Introduction 12.6 livan.J.F. 15(1)5 abugVsmWc698.8emaiog0enctanemisionot A1968. 16.Oliphant.J.W.Parker.R.R. ction.Publ n of a Cluster.Ann of Int Med 112:833-839. 20. es and preven on.Ann Re d 4th 2.Nanal1haotescathieath19eugidew2efegeepr 23. Register.59FR34496 Saf and alth E hsaebeatony mbrnamDNARasearahEeth8saiNd,Naionarinsiesod Re Hepatitis B Virus and Other Bloodborne Pathogens in Healthcare 27.Ushogens.Final 35i5.428sc.1692.69 feaRegg56647A410198aHR 6
Introduction 6 Iowa. 12. Sullivan, J.F., Songer, J.R., Estrem, I.E. 1978. Laboratory-acquired infections at the National Animal Disease Center, 1960-1976. Health Lab Sci 15(1):58-64. 13. Martini, G.A., Schmidt, H.A. 1968. Spermatogenic transmission of Marburg virus. Klin Wschr 46:398-400. 14. Report of the Committee of Inquiry into the Smallpox Outbreak in London in March and April 1973. 1974. Her Majesty's Stationery Office, London. 15. World Health Organization. 1978. Smallpox surveillance. Weekly Epidemiological Record 53(35):265-266. 16. Oliphant, J.W., Parker, R.R. 1948. Q fever: Three cases of laboratory infection. Public Health Rep 63(42):1364-1370. 17. Oliphant, J.W., Parker, R.R. 1948. (16) 18. Beeman, E.A. 1950. Q fever - An epidemiological note. Pub Hlth Rep 65(2):88-92. 19. Holmes, G.P., Hilliard, J.K., Klontz, K.C., et al. 1990. B Virus (Herpesvirus simiae) Infection in Humans: Epidemiologic Investigation of a Cluster. Ann of Int Med 112:833-839. 20. Pike, R.M. 1979. Laboratory-associated infections: incidence, fatalities, causes and prevention. Ann Rev Microbiol 33:41-66. 21. Centers for Disease Control, Office of Biosafety. 1974. Classification of Etiologic Agents on the Basis of Hazard, 4th Edition. U.S. Department of Health, Education and Welfare, Public Health Service. 22. National Institutes of Health. 1994. Guidelines for Research Involving Recombinant DNA Molecules. (Washington: GPO) Federal Register. 59FR34496. 23. National Cancer Institute, Office of Research Safety, and the Special Committee of Safety and Health Experts. 1978. Laboratory Safety Monograph: A Supplement to the NIH Guidelines for Recombinant DNA Research. Bethesda, MD, National Institutes of Health. 24. Centers for Disease Control, Office of Biosafety. 1974. (20) 25. Centers for Disease Control. 1988. Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus and Other Bloodborne Pathogens in Healthcare Settings. MMWR, 37:377-382, 387, 388. 26. U.S. Department of Labor, Occupational Safety and Health Administration. 1991. Occupational Exposure to Bloodborne Pathogens, Final Rule. Fed. Register 56:64175-64182. 27. U.S. Congress, 1988. Medical Waste Tracking Act of 1988. H.R. 3515, 42 U.S.C. 6992-6992k
Introduction 28.Biosafety in the Labora 30. Nrug-Res Tuberculosis.MMWR 41,No.RR-11. 7
Introduction 7 28. Biosafety in the Laboratory: Prudent Practices for the Handling and Disposal of Infectious Materials. 1989. National Research Council. National Academy Press, Washington, D.C. 29. Centers for Disease Control. 1990. Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues. MMWR 39, No. RR-17. 30. Centers for Disease Control. 1992. National Action Plan to Combat Multi-drug-Resistant Tuberculosis. Meeting the Challenge of Multidrug-Resistant Tuberculosis: Summary of a Conference. Management of Persons Exposed to Multi-drug-Resistant Tuberculosis. MMWR 41, No. RR-11
SECTION II Principles of Biosafety The term"containment"is used in describing safe methods d or maintained.The pur containment is to reduce or eliminate exposure of laboratory tilyihazaPouspagels,andheoutsideenironmenttopoen- ni2eYaBnhhmentheprote ction of andh is provided byboth the use of appropriate safety equipment. se of vace cines labor atory from exposure to infectious materials,is provided by a the th ent ina nere sign nt of the approp a specific agent Laboratory Practice and Technique.The most importan tious agents or potentially infected materials must be aware of s and tech a m and pro h th rial The dire ector or person in charge of the laboratory is res ponsible or provid ing or arran ging the ap propriate training of person ne Each laboratory should develop or adopta biosafety or operatio ons m the hazards that will may be sianed to minimize or eliminate exnosu es to these hazards Personnel should be advised of special hazards and should be ppropriate laboratory techniques,safety procedures,and hazards
8 SECTION II Principles of Biosafety The term "containment" is used in describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate ex posure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. Primary containment, the protection of personnel and the immediate laboratory environment from exposure to infectious agents, is provided by both good microbiological technique and the use of appropriate safety equipment. The use of vaccines may pr ovide an increas ed level of p ersona l protection. Secondary containment, the protection of the environment external to the labor atory from expo sure to infe ctiou s m ateria ls, is provid ed by a combination of facility design and operational practices. Therefore, the three elements of containm ent include laboratory practice and tech nique, sa fety equipm ent, and fa cility design. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements. Laboratory Practice and Technique. The most important elem ent of con tainm ent is strict a dherenc e to s tand ard m icrob iological practices and techniques. Persons working with infectious agents or potentially infected materials must be aware of potential hazards, and must be trained and proficient in the practices and techniqu es requ ired to han dle such mate rial safely. The direc tor or pers on in c harg e of th e labo rator y is res ponsible for provid ing or arran ging the ap prop riate tr aining of pe rson nel. Each laboratory should develop or adopt a biosafety or operations manual that identifies the hazards that will or may be encountered, and that specifies practices and procedures designed to minim ize or elimin ate exp osures to these h azards. Personnel should be advised of special hazards and should be required to read and follow the required practices and proced ures. A s cientist traine d and k nowled geable in a ppropria te laboratory techniques, safety procedures, and hazards
Principles of Biosafety socaedwhganekgneciosagentsmustbeesponsbi This individual should consult with biosafety or other health and safety professionals with regard to risk asses smer When standard laboratory practices are not sufficient to control e hazards associated with a particular agent or labora t9%aoceere8c8cis1ospom8B0ier8goaectgadnah9aioy Crar8igehr0rproces8kepgwmththehaardsasocaied Laboratory personnel,safety practices,and techniques must Safety Equipm ent(Prim ry Ba Safety equpmen neering controls designed to remoe or minimize ousbiologcal materials. ainmen mapymtcrobiologealprocedures.Threeiypesfbioioga us mi diA as8a8Clasboogicalsatatyeabnes n-fr are primary barriers whicho er significant levels of prote on to la orat ory personnel ieChigUesThecasslbo1ogicalsafaeycabnetasopronidas prote ction from exte rna al onta ation of th maten cabinet.The gas-tight Class biological safety cabinet provides the highest attainable level of protection o personnel and the environm ent An example of another primary barrier is the safety centrifuge cup,an enc conta signea to prevent sed di e is containment contrls such as BSCsor centifuge cups must be
Principles of Biosafety 9 associated with handling infec tious agen ts m ust be res ponsible for the co nduct o f work w ith any infectiou s agen ts or m aterial. This individual should consult with biosafety or other health and safety pro fession als with reg ard to risk asses sme nt. W hen sta ndard lab oratory pra ctices are not suffic ient to control the hazards associated with a particular agent or laboratory procedure, additional measures may be needed. The laborator y director is res ponsible for selec ting additiona l safety practices, which must be in keeping with the hazards associated with the agent or procedure. Laboratory personnel, safety practices, and techniques must be supplemented by appropriate facility design and engineering features, safety equipment, and management practices. Safety Equipm ent (Primary Barriers). Safety equipment includes biological safety cabinets (BSCs), enclosed containers, and othe r enginee ring contr ols desig ned to re mov e or m inimize exposures to hazardous biological materials. The biological safety cabinet (BSC) is the principal device used to provide containment of infectious splashes or aerosols generated by many microbiological procedures. Three types of biological safety cabinets (Class I, II, III) used in microbiological laboratories are described and illustrated in Appendix A. Open-fronted Class I and Class II biological safety cabinets are primary barriers which offer significant levels of protection to laboratory personnel and to the environment when used with good microbiological techniques. The Class II biological safety cabinet also provides prote ction from external c onta min ation of the ma terials (e.g., cell cultures, microbiological stocks) being manipulated inside the cabinet. The gas-tight Class III biological safety cabinet provides the highest attainable level of protection to personnel and the environm ent. An example of another primary barrier is the safety centrifuge cup, an enclosed container designed to prevent aerosols from being released during centrifugation. To minimize this hazard, containment controls such as BSCs or centrifuge cups must be
Principles of Biosafety ersonal protec tors,face shields,safety glasses,or goggles.P ersonal protective materials be ing handled.In some situations in which it is impractical to work in biological satety cabine andhenecdoCYmgemase Examples include certain animal anima prod on abrato facilt nce,servic laboratory workers'protection,provides a barrier to protec in the com infectiou tally released from the laboratory.Laboratory management is for provding ta ate agentsbengmanpu2nead el for the r most laboratory work in Bios afety Leve I1 and 2 Secondary barriers in these laboratories may include s ity (e. from publi ve)and When the risk of infectior aerosol is present,hgher levebs of primary containment and ne tous age 10
Principles of Biosafety 10 used when handling infectious agents that can be transmitted through the aerosol route of exposure. Safety equipment also may include items for personal protection, such as gloves, coats, gowns, shoe covers, boots, respirators, face shields, safety glasses, or goggles. Personal protective equipm ent is often used in c omb ination with bio logical safe ty cabinets and other devices that contain the agents, animals, or ma terials being hand led. In som e situations in wh ich it is impractical to work in biological safety cabinets, personal protective equipment may form the primary barrier between personnel and the infectious materials. Examples include certain animal studies, animal necropsy, agent production activities, and activities relating to maintenance, service, or support of the labor atory f acility. Facility Design and C onstruction (Se condary Ba rriers). The design and construction of the facility contributes to the laboratory workers’ protection, provides a barrier to protect pers ons outs ide the labo rator y, and prote cts p erso ns or anim als in the community from infectious agents which may be accidentally rele ased from th e labo rator y. Laborato ry ma nagem ent is responsible for providing facilities commensurate with the laboratory's function and the recommended biosafety level for the agents being manipulated. The recommended secondary barrier(s) will depend on the risk of transmission of specific agents. For example, the exposure risks for most laboratory work in Biosafety Level 1 and 2 facilities will be direct contact with the agents, or inadvertent contac t expos ures thro ugh co ntam inated wo rk enviro nme nts. Secondary barriers in these laboratories may include separation of the laboratory work area from pu blic access, availability of a decontamination facility (e.g., autoclave), and handwashing facilities. When the risk of infection by exposure to an infectious aerosol is present, higher levels of primary containment and multiple secondary barriers may become necessary to prevent infectious agents from escaping into the environment. Such