Chapter 26

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BIOSAFETY

Contents

Approved by Bruce King
Revised 08/14

26.1 Policy

26.2 Scope

26.3 Applicability

26.4 Exceptions

26.5 Roles and Responsibilities

26.6 Definitions

26.7 Required Work Processes

Work Process A. Starting and Conducting Work Safely

Work Process B. Work and Risk Assessment

B.1 LBNL Assessment and Authorization Processes

B.2 Biosafety Risk Assessment Process

B.3 Material or Agent Hazards and Requirements

B.3.c Risk Group Classification

B.3.d Pathogenic Agents and Toxins

B.3.d.i Pathogen and Toxin Information and Guidance

B.3.d.ii Human Pathogens

B.3.d.iii Plant and Animal Pathogens

B.3.d.iv Toxins

B.3.d.v Select Agents and Toxins

B.3.d.vi Prions

B.3.e USDA-Regulated Materials, Organisms, and Agents

B.3.f Bloodborne Pathogens and Human Materials

B.3.g Recombinant Materials, Organisms, and Agents

B.3.h Animals

B.4 Laboratory Procedure Hazards

B.5 Worker Competence and Health

Work Process C. Biosafety Principles and Levels

C.1 Laboratory Practices

C.2 Safety and Personal Protective Equipment

C.3 Facility Design and Construction

C.4 Biosafety Containment Levels and Criteria

C.4.a Laboratory Containment Levels

C.4.a.i Laboratory Biosafety Level 1

C.4.a.ii Laboratory Biosafety Level 2

C.4.b Additional Containment Categories

C.4.b.i Recombinant Large-Scale Containment Levels

C.4.b.ii Recombinant Plant Containment Levels

C.4.b.iii Vertebrate Animal Containment Levels

C.4.b.iv Arthropod Containment Levels

Work Process D. Specific Biosafety Controls

D.1 Work Authorizations

D.2. Training, Instruction, and Qualification

D.2.a Job Hazards Analysis

D.2.b Training Courses and Tracking

D.2.c Job-Specific Instruction, Information, and Practices

D.3 Occupational Health and Immunization

D.4 Personal Protective Clothing and Equipment

D.4.a Body Protection

D.4.b Eye and Face Protection

D.4.c Hand Protection

D.4.d Foot Protection

D.4.e Respiratory Protection, Respirators, and Face Masks

D.5 Labels and Signs

D.6 Facilities, Laboratory Equipment, and Related Practices

D.6.a Cleanable Surfaces and Furnishings

D.6.b Doors and Windows

D.6.c Plumbing Systems and Equipment

D.6.c.i Sinks and Handwashing

D.6.c.ii Drains and Disposal

D.6.c.iii Water Systems and Backflow Prevention

D.6.c.iv Emergency Eyewashes and Showers

D.6.d Ventilation and Hoods

D.6.d.i Room Ventilation

D.6.d.ii Hoods and Biosafety Cabinets

D.6.e Food Facilities and Eating

D.6.f Laboratory Tools and Equipment

D.6.f.i Sharps

D.6.f.ii Centrifuges

D.6.f.iii Waste Containers

D.6.f.iv Equipment Connected to Building Vacuum Systems

D.7 Decontamination, Waste, and Decommissioning

D.7.a Decontamination Processes and Antimicrobials

D.7.b Surface and Equipment Decontamination

D.7.c Waste Decontamination and Disposal

D.7.d Laboratory and Equipment Decommissioning and Moves

D.8 Access and Security

D.9 Pest Management

D.10 Incident, Accident, and Emergency Response

D.10.a General Incident Response and Reporting

D.10.b Worker Exposure, Injury, or Illness

D.10.c Biological Spills and Cleanup

D.10.d Additional Biosafety Incident Reporting

D.11 Procurement, Transportation, and Transfer

D.11.a Procurement

D.11.b Transportation and Shipping

D.11.c Import, Export, and Transfer Restrictions

Work Process E. Assessment and Improvement

Work Process F. Institutional Biosafety Committee

26.8 Source Requirements

26.9 Reference Documents

26.10 Appendices

Appendix A. Biological Safety Worker Health & Safety Program (10 CFR 851)

Appendix B. Pathogen and Toxin Lists

B.1 Introduction and Scope

B.2 NIH Guidelines Human Etiologic Agents

B.2.1 Risk Group 1 Agents

B.2.2 Risk Group 2 Agents

B.2.3 Risk Group 3 Agents

B.2.4 Risk Group 4 Agents

B.2.5 Animal Viral Etiologic Agents in Common Use

B.2.6 Murine Retroviral Vectors

B.3 Select Agents and Toxins

B.4 Plant Pathogens

B.4.1 Plant Pathogen Bacteria (by Scientific Name)

B.4.2 Plant Pathogen Fungi (by Scientific Name)

B.4.3 Plant Pathogen Viruses (Regulated by the State of California)

Appendix C. Laboratory Biosafety Level 1 and Biosafety Level 2 Criteria

C.1 Introduction and Scope

C.2 Laboratory Biosafety Level 1

C.2.1 BL1 Standard Microbiological Practices

C.2.2 BL1 Special Practices

C.2.3 BL1 Safety Equipment (Primary Barriers and Personal Protective Equipment)

C.2.4 BL1 Laboratory Facilities (Secondary Barriers)

C.3 Laboratory Biosafety Level 2

C.3.1 BL2 Standard Microbiological Practices

C.3.2 BL2 Special Practices

C.3.3 BL2 Safety Equipment (Primary Barriers and Personal Protective Equipment)

C.3.4 BL2 Laboratory Facilities (Secondary Barriers)

Appendix D. Good Microbiological Practice

D.1 Introduction and Scope

D.2 Good Microbiological Practice

D.2.1 Aseptic Technique

D.2.2 Personal Hygiene and Dress

D.2.3 Area Cleanliness and Organization

D.2.4 Biosafety Cabinets and Airborne Contamination

D.2.5 Manipulation Techniques for Minimizing Aerosols

D.2.6 Worker Qualifications

D.2.7 Microbial Contamination Checks

D.3 References

Appendix E. Biosafety Cabinets

E.1 Introduction and Scope

E.2 Biosafety Cabinet Classifications

E.2.1 Class I Biosafety Cabinet

E.2.2 Class II Biosafety Cabinet

E.2.3 Class III Biosafety Cabinet

E.2.4 Clean Benches (Not BSCs)

E.3 Biosafety Cabinet Work Practices and Procedures

E.3.1 Preparing for BSC Work

E.3.2 Material Placement inside the BSC

E.3.3 Operations within a Class II BSC

E.4 Biosafety Cabinet Decontamination and Moves

E.4.1 Cabinet Surface Decontamination

E.4.2 Internal Cabinet Gaseous Decontamination

E.5 Biosafety Cabinet Installation and Engineering

E.6 Biosafety Cabinet Testing and Certification 

E.7 References 

Appendix F.  Decontamination and Antimicrobials

F.1 Introduction and Scope

F.2 Decontamination Principles and Terms

F.2.1 Decontamination Processes and Levels

F.2.1.1 Sterilization

F.2.1.2 Disinfection

F.2.1.3 Sanitization

F.2.1.4 Antisepsis

F.2.2 Antimicrobial Categories

F.2.3 Antimicrobial Selection and Registered Disinfectants

F.3 Chemical Antimicrobials

F.3.1 Surfactants (Soaps and Detergents)

F.3.1.1 Soaps

F.3.1.2 Detergents and Quaternary Ammonium Compounds

F.3.2 Halogens (Chlorine and Iodine)

F.3.2.1 Chlorine and Sodium Hypochlorite

F.3.2.2 Iodine and Iodophors

F.3.3 Alcohols

F.3.4 Phenol and Phenol Derivatives (Phenolics)

F.3.5 Oxidizing Agents (Hydrogen Peroxide)

F.3.6 Alkylating Agents (Formaldehyde, Glutaraldehyde, Ethylene Oxide)

F.3.6.1 Formaldehyde

F.3.6.2 Glutaraldehyde

F.3.6.3 Ethylene Oxide

F.4 Physical Antimicrobials

F.4.1 Heat

F.4.1.1 Dry Heat (Baking and Incineration)

F.4.1.2 Wet Heat (Boiling and Autoclaving)

F.4.2 Ultraviolet (UV) Radiation

F.4.2.1 UV Light Health Effects and Categories

F.4.2.2 Biosafety Cabinet UV Light

F.4.3 Ionizing Radiation

F.4.4 Visible Light

F.4.5 Filtration (HEPA Filters)

F.5 Autoclave Sterilization and Safety

F.5.1 Autoclaves and Sterilization

F.5.2 Autoclave Operation and Safety

F.5.2.1 Autoclave Instruction

F.5.2.2 Autoclave Operation Modes

F.5.2.3 Autoclave Container Selection

F.5.2.4 Autoclave Preparation and Loading

F.5.2.5 Autoclave Cycle and Time Selection

F.5.2.6 Removing Autoclave Loads

F.5.2.7 Autoclave Material Staging

F.5.2.8 Burn Emergencies

F.5.3 Autoclave Maintenance and Monitoring

F.6 References

Appendix G. Biological Spills and Cleanup

G.1 Introduction and Scope

G.2 Precleanup Considerations

G.3 Biological Spill outside a Biosafety Cabinet

G.4 Biohazardous Spill inside a Biosafety Cabinet

G.5 Centrifuge Malfunction or Spill

G.6 Radioactive and Biohazardous Spill

G.7 Chemical and Biohazardous Spill

G.8 Cleanup of Small Dead Animals, Nests, or Droppings 

Appendix H. Transportation and Shipping

H.1 Introduction and Scope

H.2 How to Determine Transportation Mode and Requirements

H.3 Requirements and Processes for Receiving, Transporting, and Shipping

H.3.1 Employee Transportation of Materials

H.3.1.1 Hand-Carry Transport between Laboratories

H.3.1.2 Hand-Carry Transport between Buildings

H.3.1.3 Personal Transportation in a Motor Vehicle

H.3.1.4 Personal Transportation on an LBNL Shuttle Bus

H.3.2 LBNL Receiving, Transportation, and Shipping

H.3.2.1 LBNL Receiving

H.3.2.2 LBNL Transportation

H.3.2.3 LBNL and Common Carrier Shipping

H.4 Unregulated and Regulated Materials

H.4.1 Unregulated Biological Materials

H.4.2 Regulated Biological Materials

H.5 References and Resources

Appendix I. Import, Export, and Transfer Restrictions

I.1 Introduction and Scope

I.2 Importing or Transfer into the U.S. and California

I.2.1 CDC and APHIS Select Agent and Toxin Restrictions

I.2.2 APHIS Agricultural Permits

I.2.2.1 APHIS Plant Health Permits

I.2.2.2 APHIS Animal Health Permits

I.2.2.3 APHIS Genetically Engineered Organisms Permits

I.2.3 CDC Agents or Vectors of Human Disease Permits

I.2.4 Food and Drug Administration Import Program

I.2.5 Fish and Wildlife Service Permits

I.3 Exporting or Transfer from the U.S.

I.3.1 Commerce Control List

I.3.2 U.S. Munitions List

I.3.3 Biological Weapons Convention Lists

I.4 References

 

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