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Biosafety inMicrobiologicaland BiomedicalLaboratories6th EditionCenters for Disease Control and PreventionNational Institutes of Health

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Biosafety inMicrobiologicaland BiomedicalLaboratories6th EditionU.S. Department of Health and Human ServicesPublic Health ServiceCenters for Disease Control and PreventionNational Institutes of HealthRevised June 2020

ForewordBiosafety in Microbiological and Biomedical Laboratories (BMBL) has servedas the cornerstone of biosafety practice in the United States since its initialrelease. We wish to emphasize that the sixth edition of BMBL remains anadvisory document recommending best practices for the safe conduct of workin biomedical and clinical laboratories from a biosafety perspective. The BMBLis not intended to be a regulatory document although we recognize that somemay use it in that way. The core principle of this document is protocol-driven riskassessment; it is not possible for a single document to identify all of the possiblecombinations of risks and mitigations feasible in biomedical and clinical laboratories. The BMBL should be used as a tool in the assessment and proposedmitigation steps in biomedical and clinical laboratories.This edition of BMBL includes revised sections, agent summary statements,and appendices. We harmonized the recommendations included in this editionwith guidance issued and regulations promulgated by other organizations andfederal agencies. Wherever possible, we clarified both the language and intentof the information provided. In order to serve the needs of our community better,this edition includes new appendices on the following topics: inactivation andverification; laboratory sustainability; large-scale biosafety; and clinical laboratorybiosafety.Over 200 of our scientific and professional colleagues contributed to the preparation of the sixth edition through participation in technical working groups andserving as reviewers, guest editors, and subject matter experts. We wish to thankthem all for their dedication and hard work. Without them, the sixth edition ofBMBL would not be possible. We also recognize the hard work and contributionsmade by all who participated in preparation of the previous editions of BMBL; wehave built on their solid work and commitment.It would have been impossible to publish this revision without recognizing thevisionary leadership of the previous BMBL editors—Drs. John Richardson,W. Emmett Barkley, Jonathan Richmond, Robert W. McKinney, Casey Chosewood,and Deborah Wilson—without whom the BMBL would not be the respectedresource it is today. The Steering Committee members, Drs. Christy Myrick,Richard G. Baumann, Margy Lambert, Patricia Delarosa, and Theresa Lawrence,were instrumental in identifying authors, selecting additions to this edition, andreviewing submissions. Their significant contribution to this edition is sincerelyappreciated.We are truly grateful to Ms. Shaina Mangino and Dr. Mallory Pomales of EagleMedical Services, LLC for their expertise and patience in assisting us with thisundertaking. Their superb organizational and editing skills were critical in thecreation of this document.Forewordiii

We hope you find the sixth edition of Biosafety in Microbiological and BiomedicalLaboratories complete, timely, and most of all, easy to use. Thank you for yourpatience and understanding during the long and comprehensive revision process.Paul J. Meechan, PhD, MPH, RBP, CBSP(ABSA)Associate Director for Laboratory SafetyOffice of Laboratory Science and SafetyCenters for Disease Control and PreventionAtlanta, GAJeffrey Potts, MPH, CBSP(ABSA)Chief, Biorisk Management BranchDivision of Occupational Health and SafetyNational Institutes of HealthBethesda, MDivBiosafety in Microbiological and Biomedical Laboratories

ParticipantsSenior Co-EditorsPaul J. Meechan, PhD, MPH, RBP, CBSP(ABSA)Associate Director for Laboratory SafetyOffice of Laboratory Science and SafetyCenters for Disease Control and PreventionJeffrey Potts, MPH, CBSP(ABSA)Chief, Biorisk Management BranchDivision of Occupational Health and SafetyNational Institutes of HealthSteering CommitteeRichard G. Baumann, PhD, SM(NRCM)Biological Safety OfficerDivision of Occupational Health and SafetyNational Institutes of HealthPatricia Delarosa, PhD, CBSP(ABSA), CTM(ATAP)Health Scientist, BiosafetyOffice of Strategy, Policy, Planning, and RequirementsOffice of the Assistant Secretary for Preparedness and ResponseDepartment of Health and Human ServicesMargy Lambert, PhDHealth ScientistOffice of Science and Technology AssessmentOccupational Safety and Health AdministrationCAPT Theresa Lawrence, PhDSenior Science OfficerOffice of the Associate Director for Preparedness and ResponseU.S. Department of Health and Human ServicesPaul J. Meechan, PhD, MPH, RBP, CBSP(ABSA)Associate Director for Laboratory SafetyOffice of Laboratory Science and SafetyCenters for Disease Control and PreventionForewordv

Christy Myrick, PhD, RBP(ABSA)Lead AuditorU.S. National Authority for Containment for PoliovirusesCenter for Preparedness and ResponseCenters for Disease Control and PreventionJeffrey Potts, MPH, CBSP(ABSA)Chief, Biorisk Management BranchDivision of Occupational Health and SafetyNational Institutes of HealthDeborah E. Wilson, DrPH, CBSP(ABSA)RADM (ret.), U.S. Public Health Service,Division of Occupational Health and Safety—DirectorOffice of Research ServicesNational Institutes of HealthTechnical EditorsShaina ManginoSenior Publications EditorEagle Medical Services, LLCMallory J. Pomales, DOSenior Program Manager for Scientific WritersSenior Scientific EditorEagle Medical Services, LLCPrimary AuthorsMatthew J. Arduino, MS, DrPH, FSHEA, M(ASCP)CMSr. Adviser, Environmental Hygiene and Infection PreventionOffice of the DirectorDivision of Healthcare Quality PromotionCenters for Disease Control and PreventionWilliam D. ArndtHealth Scientist—BioriskDivision of Laboratory SystemsCenters for Disease Control and PreventionHeike Bailin, MDStaff Physician, Occupational Medical ServiceDivision of Occupational Health and SafetyNational Institutes of HealthviBiosafety in Microbiological and Biomedical Laboratories

Richard G. Baumann, PhD, SM(NRCM)Biological Safety OfficerDivision of Occupational Health and SafetyNational Institutes of HealthRichard S. Bradbury, PhD, FFSc RCPADivision of Parasitic Diseases and MalariaCenter for Global HealthCenters for Disease Control and PreventionMary E. Brandt, PhDOffice of Laboratory Science and SafetyCenters for Disease Control and PreventionCristina Bressler, MBAHealth ScientistOccupational Health and Safety OfficeOffice of Safety, Security and Asset ManagementCenters for Disease Control and PreventionByron Caughey, PhDSenior InvestigatorLaboratory of Persistent Viral Diseases, Rocky Mountain LaboratoriesNational Institute for Allergy and Infectious DiseasesNational Institutes of HealthRear Admiral Terri R. Clark, DVM, DACLAMDirector (ret.), Office of Animal Care and UseAssistant Surgeon GeneralUSPHS Commission CorpsNational Institutes of HealthDanielle Daniely, PhD, RBP(ABSA)Director, Research Safety Programs and High Containment LaboratoriesOffice of Research IntegrityGeorgia State UniversityPatricia Delarosa, PhD, CBSP(ABSA), CTM(ATAP)Health Scientist, BiosafetyOffice of Strategy, Policy, Planning, and RequirementsOffice of the Assistant Secretary for Preparedness and ResponseDepartment of Health and Human ServicesForewordvii

Stephen Denny, DVM, MS, DACLAM, DACVPMActing Director, Office of Animal Care and UseOffice of Intramural ResearchNational Institutes of HealthEileen EdmonsonTransportation Regulations SpecialistStandards and Rulemaking DivisionPipeline and Hazardous Materials Safety AdministrationU.S. Department of TransportationSamuel S. Edwin, PhDDirectorDivision of Select Agents and ToxinsCenter for Preparedness and ResponseCenters for Disease Control and PreventionElizabeth (Zeba) Floyd, AIA, LEED AP BD C ID CProject DirectorSustainable Design Consulting, LLCKaren M. Frank, MD, PhD, D(ABMM)Chief, Department of Laboratory MedicineClinical CenterNational Institutes of HealthMark D. Gibson, MS, CIHSenior Industrial HygienistDivision of Occupational Health and SafetyNational Institutes of HealthEduardo Gomez-Saladin, PhD, SM, RBP, CBSP(ABSA)Deputy DirectorOffice of Laboratory SafetyCenters for Disease Control and PreventionNatasha K. Griffith, MSChief, Quality and Safety Systems BranchDivision of Laboratory SystemsCenters for Disease Control and PreventionviiiBiosafety in Microbiological and Biomedical Laboratories

Ted Hackstadt, PhDChief, Host-Parasite Interactions SectionLaboratory of BacteriologyRocky Mountain LaboratoriesNational Institute for Allergy and Infectious DiseasesNational Institutes of HealthSusan B. Harper, DVM, MS, DACLAM, DACVPM, RBP(ABSA)Office of National ProgramsUSDA Agricultural Research ServiceKathryn L. Harris PhD, RBP(ABSA)Senior Outreach and Education SpecialistBiosafety, Biosecurity and Emerging Biotechnology Policy DivisionOffice of Science PolicyNational Institutes of HealthMark L. Hemphill, MSDeputy Director, Division of Select Agents and ToxinsCenter for Preparedness and ResponseCenters for Disease Control and PreventionBarbara L. Herwaldt, MD, MPHMedical Epidemiologist, Division of Parasitic Diseases and MalariaCenters for Disease Control and PreventionNancy P. Hoe, PhD, CBSP(ABSA)Biosafety Officer/Responsible Official for Rocky Mountain LaboratoriesDivision of Occupational Health and SafetyOffice of the Director, National Institutes of HealthJoseph P. Kozlovac, MS, RBP, CBSP(ABSA), SM(NRCM)Agency Biosafety OfficerUSDA Agricultural Research ServiceOffice of National ProgramsMargy Lambert, PhDHealth ScientistOffice of Science and Technology AssessmentOccupational Safety and Health AdministrationGeorge W. LathropVeterinary Medical OfficerNational Center for Emerging and Zoonotic Infectious DiseasesCenters for Disease Control and PreventionForewordix

Susan Lawrence, PhDBranch ChiefMicrobiology BranchEnvironmental Protection AgencySusan A. Lippold, MD, MPHMedical DirectorOccupational Health ClinicCenters for Disease Control and PreventionR. Trevor LubbertBoard Certified Senior Staff EntomologistCommunity Health BranchDivision of Occupational Health and SafetyOffice of Research SafetyNational Institutes of HealthCarolina Lúquez, PhDNational Botulism and Enteric Toxins TeamEnteric Diseases Laboratory BranchDivision of Foodborne, Waterborne, and Environmental DiseasesNational Center for Emerging and Zoonotic Infectious DiseasesCenters for Disease Control and PreventionPatrick M. McNutt, PhDPrincipal InvestigatorDepartment of NeuroscienceU.S. Army Medical Research Institute of Chemical DefensePaul J. Meechan, PhD, MPH, RBP, CBSP(ABSA)Associate Director for Laboratory SafetyOffice of Laboratory Science and SafetyCenters for Disease Control and PreventionBarbara Owen, MPH, CBSP(ABSA), RBP, NRCM, CMMDirector, Global Safety and EnvironmentCorporate Biosafety OfficerMerck & Co., Inc.Steven Piguet, AIA, LEED Fellow, Fitwel AmbassadorAssociate PrincipalSustainable Design Consulting, LLCxBiosafety in Microbiological and Biomedical Laboratories