Biosafety In Microbiological And Biomedical Laboratories
Biosafety inMicrobiologicaland BiomedicalLaboratories5th EditionU.S. Department of Health and Human ServicesPublic Health ServiceCenters for Disease Control and PreventionNational Institutes of HealthHHS Publication No. (CDC) 21-1112Revised December 2009
ForewordBiosafety in Microbiological and Biomedical Laboratories (BMBL) quickly becamethe cornerstone of biosafety practice and policy in the United States upon firstpublication in 1984. Historically, the information in this publicationhas been advisory is nature even though legislation and regulation, in somecircumstances, have overtaken it and made compliance with the guidanceprovided mandatory. We wish to emphasize that the 5th edition of the BMBLremains an advisory document recommending best practices for the safeconduct of work in biomedical and clinical laboratories from a biosafetyperspective, and is not intended as a regulatory document though werecognize that it will be used that way by some.This edition of the BMBL includes additional sections, expanded sectionson the principles and practices of biosafety and risk assessment; and revisedagent summary statements and appendices. We worked to harmonize therecommendations included in this edition with guidance issued and regulationspromulgated by other federal agencies. Wherever possible, we clarified both thelanguage and intent of the information provided. The events of September 11,2001, and the anthrax attacks in October of that year re-shaped and changed,forever, the way we manage and conduct work in biological and clinicallaboratories and drew into focus the need for inclusion of additional informationin the BMBL. To better serve the needs of our community in this new era, thisedition includes information on the following topics: Occupational medicine and immunizationDecontamination and sterilizationLaboratory biosecurity and risk assessmentBiosafety level 3 (Ag) laboratoriesAgent summary statements for some agricultural pathogensBiological toxinsAt last count, over two hundred of our scientific and professional colleagueshave assisted in the preparation of the 5th edition through participation in technicalworking groups, serving as reviewers and guest editors, and as subject matterexperts. We wish to thank them all for their dedication and hard work for withoutthem the 5th edition of the BMBL would not be possible. We also recognize thehard work and contributions made by all who participated in preparation of theprevious editions of the BMBL; we have built on their solid work and commitment.It is impossible to publish this revision without recognizing the visionary leadershipof the previous BMBL editors, Drs. John Richardson and W. Emmett Barkley, andDrs. Jonathan Richmond and Robert W. McKinney, without whom the BMBLwould not be the widely and well-regarded resource it is today. The ExecutiveSteering Committee did a stellar job in shepherding this massive revision effortiii
and not without many bumps and bruises along the way. It is through their absolutecommitment to quality, technical accuracy, and dedication to the professionalpractice of biosafety that the 5th edition is born. We are truly grateful to Ms.Kerstin Traum, Council Rock Consulting for her expertise, keen eye for detail andseemingly tireless efforts in performing the duties of technical writer-editor. Wealso gratefully acknowledge Ms. Cheryl Warfield of Proven Practices, LLC for hercopy-editing and formatting skills that significantly enhanced this edition’sreadability and ease of use.Finally, without the superb project management abilities and leadership ofDr. Joseph McDade and the technical/scientific editing expertise of Dr. Karl Johnson,especially in virology, the 5th edition of the BMBL would not be possible.We hope you find this 5th 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.We believe you will find it was well worth the wait.Deborah E. Wilson, DrPH, CBSPL. Casey Chosewood, M.D.DirectorDirectorDivision of OccupationalOffice of Health and SafetyHealth and SafetyCenters for Disease ControlNational Institutes of Health and PreventionBethesda, MarylandAtlanta, GeorgiaSeptember 2009ivBiosafety in Microbiological and Biomedical Laboratories
EditorsL. Casey Chosewood, MDDirector, Office of Health and SafetyCenters for Disease Control and PreventionAtlanta, GA 30333Deborah E. Wilson, DrPH, CBSPDirector, Division of Occupational Health and SafetyOffice of the DirectorNational Institutes of HealthBethesda, MD 20892Steering CommitteeShanna Nesby-O’Dell, DVM, MPHChief, External Activities Program andWHO Collaborating Center for Biosafety and TrainingOffice of Health and SafetyCenters for Disease Control and PreventionRobbin S. Weyant, PhDChief, Laboratory Safety BranchOffice of Health and SafetyCenters for Disease Control and PreventionMartin L. Sanders, PhD, CBSP, RBPDeputy DirectorOffice of Health and SafetyCenters for Disease Control and PreventionDeborah E. Wilson, DrPH, CBSPDirector, Division of Occupational Health and SafetyOffice of the DirectorNational Institutes of HealthGuest EditorsMatthew J. Arduino, MS, DrPHChief, Environmental and Applied Microbiology SectionDivision of Healthcare Quality PromotionCenters for Disease Control and PreventionW. Emmett Barkley, PhDPresidentProven Practices, LLCGuest Editorsv
Mark Q. BenedictDivision of Parasitic DiseasesCenters for Disease Control and PreventionLouisa Chapman, MD, MSPHAssistant to the Director for Immunization PolicyNational Immunization ProgramCenters for Disease Control and PreventionDennis M. Dixon, PhDChief, Bacteriology and Mycology BranchDivision of Microbiology and Infectious DiseasesNational Institutes of HealthMark L. Eberhard, PhDDirector, Division of Parasitic DiseasesCenters for Disease Control and PreventionMartin S. Favero, PhDDirector, Scientific and Clinical AffairsAdvanced Sterilization ProductsJohnson and Johnson, Inc.Susan GorskyRegulations Officer, Office of Hazardous Materials StandardsPipeline and Hazardous Materials Safety AdministrationUnited States Department of TransportationMary E. Groesch, PhDSenior Advisor for Science PolicyOffice of Science Policy, Office of the DirectorNational Institutes of HealthTed Hackstadt, PhDLaboratory of Intracellular ParasitesNational Institute of Allergy and Infectious DiseasesRocky Mountain LaboratoryRobert A. Heckert, DVM, PhDNational Program Leader, Animal HealthUSDA, Agriculture Research ServiceBeltsville, MDMark L. Hemphill, MSChief of PolicySelect Agent ProgramCenters for Disease Control and PreventionviBiosafety in Microbiological and Biomedical Laboratories
Barbara L. Herwaldt, MD, MPHMedical OfficerParasitic Diseases BranchDivision of Parasitic DiseasesCenters for Disease Control and PreventionJulia K. Hilliard, PhDViral Immunology Center,Department of BiologyGeorgia State UniversityWilliam C. Howard, MSIndustrial Hygiene/Safety ManagerOffice of Health and SafetyCenters for Disease Control and PreventionHerbert JacobiDeputy DirectorDivision of Occupational Health and SafetyNational Institutes of HealthRachel E. Levinson, MADirectorGovernment and Industry Liaison OfficeThe Biodesign InstituteArizona State UniversityBrian W. J. Mahy, MA, PhD, ScD, DScSenior Scientific AdvisorNational Center for Infectious DiseasesCenters for Disease Control and PreventionCharles B. Millard, PhDLieutenant Colonel, U.S. ArmyDirector, Division of BiochemistryWalter Reed Army Institute of ResearchShanna Nesby-O’Dell, DVM, MPHChief, External Activities Program andWHO Collaborating Center for Biosafety and TrainingOffice of Health and SafetyCenters for Disease Control and PreventionGuest Editorsvii
Amy P. Patterson, MDDirectorOffice of Biotechnology Activities/Office of Science PolicyOffice of the DirectorNational Institutes of HealthJonathan Y. Richmond, PhDBiosafety ConsultantJonathan Richmond and AssociatesSouthport, North CarolinaMartin Sanders, PhD, CBSP, RBPDeputy DirectorOffice of Health and SafetyCenters for Disease Control and PreventionJames Schmitt, MD, MSMedical DirectorOccupational Medical ServiceDivision of Occupational Health and SafetyNational Institutes of HealthFrank Simione, MSAmerican Type Culture CollectionManassas, VADavid G. Stuart, PhDMicrobiologistThe Baker CompanyLee Ann Thomas, DVMDirectorSelect Agent, Organisms and Vectors, and AnimalsAnimal and Plant Health Inspection ServiceU.S. Department of AgricultureLarry G. ThompsonVeterinary Diagnostic LaboratoryTifton, GARobbin S. Weyant, PhDChief, Laboratory Safety BranchOffice of Health and SafetyCenters for Disease Control and PreventionviiiBiosafety in Microbiological and Biomedical Laboratories
ContributorsBMBL is by its nature a continuously revised manual, and each revision refinesand extends the contributions to previous editions. Since 1984, when the firstedition of BMBL was published, many scientists and biosafety specialists havecontributed to this important reference work. The 5th edition is no exception,as specialists in multiple disciplines generously provided their considerableexpertise to this revision. The Editors and Steering Committee gratefullyacknowledge the contributions of all of these many contributors over the life ofthe BMBL, especially contributors to the current edition, who are listed below.Contributors to BMBL 5th EditionDavid AbrahamL. Garry AdamsMichael AdlerLee AldermanChristopher E. AnsellAmy BarringerRonald A. BarryRaymond L. BeetsErmias BelayKathryn BernardCarolyn BlackWalter BondCheryl BoppSandra BraggDavid BresslerCharles BrokoppElizabeth J. BrowderBobby Gene BrownCorrie BrownDouglas R. BrownMichael BuchmeierRobert BullKaren B. ByersJane CaputoArturo CasadevallChristina CassettiByron CaugheyVishnu ChaturvediLouisa ChapmanBruce ChesebroMay ChuJeffrey I. CohenMurray CohenL. Eugene Cole IIChester CooperDavid CoxNancy CoxRebecca CoxJon CraneJack CrawfordInger DamonCharles L. DivanWalter DowdleDennis EaglesonEileen EdmondsonCarol L. EisenhauerAna Espinel-IngroffJoseph EspositoMichael T. FallonHeinz FeldmannBarry FieldsHoward FieldsMichael J. FirkoCollette FitzgeraldDiane O. FlemingThomas FolksKen GageJohn GalgianiG. Gale GallandLeslie Garry AdamsMahmoud GhannoumMark GibsonContributorsix
Chester GipsonIrene GlowinskiRichard GreenWilliam GrizzleMary E. GroeschTed HackstadtTed HadfieldSusan B. HarperLynn HardingKathryn L. HarrisRobert J. HawleyMark L. HemphillDavid K. HendersonRichard HenkelSherry HenryRobert H. HillJulia HilliardAlex HoffmasterJames D. HoltWilliam C. HowardMelony IhrigEddie L. JacksonPeter JahrlingRobert C. JambouJ. Michael JandaJackie KatzCarole KauffmanMolly KellumFred KhoshbinMaxim KieferMichael P. KileySusan K. KingstonBruce KleinPhillip H. KlesiusJoseph P. KozlovacRandy KrayKatrina KretsingerSteve KridelThomas G. KsiazekRobert LambLinda LambertRoss D. LeClaireGeoffrey J. LetchworthPaul N. LevettxRandall LevingsStuart LevitzDouglas LusterKeither MansfieldDale MartinAl MateczunHenry MathewsMichael McGinnisJohn J. McGloneFarhad MemarzadehClaudia A. MickelsonBarry MillerJohn G. MillerThomas L. MillerDouglas M. MooreMario MoralesRonald L. MorganRand MortimerBernard MossWaleid I. MuhmedBrian MurphyIrving NachamkinJanet K. A. NicholsonAlison D. O’BrienMarina O’ReillyPeter PaleseRoss PastelBill PetersCJ PetersJeannine PetersenJanet S. PetersonLouise M. PittMark A. PoliTanja PopovicNathaniel PowellAnn M. PowersSuzette PriolaRobert PurcellGreg RaymondYvonne M. ReidEric ResultanJudith RhodesRobert L. RiceJonathan RichmondBiosafety in Microbiological and Biomedical Laboratories
Betty RobertsonLuis RodriguezPierre RollinNancy RosensteinEugene RosenthalMichael D. RuffCharles RupprechtScott RuskJanice M. RusnakElliot RyserReynolds M. SalernoJim SamuelGary SandenThomas SawickiMichelle SaylorLinda R. K. SchlaterConnie SchmaljohnJames J. SchmidtBeverly SchmittJames M. SchmittGregg N. SchuilingLynne SehulsterDennis SenneTom ShihAllan ShippLance SimpsonTheresa J. SmithChristine SpiropolouGregory J. StewartYvonne J. StifelRudy StotzJanet E. StoutNancy StrockbineKanta SubbaraoBala SwaminathanDavid SwayneJames R. SwearengenBill SwitzerMallory K. TateJames F. TaylorLouise D. TeelRobert B. TeshLarry ThompsonAlfonso TorresKerstin E. TraumTheodore J. TraumDavid TreesCharles TrimarchiRobert G. UlrichCristina VargasDon VesleyPaul E. VinsonDavid WaagRobert W. WannemacherCheryl WarfieldDavid WarnockWilliam WatsonMike WeathersRobert WebsterElizabeth WeirichLouis S. WelkerDiane L. WhippleDenise WhitbyRichard WhitleyCatherine L. WilhelmsenAxel WolffDavid WoodsScott D. WrightJack WunderRobert YarchoanUri YokelLisa YoungGary L. ZackowitzContributorsxi
ContentsSection I—Introduction. 1The Occurrence of Laboratory-Associated Infections. 1Evolution of National Biosafety Guidelines . 3Risk Criteria for Establishing Ascending Levels of Containment. 4Agent Summary Statements . 5Biosecurity. 6Using BMBL. 6Looking Ahead . 6References. 7Section II—Biological Risk Assessment. 9Hazardous Characteristics of an Agent. 10Hazardous Characteristics of Laboratory Procedures. 14Potential Hazards Associated with Work Practices, SafetyEquipment and Facility Safeguards. 15An Approach to Assess Risks and Select Appropriate Safeguards. 16Conclusion. 19References. 19Section III—Principles of Biosafety. 22Laboratory Practices and Technique. 22Safety Equipment (Primary Barriers and Personal Protective Equipment). 22Facility Design and Construction (Secondary Barriers). 23Biosafety Levels. 24Animal Facilities. 27Clinical Laboratories. 27Importation and Interstate Shipment of Certain Biomedical Materials. 28Select Agents. 28References. 28Section IV—Laboratory Biosafety Level Criteria. 30Biosafety Level 1. 30A.Standard Microbiological Practices. 30B.Special Practices. 32C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 32D.Laboratory Facilities (Secondary Barriers). 33Contentsxiii
Biosafety Level 2. 33A.Standard Microbiological Practices. 33B.Special Practices. 35C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 36D.Laboratory Facilities (Secondary Barriers). 37Biosafety Level 3. 38A.Standard Microbiological Practices. 38B.Special Practices. 40C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 41D.Laboratory Facilities (Secondary Barriers). 42Biosafety Level 4. 45A.Standard Microbiological Practices. 45B.Special Practices. 47C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 49D.Laboratory Facilities (Secondary Barriers). 51Section V—Vertebrate Animal Biosafety Level Criteria forVivarium Research Facilities. 60Animal Biosafety Level 1. 61A.Standard Microbiological Practices. 61B.Special Practices. 64C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 64D.Laboratory Facilities (Secondary Barriers). 65Animal Biosafety Level 2. 67xivA.Standard Microbiological Practices. 67B.Special Practices. 70C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 72D.Laboratory Facilities (Secondary Barriers). 73Biosafety in Microbiological and Biomedical Laboratories
Animal Biosafety Level 3. 75A.Standard Microbiological Practices. 76B.Special Practices. 79C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 80D.Laboratory Facilities (Secondary Barriers). 82Animal Biosafety Level 4. 85A.Standard Microbiological Practices. 86B.Special Practices. 89C.Safety Equipment (Primary Barriers and PersonalProtective Equipment). 92D.Laboratory Facilities (Secondary Barriers). 94References.
patience and understanding during the long and comprehensive revision process. We believe you will find it was well worth the wait. Deborah E. Wilson, DrPH, CBSP L. Casey Chosewood, M.D. Director Director Division of Occupational Office of Health and Safety Health and Safety Centers for Disease Control National Institutes of Health and Prevention Bethesda, Maryland Atlanta, Georgia September .
Laboratory Biosafety. Laboratory Biosafety Manual - Third Edition WHO Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition Center for Disease Control Canadian Biosafety Standard, Second Edition Canadian Government . Environmental Biosafety. Cartagena Protocol, A
Biosafety in Microbiological and Biomedical Laboratories 5th Edition, commonly referred to as “BMBL”: ). The four biosafety levels consist of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities. The biosafety levels are outlined in a summary table in . Section IV—Laboratory Biosafety Level Criteria
a The concept and classification of risk groups are being reevaluated and will be addressed in the third edition of the Laboratory biosafety manual. Table 2. Relation of risk groups to biosafety levels, practices and equipment Risk Group Biosafety Level Laboratory type Laboratory practices Safety equipment 1 Basic – Biosafety Level 1 Basic .
WHO Laboratory Biosafety Manual Having served for global biosafety community – Hereinafter, “WHO Manual” – “ For more than 20 30 years, since it was first published in 1983, the Laboratory Biosafety Manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. ” – WHO web site The 3. rd
of Health Biosafety in Microbiological and Biomedical Laboratories to all Yale research laboratories. The text has served as a functional biosafety manual for the University. This document and other pertinent biosafety training information and training materials are now available on the Office of Environmental Health and Safety Web site
Research Safety and Training Manual (Safety Plan) VA Hospital, Madison, WI (607) Research Service (151) Acronyms ABSL animal biosafety level AO Administrative Officer for Research ARC Animal Research Committee ARF Animal Research Facility BMBL Biosafety in Microbiological and Biomedical Laboratories BSL biosafety level
LABORATORY 1. Microbiological specification and regulations 2. Local and international approaches to obtaining safe food 3. Management and quality assurance in the microbiology laboratory Lecturer: Miss Elemba, O. M. Microbiological specification and regulations Microbiological Criteria: Microbiological criteria are
This Biosafety Manual represents the institutional practices and procedures for the safe use and handling of biological materials, recombinant DNA and synthetic nucleic acids at Stanford University. The Administrative . Panel on Biosafety and the Biosafety & Biosecurity Program have revised this document based on the latest
