Chapter 26

BIOSAFETY

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26.7 Required Work Processes

Work Process A. Starting and Conducting Work Safely

 

Biosafety-revised-4-16-14.png

This section and Table 1 provide a simplified list to assist supervisors, work leads, and principal investigators in getting work with biological materials planned, assessed, authorized, and conducted. Specific sections of this manual should be consulted for additional information and requirements:

Table 1. Guidance for Starting and Conducting Work

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Guidance

Berkeley Lab Policy Section

Work Operation Planning, Risk Assessment, Authorization, and Control
Complete and maintain a Biosafety Work Authorization or Exposure Control Plan (ECP) and any other required authorization. The Biosafety Work Authorization documents the work, risks, and controls. Implement the controls listed in the authorization.

Work Process D.1

Work Process D.1.a.iv

    • Submit the application form to the Environment/Health/ Safety (EHS) Biosafety Office (biosafety@lbl.gov) for review by the Institutional Biosafety Committee (IBC) and/or Biosafety Officer.

Work Process D.1.a.iv

    • Resolve any review comments.

 

    • Work with the Biosafety Office to get the completed Biosafety Work Authorization signed and authorized. The Biosafety Office will load the authorization into the Biosafety Authorization System (BAS).

Table 10

    • Ensure workers are familiar with the authorization document, understand the required controls, and are trained.

Work Process D.2

    • Ensure the containment controls noted in the authorization document are implemented. Also implement applicable controls noted in this ES&H Manual Biosafety Program. Standard Laboratory Biosafety Level (BL) 1 and BL2 criteria are summarized in Appendix C.

Work Process C and Work Process D

    • Update personnel, biosafety training, and work locations as needed in the BAS.

 

  • Update the authorization document and submit it for review to the Biosafety Office prior to the target renewal date. Ensure authorization document is re-authorized as needed.

Table 10

  • Complete and submit an Exposure Control Plan for nonresearch work that involves exposure to bloodborne pathogen materials.

Work Process D.1.a.v

  • Complete and get approval on any required protocols for research involving vertebrate animals or human subjects (including human-derived data or human-derived tissues) via the Animal Welfare and Research Committee (AWRC) or Human Subjects Committee (HSC), respectively.

ES&H Manual: Research with Human and Animal Subjects Program

 

 

Worker Authorization and Control
Identify the work, hazards, and controls for each worker or subcontractor and ensure the controls are implemented. Ensure each worker completes:

 

  • A Job Hazards Analysis (JHA) or Subcontractor Job Hazards Analysis and Work Authorization (SJHAWA)

Work Process D.2.a

  • Required controls on their JHA or SJHAWA, including required training courses

Work Process D.2.b

  • Applicable job and operation-specific instruction related to biosafety

Work Process D.2.c

  • Any required medical surveillance noted on their JHA, SJHAWA, or work authorization document

Work Process D.3

 

 

Assessment and Improvement

  • Assess and continuously improve the biosafety of the work.

Work Process E

  • Conduct periodic biosafety assessments of the operation as specified in the Division Self-Assessment Program, including assessment of the safety of tasks being performed, safety of the work area and equipment, training, and compliance with the Biosafety Work Authorization and standards.

Work Process E.1

  • Participate in periodic Biosafety or other ES&H Program Self-Assessments of the operation, when scheduled.

Work Process E.2

  • Continuously improve the biosafety of the work, including tracking and correcting deficiencies when required in the Corrective Action Tracking System (CATS).

Work Process E.2

Whom to Call
Refer to the Whom to Call list in Section 26.5.1.

Section 26.5.1


Work with biological materials, like all work at Berkeley Lab, 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 ES&H Manual General ES&H Requirements, Responsibilities, and Work Practices program. These core functions are integrated into the work authorization and control functions summarized above in Table 1.

 

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