4TH EDITION Biological Safety · LOUANN CRAWFORD BURNETT, CBSP (Section IV) Vanderbilt University,...
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Principles and Practices
BiologicalSafety
4TH EDITION
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Principles and Practices
Editors:
Diane O. Fleming, Ph.D., RBP, CBSP (ABSA)Biosafety Consultant, Bowie, MD 20716
Debra L. Hunt, Ph.D., RBP, CBSP Environmental Safety, Duke University Medical Center,Durham, NC 27710
BiologicalSafety
4TH EDITION
Washington, D.C.
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Copyright © 2006 ASM PressAmerican Society for Microbiology1752 N Street, N.W.Washington, DC 20036-2804
Library of Congress Cataloging-in-Publication Data
Biological safety: principles and practices / editors, Diane O. Fleming, Debra L. Hunt.—4th ed.p. ; cm.
Includes bibliographical references and index.ISBN-13: 978-1-55581-339-0ISBN-10: 1-55581-339-9
1. Microbiological laboratories—Safety measures. 2. Biological laboratories—Safety measures. I. Fleming, Diane O. II. Hunt, Debra Long.
[DNLM: 1. Accidents, Occupational—prevention & control. 2. Laboratories—standards. 3. Safety. WA 485 B615 2006]
QR64.7.L33 2006570’.289—dc22
2006019406All Rights ReservedPrinted in the United States of America
10 9 8 7 6 5 4 3 2 1
Address editorial correspondence to: ASM Press, 1752 N St., N.W., Washington, DC 20036-2904, U.S.A.
Send orders to: ASM Press, P.O. Box 605, Herndon, VA 20172, U.S.A.Phone: 800-546-2416; 703-661-1593Fax: 703-661-1501Email: [email protected]: estore.asm.org
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v
Contents
Contributors / xi
Preface / xvii
I Hazard Identification
1 Microbial Flora of Humans and Microbial Virulence Factors / 3PAUL A. GRANATO
2 Indigenous and Pathogenic Agents of Research Animals / 19DIANE O. FLEMING
3 Laboratory, Growth Chamber, and Greenhouse Microbial Safety: Plant Pathogens and Plant-AssociatedMicroorganisms of Significance to Human Health / 35ANNE K. VIDAVER, SUE A. TOLIN, AND PATRICIA LAMBRECHT
4 Epidemiology of Laboratory-Associated Infections / 53A. LYNN HARDING AND KAREN BRANDT BYERS
II Hazard Assessment
5 Risk Assessment of Biological Hazards / 81DIANE O. FLEMING
6 Bacterial Pathogens / 93JOSEPH H. COGGIN, JR.
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7 Protozoa and Helminths / 115BARBARA L. HERWALDT
8 Mycotic Agents of Human Disease / 163WILEY A. SCHELL
9 Viral Agents of Human Disease: Biosafety Concerns / 179JASON PARAGAS AND TIMOTHY P. ENDY
10 Biosafety for Microorganisms Transmitted Primarily by the Airborne Route / 209MICHAEL A. PENTELLA, PAMELA A. KOSTLE, LUCY DESJARDIN, AND MARY J. R. GILCHRIST
11 Cell Lines: Applications and Biosafety / 221OTTO DOBLHOFF-DIER AND GLYN STACEY
12 Allergens of Animal and Biological Systems / 241WANDA PHIPATANAKUL AND ROBERT A. WOOD
13 Biological Toxins: Safety and Science / 253JOSEPH P. KOZLOVAC AND ROBERT J. HAWLEY
III Hazard Control
14 Design of Biomedical Laboratory Facilities / 273JONATHAN T. CRANE AND JONATHAN Y. RICHMOND
15 Primary Barriers and Equipment-Associated Hazards / 295ELIZABETH A. GILMAN DUANE AND RICHARD C. FINK
16 Primary Barriers: Biological Safety Cabinets, Fume Hoods, and Glove Boxes / 303DAVID G. STUART, DAVID C. EAGLESON, AND CHARLES W. QUINT, JR.
17 Personal Respiratory Protection / 325NICOLE VARS MCCULLOUGH
18 Standard (Universal) Precautions for Handling Human Specimens / 341DEBRA L. HUNT
19 Prudent Biosafety Practices / 361DIANE O. FLEMING
20 Decontamination and Disinfection / 373MARTIN S. FAVERO AND MATTHEW J. ARDUINO
21 Packing and Shipping Biological Materials / 383LARRY D. GRAY AND JAMES W. SNYDER
vi CONTENTS
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IV Administrative Controls
22 Biological Safety Program Management / 405LOUANN CRAWFORD BURNETT
23 Biosafety Compliance: a Global Perspective / 417RICHARD REBAR AND HALLEY MORIYAMA
24 Occupational Medicine in a Biomedical Research Setting / 437DEBORAH E. WILSON AND JAMES M. SCHMITT
25 Measuring Biosafety Program Effectiveness / 445JANET S. PETERSON AND ROBERT J. HASHIMOTO
V Special Considerations for Biosafety
26 Biosafety of Prion Diseases / 461HENRY BARON AND STANLEY B. PRUSINER
27 Safety Considerations in the BSL-4 Maximum- Containment Laboratory / 487DAVID S. BRESSLER AND ROBERT J. HAWLEY
28 Biosafety and Viral Gene Transfer Vectors / 509THOMAS A. KOST, PATRICK J. CONDREAY, AND CLAUDIA A. MICKELSON
29 Biosafety in the Teaching Laboratory / 531DAVID M. CARLBERG AND MICHAEL R. YEAMAN
30 Biosafety in the Pharmaceutical Industry / 551PAUL J. MEECHAN, JOSEPH GYURIS, BRIAN R. PETUCH,MICHEL M. CHARTRAIN, AND WAYNE K. HERBER
31 Large-Scale Production of Microorganisms / 561MARY L. CIPRIANO
32 Special Considerations for Agriculture Pathogen Biosafety / 579ROBERT A. HECKERT AND JOSEPH P. KOZLOVAC
33 Biosafety and Biosecurity: Regulatory Impact / 587ROBERT J. HAWLEY AND THERESA D. DULEY
Index / 597
CONTENTS vii
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ix
Section Editors
LOUANN CRAWFORD BURNETT, CBSP (Section IV)Vanderbilt University, EH&SBSP Manager U-2-11 MCN1161 21st Avenue SouthNashville, TN 37232-2665
MARY L. CIPRIANO, MBA, RBP, CBSP (Section V)Abbott LaboratoriesD-03B4, AP1A 100 Abbott Park RoadAbbott Park, IL 60064-3500
RICHARD C. FINK, Ph.D., CBSP (Section III)Wyeth1 Burtt Road, Mailstop b1202Andover, MA 01810
ELIZABETH GILMAN DUANE, MS, RBP, CBSP (Section III)Wyeth Research35 Cambridge Park DriveCambridge, MA 02140
A. LYNN HARDING, MPH, CBSP (Section I) Biosafety Consultant2846 Crestwood AvenueChattanooga, TN 37415
ROBERT J. HAWLEY, Ph.D., RBP, CBSP (Section V)Midwest Research Institute365 West Patrick St., Suite 223Frederick, Md 21701-4856
JANET S. PETERSON, MS, RBP, CBSP (Section IV)Dept. of Environmental Safety University of Maryland3115 Chesapeake Bldg.College Park, MD 20742
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xi
Contributors
MATTHEW J. ARDUINOEnvironmental and Applied Microbiology Team, Epidemiology and Laboratory Branch, Division of Healthcare Quality Promotion,Centers for Disease Control and Prevention, 1600 Clifton Rd., MS-C16, Atlanta, GA 30333
HENRY BARONConsultant on Prion Diseases, 5 Rue du Puits de l’Ermite, 75005 Paris, France
DAVID S. BRESSLERBioterrorism Preparedness and Response Program, National Centerfor Infectious Diseases, Coordinating Center for Infectious Diseases,Centers for Disease Control and Prevention, 1600 Clifton Rd., NE,Mailstop C-18, Atlanta, GA 30333
LOUANN CRAWFORD BURNETTVanderbilt University Environmental Health & Safety, U-0211 MCN,Box 2665, 1161 21st Ave. South, Nashville, TN 37232-2665
KAREN BRANDT BYERSDana Farber Cancer Institute, 44 Binney St., Boston, MA 02115
DAVID M. CARLBERGCalifornia State University, Long Beach, 1250 Bellflower Blvd., LongBeach, CA 90840 (Emeritus)
MICHEL M. CHARTRAINDept. of Biocatalysis and Fermentation, Merck & Co., Inc., P.O. Box2000, RY80Y-105, Rahway, NJ 07065
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MARY L. CIPRIANOBiological Safety, Abbott Laboratories, D-3A4, AP8B, 100 Abbott Park Rd., Abbott Park, IL 60064-6041
JOSEPH H. COGGIN, JR.Dept. of Microbiology and Immunology, University of SouthernAlabama, LMB Bldg., 307 University Blvd., Mobile, AL 36688
PATRICK J. CONDREAYGene Expression Protein Biochemistry, GlaxoSmithKline Researchand Development, 5 Moore Dr., Research Triangle Park, NC 27709
JONATHAN T. CRANECUH2A, 1201 Peachtree St., N.E., 400 Colony Square, Suite 600,Atlanta, GA 30361-3500
LUCY DESJARDINUniversity of Iowa Hygienic Laboratory, 102 Oakdale Campus, H101 OH, Iowa City, IA 52242-5002
OTTO DOBLHOFF-DIERonepharm Research and Development GmbH, Gersthofer Strasse 29-31, A-1180 Vienna, Austria
THERESA D. DULEYSAIC-Frederick, National Cancer Institute at Frederick, P.O. Box B,Fort Detrick, MD 21702-1201
DAVID C. EAGLESONThe Baker Company, Inc., 161 Gatehouse Rd., P.O. Drawer E, Sanford,ME 04073
TIMOTHY P. ENDYDivision of Communicable Diseases and Immunology, Walter ReedArmy Institute of Research, 503 Robert Grant Ave., Rm 3S28, SilverSpring, MD 20910-7500
MARTIN S. FAVEROScientific and Clinical Affairs, Advanced Sterilization Products,Johnson & Johnson, 33 Technology Dr., Irvine, CA 92618
RICHARD C. FINKEnvironmental Health and Safety Dept., Wyeth Biotech, 1 Burtt Rd.,Andover, MA 01810
DIANE O. FLEMINGBiosafety Consultant, 15611 Plumwood Ct., Bowie, MD 20716-1434
MARY J. R. GILCHRISTUniversity of Iowa Hygienic Laboratory, 102 Oakdale Campus, H101OH, Iowa City, IA 52242-5002
ELIZABETH A. GILMAN DUANEWyeth Research, 35 Cambridge Park Dr., Cambridge, MA 02140
xii CONTRIBUTORS
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PAUL A. GRANATODept. of Microbiology and Immunology, WH 2204, SUNY UpstateMedical University, 750 East Adams St., Syracuse, NY 13210
LARRY D. GRAYTrihealth Laboratories, Cincinnati, OH 45206; Dept. of Pathology andLaboratory Medicine, University of Cincinnati College of Medicine,Cincinnati, OH 45267; and Clinical Microbiology LaboratoryConsultants, LLC, Cincinnati, OH 45227
JOSEPH GYURISDept. of Health Physics, Biosafety and Environmental Affairs, Merck & Co., Inc., P.O. Box 2000, RY80HP, Rahway, NJ 07065
A. LYNN HARDINGBiosafety Consultant, 2846 Crestwood Ave., Chattanooga, TN 37415-6116
ROBERT J. HASHIMOTOBiosafety Consultant, 578 39th Ave., San Francisco, CA 94121
ROBERT J. HAWLEYMidwest Research Institute, 365 West Patrick St., Suite 223, Frederick,MD 21701-4856
ROBERT A. HECKERTNational Program Staff, USDA, Agriculture Research Service, 5601Sunnyside Ave., Rm 4-2176, Beltsville, MD 20705-5138
WAYNE K. HERBERDept. of Fermentation and Cell Culture, Merck & Co., Inc., P.O. Box 4,WP26C-1, West Point, PA 18940
BARBARA L. HERWALDTDivision of Parasitic Diseases, Centers for Disease Control andPrevention, 4770 Buford Hwy., N.E., Atlanta, GA 30341-3724
DEBRA L. HUNTBiological Safety, Duke University Medical Center, P.O. Box 3149,Durham, NC 27710
THOMAS A. KOSTGene Expression Protein Biochemistry, GlaxoSmithKline Researchand Development, 5 Moore Dr., Research Triangle Park, NC 27709
PAMELA A. KOSTLEUniversity of Iowa Hygienic Laboratory, 102 Oakdale Campus, H101OH, Iowa City, IA 52242-5002
JOSEPH P. KOZLOVACUSDA-ARS Homeland Security Office, Biological Safety Program,5601 Sunnyside Ave., Rm 2-1110, Beltsville, MD 20705-5146
CONTRIBUTORS xiii
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PATRICIA A. LAMBRECHTDept. of Plant Pathology, University of Nebraska, Lincoln, NE 68583-0722
NICOLE VARS MCCULLOUGH3M Occupational Health and Environmental Safety Division, 3M Company, 3M Center, Bldg. 235-2E-85, St. Paul, MN 55144-1000
PAUL J. MEECHANDept. of Health Physics, Biosafety and Environmental Affairs, Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, WP44-204, West Point, PA 18946
CLAUDIA A. MICKELSONEHS Office, N52-496, Massachusetts Institute of Technology, 77 Massachusetts Ave., Cambridge, MA 02139-4307
HALLEY MORIYAMAENSR International, 2 Technology Park Dr., Westford, MA 01886
JASON PARAGASDivision of Virology, United States Army Medical Research Institutefor Infectious Disease, 1425 Porter St., Fort Detrick, MD 21702-5011
MICHAEL A. PENTELLAUniversity of Iowa Hygienic Laboratory, 102 Oakdale Campus, H101 OH, Iowa City, IA 52242-5002
JANET S. PETERSONDept. of Environmental Safety, University of Maryland, College Park,MD 20742
BRIAN R. PETUCHDept. of Health Physics, Biosafety and Environmental Affairs, Merck & Co., Inc., P.O. Box 4, WP44-204, West Point, PA 18940
WANDA PHIPATANAKULChildren’s Hospital Boston, and Harvard Medical School,Immunology, Fegan 6, 300 Longwood Ave., Boston, MA 02115
STANLEY B. PRUSINERInstitute for Neurodegenerative Diseases, University of California,San Francisco, Box 0518, San Francisco, CA 94143-0518
CHARLES W. QUINT, JR.The Baker Company, Inc., 161 Gatehouse Rd., P.O. Drawer E, Sanford,ME 04073
RICHARD REBARGlaxoSmithKline R&D, 709 Swedeland Rd., UE-0393, King of Prussia,PA 19406-0939
JONATHAN Y. RICHMONDJonathan Richmond and Associates, 927 East Leonard St., Southport,NC 28461
xiv CONTRIBUTORS
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WILEY A. SCHELLDept. of Medicine, Division of Infectious Diseases and InternationalHealth, Duke University, Box 3303, Room 1552 South, DukeUniversity Medical Center, Durham, NC 27710
JAMES M. SCHMITTDivision of Occupational Health and Safety, National Institutes ofHealth, Bldg. 13, Rm. 3K04, 10 Center Dr., Bethesda, MD 20892-1584
JAMES W. SNYDERDept. of Pathology and Laboratory Medicine, University of LouisvilleSchool of Medicine and Hospital, Louisville, KY 40202
GLYN STACEYHead of Cell Biology and Biological Imaging, Division of Virology,National Institutes of Biological Standards and Control, Blanche Lane,South Mimms, Potters Bar, Herts, EN6 3QG, United Kingdom
DAVID G. STUARTThe Baker Company, Inc., 161 Gatehouse Rd., P.O. Drawer E, Sanford,ME 04073
SUE A. TOLINVirginia Polytechnic Institute and State University, Plant Pathology,Physiology, and Weed Science, Blacksburg, VA 24061-0330
ANNE K. VIDAVERDept. of Plant Pathology, University of Nebraska, Lincoln, NE 68583-0722
DEBORAH E. WILSONDivision of Occupational Health and Safety, National Institutes ofHealth, Bldg. 13, Rm. 3K04, 13 South Dr., Bethesda, MD 20892-5706
ROBERT A. WOODDept. of Pediatrics, Division of Allergy and Immunology, JohnsHopkins Hospital, 600 N. Wolfe St., CMSC 1102, Baltimore, MD 21287-3923
MICHAEL R. YEAMANDavid Geffen School of Medicine, Division of Infectious Diseases,LAC-Harbor UCLA Medical Center, Los Angeles Biomedical ResearchInstitute, 1000 W. Carson St., Torrance, CA 905098
CONTRIBUTORS xv
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xvii
Preface
THIS FOURTH EDITION OF THE ASM BOOK BIOSAFETY: PRINCIPLES AND
PRACTICES consists of 33 chapters from over 50 authors with manydecades of experience in biological safety. We especially appreci-
ate the additional effort of seven of these authors who also served asSection Editors. Fifteen new authors provide fresh insight on biologicaltoxins, packaging and shipping, biological safety program manage-ment, Occupational Medicine in a biomedical research setting, safetyconsiderations in the BSL-4 maximum containment laboratory, andspecial considerations for agriculture pathogens. All of the other chap-ters have been appropriately updated. For example, the prion chapterunderwent major changes to address the transmission of variantCreutzfeldt-Jakob disease via blood transfusion, which occurred sincethe previous edition. Of special significance are chapter 4, “Epidemiologyof Laboratory-Associated Infections,” and chapter 7, “Protozoa andHelminths,” both of which contain previously unreported cases andreviews of previous surveys.
Since the third edition of this book, untoward events, such as theanthrax letters in 2002, have had an impact on the field of biosafety andthose who work with microbial agents. Regulations have been broad-ened to prevent terrorists from obtaining certain microbes believed tobe useful as biological weapons. These Select Agent regulations fromthe Centers for Disease Control and Prevention (CDC) and from theUnited States Department of Agriculture include stringent require-ments to limit those who can obtain, store, or use these agents. Suchindividuals must undergo a security check, including fingerprinting,and receive a clearance from the Department of Justice. Biosafety per-sonnel now have the additional duty of implementing key biosecuritysections of this regulation. Chapter 33 provides a discussion of theimpact of regulations on biosafety and biosecurity.
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One of the features of previous editions of this book has been theinclusion of the actual regulation from the Occupational Safety andHealth Administration (OSHA), the National Institutes of Health(NIH) guidelines, and the CDC/NIH guidelines “Biosafety inMicrobiological and Biomedical Laboratories” (BMBL). Unfortunately,the 5th edition of BMBL is still in press, with no clear date of publica-tion. Since all of the documents are available on the Internet, we referthe reader to those sources instead.
This book is meant to be used as a resource by biosafety profession-als, those who teach them, and those who work with pathogenic agentsin research, production, or teaching. We have included what is knownto be important today. However, biotechnology breakthroughs, such asnanotechnology and synthetic genomics, can be expected to challengeour ability to do appropriate risk assessments in the future. In the sixyears since the previous edition, poliovirus was synthesized by using amap of the genome which was published in the literature. The synthe-sis of any virus from its genetic map has become a reality. Will ourefforts to recognize and assess the potentially unrecognizable hazardsthat could arise from combining pieces of many synthesized virusesallow us to continue to find effective methods of containment? Suchchallenges require that we continuously strive to share informationgathered in the broad scope of biological research. We hope this bookwill aid in this endeavor.
Diane O. FlemingDebra L. Hunt
xviii PREFACE
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Index
AAV (adeno-associated viruses)as gene transfer vector, 517, 523in pharmaceutical production, 552
A-B toxins, 14Academic laboratories, see Teaching laboratoriesAcanthamoeba, 128Accidental release, for pharmaceutical production, 557Accidents, see also Incidents; Needlesticks
behavioral factors in, 69in BSL-4 laboratory, 489causes of, 69infections associated with, 63, 119, 123medical care in, 439–440viral exposure in, management after, 201;
see also specific virusesAccountability, in biosafety program management, 408Acholeplasma laidlawii, 226Acinetobacter, 6Acoustical considerations, in laboratory design, 288–289Actinomyces, 9Actinomyces israelii, 9Actinomyces naeslundii, 9Activity-based risk assessment, 86–87Adeno-associated viruses (AAV)
as gene transfer vectors, 517, 523in pharmaceutical production, 552
Adenoviruses, 197clinical manifestations of, 185, 186as gene transfer vectors, 515–517, 522in pharmaceutical production, 552
Adherence, as virulence factor, 11–12Adhesins, as virulence factors, 11–12Administration, facilities for, in laboratory design,
280–281Administrative controls, 369–370; see also
Biosafety programs; Occupational medicinecompliance issues in, 417–436
Aeromonas, toxin of, 102
Aerosolsfrom animal housing, 295–296barriers to, 368–369bioterrorism agents in, 587from centrifuges, 296–297containment of, see Biological safety cabinets (BSCs);
Fume hoodscreation of, 210, 539from fermentors, 298HIV in, 346laboratory-associated infections due to, 63, 66–67from large-scale production, 565from mixing equipment, 297–298particle size of, 66, 67respirators for, 337–338safety containers for, 214in teaching laboratories, 539
Aflatoxin, 262, 267African horse sickness virus, 65African trypanosomiasis (Trypanosoma brucei), 147–150Agent-based risk assessment, 82–85Agricultural pathogens, 579–586; see also Plant
pathogensbiosafety levels for, 579–582facility for, certification of, 582–584
Agrobacterium, 36AIDS, see Human immunodeficiency virus infectionAir
changes per hour, 567compressed, 289contaminated, respirators for, see Respiratorsintake systems for, 288
Air conditioning systems, 287–288, 567–568Airborne allergens, 243–244Airborne pathogens, 209–220; see also Aerosols
bacteria as, 215, 217biosafety levels for, 210–211, 214–215fungi as, 217–219
597
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incident reporting practices for, 212Mycobacterium tuberculosis as, 210, 212–215, 217personal protective equipment for, 211–212regulations on, 215safety policy for, 210safety stratification for, 214–215, 216waste disposal procedures for, 212
Airflowin biological safety cabinets
Class I, 307–308Class II, 308–315
in fume hoods, 305in laboratory design, 287–288in large-scale production, 566in protective suits, 494in surgical masks, 329
Air-line respirators, 325–326Air-purifying respirators, 326Alarms
for BSL-4 laboratory, 507fire, 290for large-scale production, 569
Allergic reactions, 241–251allergens causing
environmental distribution of, 243–244surveillance of, 244–245types of, 242–243, 443–444
diagnosis of, 242, 245, 247emergency treatment of, 247epidemiology of, 443to laboratory substances, 68management of, 245–247, 443pathogenesis of, 241to plant pathogens, 43prevalence of, 241prevention of, 244–247risk factors for, 241–242, 244symptoms of, 241–242, 443
Alpha toxin, Staphylococcus aureus, 261Alphaviruses, 188–189, 517–518Alternaria, 171
allergic reactions to, 42in normal microbial flora, 8plant-associated, 36
Alternaria alternata, 169Amebiasis (Entamoeba histolytica), 23, 150–151American Biological Safety Association, 81–82American College of Laboratory Animal Medicine,
animal categories of, 21–23American Conference of Governmental Industrial
Hygienists, threshold limit values of, 330American Hospital Association, sharps injury prevention
program of, 349American Industrial Hygiene Association, fungal
handling requirements of, 175American Institute of Architects, Guidelines for
Construction and Equipment of Hospital and Medical Facilities, 278
American Society of Heating, Refrigeration and Air-conditioning Engineers (ASHRAE), fumehood test of, 306, 318–319
American Thoracic Society, safety stratification guidelines of, 214–215
American trypanosomiasis (Trypanosoma cruzi), 63, 119,126, 129, 142–147
American Type Culture Collection, 545, 555
Americans with Disabilities Act, 88Anaerobic bacteria, in normal microbial flora, 9–11Anaphylaxis, in animal allergy, 247Ancylostoma, 153Ancylostoma braziliense, 153Ancylostoma caninum, 153Ancylostoma duodenale, 15Animal(s)
agricultural, biosafety level for, 579–582infected, shipping of, 388laboratory, see Laboratory animalsprions in
biosafety of, 479–480experimental, 465monitoring for, 478–479regulations on, 465–478transmission of, 464–466, 474–479
toxins of, 253, 254, 262–263wild-caught, 19, 21zoonotic hazards of, 19–33, 443–444
Animal and Plant Health Inspection Service (APHIS), 44,433, 447–450
Anthrax, see Bacillus anthracisAntibiotics, resistance to, decontamination and, 379Anti-Terrorism and Effective Death Penalty Act of 1996,
590–593APHIS (Animal and Plant Health Inspection Service), 44,
433, 447–450Aphthovirus, 188Apoptosis, due to bacteria, 94Apprenticeship, for BSL-4 laboratory, 499–500Approved Codes of Practice (United Kingdom), 430Aprons, 299–300Arabidopsis thaliana, as model plant, 44Arboviruses, see also specific arboviruses
biosafety levels for, 366clinical manifestations of, 185diversity of, 182–183epidemiology of, 183–184laboratory-associated infections due to, 61, 62, 65, 182
Arenaviridae, 194–195, 489Arenaviruses, as bioterrorism agents, 587Argentine hemorrhagic fever virus, 186, 195Aroa virus, 189Arthroderma benhamiae, 63Arthropods, toxins of, 262Asahara, Shoko, as bioterrorist, 588Ascaris lumbricoides, 153Aspergillus
inhalation of, 539in normal microbial flora, 8in pharmaceutical production, 554–555proteases of, 15
Aspergillus flavus, 169, 262Aspergillus fumigatus, 169Aspergillus nominus, 262Aspergillus parasiticus, 169, 262Aspergillus terreus, 169Assigned protection factors, of respirators, 329–330Asthma, in animal allergy, 242, 247Astroviruses, 186Atmosphere-supplying respirators, 325–326Attenuated strains
risk assessment of, 85for teaching laboratories, 545of viruses, 513, 551–552
598 INDEX
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Audits, of biosafety programs, 446–448, 453–454Aum Shinrikyo (Aum Supreme Truth) cult,
as bioterrorist group, 588Australia, biosafety regulations of, 82–85, 89, 417–418Autoclaving
of Bacillus anthracis spores, 378in BSL-4 laboratory, 503in BSL-3Ag laboratory, 580facilities for, 285of prions, 380, 466of toxins, 267
Autographa california nuclear polyhedrosis virus, 520–521Automated equipment, containment enclosures for, 321Autopsy, in prion diseases, 464Avian influenza virus, 85, 86, 192–193Avian leukosis virus, 196Avirulent organisms, for teaching laboratories, 545
B virus, 197–198BSL-4 laboratory for, 489in laboratory animals, 21, 25–26laboratory-associated infections due to, 61, 65, 198,
300, 301Babesia, 128–129Babesia divergens, 128Babesia microti, 128Bacillary angiomatosis (Bartonella quintana), 109Bacille Calmette-Guérin vaccine, 112–113, 215Bacillus
in normal microbial flora, 6, 8as plant pathogen, 36
Bacillus anthracis, 102–103as bioterrorism agent, 378–379, 587–590decontamination of, 378–379laboratory-associated infections due to, 64respirator for, 334risk assessment of, 85in teaching laboratory, 543–544toxins of, 257vaccine for, 553work clothing contamination by, 300
Bacillus cereus, 102Bacillus subtilis
as BSL-1 agent, 542recombinant, in pharmaceutical production, 553
Bacillus thuringiensis, 365Baclovirus
as gene transfer vector, 520–521in pharmaceutical production, 552
Bacteria, see also specific bacteriacell line contamination with, 225–226, 235laboratory-associated infections due to, 56–57, 60–61,
63–64, 93–114pathogenicity of, 93–113in pharmaceutical production, 552–554
Bacteroides, 9, 10, 11, 101, 105Bacteroides fragilis, 101
in normal microbial flora, 10risk assessment of, 84
Bagaza virus, 189Balantidium coli, 24Balmuthia mandrillaris, 128Banzi virus, 189Barmah Forest virus, 188Barriers, 69
to ingestion, 368
to inhalation, 368for percutaneous exposures, 367–368primary, 280, 295–301, 366–367; see also Biological
safety cabinets (BSCs); Personal protective equipment; Respirators
animal housing, 295–296for blenders, 297–298for centrifuges, 296–297certification of, 318–319fermentors, 298fume hoods, 305–307, 318–321glove boxes, 315–322history of, 303–304for homogenizers, 297–298location of, 321for mixing equipment, 297–298positive-pressure suits, 298, 326, 333, 494–497, 500,
505–506selection of, 304–305for transport containers, 298use of, 321–322for vacuum protectors and traps, 298
secondary, 280Bartonella henselae, 109
airborne transmission of, 217in laboratory animals, 21, 27
Bartonella quintana, 109, 217Beauveria nivea, 554Bedding, for animals, fungi in, 174Behavioral factors, in laboratory-associated infections, 69Belgium, biosafety regulations of, 418–419Benches
for teaching laboratories, 532–534vertical-flow clean, 315
Beta toxin, Staphylococcus aureus, 261Bifidobacterium, 10Bioanalog test, for biological safety cabinets, 319Bio-clean systems, 317–318Biofilms, as virulence factors, 12Biohazard, definition of, 405Biological Control Act of 1984 (Australia), 418Biological Defense Program, 433Biological safety cabinets (BSCs)
in agricultural research laboratory, 581–582for automated equipment, 321in bioterrorism response vehicles, 321for blood-borne pathogens, 351BSL-3, 333BSL-4, 333, 503for cell lines, 228–230certification of, 318–319, 446, 449, 582Class I, 305, 307–308, 318–319Class II, 305, 308–314, 319Class III, 305, 316–317, 319, 321, 488, 492–494, 505gases in, 304–305history of, 303–304installation of, 230, 276laboratory design for, 274in large-scale production, 565–566location of, 321look-alikes of, 315, 319maintenance of, 230for molds, 164–165for mycobacteria, 213–215risk assessment for, 304–305in teaching laboratories, 534–535
INDEX 599
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for toxins, 265–266work practices for, 321–322
Biological safety officer, 496Biological toxins, see ToxinsBiological warfare, see BioterrorismBiopsy, brain, in prion diseases, 463Bioreactor bags, in pharmaceutical production, 559Biosafety, definition of, 531Biosafety guidelines, see GuidelinesBiosafety in Microbiological and Biomedical Laboratories
(CDC/NIH), 361, 432on BSL-4, 490on BSL-3 reverification, 450–452, 456–457on laboratory design, 276on laboratory management, 407, 408production quantities defined in, 562provisions of, 434on respirators, 333on risk assessment, 83–84on teaching laboratories, 542on zoonotic diseases, 23
Biosafety in the Laboratory: Prudent Practices for theHandling of Infectious Materials (NRC), 362,434–435
Biosafety levels, 362–363; see also specific organismsABSL-3, 582for airborne pathogens, 210–211, 214–215, 218for bacteria, 96–113BSL-1
for airborne pathogens, 211description of, 364–365for plant pathogens, 36, 44in teaching laboratories, 542
BSL-1LS, 365, 563, 567, 571BSL-1P, for plant pathogens, 44BSL-2
for airborne pathogens, 211for blood-borne pathogens, 346–347for cell lines, 228–230description of, 365in laboratory design, 273, 276, 277for parasites, 122for plant pathogens, 44in teaching laboratories, 542–543
BSL-2LS, 365, 563, 567–568, 572–574BSL-3
for agriculture, 594for airborne pathogens, 211for blood-borne pathogens, 347decontamination and, 376–377description of, 365floor cleaning, 415in laboratory design, 275, 276, 282–285in teaching laboratories, 543
BSL-3Ag, 579–582BSL-3LS, 366, 563, 567–568, 574–577BSL-3P, for plant pathogens, 44BSL-4, 487–508
accidents in, 489agents handled in, 489–490for airborne pathogens, 211animals in, 504–505apprenticeship for, 499–500autoclaves in, 503biological safety cabinet for, 488, 492–494, 503, 505CDC guidelines for, 490
centrifuges in, 504chemical use in, 503class III cabinet for, 488, 492–494, 505communication in, 501–502decontamination and, 376–377, 507description of, 366dunk tanks in, 504emergency response in, 505–506equipment maintenance in, 505gloves for, 497goals of, 488–489hazards in, 492hearing protection for, 495inside containment envelope procedures in, 501–505job hazard analysis for, 490, 491laboratory design for, 274, 275, 277, 506–507medical evaluation and surveillance in, 497need for, 487–488occupational medicine and, 444outside containment envelope procedures in,
500–501overview of, 488–492personnel suitability for, 496–497positive-pressure suits in, 298, 326, 333, 494–497,
500, 505–506risk assessment and risk management for, 490–492security issues in, 501sharps handling in, 503training for, 497–506waste management in, 505work practices in, 502
for cell lines, 228–230criteria for, 90decontamination and, 376–377description of, 364–366for fungi, 165–166, 218in laboratory design, 273, 276–277, 282–285for large-scale production, 362–363, 567–568, 571–577for mycobacteria, 214–215for pharmaceutical production, see Pharmaceutical
industryfor plant pathogens, 36, 42–43for prions, 380in teaching laboratories, 542–543for toxins, 265–266for viral vectors, 523–525
Biosafety manager, 447Biosafety manuals, see ManualsBiosafety programs
academic, 447–448for bioterrorism deterrence, 590–594communication in, 409–410components of, 445–446, 453–454documentation in, 410–411evaluation of, 445–457
administrative, 448–449audits in, 446–448BSL-2 level, 445, 453–454BSL-3 level, 446, 450–452select agent inspection in, 449–450
governmental, 448hazard identification in, 406–407hospital, 448industrial, 448legal requirements of, 407management of, 405–415
600 INDEX
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benefits of, 405BSL-4 laboratory, 490–492corrective action in, 412implementation in, 408–411ineffective, 405monitoring in, 411–412planning in, 406–408policy for, 406preventive action in, 412review in, 412–414
objectives of, 407–408policy for, 406for respiratory protection, 331responsibility assignment in, 408structure of, 408for teaching laboratories, 544training in, 408–409; see also Trainingtypes of, 447–448
Biosafety regulations, see RegulationsBioterrorism, 587–596
agents used in, 587–590BSL-4 laboratory for, 487security for, 501
biological safety cabinets for, 321decontamination for, 378–379definition of, 587history of, 587–590programs deterring, 590–594regulatory agencies involved in, 364teaching laboratory and, 543–545
Bipolaris, 36, 171Bird flu virus, 85, 86, 192–193Bites
arthropod, 262mosquito, 132–137rat, 31, 105, 109sand fly, 129snake, 263
Black lamps, 541Blastomyces dermatitidis, 169–170, 174
airborne, 209, 217laboratory-associated infections due to, 63safety measures for, 166, 167
Bleach, see Sodium hypochloriteBlenders, 297–298, 351Blood, prion transmission in, 468–474Bloodborne Pathogen Standard (OSHA), 96–97, 122,
364, 432adherence to, 445, 453–454airborne pathogens and, 212basic requirements of, 348effectiveness of, 355–356glove use, 300gown use, 299medical care in, 355as performance standard, 347for pharmaceutical production, 559revised (2001), 348sharps disposal specifications of, 350training program in, 354–355
Blood-borne pathogens, see also specific pathogens, e.g.,Human immunodeficiency virus
biosafety levels for, 346–347decontamination of, 352–353definition of, 341medical care related to, 355
risk assessment of, 341–346Standard precautions for, see Standard (Universal)
PrecautionsBolivian hemorrhagic fever virus, 195Bordetella, toxin of, 255Bordetella pertussis
as BSL-2 agent, 542laboratory-associated infections due to, 61, 64vaccine for, 546, 553
Borna virus, 365Borrelia, 103–104Borrelia burgdorferi, 104Borrelia hermsii, 103–104Borrelia recurrentis, 103–104Botulism, see Clostridium botulinumBovine spongiform encephalopathy, 461, 462, 465
cell line contamination and, 226monitoring for, 478–479regulations on, 476–478transmission of, 474–475
Bovine viral diarrhea virus, 189, 225, 227Boxes, glove, see Glove boxesBrain
biopsy of, in prion diseases, 463prions in, see Prions
Brazilian hemorrhagic fever virus, 186Brill-Zinsser disease (Rickettsia prowazekii), 110, 297Brucella, 24–25
airborne transmission of, 215, 217laboratory-associated infections due to, 54, 60, 61, 63,
64, 296Brucella abortus, 55, 63–64, 105Brucella canis, 64, 105Brucella melitensis, 55, 60, 63, 64, 105–106Brucella suis, 105, 365BSCs, see Biological safety cabinets (BSCs)Budget constraints, in laboratory design, 278Buildings
design of, see Laboratory designsafety codes for, 280
Bunyaviridae, 193–194, 489Bunyaviruses
as bioterrorism agents, 587diversity of, 183in laboratory animals, 29
Bureau of Medical Devices and Radiological Health, 433Bureau of Veterinary Medicine, 433Burkholderia, 36, 106Burkholderia cepacia, 35Burkholderia mallei, 106Burkholderia pseudomallei, 106
airborne transmission of, 215, 217laboratory-associated infections due to, 55, 61
Bussuquara virus, 189
Cabinets, see Biological safety cabinets (BSCs)Cacipacore virus, 189Cages
access to, 282aerosol hazards from, 295–296
Campylobacter coli, 26Campylobacter enteritidis, 61Campylobacter fetus, 26Campylobacter hyointestinalis, 26Campylobacter jejuni, 26Canada, biosafety regulations of, 82–85, 89–90, 419–421
INDEX 601
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Canadian Environmental Protection Act, 419Candida, 8, 9, 11, 167Candida albicans, 167–168, 542Candida glabrata, 167–168Candida tropicalis, 167–168Canine hepatitis virus, 542Capnocytophaga, 9Capnocytophaga canimorsus, 26Capnocytophaga cynodegmi, 26Capsules, as virulence factors, 13Carcinogens, in biological safety cabinets, 304Cardiovirus, 188Carriers, 4Casework systems, 291–292, 506Castor bean, ricin from, 263Cat(s)
allergens of, 243–244feline spongiform encephalopathy in, 465natural pathogens of, 20zoonosis associated with, 26
Cat scratch fever (Bartonella henselae), 21, 27, 109Categorisation of Biological Agents According to Hazard and
Categories of Containment (United Kingdom), 431Cattle, prion disease of, see Bovine spongiform
encephalopathyCDC, see Centers for Disease Control and Prevention
(CDC)Ceilings
in agricultural research facility, 581for large-scale production, 567
Cell(s)apoptosis of, 94damage of, 93–97death of, 93lysis of, 93–94mechanical disturbances of, 94metabolic alterations in, 94
Cell banks, 231Cell lines, 221–239
acquired properties of, 228applications of, 221, 222characterization of, 232–235contamination of, 222, 224–227, 235–237culture vessels for, 564–565cytogenic analysis of, 234DNA fingerprinting of, 234–235for gene therapy, 222, 230growth of, 232–233historical review of, 221immortalized, 227–228immunological characteristics of, 234information resources for, 237isoenzyme patterns of, 233for large-scale production, 231–232list of, 223molecular characterization of, 234morphology of, 233in pharmaceutical production, 222, 555, 558–559plating efficiency of, 233primary, 227protein-free, 228–229quality standards for, 237quarantine for, 229recombinant, 228risks of, 224–227, 227–228safety measures for, 228–232
serum-free, 228–229shipping of, 230sources of, 227as test systems, 224for transplants, 223–224, 230tumorigenicity of, 237
Cell-associated toxins (endotoxins), 15, 94–96, 255, 257Center for Infectious Diseases, risk assessment informa-
tion from, 82Centers for Disease Control and Prevention (CDC)
Biosafety in Microbiological and Biomedical Laboratories,see Biosafety in Microbiological and BiomedicalLaboratories (CDC/NIH)
biosafety program inspection by, 447biosafety regulations of, 90Division of Parasitic Diseases, 121–122Drug Service, 122fungal safety measures of, 164–166hantavirus recommendations of, 337laboratory guidelines of, 362–363personal protective equipment recommendations
of, 299Primary Containment for Biohazards: Selection,
Installation and Use of Biological Safety Cabinets, 434risk assessment information from, 82safety policy guidelines of, 210Select Agent Program administration by, see Select
Agent Programsharps injury prevention program of, 349teaching resources of, 545
Central European tick-borne encephalitis virus, 489Centrifuges, 296–297, 504Cephalosporium, toxin of, 262Cephalosporium acremonium, 365Cercopithecine herpesvirus 1 (B virus), 197–198
BSL-4 laboratory for, 489in laboratory animals, 21, 25–26laboratory-associated infections due to, 61, 65, 198,
300, 301Certification
of agricultural research facility, 582–584of barriers, 318–319of biological safety cabinets, 318–319, 446, 449, 582of containment rooms, 582–583of fume hoods, 318–319of glove boxes, 319of greenhouses, 584of HEPA filters, 582for shipping, 398
Cestodes, 153–154Chagas’ disease (Trypanosoma cruzi), 63, 119, 126, 129,
142–147Chain of infection, 373Chemicals
in biological safety cabinets, 304in BSL-4 laboratory, 503in glove boxes, 316for plant pathogen control, 44respirator removal of, 329, 333for showers, 500–501for toxin inactivation, 267
Chemturion reusable level A suit, 494–495Cheyletiella parasitivorax, 28Chikungunya virus, 188
clinical manifestations of, 185laboratory-associated infections due to, 65, 182
602 INDEX
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Chlamydia, laboratory-associated infections due to, 60, 61Chlamydia pneumoniae, 108–109Chlamydia psittaci, 108–109Chlamydia trachomatis, 64, 108–109Chlamydophila abortus, 27Chlamydophila pecorum, 27Chlorine dioxide gas, for decontamination, 377Cholera, see Vibrio choleraeChromoblastomycosis, 170–171Chronic wasting disease, 461, 462, 465, 479Cladophialophora bantiana, 166, 171Classification of Microorganisms (European Union),
421–422Classrooms, see Teaching laboratoriesClean air fume hood, 315Cleaning, in large-scale production, 566–567Clean-in-place system, 566Clinical and Laboratory Standards Institute
parasite standards of, 122work practice monitoring by, 354–355
Clinical laboratory design, 277–278, 281Closed processing, in pharmaceutical production, 558–559Clostridium
abscess from, 101as BSL-2 agent, 542in normal microbial flora, 10
Clostridium botulinumhost cell metabolic alterations due to, 94toxin of, 254, 255, 257, 260, 587, 588
Clostridium difficile, toxin of, 102Clostridium perfringens, 94, 102, 255Clostridium tetani
host cell metabolic alterations due to, 94toxins of, 14, 54, 255, 260vaccine for, 546, 553
Clothingchanging
in agricultural laboratory, 580in BSL-4 laboratory, 266in BSL-3Ag laboratory, 580
protective, 299–301, 367for blood-borne pathogens, 354for toxins, 266
Coagulopathy, in hemorrhagic fevers, 186Coats, lab, 299–300Coccidioides, 174
as BSL-3 agent, 543epidemiology of, 164in fomites, 174safety measures for, 166–167
Coccidioides immitis, 170airborne, 209, 217–218cultures of, 217–218laboratory-associated infections due to, 63safety measures for, 166–167transport of, 167
Coccidioides posadasii, 166, 167, 170Code of Federal Regulations, 432Collagenase, as virulence factor, 15College of American Pathologists, safety policy
guidelines of, 210Colletotrichum, 36Colon, normal microbial flora of, 10–11Colonization, 4; see also Microbial flora, normal
of newborn infant, 6as virulence factor, 11–13
Commensal flora, see Microbial flora, normalCommission of the European Communities
Directorate-General XII for Science, Research and Development, 230
Committee for Human Medicinal Products (EuropeanMedicinal Evaluation Agency), prion regulationsof, 472–473, 475–477
Committee for Proprietary Medicinal Products, prionregulations of, 472
Committee on Hazardous Biological Substances in theLaboratory (NRC), 363–364
Communicationin biosafety programs, 409–410in BSL-4 laboratory, 501–502in large-scale production, 569in occupational medicine programs, 442system for, design of, 291
Complement, resistance to, 13–14Comprehensive Guide to Steam Sterilization and Sterility
Assurance in Health Care Facilities, 380Compressed-air systems, 289Computer system, 291Cone snail toxin, 263Conference space, in laboratory design, 280–281Conotoxins, 263Consultants, for biosafety program evaluation, 447Contagious echythma (orf), in laboratory animals, 29–30,
199–200Containers, for specimen transport, 298Containment, 69; see also Barriers
of agricultural pathogens, 579–584of airborne pathogens, 209–220certification of, 582–583of fungi, 164–166laboratory design for, 282–285levels of, see Biosafety levelsmaximum, see Biosafety levels, BSL-4of Mycobacterium tuberculosis, 213–214of parasites, 122physical, 558–559of plant pathogens, 43–44primary, see also Barriers, primary
definition of, 304for large-scale production, 563–566
requirements for, 96–97secondary, 285
for accidental releases, 557in large-scale production, 566–569
Containment research laboratories, design of, 276–277
Contaminationof cell lines, 222, 224–227, 235–237of gloves, 354of lab coats, 299–300of pipettes, 369of surfaces, prevention of, 352–353with toxins, 265–266
Continuous cell lines, 221, 222, 227–228Control of Communicable Disease Manual, 23, 84Control of Substances Hazardous to Health Regulations, 1999
(United Kingdom), 430–431Controlled Products Regulations (Canada), 420Coordinated Framework for Regulation of
Biotechnology, 364Coronaviridae, 189–190Coronavirus, 185
INDEX 603
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Corridorsin laboratory design, 281in large-scale production, 568
Corynebacterium, saprophytic, 6, 8Corynebacterium diphtheriae
laboratory-associated infections due to, 64toxin of, 14vaccine for, 546, 553
Cost constraints, in laboratory design, 278Coveralls, 299–300Cowpox virus, 512–513Coxiella burnetii, 110, 112
biosafety levels for, 365as BSL-3 agent, 543in laboratory animals, 21, 30laboratory-associated infections due to, 54, 61, 65, 67, 296work clothing contamination by, 300
Coxsackievirus, 66, 67, 185, 188Creutzfeldt-Jakob disease, 461, 462
autopsy in, 464brain biopsy in, 463decontamination protocols for, 379–380familial, 461iatrogenic, 468management of, 463regulations on, 472–474sporadic, 461transmission of, 380, 468–471
Crimean-Congo hemorrhagic fever virus, 183, 193–194BSL-4 laboratory for, 489clinical manifestations of, 185, 186, 187
Critical systems checklist, for BSL-4 laboratory, 500Cryogenic liquids, in BSL-4 laboratory, 503Cryptococcus neoformans, 168
as BSL-2 agent, 542capsule formation by, 13in fomites, 174in laboratory animals, 174
Cryptosporidium, 27, 62–63, 66Cryptosporidium canis, 27Cryptosporidium felis, 27Cryptosporidium hominis, 150Cryptosporidium parvum, 27, 150Ctenocephalides canis, 28Ctenocephalides felis, 28C-type particles, cell line contamination with, 225Culture(s)
airborne pathogens from, 210, 213cell, see Cell linesdisposal of, 353fungal, 166, 217–219for pharmaceutical production, 556removal of, from teaching laboratories, 536security for, 557–559transport of, 352
Culture mediacell line contamination with, 226–227facilities for, 286
Current good manufacturing practices, 555Curvularia, 36, 171Cyclospora cayetanensis, 150–152Cytogenic analysis, of cell lines, 234Cytotoxins, 14
Dangerous goods, shipping of, see Transport and shippingDangerous Goods Regulations (IATA), 384, 386, 392–394
De minimus releases, 557Decontamination, 367
of agricultural research effluents, 581antibiotic resistance and, 379of bioterrorism agents, 378–379of BSL-4 laboratory, 507of Clostridium botulinum toxin, 260definition of, 375–376laboratory design for, 292of laboratory equipment, 353of large spaces, 376–377in large-scale production, 566–567, 569of liquid effluents, 285methods for, 375–376of prions, 379–380of protozoan oocysts, 151purpose of, 375of surfaces, 352–353, 375, 377–378, 566–567terminology of, 374–375of toxins, 267ultraviolet radiation for, 541validation of, 379of wastes, 353, 569
Dehydration, in BSL-4 laboratory, 505–506Delta Protection suit, 494Delta toxin, Staphylococcus aureus, 261Dematiaceous fungi, 170–171Dengue viruses, 65, 183, 186, 189Dental plaque, microflora of, 94-Deoxynivalenol, 262Department of Agriculture, see United States
Department of Agriculture (USDA)Department of Health and Human Services,
Select Agent Program and, see Select AgentProgram
Department of Transportation (DOT)bioterrorism regulations of, 594shipping regulations of, 435
certification for, 398labeling, 392–394marking packages, 392–394packaging, 385refrigerants, 395, 397–398training for, 398
Dermacentor variabilis, 28Dermatophytes, 163, 171, 174
in laboratory animals, 27safe handling of, 175
Design, laboratory, see Laboratory designDiacetoxyscirpenol, 262Diagnostic specimens, shipping of, see Transport and
shippingDiarrhea, bacteria causing, 101–102Dinoflagellates, toxins of, 263Diphtheria, see Corynebacterium diphtheriaeDisabled persons
laboratory design for, 280legislation on, 88in teaching laboratory, 546
Disasters, teaching laboratory preparation for, 536–537Disease, vs. colonization, 4Disinfectants
for Bacillus anthracis spores, 378for blood-borne pathogens, 352glove damage from, 495hand sanitizers, 535
604 INDEX
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for showers, 500–501for surfaces, 377–378
Disinfectionclassification of, 375in large-scale production, 566in pharmaceutical production, 556–558principles of, 374–375
Disposal, see Waste handling and disposalDNA
oncogenic, in cell lines, 222recombinant, see Recombinant DNA
DNA fingerprinting, of cell lines, 234DNA viruses, 182–183DNases, as virulence factors, 15Documentation
in biosafety program, 410–411of occupational injury, 439in occupational medicine programs, 442for shipping, 394–396
Dogsallergens of, 243natural pathogens of, 20zoonosis associated with, 26
Domestic Mail Manual, 385, 433Doors
laboratory, 281, 283, 580for large-scale production, 567
DOT, see Department of Transportation (DOT)Drainage systems, in laboratory design, 289Droplet nuclei, Mycobacterium tuberculosis, 212–215Dry ice, for shipping, 395, 397–398Ductwork, testing of, 583–584Dugbe virus, 65Dunk tanks, for BSL-4 laboratory, 504Dwarf tapeworm (Hymenolepis nana), 153
Ear, normal microbial flora of, 8Earthquakes, teaching laboratory preparation for, 536–537Eastern equine encephalitis virus, 188
as bioterrorism agent, 587clinical manifestations of, 185
Ebola Reston virus, 490Ebola virus, 183, 191
biosafety levels for, 366as bioterrorism agent, 588BSL-4 laboratory for, 487, 489clinical manifestations of, 186laboratory-associated infections due to, 61, 62needlestick accident with, 489
Echinococcus, 28, 153Echinococcus granulosus, 28, 153Echinococcus multilocularis, 28, 153Echinococcus oligarthrus, 28, 153Echinococcus vogeli, 28, 153Echoviruses, 185, 188Ecthyma, contagious (orf), 29–30, 199–200Ectoparasites, of laboratory animals, 25, 28Edema factor, Bacillus anthracis, 257Educational institutions, see Teaching laboratoriesEffluents, from BSL-3Ag laboratory, 581Eikenella, in normal microbial flora, 9Elastinase, as virulence factor, 15Electrical hazards, in teaching laboratories, 541–542Electrical systems, 290–291Electron microscopy, for cell line contamination
detection, 236
Emergency power, 290Emergency response
to accidental releases, 557in biosafety programs, 411in bioterrorism situation, 592in BSL-4 laboratory, 502, 505–506training in, 440
Employees, see Personnel/employees/workersEmployment Standards Administration, 442Encephalitis, in viral infections, 185Endemic typhus (Rickettsia prowazekii), 110, 297Endogenous reservoirs, of microorganisms, 4Endotoxins, 15, 94–96, 255, 257Energy costs, in laboratory design, 274–275Engineering controls
for aerosols, 368–369for blood-borne pathogen exposure, 347–351
Entamoeba histolytica, 23, 150–151Entebbe bat virus, 189Enterobacter, 6, 36Enterobacter aerogenes, 84Enterobacteriaceae, 101–102
as BSL-2 agent, 542in normal microbial flora, 10, 11
Enterobius vermicularis, 153Enterococcus, 11, 15Enterococcus faecalis, 11, 97Enterococcus faecium, 97Enterotoxins, 255, 587Enteroviruses, 188Entry and exit procedures, for BSL-4 laboratory, 500env gene
in lentiviruses, 514–515in retroviruses, 513–514
Environmental factorsin BSL-4 laboratory, 492in laboratory-associated infections, 69, 373in large-scale production, 562–563
Environmental Protection Agency (EPA), 433National Oil and Hazardous Substances Pollution
Contingency Plan of, 593–594Environmental rooms, 286Environmental samples, in teaching laboratories, 536EPA, see Environmental Protection Agency (EPA)Epidermophyton, 171Epstein-Barr virus
cell line contamination with, 225clinical manifestations of, 185, 186
Equine encephalitis viruses, as bioterrorism agents, 587Equine infectious anemia virus, 514, 551Equipment
for allergen control, 245decontamination of, see Decontaminationdisinfection of, 566grounding of, 290hazard warnings for, 367for large-scale production, 563–566maintenance of, in BSL-4 laboratory, 505personal protective, see Personal protective equipmentpower supply for, 290–291selection of, 291–292for support rooms, 285–287for toxin handling, 265–266
Erwinia, 542Erysipelothrix rhusiopathiae, 28, 110Escape self-contained breathing apparatuses, 326
INDEX 605
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Escherichia coliabscess from, 101adherence of, 12biosafety levels for, 365clinical manifestations of, 101–102laboratory-associated infections due to, 64in normal microbial flora, 10, 11recombinant, in pharmaceutical production, 553serum-resistant, 14toxins of, 255, 260
Esophagus, normal microbial flora of, 9Etiologic agents, definition of, 587Eubacterium, 10European Federation Biotechnology group, risk groups
of, 224European Medicinal Evaluation Agency, prion
regulations of, 472–473, 475–477European Union
biosafety regulations of, 82–85, 90, 421–422prion regulations of, 472–478
European Working Group of Human Gene Transfer andTherapy, 230
Exempt substances, shipping of, 388, 392Exhaust
from animal facilities, 287–288from biological safety cabinets
Class I, 307Class II, 308, 310–315Class III, 316–317
from culture systems, 564from fermentors, 298from fume hoods, 305–306from large-scale production, 568
Exogenous reservoirs, of microorganisms, 4Exotic ungulate encephalopathy, 465Exotoxins, 14–15, 94–96, 255, 257Exposure, see also specific substances
to allergens, 244barriers to, see Barriersto blood-borne pathogens, 341–346, 355in BSL-4 laboratory, 505determination of, in risk assessment, 87to fungi, 175to HIV, 341–346to laboratory-associated pathogens, 63–67routes for, 361to toxins, 254–255
Extinguishers, fire, 289Eye
infectious agent contact with, 300–301, 539normal microbial flora of, 7–8protection of, 266, 300–301, 366–367
Eyewash fountains, 265, 289, 535
Face, protection of, 266, 300–301, 354Facepieces, for respirators, 326Facilities
allergen control in, 245animal, 281–282, 285, 287–288design of, see Laboratory design; Large-scale
productionFacilities Design Standards (USDA), 579Factories Act, 1955 (Ireland), 426Fasciola hepatica, 153–154Fatal familial insomnia, management of, 463FDA (Food and Drug Administration), 433, 472, 477–478
Feces, normal microbial flora in, 9–10Federal Aviation Administration, inspections by, 398Federal Bureau of Investigation
background checks by, 590terrorism definition of, 587
Federal Transportation of Dangerous Goods Act, 1992(Canada), 420
Feline coronavirus, 189Feline immunodeficiency virus, 514Feline leukemia virus, 196Feline sarcoma virus, 225Feline spongiform encephalopathy, 465Fermentors, 298, 558–559, 564–565Fever, in viral infections, 185Filariasis, 153Filoviridae, 190–191, 489Filoviruses
as bioterrorism agents, 587laboratory-associated infections due to, 61, 65
Filter bonnet, for animal cages, 295Filters
in biological safety cabinets, 308, 310, 312–315for culture systems, 564HEPA, see HEPA filtersin laboratory design, 277, 285, 291for plant pathogen protection, 43for respirators, 327–329, 333in surgical masks, 329
Fire, in teaching laboratories, 541–542Fire protection, 289–290First aid, 439Fit testing, of respirators, 331–332Flaviviridae, 489Flaviviruses, 189, 587Fleas, of laboratory animals, 25, 28Flooding, teaching laboratory preparation for, 536–537Floors, 281, 283–284
in agricultural research facility, 581in BSL-4 laboratory, 506cleaning of, 415in large-scale production, 566–567
Flukes, 153–154Fluorescence antibody test, of cell lines, 234Foamy virus, 32, 196, 225Fomites, fungi associated with, 174–175Fonsecaea pedrosoi, 170–171Food
prions in, 475in teaching laboratories, 536, 538toxins in, 260–261, 262
Food and Drug Administration (FDA), 433, 472, 477–478Foot-and-mouth-disease virus, 188Formaldehyde, for decontamination, 377Fountains, eyewash, 535Fowl plague virus, 197, 300France, biosafety regulations of, 422–423Francisella tularensis, 107–108
airborne transmission of, 215, 217as bioterrorism agent, 587as BSL-3 agent, 543laboratory-associated infections due to, 54, 61, 64, 67risk assessment of, 85
Fume hoods, 305–307certification of, 318–319clean air, 315continuous-bypass, 305
606 INDEX
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island, 320location of, 321low-flow, 320specialized, 306–307triple, 319work practices for, 321–322
Fumigation, 377Fungi, 163–178; see also specific fungi
airborne transmission of, 217–219biosafety levels for, 165–166cell line contamination with, 235cultures of, 166, 217–219epidemiology of, 164in fomites, 174–175as frank pathogens, 163inhalation of, 539in laboratory animals, 174laboratory-associated infections due to, 59, 63, 66,
163–178, 217–219in medical specimens, 175in normal microbial flora, 6–11opportunistic, 163in pharmaceutical production, 554–555plant-associated, 36, 39–42regulations for, 166–167safety measures for, 164–166shipping of, 167of special concern, 166toxins of, 169, 267, 587virulence of, 163
Fusarium, 171–172allergic reactions to, 42plant-associated, 36toxin of, 262, 587
Fusarium graminearum, 169Fusarium sporotrichoides, 169Fusobacterium, 9, 10Fusospirochetes, 105
gag genein lentiviruses, 514–515in retroviruses, 513–514
Gamma toxin, Staphylococcus aureus, 261Gases, 289
in biological safety cabinets, 304for large-scale production, 568removal of, in respirators, 328–329, 333
Gastroenteritis, in viral infections, 186Gastrointestinal tract, normal microbial flora of, 8–11Gene therapy, cell lines for, 222, 230Gene transfer vectors, 509–529
adeno-associated viruses, 517, 523adenovirus, 515–517, 522alphavirus, 517–518baclovirus, 520–521biology of, 511characteristics of, safety issue and, 521–523containment levels for, 523–525herpesvirus, 518–520history of, 509–510large-scale considerations in, 525–526lentivirus, 514–515, 525poxvirus, 511–513replication-defective, 522retrovirus, 513–514, 522, 525side effects of, 521–523
General Labor Protection Rules (Belgium), 419General Order on Health and Safety at Work of 9 March
1971 (Spain), 429General Respiratory Protection Standard (OSHA), 331Generator, emergency, 290Genetic Manipulation Advisory Committee
(Australia), 418Genetic Manipulation Regulations (United Kingdom), 431Genetically modified organisms (GMOs)
regulations on, 418, 421, 431shipping of, 388
Genitourinary tract, normal microbial flora of, 11Geotrichum, 9German Microorganism and Cell Culture Center, 545Germany, biosafety regulations of, 423–426Germicidal lamps, 541Germicides
activity levels of, 375, 376for Bacillus anthracis spores, 378–379in disinfection, 375resistance to, 374Spaulding classification of, 375for surfaces, 377–378
Gerstmann-Straüssler-Scheinker syndrome, 463Getah virus, 188Giardia, 28Giardia duodenalis, 28Giardia intestinalis, 28, 150–151Giardia lamblia, 28, 150–151Gibberella, toxin of, 262Gingiva, normal microbial flora of, 9Gingivostomatitis, ulcerative, 105Glanders (Burkholderia mallei), 106Glasses, safety, 266Glassware
breakage of, 348–351, 503, 540cleaning of, 286
Glove(s), 300for blood-borne pathogens, 353for BSL-4 laboratory, 495changing, 354double, 353–354holes in, 354materials for, 353–354puncture resistance of, 353–354for toxins, 266types of, 353–354
Glove boxes, 315–320applications of, 315–316bio-clean system as, 317–318BSC class III as, 316–317, 319, 321certification of, 319design of, 315location of, 321pharmacy, 317specialized, 319–320work practices for, 321–322
GMOs (genetically modified organisms), 388, 418, 431Goggles, 266, 366–367Gonorrhea, see Neisseria gonorrhoeaeGood biosafety practices, 555Good laboratory practices, for cell lines, 237Good large-scale practices, 525, 563, 570Good manufacturing practices, 555Government, see also Regulations; specific agencies
laboratory facilities of, evaluation of, 448
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Gowns, 299–300, 367for blood-borne pathogens, 354for toxins, 266
Greenhousescertification of, 584construction of, 581pathogens in, see Plant pathogens
Growth chambers, plant pathogens in, see Plantpathogens
Guide for the Care and Use of Laboratory Animals (NRC),281–282, 504
Guidelinesfor biohazard handling
Australia, 418Canada, 420–421France, 422–423Germany, 424–426United Kingdom, 431–432United States, 434–435World Health Organization, 435
Biosafety in Microbiological and Biomedical Laboratories,see Biosafety in Microbiological and BiomedicalLaboratories (CDC/NIH)
extent of service, 214–215host-agent-activity triad and, 88laboratory, CDC, 362–363for plant pathogen containment, 44for recombinant DNA, 86, 87, 90, 212, 361–364, 432,
445, 448–449for safety policy, 210safety stratification, American Thoracic Society,
214–215for toxin handling, 594for waste handling and disposal, 363–364
Guidelines for Assessing the Risk of Exposure toBiological Contaminants in the Workplace(Australia), 418
Guidelines for Construction and Equipment of Hospital andMedical Facilities, 278
Guidelines for Deliberate Release of GMOs (Australia), 418
Guidelines for Research Involving Recombinant DNAMolecules (NIH), 361–362, 446, 448–449
on Escherichia coli strains, 533on laboratory management, 407
Guidelines for Small-Scale Genetic Manipulation atWork (Australia), 418
Guidelines for the Safe Transport of Infectious Substances andDiagnostic Specimens (WHO), 435
Guinea pigs, allergens of, 243
Haemophilus influenzaeimmunoglobulin A proteases of, 13iron acquisition mechanisms of, 12in normal microbial flora, 8risk assessment of, 84vaccine for, 546, 553
Hair, normal microbial flora of, 7Half-mask respirators, 326Hamsters, prion diseases in, 465Handwashing, 367
for blood-borne pathogen control, 352sinks for, 535
Hantaviruses, 183, 193–194BSL-4 laboratory for, 489clinical manifestations of, 185, 186
in laboratory animals, 29laboratory-associated infections due to, 61respirator for, 337
Harris, Larry Wayne, as bioterrorist, 588Hazard(s)
aerosol, 295–296assessment of, see Risk assessmentdefinition of, 405electrical, 541–542identification of, 264–265, 406–407in teaching laboratories, 531, 540–542warning signs for, 367zoonotic, 19–33, 443–444
Hazard groups, European Union, 421–422Hazardous Materials Information Review Act
(Canada), 420Hazardous Products Act (Canada), 420Head covering, 300Health and Safety at Work Act, 1974 (United Kingdom),
430–432Health and Safety Authority (Ireland), 426Health and Safety Commission (United Kingdom), 430Health and Safety Executive regulations (United
Kingdom), 430–432, 559Health and Safety (Dangerous Pathogens) Regulations, 1981
(United Kingdom), 430Health care facilities, evaluation of, 448Hearing protection, for protective suits, 495Heat, for toxin inactivation, 267Heating and air conditioning systems, 287–288, 567–568Heat-labile toxin, Shigella, 260Helicobacter, 9Helicobacter pylori, 102
laboratory-associated infections due to, 61motility of, 12
Helmets, 326Helminths, laboratory-associated infections due to,
117–118, 153–154Hemorrhagic fever viruses, see also specific viruses
biosafety levels for, 366as bioterrorism agents, 587clinical manifestations of, 186
Hemorrhagic fever with renal syndrome, 183, 194Hendra virus, 192, 487, 489HEPA filters
in animal housing, 295–296in biological safety cabinets
Class I, 307–308Class II, 308, 310, 312–315Class III, 492
in BSL-3Ag laboratory, 580–582certification of, 582in culture systems, 564definition of, 303in laboratory design, 285, 291in protective suits, 494–495in respirators, 328–329
Hepacivuses, 189Hepatitis, in viral infections, 185–186Hepatitis A virus
clinical manifestations of, 186laboratory-associated infections due to, 188vaccine for, 555
Hepatitis B virus, 200–201baculovirus hybrid of, 521biosafety levels for, 365
608 INDEX
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as BSL-2 agent, 542cell line contamination with, 225clinical manifestations of, 185, 186epidemiology of, 342, 356as gene transfer vectors, 521incubation period of, 185laboratory-associated infections due to, 61, 62, 201transmission of, 341–342vaccine for, 62, 201
Hepatitis C virus, 189baculovirus hybrid of, 521as BSL-2 agent, 542clinical manifestations of, 185, 186epidemiology of, 342laboratory-associated infections due to, 62transmission of, 342
Hepatitis D virus, 186, 201Hepatitis E virus, 186Hepatotoxins, 14Hepatovirus, 188Herpes simplex viruses, 197–198, 518–520, 523Herpesviridae, 489Herpesvirus simiae, see B virusHerpesviruses, 197–198, 518–520Highly pathogenic avian influenza virus, 85, 86, 192–193Histoplasma capsulatum, 172, 174
airborne, 209, 217–218culture of, 217–218in fomites, 174in pharmaceutical production, 554risk assessment of, 86safety measures for, 166, 167
HIV infection, see Human immunodeficiency virus infection
Hog cholera virus, 189Homogenizers, 297–298Hoods
fume, 305–307, 318–321for head, 326
Hospital disinfectants, 375Hospital laboratories, evaluation of, 448Host
agent-activity interactions with, 87–88normal microbial flora relationship with, 3–5
Host defenses, 3eye, 7–8gastrointestinal tract, 8–11genitourinary tract, 11laboratory-associated infections and, 68–69respiratory tract, 8in risk assessment, 87–88skin, 6–7virulence factors evading, 13–14
Human immunodeficiency virus, 196biosafety regulations for, 83as BSL-2 agent, 542cell line contamination with, 225engineering controls for, 351as gene transfer vector, 514–515, 522glove protection from, 353mucous membrane exposure to, 346in pharmaceutical production, 552single exposure to, 345–346
Human immunodeficiency virus infectionclinical manifestations of, 186epidemiology of, 342–343
laboratory-associated, 62, 65–66, 68, 196, 296occupational, 341–347prophylaxis for, 196–197surveillance data on, 343transmission of, 342–346
Human papillomavirus, 225Human Pathogens Importation Regulations
(Canada), 420Human T-cell leukemia virus, 196
cell line contamination with, 225clinical manifestations of, 186
Hyaluronidase, as virulence factor, 15Hydatid disease, 28Hydrogen peroxide, for decontamination, 377, 378Hydrolytic enzymes, as virulence factors, 15Hymenolepis nana, 153Hypoxia, in BSL-4 laboratory, 505
IATA, see International Air Transport Association (IATA)ICAO (International Civil Aviation Organization)
biosafety regulations of, 435shipping regulations of, 383, 384, 389
Ice, for shipping, 395, 397–398Iguape virus, 189Ilhéus virus, 189Immune function, normal microbial flora and, 5Immune response, in bacterial infections, 94Immunodeficiency
conditions causing, 68laboratory-associated infections in, 68–69opportunistic infections in, 4plant pathogens and, 43in teaching laboratories, 546–547in viral infections, 186
Immunoglobulin(s), production of, normal microbial flora in, 5
Immunoglobulin A, proteases for, as virulence factors, 13
Improvement of the Safety and Health of Workers at theWorkplace (Italy), 427
Inactivationof alphaviruses, 518of baculoviruses, 521of bioterrorism agents, 378–379in pharmaceutical production, 556–558of prions, 463, 466
Incidents, reporting of, 212Incineration, 292
for Bacillus anthracis spores, 378for toxin inactivation, 267
Indigenous flora, see Microbial flora, normalIndustrial biosafety programs, evaluation of, 448Infection at Work: Controlling the risks, 2003 (United
Kingdom), 431–432Infections, laboratory-associated, see Laboratory-associated
infectionsInfectious bovine rhinotracheitis virus, 225Infectious dose, of viruses, 184Infectious substances
safety audit of, 446shipping of, see Transport and shipping
Influenza viruses, 192–193clinical manifestations of, 185as gene transfer vectors, 521laboratory-associated infections due to, 62, 65, 193risk assessment of, 85, 86
INDEX 609
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Information management system, 291Ingestion, 14
barriers to, 368of microorganisms
stomach microflora and, 9–10in teaching laboratories, 538
of toxins, 14, 254of Toxoplasma gondii, 139
Inhalation, see also Airborne pathogensbarriers to, 368of fungal spores, 169–174of HIV, 346of microorganisms, in teaching laboratories, 539protection against, see Respiratorsof ricin, 264of toxins, 254
Injuries, see also Needlesticksoccupational, 439–440pathogen transmission in, 540
Inoculating loops, sterilization of, 539Inspections
in biosafety program evaluation, 446–452Select Agent Program, 449–450by shipping regulatory agencies, 398
Institutional Biosafety Committee, 265Instructors, in teaching laboratories
biosafety training preparation by, 540visibility of, 532–534
International Air Transport Association (IATA), shippingregulations of, 383
cell lines, 230changes of 2005, 383, 399classification, 385–398dangerous goods list, 391Dangerous Goods Regulations, 384, 386, 392–394documentation, 394–396labeling, 392–394marking packages, 392–394minimum requirements, 385naming substances, 390packing instructions, 385–398packing materials and methods, 390–392training for, 398
International Civil Aviation Organization (ICAO)biosafety regulations of, 435shipping regulations of, 383, 384, 389
International Committee on Taxonomy of Viruses, 182
International Health Care worker Safety Center, 349International Organization for Standardization (ISO),
biosafety management standards of, 405–414
Intracellular residence, as virulence factor, 13Inventory, of hazardous substances, 406–407Iodophor disinfectants, for surfaces, 378Ireland, biosafety regulations of, 426–427Iron acquisition, as virulence factor, 12Island fume hoods, 320ISO (International Organization for Standardization),
biosafety management standards of, 405–414Isoenzyme analysis, of cell lines, 233Isolation valves, testing of, 583–584Isolators, 317–318, 319–320Isospora belli, 150–152Italy, biosafety regulations of, 427–428Ixodes, 104, 128–129
Japanese encephalitis virus, 185, 189Job hazard analysis, 87, 264–265, 490, 491Joint Committee on Accreditation of Healthcare
Organizationsinspections by, 448safety policy guidelines of, 210
Junin virus, 182, 489
Kaposi’s associated herpesvirus, 186Karshi virus, 189Karyology, of cell lines, 234KATTAR approach, to root cause analysis, 412Keddougou virus, 189Keratinocytes, cell lines from, 223KI Discus test, for biological safety cabinets, 319Klebsiella, 6, 36Kokobera virus, 189Kostov, Vladimir, assassination of, 588Koutango virus, 189Kuru, 463, 467Kyasanur Forest disease virus
BSL-4 laboratory for, 489clinical manifestations of, 186laboratory-associated infections due to, 182
Labeling Requirements for the Transportation ofHazardous Materials and Wastes (Mexico),428–429
Labels and labeling, for shipping packages, 392–394Laboratory(ies)
audits of, 446–448teaching, see Teaching laboratoriestypes of, 531
Laboratory animals, 19–33allergic reactions to, 241–251bedding for, fungi in, 174in BSL-4 laboratory, 504–505cell lines from, see Cell linescommonly used, 21–23diseases associated with, 23–33, 174facilities for, 281–282, 285, 287–288holding facility for, 285housing of, 295–296natural pathogens of, 19–21zoonotic hazards from, 19, 21, 443–444
Laboratory Biosafety Guidelines (Canada), 420–421Laboratory Biosafety Manual (WHO), 82–85, 89, 435Laboratory design, 273–293
acoustical considerations in, 288–289for allergen control, 245animal facilities in, 281–282, 285, 287–288approach to, 273–275barriers in, see Barriersbasic research, 276, 281for BSL-3 laboratory, 282–285for BSL-4 laboratory, 502–503, 506–507clinical, 277–278, 281commissioning in, 292–293communications in, 291containment research laboratories, 276–277cost constraints in, 278decontamination and, 292, 376–377electrical systems in, 290–291equipment in, 291–292fire protection in, 289–290heating and air conditioning systems in, 287–288
610 INDEX
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information management in, 291maintenance issues in, 279maximum-containment, 277needs evaluation for, 274office space in, 280–281operational issues in, 279plumbing in, 289preplanning for, 276–279questioning about, 275signage in, 292small, 278space validation in, 279support rooms in, 285–287sustainable (green) design, 274–275systems distribution in, 291teaching, 532–535time constraints in, 278–279for toxin handling, 265–266ventilation, 287–288vermin control in, 292visualization of, 275waste handling and removal in, 292
Laboratory-associated infections, 53–77aerosols in, 66–67airborne, 209–220bacterial, 56–57, 60–61, 63–64, 93–114causes of, 123from cell lines, 221–239definition of, 54environmental factors in, 69epidemiology of, 53–55, 67–68, 122, 124–128exposure to, 63–67fungal, 59, 63, 66, 163–178, 217–219helminthic, 117–118, 153–154historical accounts of, 54host factors in, 68–69incidence of, 67–68from laboratory animals, 19–33parasitic, 59, 62–63, 66, 115–161protozoan, 116–117, 122–152rickettsial, 57, 61, 65, 110–112in teaching laboratories, 532viral, 57–59, 61–62, 65–66, 179–207zoonotic, 19, 21, 443–444
Labour Protection Act (Germany), 423Lactobacillus, 8–11, 542Lactobacillus casei, 365LAIs, see Laboratory-associated infectionsLaminar-flow units, in large-scale production, 566Lamps, germicidal, 541Langat virus, 189Large spaces, decontamination of, 376–377Large volumes, of microorganisms, 540
airborne transmission of, 210in centrifuges, 297
Large-scale production, 561–577agent considerations in, 562Australian guidelines for, 418biosafety guidelines for, 570–577biosafety levels for, 362–363, 365, 366, 525–526, 563,
570–577cleaning in, 566definition of, 561–562disinfection in, 566environmental considerations in, 562–563equipment for, 563–566
fermentation tank for, 298of gene transfer vectors, 525–526heating, ventilation, and air conditioning in, 567–568layout arrangement for, 568–569maintenance in, 568in pharmaceutical industry, 555–559primary containment in, 563–566process considerations in, 562recovery in, 565–566regulations on, 561–562risk assessment of, 86–87safety measures for, 231–232secondary containment for, 566–569security for, 569support systems for, 568–569surfaces in, 566–567technology transfer in, 555–556of toxins, 265utilities for, 568waste treatment in, 569
Lassa fever virus, 195biosafety levels for, 366BSL-4 laboratory for, 489clinical manifestations of, 186
Latent infections, herpes simplex virus, 519Latex gloves, 353Leaks
from biological safety cabinets, 319from containment rooms, 582–583from fume hoods, 318–319from glove boxes, 316from shipping containers, 384, 390
Legal requirements, of biosafety programs, 407Legionella pneumophila, 102, 217Legislation, see also specific acts
Australia, 417–418Belgium, 418–419on bioterrorism, 544, 590–594Canada, 419–420European Union, 421–422Germany, 423–424ICAO, 435Ireland, 426–427Italy, 427–428Mexico, 428–429Spain, 429–430United Kingdom, 430–431United States, 432–434
Leishmania, 62, 127, 129–132Leishmania amazonensis, 132Leishmania braziliensis, 131–132Leishmania chagasi, 131Leishmania donovani, 130–131Leishmania guyanensis, 132Leishmania mexicana, 132Leishmania tropica, 132Lentiviruses
cell line contamination with, 225as gene transfer vectors, 514–515, 525in pharmaceutical production, 551, 552
Leprosy (Mycobacterium leprae), 113, 542Leptospira, 29Leptospira canicola, 29Leptospira hardjo, 29Leptospira icterohaemorrhagiae, 29Leptospira interrogans, 104–105
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in laboratory animals, 29laboratory-associated infections due to, 61, 64
Leptospira pomona, 29Leptospira sejroe, 29Lethal dose, of toxins, 255Lethal factor, Bacillus anthracis, 257Leukotoxins, 14Lighting, 275, 290
for BSL-4 laboratory, 507for large-scale production, 568
Liponyssoides sanguineus, 28Lipopolysaccharides, 15, 94–96Liquid nitrogen, in BSL-4 laboratory, 503Listeria monocytogenes, 109–110Livestock pathogens, biosafety level for, 579–582Long terminal repeats, in retroviruses, 513–514Loops, sterilization of, 539Louping-ill virus, 182, 189Low-flow fume hoods, 320Lyme disease (Borrelia burgdorferi), 104Lymphocytic choriomeningitis virus, 194–195
cell line contamination with, 225clinical manifestations of, 185in laboratory animals, 21, 29, 195laboratory-associated infections due to, 61, 65, 179,
195, 295Lyssavirus, 185
Machupo virusbiosafety levels for, 366BSL-4 laboratory for, 489laboratory-associated infections due to, 65, 182
Mad cow disease, see Variant Creutzfeldt-Jakob diseaseMaintenance
of biological safety cabinets, 230for large-scale production, 568
Major histocompatibility complex, bacterial superantigen interactions with, 15
Malaria (Plasmodium), 62, 127, 132–137Malassezia, 6, 168–169Malta fever, see BrucellaManagement, see Biosafety programs, management ofManometer, for containment room testing, 583Manuals, 87
BSL-4 laboratory, 497–499Control of Communicable Disease Manual, 23, 84Laboratory Biosafety Manual (WHO), 82–85, 89, 435, 537risk assessment, 87shipping, 385
Marburg virus, 191BSL-4 laboratory for, 489clinical manifestations of, 186laboratory-associated infections due to, 61, 62
Marine animal toxins, 263Marking, of packages, 392–394Masks, 245, 329Maximum-containment laboratory, see also Biosafety
levels, BSL-4design of, 277
Mayaro virus, 188Measles virus, 192
clinical manifestations of, 185laboratory-associated infections due to, 67
Media, culture, see Culture mediaMedical history, preplacement, 438Medical surveillance, see Surveillance
Melioidosis (Burkholderia pseudomallei), 55, 61, 106Membrane-disrupting toxins, 14Mengo encephalomyocarditis virus, 188Meningococci, see Neisseria meningitidisMeningoencephalitis, in viral infections, 185Mexico, biosafety regulations of, 428–429Mice
allergens of, 242–243lymphocytic choriomeningitis virus in, 195natural pathogens of, 20–21prion diseases in, 465zoonosis associated with, 26
Microbial flora, normal, 3–11composition of, 4–5ear, 8eye, 7–8functions of, 5gastrointestinal tract, 8–11genitourinary tract, 11host relationship with, 3–5respiratory tract, 8skin, 6–7types of, 3–4
Microbiological aerosol tracer test, for BSCs, 308–309Micrococcus, 6, 8Micrococcus luteus, 6, 542Microorganisms, see also specific microorganisms
indigenous, see Microbial flora, normalMicroscopes, cabinets for, 534Microsporum, 171Microsporum audouinii, 171Microsporum canis, 27, 171Microsporum gypseum, 171Minimum lethal dose, of toxins, 255Mites, of laboratory animals, 25, 28Mixing equipment, 297–298Model Regulations, 384Modules, laboratory, 281Mokola virus, 65Molds, see FungiMonkeypox virus, 199
as gene transfer vector, 512–513in laboratory animals, 30
Mosquitos, in Plasmodium transmission, 132–137Most penetrating particle size, in respirators, 327–328Motility, as virulence factor, 12–13Mouse mammary tumor virus, 196Mouse parainfluenza virus, 192Mouth, normal microbial flora of, 8–9Mumps virus, 185, 192Murine leukemia virus, 196, 513–514, 522Murine toxin, Yersinia pestis, 261Murray Valley virus, 189Mycetoma, 170–171Mycobacterium
atypical, 6saprophytic, 8
Mycobacterium avium complex, 32–33Mycobacterium bovis
biosafety level for, 215in laboratory animals, 32–33risk assessment of, 85
Mycobacterium leprae, 113, 542Mycobacterium smegmatis, 11Mycobacterium tuberculosis, 112–113
airborne transmission of, 210, 212–215, 217
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biosafety levels for, 365as BSL-3 agent, 543culture of, 213, 217drug-resistant, 84, 85in laboratory animals, 32–33laboratory-associated infections due to, 54–56, 61, 63, 67respirator for, 334, 336–338
Mycoplasma, 235Mycoplasma arginini, 226Mycoplasma fermentans, 226Mycoplasma hominis, 11, 226Mycoplasma hyorhinis, 226Mycoplasma orale, 226Mycotic agents, see FungiMycotoxins, 169, 261–262
as bioterrorism agents, 587decontamination of, 267
Myrothecium, toxin of, 262, 587
Naegleria fowleri, 128Nairoviruses, 489Naranjal virus, 189Nares, normal microbial flora of, 8Nasopharynx, normal microbial flora of, 8National Authority for Occupational Safety and Health
(Ireland), 426National Center for Drugs and Biologicals, 433National Institute for Health and Safety at Work
(Spain), 429National Institute of Occupational Safety and Health
(NIOSH), 433respirator regulations of, 330–332respiratory filter approval by, 328sharps disposal specifications of, 350–351sharps injury prevention program of, 349
National Institutes of Health (NIH)Biosafety in Microbiological and Biomedical Laboratories,
see Biosafety in Microbiological and BiomedicalLaboratories (CDC/NIH)
biosafety regulations of, 83, 90contract with, 407Guidelines for Research Involving Recombinant DNA
Molecules, 446, 448–449laboratory guidelines of, 362–363Primary Containment for Biohazards: Selection,
Installation and Use of Biological Safety Cabinets, 434recombinant guidelines of, 86, 87, 90, 212, 361–363,
432, 448–449National Occupational Health and Safety Commission
(Australia), 418National Oil and Hazardous Substances Pollution
Contingency Plan, 593–594National Research Council (NRC)
Biosafety in the Laboratory: Prudent Practices for theHandling of Infectious Materials, 362, 434–435
Guide for the Care and Use of Laboratory Animals, 504infectious material handling, 363–364recombinant DNA hazard statement of, 364
Natural disasters, teaching laboratory preparation for,536–537
Needlestick Safety and Prevention Act of 2000, 432Needlesticks
in BSL-4 laboratory, 489cryptococcosis due to, 168disposal methods and, 350Ebola virus infection due to, 191
epidemiology of, 356hepatitis B due to, 342hepatitis C due to, 189herpesvirus infections due to, 197–198HIV infection due to, 196leishmaniasis due to, 130–132malaria due to, 134–136prevention of, 347–350, 367–368, 432, 540statistics on, 347–348in teaching laboratories, 540toxoplasmosis due to, 139–141trypanosomiasis due to, 143–146, 148–149
Neisseria, 101iron acquisition mechanisms of, 12saprophytic, 8
Neisseria gonorrhoeae, 101adherence of, 12immunoglobulin A proteases of, 13laboratory-associated infections due to, 61pus formation by, 94
Neisseria meningitidis, 101biosafety levels for, 365immunoglobulin A proteases of, 13laboratory-associated infections due to, 60, 61, 64in normal microbial flora, 8vaccine for, 553
Neurologic disorders, in viral infections, 185Neurotoxins, 14, 254, 257, 260, 263New Substances Notification Regulations (Canada), 419New Zealand, biosafety regulations of, 89Newcastle disease virus, 191–192Nicotiana tabacum, as model plant, 44NIH, see National Institutes of Health (NIH)NIOSH, see National Institute of Occupational Safety
and Health (NIOSH)Nipah virus, 192
BSL-4 laboratory for, 487, 489clinical manifestations of, 185
Nivalenol, 262Noise control
in laboratory design, 288–289in protective suits, 495
Norwalk virus, clinical manifestations of, 186Nose, normal microbial flora of, 8Notoedres cati, 28NRC, see National Research Council (NRC)Ntaya viruses, 189
Obligate pathogens, for teaching laboratories, 545Occupational exposure limits (OELs), respirators and, 339Occupational Health and Safety Act (Canada), 420Occupational infections, see Laboratory-associated
infectionsOccupational medicine programs, 437–444
for animal research, 443–444for BSL-4 laboratory, 497communication in, 442goals of, 437for injuries and illnesses, 439–440for maximum-containment laboratories, 444preplacement evaluations in, 437–439record keeping in, 442serum storage in, 443surveillance in, 440–442for toxin exposure, 264workers’ compensation and, 442
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Occupational Safety and Benefit Authority of theChemical Industry (Germany), 424
Occupational Safety and Health Act of 1970, 364Occupational Safety and Health Administration (OSHA)
Bloodborne Pathogen Standard, see BloodbornePathogen Standard (OSHA)
General Respiratory Protection Standard of, 331Mycobacterium tuberculosis recommendations of, 337personal protective equipment requirements of,
211–212, 299record keeping requirements of, 442regulations of, 432respirator protection factors of, 329–330safety policy guidelines of, 210
Ochroconis gallopavum, safety measures for, 166Office space
in laboratory design, 280–281in large-scale production, 568
Omsk hemorrhagic fever virus, 189BSL-4 laboratory for, 489clinical manifestations of, 186
On the Contained Use of Genetically ModifiedMicroorganisms (European Union), 421
On the Deliberate Release into the Environment ofGenetically Modified Organisms (EuropeanUnion), 421
On the Protection of Workers from Risks Related toExposure to Biological Agents at Work (European Union), 421
On the Protection of Workers from Risks Related toExposure to Chemical, Physical and BiologicalAgents at Work (European Union), 422
Oncogenic cell lines, 226Oncogenic viruses, 225Oncoviruses, cell line contamination with, 225O’nyong-nyong virus, 185, 188Opportunistic pathogens, 4
plant-associated, 35risk assessment of, 88for teaching laboratories, 545
Orf virus, 29–30, 61, 199–200Orientia (Rickettsia) tsutsugamushi, 61, 110–111, 217Ornithonyssus bacoti, 28Ornithosis (Chlamydia psittaci), 108–109Orthomyxoviridae, 192–193OSHA, see Occupational Safety and Health
Administration (OSHA)Overlap select agents and toxins, 166–167, 590, 592
Packagingdefinition of, 400labeling, 392–394leakproof, 390refrigerants for, 395, 397–398requirements for, 385, 390, 392
Paecilomyces lilacinus, 172Pantoea, 36Paracoccidioides brasiliensis, 166, 172Paraformaldehyde, for decontamination, 377Parainfluenza virus, 192
cell line contamination with, 225clinical manifestations of, 185
Paralysis, in viral infections, 185Paramyxoviridae, 191–192, 489Parasites
cell line contamination with, 226
of laboratory animals, 24, 25, 28laboratory-associated infections due to, 59, 62–63, 66,
115–161Parechovirus, 188Parrot fever (Chlamydia psittaci), 108–109Particle filtration, in respirators, 327–329Parvovirus
clinical manifestations of, 185as gene transfer vectors, 521laboratory-associated infections due to, 61
Pasteurella, 108, 255Pasteurella haemolytica, 108Pasteurella multocida, 30, 108Pasteurella pneumotropica, 108Pasteurella ureae, 108Pathogenicity, definition of, 4Pathogens
blood-borne, see Bloodborne Pathogen Standard(OSHA); Standard (Universal) Precautions
virulence of, see Virulence; Virulence factorsPatriot Act of 2001, 268, 544PCR (polymerase chain reaction)
for cell line characterization, 234for cell line contamination detection, 235–236
Penicillium, 8, 539Penicillium camembertii, 365Penicillium marneffei, 172–173
laboratory-associated infections due to, 63safety measures for, 166
Peptostreptococcus, 9–11, 100Perchloric acid fume hoods, 306Personal protective equipment, 298–301, 366–367
for allergens, 245for blood-borne pathogens, 353–354positive-pressure suits, 298, 326, 333, 494–497, 500,
505–506respiratory, see Respiratorsstandards for, 299
Personnel reliability program, in Select Agent Program, 592Personnel/employees/workers, see also subjects starting
with Occupationalfor BSL-4 laboratory, 496–497medical surveillance of, for bioterrorism agents,
592–593zoonotic hazards for, 19–33, 443–444
Pest control programs, 292, 569Pestiviruses, 189Pfiesteria piscicida, toxin of, 263Phaeohyphomycosis, 170–171Phagocytosis, resistance to, as virulence factor, 13Pharmaceutical industry, 551–560
accidental releases in, 557bovine product use in, 475–478cell line use in, 222culture identification in, 556disinfection in, 556–557head coverings for, 400inactivation in, 556–557microorganisms used in, 551–555regulations in, 559scale-up in, 555–559security in, 557–559shoe coverings for, 400
Pharmaceutical Manufacturers Association, on recombinant DNA, 432–433
Pharmacy glove boxes, 317
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Pharynx, normal microbial flora of, 8Phenolic disinfectants, 378, 466Phialophora verrucosa, 170–171Phospholipases, as virulence factors, 14, 15Physical examination, preplacement, 438Picornaviridae, 188Pigs, see SwinePili, as virulence factors, 11–12Pinworm (Enterobius vermicularis), 153Pipetting, 369Plague, see Yersinia pestisPlant pathogens, 35–52
containment of, 43–44dematiaceous fungi, 170–171diseases from, 35–43
reemergence of, 35–36risk assessment of, 36, 42–43
disposal of, 44transportation of, 44
Plant Protection Act regulations (USDA), 44Plant toxins, 263–264, 287–288Plaque, dental, microflora of, 9Plasmodium, 62, 127, 132–137Plasmodium cynomolgi, 126, 133, 134Plasmodium falciparum, 126, 133–137Plasmodium malariae, 133–137Plasmodium ovale, 133–137Plasmodium vivax, 133–137Plating efficiency, of cell lines, 233Plesiomonas shigelloides, 102Plumbing, 289Pneumococci, see Streptococcus pneumoniaePneumonia, viral, 185Poison darts, 588Poisonous substances, from living organisms, see Toxinspol gene
in lentiviruses, 514–515in retroviruses, 513–514
Policyfor airborne pathogen safety, 210for biosafety program management, 406
Poliovirusclinical manifestations of, 185as gene transfer vectors, 521laboratory-associated infections due to, 61, 188risk assessment of, 85vaccines for, 85, 555
Polymerase chain reaction, see PCRPolysaccharide capsules, as virulence factors, 13Porcine epidemic diarrhea virus, 189Positive-pressure suits, 298, 326, 333, 494–497, 500, 505–506Postal Service, shipping regulations of, 385, 433Postexposure management, of virus exposure, 201Powassan virus, 189Power supply, 290–291Powered-air purifying respirators, 326Poxviridae, 198–200, 489Poxviruses
clinical manifestations of, 185as gene transfer vectors, 511–513in laboratory animals, 30in pharmaceutical production, 552
Pregnancylaboratory-associated infections in, 68precautions in, in teaching laboratory, 546risk assessment in, 88
vaginal microflora in, 11Preplacement evaluation, 437–439Pressure decay test
in agricultural research facility, 581for containment room, 583for glove boxes, 316
Pressure relief systems, 564–565Prevention of Work-Related Risks (Spain), 429Prevotella, 9Prevotella melaninogenica, 9Primary containment, see Barriers, primary;
Containment, primaryPrimary Containment for Biohazards: Selection,
Installation and Use of Biological Safety Cabinets(CDC/NIH), 434
Primates, nonhumanherpesviruses in, 197–198Mycobacterium tuberculosis in, 113Plasmodium in, 134poxviruses in, 199–200retroviruses in, 196zoonotic hazards of, 19, 21, 26
Prions, 461–485biosafety of, 380, 463–466, 479–480in blood products, 467–471cell line contamination with, 226, 227decontamination protocols for, 379–380detection of, 480diseases of, 461–462
animal, 464–466autopsy in, 464biopsy in, 463epidemiology of, 471–472experimental, 465management of, 463
in foodstuffs, 475inactivation of, 463, 466laboratory exposure to, 463molecular nature of, 461–462monitoring animals for, 478–479pathogenicity of, 461–462physical properties of, 463regulations on, 472–478transmission of, 380, 462
animal-to-human, 474–479human-to-human, 467–474
Probability, in significance criteria model, 407Procedures for Assessment of the Planned Release of
Recombinant DNA Organisms (Australia), 418Process, in large-scale production, 562Processing
closed, 558–559downstream, 565
Product protection test, for biological safety cabinets, 319Prophylaxis, see Vaccines and vaccinationPropionibacterium acnes, in normal microbial flora, 6Proteases, as virulence factors, 13, 15Protection factor, of respirators, 329–330Protection of Laboratory Workers from Occupationally
Acquired Infections, 380Protection of Workers Against Risks Related to the
Exposure of Biological Agents in the Workplace(Spain), 429–430
Protection of Workers from the Risks Related toExposure to Chemical, Physical, and BiologicalAgents at Work (Italy), 427
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Protective antigen, Bacillus anthracis, 257Protective clothing, for toxins, 266Protective suits, 298, 326, 333, 494–497, 505–506Proteus, 6, 102Protozoa, see also specific protozoa
laboratory-associated infections due to, 116–117, 122–152Providing Minimum Health and Safety Requirements
Relating to the Use of Personal ProtectiveEquipment (Spain), 430
PrP genes and proteins, 461, 463, 468–469, 477–480Pseudallescheria boydii, 171Pseudomonas
as BSL-2 agent, 542direct contact with, 539in normal microbial flora, 6as plant pathogen, 36
Pseudomonas aeruginosaalginate production by, 94in biofilms, 12as plant pathogen, 35toxin of, 14, 102, 255
Pseudomonas cepacia, 61Pseudomonas mallei, 296Psittacosis (Chlamydia psittaci), 108–109Public Health Security and Bioterrorism Preparedness
and Response Act of 2002, 166–167, 544Public Health Services, regulations of, 433Purification, in large-scale production, 565Pyrogenic toxin superantigens, 14–15
Q fever, see Coxiella burnetiiQuality standards, for cell lines, 237Quarantine, for cell lines, 229
Rabbits, zoonosis associated with, 26Rabies virus, 190
clinical manifestations of, 185in laboratory animals, 30–31laboratory-associated infections due to, 297vaccine for, 555
Raccoon pox virus, 66Radioactive waste disposal, 292Radioallergosorbent tests, in animal allergy, 242Radionuclides
in biological safety cabinets, 304–305fume hoods for, 306
Rajneeshee cult, bioterrorist activities of, 588Ramichloridium obovoideum, 166, 171Rash, in viral infections, 185Rat(s)
allergens of, 242–244bites of, 31, 105, 109natural pathogens of, 20–21zoonosis associated with, 26
Rat-bite fever (Spirillum minus), 105Rat-bite fever (Streptobacillus moniliformis), 31, 109Recirculated fume hoods, 307Recombinant DNA, see also Gene transfer vectors
in cell lines, 228containment requirements for, 97guidelines for, 432
Australia, 418United States, 86, 87, 90, 212, 361–364, 445, 448–449
in pharmaceutical production, 551–555registration of, 267risk assessment of, 83, 86–87, 90
safety audit of, 446work practices for, 361–362
Recombinant organismsinfluenza virus, 193risk assessment of, 86, 90
Records, in biosafety program, 310Refrigerants, for shipping, 396–398Registration, of toxins, 267–268Regulations, biosafety
Australia, 82–85, 89, 417–418Belgium, 418–419Canada, 82–85, 89–90, 419–421European Union, 82–85, 90, 421–422France, 422–423Germany, 423–426internet resources on, 435Ireland, 426–427Italy, 427–428Mexico, 428–429Mycobacterium tuberculosis, 215pharmaceutical production, 559prions, 472–478respirator use, 330–332shipping, 383–401Spain, 429–430toxins, 267–268United Kingdom, 430–432, 559United States, 82–85, 364, 383–401, 432–435, 544,
590–594, see also specific agenciesWorld Health Organization, 435
Relapsing fevers (Borrelia), 103–104Releases
minimizing, 565in pharmaceutical production, 556–557prevention of, 565
Reproductive system, laboratory-associated infectionsaffecting, 68
Requirements for Hazardous Substances, Materials andWastes (Mexico), 428
Research, animals used in, see Laboratory animalsResearch laboratories
design of, 276–277, 281vs. teaching laboratories, 532
Respirators, 325–340, 367for aerosolized microorganisms, 337–338air-line, 325–326air-purifying, 326approval of, 330–331atmosphere-supplying, 325–326for Bacillus anthracis, 334cartridge change-out schedule for, 333fit and fit testing of, 331–332gas removal by, 327–329for hantavirus, 337for Mycobacterium tuberculosis, 213, 215, 334, 336–338occupational exposure limits and, 330OSHA standard on, 331particle filtration by, 327–329for plant pathogen protection, 43powered air-purified, 283program for, 325protection factors for, 329–330recommendations for, 333, 335–336regulations on, 330–332Respirator Decision Logic for, 332–333for SARS, 334
616 INDEX
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selection of, 332–338self-contained breathing apparatuses, 325–326surgical mask combined with, 329surgical masks as, 329for toxins, 266types of, 325–326
Respiratory disorders, in viral infections, 185Respiratory syncytical virus, 185, 196Respiratory syndrome, 192Respiratory tract, normal microbial flora of, 8Responsibility, for biosafety program management, 408Restriction fragment length polymorphism, of cell lines,
234–235Retroviridae, 195–197Retroviruses
cell line contamination with, 225, 236as gene transfer vectors, 513–514, 522, 525laboratory-associated infections due to, 62in pharmaceutical production, 551, 552
Rhabdoviridae, 190Rhinoviruses, 185, 188Rhipicephalus sanguineus, 28Rhizobium meliloti, 365Rhizopus, inhalation of, 539Rhizopus oryzae, 173Ricin toxin, 263–264, 587, 588Rickettsia akari, 112Rickettsia conorii, 61Rickettsia prowazekii, 110, 297Rickettsia rickettsii, 94, 111–112Rickettsia tsutsugamushi, 61, 110–111, 217Rickettsia typhi, 61Rickettsiae, 57, 61, 65, 110–112Rickettsialpox (Rickettsia akari), 112Rift Valley fever virus, 183
clinical manifestations of, 186laboratory-associated infections due to, 179, 182
Rinderpest virus, 192Rio Bravo virus, 189Risk
acceptability of, 88classification of, 89–90prioritization of, 88–89in significance criteria model, 407
Risk assessmentacceptability of risk in, 88activity-based, 86–87agent-activity interaction in, 87agent-based, 82–85assessor for, 81–82biosafety manual and, 87of biosafety program, 407of blood-borne pathogens, 341–346of BSL-4 laboratory, 490–492classification criteria in, 89–90definition of, 210exposure determination in, 87of gene transfer vectors
adeno-associated viruses, 517adenovirus, 516–517alphavirus, 518baculovirus, 520–521herpesvirus, 519–520lentivirus, 515poxvirus, 512–513retroviruses, 514
host factors in, 87–88for laboratory design, 280of large-scale activities, 86–87of mycobacteria, 213–214of plant pathogens, 36, 42–43of prions, 226of recombinants, 86, 90risk groups in, 82–85risk prioritization in, 88–89in scale-up, 86–87of unknowns, 85–86
Risk factors, for allergic reactions, 244Risk groups, 82, 89–90
for cell lines, 224France, 422
Risk managementin animal handling, 504–505for toxins, 264–265
Risk Management (U.S. Army), 492Risk matrix, for viruses, 184–185RNA viruses, 182–183Rochalimaea (Bartonella) henselae, 21, 27, 109, 217Rocky Mountain spotted fever (Rickettsia rickettsii), 94,
111–112Rodents
allergens of, 242–243arenaviruses in, 194–195control of, 292hantavirus transmission from, 193–194lymphocytic choriomeningitis virus in, 195natural pathogens of, 20–21prion diseases in, 465rat-bite fever from, 31, 105, 109Yersinia pestis in, 106–107zoonosis associated with, 26
Root cause analysis, 412Ross River virus, 188Rotavirus, 186Rotors, centrifuge, 297Rubella virus, 185, 188–189Rubiviruses, 188–189Russian spring-summer encephalitis, 489
Sabia virus, 195BSL-4 laboratory for, 489clinical manifestations of, 186laboratory-associated infections due to, 65, 296–297
Saccharomyces cerevisiaebiosafety levels for, 365in pharmaceutical production, 554
Safe Biotechnology (Germany), 424–426Safety and Hygiene Conditions in Workplaces Where
Chemical Substances Capable of CausingContamination of the Work Environment areProduced, Stored or Handled (Mexico), 429
Safety Conditions for the Prevention of and ProtectionAgainst Fires in the Workplace (Mexico), 428
Safety generalist, 447Safety Health and Welfare at Work Regulations, 1993
(Ireland), 426–427Safety manuals, see ManualsSt. Louis encephalitis virus, 185, 189, 365Salmonella, 102
in laboratory animals, 31laboratory-associated infections due to, 60, 61, 64serum-resistant, 14
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Salmonella enterica serovar Enteritidis, 31, 365Salmonella enterica serovar Typhi, 54, 64, 102Salmonella enterica serovar Typhimurium, 31, 588Salmonella paratyphi A, 536Samples
Ebola virus in, 191environmental, in teaching laboratories, 536
Sampling devices, for large-scale production, 565Sand flies, in Leishmania transmission, 129Sanitary drainage, in laboratory design, 289Sanitizers, hand, 535Saprophytes, 4Sarcocystis, 137Sarcocystis hominis, 137Sarcocystis suihominis, 137Sarcoptes scabiei, 28Sarin, as bioterrorism agent, 588SARS (severe acute respiratory syndrome)-associated
virus, 189–190laboratory-associated infections due to, 61, 65, 190respirator for, 334risk assessment of, 85
Sashes, of fume hoods, 305–306Scabies, 28Scale-up activities
in pharmaceutical production, 555–559risk assessment of, 86–87
Scedosporium apiospermum, 171Scedosporium prolificans, 171Schedule constraints, in laboratory design, 278–279Schistosoma, 62Schistosoma mansoni, 119, 154Scolecobasidium gallopava, 171Scrapie, 226, 461–465Scrub typhus (Rickettsia tsutsugamushi), 61, 110–111, 217Scrubs, 299–300SEB toxin, Staphylococcus aureus, 261Security
bioterrorism and, 590, 592for BSL-4 laboratory, 501for large-scale production, 569systems for, 290–291for toxins, 268
Select Agent Programaudit of, 446bioterrorism agents and, 501, 590–593BSL-4 laboratory and, 501fungi and, 166–167inspections of, 449–450shipping regulations and, 386, 401toxins and, 267–268
Self-audits, 447Self-contained breathing apparatuses, 325–326Semliki Forest virus, 188, 517–518Sendai virus, 192Seoul virus, 29Sepik virus, 189Serratia, 36Serratia marcescens, 297–298Serum resistance, as virulence factor, 13–14Serum storage, in occupational medicine
programs, 443Service of Biosafety and Biotechnology (Belgium), 419Severe acute respiratory syndrome-associated virus,
see SARS (severe acute respiratory syndrome)-associated virus
Sharps, see also Needlesticksin BSL-4 laboratory, 503–505disposal of, 350–351, 503HIV transmission by, 343–344precautions for, 347–349, 367–368safety-engineered devices for, 349–350work practice controls for, 351–353
Sheepscrapie in, 226, 461–465zoonosis associated with, 26
Shellfish toxins, 587Shiga toxin, 14Shigella, 102
apoptosis due to, 94in laboratory animals, 31–32laboratory-associated infections due to, 60, 61, 64toxin of, 255
Shigella dysenteriaein laboratory animals, 31–32toxins of, 255, 260–261
Shigella flexneriin laboratory animals, 31–32laboratory-associated infections due to, 300–301toxins of, 260
Shigella sonneiin laboratory animals, 31–32laboratory-associated infections due to, 64toxins of, 260
Shipper’s Declaration for Dangerous Goods, 383, 394–398Shipping, see Transport and shippingShock, electrical, 542Shoe coverings, 300Showers, 289
for BSL-4 laboratory, 496, 500–501for BSL-3Ag laboratory, 580for containment facility, 285for toxin laboratory, 265
Siderophores, as virulence factors, 12Sight lines, in teaching laboratories, 534Signage systems, 292Significance model, 407Simian foamy virus, 196
in laboratory animals, 32laboratory-associated infections due to, 62
Simian immunodeficiency virus, 62, 196Simian type D retrovirus, 62Simian virus 40, 521, 555Sindbis virus, 188, 517–518Sinks
handwashing, 535for large-scale production, 569for toxin laboratory, 265
Skincell lines from, 223infectious agent contact with, 539, 540lesions on, work practices with, 352normal microbial flora of, 6–7
Sleeping sickness (Trypanosoma brucei), 147–150Small intestine, normal microbial flora of, 10–11Smallpox, see Variola virusSnake venom, 263, 266Sodium dodecyl sulfate, for prion inactivation, 466Sodium guanidine isocyanate, for prion inactivation, 466Sodium hydroxide, for prion inactivation, 466Sodium hypochlorite, for decontamination, 352, 376
of prions, 380
618 INDEX
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of surfaces, 378of toxins, 267
Sonicators, 297–298Spain, biosafety regulations of, 429–430Spaulding classification, of germicides, 375Special Program on Safety Measures in Microbiology
(WHO), 537Specified risk materials, in prion diseases, 477Specimens, medical
fungi in, 175laboratory design for, 278transport of, see Transport and shipping
Spillsof bioterrorism agents, 592of blood-borne pathogens, 352–353in BSL-4 laboratory, 503disinfectants for, 378in large-scale production, 558management of, 290, 353, 378
Spirillum minus, 31, 105Spirochetes, nontreponemal, 104–105Splatter, control of, 352Spondweni viruses, 189Spores, from molds, 169–174Sporothrix schenckii, 63, 173–174Sprinkler systems, 290Spumavirus, 65Stachybotrys chartarum, 169, 175Stachybotrys, toxin of, 262, 587Stainless steel mesh gloves, 353Standard operating procedures
for pharmaceutical production, 556for toxins, 265, 266–267
Standard (Universal) Precautions, 341–359; see alsoBloodborne Pathogen Standard (OSHA)
effectiveness of, 355–356engineering controls in, 347–351for hepatitis viruses, 341–342for HIV, 342–346medical care in, 355monitoring of, 354–355personal protective equipment for, 353–354risk assessment and, 341–346specific, 346–353training for, 354–355work practice controls in, 351–353worldwide adoption of, 346
Staphylococci, 97coagulase-negative, 8, 11direct contact with, 539laboratory-associated infections due to, 61in normal microbial flora, 6, 9toxins of, 15, 102
Staphylococcus albus, 542Staphylococcus aureus, 97
as BSL-2 agent, 542enterotoxins of, 587in normal microbial flora, 6, 8risk assessment of, 84toxins of, 255, 261vancomycin-resistant, risk assessment of, 85
Staphylococcus auricularis, 6Staphylococcus capitis, 6Staphylococcus epidermidis, 6, 97Staphylococcus haemolyticus, 6Staphylococcus hominis, 6
Staphylococcus lugdunensis, 6Staphylococcus saprophyticus, 97Staphylococcus warneri, 6Stem cells, 223–224Stenotrophomonas, 36Sterility assurance level, 374Sterilization
of Bacillus anthracis spores, 378–379definition of, 374of inoculating loops, 539organic matter effects on, 376of prions, 380, 466
Sterilization in place, 558Stomach, normal microbial flora of, 9–10Storms, teaching laboratory preparation for, 536–537Streptobacillus moniliformis, 109
in laboratory animals, 31laboratory-associated infections due to, 61
Streptococci, 100abscess from, 101hemolytic, 6in normal microbial flora, 8, 9, 11toxins of, 15viridans group, in normal microbial flora, 8, 9
Streptococcus agalactiae, 100Streptococcus mitis, 9Streptococcus mutans, 8, 9Streptococcus pneumoniae, 100
containment requirements for, 97immunoglobulin A proteases of, 13in normal microbial flora, 8vaccine for, 553
Streptococcus pyogenes, 100Streptococcus salivarius, 8, 9Streptococcus sanguinis, 8, 9Streptococcus suis, 32Streptomyces avermitilis, in pharmaceutical production, 553Strongyloides fuelleborni, 32Strongyloides stercoralis, 32, 153Students, see Teaching laboratoriesSuits, positive-pressure, 298, 326, 333, 494–497, 500,
505–506Superantigens, bacterial, 14–15Supervisor, for BSL-4 laboratory, 496–497Supplied-air (air-line) respirators, 325–326Supplied-air suit, 298, 326, 333, 494–497, 500, 505–506Support rooms, for laboratories, 285–287Support systems, for large-scale production, 568–569Surfaces
decontamination of, 352–353, 367, 375, 377–378in large-scale production, 566–567for prions, 380
Spaulding classification of, 375splatter protection for, 352
Surgical masks, 329Surveillance
in allergic reactions, 244–245for bioterrorism agents, 592–593in BSL-4 laboratory, 497in HIV infection, 343in occupational medicine programs, 440–442
Sustainable design, for laboratories, 274–275Swine
natural pathogens of, 21zoonosis associated with, 26
Swine fever virus, 189
INDEX 619
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Swine influenza virus, 65Systems distribution, in laboratory design, 291
T-2 mycotoxin, 262Tacaribe complex viruses, 194–195Tackle box, for blood-borne pathogen transport, 352Taenia solium, 153Tanapox virus, 30, 199Tapeworms, 153–154TBE virus, 185, 189Teaching laboratories, 531–549
American Society for Microbiology safety recommendations for, 548
appropriate study materials for, 545–546biosafety environments in, 542–543biosafety program of, evaluation of, 447–448bioterrorism and, 543–545definition of, 532design of, 532–535hazards in, 531, 540–542natural disasters and, 536operation of, 536–537shared with other classes and courses, 536special risk students in, 546–547student safety training in, 537–540, 549unique nature of, 531
Technical Instructions for the Safe Transportation ofDangerous Goods by Air (ICAO), 384
Telephone system, 291Tembusu virus, 189Terrorism, see BioterrorismTetanus, see Clostridium tetaniTetrodotoxin, 263Threshold limit values, 330Tick-borne encephalitis virus, 182, 489Ticks, 25, 28, 103–104Time constraints, in laboratory design, 278–279Tissue cultures, as test systems, 224Togaviridae, 188–189Toxic shock syndrome toxin, 261Toxins, 253–270; see also specific toxins
animal (zootoxins), 253, 254, 262–263bacterial, 94–96, 255–261as bioterrorism agents, 587classification of, 253decontamination of, 267definition of, 587degree of toxicity of, 255exposure routes for, 254–255fungal, 169, 261–262, 267, 587guidelines for handling, 594job hazard analysis for, 264–265laboratory facility design for, 265–266lethal dose of, 255mechanism of action of, 253, 254occupational management of, 264personal protective equipment for, 266plant, 263–264registration of, 267–268regulations on, 267–268risk management for, 264–265safety equipment for, 265–266in Select Agent Program, 590–594for teaching laboratories, 545–546uses of, 253as virulence factors, 14–15work practices for, 266–267
Toxoplasma gondii, 137–142biosafety levels for, 365intracellular residence of, 13in laboratory animals, 32laboratory-associated infections due to, 63, 119, 126,
128, 138–142in pregnancy, 88
Traffic flow patterns, 282Training
in biosafety programs, 408–409for blood-borne pathogens, 354–355for BSL-4 laboratory, 497–506evaluation of, 451resources for, 237for respirator use, 325for shipping dangerous goods, 398for stock culture security, 557of students, 537–540for toxin management, 265
Training for Development of Innovative ControlTechnologies Project, safety-engineered sharpdevice evaluation form of, 350
Transfusions, prion transmission in, 468–474Transilluminator lamps, 541Transmissible mink encephalopathy, 465Transmissible spongiform encephalopathies, 226, 379–380Transmission, see also specific organisms
airborne, see Airborne pathogensenvironmentally mediated, 373of exogenous microorganisms, 4to newborn infants, 8routes for, 361in teaching laboratories, 538–540of zoonotic diseases, 21–23, 443–444
Transplantation, cell lines for, 223–224Transport and shipping, 383–401
agencies governing, 383–385of bacteria, 97of bioterrorism agents, 594of blood-borne pathogens, 352of cell lines, 230certification for, 398definitions used in, 399–400documentation for, 394–396of fungi, 167labeling packages for, 392–394marking packages for, 392–394naming substances for, 390packing for, 390–392of plant pathogens, 44refrigerants for, 396–398regulations on, 84, 383–401, 433of specimen containers, 298substance classification for, 385–389training for, 398
Trauma, see InjuriesTrematodes, 153–154Trench mouth, 105Treponema pallidum, hydrolytic enzymes of, 15Trexler isolator, 317Trichinella spiralis, 153Trichoderma, toxin of, 262, 587Trichophyton, 171Trichophyton mentagrophytes, 27, 171Trichophyton verrucosum, 27, 171Trichothecene mycotoxins, 262, 587Trichuris trichiura, 153
620 INDEX
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Triple fume hood, 319Triple packaging, 390, 392Trypan blue test, for cell lines, 232, 233Trypanosoma, 62Trypanosoma brucei brucei, 149Trypanosoma brucei gambiense, 147–150Trypanosoma brucei rhodesiense, 147–150Trypanosoma cruzi, 63, 119, 126, 129, 142–147Tuberculosis, see Mycobacterium tuberculosisTularemia, see Francisella tularensisTumorigenicity, of cell lines, 237Typhoid (Salmonella enterica serovar Typhi), 54, 64, 102Typhus
endemic (Rickettsia prowazekii), 110, 297laboratory-associated, 297scrub (Rickettsia tsutsugamushi), 61, 110–111, 217
Uganda S virus, 189Ulcerative gingivostomatitis, 105Ultraviolet radiation, 541Undulant fever, see BrucellaUnited Kingdom, biosafety regulations of, 430–432, 559United Nations, see also World Health Organization (WHO)
International Civil Aviation Organization (ICAO), 383,384, 389
United Nations Industrial Development Organization,Biotechnology Information and Advisory Service, 228
United States, biosafety regulations of, 82–85, 432–435United States Army
Biological Defense Program of, 433Risk Management, 492
United States Department of Agriculture (USDA)Animal and Plant Health Inspection Service (APHIS)
of, 44, 433, 447–450biosafety program inspection by, 447Facilities Design Standards, 579Plant Protection Act regulations, 44Select Agent Program and, see Select Agent Program
United States Department of Transportation, seeDepartment of Transportation
United States Environmental Protection Agency (EPA),National Oil and Hazardous Substances PollutionContingency Plan of, 593–594
United States Postal Service, shipping regulations of,385, 433
Uniting and Strengthening America by ProvidingAppropriate Tools Required to Intercept andObstruct Terrorism Act of 2001 (USA PATRIOTAct), 268, 544
Universal Precautions, see Standard (Universal)Precautions
University of Reading, teaching resources of, 545Unknowns
risk assessment of, 85–86in teaching laboratories, 536
Ureaplasma urealyticum, 11Urethra, normal microbial flora of, 11Urinary tract, normal microbial flora of, 11USDA, see United States Department of Agriculture
(USDA)Utilities, for large-scale production, 568
Vaccination of Laboratory Workers Handling Vaccinia andRelated Poxviruses Infectious for Humans (UnitedKingdom), 431
Vaccines and vaccination
Bacillus anthracis, 103Borrelia burgdorferi, 103for BSL-4 laboratory agents, 492, 497cell lines for, 221, 222Clostridium botulinum, 260Francisella tularensis, 108fungi, 175hepatitis A virus, 188hepatitis B virus, 62, 201influenza virus, 193manufacture of, laboratory-associated infections
due to, 61Mycobacterium tuberculosis, 112–113orf, 200for pharmaceutical production workers, 556poliovirus, 85preplacement, 438–439production of, 551–555rabies virus, 190ricin, 264rubella virus, 189for teaching laboratory occupants, 546toxins, 264variola virus, 199–200, 511–512Yersinia pestis, 107
Vaccinia virus, 199–200attenuation of, 513as gene transfer vector, 511–513laboratory-associated infections due to, 62, 66in pharmaceutical production, 552
Vacuum protectors and traps, 298Vacuum systems, 289Vagina, normal microbial flora of, 11Variant Creutzfeldt-Jakob disease, 461, 462
autopsy in, 464management of, 463regulations on, 472–474transmission of, 466, 468, 470–472, 474–475
Varicella-zoster virus, 185, 555Variola virus
as bioterrorism agent, 511–512, 587, 588BSL-4 laboratory for, 489–490eradication of, 511as gene transfer vector, 511–513
Veillonella, 8, 9Venezuelan equine encephalitis virus, 188–189, 517–518
as bioterrorism agent, 587clinical manifestations of, 185laboratory-associated infections due to, 62, 179, 182
Venoms, 253, 254, 262–263, 266Vent systems, in laboratory design, 289Ventilation
for BSL-3Ag laboratory, 580–581for fume hoods, 305in laboratory design, 276–278, 287–288for large-scale production, 567–568for toxin handling, 265
Verification forms, for student training, 540, 549Vermin control, 292Vertical-flow clean benches, 315Vesicular stomatitis virus, 185
as BSL-3 agent, 543in gene transfer, 513–514laboratory-associated infections due to, 182
Vibration control, in laboratory design, 288–289Vibrio, 64Vibrio alginolyticus, 101
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Vibrio cholerae, 101host cell metabolic alterations due to, 94motility of, 12toxin of, 14, 255
Vibrio mimicus, 101Vibrio parahaemolyticus, 61Vibrio vulnificus, 12, 101Vibrionaceae, 101Vincent’s stomatitis, 105Vinyl gloves, 353Virulence
definition of, 4in risk assessment, 84–85
Virulence factors, 11–15colonization, 11–13definition of, 4host immune system evasion, 13–14in plant pathogens, 43toxins, 14–15
Viruses, 179–207; see also specific virusesattenuated, 551–552in blood (viremia), 186cell line contamination with, 224–225, 235–236classification of, 182clinical manifestations of, 185–186diversity of, 182–183epidemiology of, 182–184as gene transfer vectors, see Gene transfer vectorsincubation period of, 185infectious dose of, 184laboratory-associated infections due to, 57–59, 61–62,
65–66, 179–201oncogenic, 225for pharmaceutical production, 551–552plant-associated, human disease and, 36postaccident management and, 201recombinant, 551–552removal of, from biologicals, 231–232risk matrix for, 184–185taxonomy of, 182
Walk-in fume hoods, 307Walls
in agricultural research facility, 581for large-scale production, 567
Warfare, biological, see BioterrorismWarnings, for hazards, 19, 21Waste handling and disposal
of airborne pathogens, 212, 214, 218–219of blood-borne pathogens, 353for BSL-2, 536, 543for BSL-4, 503–505of cultures, 353of fungi, 166, 218–219laboratory design for, 292for large-scale production, 569of mycobacteria, 214NRC guidelines for, 363–364of plant pathogens, 44regulations on, 433–434of sharps, 350–351, 503shipping regulations for, 388for teaching laboratories, 536, 543
Water supply systems, in laboratory design, 289Weapons, biological, see BioterrorismWebsites, for cell lines, 237
Wesselbron virus, 65, 189West Nile virus, 62, 65, 185, 189Western equine encephalitis virus, 182, 185, 188WHO, see World Health Organization (WHO)Windows, for BSL-4 laboratory, 506Woods lamps, 541Work practices
administrative controls in, 369–370for agricultural pathogens, 580barrier use in, see Barriersbiosafety levels in, see Biosafety levelsfor blood-borne pathogens, 351–353in BSL-4 laboratory, 502CDC guidelines for, see Centers for Disease Control
and Prevention (CDC)for handling infectious materials, 363–364history of, 361–362laboratory design and, 280NIH guidelines for, see National Institutes of
Health (NIH)for open-fronted barriers, 321–322for recombinant DNA, 363, 364for sharps injury prevention, 349for toxins, 266–267for waste disposal, 363–364
Work surfaces, see Surfaces“Workbook for Designing, Implementing, and Evaluation
of a Sharps Injury Prevention Program” (CDC), 349Workers, see Personnel/employees/workersWorkers’ compensation, 442Workplace Hazardous Materials Information System
(Canada), 419–420Workplace Safety and Hygiene (Mexico), 429WorkSafe Australia, 418World Health Organization (WHO)
biosafety regulations of, 435Guidelines for the Safe Transport of Infectious Substances
and Diagnostic Specimens, 435Laboratory Biosafety Manual of, 82–85, 89, 435, 537recombinant guidelines of, 86risk groups of, 82–85shipping regulations of (ICAO), 383, 384, 389, 390
Xanthomonas, as plant pathogen, 36
Yaba virus, 30, 199Yaounde virus, 189Yatapoxvirus, 199Yeasts, see FungiYellow fever virus, 179, 189
as BSL-3 agent, 543in laboratory animals, 33laboratory-associated infections due to, 179, 182
Yersinia enterocolitica, 107risk assessment of, 84–85toxin of, 102
Yersinia pestis, 106–107as bioterrorism agent, 587, 588iron acquisition mechanisms of, 12toxin of, 261
Yersinia pseudotuberculosis, 107
Zika virus, 189Zoonoses, see also Laboratory-associated infections;
individual microorganismsfrom laboratory animals, 19–33, 443–444
622 INDEX