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