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BIOSAFETY MANUALEnvironmental Health and Safety DepartmentUniversity of WashingtonBox 354400 Seattle, WA 98195-4400Phone: 206.543.7262 FAX: 206.543.3351www.ehs.washington.edu
TABLE OF CONTENTSPage 2 of 110 ￜ November 2021TABLE OF CONTENTSTABLE OF CONTENTS . 2FORWARD . 9EMERGENCY INFORMATION .10SECTION 1 – INTRODUCTION.11A.PURPOSE OF THE MANUAL .11B.DEFINITION OF BIOHAZARDS .12C.THE OCCURRENCE OF LABORATORY-ASSOCIATED INFECTIONS .12D. RULES, REGULATIONS AND GUIDELINES GOVERNING THE USE OF BIOHAZARDS AND recDNAMOLECULES .131.NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules .142.CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) .143.The Select Agent Rule .144.Washington Industrial Safety and Health Act .145.Bloodborne Pathogens Standard .146.Seattle Municipal Code Infectious Waste Management .147.Washington State Definition of Biomedical Waste .148.Department of Transportation .159.United States Government Policy for Institutional Oversight of Life Sciences DURC (DualUse Research of Concern) .15E.UNIVERSITY POLICY .16F.ROLES AND RESPONSIBILITIES FOR CONTROL OF BIOHAZARDOUS RESEARCH .161.Principal Investigator (PI) .162.Department of Environmental Health and Safety (EH&S) .183.Institutional Biosafety Committee (IBC) .184.Deans, Directors, Chairpersons, and Organizational Supervisors .195.Department of Comparative Medicine .196.Washington National Primate Research Center .19SECTION 2 – REVIEW PROCEDURES FOR RESEARCH AT UW .20A.B.Research Project Reviews .201.Policy .202.Procedures .20Levels of Review Required for recDNA Research .21Environmental Health & Safety Department www.ehs.washington.edu BIOSAFETY MANUAL
TABLE OF CONTENTSNovember 2021ￜ Page 3 of 110SECTION 3 – BIOLOGICAL RISK ASSESSMENT .24A.BIOLOGICAL RISK ASSESSMENT .24B.ROUTES OF EXPOSURE .251.Oral Infection: Ingestion or Hand to Mouth Exposure .252.Parenteral Inoculation .253.Direct Skin, Eye or Mucosal Membrane Exposure .254.Inhalation of Infectious Aerosols .255.Fomites.25C.RISK GROUPS AND BIOSAFETY CONTAINMENT LEVELS .261.Biological Risk Groups .262.Biosafety Containment Levels .27D.LARGE-SCALE CULTURE ( 10 LITERS) .27E.USE OF BIOLOGICAL TOXINS .28SECTION 4 – PROCEDURES FOR BIOHAZARD CONTROL.29A.FACILITY REQUIREMENTS.311.BSL-1 Laboratory Facilities .312.BSL-2 Laboratory Facilities (in addition to BSL-1 requirements stated above) .313.BSL-2 with BSL-3 practices Laboratory Facilities (in addition to BSL-2 requirements statedabove) .324.BSL-3 Laboratory Facilities (in addition to BSL-2 with BSL-3 practices requirements statedabove) .32B.PERSONAL PROTECTIVE EQUIPMENT (PPE) .331.Laboratory Coats .332.Gloves .333.Eye and Face Protection .344.Respiratory Protection .35C.GOOD LABORATORY PRACTICES AND TECHNIQUES .351.Technical Proficiency .352.Hazard Awareness Training .353.Prohibited Activities.364.Restrict Traffic in Laboratories .365.Handwashing .376.Long Hair.37Environmental Health & Safety Department www.ehs.washington.edu BIOSAFETY MANUAL
TABLE OF CONTENTSPage 4 of 110 ￜ November 20217.Biosafety Manual and Laboratory-Specific Biosafety Manual .378.Good Housekeeping .379.Inventory Control .3710. Pest Control .3711. Minimization of Aerosols .38D.LABORATORY EQUIPMENT .381.Biological Safety Cabinets (BSC) .382.Blenders, Ultrasonic Disintegrators, Grinders, and Mortar and Pestle .413.Automated Equipment .414.Water Baths and Incubators .415.Refrigerators, Deep Freezers and Dry Ice Chests.416.Laboratory Vacuum Lines .417.Microtomes and Cryostats .42E.LABORATORY PROCEDURES .431.Pipetting .432.Using Needles and Other Sharps .433.Centrifugation .444.Resuspending Sediment of Centrifuged Material .455.Working Outside a BSC Using a Splash Guard and/or Additional PPE .456.Opening Culture Plates, Tubes, Bottles, and Ampoules .457.Using Test Tubes and Other Laboratory Glassware .468.Cell Sorting.46F.CONTROL OF BIOHAZARDS ASSOCIATED WITH LABORATORY ANIMALS .471.Responsibility .472.Animal Blood and Blood Products .473.Animal Biosafety Levels and Vivarium Research Facilities .484.Animal Work Practices and Engineering Controls .485.Occupational Health Program .496.Pest Control Program .497.Animal Waste Handling Procedures .49G.DECONTAMINATION.501.Resistance .502.Ineffectiveness .50Environmental Health & Safety Department www.ehs.washington.edu BIOSAFETY MANUAL
TABLE OF CONTENTSNovember 2021ￜ Page 5 of 1103.Residual Action.514.Exposure Time .515.Sterilization .526.Disinfection .537.Sanitization .558.General Procedures .559.Selecting Chemical Decontaminants for Research on recDNA Molecules .56H.BIOHAZARDOUS WASTE .581.Responsibility .582.Identifying Biohazardous Waste .583.Packaging and Handling of Biohazardous Waste.594.Transporting Biohazardous Waste .605.Decontaminating Biohazardous Waste .616.Site-Specific Information .637.Autoclave Quality Control .638.Refusal to Collect Waste .64I.CONTROL OF recDNA EXPERIMENTATION .651.Responsibility .652.Physical Containment .653.Biological Containment .65SECTION 5 – EMPLOYEE OCCUPATIONAL HEALTH PROGRAM .66A.OVERVIEW .66B.ROLES AND RESPONSIBILITIES .671.Environmental Health and Safety.672.Principal Investigators .673.Employees .684.UW Employee Health Centers .69C.IMMUNIZATION GUIDELINES .69D.ANIMAL USE MEDICAL SCREENING (AUMS) .69E.RESEARCH PROTOCOL REVIEW .70F.POST EXPOSURE TREATMENT .70G.EMPLOYEE HEALTH AND IMMUNIZATION RECORDS.70H.SERUM BANKING AND MONITORING .70Environmental Health & Safety Department www.ehs.washington.edu BIOSAFETY MANUAL
TABLE OF CONTENTSPage 6 of 110 ￜ November 2021SECTION 6 – EMERGENCY PREPAREDNESS AND RESPONSE .72A.BIOHAZARDOUS SPILL CLEAN-UP PROCEDURES .721.Responsibility .722.Biohazard Spill Kit .723.Spill Advice .734.Immediate Response .745.Biohazardous Spill Inside a Biological Safety Cabinet (BSC) .756.Biohazardous Spill Outside a BSC .767.Spills Outside the Laboratory in Public Spaces .778.Radioactive Biohazardous Spill .77B.INJURY POLICY AND ACCIDENT REPORTING .781.Injury Policy .782.Immediate Response .793.Accident Reporting .80APPENDIX A – BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN .81A.INTRODUCTION .83B.ROLES AND RESPONSIBILITIES .831.Principal Investigator/Supervisor .832.Employee .833.Employee Health Center .834.Environmental Health and Safety Department .83C.EXPOSURE DETERMINATION .84D.UNIVERSAL PRECAUTIONS .85E.ENGINEERING/WORK PRACTICE CONTROLS .851.Engineering Controls .852.Hand Hygiene .853.Sharps .854.Eating, Drinking, and Smoking .865.Mouth Pipetting/Suctioning .866.Aerosols .867.Centrifuging .868.Transporting and Shipping Biohazardous Materials .869.Equipment Servicing and Maintenance .87Environmental Health & Safety Department www.ehs.washington.edu BIOSAFETY MANUAL
TABLE OF CONTENTSNovember 2021ￜ Page 7 of 110F.PERSONAL PROTECTIVE EQUIPMENT .871.Requirements .872.Gloves .873.Face Protection .884.Use and Removal .885.Cleaning, Laundering or Disposal.88G.WORKSITE CONDITIONS .881.Responsibility .882.Spill Clean-up.883.Cleaning Schedule .894.Protective Coverings .895.Biohazardous Waste .89H.BIOHAZARD SIGNS AND LABELS .90I.HEPATITIS B IMMUNIZATION .901.Offering Hepatitis B Vaccine .902.Administering Hepatitis B Vaccine .91J.POST-EXPOSURE REQUIREMENTS .911.Exposure Incident .912.Immediate Response .91923.Principal Investigator/Supervisor Responsibility .934.Evaluation Post Exposure .93K.TRAINING PROGRAM .941.Responsibility .942.Training Requirements .95L.RECORDKEEPING .951.Medical Records .952.Training Records .963.Availability .96M.ACCESSIBILITY OF THE ECP .96N.ANNUAL UPDATE OF THE ECP.96O.ADDITIONAL REQUIREMENTS FOR HIV, HBV, AND HCV RESEARCH LABORATORIES.971.Application .97Environmental Health & Safety Department www.ehs.washington.edu BIOSAFETY MANUAL
TABLE OF CONTENTSPage 8 of 110 ￜ November 20212.Facility Requirements .973.Access Policy .974.Biosafety Manual .975.Containment.986.Protective Clothing and Practices .987.Use of Sharps .988.Spills .989.Decontamination of Waste.9810. Additional Initial Training for Laboratory Staff and Workers in HIV, HBV, and HCVLaboratories .99P.HIV, HBV, AND HCV PRODUCTION FACILITY .99APPENDIX B – POSTING BIOHAZARD SIGNS AND LABLES . 100A.PURPOSE . 100B.RESPONSIBILITY . 100C.BIOHAZARD WARNING SIGN USE . 100D.BIOHAZARD WARNING LABELS USE . 101APPENDIX C – TRANSPORTING AND SHIPPING BIOHAZARDS . 102A.B.TRANSPORTING BIOHAZA
BIOSAFETY MANUAL Environmental Health and Safety Department University of Washington Box 354400 Seattle, WA 98195-4400 Phone: 206.543.7262 FAX: 206.543.3351
