5Th edition principles and practices biological

5TH EDITION Biological Safety PRINCIPLES AND PRACTICES DAWN WOOLEY AND KAREN BYERS Tai ngay!!! Ban co the xoa dong chu nay!!! 16990153203411000000 5TH EDITION Biological Safety PRINCIPLES AND PRACTICES 5TH EDITION Biological Safety PRINCIPLES AND PRACTICES EDITED BY DAWN P WOOLEY Wright State University, Dayton, Ohio KAREN B BYERS Dana Farber Cancer Institute, Boston, Massachusetts Washington, DC Copyright © 2017 by ASM Press ASM Press is a registered trademark of the American Society for Microbiology All rights reserved No part of this publication may be reproduced or transmitted in whole or in part or reutilized in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage and retrieval system, without permission in writing from the publisher Disclaimer: To the best of the publisher’s knowledge, this publication provides information concerning the subject matter covered that is accurate as of the date of publication The publisher is not providing legal, medical, or other professional services Any reference herein to any specific commercial products, procedures, or services by trade name, trademark, manufacturer, or otherwise does not constitute or imply endorsement, recommendation, or favored status by the American Society for Microbiology (ASM) The views and opinions of the author(s) expressed in this publication not necessarily state or reflect those of ASM, and they shall not be used to advertise or endorse any product Library of Congress Cataloging-in-Publication Data Names: Wooley, Dawn P., editor | Byers, Karen B., editor Title: Biological safety : principles and practices / edited by Dawn P Wooley, Department of Neuroscience, Cell Biology and Physiology, Wright State University, Dayton, OH, Karen B Byers, Dana Farber Cancer Institute, Boston, MA Description: 5th edition | Washington, DC : ASM Press, [2017] | Includes index Identifiers: LCCN 2017000395 (print) | LCCN 2017004110 (ebook) | ISBN 9781555816209 (print) | ISBN 9781555819637 (ebook) Subjects: LCSH: Microbiological laboratories—Safety measures | Biological laboratories—Safety measures Classification: LCC QR64.7 L33 2017 (print) | LCC QR64.7 (ebook) | DDC 570.289—dc23 LC record available at https://lccn.loc.gov/2017000395 doi:10.1128/9781555819637 Printed in the United States of America 10 Address editorial correspondence to: ASM Press, 1752 N St., N.W., Washington, DC 20036-2904, USA Send orders to: ASM Press, P.O Box 605, Herndon, VA 20172, USA Phone: 800-546-2416; 703-661-1593 Fax: 703-661-1501 E-mail: books@asmusa.org Online: http://www.asmscience.org Contents INTRODUCTION Contributors ix Foreword—Caryl P Griffin and James Welch xiii Preface xv SECTION I HAZARD IDENTIFICATION The Microbiota of Humans and Microbial Virulence Factors Paul A Granato Indigenous Zoonotic Agents of Research Animals 19 Biological Safety Considerations for Plant Pathogens and Plant-Associated Microorganisms of Significance to Human Health 39 Laboratory-Associated Infections 59 Lon V Kendall Anne K Vidaver, Sue A Tolin, and Patricia Lambrecht Karen Brandt Byers and A Lynn Harding SECTION II HAZARD ASSESSMENT Risk Assessment of Biological Hazards Dawn P Wooley and Diane O Fleming Protozoa and Helminths Barbara L Herwaldt 95 105 vi | CONTENTS Mycotic Agents 147 Bacterial Pathogens 163 Viral Agents of Human Disease: Biosafety Concerns 187 10 Emerging Considerations in Virus-Based Gene Transfer Systems 221 11 Biological Toxins: Safety and Science 247 12 Molecular Agents 269 13 Biosafety for Microorganisms Transmitted by the Airborne Route 285 14 Cell Lines: Applications and Biosafety 299 15 Allergens of Animal and Biological Systems 327 Wiley A Schell Travis R McCarthy, Ami A Patel, Paul E Anderson, and Deborah M Anderson Michelle Rozo, James Lawler, and Jason Paragas J Patrick Condreay, Thomas A Kost, and Claudia A Mickelson Joseph P Kozlovac and Robert J Hawley Dawn P Wooley Michael A Pentella Glyn N Stacey and J Ross Hawkins Wanda Phipatanakul and Robert A Wood SECTION III HAZARD CONTROL 16 Design of Biomedical Laboratory and Specialized Biocontainment Facilities 343 17 Primary Barriers and Equipment-Associated Hazards 367 18 Primary Barriers: Biological Safety Cabinets, Fume Hoods, and Glove Boxes 375 19 Arthropod Vector Biocontainment 399 20 Aerosols in the Microbiology Laboratory 411 21 Personal Respiratory Protection 425 22 Standard Precautions for Handling Human Fluids, Tissues, and Cells 443 23 Decontamination in the Microbiology Laboratory 463 24 Packing and Shipping Biological Materials 475 Jonathan T Crane and Jonathan Y Richmond Elizabeth Gilman Duane and Richard C Fink David C Eagleson, Kara F Held, Lance Gaudette, Charles W Quint, Jr., and David G Stuart Dana L Vanlandingham, Stephen Higgs, and Yan-Jang S Huang Clare Shieber, Simon Parks, and Allan Bennett Nicole Vars McCullough Debra L Hunt Matthew J Arduino Ryan F Relich and James W Snyder C O N T E NTS | vii SECTION IV ADMINISTRATIVE CONTROL 25 Developing a Biorisk Management Program To Support Biorisk Management Culture 495 26 Occupational Medicine in a Biomedical Research Setting 511 27 Measuring Biosafety Program Effectiveness 519 28 A "One-Safe" Approach: Continuous Safety Training Initiatives 537 29 Biosafety and Biosecurity: Regulatory Impact 551 LouAnn C Burnett James M Schmitt Janet S Peterson and Melissa A Morland Sean G Kaufman Robert J Hawley and Theresa D Bell Toms SECTION V SPECIAL ENVIRONMENTS 30 Biological Safety and Security in Teaching Laboratories 565 31 Biosafety in the Pharmaceutical Industry 585 32 Biosafety Considerations for Large-Scale Processes 597 33 Veterinary Diagnostic Laboratories and Necropsy 619 34 Special Considerations for Animal Agriculture Pathogen Biosafety 647 35 Biosafety of Plant Research in Greenhouses and Other Specialized Containment Facilities 665 36 Biosafety Guidelines for Working with Small Mammals in a Field Environment 679 37 Components of a Biosafety Program for a Clinical Laboratory 687 Christopher J Woolverton and Abbey K Woolverton Brian R Petuch Mary L Cipriano, Marian Downing, and Brian R Petuch Timothy Baszler and Tanya Graham Robert A Heckert, Joseph P Kozlovac, and John T Balog Dann Adair, Sue Tolin, Anne K Vidaver, and Ruth Irwin Darin S Carroll, Danielle Tack, and Charles H Calisher Michael A Pentella 38 Safety Considerations in the Biosafety Level Maximum-Containment Laboratory 695 David S Bressler and Robert J Hawley Index 719 Contributors Dann Adair Conviron, Pembina, North Dakota Deborah M Anderson Laboratory for Infectious Disease Research and Department of Veterinary Pathobiology, University of Missouri, Columbia, Missouri Paul E Anderson Laboratory for Infectious Disease Research and Department of Veterinary Pathobiology, University of Missouri, Columbia, Missouri David S Bressler Centers for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia LouAnn C Burnett International Biological and Chemical Threat Reduction, Sandia National Laboratories, Albuquerque, New Mexico Karen Brandt Byers Dana Farber Cancer Institute, Boston, Massachusetts Matthew J Arduino Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia Charles H Calisher Arthropod-borne and Infectious Diseases Laboratory, Department of Microbiology, Immunology and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado John T Balog U.S Food and Drug Administration, Office of Operations, Employee Safety and Environmental Management, Silver Spring, Maryland Darin S Carroll Poxvirus and Rabies Branch, Division of High Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, Georgia Timothy Baszler Washington State University, Paul G Allen School for Global Animal Health, Pullman, Washington Mary L Cipriano Abbott Laboratories, North Chicago, Illinois (retired) Allan Bennett Public Health England, Biosafety, Porton, Salisbury, Wiltshire, United Kingdom J Patrick Condreay pc Biosafety Consulting Services, LLC, Carrboro, North Carolina ix I n d e x | 729 Herpes simplex virus (HSV), 193, 206 Herpes simplex virus (HSV-1), 232, 233 Herpesviridae, 206–207 Herpesviruses, 33–34, 198 latent infections, 232 lytic growth phase, 232 as vectors, 232–233 hESCs See Human embryonic stem cells HFRS See Hemorrhagic fever with renal syndrome HICPAC See Hospital Infection Control Practices Advisory Committee Hi Five cell line, 588 High-containment facility, 674 High-containment laboratories, evaluation and verification, 521 High-efficiency particulate air filtration (HEPA filters), 354, 375–376, 411 aerosol containment and, 417–418 decontamination and changing of, 467 in large-scale systems, 601, 603, 605 nanoparticle capture by, 276 paired indicators for use of, 500 standards for, 418 testing and certification of assemblies, 659–660 Highly pathogenic avian influenza (HPAI), 437 High-reliability organizations (HROs), 498, 504 High Security Containment Facilities (HCSFs), 670 hiPSC See Human induced pluripotent stem cell Histology laboratories, 639–640 Histoplasma capsulatum, 68, 156, 285, 435 Histoplasma spp., 150 HIV See Human immunodeficiency virus HMP See Human Microbiome Project Homogenizers, 369 Honeywell protective suit, 702 Hoods, 426 Hormones, 301 Hospital Infection Control Practices Advisory Committee (HICPAC), Universal Precautions and, 449 Host defense mechanisms, Host immune systems, evading, 13–14 Host-parasite relationship, dynamics of, 4–5 Host susceptibility, to zoonotic diseases, 22 HPAI See Highly pathogenic avian influenza HPS See Hantavirus pulmonary syndrome hPSC See Human pluripotent stem cells HR See Hazard ratio HRIG See Human rabies immunoglobulin HROs See High-reliability organizations HSCs See Hematopoietic stem cells HSV See Herpes simplex virus HSV-1 See Herpes simplex virus HTLV See Human T-cell lymphotropic virus HTLV-associated myelopathy, 211 HTLV-I See Human T-cell leukemia virus HTLV-II See Hairy cell leukemia virus Human botulism immune globulin, 253 Human colonic adenocarcinoma, 308 Human diploid cells (HDCs), 300 Human embryonic kidney cells (HEK-293), 586 Human embryonic stem cells (hESCs), 303–304, 305 Human foamy virus, 211 Human granulocytic anaplasmosis, 179 Human immunodeficiency virus (HIV), 193, 211, 225, 443, 470 blastomycosis and, 154 documented occupational exposures, 445, 446 gloves effect on transmission of, 454–455 monitoring after exposure to, 447 occupational risk assessment, 444–447 PIs causing, 445 postexposure treatment, 212, 456 RG classification of, 97–98 risk management in handling, 237 standard precautions, 448–449 TB and, 175 Human induced pluripotent stem cell (hiPSC), 304, 305 Human infectious diseases normal microbial flora and, sources or reservoirs of, Human Microbiome Project (HMP), Human monocytic ehrlichiosis, 179 Human pluripotent stem cells (hPSC), 304 Human rabies immunoglobulin (HRIG), 212 Human risk factors, 538–539, 543 Human T-cell leukemia virus (HTLV-I), 306 Human T-cell lymphotropic virus (HTLV), 196, 211 HUS See Hemolytic uremic syndrome HVAC See Heating, ventilation, and air conditioning Hybridomas, 306 Hydrogen peroxide, 464, 466, 468, 469 vapor, 467–468, 470 Hydrolytic enzymes, 15 Hymenolepis nana, 138 Hypoxia, 713 IABS See International Association of Biological Standardization IACUCs See Institutional Animal Care and Use Committees IATA See International Air Transport Association IBCs See Institutional Biosafety Committees ICAO See International Civil Aviation Organization Ice, 488–489 ICTV See International Committee on Taxonomy of Viruses IDLH See Immediately dangerous to life or health IFN See Interferon IgA See Immunoglobulin A IgA proteases, 13 IgE See Immunoglobulin E IL-1β See Interleukin-1β IL-8 See Interleukin-8 Immediately dangerous to life or health (IDLH), 426 atmospheres considered, 432 contaminant levels and, 432 Immune suppression, 304 Immunizations for veterinary diagnostic laboratory personnel, 632–634 for workplace hazards, 512 Immunoglobulin A (IgA), Immunoglobulin E (IgE), 327 Immunological characterization, 315 Immunological mismatch, 304 Immunotherapy, 274, 333 Imported plants, 668 Inactivation procedures for manufacturing processes, 590 verification at scale of, 591 Incident reporting, airborne transmission and, 289 Incineration, 639 carcass disposal, 656 IND See Investigational New Drug Individually vented caging (IVC), 352 IND vaccines, 213 Infected animals, packing and shipping regulations, 480 Infection See also Laboratory-acquired infections; Occupational acquired infections of arthropods, 407–408 environmentally mediated transmission of, 463–464 parasitic, 105–112 zoonotic, 70, 72–73 Infectious agents, 443 wild-type, 519–520 Infectious disease normal microbial flora and, sources or reservoirs for human, Infectious dose, 413–414 of viruses, 193 Infectious materials, shipping regulations, 151–152 Inflammation, 164–165 730 | Index Inflammatory cytokines, 275 Influenza A H5N1 subtype, 207 H7N9 subtype, 437 Influenza B, 207 Influenza C, 207 Influenza vaccine, 301 Influenza viruses, 68, 207–208, 435 avian, 207, 213, 437 respiratory protection guidelines, 437 Ingestion exposure, laboratory-acquired infections from, 68–69, 688 Inhalation, laboratory-acquired infections from, 688 Initial training, 544 Injuries animal-related, 23 field biosafety and, 652 sources of, on necropsy floor, 634–635 Insectaries biosafety and regulations for, 402–404 design resources, 402 general design criteria, 400–402 genetically engineered arthropod containment and, 405–406 planning and designing, 406–407 Insect cells, pharmaceutical company use of, 588 Insertional mutagenesis, 239 Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), 439 Institutional Animal Care and Use Committees (IACUCs), 406 ACLs and, 402 Institutional Biosafety Committees (IBCs), 221, 239, 520, 668 ACLs and, 402 risk assessment and, 236–238, 258 Instrument grounding, 363 Integrated single-use bioreactor systems, 592 Interfering RNAs, 272 Interferon (IFN), 164–165 production of, 589 “Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Middle East Respiratory Syndrome Coronavirus (MERS- CoV)—Version 2” (CDC), 438 “Interim Risk Assessment and Biosafety Level Recommendations for Working With Influenza A (H7N9) Viruses” (CDC), 437 Interkingdom pathogenic microorganisms, 39 Interleukin-1β (IL-1β), 164, 165 Interleukin-8 (IL-8), 164, 165 International Agency for Research on Cancer, 467 International Air Transport Association (IATA), 312–313, 475–476, 478, 489, 558 dangerous goods classes, 477 list of dangerous goods, 481, 482 packing instructions, 481, 483 types, proper shipping names, UN numbers, and packing instructions, 477 International Association of Biological Standardization (IABS), 300 International Association of Microbiological Societies, 300 International Biological Threat Reduction Department, 624 International Civil Aviation Organization (ICAO), 475–476 International Committee on Taxonomy of Viruses (ICTV), 191 International Healthcare Worker Safety Center, 451 International Organization for Standardization (ISO), 567 risk management principles, 680 International Plant Protection Convention (IPPC), 667 International Society for Advancement of Cytometry, 370 International Standards for Phytosanitary Measures (IPPC), 667 Intestinal protozoa, 107 environmental contamination, 136 laboratory-acquired cases, 136–137 postexposure diagnostic testing, 137 precautions for working with, 136 Intestine, normal microbial flora, 9–10 Intracellular pathogens, 175–181 Intracellular residence, 13 Investigational New Drug (IND), 211 In Vitro Diagnostics Directive, 320 In vitro transcription, 270 In vivo assays, for cell line safety testing, 319 Iodophor disinfectants, 468, 469 IPPC See International Plant Protection Convention Iron acquisition mechanisms, 12–13 Irradiation, 464 IRSST See Institut de recherche Robert-Sauvé en santé et en sécurité du travail ISO See International Organization for Standardization ISO 13485, 320 Isoenzyme patterns, 315 ISO Guide 25 quality standard, 320 Isolation valves, testing and certification of, 661 IVC See Individually vented caging Ivermectins, 586 Ivins, Bruce, 554 Japanese encephalitis virus (JEV), 196, 204, 205, 407 JCAHO See Joint Commission on Accreditation of Healthcare Organizations JEV See Japanese encephalitis virus Job hazard analysis for biological toxins, 258–259 BSL4, 699 Job safety analysis, 101 Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 524, 687 Junin virus, 191 Karyology, 315–316 Keratinocytes, 303 KFD See Kyasanur Forest disease KI discus test, 392 Klebsiella pneumoniae, 173 Kokobera viruses, 204 Kuru, 307 Kyasanur Forest disease (KFD), 191, 204 LAA See Laboratory animal allergy Lab coats, 371–372, 653–654 colored, 669 white, 669 Labeling, 483–485, 486 Laboratory-acquired infections, biosafety program, 687–688 Laboratory animal allergy (LAA) etiology, 328–330 exposure level, 330–331 facility design and equipment, 331–332 individual susceptibility, 330 management of workers with, 333 pathogenesis, clinical symptoms, and diagnosis, 327–328 prevention and interventions, 330–331 surveillance and monitoring, 331–333 Laboratory animals natural pathogens of, 21 zoonotic hazards, 20, 24–36 Laboratory-associated infections (LAIs), 187, 375 aerosols and, 414, 416–421 bacterial, 63–69 common explanations for, 627 commonly reported, 62 epidemiologic studies of, 59–61 fungal, 76–77, 148–150 H capsulatum, 156 incidence, 60 infectious aerosols in, 77 ingestion exposures, 68–69 interventions, 60–61 laboratory function and, 62–63 occupational health programs and, 77–80 parasitic, 75–76, 108–109 parenteral exposures, 68 rickettsial, 69 I n d e x | 731 studies of, 566 underreporting of, 63 veterinary diagnostic laboratories and management of, 644–645 viral, 69–75, 187, 188–190, 198–213 Laboratory biorisk management, 496 Laboratory biosafety, 668–669 competency assessment, 691, 692 Laboratory Biosafety Manual (WHO), 96–97, 644 Laboratory BSL3, 658 Laboratory clothing, 371–373 Laboratory commissioning and acceptance, 365 Laboratory designs, 351 acoustical considerations, 361–362 approach and process, 343–346 BSL3 containment facilities, 352–355 budget or cost constraints, 348–349 decontamination considerations, 365 electrical considerations, 363 equipment selection, 364–365 fire protection, 362–363 HVAC, 360–361 laboratory gases, 362 maintenance capabilities and, 349 for maximum-containment laboratories, 347 operational issues, 349 plumbing, 362 practice and procedure impact on eff ectiveness, 350 preplanning for, 346–349 risk mitigation through, 714–715 schedule or time constraints, 349 security considerations, 363 space validation packages, 349 systems distribution, 364 for teaching laboratories, 578–580 vacuum and compressed-air systems, 362 Laboratory equipment aerosol release prevention in, 415 decontamination of, 454 Laboratory facilities aerosols and LAIs in, 416–421 airborne transmission risks in, 286–287 for biological toxins, 259–260 M tuberculosis safety issues for, 290 Laboratory gases, 362 Laboratory information management systems, 364 Laboratory practices aerosol generation and, 414–416 airborne fungi control, 295 for M tuberculosis, 291 for open-fronted barriers, 395–396 Laboratory site visits, 522–523 “Labs for the 21st Century” program, 345 LAIs See Laboratory-associated infections Large-animal BSL3-Ag, 657, 658 Large animal necropsy, 654–656 Large-scale fume hoods, 393–394 Large-scale processes cleaning and disinfection mechanisms, 603–604 defining, 597–598 equipment selection and usage, 600–603 general biosafety recommendations, 599 guidelines for, 607–616 primary containment for, 599–604 risk assessment for agent considerations, 598 environmental considerations, 599 process considerations, 598–599 secondary containment for, 604–607 Large spaces, decontamination of, 466–468 Lassa fever virus, 199, 697, 698 LCMV See Lymphocytic choriomeningitis virus LD50, 249 for viruses, 193 LD100, 249 Leadership training, 539–541 Leak rate, 389–390 Legionella pneumophila, 67, 165, 181 Legionella spp., 436 Legionnaires’ disease, 181 Leishmania amazonensis, 118 Leishmania (viannia) braziliensis, 117 Leishmania chagasi, 117 Leishmania donovani species complex, 115–117 Leishmania (viannia) guyanensis, 118 Leishmania infantum, 116 Leishmania major, 118 Leishmania mexicana, 118 Leishmania spp., 114 laboratory-acquired cases, 115–118 postexposure management, 118 Leishmania tropica, 117–118 Lentivirus vectors, 225–226, 229–230 Leprosy, 176 Leptospira spp., 175 Leptospirosis, 30, 175 Lethal dose, of viruses, 193 Life support systems, for BSL4 and ABSL4 laboratories, 433 Lighting, 345, 363 Lipopolysaccharides (LPSs), 163 Liquid decontamination, 467 Liquid nitrogen containers, 711 Listeria monocytogenes, 165, 177–178 Listeriosis, 177 Lloviu virus, 202 lncRNA See Long noncoding RNA Local health departments, 554 Long noncoding RNA (lncRNA), 272 Long terminal repeats (LTRs), 228 retroviral vector integration and, 238–239 Loose-fitting respirators, 426, 427 Los Alamos National Laboratory, 426 Louping-ill virus, 191, 204 Low-flow fume hoods, 393 LPSs See Lipopolysaccharides LTRs See Long terminal repeats Lyme disease, 174, 179 Lymphocytic choriomeningitis virus (LCMV), 34–35, 72, 190, 199–200, 367 Lysol, 709 M2 ion channel blockers, 207 Macacine herpesvirus (B virus), 24, 33–34, 206 Macacine herpesvirus 1, 73 Machupo virus, 191 MacLeod, Colin Munro, 270–271 Madin-Darby canine kidney cells (MDCK cells), 301 Major histocompatibility complex (MHC), 274 Malassezia spp., 7, 153 Malignant melanoma, 302 Mammalian cells, pharmaceutical company use of, 587 Management, containment facilities, 676 Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (OIE), 650 MAP test See Mouse antibody production test Marburg virus, 202 Marine animal toxins, 256–257 Material Safety Data Sheets (MSDS), 631, 644 Maximum-containment laboratories design requirements, 347 safety manual, 705–706 McCarty, Maclyn, 271 MDCK cells See Madin-Darby canine kidney cells MDR See Multidrug-resistant MDR Mycobacterium tuberculosis, 286 Measles virus, 208 Mechanical filtration, 428 Medical care Bloodborne Pathogens Standard requirements, 456 for occupational injuries and illnesses, 513–515 Medical evaluations for BSL4 personnel, 705 preplacement, 512 routine periodic, 512–513 Medical record keeping, 516 Medical specimens, fungal biosafety considerations, 158 Medical surveillance for BSL4 personnel, 705 employee, 558 Medical wastes, packing and shipping regulations, 480 Meganucleases, 269, 274 732 | Index Melioidosis, 172–173 Mendelian inheritance, 194 Meningitis, 173, 174 Meningococcus, 173–174 MERS-CoV See Middle East respiratory syndrome coronavirus Mesenchymal stromal cells, 303 Metagenomics, Methicillin-resistant Staphylococcus aureus (MRSA), 167, 470, 575 Metrics, 499–501 MHC See Major histocompatibility complex Microbial agent hazards, in laboratories, 689 Microbial flora, normal, 5–11 Microbiological aerosol tracer test, 380, 381, 392 Microbiological laboratories See also Teaching laboratories respirators recommendations and, 433–434 Microbiology, 642 Microbiota, 3–4 Microcephaly, 193 MicroChem Plus, 709 Micrococcus luteus, Microorganisms survival in air, 413 use in pharmaceutical companies, 585–588 microRNA (miRNA), 269, 272 Middle East respiratory syndrome coronavirus (MERS-CoV), 201–202, 213, 429, 436, 438 Mine Safety and Health Administration, 430 Miniature bioreactor systems, 593 Minimum lethal dose (MLD), 249 miRNA See microRNA Mitigation tools, in biosafety programs, 689–691 Mixing equipment, 369–370 MLD See Minimum lethal dose Mobile laboratories, 395 Modified vaccinia Ankara (MVA), 210, 223 Molds, 148, 151, 153, 156 biosafety levels required for, 150 dematiaceous, 154–155 spore formation, 150 Molecular characterization, 315 Molecular cytogenetic analysis, 316 Molecular diagnostics, 642 Molecular tools, 269 Monitoring for LAA, 331–333 laboratory design considerations, 363 Monkeypox virus, 35, 209, 226 Monoclonal antibodies, 301, 587, 589, 600 Mononucleosis syndrome, 196 Morbidity and Mortality Weekly Report (MMWR), 2011 guidelines, 691 Morphology, 315 Motility, 13 Mouse allergens, 328 Mouse antibody production test (MAP test), 319 Mouse mammary tumor virus, 211 Mouth, normal microbial flora, 8–9 MRC-5, 299 MRSA See Methicillin-resistant Staphylococcus aureus MSDS See Material Safety Data Sheets Mucoraceous fungi, 156 Mucosal splash, laboratory-acquired infections from, 688 Multidrug-resistant (MDR), 286 Multidrug-resistant Mycobacterium tuberculosis, 3, 470 Multiple antibiotic resistance, 100 Multiuse facilities, 590 Mumps, 208 Murine leukemia viruses, 211, 228 MVA See Modified vaccinia Ankara Mycobacterial diseases, 30–31 Mycobacterium bovis, 30–31, 176, 292, 438 Mycobacterium leprae, 176 Mycobacterium spp., 175–176 Mycobacterium tuberculosis, 3, 286, 429, 436–437, 512 airborne transmission hazards, 67, 289–291 apoptosis inhibited by, 165 clinical laboratory infections, 67–68 dormancy, 164 droplet nuclei, 289–291 laboratory practices for, 291, 292 laboratory transmission, 290 LAIs and, 60 multidrug-resistant, 3, 470 research laboratory infections, 68 RG classification of, 99 risk assessment, 290–291 XDR, 286, 288 Mycobacterium tuberculosis complex, 30–31, 175–176, 436 Mycobacterium tuberculosis subsp bovis, 464 Mycology, 640–641 Mycology laboratories, 148–149 Mycoplasmas, 307 cell line safety testing and, 317–318 Mycosis, 640–641 Mycotoxicoses, 40 Mycotoxins, 153 trichothecene, 255 N95 NIOSH filters, 48, 428, 433, 434, 629 Naegleria fowleri, 113 Naked nucleic acids, 270, 272 Nanomaterials, 276 Nanoparticles, 275–276 Nanotechnology, 269, 275–276 containment procedures altered by, 669 Nares, normal microbial flora, 7–8 NaSH See National Surveillance System for Health Care Workers Nasopharynx, normal microbial flora, NASPHV See National Association of State Public Health Veterinarians National Academies of Sciences, U.S., 495, 637 National Association of State Public Health Veterinarians (NASPHV), 653 National Cancer Institute, 206 National Gene Vector Biorepository (NGVB), 238 National Greenhouse Manufacturers Association, 671 National Institute for Biological Standards and Control, 303 National Institute for Occupational Safety and Health (NIOSH), 23, 48, 426, 431, 629 APFs, 429 particulate air-purifying respirator approval, 428 respirator certification, 425, 430, 433, 436 respirator selection process, 432, 438 sharps disposal guidelines, 452 sharps precautions advisories, 450, 451 surgical respirator approvals, 429 National Institute of Standards and Technology, 392 National Institutes of Health (NIH), 3, 166, 667, 681 accidental release guidelines, 590 biosafety guidelines, 496 biosafety levels, 620, 621 Design Policy Guidelines, 620 Genetic Modification Clinical Research Information System, 238 laboratory work precaution recommendations, 449 National Science Advisory Board for Biosecurity, 213 Office of Biotechnology Activities, 236, 520 Office of Science Policy, 96 Recombinant DNA Advisory Committee, 227, 237, 240 risk assessment guidelines, 96 ventilation recommendations, 346 work practice guidelines, 453 National Oil and Hazardous Substances Pollution Contingency Plan, 558 National Personal Protective Technology Laboratory (NPPTL), 629 National Plant Diagnostic Network, U.S., 47 I n d e x | 733 National Research Council, 100 Committee on Hazardous Biological Substances in the Laboratory, 102, 627 nanomaterial safety study, 276 National Sanitation Foundation (NSF), 259 decontamination guidance, 468 HEPA standards, 418 National Science Advisory Board for Biosecurity (NSABB), 213 National Select Agent Registry, 148, 151 National Surveillance for Occupationally Acquired HIV Infection, 445 National Surveillance System for Health Care Workers (NaSH), 450 Natural killer cells (NK cells), 302 NBF See Neutral buffered formalin Necropsy carcass disposal, 637, 655–656 cleanup, 637 field, 654–655 injury sources in, 634–635 large animal, 654–656 loading dock, 634 PPE for, 635–636 procedures inside BSCs, 635 procedures outside BSCs, 636 Necroptosis, 166 Needlestick Safety and Prevention Act of 2000, 450 Needlesticks and sharp injuries, laboratory-acquired infections from, 688 Negative reinforcement, 546–547 Neisseria gonorrhoeae, 173 Neisseria meningitidis, 173–174 airborne transmission, 67 LAIs, 60–61, 65, 66, 68 vaccination for, 78 Neisseria spp., 173–174 Nematodes, 138 NETs See Neutrophil extracellular traps Neuraminidase inhibitors, 207 Neutral buffered formalin (NBF), 639 Neutrophil extracellular traps (NETs), 166 Newcastle disease virus, 208 New World hantaviruses, 34, 200 NGVB See National Gene Vector Biorepository NHP See Non-human primate NIH See National Institutes of Health NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH), 148, 166, 236–237, 259, 269–270, 289, 496, 497, 519, 520, 558 on accidental release, 590 containment goals of, 668 on E coli strains, 586 engineered arthropods and, 405 federal research complying with, 667 genetically engineered organisms, 669 host factors, 102 IBCs described, 668 RG classification, 97 risk assessment guidelines, 96 vaccination recommendations, 589 NIH RAC See Recombinant DNA Advisory Committee NIH Risk Group 1, 47 C.F.R Part 121, 556, 622 NIOSH See National Institute for Occupational Safety and Health Nipah virus, 208, 695, 698 Nitric oxide, 164–165 NK cells See Natural killer cells Noise levels, 361–362 Noncoding RNA, 272 Nonhomologous end joining, 274 Non-human primate (NHP), 20 herpesviruses in, 33–34, 198 M tuberculosis and, 176 poxviruses in, 35 shigellosis in, 33 SIV and, 70 zoonotic infections and, 73 Nonintegrating vectors, 228 Nonlipid viruses, 464 Nonoxynol-9, 455 Nonpathogens, Nonpowered air-purifying respirators, 426, 427 particulate filters, 428 Nonrecombinant DNA, 270 Nonsporicidal disinfectants, 464 Normal microbial flora, ear, eye, gastrointestinal tract benefits of intestinal, 10 esophagus, intestine, 9–10 mouth, 8–9 stomach, genitourinary tract urethra, 10–11 vagina, 11 infectious disease and, respiratory tract nares, 7–8 nasopharynx, on skin, 6–7 North American Plant Protection Organization, 667 Notifiable diseases, zoonotic, 22 Novices, 545, 546 NPPTL See National Personal Protective Technology Laboratory NSABB See National Science Advisory Board for Biosecurity NSF See National Sanitation Foundation NSF/ANSI standard 49, 376 NSF Class II BSC testing, 381 Ntaya viruses, 204 Nucleic acids, 269–273 introducing into cells, 271 synthesis of, 270 types of, 270 OBA See Office of Biotechnology Activities Occupational acquired infections, 22 medical care for, 513–515 parasitic, 110, 111, 112 risk assessment for, 443–448 Ebola virus, 447–448 hepatitis viruses, 444 HIV, 444–447 standard precautions for, 448–457 Occupational exposure limit (OEL), 430 respirator selection and, 432 Occupational health, 520–521 biological toxins and, 258 Occupational health programs, 77 behavioral factors, 79–80 host factors, 79 postexposure prophylaxis, 78–79 safety committee collaboration with, 693–694 vaccination, 78 Occupational injuries, medical care for, 513–515 Occupational medicine, 511 animal research and, 516–517 communications, 515–516 record keeping and workers’ compensations, 516 serum storage, 516 training and drills, 515 Occupational Safety and Health Administration (OSHA), 23, 166, 444, 682, 687 assigned protection factors, 429 Bloodborne Pathogens Standard, 77, 110, 371, 372, 450, 452, 496, 519, 567 exposure control training recommendations, 455 medical care requirements, 456 work practices and, 454 Ebola guidance, 457–458 facepiece fit standards, 436 general respiratory protection standard, 430–431 General Respiratory Protection Standard, 430–431, 432, 434 hand washing product guidelines, 453 medical records requirements, 516 noise level requirements, 362 PPE definitions, 628 PPE requirement standards, 371, 568 respirator selection requirements, 432 respirator use regulations, 430–431 respiratory protection program specifications, 425 sharps disposal guidelines, 452 sharps precautions advisories, 450 734 | Index Occupational Safety and Health Administration (OSHA) (continued ) teaching laboratories and, 567 tuberculosis exposure regulations, 437 work practice guidelines, 453 October 2001 anthrax attacks, 553–554 Ocular splash, laboratory-acquired infections from, 688 OECD See Organisation for Economic Co-operation and Development OEL See Occupational exposure limit Office of Biotechnology Activities (OBA), NIH, 236, 520, 668 Office of Science and Technology Policy, 100 Office of Science Policy (OSP), risk assessment guidelines, 96 Offices, 350 OIE See World Organisation for Animal Health Old World hantaviruses, 34 Oncogenic DNA, 270, 271–272 Oncogenic potential, 308 Oncogenic viruses, 306–307 One Health Initiative, 619 “One-safe” approach, 537 developing culture for, 542 On-the-job training, 540, 544 Optaflu, 301 Orf, 35, 210 Organic vapors, 428 Organisation for Economic Co-operation and Development (OECD), Environment Directorate, 499 Organizational expectations, 541 Orientia tsutsugamushi, 68, 179 Orthomyxoviridae, 207–208 ortho-Phthalaldehyde, 469 Orthopoxvirus, 198, 210–211 Orthopoxvirus spp., 226 OSHA See Occupational Safety and Health Administration OSP See Office of Science Policy Outside consultants, 523 Overlap agents, 151, 262 Oxidative disinfectants, 468 Oxygen-deficient atmospheres, 426 Ozone, 464 Packages documentation, 485–488 marking and labeling, 483–485 veterinary diagnostic laboratories and, 642 Packaging cell lines, 312 Packing instructions, 481, 482, 483 Packing substances, 481, 483 Paecilomyces lilacinus, 156–157 Paired indicators, 500, 501 PAMPs See Pathogen-associated molecular patterns PANDAS See Pediatric neuropsychiatric disorder associated with streptococcal infection PAPRs See Powered air-purifying respirators Paracoccidioides brasiliensis, 156 Paraformaldehyde, 467, 468 Parainfluenza, 208 Paramyxoviridae, 208 Parapoxvirus spp., 35 Parasites, in animal cell cultures, 307 Parasitic infections, 105, 106–107 accidental exposure factors, 108–109 common lab animals and, 36 occupationally acquired, 110–112 practices and occurrences leading to, 112 Parasitic LAIs, 75, 108–109 means of exposure, 76 Parasitology, 640 Parenteral exposure LAIs, 68 PARP See Poly(ADP-ribose) polymerase Particle filtration, 428 Particle size, 412, 413 Particulate filter respirators, 48, 629 Pasteurella haemolytica, 174 Pasteurella multocida, 31, 174 Pasteurella spp., 174 Pasteurellosis, 31 Pathogen-associated molecular patterns (PAMPs), 164 Pathogen data sheets, 569 Pathogenic DNA, 270, 272 Pathogenicity, 4–5 disabling for viral vectors, 223–224 Pathogen Safety Data Sheet, 573 Patient biocontainment units (PBUs), 343, 356–359 models of, 359 preparedness and, 357 principles for, 357–359 risks unique to, 357 Patient care spaces, 358 Patient specimens, packing and shipping regulations, 481 Pattern-recognition receptors (PRRs), 164, 165 PBUs See Patient biocontainment units PCR, 270 cell line safety testing and, 318 PCR profiling, 316–317 Pediatric neuropsychiatric disorder associated with streptococcal infection (PANDAS), 168 Peer review, of biosafety programs, 523 PELs See Permissible exposure limits Pelvic inflammatory disease (PID), 173 Penicillium marneffei, 157 PEP See Postexposure prophylaxis Pepper mild mottle virus (PMMoV), 45–46 Peptic ulcers, 170 Peracetic acid, 468, 469 Perceived mastery, 538 Perception training, 547 Perchloric acid fume hoods, 379 Percutaneous injury (PI), 444 occupationally acquired HIV infections and, 445 Permissible exposure limits (PELs), 430 Personal protective equipment (PPE), 19, 20, 367, 370–373, 668–669 for airborne route, 288–289 for allergens, 331, 332 for biological toxins, 260 for Ebola work, 438, 448, 458 metrics measuring use of, 500 for necropsy work, 635–636 for spill management, 631–632 surgical masks in, 428–429 teaching laboratories and, 568, 577–578 for veterinary diagnostic laboratories, 626, 628–630 work practices, 454–455 for zoonotic disease risk mitigation, 682 Personal protective suit laboratories, 702–705 emergency response issues, 713–714 Personnel reliability program (PRP), 557 Person-to-person transmission, fungal diseases and, 285 Pertussis, 173 Pest control, in containment facilities, 675–676 Pfiesteria toxins, 257 PHAC See Public Health Agency of Canada Pharmaceutical companies microorganisms used in bacteria, 586–587 fungi, 587 insect cells, 588 mammalian cells, 587 viruses, 585–586 scale-up to manufacturing, 588–594 culture identification, 590 technology transfer for, 589–590 Pharmaceutical production, cell line acceptance for, 300–302 Pharmacy glove box, 391 Phenolic disinfectants, 468, 469, 709 Phialophora verrucosa, 155 Phycodnaviridae, 46–47 Physical containment, 670–676 Phytotoxins See Plant toxins Phytoviruses, 42 PI See Percutaneous injury; Principal investigator Pichia, 587, 588 Picornaviridae, 208–209 PID See Pelvic inflammatory disease Pinworm, 138 Piwi-interacting RNA (piRNA), 272, 273 Plague, 171 biological warfare with, 552 Plant breeders, technology exploited by, 667 I n d e x | 735 Plant containment symbol, 673 Plant-human cross-kingdom pathogenic microorganisms containment of, 48–49 disposal, 49 laboratory personnel risk potential, 47–48 movement of, 49 Plant pathogens cross-kingdom microorganisms, 40–47 movement of, 49 risk assessment and biosafety levels for, 47–49 surface disinfectants for, 675 Plant Protection Act, 49 Plant Protection and Quarantine (PPQ) program, 666 Plant research, in containment facilities, 665–666 guidelines and regulations, 667–668 objectives, 668–669 Plants, 669 imported, 668 Plant toxins (phytotoxins), 257–258 Plant viruses, 40, 42, 45–46, 47–48 Plasmids, 271 Plasmodium cynomolgi, 119, 120 Plasmodium falciparum, 119, 120–122 Plasmodium spp., 76, 118, 443 laboratory-acquired cases, 119–122 postexposure management, 122–123 Plasmodium vivax, 119, 120, 122 Plumbing, 362 PMCA See Protein misfolding cyclic amplification PMMoV See Pepper mild mottle virus Pneumococcus spp., 168 Pneumonic plague, 171 Polio vaccine, 299, 587 Poliovirus, 70, 99, 208–209 Pollen and spores, 669, 672 Poly(ADP-ribose) polymerase (PARP), 166 Polymerases, 270 Positive-pressure suits, 370 Possession, Use, and Transfer of Select Agents and Toxins (42 C.F.R Part 73), 693 Postaccident management for retroviruses, 212 for viral exposures, 198 Postexposure prophylaxis (PEP), 78–79, 212 Postincident training, 545 Powered air-purifying respirators (PAPRs), 352, 426, 427, 682 for influenza virus work, 437 Power supply and distribution, 363 Poxviridae, 209–211 Poxviruses, 35, 70 as vectors, 226–227 PPE See Personal protective equipment PPQ See Plant Protection and Quarantine program Practitioners, 545, 546 PRD See Pressure relief device Preplacement medical evaluations, 512 Preplanning budget or cost constraints, 348–349 program, 346–348 Pressure decay test, 389, 660 Pressure-demand SCBAs, 432 Pressure relief device (PRD), 601 Pressure vessels, 601 Pretesting, 660 Primary barriers, 349, 367, 371, 375 automated equipment enclosures, 394–395 certification of, 392–393 for mobile laboratories, 395 risk assessment and, 376–377 selection and use of, 376–377 special designs and modifications, 393–395 special-purpose, 393–394 use of, 395–396 Primary containment for aerosols, 417 for large-scale processes, 599–604 Primary containment devices, 367–370, 376 Principal investigator (PI), 668 Prion protein (PrP), 276 Prions, 436 animal, 278 in animal cell cultures, 307–308 cell line safety testing and, 318 decontamination issues, 470–471 diseases from, 276, 277 exposure to, 278 inactivation of, 278–279 physical properties, 277–278 sample handling, 638 Production laboratories, bacterial LAIs in, 66 Production processes, for biologicals, 313–314 PROGNOS, 274 Programmed host cell death, 165–166 Proinflammatory cytokines, 164 Prophylactic antifungal therapy, 159 Propionibacterium acnes, Protection of Laboratory Workers From Occupationally Acquired Infections (CLSI), 567 Protective clothing, 577 for biological toxins, 260 zoonotic disease prevention and, 653–654 Protective suits, 702–703 entry preparation, 708 Protein misfolding cyclic amplification (PMCA), 318 Protozoa blood and tissue, 106–107, 110–136 intestinal, 107, 136–137 Protozoan diseases, laboratory animals and, 24–27 Provenge (sipuleucel-T), 302 PrP See Prion protein PRP See Personnel reliability program PRRs See Pattern-recognition receptors Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards, Updated Version (National Academies of Science), 637 Pseudomonads, 172–173 Pseudomonas aeruginosa, 40, 172, 249 Public Health Agency of Canada (PHAC), 569 Public health departments, 554 teaching laboratory guidance from, 567 “Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS) Version 2” (CDC), 434 Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 151 Public Health Service, U.S biosafety guidance, 648 medical care evaluation recommendations, 456 postexposure treatment recommendations, 456 Puffer fish, 256 Pulmonary mycosis, 641 PulseNet, 61 Puncture resistance, 455 Punishment, 546 Purification, 602–603 Purification equipment, 603 Pyroptosis, 165 Q fever, 24, 32, 69, 180, 286 Qualitative fit testing, 432 Quantitative fit testing, 431–432 Quarantine procedures, for cell line work, 310–311 Quarantines, 665 Quaternary ammonium compounds, 469 Query fever See Q fever Rabbit fever, 180–181 Rabies, 35–36, 212 RAC See Recombinant DNA Advisory Committee Radiation sterilization, 470 Radioactive isotopes, 637 Radioisotope fume hoods, 379 Radionuclides, 376 Rajneeshee cult, 553, 571–572 Random amplified polymorphic DNA (RAPD), 317 Rapid tests, 642 Rash, in viral infections, 195 rasiRNA See Repeat-associated small interfering RNA Rat allergens, 328 Rat-bite fever, 31–32 736 | Index Ravn virus, 202 RCL See Replication-competent lentivirus RDA See Replication-deficient adenovirus rDNA See Recombinant DNA Recapping devices, 451 Receiving areas, 626 Recirculated fume hoods, 379 Recombinant activities, risk associated with, 100–101 Recombinant adenoviruses, 230 Recombinant bacteria, 586 Recombinant cell lines, 309 Recombinant DNA (rDNA), 270 biosafety programs and, 524 scale-up and, 597 vectors for, 271 Recombinant DNA Advisory Committee (NIH RAC), 227, 237, 240, 270 risk assessment guidelines and, 96 Recombinant DNA Molecule Program Advisory Committee, 270 Recombinant organisms, 148 Recombinant vectors baculoviruses, 233–234 herpesviruses as, 232–233 lentiviruses, 229 poxviruses, 226–227 retroviruses, 227–228 Recombinant viruses, 585 Recombination events, 225, 229 Recovery, 602–603 Redundancy, 359 Refrigerants, 488–489 Regulations for bioprocess-based pharmaceutical production, 592 biorisk management culture and, 499 respirator performance, 430 for respirator use, 430–431 shipping and packing, 151–152, 475–476, 480 teaching laboratories and, 566–567 Regulatory agencies, biosafety program evaluation by, 523 Regulatory issues, for biological toxins, 262–263 Release of dominant lethal mosquitoes (RIDL mosquitoes), 405 Rendering, 656 Repeat-associated small interfering RNA (rasiRNA), 273 Replication-competent lentivirus (RCL), 237 Replication deficiency adenovirus, 230 maintenance of, in viral vectors, 224–226 Replication-deficient adenovirus (RDA), 230 Requirements for an Accredited Veterinary Medical Diagnostic Laboratory (AAVLD), 643 RES See Reticuloendothelial system Research laboratories bacterial LAIs in, 66 HVAC for, 360–361 Respirators, 629 air-purifying, 426 air-purifying particulate filter, 48 atmosphere-supplying, 426 for Bacillus anthracis work, 434 cartridge and canister change-out schedules, 432–433 fit and testing of, 431–432 gas removal, 428 IDLH atmospheres and, 432 for M tuberculosis work, 436–437 OSHA procedures for use of, 431 particle filtration, 428 performance requirement regulations, 430 powered air-purifying, 426 preplacement medical evaluation and, 512 protection factors, 429–430 recommendations for biosafety applications, 434, 435–436 recommendations for microbiological laboratories, 433–434 regulations regarding use of, 430–431 regulatory approval, 430 for SARS-CoV work, 434 selection for aerosolized microorganisms, 438–439 selection of, 432–433 types of, 425 Respiratory illnesses, 196 Respiratory protection ABSL2 and, 433 for biological toxins, 260 BSCs and, 433 BSL2 and, 433 BSL3 and, 433 BSL4 and, 433 for Ebola virus, 437–438 hantavirus guidelines, 437 influenza viruses, 437 zoonotic disease prevention and, 653 Respiratory syncytial virus (RSV), 208, 211 Respiratory tract, 412–413 normal microbial flora, 7–8 Reston virus, 202 Restriction fragment length polymorphism, 316–317 Reticuloendothelial system (RES), Retroviral vector integration, side effects of, 238–239 Retroviridae, 211–212 Retroviruses in animal cell cultures, 306 LAIs, 70 postaccident management, 212 as vectors, 227–229, 238–239 Reverse transcriptase, cell line safety testing and, 318–319 Reverse transcriptase PCR (RT-PCR), 318 RG4 biological agents, 696, 697–698 RGs See Risk groups Rhabdoviridae, 212 Rheumatic heart disease, 168 Ribavirin, 199, 697 Ribosomal RNA (rRNA), 272 Ricin, 257–258, 552–553, 554 Rickettsial LAIs, 69 Rickettsia prowazekii, 178 Rickettsia rickettsii, 178–179 Rickettsia spp., 178–179 RIDL mosquitoes See Release of dominant lethal mosquitoes Rift Valley fever (RVF), 190, 191, 192 Rinderpest virus, 208 RISC See RNA-induced silencing complex Risk acceptability of, in work with biological hazards, 102–103 defining, 95–96 identifying, 681 prioritization of, 103 recombinant activity-associated, 100–101 Risk assessment activity-based, 100 for aerosols, 421–422 agent-activity interaction in, 101 agent-based, 598 for agricultural biosafety, 647–651 biohazardous agents in, 96 biological, 622 biosafety manuals and, 101 biosafety programs, 688–689 for BSL4 facilities, 698–700 for cell lines, 309–310 for cross-kingdom pathogenic microorganisms, 47–49 defining, 95–96 evaluator role in, 96 exposure determination for, 101 guidelines for, 96, 568 host factors, 102 IBCs and, 236–238, 258 immortalizing, 689 iterative process for, 569 for large-scale processes, 598–599 for M tuberculosis, 290–291 for nanoparticles, 276 for occupational acquired infections, 443–448 for primary barrier selection and use, 376–377 for recombinant or synthetic DNA, 270 for recombinant work, 100–101 of scale-up and large-scale activities, 101 security, 262 site-specific, 557 for teaching laboratories, 568–572 I n d e x | 737 technology transfer and, 589 tool, 690 of unknowns, 100 for veterinary diagnostic laboratories, 622–626 Risk classifications, 620–622 Risk factors, human, 538–539 Risk groups (RGs), 166, 620, 669 classification of, 96–99 European Federation of Biotechnology, 305 teaching laboratories and, 570–571 for zoonotic agents, 681–682 Risk management See also Biorisk management SEE strategy for, 96 agricultural pathogens and, 648 for biological toxins, 258–259 for BSL4 facilities, 698–700 in HIV handling, 237 for zoonotic agents, 680, 684 Risk matrix, 193–195 for gene-editing technologies, 194–195 Risk mitigation BSL4 design for, 714–715 for zoonotic diseases, 682–684 Risk of disease (RoD), 513, 514, 515 Risk of exposure (RoE), 513, 514 RMSF See Rocky Mountain spotted fever RNA, 272–273 RNAi See RNA interference RNA-induced silencing complex (RISC), 272 RNA interference (RNAi), 269, 272, 273 RNA viruses, 191–192, 306 Rocky Mountain spotted fever (RMSF), 178–179 RoD See Risk of disease Rodent control, 364 Rodentolepis nana, 36 Rodents hantavirus reservoirs, 200 zoonotic infections from, 72 RoE See Risk of exposure Routine periodic medical evaluations, 512–513 rRNA See Ribosomal RNA RSV See Respiratory syncytial virus RT-PCR See Reverse transcriptase PCR Rubella virus, 193, 212–213 RVF See Rift Valley fever rVSV-ZEBOV, 203 Sabia virus, 198, 199, 368 Saccharin, 432 Saccharomyces cerevisiae, 587 Safety, culture of, 694 Safety audits, biosafety program, 693 Safety committee biosafety program, 693–694 occupational health program collaboration with, 693–694 Safety culture, 497–498, 541 Safety-engineered sharps devices, 451–453 Safety equipment for biological toxins, 259–260 for teaching laboratories, 576–578 Safety generalists, 522–523 Safety measures, for cell line work, 311 Safety policies, for airborne route transmission, 287–288 Safety testing, of cell lines, 317–319 Saimiriine herpesvirus, 206 Salk polio vaccine, 299 Salmonella enterica, 171, 573 Salmonella spp., 32–33, 171, 571–572 LAIs, 60, 61 Salmonella enterica serovar Typhimurium, 65–66, 566, 573–574 Salmonellosis, 32–33 Sampling devices, 601–602 Sandia National Laboratories, 624 Sandimmune, 587 SAP See Select Agent Program Sappinia pedata, 113 Saprophytes, Sarcocystis spp., 123 Sarin, 553 SARS See Severe acute respiratory syndrome SARS-CoV See Severe acute respiratory syndrome coronavirus Saxitoxin (STX), 256 Scale-up to manufacturing, 588–594 culture identification, 590 technology transfer for, 589–590 SCBA See Self-contained breathing apparatus scFv See Single-chain variable fragment Schedule constraints, 349 Schistosoma mansoni, 109, 139 Schistosomiasis, 138–139 SCID-X1 See X chromosome-linked severe combined immunodeficiency sCJD See Sporadic CJD Scrapie, 276, 277, 278, 307, 471, 638 Screened cages, 672 Screens, 672 scRNA See Small cytoplasmic RNA Scrubs, 371–372 Scrub typhus, 179 Scrub typhus pneumonitis, 68 SCUBA See Self-contained underwater breathing apparatus SDV See Simian D retrovirus Sealing, containment facilities, 671–672 Search-Evaluate-Execute strategy (SEE), 96 Secondary barriers, 349–350 Secondary containment for aerosols, 417, 420–421 for large-scale processes, 604–607 Security BSL4 facilities, 709 HCSFs, 670 laboratory design considerations, 363 plans, 556–557 risk assessment for, 262 Select Agent Program requirement, 556–557, 709 of stock cultures, 590–591 of toxins, 262–263 Security culture, 497–498 Security Risk Assessment, 262 SEE See Search-Evaluate-Execute strategy Select Agent Program (SAP), 65, 148, 151, 496, 521, 588, 622, 623, 695 biological toxins and, 262 employee medical surveillance, 558 facility inspection, 524–526 inventory requirements, 557 security requirements, 556–557, 709 transportation provisions, 557–558 Select Toxins list, 262, 263, 555, 556, 623 Self-audits, 522 Select Agent Program requirements for, 526 Self-blunting needles, 451 Self-contained breathing apparatus (SCBAs), 426, 427 IDLH atmospheres and, 432 pressure-demand, 432 Self-contained underwater breathing apparatus (SCUBA), 426 Sendai virus, 208 Septicemic plague, 171 Sequence-specific nuclease (SSN), 667 Serum banking, 633–634 Serum resistance, 13 Serum storage, 516 C.F.R part 331, 622 Severe acute respiratory syndrome (SARS), 434 Severe acute respiratory syndrome coronavirus (SARS-CoV), 191, 198, 201–202, 213, 434, 436, 470, 497 SFV See Simian foamy virus Sharps disposal containers, 452 Sharps precautions, 450–451 Shiga toxin-producing E coli (STEC), 170 Shigella dysenteriae type 2, 572 Shigella spp., 171, 249 toxins, 254 Shigellosis, 33, 171 Shipper’s Declaration for Dangerous Goods, 487, 488 Shipper’s Declarations, 485–488 Shipping cell lines, 312 documentation, 485–488 governing authorities, 475–476 marking and labeling packages, 483–485, 486 738 | Index Shipping (continued ) packing instructions and packing substances, 481–483 refrigerants for, 488–489 regulations clinical wastes, 480 for fungi, 151–152 for patient specimens, 475–476 substance classification for, 476–481 training and certification for, 489 veterinary diagnostic laboratories and, 642 Shoe covers, 372, 669 Short hairpin RNA (shRNA), 272, 273 Shuttle vectors, 271 Signage, 365 Simian D retrovirus (SDV), 70, 73 Simian foamy virus (SFV), 70, 73, 211 Simian immunodeficiency virus (SIV), 70, 211, 272 Single-chain variable fragment (scFv), 274 Sin Nombre virus, 679 SIP See Sterilize in Place siRNA See Small interfering RNA Site-specific risk assessment, 557 Site visits, 522–523 Situational response training, 548 SIV See Simian immunodeficiency virus Skin, normal microbial flora, 6–7 Small cytoplasmic RNA (scRNA), 272 Small interfering RNA (siRNA), 269, 272 Small noncoding RNAs, 272 Small nuclear RNA (snRNA), 272 Smallpox, 226, 698 biological warfare with, 552 vaccination for, 209 Snake venoms, 256 snRNA See Small nuclear RNA Sodium hydroxide, 471 Sodium hypochlorite, 466, 468, 471 Solid-phase DNA synthesis, 270 Sonicators, 369 SOPs See Standard operating proce dures Sorters, 370 Space decontamination, 466 Spaulding classification, 464–465 Specialized biocontainment facilities, 355–360 Specimen containers, 626 Specimen transport, 453 Specimen transport containers, 370 Spill control plans, 468–469 Spill management, 363 containment zones, 632, 633 for veterinary diagnostic laboratories, 631–632 Spirillum minus, 31–32 Spirochetes, 174–175 Splatter control, 453 Spondweni viruses, 204 Sporadic CJD (sCJD), 276 Sporothrix schenkii, 157, 295 Sporulation, 164 Spotted fevers, 178–179 Spray factors, 414, 415, 416, 421–422 Sprinklers, 362 SSN See Sequence-specific nuclease Stachybotrys, 436 Standard microbiological practices or techniques, 576 Standard operating procedures (SOPs), 19, 425, 504, 537, 669 behavioral preparation and, 547 development for arthropods, 408–409 employee medical surveillance and, 558 job hazard analysis and, 258 nonadherence to, 540 on-the-job training and, 544 organizational expectations for following, 541 technology transfer and, 589 training generations and, 547 Standard precautions Ebola virus enhancements to, 457–458 eff ectiveness of, 456–457 employee training and monitoring, 455–456 engineering controls for, 449–453 for occupationally acquired infection control, 448–457 sharps precautions, 450–451 work practice controls, 453–455 Standard (Universal) Precautions, 444 Standby power, 363 Staphylococcus aureus, 7, exotoxins from, 249 Staphylococcus auricularis, Staphylococcus capitis, Staphylococcus epidermis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus spp antibiotic resistance in, 167 as pathogen, 167 toxins, 254–255 State Research Center of Virology and Biotechnology, 698 Steam sterilization, 470 STEC See Shiga toxin-producing E coli Stem cells human embryonic, 303–305 human induced pluripotent, 304–305 human pluripotent, 304 transplantation of, 303 Sterile sampling, 593–594 Sterilization for anthrax, 470 CD gas, 468 EPA classifications for, 465 principles of, 464 Sterilize in Place (SIP), 591 Stock culture security, 590–591 Stomach, normal microbial flora, Stomachers, 369 Strategic National Stockpile, U.S., 211 Streptobacillus moniliformis, 31–32 Streptococcus aglactiae, 167 Streptococcus mutans, Streptococcus pneumoniae, 168 RG classification of, 99 Streptococcus pyogenes, 167–168 Streptococcus sanguinis, Streptococcus spp., 167–168 Streptomyces avermitilis, 586 Strongyloides, 36 STX See Saxitoxin S Typhimurium, 65–66 Subcultures, blending, 542 Subcutaneous mycosis, 640–641 Substance classification, 476–481 Substance naming, 481 Sudan virus, 202 Sulfur hexafluoride tracer test, 378, 392 Superantigens, 14–15 Supplied-air respirators (SARs), 426, 427 IDLH atmospheres and, 432 Supplied-air suits, 426 Support rooms, 354–355 Surface disinfectants, 675 Surfaces cleaning, 453–454 decontamination of, 468–469 for large-scale process facilities, 604 Surgical masks, 428–429 Surveillance, for LAA, 331–333 Sustainable (green) design, 345 Swine flu, 207 Synthetic biology, containment procedures altered by, 669 Synthetic DNA, biosafety programs and, 524 Synthetic nucleic acids, 270 Systemic mycosis, 641 Systems distribution, 364 T-2 mycotoxin, 255 Taenia solium, 138 Tai Forest virus, 202 TALENs See Transcription activator-like eff ector nucleases Tanapox virus, 35, 209 Tapeworms, 138 Task Committee on Guidelines for Biosafety in Teaching Laboratories, 576 Task Force on Curriculum Guidelines for Undergraduate Microbiology Education, 575 TB See Tuberculosis TBEV See Tick-borne encephalitis virus TC-21C filters, 48 T-cell leukemia, 211, 238 TCP See Toxin-coregulated pilus TCRs See Engineered T-cell receptors I n d e x | 739 TDICT See Training for the Development of Innovative Control Technology Project Teaching laboratories, 565 bacterial LAIs in, 65–66 biosafety cautions for, 575 biosafety guidelines for, 574–575 biosafety manuals for, 580, 581 BSCs in, 577 BSL1, 579 BSL2, 579–580 curricular design and, 572–573 laboratory designs for, 578–580 PPE and, 568, 577–578 risk assessment for, 568 application of, 569–570 biosecurity, 571–572 risk groups and biosafety levels, 570–571 safety equipment for, 576–578 standard microbiological practices or techniques for, 576 Technical Instructions for the Safe Transportation of Dangerous Goods by Air (ICAO), 475 Technology transfer, 589–590 Tecovirimat, 211 Terrorism, defining, 551 Testing, of respirators, 431–432 Tetanospasmin, 253–254 Tetanus, 61 Tetrodotoxin, 256 30 C.F.R Part 11 (16), 430 Threshold limit values (TLVs), 430 Tick-borne encephalitis virus (TBEV), 191, 196, 204 Tick-borne viruses, 204 Tier Select Agents, 167 Tight-fitting respirators, 431 Time constraints, 349 Tissue fixation, 639 Titi monkey adenovirus (TMAdV), 199 TKM-100802, 203 TKM-Ebola, 203 TLVs See Threshold limit values TMAdV See Titi monkey adenovirus TME See Transmissible mink encephalopathy Tobacco mosaic virus (TMV), 42 Togaviridae, 212–213 Tōhoku earthquake of 2011, 497 Tokyo subway sarin attack, 553 Toxin-coregulated pilus (TCP), 169 Toxins, 14–15 See also Biological toxins; specific toxins animal, 255–257 bacterial, 249–255 biological, 247 defining, 247, 551 degree of toxicity, 249 fungal, 255 plant, 257–258 production of, 589 sources and mechanisms, 248 Toxoplasma gondii, 13, 26–27, 109, 512 laboratory accident and infection risks, 123–124 laboratory-acquired cases, 124–127 postexposure management, 127–128 Toxoplasmosis, 26–27 Training aerosols and, 415–416 approaches for, 545–548 for arthropods, 408–409 behavioral evolution and, 543–544 behavioral preparation, 547–548 for biosafety, 631 biosafety programs, ongoing, 691, 693 for BSL4 personnel, 705–714 cognitive awareness and, 546–547 communication, for BSL4, 709–710 continuous, 544 developing “one-safe” culture, 542 generations, 545–546 goals of, 538–539 initial, 544 leadership, 539–541 on-the-job, 540, 544 perception, 547 postincident, 545 shipping, 489 situational response, 548 in standard precautions, 455–456 technology transfer and, 589 timing of, 542–545 veterinary diagnostic laboratory biosafety, 643–644 for veterinary diagnostic laboratory safety, 631 workforce, 541 Training for the Development of Innovative Control Technology Project (TDICT), 452 trans-acting functions, 223, 224, 225 Transcription activator-like eff ector nucleases (TALENs), 269, 273, 667 Transduction, 271 Transfer RNA (tRNA), 272 Transgenic plants, risks of, 668 Translational RNAs, 272 Transmissible mink encephalopathy (TME), 278, 638 Transmissible spongiform encephalopa thies (TSEs), 307–308 Transmissible spongiform encephalopathy agents, 470–471 Transportation, of Select Agents and Toxins, 557–558 Transposons, 271 Treponema pallidum, 443 Trichosporon spp., 153 Trichothecene mycotoxins, 255 Triple fume hood, 393 tRNA See Transfer RNA Tropical spastic paraparesis, 211 Trypanosoma brucei gambiense, 134–136 Trypanosoma brucei rhodesiense, 134–136 Trypanosoma cruzi, 109 detection by light microscopy, 133 laboratory-acquired cases, 128–132 monitoring for, 133 postexposure management, 132–134 TSEs See Transmissible spongiform encephalopathies Tuberculin skin test (TST), 286 Tuberculosis (TB), 30–31, 175–176 Tularemia, 180–181 Tumorigenicity, 308 studies of, 319–320 Tumor-infiltrating lymphocytes, 302 Tumor virus receptor A (TVA), 226 29 C.F.R 1910.134, 430–431, 434 canister change-out requirements, 432 Type I interferon (Type I IFN), 164–165 Typhoid fever, 61, 171, 286 Typhus, 178, 179 Umbilical cord blood (UCB), 303 Undulant fever See Brucellosis United Nations Committee of Experts, 475 Food and Agriculture Organization, 667 United States, transgenic plant handling in, 667–668 United States Postal Service (USPS), 434, 476 Universal Precautions, 449, 625 eff ectiveness of, 456–457 specimen transport, 453 UN numbers, 477 Urethra, normal microbial flora, 10–11 U.S Army Medical Research Institute of Infectious Diseases (USAMRIID), 32, 78, 553–554 BSL4 laboratory, 695 U.S Department of Agriculture (USDA), 28, 48, 151, 166, 259, 405, 666 See also Animal and Plant Health Inspection Service agricultural biocontainment guidance, 648, 650 Agricultural Research Service, 676 security policy and biosafety rules, 558 Select Agent Program and, 554, 556, 622 site visits by, 524 USPS See United States Postal Service Vaccination BMBL recommendations, 589 for Brucella, 79 for Neisseria meningitidis, 78 NIH Guidelines recommendations, 589 occupational health programs, 78 programs for, 78 for smallpox, 209 740 | Index Vaccines See also specific vaccines attenuated microorganisms for, 99 cell substrates for manufacture of, 308 for Ebola, 204 hepatitis B, 444, 512 IND, 213 influenza, 301 polio, 587 production of, 585, 587 Salk polio, 299 Vaccinia immune globulin (VIG), 211 Vaccinia virus, 70, 191, 209, 210, 226 as recombinant vector, 227 Vacuum and compressed-air systems, 362 Vacuum protectors, 370 Vacuum traps, 370 Vacuum tube phlebotomy devices, 451 Vagina, normal microbial flora, 11 Vancomycin-resistant enterococci, 470, 575 Vancomycin-resistant S aureus, 167 Vaporized hydrogen peroxide (VHP), 356 Vapor-phase hydrogen peroxide (VHP), 467–468, 470 Variant CJD (vCJD), 277, 278, 307, 309 Varicella-zoster virus (VZV), 193 Variola virus, 209, 226 vCJD See Variant CJD Vector genome constructs, 224 Venezuelan equine encephalomyelitis (VEE), 190, 191 Venomous animals, handling, 260 Venoms, 248 Ventilation, 360–361 See also Heating, ventilation, and air conditioning containment facilities, 672–673 Vermin control, 364 Vero cell line, 300 Vertical-flow clean bench (VFCB), 388, 389 Vesicular stomatitis virus (VSV), 191, 212, 226 Veterinary diagnostic laboratories, 619 biological spill management, 631–632 biosafety education and training, 643–644 biosafety guidelines for, 626–634 BSCs for, 630–631 employer and employee responsibili ties, 642–643 histology laboratory, 639–640 immunizations for personnel, 632–634 LAI management, 644–645 microbiology, 642 molecular diagnostics and rapid tests, 642 mycology, 640–641 parasitology, 640 PPE for, 626, 628–630 risk assessment for, 622–626 risk classifications and, 620–622 serum banking for, 633–634 storage, packaging, and shipping, 642 suspected prion sample handling, 638 virology, 641–642 VFCB See Vertical-flow clean bench VHF See Viral hemorrhagic fever VHP See Vaporized hydrogen peroxide; Vapor-phase hydrogen peroxide Vibrio cholerae, 169 Vibrionaceae, 169–170 Vibrio parahaemolyticus, 169–170 Vibrio vulnificus, 169–170 VIG See Vaccinia immune globulin Viral diseases, 187 clinical manifestation of, 195–198 common lab animals and, 33–36 LAI-producing, 198–213 plant and human cross-kingdom pathogens, 46 postaccident management for exposures to, 198 Viral epidemiology, 191 Viral gene transfer vectors, 221, 271 Viral hemorrhagic fever (VHF), 448 Viral hemorrhagic fever viruses, 443 Viral LAIs, 69, 187–190, 198–213 aerosol exposures, 74 in field work, 73 means of exposure, 74–75 mucocutaneous exposures, 75 parenteral exposures, 74–75 in research and clinical activities, 73–74 zoonotic, 70–73 Viral-vectored CRISPR/CAs9, 213–214 Viral vectors, 222 characteristics and safety issues, 238–239 cis-acting elements, 223 common types, 226–236 containment levels for, 235, 239–240 development and production, 224 disabling pathogenicity, 223–224 genetic structure, 223 nonintegrating, 228 replication deficiency maintenance, 224–226 trans-acting elements, 223, 224, 225 Viremia, 196–198 Virology, 191 in veterinary diagnostic laboratories, 641–642 Viromes, 42 Virulence, 5, 193 bacteria strategies, 163–164 factors and mechanisms colonization factors, 11–13 evading host immune system, 13–14 toxins, 14–15 of fungal diseases, 147–148 Viruses See also specific viruses airborne transmission, 294 in animal cell cultures, 306–307 attenuated, 585 cell line safety testing and, 318 diversity, 191–192 genetically engineered, 213–214 genetic structure, 223 infectious and lethal doses, 193 oncogenic, 306–307 pharmaceutical company use of, 585–586 placenta crossing, 193 recombinant, 585 risk matrix for, 193–195 taxonomy and classification, 191 Visualization, 345–346 Vitamin K, Vivarium, 656 VSV See Vesicular stomatitis virus VZV See Varicella-zoster virus Walk-in fume hoods, 379 Waste disposal Bloodborne Pathogens Standard rules for, 454 BSL3 and, 289 BSL4 and, 289 sharps disposal, 452 Waste handling and removal, 364–365 Waste treatment, 606–607 Water supply systems, 362 Wedum, Arnold, 567 WEE See Western equine encephalitis Weighted disease triangle, 666 Western equine encephalitis (WEE), 191 West Nile Virus (WNV), 191, 196, 399, 443 Wet ice, 488–489 WHO See World Health Organization Whooping cough, 173 WI-38, 299 Wild-type infectious agents, 519–520 WNV See West Nile Virus WOAH See World Organisation for Animal Health Wolbachia-infected mosquitoes, 406 “Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program” (CDC), 451 Workers’ compensation, 516 Workforce training, 541 Workplace exposures bacterial LAIs, 63–69 fungal LAIs, 76–77 parasitic LAIs, 75–76 viral LAIs, 69–75 Work practice controls, 453–455 enhanced precautions, 457 Work practices for biological toxins, 260 Bloodborne Pathogen Standard, 454 PPE, 454–455 Work surface cleaning, 453–454 I n d ex | 741 World Health Organization (WHO), 166, 226, 357, 644, 668, 681 biosafety definition by, 496 cell coculture guidance, 319 cell substrate guidelines, 308 cell therapy guidelines, 304 Ebola reports, 448 prion guidelines, 278 recombinant work risk assessment guidelines, 100–101 RG classifications, 96–97 shipping and packing guidelines, 489 Study Group on Biologicals, 300 World Organisation for Animal Health (WOAH/OIE), 620–622, 648 Written responsibilities, 506 XDR Mycobacterium tuberculosis, 286, 288 X-linked chronic granulomatous disease (CGD), 238 X chromosome-linked severe combined immunodeficiency (SCID-X1), 238–239 XDR See Extensively drug-resistant ZFNs See Zinc finger nucleases Zika virus, 70, 192, 193, 204, 205, 399 Zinc finger nucleases (ZFNs), 269, 273, 274, 667 Yaba monkey tumorvirus, 210 Yatapoxvirus spp., 35 Yeasts, 152–153 Yellow fever (YF), 187, 190, 191 Yersinia enterocolitica, 99, 171 Yersinia pestis, 19, 171–172 toxins, 255 Yersinia pseudotuberculosis, 171 Yersinia spp., 171–172 Yersiniosis, 171 YF See Yellow fever YF virus group, 204 zMapp, 203 Zoonoses, 20 Zoonotic agents biosafety guidelines, 680–684 biosecurity and biocontainment, 19–20 common lab animals and, 24–36 context to, 680–681 field work risks, 683 host susceptibility, 22 notifiable, 22 occupational acquired infections, 22 preventing exposure to, 652–654 risk assessment, 681–682 risk identification, 681 risk mitigation, 682–684 risk reduction, 23–24 working with, 19–24 Zoonotic biohazards, 516–517 Zoonotic potential, 20 Zoonotic viral infections, 70, 72–73 Zootoxins, 255–257

Tiêu đề	Biological Safety: Principles and Practices
Tác giả	Dawn P. Wooley, Karen B. Byers
Trường học	Wright State University
Chuyên ngành	Neuroscience, Cell Biology and Physiology
Thể loại	edited book
Năm xuất bản	2017
Thành phố	Washington, DC

Định dạng
Số trang	760
Dung lượng	9,6 MB