafety Risk Assessment Process
The institutional assessment and authorization processes and documents noted in Section 3.1
above incorporate the standard biosafety risk assessment process defined and required by
CDC, NIH, and DOE in the Biosafety in Microbiological and Biomedical Laboratories (BMBL),
the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines),
and the Worker Health and Safety Program (WSHP).
The standard biosafety risk assessment process starts with considering three primary factors: 1)
the inherent work hazard posed by the biological material or agent, 2) the susceptible hosts (i.e.,
receptors) that may be affected by the material or agent, and 3) the exposure pathways
between the threat hazard and the susceptible host.
In addition, BMBL outlines the following five-step approach for laboratory supervisors and work
leads to assess biological risk and to select controls for laboratory work:
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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