Chapter 26
Biosafety

Contents

Approved by Bruce King
Revised 12/12

26.1 Policy
26.2 Purpose
26.3 Scope
26.4 Roles and Responsibilities

26.4.1 Line Management

26.4.1.1 Laboratory Director
26.4.1.2 Division Directors
26.4.1.3 Line Managers and Staff

26.4.2 Institutional Biosafety Committee
26.4.3 Environment, Health, and Safety Division

26.4.3.1 Environment, Health, and Safety Division Director
26.4.3.2 Industral Hygiene Group
26.4.3.3 Health Services Group
26.4.3.4 Waste Management Group
26.4.3.5 Security and Emergency Operations Group

26.5 Biosafety Program Requirements

26.5.1 Biosafety Manual
26.5.2 General Biosafety
26.5.3 Recombinant Organisms and Genomic Materials
26.5.4 Bloodborne Pathogens and Human Materials
26.5.5 Pathogenic and Etiologic Agents

26.5.5.1 General Pathogen Safety
26.5.5.2 Biological Etiologic Agents
26.5.5.3 Select Agents and Toxins
26.5.5.4 Animal and Plant Pathogens
26.5.6 Animal, Plant, and Soil Pests
26.5.7 Decontamination and Waste
26.5.8 Transportation
26.5.9 Human Subjects Use
26.5.10 Experimental Animal Use
26.6 Work Definition and Hazard Assessment
26.6.1 Introduction
26.6.2 Risk Assessment Process
26.6.3 Risk Group Classifications
26.6.4 Risks Defined in Standards
26.7 Biosafety Levels and Controls
26.7.1 Containment Categories and Levels
26.7.1.1 Laboratory Containment and Biosafety Levels
26.7.1.2 Additional Containment Categories
26.7.2 Laboratory Practices and Techniques
26.7.3 Personal Protective Equipment
26.7.4 Signs and Labels
26.7.5 Biosafety Cabinets and Other Containment Devices
26.7.6 Facilities
26.7.7 Occupational Health and Immunization
26.7.8 Training and Qualifications
26.7.8.1 Requirements for Training and Qualifications
26.7.8.2 Training Courses
26.7.8.3 Systems for Establishing and Tracking Worker Training
26.7.9 Decontamination and Waste
26.7.9.1 Decontamination Levels
26.7.9.2 Waste Decontamination and Disposal
26.7.10 Integrated Pest Management
26.7.11 Access and Security
26.7.12 Incident, Accident, and Emergency Response
26.7.12.1 General Incident Response and Training
26.7.12.2 Worker Exposure, Injury, or Illness
26.7.12.3 Biological Spills
26.7.12.4 Additional Biosafety-related Incident Reporting
26.8 Work Review and Authorization
26.8.1 Job Hazards Analysis
26.8.2 IBC Review and Research Biosafety Authorization
26.8.2.1 General Review and Authorization Process
26.8.2.2 Biological Use Notification
26.8.2.3 Biological Use Registration
26.8.2.4 Biological Use Authorization
26.8.3 Exposure Control Plans
26.8.4 Human Subjects and Animal Use Approvals
26.9 Assessment and Improvement
26.9.1 Division Self-Assessment Program
26.9.2 Environment, Safety, and Health Technical Assurance Program
26.9.3 Other Environment, Safety, and Health Self-Assessment Programs
26.10 Standards
26.11 Related PUB-3000 Chapters and Publications
26.11.1 Related PUB-3000 Chapters
26.11.2 Other Related LBNL Publications
26.12 References
26.13 Biosafety Resources


Appendices
Appendix A. Glossary
Appendix B. Additional Biosafety Roles and Responsibilities
Appendix C. Institutional Biosafety Committee Charter
Appendix D. Biological Safety Worker Health and Safety Program (10 CFR 851)

Tables
Table 26-1. Human and Other Materials Covered by the OSHA Bloodborne Pathogens Standard
Table 26-2. NIH Risk Groups and Definitions
Table 26-3. Laboratory Biosafety Level Summary
Table 26-4. Additional Containment Categories
Table 26-5. Biosafety-related Training Course Summary
Table 26-6. Berkeley Lab Review, Documentation, and Authorization for Work with Biological Materials in Research
Table 26-7. Biosafety-related Technical Assurance Assessments

 
NOTE:
  Denotes a new section.
Denotes the beginning of changed text within a section.
Denotes the end of changed text within a section.

_____________________

26.1 Policy

Work with or worker exposure to biological materials in the course of research or other work activities at Lawrence Berkeley National Laboratory (LBNL or Berkeley Lab) must be conducted in a safe, ethical, environmentally sound, and compliant manner using established biosafety standards and the principles and functions of Integrated Safety Management (ISM).

26.2 Purpose

The Biosafety Program ensures that work at LBNL is conducted in accordance with Berkeley Lab’s policy that work with or worker exposure to biological materials is performed and conducted in compliance with applicable biosafety standards and firmly based on the principles and functions of ISM and work authorization (PUB-3000, Chapter 1 and Chapter 6). The Biosafety Program has three interrelated components to achieve this purpose: applicable regulations, standards, and guidance documents; the role and responsibilities of line management and staff in achieving effective integration and implementation of the Biosafety Program elements at the bench and in the workplace; and the responsibility of Environment, Health, and Safety (EH&S) Division biosafety experts in identifying and interpreting standards as a basis for the policies and technical components of the LBNL Biosafety Program.

26.3 Scope

This chapter, the Biosafety Manual, and other LBNL policy documents presented in this chapter are the foundation of the Biosafety Program.

The Biosafety Program addresses biosafety concerns related to worker safety, public health, agricultural protection, and environmental protection for work activities that involve:

The Biosafety Program is applicable to personnel conducting work at locations where LBNL has management responsibility. This includes employees (i.e., staff and guests), visitors, and subcontractors.

Terms, acronyms, and abbreviations used in this chapter are defined in Appendix A of this chapter.

26.4 Roles and Responsibilities

Biosafety-related roles and responsibilities are divided into three functional categories: line management, the Institutional Biosafety Committee (IBC), and the EH&S Division. Roles and responsibilities under these categories are summarized in this section and further detailed in Appendix B (Additional Roles and Responsibilities) of this chapter.

26.4.1 Line Management

26.4.1.1 Laboratory Director

26.4.1.2 Division Directors

26.4.1.3 Safety Line Management and Staff

The expectation is that safety line management will work with their staff to analyze the hazards, assess the risks associated with work activities, as well as identify and apply controls to avoid and/or mitigate those hazards. This expectation is accomplished with the assistance and oversight of the IBC, the Biosafety Officer, and other subject matter experts in the EH&S Division. This policy means that safety program managers and staff must work with the IBC (i.e., for research work), the Biosafety Officer, and their divisions in establishing the appropriate work authorizations to ensure that:

The Biosafety Program uses the Job Hazards Analysis (JHA) and the biosafety authorization processes as the administrative tools to aid and guide supervisors, work leads, and staff in meeting their expectations. The JHA and additional biosafety authorization processes are discussed in Section 26.8.

Safety line management’s roles and responsibilities are delineated generally in PUB-3000, Chapter 1, Section 1.3.2.5, and specifically to biosafety in Appendix B.

26.4.2 Institutional Biosafety Committee

The Laboratory Director has assigned to the Institutional Biosafety Committee (IBC) responsibilities for oversight, administration, and review of Berkeley Lab policies and projects involving research with biological materials that may pose safety, health, or environmental risks. These responsibilities are summarized below and further detailed in the IBC Charter located in Appendix C of this chapter:

26.4.3 Environment, Health, and Safety Division

26.4.3.1 Environment, Health, and Safety Division Director

26.4.3.2 Industrial Hygiene Group

The Industrial Hygiene Group Leader

The Biosafety Officer

In addition, the Biosafety Officer provides advice and technical guidance to managers during work authorization development, input to the IBC as a voting member, and IBC signature concurrence on Biological Use Notifications (BUNs) as described in Section 26.8.2.2. The Biosafety Officer’s role and responsibilities are further delineated in Appendix B of this chapter.

Responsible Official for Select Agents

The Responsible Official (RO) is designated by the EH&S Division Director. The RO has the authority and responsibility to ensure Berkeley Lab’s compliance with Center for Disease Control and Prevention (CDC) and United States Department of Agriculture (USDA) regulations for the possession, use, or transfer of select agents and toxins. Specific duties of the RO are further delineated in Appendix B and Appendix D of this chapter.

26.4.3.3 Health Services Group

The EH&S Division Health Services Group develops and implements the occupational health programs needed to maintain the health of employees exposed to biological materials. Roles and responsibilities of the Health Services Group are further delineated in Chapter 3 of PUB-3000 and Appendix B of this chapter.

26.4.3.4 Waste Management Group

The EH&S Division Waste Management Group develops and maintains the waste disposal programs needed and required to properly collect and dispose of medical/biohazardous waste that is generated during work with biological materials at LBNL. Roles and responsibilities of the Waste Management Group are further delineated in Chapter 20 of PUB-3000 and Appendix B of this chapter.

26.4.3.5 Security and Emergency Operations Group
The EH&S Division Security and Emergency Operations Group develops and maintains the core security and emergency management programs required to maintain the security of work and research with biological materials conducted at LBNL. The Group is also responsible for emergency planning and responding at LBNL. Roles and responsibilities of security and emergency management are further delineated in Chapter 9 of PUB-3000, the Master Emergency Program Plan, and the Site Security Plan.

26.5 Biosafety Program Requirements

This section provides an overview of biosafety standards and LBNL policy. Biosafety standards, references, and related LBNL policies are also listed in Section 26.10. These standards include a variety of regulatory and nonregulatory government, contract, and funding standards. They also form the primary basis of LBNL biosafety policy.

Line management must ensure that work complies with these standards and policies when they implement the ISM steps and specific biosafety requirements outlined in Sections 26.6 to 26.9 of this chapter. The work review and authorization process detailed in Section 26.8 guides compliance.

26.5.1  Biosafety Manual

Berkeley Lab biosafety polices and requirements are covered generally in this chapter and are further detailed in the LBNL Biosafety Manual, a comprehensive policy and tool developed by LBNL that covers fundamental principles of biosafety and integrates requirements from the biosafety standards. These principles and requirements must be used by workers, line management, the EH&S Division, the IBC, and others to identify and implement work and required controls related to biological risks.

The Biosafety Manual is developed by the EH&S Division and approved by the IBC. The manual covers principles and requirements related to risk assessment, controls and containment, decontamination and disinfection, transportation, security, occupational health, training, and waste. The manual also covers other biosafety programmatic elements and controls required by the standards outlined in Section 26.5. Work with biological materials at LBNL will be conducted in accordance with the Biosafety Manual.

26.5.2  General Biosafety

Working safely with biological materials involves identifying risks and implementing controls required to mitigate hazards. The NIH-CDC standard Biosafety in Microbiological and Biomedical Laboratories (BMBL) is the national code of practice and Berkeley Lab biosafety standard that outlines and defines biosafety risk assessment and control. BMBL forms the general framework of biosafety topics and requirements covered in this chapter and the Biosafety Manual. Work with biological materials at LBNL will be conducted in accordance with the fifth edition of BMBL.

26.5.3  Recombinant Organisms and Genomic Materials

Work with recombinant organisms or specific recombinant genomic materials and nucleic acids may involve risks to humans, animals, plants, or the environment. Requirements for work with recombinant DNA molecules are specified in the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), and recombinant DNA molecules are defined in Section I-B. The NIH Guidelines have broad requirements for biosafety risk assessment and control similar to BMBL requirements. In addition, the NIH Guidelines have special institutional and line management requirements such as an Institutional Biosafety Committee (IBC) review process and responsibilities specifically defined for principal investigators (PIs). Institutions such as LBNL that receive NIH funding are required to comply with the NIH Guidelines. As a condition for NIH funding, LBNL and lead investigators (e.g., PIs) must ensure that all nonexempt recombinant DNA research experiments conducted at or sponsored by LBNL, regardless of the source of funding, comply with the NIH Guidelines. The work review and authorization processes and documents detailed in Section 26.8 are key tools that assist researchers to comply with the NIH Guidelines.

26.5.4  Bloodborne Pathogens and Human Materials
           
The Federal Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard has comprehensive requirements for workers that are or may be exposed to bloodborne pathogens (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. BMBL also has guidelines for working with human and mammalian cells and tissues.

BBPs are infectious agents capable of causing human disease and are transmitted through human blood and tissues. Examples include the hepatitis B virus (HBV) and the human immunodeficiency virus (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 other potentially infectious materials (OPIM) listed in Table 26-1. 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 blood are not considered OPIM even though they may contain other types of infectious agents or present health concerns.

Table 26-1 
Human and Other Materials
Covered by the OSHA Bloodborne Pathogens Standard*

Blood, including human blood, human blood components, and products made from human blood

Other potentially infectious materials (OPIM):

  • Unfixed human tissue or organ (other than intact skin) from a living or dead human.
  • Primary human tissue cultures. These cultures are explants of living human tissue placed in a medium for tissue culture.
  • 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.
  • Established human cell lines.**  These cell lines are immortalized cells that have been transformed by spontaneous mutation or natural or laboratory infection with an immortalizing agent, and then propagated or passaged many times (e.g., in vitro or in animals such as mice).
  • 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 blood are not considered OPIM (e.g., urine, feces, vomit, tears, sweat, sputum, nasal secretions, and saliva).
  • HIV- or HBV-infected materials. HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from humans or experimental animals infected with HIV or HBV.

Footnotes:

*     Text taken from  OSHA Bloodborne Pathogens 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., ATCC 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 (e.g., hepatitis B), 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.

 

Appendix H of BMBL states that a risk assessment should be conducted for human and primate cells based on the origin and source of cells or tissues, and such cells should be handled using Biosafety Level 2 (BL) practices and containment (see Section 26.7 for further discussion of BLs). While many requirements in the BMBL and OSHA Bloodborne Pathogens Standard are similar to each other, the OSHA standard requires initial and annual BBP training, availability of hepatitis B vaccination at no cost to employees, and a written Exposure Control Plan (ECP). Researchers satisfy documentation requirements for a risk assessment, BL2 containment, and an ECP once they have an approved Biological Use Authorization (BUA). BL2 containment must be used unless the BUA risk assessment indicates that alternative controls are sufficient. BUAs are further discussed in Section 26.8.2.

Work at LBNL that involves BBP materials will be performed in compliance with the Fed/OSHA Bloodborne Pathogens Standard and BMBL. BBPs must also be managed in accordance with requirements for Biological Etiologic Agents in Section 26.5.5.2.

26.5.5  Pathogenic and Etiologic Agents

Pathogens are infectious microbial (e.g., bacteria, protozoa, fungi, viruses, etc.) or other agents that cause disease in healthy host organisms such as humans, animals, or plants. “Opportunistic pathogens” may infect immuno-compromised hosts. Avirulent or attenuated agents are pathogens that were physiologically modified or genetically altered into being several orders of magnitudes less likely to produce disease in a healthy host organism. Pathogens may be regulated by a variety of agencies (e.g., NIH, CDC, Department of Energy [DOE], USDA, and OSHA) depending on the potential hosts and impacts (e.g., humans or livestock). Standards and LBNL policies that are especially applicable to pathogens are discussed in the following sections:

26.5.5.1     General Pathogen Safety

The NIH Guidelines and CDC BMBL have requirements for risk assessment that include a Risk Group (RG) classification system and a set of implementing controls defined as biosafety levels (BLs). Work with human pathogens at LBNL will be conducted in accordance with the agent-specific RG designations in Appendix B of the NIH Guidelines and the BL determinations made by the IBC. The IBC will determine the proper containment level for pathogenic work, and use the recommended BLs presented in the BMBL Agent Summary Statements when available. See Sections 26.6.3 and 26.7.1 for further discussion of risk groups and biosafety levels, respectively.

26.5.5.2     Biological Etiologic Agents

The DOE Worker Safety and Health Program regulation (10 CFR 851, Appendix A, Section 7) has specific requirements for “biological etiologic agents.” In regards to LBNL’s program related to 10 CFR 851, a “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). See Appendix B of the NIH Guidelines for a list and risk group categorization of human etiologic agents. Work with biological etiologic agents must be documented, reviewed, and authorized as discussed in Section 26.8. During and following the review and authorization process, the IBC and EH&S Division ensure the implementation of oversight and reporting responsibilities for biological etiologic agents. See Appendix D of this chapter for specific LBNL requirements related to biological etiologic agents under 10 CFR 851.

26.5.5.3     Select Agents and Toxins

The term “select agents and toxins” is used by the CDC and USDA to describe specific pathogenic agents and toxins that have the potential to be used as biological weapons or pose a severe threat to human, animal, and plant health. These select agents and toxins along with their specific genetic elements, recombinant nucleic acids, and recombinant organisms are strictly regulated by the CDC and USDA. The possession, use, or transfer of select agents and toxins at LBNL will be conducted in accordance with CDC and USDA regulations related to human, plant, and animal select agents and toxins, and the Biosafety, Security, and Incident Response Plan for Select Agents. In addition, select agent registrations, transfers, and destructions will be reported to the DOE Berkeley Site Office when and as described in Appendix D of this chapter.

26.5.5.4     Animal and Plant Pathogens

See Sections 26.5.5.3 and 26.5.6 for information on pathogens that may significantly harm domestic or native animals and plants, or U.S. agricultural and natural resources.

26.5.6  Animal, Plant, and Soil Pests

Some organisms, agents, or materials that significantly harm domestic or native animals or plants, or natural resources, are regulated and considered pests by the USDA Animal Plant and Health Inspection Service (APHIS). These pests may cause harm directly (e.g., predator or pathogen) or indirectly (e.g., vector). General examples include specific animals, plants, animal pathogens, plant pathogens, soil that may contain such pathogens, and agents that pose a severe threat.

Transfer, storage, use, and disposal of such pests at LBNL must be conducted in accordance with the USDA-APHIS regulations. Generally, APHIS requires a permit to ship, receive, or store pests from locations outside the continental United States (U.S.) or between U.S. states. Permits are issued by APHIS to individuals and are not transferrable to other individuals. Individuals responsible for transfer, storage, use, or disposal of such pests will obtain permits when required, ensure that the pests and permits are covered in the LBNL work authorization, and ensure that specific permit requirements are implemented.

26.5.7  Decontamination and Waste

Work surfaces, work areas, furniture, equipment, materials, and waste involved in work with biological materials covered by the standards in this section must be routinely decontaminated during the work or prior to disposal. Decontamination is the reduction or inactivation of biological contaminants or components to an acceptable level to reduce or eliminate the possibility of transmitting pathogens to undesired hosts.

Some wastes that are biological materials or may be contaminated with biological materials must be decontaminated (or inactivated) in an approved manner prior to final disposal to protect humans, plants, animals, or the environment. LBNL defines these wastes as medical/biohazardous waste and provides specific guidance for their disposal in the Medical and Biohazardous Waste Generator’s Guide (PUB-3095).

Decontamination and waste disposal must be conducted in accordance with the following standards and requirements:

26.5.8 Transportation

The transportation of biological materials may be subject to state, federal, and international regulations and permits governing the licensing, packaging, and shipment of material. These regulations may be particularly applicable if the material is transported via public right-of-ways or transferred between countries or states. Examples of public right-of-ways include roadways, airways, railways, and sea lanes accessible to the public. Transportation and permitting of biological materials will be conducted in accordance with the following regulations:

26.5.9  Human Subjects Use

Research involving human subjects, human-derived data, or human-derived tissues must be evaluated through ethical review using established principles and requirements. These requirements are based on U.S. Department of Health and Human Services (HHS) regulations and DOE orders. These standards require that an Institutional Review Board (IRB) review and approve any proposed research project involving human subjects before research begins. The IRB for Berkeley Lab is the Human Subjects Committee (HSC). See the HSC Web site and Chapter 22 (Research with Human and Animal Subjects) of PUB-3000 for additional information.

26.5.10 Experimental Animal Use

Research involving vertebrate animals must comply with established standards and requirements for the care, treatment, and use of animals. These requirements are based on USDA animal welfare regulations and the PHS Policy on Humane Care and Use of Laboratory Animals. Compliance with the PHS policy is overseen by the NIH Office of Laboratory Animal Welfare (OLAW). These standards require that the Animal Welfare and Research Committee (AWRC) review and approve proposed research that involves vertebrate animals and is performed at or funded through LBNL before research begins. See the AWRC Web site and Chapter 22 (Research with Human and Animal Subjects) of PUB-3000 for additional information.

26.6 Work Definition and Hazard 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 functions of ISM and fundamental steps required by biosafety standards.

26.6.1 Introduction

Berkeley Lab uses Job Hazards Analysis (JHA) and biosafety authorization processes (See Section 26.8) to define work scope, identify biological hazards and potential exposures, assess biological risks, and establish biosafety controls.

An accurate and complete definition of work and potential adverse biological exposures is fundamental for a thorough risk analysis and the effective tailoring of hazard controls. For this reason, the Biosafety Officer and other subject matter experts must be involved with line managers, supervisors, and their staff to ensure that the work to be performed and hazards involved are sufficiently defined to provide the basis for a thorough hazard analysis and implementation of effective controls. In the case of biosafety work authorization documents, clear delineation of the work and hazards are the initial step of the review and approval process.

In the case of research involving biological materials, the IBC reviews and approves the definition of work as part of the authorization process presented in Section 26.8. In addition to a description of the work to be performed, a complete work definition must include the biological agents and/or materials to be used, where and how they will be handled and stored, and the workers responsible for each of these activities. The analysis of the hazards must include all these aspects as well.

26.6.2  Risk Assessment Process

Assessment of biological hazards and risks associated with a work activity or operation must start with considering three primary factors: the inherent work hazard (perceived or real) posed by the biological material or agent, the susceptible hosts (i.e., receptors) that may be affected by the material or agent, and the exposure pathways between the threat hazard and the susceptible host.

In addition, BMBL outlines the following five-step approach to assessing biological risk and selecting controls for laboratory work:

  1. Identify agent hazards and perform an initial assessment of risk.
  2. Identify laboratory procedure hazards.
  3. Make a final determination of the appropriate BL and select additional controls indicated by the risk assessment.
  4. Evaluate a worker’s proficiencies in safe work practices and the integrity of safety equipment.
  5. Review the risk assessment with the biosafety professional, subject matter expert, and IBC.

Elements of each of these steps are covered in the work authorization documents and review processes detailed in Section 26.8.

26.6.3  Risk Group Classification

While identifying agent hazards and completing the initial risk assessment, the principal hazardous characteristics of the agent, including its capability to infect and cause disease in a susceptible human or other host, severity of disease, and the availability of preventive measures and effective treatments, must be considered. Both the World Health Organization (WHO) and NIH have established an agent risk group classification for laboratory use that describes four general risk groups (RGs) based on these principal characteristics and the transmission route of natural disease.

Berkeley Lab uses the NIH RG categories and definitions provided in Appendix B of the NIH Guidelines and shown in Table 26-2. These definitions are based on the risk of disease in humans. Assignments of specific agents to RGs can also be found in Appendix B of the NIH Guidelines or in other sources such as the American Biological Safety Association (ABSA) Risk Group Database. RG definitions and classification may vary slightly between countries, so Berkeley Lab uses the NIH RG definitions and agent-specific classifications since they are contained in the U.S.-based NIH Guidelines. Agents not listed in RGs 2, 3, or 4 by NIH are not automatically or implicitly classified as RG1. A risk assessment must be conducted for these agents based on the known properties of the agent and their relationship to agents that are listed.

Table 26-2
NIH Risk Groups and Definitions

Risk Group (RG)

Risk Group Definition

1

Agents that are not associated with disease in healthy adult humans.

2

Agents that are associated with human disease that is rarely serious, and for which preventive or therapeutic interventions are often available.

3

Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk).

4

Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk).

As required by LBNL policy, each biological agent or material used for research must be categorized in the biosafety work authorization document by RG, and the RG must be based on the agent’s or material’s potential for causing disease in humans.

26.6.4 Risks Defined in Standards

Assumed risks and required controls are often specified in established biosafety standards (i.e., see Sections 26.5 and 26.10). Examples include:

Risks that are pre-defined in such biosafety standards must generally be assumed and incorporated into the risk assessment, which is one component of the LBNL biosafety work authorization document.

26.7   Biosafety Levels and Controls

The work definition, hazard identification, and risk assessment processes and requirements discussed in Section 26.6 must be used to determine and establish the required and needed controls to mitigate the hazards and perform the work safely. Controls are safeguards employed to contain the biological agent or material and therefore reduce or eliminate exposure of workers, other people, or the environment to agents that may cause harm. One or more biosafety standards (see Sections 26.4 and 26.10) may require similar or different biosafety controls. These required controls are consolidated and documented using LBNL JHAs and biosafety work authorization documents (Section 26.8).

Biosafety controls are often categorized by the following categories that are covered in this section, including:

26.7.1  Containment Categories and Levels

The NIH Guidelines and BMBL categorize containment controls into biosafety levels (BLs). Work at Berkeley Lab requires routine application of BLs developed for biological laboratories, and occasional application of BLs developed for other types of work such as large-scale recombinant operations. BLs for laboratories are presented in the next section. BLs for large-scale, plant, and animal uses are presented in Section 26.7.1.2.

26.7.1.1 Laboratory Containment and Biosafety Levels

Physical containment controls for laboratory biosafety are categorized into four biosafety levels (BLs) that consist of standard combinations of laboratory work practices, safety equipment, and laboratory facilities. Controls within laboratory BLs are categorized in BMBL as follows:

Laboratory work at LBNL must be conducted in accordance with the laboratory BL1 and BL2 criteria detailed in BMBL. Laboratory BL criteria from BMBL are more comprehensive than BL criteria detailed in the NIH Guidelines. Table 26-3 provides definitions of laboratory BLs. See the Containment section of the Biosafety Manual for additional information. BL3 and BL4 work are not currently conducted at LBNL.

 

Table 26-3
Summary of Laboratory Biosafety Levels

Biosafety Level (BL)

Biosafety Level Definition

1

BL1 is suitable for work involving agents of unknown or minimal potential hazard to laboratory personnel and the environment,1 or work with defined and characterized strains of viable microorganisms not known to consistently cause disease in healthy adult humans.2

2

BL2 is suitable for laboratory work involving agents of moderate potential hazard to personnel and the environment.1  Primary hazards to personnel working with these agents relate to accidental percutaneous or mucous membrane exposures, or ingestion of infectious materials.2

3

BL3 is applicable to facilities in which work is conducted with indigenous or exotic agents that may cause serious or potentially lethal disease as a result of exposure by the inhalation route.3

4

BL4 is required for work with dangerous and exotic agents that pose a high individual risk of life-threatening disease, with aerosol transmission, or with related agents having an unknown transmission risk.3

Footnotes:

At BL1, laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open benchtops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment. Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist trained in microbiology or a related science.

BL2 laboratories incorporate all BL1 requirements and have additional requirements.  Examples of additional BL2 controls include:

26.7.1.2 Additional Containment Categories

Additional types of containment specified in the NIH Guidelines or BMBL may also be  applicable to work with biological materials at LBNL. These containment categories are listed below in Table 26-4. Sections from the NIH Guidelines or BMBL that are noted in Table 26-4 must be reviewed carefully to determine applicability of the containment category and criteria to a specific LBNL operation since there are many exceptions and specific conditions noted in these standards.

Containment criteria from these containment categories will be applied to LBNL work when the containment category and criteria are applicable to the work being performed. In this case, laboratory or operation-specific authorizations, biosafety manuals, or other documents will be used to document the containment requirements related to the work.  When the containment categories or criteria presented in Table 26-4 are not applicable to the work, the laboratory BLs presented in Section 26.7.1.1 are typically applied to the work.
 

Table 26-4
Additional Containment Categories

Containment Category

Standard and Section

Focused Scope of Containment Criteria

Large-Scale Uses of Organisms Containing Recombinant DNA Molecules

NIH Guidelines, Appendix K

Physical containment guidelines for large-scale (greater than 10 liters of culture) research or production activities involving viable organisms containing recombinant DNA molecules. These containment criteria address only the biological hazard associated with organisms containing recombinant DNA.

Recombinant DNA Research Involving Plants

NIH Guidelines, Appendix P

Physical and biological containment conditions and practices suitable to greenhouse operations that conduct experiments involving recombinant DNA-containing plants, plant-associated microorganisms, and small animals.

Recombinant DNA Research Involving Animals

NIH Guidelines, Appendix Q

Containment and confinement practices for research involving whole animals when the animals are of a size or have growth requirements that preclude the use of containment for laboratory animals (i.e., including but not limited to cattle, swine, sheep, goats, horses, and poultry), and:

  • The animal's genome has been altered by the stable introduction of recombinant DNA, or DNA derived therefrom, into the germ line (transgenic animals), or
  • Experiments involving viable recombinant DNA-modified microorganisms tested on whole animals.

Vertebrate Animal BL Criteria for Vivarium Research Facilities

BMBL,
Section V

Use of experimentally infected animals housed in indoor research facilities (e.g., vivaria), and the maintenance of laboratory animals that may naturally harbor zoonotic infectious agents.

Arthropod Containment Guidelines

BMBL, Appendix E

Risk assessment and containment for arthropods of public health importance including those that transmit pathogens. Arthropods that cause only myiasis, infestation, biting, and stinging are not included.

26.7.2  Laboratory Practices and Techniques

The first and most important element of control in laboratory containment is strict adherence to standard and special microbiological practices and techniques. Standard and special practices and techniques are summarized in the work authorization document and listed in the Containment section of the Biosafety Manual.

Standard practices include ensuring that persons working with biohazardous materials are aware of the potential hazards, receive proper and required training, and are proficient in the practices and techniques required for handling such material safely. Work leads must provide or arrange for appropriate training and instruction for each person, including but not limited to:

Work authorization documents must be available and accessible to each worker so that they can understand the work, hazards, and required controls. Authorization documents include Biological Use Authorizations (BUAs), Biological Use Registrations (BURs), Biological Use Notifications (BUNs), and Exposure Control Plans (ECPs). Each worker has access to their authorization, registration, and notification through the Biosafety Authorization System (BAS). The BUA is also considered:

26.7.3  Personal Protective Equipment

Use of safety equipment including personal protective equipment (PPE) is another element of BL1 and BL2 containment. PPE may include foot, hand, eye, face, body, and respiratory protection. This PPE must be used, maintained, and disposed of in accordance with federal regulations, biosafety standards, and LBNL-specific PPE policies to prevent the spread of contamination and accidental infection. LBNL policies related to PPE when working with biological materials include:

Area-specific and activity- or operation-specific PPE requirements related to biosafety include:

26.7.4  Signs and Labels

Biological materials, agents, and potentially contaminated items must be properly identified. Biohazard warning symbols and red-orange colors must also be used to provide warning. The display of signs, labels, and colors must be in accordance with the applicable requirements in the biosafety standards and LBNL policies. The following types of labels and signs are included:

See specific biosafety labeling and posting requirements in:

26.7.5  Biosafety Cabinets and Other Containment Devices

Biosafety cabinets (BSCs) are hoods with high efficiency particulate air (HEPA) filters that provide personnel, environmental, and product protection when appropriate practices and procedures are followed. Safety equipment including BSCs, PPE, or other physical containment devices (e.g., safety centrifuge cups) must be used whenever procedures with a potential to create infectious aerosols or splashes are conducted, or whenever high concentrations or large volumes of infectious agents are used. Examples of such procedures include pipetting, centrifuging, grinding, blending, shaking, mixing, vortexing, sonicating, opening containers with pressure differentials, or harvesting infected tissues. The BSC is the principal BL2 device used in laboratories to provide such containment.

BSCs must be designed, installed, tested, and surveyed in accordance with LBNL EH&S policies for all hoods and HEPA filters (i.e., PUB-3000, Section 4.6). In addition, BSCs must be designed, constructed, installed, operated, used, decontaminated, and tested in accordance with BMBL (Appendix A) guidelines and requirements and BL2 criteria. See the Containment section of the Biosafety Manual for more information on BSCs and other containment devices, in addition to the following overview of BSC policies and management at LBNL:

26.7.6  Facilities

The design and construction of the facility contributes to the laboratory worker’s protection, provides a barrier to protect persons outside the laboratory, and protects the community and environment from potentially hazardous materials or agents that may be accidentally released from the laboratory.

LBNL designs and operates its facilities where work with biological materials is conducted in accordance with applicable BL1 and BL2 facilities criteria detailed in the containment categories outlined in Section 26.7.1. Since risks related to most laboratory work at LBNL require direct contact with materials or agents, standard BL1 and BL2 Laboratory Facilities barriers are sufficient to control most work. Examples of standard facility barriers include doors, sinks, cleanable surfaces and furnishings, window screens, BSCs, ventilation, eyewashes, and autoclaves. Some standard facility barriers are summarized in the biosafety work authorization document. Any additional special facility barriers that are required must also be included in the authorization document. See the “Containment” section of the Biosafety Manual for additional information on facilities and laboratory secondary containment.

In addition, LBNL designs, constructs, approves, and operates its buildings and laboratories in accordance with nationally recognized codes regulations, standards, acts, and manuals as detailed in the Facilities Division Construction Details and Design Guidelines and Chapter 12 (Fire Prevention and Protection) of PUB-3000. In addition, EH&S teams are assigned to conduct design reviews for new projects as described in the Capital Projects Procedures Manual (PUB-3193). The EH&S Industrial Hygienist assigned to the EH&S Design Review Team is responsible for reviewing facility design and installation for concerns and requirements related to biosafety. Line management is responsible for ensuring that facilities are appropriate for the laboratory activities and meet the required BL for the agents or materials being handled.

26.7.7 Occupational Health and Immunization

LBNL occupational health and immunization policies, programs, and services are provided by the Health Services Group of the EH&S Division under the direction of the Site Occupational Medical Director (SOMD). These policies, programs, and services are described in the Health Services Web site and in Chapter 3 (Health Services) of PUB-3000. The occupational health program related to biosafety is designed to proactively identify and prepare workers who may be exposed to certain biological materials or agents, and provide procedures for the treatment and management of workers who have been injured or may have been exposed.

Potential exposures to biological agents or materials that generate health concerns or may cause disease are assessed as part of the work review and authorization process discussed in Section 26.8. This assessment includes an evaluation and determination of the need for employee medical evaluations, immunizations, serum banking, or other occupational health controls. For research projects, this assessment is conducted by IBC members including the Biosafety Officer and the SOMD. The IBC review includes SOMD recommendations and is the basis of required or recommended occupational health controls for potentially exposed employees. These controls are then documented in the biosafety work authorization document. Health Services has specific policies and procedures related to assessing and offering immunization and serum banking to workers.

In limited cases, requirements for occupational health controls such as immunization are covered in biosafety standards for specific agents or categories of agents. Examples include:

The two basic occupational health requirements of the Bloodborne Pathogens Standard, and Berkeley Lab’s programmatic policies and systems for implementing these requirements, are described below:

Consult the LBNL Health Services Group (510-486-6266), Health Services Web site, and PUB-3000 (i.e., Chapter 3, Health Services) for additional information, policies, and procedures regarding occupational health and immunization. See Section 26.7.12 for additional information on worker exposure, injury, and illness reporting.

26.7.8  Training and Qualifications

Work leads, supervisors, and principal investigators (i.e., PIs for recombinant research) are responsible for ensuring their workers have sufficient skills, knowledge, and ability to perform their work safely. This includes sufficient understanding of the work, hazards, and controls. In ISM terms, each worker’s competence must be commensurate with their responsibilities. This competence is one component of biosafety containment and includes both required LBNL courses and sufficient operation-specific training. Requirements and administrative systems for institutional and operation-specific training are further detailed in this section. Also see Section 26.7.2 for more information about operation-specific training and qualifications not presented in this section.

26.7.8.1 Requirements for Training and Qualifications

Requirements for training and qualifications are covered in this section and the following policies and standards:

LBNL Policies:

Biosafety Standards:

26.7.8.2 Training Courses

Specific biosafety, biohazardous waste, and occupational health courses are developed and maintained by EH&S to meet requirements that can be fulfilled at an institutional level. LBNL course requirements are presented below and summarized in Table 26-5:

Table 26-5
Biosafety-related Training Course Summary

Work Exposure or Role

EHS0739 Biosafety for Researchers

EHS0730 Medical/ Biohazardous Waste

EHS0735 Bloodborne Pathogen for Researchers

EHS0738 Bloodborne Pathogen Refresher

EHS0745 Hepatitis B Medical Surveillance

EHS0749
PI rDNA Responsibilities

Researchers who use biological materials of any risk level, generate medical/biohazardous waste, or are PIs or leaders of the work activity

X

X

 

 

 

 

Researchers who use or  are exposured to Bloodborne Pathogen Materials

X

X

X

X

X

 

Nonresearchers who use or  are exposured to Bloodborne Pathogen Materials

 

 

 

X

X

 

PIs of non-exempt recombinant research

X

X

 

 

 

X

26.7.8.3 Systems for Establishing and Tracking Worker Training

Biosafety training course requirements for each worker are identified through each worker’s Job Hazards Analysis (JHA), and inclusion in the Personnel and Training sections of the biosafety work authorization document in the Biosafety Authorization System (BAS). Each worker’s course requirements and training status are then displayed in the worker’s Training Profile, JHA Profile, and biosafety work authorization document. Polices related to JHA are covered in PUB-3000, Chapter 32, and information related to the BAS is covered in this chapter.

26.7.9 Decontamination and Waste

Work surfaces, work areas, furniture, equipment, materials, and wastes involved in most work with biological materials must be routinely decontaminated during the work or prior to disposal. General decontamination levels and methods are first discussed in this section, followed by a specific discussion of waste. See Section 26.5.7 for a summary of decontamination and waste standards and LBNL policies.

26.7.9.1 Decontamination Levels

Decontamination is the reduction or inactivation of biological contaminants or components to an acceptable level to reduce or eliminate the possibility of transmitting pathogens to undesired hosts. Prevention of pathogen transmission is needed to control contamination of the work and prevent disease in hosts such as laboratory workers, the general public, and other organisms in the environment. Different levels and methods of decontamination are listed below:

The levels, methods, and frequency of decontamination are based on the work activity and decontamination objective or requirements. In general:

26.7.9.2 Waste Decontamination and Disposal

LBNL uses the term medical/biohazardous waste to describe wastes that are biological materials or may be contaminated with biological materials and require inactivation (i.e., decontamination) in an approved manner prior to final disposal. See the Medical and Biohazardous Waste Generator’s Guide (PUB-3095) for LBNL definitions and requirements for disposal of medical/biohazardous waste. Collection and disposal of medical/biohazardous waste will be conducted in accordance with PUB-3095, the standards listed in Section 26.5.7, and methods approved to inactivate the materials.

The EH&S Waste Management Group manages the disposal of medical/biohazardous waste including the contract with a licensed subcontractor that transports, treats, and disposes of LBNL’s solid waste as regulated medical waste. Examples of such solid waste include materials that are placed in lined and labeled biohazardous waste containers, biologically contaminated sharps in sharps containers, and pathological materials such as carcasses.

Although EH&S Waste Management manages the waste component of the Biosafety Program, it is the responsibility of the waste generator to ensure that medical/biohazardous waste is properly:

The Joint Genome Institute (JGI) at the Production Genome Facility is the only LBNL site that does not use a licensed subcontractor to dispose of solid biological waste as regulated medical waste. Instead, JGI uses autoclaves to sterilize solid, recombinant, biohazardous waste prior to disposal as detailed in PUB-3095.

26.7.10 Integrated Pest Management

Biosafety level (e.g., BL1 and BL2) criteria in BMBL and the NIH Guidelines require a program to control pests such as insects and rodents. Pests such as flies, cockroaches, ants, or mice can mechanically transmit biological materials and pathogens.

Appendix G of BMBL provides guidance and requirements for an Integrated Pest Management Program (IPM). IPM is a comprehensive program approach that integrates housekeeping, maintenance, and pest control services. The primary goal of the IPM program is to prevent pest problems by managing the facility environment to make it less conducive to pest infestation. Along with limited applications of pesticides, pest control is achieved through proactive operational and administrative intervention strategies to correct conditions that foster pest problems. Research supervisors, work leads, and LBNL Facilities are each responsible for elements of an IPM program for each operation.

The LBNL Facilities Division is responsible for the general construction and maintenance of facilities including the design of laboratory buildings, periodic floor cleaning, disposal of general trash, and pest management. Pest management includes maintenance of a contract with a licensed California State/County applicator to provide insect and rodent control services. The licensed applicator conducts preventative services (e.g., periodically spray foundation of building) and responds to control reported infestations. The Facilities Division also maintains the Facilities Work Request Center (510-486-6274) to track and respond to requests to repair and clean facilities and control infestations.

Research supervisors and work leads must ensure implementation of the following IPM elements:

26.7.11 Access and Security

Laboratory supervisors and work leads conducting work at BL1 or BL2 must enforce LBNL Institutional policies that control access to the site and to laboratory facilities as described in the LBNL Site Security Plan. Policies and practices include, for example, the hosting of visitors and the issuance of gate passes, badges, and/or keys to control access to the site, building, and/or room based on each individual’s business need. In addition, laboratory areas should have doors for access control. Consult the Safeguards and Security Web site for security policies and additional information.

In addition to the above access requirements, the following additional controls are applicable when working at BL2:

Additional security assessments and security measures should be considered when select agents, other agents of high public health or agricultural concern, or agents of high commercial value are introduced into the laboratory. In this case, advisory recommendations of Section VI (Principles of Laboratory Biosecurity) of BMBL should be considered. In addition, when a security risk assessment has determined that additional physical security measures are needed to mitigate specific vulnerabilities, the laboratory or facility may be designated a property protection area (PPA). Lastly, when the agents are select agents or toxins (see Section 26.5.5.3), then the security requirements of the select agent regulations must be implemented as outlined in a specific security plan for the laboratory or building.

26.7.12 Incident, Accident, and Emergency Response

This section outlines policy-related incident response and reporting. Biosafety-related incidents may include worker exposure to biological material, injuries or illnesses involving or resulting from exposure to biological material, spillage of biological material, or release of biological material outside of biosafety secondary containment. Such incidents may require reporting, medical evaluation and treatment, emergency response, incident review and documentation, and/or corrective actions.

Response to biosafety-related incidents will be managed in accordance with this section and the following guidelines, policies, and authorizations:

26.7.12.1 General Incident Response and Reporting

Worker instructions for reporting incidents and general emergency response are covered in the LBNL Emergency Response Guide, a flip chart that covers response guidelines for a variety of common emergencies including biological spills and personal injury, and provides both emergency and nonemergency telephone numbers. The Emergency Response Guide must be posted in areas wherever work with biological materials is conducted, and emergency response guidelines should be employed when responding to incidents.

LBNL PUB-3000 Chapter, Section 5.1, also provides general requirements for incident reviewing and reporting such as responding to emergencies, and reporting and reviewing incidents and occupational injuries or illnesses.

Division directors and their designees are also responsible for reporting certain adverse or abnormal occurrences in accordance with the Occurrence Reporting and Processing System (ORPS) polices and system.

In addition to ORPS reporting, incidents of security concern must be reported to LBNL Security. Incidents of security concern are categorized in DOE Manual 470.4-1 in accordance with their potential to cause serious damage or place safeguards and security interests and activities at risk. This includes confirmed threats that immediately endanger personnel health and safety and may require immediate security personnel/law enforcement intervention. An example would be confirmed or suspected acts of sabotage at any LBNL facility that places the safety or security of personnel, facilities, or the public at risk.

26.7.12.2 Worker Exposure, Injury, or Illness

Workers are responsible for immediately reporting all occupational injuries, illnesses, and exposures to biological materials of concern to their supervisor and Health Services. The Biosafety Officer must also be notified of exposures to biological materials of concern or any related illness. Health Services will manage the occupational health case and initiate a Supervisor Accident Analysis Report (SAAR). In addition, an incident review team will be assigned to review the case and determine the causes and any needed actions. See PUB-3000, Chapter 5, Section 5.1, for additional information.

Biological materials of concern related to exposures include materials or animals that may contain agents or properties that have known, potential, or unknown health risks. Examples of materials include all recombinant genomic materials, viable biological microbes in research, or Risk Group 2 or higher agents or materials. Examples of worker exposures to such biological materials of concern include:

Additional information on biosafety-related accidents, response, and reporting is contained in the applicable BUA or ECP (see Section 26.8) and the “Accident” section of the Biosafety Manual.

26.7.12.3 Biological Spills

Supervisors, work leads, and PIs are responsible for ensuring spill response procedures and materials needed to safely respond to potential biological spills are maintained in operations where biological materials are used.

The Emergency Response Guide, which must be posted in work areas, provides guidance and materials needed to safely respond to and clean up most biological spills at LBNL. Additional guidance regarding biohazardous spills inside and outside of biosafety cabinets is provided in the Spill Response section of the Biosafety Manual. Any additional guidance or materials needed to safely respond to or clean up biological spills must be included in the operation’s biosafety authorization document (see Section 26.8).

Response to biological spills should be conducted in accordance with applicable guidelines or requirements contained in the Biological Spill section of the Emergency Response Guide, the Biosafety Manual, and the operation’s work authorization document.
                             
26.7.12.4 Additional Biosafety-related Incident Reporting

Line management, the Biosafety Officer, the Responsible Official, Waste Management, the IBC, and other LBNL employees have various internal and regulatory responsibilities for reporting biosafety-related incidents. The following incidents must be reported to the Biosafety Officer in the EH&S Division:

Release outside of secondary containment includes, for example:

26.7.13 Transportation

Transportation of biological materials will be conducted in accordance with all domestic and international transport, shipment, and permit regulations (see Section 26.5.8) and LBNL policies in the Transportation section of the Biosafety Manual. General guidance and example requirements include:

26.8 Work Review and Authorization

Safety line management must ensure that work or activities with potential exposure to biological materials are defined, biological hazards are evaluated, biosafety controls are implemented, and work is authorized, resulting in one or more of the authorizations listed below.

26.8.1  Job Hazards Analysis

Supervisors, work leads, and staff must use the Job Hazards Analysis (JHA) process presented in Chapter 32 of PUB-3000 to define work with biological materials, determine the potential for exposure to biological hazards, and establish biosafety controls for each worker. The Laboratory-wide JHA has standardized questions to assist in identifying workers that work with or have potential exposure to biological materials (e.g., BBP materials).

The JHA process establishes an Individual Baseline JHA, or in some cases a task-based JHA. Both types of JHAs are work authorizations signed by the worker and work lead prior to conducting work. The JHA work authorization includes a description of the worker’s work activities, tasks incorporated into that work, hazards associated with those tasks, and controls that mitigate the hazards. Controls include, but are not limited to, any required EH&S courses and formal or other types of authorizations such as a BUA for work or activities in which the worker participates, as discussed in Section 26.8. Consult the JHA Web site, JHA Frequently Asked Questions, and Chapter 32 of PUB-3000 for additional information.

26.8.2 Institutional Biosafety Committee Review and Research Biosafety Authorization

In addition to worker-specific JHAs, work leads and principal investigators (PIs) must define their research projects or operations with biological materials, evaluate the biological hazards, implement biosafety containment controls, and ensure their work is documented and authorized as a BUN, BUR, or BUA. These authorizations are maintained in and accessible through the LBNL Biosafety Authorization System (BAS). See Table 26-6 for a summary of Institutional Biosafety Committee (IBC) review, documentation, and authorization requirements for research work with biological materials. The sections below provide additional explanation.

26.8.2.1 General Review and Authorization Process

The work lead and PI are responsible for ensuring that research with biological material and any regulatory permits are documented, reviewed by the IBC, and authorized under a Biosafety Work Authorization when and as required. Submission of a Biological Use Application form by the work lead or PI and approval by the IBC and line management results in a Biosafety Work Authorization (e.g., BUN, BUR, or BUA), as detailed in Table 26-6. EH&S Division Biosafety Program personnel assist the work lead or PI in screening the work documentation, determining the applicable requirements and documentation, and coordinating the IBC review process.

26.8.2.2 Biological Use Notification

An approved Biological Use Notification (BUN) is required for work that involves only Risk Group (RG) 1 biological material or recombinant material exempted by NIH Guidelines and does not involve other conditions that require review (see Table 26-6). The PI-authorized BUN must be submitted to the IBC prior to or simultaneously with experiment initiation, and must receive concurrence by the Biosafety Officer or IBC Chair. This notification process at the start of a project defines and assesses the work, establishes containment levels, and ensures that the requirements and hazards for the project are correctly identified and addressed.

26.8.2.3 Biological Use Registration

An approved Biological Use Registration (BUR) is required for work with RG1 recombinant biological materials that are covered by NIH Guidelines (i.e., recombinant DNA molecules or RG1 organisms and viruses containing recombinant DNA molecules). The PI-authorized BUR must be submitted to the IBC prior to or simultaneously with experiment initiation. The BUR must be reviewed and approved by the IBC.

26.8.2.4   Biological Use Authorization

An approved Biological Use Authorization (BUA) is required for research with biological materials that involve biohazardous materials (i.e., RG2 or higher materials, biological etiologic agents, select agents or toxins, or the use of Biosafety Level (BL) 2 containment for safety).

A BUA is a type of LBNL “Formal Authorization” as defined in Chapter 6 of PUB-3000. The BUA meets ECP requirements and is also considered the OSHA-required ECP for the use of BBP materials and the BMBL-required laboratory-specific biosafety manual when work is performed with RG2 agents or materials at BL2. The PI-approved BUA requires full IBC review and approval, and authorization by the PI’s supervisor prior to commencing work.


Table 26-6     Berkeley Lab Review, Documentation, and Authorization for
Work with Biological Materials in Research

To determine work review requirements for any given project with biological materials, classify the work types in accordance with the first column, and then select the highest-level authorization type indicated in the second column. Generally, work that involves recombinant DNA, Risk Group 2 agents, Biosafety Level 2, or human bloodborne pathogen material has more stringent requirements. Further conditions that determine the level of review include requirements for specific regulatory permits, regulatory registrations, or funding agency assurance.

 

Biological Work Type

LBNL Authorization Type [1]

Required Biosafety Work Documentation (Approximate Renewal Cycle)[4]

LBNL Approval Process
IBC = Institutional Biosafety Committee
PI = principal investigator
BSO = Biosafety Officer

Risk Group 1

Work with Risk Group 1 biological material, including work with NIH-exempt [2] recombinant DNA molecules

Line management
authorization

BUN
(3 years)

BUN process:

  • BSO or IBC Chair reviews and provides concurrence signature.
  • PI reviews and provides authorizing signature.
  • BSO notifies PI Supervisor and EH&S Div. Liaison.

Risk Group 1 work
with recombinant DNA molecules and organisms or viruses containing recombinant DNA molecules[2]

Registration

BUR
(2 years)

BUR process:

  • IBC reviews and approves. IBC Chair provides approval signature on behalf of the IBC.
  • PI reviews and provides authorizing signature.
  • BSO notifies PI Supervisor and EH&S Div. Liaison.

Risk Group 2

Risk Group 2 [2] or higher work, Biosafety Level 2 2used for safety, or work with BBP materials as defined in Section 26.5.4 [3]

Formal authorization

BUA
(1 year)

BUA process:

  • IBC reviews and approves. IBC Chair provides approval signature on behalf of the IBC.
  • PI reviews and provides approval signature.
  • PI’s supervisor reviews and provides authorizing signature.
  • BSO notifies IBC members, PI, PI’s supervisor, Div. Safety Coordinator, and EH&S Div. Liaison.

References
1   Authorization principles and types are specified in PUB-3000, Chapter 6 (Safe Work Authorizations), and the Integrated EH&S Management Plan: Integrated Safety Management System (PUB-3140).
2   NIH Guidelines, the most recent version.
3   OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030.
4   In general, the renewal date of the authorization should also not extend beyond the expiration date of any regulatory permit covered by the authorization.

26.8.3 Exposure Control Plan

Work with or worker exposure to bloodborne pathogen materials defined in Section 26.5.4requires an Exposure Control Plan (ECP). The ECP must meet the requirements of the OSHA Bloodborne Pathogens Standard and must be authorized before work or designated job duties are initiated. If the work pertains to research, a BUA meets ECP requirements and is considered the OSHA-required ECP. If the work does not pertain to research, an ECP must be developed, authorized, and maintained by the supervisor or program manager and division line management. See the Biosafety Manual for more information regarding ECPs.

26.8.4 Human Subjects and Animal Use Approvals

Review and authorization of work that may have biosafety concerns related to use of humans, human-derived tissues, or animals must be conducted as described in the previous sections. General biosafety concerns include worker safety, public health, agricultural protection, and environmental protection (e.g., waste). Research involving human subjects or animals may also require review and approval by other processes and committees as summarized below.

Research involving human subjects, human-derived data, or human-derived tissues may be considered human-subjects research as summarized in Section 26.5.9. Such research may require a pre-approved human subjects protocol or determination of exemption by the Human Subjects Committee (HSC).

In addition, research involving warm-blooded vertebrate animals may require an Animal Use Protocol that has been reviewed and approved by the Animal Welfare and Research Committee (AWRC) as summarized in Section 26.5.10.

While the HSC, AWRC, and IBC conduct separate review processes, they all request that researchers document in each application form that the appropriate committee has reviewed their research. See the HSC Web site, AWRC Web site and Chapter 22 of PUB-3000 for additional information and requirements.

26.9 Assessment and Improvement

The fifth core function of ISM requires that feedback and continuous improvement be incorporated into the work cycle for activities that involve work with or exposure to biological materials. Established assessment and continuous improvement systems are used at LBNL and incorporated into the Biosafety Program to assess ISM implementation and effectiveness, identify improvement opportunities, and implement appropriate improvement strategies. LBNL assessment and improvement requirements and systems are defined in general assurance plans, ES&H assurance system documents, and the Issues Management Program Manual (PUB-5519).

This section provides an overview of how assessment and improvement are incorporated into work with biological materials and the Biosafety Program. These are based primarily on LBNL’s ES&H Self-Assessment Program as outlined in PUB-5344. LBNL uses the self-assessment process to ensure that ISM is fully implemented and effective at all levels of Laboratory activities and operations. Two self-assessment programs are described in this section: the Division Self-Assessment Program and the ES&H Technical Assurance Program (TAP). Two other self-assessments, the Management of ES&H Reviews (MESH) and DOE/UC annual contract performance measures, are mentioned briefly below.

26.9.1 Division Self-Assessment Program

The Division Self-Assessment Program requires each LBNL division to evaluate how well the division is maintaining an Integrated Safety Management System (ISMS) in its operations and work activities. Each division manages a Division Self-Assessment Program as part of the LBNL Self-Assessment Program. The Division Self-Assessment Program includes performance criteria related to the ISM plan, goals and opportunities identified by the division, and annual institutional division ES&H self-assessment performance measures. Requirements for the Division Self-Assessment Program are described in the Division ES&H Self-Assessment Manual (PUB-3105).

Division self-assessments include biosafety as one aspect of ES&H that needs to be managed and assessed. These assessments include, for example, regular safety walkarounds, annual formal inspections of all operations and workspaces, tracking and analysis of deficiencies, lessons learned, and conformance with formal authorizations such as BUAs.

26.9.2 Environment, Safety, and Health Technical Assurance Program

The EH&S Division manages the Environment, Safety, and Health (ES&H) Technical Assurance Program (TAP) as one component of the LBNL Self-Assessment Program. The ES&H TAP reviews ES&H programs and processes Laboratory-wide to ensure they are compliant with guiding regulations, effective, and properly implemented by Laboratory divisions. Requirements for the ES&H TAP are described  in the ES&H Technical Assurance Program Manual (LBNL 913E).

The EH&S Division conducts periodic assessments of biosafety program elements as defined in Technical Assurance Assessment Plans (TAAPs). TAAPs that are applicable to the Biosafety Program are listed in Table 26-7.

Table 26-7
Biosafety-related TAP Assessments

TAAP Program

EH&S Group

Examples of Assessed Biosafety Program Elements

Biosafety

Industrial Hygiene

Field assessments of operations that have BUAs, BURs, and BUNs. Data review including biosafety training, biosafety authorization renewals, and biosafety cabinet certifications.

Ventilation

Industrial Hygiene

Random sampling of hood and biosafety cabinet condition, performance, installation, and compliance with internal survey or certification requirements.

Medical/ Biohazardous Waste

Waste Management

Periodic compliance inspections of medical and biohazardous waste generation areas using inspection forms. Documentation and data review including waste generator registration, biosafety authorizations, and medical/biohazardous waste training to monitor issues related to medical or biohazardous waste.

In general, TAP assessments determine whether the ES&H program (e.g., the LBNL Biosafety Program) under evaluation is compliant and effective, operations (e.g., work authorizations) and divisions are compliant, corrective actions and lessons learned are implemented and effective, and opportunities for improvement in the LBNL ES&H program or process are available. Inspections, data reviews, and document reviews are performed as part of the TAP assessment. TAP data reviews include issues documented in the Corrective Action Tracking System (CATS), injuries or illnesses in the Supervisor Accident Analysis (SAAR) system, items in the Lessons Learned and Best Practices Database, and occurrence reports in the Occurrence Reporting and Processing System (ORPS). The TAP assessment also reports any needed corrective action to the responsible management chain responsible for entering actions into CATS.

26.9.3 Other Environment, Safety, and Health Self-Assessment Programs

LBNL uses two other types of ES&H self-assessments: MESH reviews and annual DOE/UC Contract ES&H performance measures. MESH reviews are management-level peer reviews focused on how well division managers implement the division’s ISM plan. Contract performance assessments evaluate performance against annual goals, objectives, measures, and targets for ES&H. These two types of assessments provide broad ISM support to the LBNL Biosafety Program.

26.10 Standards

26.11 Related PUB-3000 Chapters and Publications

26.11.1 Related PUB-3000 Chapters

26.11.2 Other Related LBNL Publications

26.12 References

26.13  Biosafety Resources

 


Appendix A

Glossary

Terms, acronyms, and abbreviations used in this chapter are listed or defined in this Appendix.

American Biological Safety Association (ABSA) is a professional association that promotes biosafety as a scientific discipline and serves the growing needs of biosafety professionals throughout the world.
Animal and Plant Health Inspection Service (APHIS) is an agency of the USDA that is responsible for protecting and promoting U.S. agricultural health, administering the Animal Welfare Act, and carrying out wildlife damage management activities.
Animal Welfare and Research Committee (AWRC) is an LBNL committee that reviews and approves proposed LBNL research for animal welfare concerns.
Biohazardous is an adjective used to describe biological materials that present potential 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 Etiologic Agents are agents of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that cause 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 Use Authorization (BUA) is a type of LBNL formal biosafety authorization for work involving RG2 or higher biological materials, BL2 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 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.
Biosafety Authorization System (BAS) is the LBNL online system used to manage and provide BUNs, BURs, BUAs, and related information.
Biosafety cabinets (BSCs) are hoods with high efficiency particulate air (HEPA) filters that provide personnel, environmental, or product protection when appropriate practices and procedures are followed.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) is the title of an NIH-CDC national code of practice and LBNL standard for biosafety that outlines and defines biosafety risk assessment and control.
Biosafety Level (BL) is a combination of practices and techniques, safety equipment, and facilities that are specified in the BMBL or NIH Guidelines as being appropriate to safely contain the biohazardous materials or agents to be used in the work.
Biosafety Manual is a comprehensive policy and tool developed by LBNL that covers fundamental principles of biosafety, integrates requirements from the biosafety standards, and provides direction on identifying biological risks and required controls.
Biosafety Officer is a person in the EH&S Division that develops and maintains the primary structure and function of the Biosafety Program in accordance with the biosafety standards.
Bloodborne pathogen (BBP) material is a term used at LBNL to describe biological agents or materials that are covered by the OSHA Bloodborne Pathogens Standard including, for example, bloodborne pathogens, human blood, human blood components, products made from human blood, and other potentially infectious materials (OPIM).
Bloodborne pathogens (BBPs) are infectious agents such as HIV and the hepatitis B virus (HBV) that are capable of causing human disease and are transmitted through human blood and tissues.
Containment is the method(s) used to reduce or eliminate exposure of workers and the environment to biohazardous materials or agents.
Centers for Disease Control and Prevention (CDC) is one of the thirteen major operating components of the U.S. Department of Health and Human Services.
Department of Energy (DOE) is a Cabinet-level department of the U.S. government concerned with the U.S. policies regarding energy and safety in handling nuclear material.  DOE also sponsors basic and applied scientific research mostly through its system of U.S. DOE National Laboratories such as LBNL.
Department of Transportation (DOT) is a federal Cabinet-level department of the U.S. government that is concerned with interstate transportation to keep the traveling public safe and secure, increase their mobility, and have a transportation system that contributes to the nation's economic growth.
Decontamination is the reduction or inactivation of biological contaminants or components to an acceptable level to reduce or eliminate the possibility of transmission of pathogens to undesired hosts such as laboratory workers, the general public, and other organisms in the environment.
Disease is any deviation from or interruption of the normal structure or function of any body part, organ, or system that is manifested by a characteristic set of symptoms and signs and whose etiology, pathology, and prognosis may be known or unknown.
Disinfection is a level of decontamination that involves the elimination of nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) from inanimate objects. Common disinfectants include household bleach or 70 percent isopropanol.
Exposure Control Plan (ECP) is an LBNL authorization document that defines work, hazards, and controls in accordance with the requirements of the OSHA Bloodborne Pathogens Standard for work with or potential exposure to BBP materials.  The BUA is the ECP for work that pertains to research.
Environment, Health, and Safety (EH&S) Division at LBNL manages environment, safety, and health programs to ensure LBNL fulfills their requirements.
Environment, Safety, and Health (ES&H) is a term used to describe subjects (e.g., policies, responsibilities, and functions) related to protecting the safety and health of workers, the public, and the environment. 
Etiologic is an adjective that means disease-causing.
Health and Human Services (HHS) is a Cabinet department of the U.S. government that contains the PHS and has the goal of protecting the health of all Americans and providing essential human services.
Hepatitis B virus (HBV) is a pathogen that causes contagious liver disease (i.e., hepatitis B) in humans. HBV is a common BBP.
Human immunodeficiency virus (HIV) is a lentivirus (a member of the retrovirus family) that causes acquired immunodeficiency syndrome (AIDS), a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections. HIV is a common BBP.
Human Subjects Committee (HSC) is an LBNL committee that reviews proposed research projects involving human subjects, human-derived data, or human-derived tissues for ethical concerns in accordance with HSS regulations and DOE Orders.
Institutional Biosafety Committee (IBC) is an LBNL committee that provides oversight, administration, and review of LBNL policies and projects involving research with biological materials that may pose safety, health, or environmental risks.
Institutional Review Board (IRB) is an HSS-mandated committee that requires the use of established principles and requirements during the ethical review of proposed research projects involving human subjects, human-derived data, or human-derived tissues. The IRB for Berkeley Lab is the HSC.
Integrated Pest Management (IPM) is a term used in the BMBL and LBNL biosafety policy to describe a comprehensive program approach that integrates housekeeping, maintenance, and pest control services to prevent pest problems by managing the facility environment to make it less conducive to pest infestation.
International Air Transport Association (IATA) is an international industry trade group of airlines that represents, leads, and serves the airline industry and publishes the Dangerous Goods Regulations used for airlines’ shipping of hazardous materials including infectious substances.
Large Scale is a term used in the NIH Guidelines and LBNL biosafety policy to describe uses of and containment levels for organisms containing recombinant DNA molecules involving quantity of culture greater than ten liters.
Lawrence Berkeley National Laboratory (LBNL), which is also called Berkeley Lab, is a DOE national laboratory that conducts unclassified, interdisciplinary scientific research.
Medical Waste is waste that is generated or produced as a result of the following: diagnosis, treatment, or immunization of human beings or animals; research pertaining to the diagnosis, treatment, or immunization of human beings or animals; or the production or testing of biologicals. See PUB-3095, Medical and Biohazardous Waste Generator Guidelines, for additional information.
National Institutes of Health (NIH) is one of eight health agencies that are components of the PHS.
NIH Guidelines is an abbreviated title used by NIH for the document titled NIH Guidelines for Research Involving Recombinant DNA molecules
Occupational Safety and Health Administration (OSHA) is an agency of the U.S. government that ensures the safety and health of U.S. workers (e.g., by setting and enforcing standards).
Office of Laboratory Animal Welfare (OLAW) is an office of NIH that oversees compliance with the PHS Policy on Humane Care and Use of Laboratory Animals.
Other Potentially Infectious Materials (OPIM) are materials that are regulated by the OSHA Bloodborne Pathogens Standard based on their potential to contain BBPs. These materials do not include bloodborne pathogens, human blood, human blood components, or products made from human blood.
Pathogens are infectious microbial (e.g., bacteria, protozoa, fungi, viruses, etc.) or other agents that can cause disease in healthy host organisms such as humans, animals, or plants.
Personal Protective Equipment (PPE) is a device worn by workers to protect the body from injury to hazardous agents or materials. Examples of PPE include foot, hand, eye, face, body, and respiratory protection. PPE is one element of biosafety containment.
Principal Investigator (PI) is the individual(s) that is assigned authority and responsibility to direct a research experiment, project, or program that is typically funded by a grant.
Public Health Service (PHS) is an umbrella organization in the U.S. Federal Government consisting of eight HHS health agencies, the Office of Public Health and Science, and the Commissioned Corps (a uniformed service of health professionals).  NIH and CDC are agencies within the PHS.
Responsible Official (RO) is an LBNL person that has the authority and responsibility to ensure compliance with CDC and USDA regulations for possession, use, or transfer of select agents and toxins, as specified in the regulations and on behalf of LBNL.
Risk Group (RG) is a system (e.g., adopted by the CDC and NIH) for classifying biological agents by the degree of human hazard. There are four risk groups: a higher RG number indicates a higher level of hazard.
Sanitization is a level of decontamination that involves the general reduction of microorganisms by the use of general cleaning agents.
Select Agents and Toxins are (a) specific pathogenic agents and toxins listed and strictly regulated by the CDC and USDA (i.e., under 7 CFR 331, 9 CFR 121, and 42 CFR 73) because they may be used as agents of mass destruction or pose a severe threat to human, animal, and plant health, and (b) specific genetic elements, recombinant nucleic acids, and recombinant organisms that are related to the list of select agents and toxins as described in the regulations.
Standards are the external rules established by government, contract, and funding regulations and non-regulatory standards that form the requirements of the LBNL Biosafety Program.
Sterilization is a level of decontamination that involves the complete destruction of all living microorganisms and viruses. Common sterilization methods include autoclaving and incineration.
United States Department of Agriculture (USDA) is an agency of the U.S. government with the following types of mission areas: farm and foreign agricultural, food, food safety, nutrition, natural resources, environment, research, education, economics, and rural development.
World Health Organization (WHO) is an agency of the United Nations that specializes in the attainment by all peoples of the highest possible level of health.

Appendix B

Additional Biosafety Roles and Responsibilities

 

26.B.1 General Biosafety Roles and Responsibilities

Roles and responsibilities related to biosafety are implemented in accordance with the principles of Integrated Safety Management (ISM). These principles, roles, and responsibilities are defined in a hierarchy of LBNL documents including the Regulations and Procedures Manual (RPM), the Integrated Environment, Health, and Safety Management Plan (PUB-3140), and the Health and Safety Manual (PUB-3000). In this section, roles and responsibilities are divided into three functional categories  (i.e., institutional, line management, and technical support) and are further defined as applied to biosafety.

In addition to the roles and responsibilities detailed in this section, definitions and descriptions of various ES&H roles and responsibilities can be found throughout the hierarchy of LBNL documents, including:

26.B.2  Line Management Biosafety Roles and Responsibilities

Researchers and line management are expected to define their work with biological materials, evaluate the biological hazards, implement biosafety containment controls, and ensure their work is authorized. See Section 26.8 for more information regarding the review, documentation, and authorization processes. The responsibilities of line management are listed below.

26.B.2.1  Division Director

The division directors’ roles and responsibilities are delineated in Section 1.3.2.4 of PUB-3000, Chapter 1, and require the division directors, with the support of their designated safety representatives, to:

26.B.2.2 Safety Line Managers (Supervisors, Managers, and Work Leads)

Supervisors, managers, work leads, and other activity leaders are part of the safety line management chain that is responsible for adhering to all ES&H policies and safe work practices. Work leads and activity leaders derive authority from formal LBNL managers and/or supervisors to ensure that day-to-day work, operations, and activities in their assigned area(s) and activities are conducted safely and within established work authorizations. In addition, the principal investigator (PI) is the individual assigned authority and responsibility to direct a research experiment, project, or program that is typically funded by a grant. The PI may or may not be part of the supervisor of the people doing the work. But when recombinant research is being performed, the NIH Guidelines require the PI to ensure that responsibilities listed below are implemented.

Line management’s biosafety roles and responsibilities include, but are not limited to, the following:

26.B.2.3 Division Safety Coordinators

The roles and responsibilities of division safety coordinators (DSCs) are described in Sections 1.3.2.1 and 1.3.2.9 of PUB-3000, Chapter 1, and Section 5.4 of PUB-3140.

Prior to initiating research, the DSCs must:

During the conduct of the research, the DSCs must:

Before the expiration of the authorization, DSCs must:

26.B.3 Institutional Biosafety Roles and Responsibilities

According to the NIH Guidelines for Research Involving Recombinant DNA, LBNL must perform the following:

26.B.3.1 Institutional Biosafety Committee

Roles, responsibilities, and functions of the IBC are detailed in the IBC Charter and generally summarized in this section. The IBC is responsible for oversight, administration, and review of LBNL policies and projects involving research with biological materials that may pose safety, health, or environmental risks. The IBC reports to the Laboratory Director to provide institutional assurance that research is conducted safely. To this end, the IBC assists and advises researchers and line managers in meeting their responsibilities to ensure that biological aspects of research are conducted in a safe manner using established biosafety standards, principles, and functions of ISM and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and LBNL policies. A graded process is used to define, document, review, and approve work with biological materials and controls, as detailed in Section 26.8. This process involves IBC approval and line management’s authorization of work.

26.B.3.2 Human Subjects Committee 

Federal regulations require that any proposed research project involving human subjects shall first be approved by the appropriate authorities. At LBNL, the Human Subjects Committee (HSC) handles this review and approval process. The HSC was established as part of LBNL’s assurance to the U.S. Department of Health and Human Services that LBNL will comply with all federal regulations for the protection of human research subjects. For more information on the HSC, see PUB-3000, Chapter 22 (Research with Human and Animal Subjects).

26.B.3.3 Animal Welfare and Research Committee

The Animal Welfare and Research Committee (AWRC) reviews and approves any research involving warm-blooded vertebrate animals. The AWRC determines whether the proposed work meets acceptable standards for the care, treatment, and use of animals in research. Assessment includes topics such as animal housing, handling, sanitation, nutrition, availability of water, veterinary care, protection from extreme weather and temperatures, waste disposal, and pest control. For more information on the AWRC, see PUB-3000, Chapter 22 (Research with Human and Animal Subjects).

26.B.4 Environment, Health, and Safety Division Biosafety Roles and Responsibilities

The roles and responsibilities of the programs within the Environment, Health, and Safety Division (EH&S) are discussed in Chapter 7 of the Regulations and Procedure Manual, Section 5.4.6 of PUB-3140, and in Chapter 2 of PUB-3000. In summary, roles and responsibilities for specific groups and individuals in EH&S are further detailed in these sections.

26.B.4.1 Industrial Hygiene Group

The Biosafety Program is administered through the Industrial Hygiene Group of the EH&S Division. The Biosafety Officer is charged by the EH&S Division Director to implement the Biosafety Program and coordinate the IBC. Subject matter experts are assigned to assist the Biosafety Officer to implement and maintain the LBNL Biosafety Program.

As a representative of the “entity” under the select agent and toxin regulations, the RO performs the following duties as specified in the regulations to ensure and coordinate compliance:

HHS or USDA-approved individuals and line management must comply with these regulations and the select agent plan. The RO’s primary role is to ensure this compliance is fulfilled.

26.B.4.2 Health Services Group

Roles and responsibilities of the Health Services Group are delineated in PUB-3000, Chapter 3. The Health Services Group has a health professional serving as a voting member of the IBC; provides analysis of health concerns and risks related to exposure to biological materials, agents, or animals; makes appropriate recommendations for medical surveillance; develops and implements policies and systems to provide needed and required medical surveillance; and provides technical assurance for medical surveillance programs.

26.B.4.3  Waste Management Group

Roles and responsibilities of the EH&S Division Waste Management Group are detailed in PUB-3000, Chapter 20. Roles and responsibilities related to medical/biohazardous waste include:


Appendix C

Institutional Biosafety Committee (IBC) Charter

 

E. O. Lawrence Berkeley National Laboratory

February 2008

Policy and Purpose

Lawrence Berkeley National Laboratory (LBNL) requires maintenance of a qualified Institutional Biosafety Committee (IBC) to perform key biosafety functions as required by and in accordance with this charter and the National Institutes of Health (NIH), Centers of Disease Control and Prevention (CDC), Department of Energy (DOE), and LBNL standards.

The IBC is responsible for oversight, administration, and review of Berkeley Lab policies and projects involving research with biological materials that may pose safety, health, or environmental risks. The IBC reports to the Laboratory Director to provide institutional assurance that research is conducted safely. To this end, the IBC assists and advises researchers and line managers in meeting their responsibilities to ensure that the biological aspects of the research are conducted in a safe manner using established biosafety standards, principles and functions of Integrated Safety Management (ISM), and work authorization (e.g., PUB-3000, Chapter 6). Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and LBNL policies. A graded process is used to define, document, review, and approve biological work and controls as detailed in PUB-3000, Chapter 26. This process involves IBC approval and line management authorization of biological work.

Functions

Functions of the IBC include:

In this program, the IBC performs initial and periodic review and approval of required project biosafety documentation that demonstrates the work will be conducted in a safe manner. Researchers and line managers are responsible for identifying and submitting project documentation to the IBC prior to performing biological work and periodically thereafter.  The IBC’s review includes:

IBC Membership

The Laboratory Director formally appoints all IBC members, and IBC membership is for a minimum three-year period of service. IBC member nominations are managed in the following manner:

As required by NIH, the IBC must have at least five members that are selected to collectively have the experience, expertise, and capability needed to assess the breath and safety of recombinant and other LBNL research with biological materials, agents, and organisms as needed to identify any potential risks to workers, public health, or the environment. Based on the types of research activities at LBNL, the IBC will normally have the following minimum representation:

IBC member duties include:

The IBC may use consulting experts or establish working groups to execute its responsibilities or acquire needed expertise for select tasks. Consultants or working group members may include, for example, persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes, the environment, or any scientific area where the IBC members do not have expertise. Consultants or working group members are not IBC voting members unless nominated and appointed as described previously.

IBC Meetings

The IBC will conduct meetings approximately quarterly and as needed for the conduct of business. A proposed agenda will be developed and distributed before the meeting. Meetings will proceed with no less than five voting members present. Meeting minutes will be taken to accurately reflect the topics of discussion. Meeting minutes will be reviewed, approved by the members, and maintained on file. Meetings will be opened to the public, and minutes will be provided to the public, when requested by the public and in accordance with the scope and requirements of the NIH Guidelines.

IBC and Biosafety Standards

The following standards have specific requirements for IBCs and biological work:

Additional biosafety standards related to LBNL biological work are summarized below:

IBC Charter Approval

IBC members will review proposed amendments to this charter and make recommendations regarding adoption of amendments. The IBC Chair will submit IBC recommendations regarding charter amendments to the Laboratory Director. The Laboratory Director will approve amendments to the IBC Charter.

Appendix D

Biological Safety Worker Health & Safety Program
(10 CFR 851)

26.D.1 Scope

This appendix describes specific requirements and program elements for biological etiologic agents and select agents that are included in the LBNL Worker Health and Safety Program and Biosafety Program, as required by the DOE Worker Safety and Health Program (10 CFR 851, Appendix A, Section 7).

26.D.2 General Policy

Work with Biological Etiologic Agents and Select Agents at Berkeley Lab is conducted in a safe, environmentally sound, and compliant manner using the principles and functions of Integrated Safety Management (ISM) and work authorization. Line managers and researchers define their work with biological materials, evaluate the biological hazards, determine the risk, and implement required biosafety containment controls (e.g., establish a biosafety level). This is accomplished with the assistance and oversight of the Institutional Biosafety Committee (IBC), the EH&S Division (e.g., Industrial Hygiene, Waste Management, and Health Services), and other Berkeley Lab ES&H functions as part of the Biosafety Program.

26.D.3 Definitions

Biological etiologic agents and select agents have the following specific definitions.

1.   Biological Etiologic Agents. “Biological etiologic agents” are agents of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that cause disease in humans (i.e., are pathogenic to humans). See Appendix B of the NIH Guidelines for a list and risk group categorization of human etiologic agents. Agents requiring implementation of Biosafety Level 3 or 4 containment are not used or stored at Berkeley Lab.

2.   Select Agents. The term “select agents” is commonly used to describe a list of specific pathogenic agents that are strictly regulated by the Centers for Disease Control and Prevention (CDC) and U.S. Department of Agriculture (USDA) because they may be used as biological weapons or pose a severe threat to human, animal, and plant health.

26.D.4 Program Elements

LBNL’s biological safety program for managing biological etiologic agents and select agents under the LBNL Worker Health and Safety Program Plan includes the program elements listed below:

  1. LBNL’s Institutional Biosafety Committee (IBC) reviews the following work, plans, and procedures:
  2. Agent Inventory and Status Report. The EH&S Division Industrial Hygiene Group maintains an inventory and status of biological etiologic agents, and provides the DOE Berkeley Site Office (through the LBNL IBC) an annual status report describing the status and inventory of biological etiologic agents and their biological safety program. The inventory includes agents’ names, the PI’s or owner’s name, and location(s) of the researcher’s laboratory operation. 
  3. Select Agent Application for Registration. The LBNL EH&S Division Responsible Official (RO) or Alternate Responsible Official (ARO) for select agents submits each CDC Laboratory Registration or Select Agent Program registration application package to the DOE Berkeley Site Office (BSO) when the application is registering a new laboratory facility for the purpose of transferring, receiving, or handling select agents. DOE’s review of the application and concurrence is required before transmittal to the CDC.
  4. Select Agent Transfer, Disposition, and/or Destruction. The LBNL EH&S RO or ARO for select agents submits to the DOE BSO:
  5. Safeguards, Security, and Emergency Management Plans and/or Program Confirmation. The EH&S Security and Emergency Operations and Industrial Hygiene Groups confirm that the site safeguards and security plans and emergency management programs address biological etiologic agents and biological select agents.
  6. Immunization Policy. The IBC (which includes the LBNL Medical Director and Biosafety Officer) assesses potential vaccines and the need for immunizations when it reviews work to be conducted with biological etiologic agents. Any immunization recommendations are then incorporated into the operation’s biosafety documentation.

_____________________

<< Chapter 25 || Table of Contents || Chapter 27 >>