Principles of Biosafety and the requred precautions to be implementec Importation and Interstate Shipment of Certain Biomedi- cal Materials.The importation of etiologic agents and vectors of to the requirements of the Publi ce and the Department of on spe cify packaging.labe g re interstate commerce (see Append ix C). The U.S.Depa tation and inters npm8tAfnpogen5sadp8hibts the importation,possession,or use of certain exotic animal threat to domestic References: 1 American Society of Heating.Refrigerating,and Air-Conditioning icati Chapter 13. 2 19910c ne min 4. R d,J.Y.1994. tman.J.R.Geo York nc 5. Hepatitis B Pathogens in Healthcare MMwR37377-382.38738 6 9 for Clin ical La ry Standards(NCCLS). and infectio nitt d by d.bod y fluid Dec.1977,NCC 16
Principles of Biosafety 16 1. American Society of Heating, Refrigerating, and Air-Conditioning Engineers, Inc. 1999. "Laboratories.” In: ASHRAE Handbook, Heating, Ventilation, and Air-Conditioning Applications, Chapter 13. 2. U.S. Department of Labor, Occupational Safety and Health Administration. 1991. Occupational Exposure to Bloodborne Pathogens, Final Rule. Fed. Register 56:64175-64182. 3. U.S. Department of Labor, Occupational Safety and Health Administration. 1991. (2) 4. Richmond, J.Y. 1994. “HIV Biosafety: Guidelines and Regulations.” In (G. Schochetman, J. R. George, Eds.), AIDS Testing, Edition 2 (pp. 346-360). Springer-Verlag New York, Inc. 5. 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. 6. National Committee for Clinical Laboratory Standards (NCCLS). 1997. Protection of laboratory workers from instrument biohazards and infectious disease transmitted by blood, body fluids, and tissue. Approved guideline. Dec. 1977, NCCLS Doc. M29-A (ISBN1-56238- 339-6. tory director. It is also the director's responsibility to establish standard, written procedures that address the potential hazards and the required precautions to be implemented. Impo rtation a nd Inte rstate Shipm ent of C ertain B iomedical Materials. The importation of etiologic agents and vectors of hum an dis eases is s ubje ct to th e req uirem ents of the Public Health Service Foreign Quarantine regulations. Companion regulations of the Public Health Service and the Department of Transportation specify packaging, labeling, and shipping requireme nts fo r etiolo gic ag ents and d iagno stic s pec ime ns shippe d in interstate comm erce (see Append ix C). The U. S. Depa rtment of Agriculture regulates the importation and interstate s hipm ent of an imal pa thogen s and p rohibits the importation, possession, or use of certain exotic animal disease agen ts wh ich po se a s eriou s dise ase threa t to do me stic livestock and poultry (see Appendix D). References:
SECTION I川 Laboratory Biosafety Level Criteria The essential elem s of the four bios are summa in Tables 1of this secton and Sectior n IV (se bglegr6e10p7OneclIOmpo9eaioper3onel.heenvronnenl and the community. Biosafety Level 1(BSL-1) Biosafety Level 1 is suitable for work involving well-char laboratory personnel and the environment. The aboratory is not conducted on open pench tops usng standard microbiological practices.Special containment equipment or fac lity design is ne dures conducted in the laboratory and are supervised by a scientist with general training n microbiology or a related science The following standard and special practices,safety equip ment and facilities apply to agents assigned to Bosafety Level 1 A.Standard Microbiological Practices work with cultures and specimens are in progress. vash their hands af升ar e viable mate- rials.after removing gloves.and before leaving the labor atory 3 Eating.drinking,smoking.handling contact lenses e are wear cor 17
17 SECTION III Laboratory Biosafety Level Criteria The essential elem ents of the four biosa fety lev els fo r activ ities involvin g infe ctiou s m icroo rgan ism s and labor atory a nim als are summarized in Tables 1 of this section and Section IV (see pages 52 and 75 ). The levels are designated in ascending order, by degree of protec tion provide d to pers onnel, the environm ent, and the com mu nity. Biosafety Level 1 (BSL-1) Biosa fety Lev el 1 is suitable for work involving well-characte rized a gents not kno wn to cons isten tly cause dis ease in healthy adu lt huma ns, and of min imal po tential hazard to laboratory personnel and the environment. The laboratory is not necessarily separated from the general traffic patterns in the building. Work is generally conducted on open bench tops using standard microbiological practices. Special containment equipm ent or fac ility des ign is n either requ ired n or ge nera lly used. Laboratory personnel have specific training in the procedure s conducted in the la bora tory an d are supe rvise d by a scientist with general training in microbiology or a related science. The following standard and special practices, safety equipment and facilities apply to agents assigned to Biosafety Level 1: A. Standard Microbiological Practices 1. Access to the laboratory is limited or restricted at the discretion of the laboratory director when experiments or work with cultures and specimens are in progress. 2. Persons wash their hands after they handle viable materials, after removing gloves, and before leaving the labor atory. 3. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for hum an use are not permitted in the work areas. Persons who wear con-
Laboratory Biosafety Level Criteria-Biosafety Level 1 gles or a epcs8mWyefigeraiosdesgnaledandusedlorthis purp ose Mouth pipeting is prohibited;mechanical pipetting devic- es are used Policies for the safe handling of sharps are instituted. 6. erfomed carefully to minimize the 7 Work surface ntaminated at least once a day and after any spill of viable material. 8 tamination method such as autoclaving.Materials to be atore for transport from the aboratory.Materials to be decon are pack lations efore remoal from th 9 sign may include the name o in use and the 10. oniri prograe B.Special Practices None 18
Laboratory Biosafety Level Criteria – Biosafety Level 1 18 tact lenses in laboratories should also wear goggles or a face shield . Foo d is stored outs ide the work ar ea in cabinets or refrigerators desig nate d and used for this purp ose only. 4. Mouth pipetting is prohibited; mechanical pipetting devices are used. 5. Policies for the safe handling of sharps are instituted. 6. All procedures are performed carefully to minimize the creation of splashes or aerosols. 7. Work surfaces are decontaminated at least once a day and after any sp ill of viab le m ateria l. 8. All cultures, stocks, and other regulated wastes are decontaminated before disposal by an approved decontamination method such as autoclaving. Materials to be decontam inated outside of the imme diate laboratory are to be placed in a durable, leakproof container and closed for transport from the laboratory. Materials to be decontaminated outside of the immediate laboratory are packaged in accordance with applicable local, state, and fede ral reg ulations be fore rem oval from the fa cility. 9. A biohazard sign may be posted at the entrance to the laboratory whenever infectious agents are present. The sign may include the name of the agent(s) in use and the name an d phone num ber of the investigator. 10. An insect and rodent control program is in effect (see Appendix G). B. Special Practices None
Laboratory BiosafetyLevel Criteria-Biosafety Level 1 C.Safety Equipment(Primary Barriers) 19
Laboratory Biosafety Level Criteria – Biosafety Level 1 19 C. Safety Equipment (Primary Barriers)
Laboratory Biosafety Level Criteria-Biosafety Level 2 Special containment devices or equipment such as a biological safety cabinet are generally not required for manipulations of agents assigned to Biosafety Level 1 It is recommended that laboratory coats,gowns,or uni forms be worn to prevent contamination or soiling of street clothes Gloves should be wom if the skin on the hands is broken 4 Protective eyew poceaurosnhcpEnesotmcrog9aiAC or othe D.Laboratory Faciities(Secondary Barriers 1. Laboratories should have doors for access control. Each laboratory contains a sink for handwashing 3 The labo or atory is designedso that itca beasily pe appropriate. Bench e resistant to andcgepmentuseatodeconiaminaletheworksurtace 5. Laboratory furniture is capable of supporting anticipated 6 ya8Yhwgi8enthatopentoheedernoi Biosafety Level 2(BSL-2) 20
Laboratory Biosafety Level Criteria – Biosafety Level 2 20 1. Special containment devices or equipment such as a biological safety cabinet are generally not required for manipulations of agents assigned to Biosafety Level 1. 2. It is rec om me nded that laborator y coat s, gowns , or un iforms be worn to prevent contamination or soiling of street clothes. 3. Gloves should be worn if the skin on the hands is broken or if a rash is present. Alternatives to powdered latex gloves should be available. 4. Protective eyewear should be worn for conduct of procedures in which splashes of microorganisms or other hazardous materials is anticipated. D. Laboratory Facilities (Secondary Barriers) 1. Laborato ries s hould hav e doo rs for acc ess control. 2. Each laboratory contains a sink for handwashing. 3. The labor atory is desig ned so that it ca n be e asily cleaned. Carpets and rugs in laboratories are not appropriate. 4. Bench tops are imper vious to w ater and are resis tant to moderate heat and the organic solvents, acids, alkalis, and chemicals used to decontaminate the work surface and eq uipm ent. 5. Laboratory furniture is capable of supporting anticipated loading and uses. Spaces between benches, cabinets, and eq uipm ent are a ccess ible for clean ing. 6. If the laboratory has windows that open to the exterior, they are fitted with fly screens. Biosafety Level 2 (BSL-2)