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Biological Safety Manual

Table of Contents

  • Foreword
  • Chapter 1: Introduction
    1. The Occurrence of Laboratory-Associated Infections
    2. Evolution of National Biosafety Guidelines
    3. Risk Criteria For Establishing Ascending Levels Of Containment
    4. Agent Summary Statements
    5. Biosecurity
    6. Using BMBL
    7. Looking Ahead
    8. References
  • Chapter 2: Biological Risk Assessment
    1. Hazardous Characteristics of an Agent
    2. Hazardous Characteristics of Laboratory Procedures
    3. Potential Hazards Associated With Work Practices, Safety Equipment and Facility Safeguards
    4. An Approach to Assess Risks and Select Appropriate Safeguards
    5. Conclusion
    6. References
  • Chapter 3: Principles of Biosafety
    1. Laboratory Practice and Technique
    2. Safety Equipment (Primary Barriers and Personal Protective Equipment)
    3. Facility Design and Construction (Secondary Barriers)
    4. Biosafety Levels
    5. Animal Facilities
    6. Clinical Laboratories
    7. Importation and Interstate Shipment of Certain Biomedical Materials
    8. Select Agents
    9. References
  • Chapter 4: Laboratory Biosafety Level Criteria
    1. Laboratory Biosafety Levels
    2. Table 1: Summary of Recommended Biosafety Levels for Infectious Agents
    3. Section I: Designating Biological Safety Level 2 at UNC
    4. Appendix A: Biological Safety Level 2 Checklist
    5. Appendix B: Cryogenic Preservation of Biological Materials
  • Chapter 5: Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities
    1. Animal Biosafety Levels
    2. References
    3. Table 1: Summary of Recommended Biosafety Levels for Infectious Agents
  • Chapter 6: Principles of Laboratory Biosecurity
    1. Biosafety and Biosecurity
    2. Risk Management Methodology
    3. Elements of a Biosecurity Program
    4. References
  • Chapter 7: Occupation Health and Immunoprophylaxis
    1. Occupational Health Support Service Elements
    2. Vaccines
    3. Occupational Health in the BSL-4 Setting
    4. References
  • Chapter 8: Agent Summary Statements
    1. Section I: Bacterial Agents
      1. Agent: Bacillus anthracis
      2. Agent: Bordetella pertussis
      3. Agent: Brucella species
      4. Agent: Burkholderia mallei
      5. Agent: Burkholderia pseudomallei
      6. Agent: Campylobacter (C. jejuni subsp. jejuni, C. coli, C. fetus subsp. fetus, C. upsaliensis)
      7. Agent: Chlamydia psittaci (Chlamydophila psittaci), C. trachomatis, C. pneumoniae (Chlamydophila pneumoniae)
      8. Agent: Neurotoxin Producing Clostridia species
      9. Agent: Clostridium tetani and Tetanus toxin
      10. Agent: Corynebacterium diphtheria
      11. Agent: Francisella tularensis
      12. Agent: Helicobacter species
      13. Agent: Legionella pneumophila and other Legionella-Like Agents
      14. Agent: Leptospira
      15. Agent: Listeria monocytogenes
      16. Agent: Mycobacterium leprae
      17. Agent: Mycobacterium tubercolosis complex
      18. Agent: Mycobacterium spp. other than M. tubercolosiscomplex and M. leprae
      19. Agent: Neisseria gonorrhoeae
      20. Agent: Neisseria meningitides
      21. Agent: Salmonella serotypes, Other Than S. typhi
      22. Agent: Salmonella typhi
      23. Agent: Shiga toxin (Verocytotoxin)-Producing Escherichia coli
      24. Agent: Shigella
      25. Agent: Treponema pallidum
      26. Agent: Vibrio enteritis species (V. cholerae, V. parahaemolyticus)
      27. Agent: Yersinia pestis
      28. References
      29. Section Ia: Policy For Laboratory Personnel who are Working with Neisseria meningitidis
    2. Section II: Fungal Agents
      1. Agent: Blastomyces dermatitidis
      2. Agent: Coccidioides immitis and Coccidioides posadasii
      3. Agent: Cryptococcus neoformans
      4. Agent: Histoplasma capsolatum
      5. Agent: Sporothrix schenckii
      6. Agent: Dermatophytes (Epidermophyton, Microsporum, And Trichophyton)
      7. Agent: Miscellaneous Molds
      8. References
    3. Section III: Parasitic Agents
      1. General Issues
      2. Agent: Blood and Tissue Protozoal Parasites
      3. Agent: Intestinal Protozoal Parasites
      4. Agent: Trematode Parasites
      5. Agent: Cestode Parasites
      6. Agent: Nematode Parasites
      7. References
    4. Section IV: Rickettsial Agents
      1. Agent: Coxiella burnetii
      2. Agents: Rickettsia prowazekii, Rickettsia typhi (R. mooseri), Orientia (Rickettsia) Tsutsugamushi and Spotted Fever Group Agents of Human Disease;Rickettsia rickettsii, Rickettsia conorii, Rickettsia akari, Rickettsia australis, Rickettsia siberica, and Rickettsia japonicum
      3. References
    5. Section V: Viral Agents
      1. Agent: Hantaviruses
      2. Agent: Hendra Virus (Formerly Known as Equine Morbillivirus) and Nipah Virus
      3. Agent: Hepatitis A Virus, Hepatitis E Virus
      4. Agent: Hepatitis B Virus, Hepatitis C Virus (Formerly Known as Nona Nonb Virus), Hepatitis D Virus
      5. Agent: Herpesvirus simiae (Cerocopithecine herpesvirusI, Herpes B Virus)
      6. Agent: Human Herpes Virus
      7. Agent: Influenza
      8. Agent: Lymphocytic Choriomeningitis Virus
      9. Agent: Poliovirus
      10. Agent: Poxviruses
      11. Agent: Rabies Virus (and Related Lyssaviruses)
      12. Agent: Retroviruses, Including Human and Simian Immunodeficiency Viruses (HIV and SIV)
      13. Agent: Severe Acute Respiratory Syndrome (SARS) Coronavirus
      14. References
      15. Section Va: Reassortant Influenza A Viruses
    6. Section VI: Arboviruses and Related Zoonotic Viruses
      1. Table 1: Explanation of Symbols Used in Table 3 to Define Basis for Assignment of Viruses to Biosafety Levels
      2. Table 2: Vaccine Strains of BSL-3 and -4 Viruses That May Be Handled As BSL-2
      3. Viruses With BSL-2 Containment Recommended
      4. Viruses With BSL-3 Containment Recommended
      5. Viruses With BSL-4 Containment Recommendations
      6. Dealing With Unknown Arboviruses
      7. Agent: West Nile Virus (WNV)
      8. Agent: Eastern Equine Encephalitis (EEE) Virus, Venezuelan Equine Encephalitis (VEE) Virus, And Western Equine Encephalitis (WEE) Virus
      9. Agent: Rift Valley Fever Virus (RVFV)
      10. References
      11. Table 3: Alphabetic Listing of 597 Arboviruses and Hemorrhagic Fever Viruses
    7. Section VII: Toxin Agents
      1. Agent: Botulinum Neurotoxin
      2. Agent: Staphylococcal enterotoxins (SE)
      3. Agent: Ricin Toxin
      4. Agent: Selected Low Molecular Weight (LMW) Toxins
      5. References
    8. Section VIII: Prion Diseases
      1. Occupational Infections
      2. Natural Modes of Infection
      3. Laboratory Safety
      4. Special Issues
      5. References
    9. Section IX: Viral Vectors
      1. General Containment
      2. Viral Vectors and Recombinant Nucleic Acids
      3. Viral Vectors as Infectious Agents
      4. Adenovirus Vectors
      5. Adeno-Associated Virus (AAV) Vectors
      6. Epstein-Barr Virus Vectors
      7. Herpesvirus Vectors
      8. Retroviruses: Murine Leukemia Virus (MLV) Vectors
      9. Retroviruses: Lentivirus Vectors
      10. Poxviruses Vectors
      11. Replication Competency Testing
  • Chapter 9: Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets
    1. Introduction
    2. The High Efficiency Particolate Air (HEPA) Filter and the Development of Biological Containment Devices
    3. Biological Safety Cabinets
    4. Other Laboratory Hazards and Risk Assessment
    5. BSC Use by the Investigator: Work Practices and Procedures
    6. Facility and Engineering Requirements
    7. Certification of BSCS
    8. Policy on the Use of Flammable Gases in Biological Safety Cabinets
    9. References
    10. Figures
    11. Acknowledgements
  • Chapter 10: Decontamination and Disinfection
    1. Environmentally Mediated Infection Transmission
    2. Principles of Sterilization and Disinfection
    3. Decontamination in the Microbiology Laboratory
    4. Special Infectious Agent Issues
    5. Section I: Biological Waste Disposal Policy
  • Chapter 11: Transportation of Infectious Substances
    1. Shipping Biological Materials
    2. Import and Transfer Permits
    3. Export Licenses
    4. Transporting on Campus
    5. Transporting Select Agents
  • Chapter 12: Agricultural Pathogen Biosafety
    1. Introduction
    2. BSL-3-Ag for Work With Loose-Housed Animals
    3. BSL-3 and ABSL-3 Plus Potential Facility Enhancements for Agriculture Agent Permitting
    4. Pathogens of Veterinary Significance
    5. Summaries of Selected Agriculture Agents
    6. USDA Contact Information
    7. References
  • Chapter 13: Arthropod Containment Guidelines (ACG)
    1. References
  • Chapter 14: Select Agents
    1. Definitions
    2. Registration
    3. Select Agent Authorization
    4. Requirements for Select Agent Personnel
    5. Required Plans and Standard Operating Procedures
    6. Required Documentation
    7. Annual Inspections
    8. Select Agents and Toxins
    9. Permissible Toxin Amounts (HHS Toxins [ยง73.3(d)(7)])
  • Chapter 15: Integrated Pest Management (IPM)
    1. Facility Design
    2. Monitoring
    3. Sanitation and Facility Maintenance
    4. Communication
    5. Record Keeping
    6. Non-pesticide Pest Control
    7. Pest Control with Pesticides
    8. Program Evaluation and Quality Assurance
    9. Technical Expertise
    10. Safety
    11. References
  • Chapter 16: Working With Human, NHP and Other Mammalian Cells and Tissues
    1. Potential Laboratory Hazards
    2. Recommended Practices
    3. References
    4. Bloodborne Pathogen Exposure Control Plan for Laboratories
    5. Safety Practices for Work with Non-Human Primate Tissues & Body Fluids
  • Chapter 17: Guidelines for Work With Toxins of Biological Origin
    1. General Considerations for Toxin Use
    2. Training and Laboratory Planning
    3. Safety Equipment and Containment
    4. Inadvertent Toxin Aerosols
    5. Mechanical Injuries
    6. Additional Precautions
    7. Decontamination and Spills
    8. Select Agent Toxins
    9. References
  • Chapter 18: NIH Oversight of Research Involving Recombinant Biosafety Issues
    1. Changes to the NIH Guidelines for Research Involving Recombinant DNA Molecules
    2. Appendix C-VII. Generation of BSL 1 Transgenic Rodents via Breeding
  • Chapter 19: Resources for Information
  • Index (Acronyms)