credits bmbl December 7 '06.doc - Central Michigan University

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Biological Risk Assessment known and suspected routes of transmission of laboratory infection and, when available, information on infective dose, host range, agent stability in the environment, protective immunizations, and attenuated strains of the agent. A thorough examination of the agent hazards is necessary when the intended use of an agent does not correspond with the general conditions described in the Summary Statement or when an agent summary statement is not available. Although a summary statement for one agent may provide helpful information for assessing the risk of a similar agent, it should not serve as the primary resource for making the risk determination for that agent. Refer to other resources for guidance in identifying the agent hazards. The Control of Communicable Diseases Manual provides information on communicable diseases including concise summaries on severity, mode of transmission, and the susceptibility and resistance of humans to disease. 3 In addition, it is always helpful to seek guidance from colleagues with experience in handling the agent and from biological safety professionals. Often there is not sufficient information to make an appropriate assessment of risk. For example, the hazard of an unknown agent that may be present in a diagnostic specimen will be unknown until after completing agent identification and typing procedures. It would be prudent in this case to assume the specimen contains an agent presenting the hazardous classification that correlates with BSL-2 unless additional information suggests the presence of an agent of higher risk. Identification of agent hazards associated with newly emergent pathogens also requires judgments based on incomplete information. Consult interim biosafety guidelines prepared by the CDC and the WHO for risk assessment guidance. When assessing the hazards of a newly attenuated pathogen, experimental data should support a judgment that the attenuated pathogen is less hazardous than the wild-type parent pathogen before making any reduction in the containment recommended for that pathogen. Make a preliminary determination of the biosafety level that best correlates with the initial risk assessment based on the identification and evaluation of the agent hazards. Remember that aerosol and droplet routes of agent transmission also are important considerations in specification of safety equipment and facility design that result in a given BSL level. Second, identify laboratory procedure hazards. The principal laboratory procedure hazards are agent concentration, suspension volume, equipment and procedures that generate small particle aerosols and larger airborne particles (droplets), and use of sharps. Procedures involving animals can present a number of hazards such as bites and scratches, exposure to zoonotic agents, and the handling of experimentally generated infectious aerosols. The complexity of a laboratory procedure can also present a hazard. The agent summary statement provides information on the primary laboratory hazards associated with typically routine procedures used in handling an agent. In proposed laboratory procedures where the procedure hazards differ from the general conditions of the agent summary statement or where an agent summary statement is not available, the risk assessment should identify specific hazards associated with the procedures. 32
Biological Risk Assessment Third, make a final determination of the appropriate biosafety level and select additional precautions indicated by the risk assessment. The final selection of the appropriate biosafety level and the selection of any additional laboratory precautions require a comprehensive understanding of the practices, safety equipment, and facility safeguards described in Chapters 3, 4 and 5 of this publication. There will be situations where the intended use of an agent requires greater precautions than those described in the agent’s Summary Statement. These situations will require the careful selection of additional precautions. An obvious example would be a procedure for exposing animals to experimentally generated infectious aerosols. It is unlikely that a risk assessment would indicate a need to alter the recommended facility safeguards specified for the selected biosafety level. If this does occur, however, it is important that a biological safety professional validate this judgment independently before augmenting any facility secondary barrier. It is also important to recognize that individuals in the laboratory may differ in their susceptibility to disease. Preexisting diseases, medications, compromised immunity, and pregnancy or breast-feeding that may increase exposure to infants to certain agents, are some of the conditions that may increase the risk of an individual for acquiring a LAI. Consultation with an occupational physician knowledgeable in infectious diseases is advisable in these circumstances. Fourth, evaluate the proficiencies of staff regarding safe practices and the integrity of safety equipment. The protection of laboratory workers, other persons associated with the laboratory, and the public will depend ultimately on the laboratory workers themselves. In conducting a risk assessment, the laboratory director or principal investigator should ensure that laboratory workers have acquired the technical proficiency in the use of microbiological practices and safety equipment required for the safe handling of the agent, and have developed good habits that sustain excellence in the performance of those practices. An evaluation of a person’s training, experience in handling infectious agents, proficiency in the use of sterile techniques and BSCs, ability to respond to emergencies, and willingness to accept responsibility for protecting one’s self and others is important insurance that a laboratory worker is capable of working safely. The laboratory director or principal investigator should also ensure that the necessary safety equipment is available and operating properly. For example, a BSC that is not certified represents a potentially serious hazard to the laboratory worker using it and to others in the laboratory. The director should have all equipment deficiencies corrected before starting work with an agent. Fifth, review the risk assessment with a biosafety professional, subject matter expert, and the IBC. A review of the risk assessment and selected safeguards by knowledgeable individuals is always beneficial and sometimes required by regulatory or funding agencies, as is the case with the NIH Guidelines. 2 Review of potentially high risk protocols by the local IBC should become standard practice. Adopting this step voluntarily will promote the use of safe practices in work with hazardous agents in microbiological and biomedical laboratories. 33
Page 1 and 2: Biosafety in Microbiological and Bi
Page 3 and 4: SECTION VIII-H: Prion Diseases 299
Page 5 and 6: Forward Biosafety in Microbiologica
Page 7 and 8: Editors: L. Casey Chosewood, MD Dir
Page 9 and 10: Guest Editors: Matthew J. Arduino,
Page 11 and 12: Charles B. Millard, PhD Lieutenant
Page 13 and 14: Robert Bull Karen B. Byers Jane Cap
Page 15 and 16: Thomas L. Miller Douglas M. Moore M
Page 17 and 18: Robert Yarchoan Uri Yokel Lisa Youn
Page 19 and 20: Introduction laboratories chose not
Page 21 and 22: Introduction RISK CRITERIA FOR ESTA
Page 23 and 24: Introduction BMBL includes an impor
Page 25 and 26: Section II Biological Risk Assessme
Page 27 and 28: Biological Risk Assessment informat
Page 29 and 30: Biological Risk Assessment The NIH
Page 31: Biological Risk Assessment effectiv
Page 35 and 36: Biological Risk Assessment 14. Oxma
Page 37 and 38: Principles of Biosafety Safety equi
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Page 41 and 42: Principles of Biosafety Four standa
Page 43 and 44: Principles of Biosafety 4. Centers
Page 45 and 46: Laboratory Biosafety Level Criteria
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Vertebrate Animal Biosafety Level C
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TABLE 1 SUMMARY OF RECOMMENDED BIOS
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Principles of Laboratory Biosecurit
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Occupational Health and Immunoproph
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Agent Summary Statements - Bacteria
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• Section VIII-B: Fungal Agents A
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Agent Summary Statements - Fungal A
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• Section VIII-C: Parasitic Agent
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Agent Summary Statements - Parasiti
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• Section VIII-D: Rickettsial Age
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Agent Summary Statements - Ricketts
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Agent Summary Statements - Ricketts
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• Section VIII-E: Viral Agents Ag
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Agent Summary Statements - Viral Ag
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• Section VIII-G: Toxin Agents Se
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Agent Summary Statements - Toxins i
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Agent Summary Statements - Toxins A
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• Section VIII-H: Prion Diseases
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Agent Summary Statement - Prion Dis
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Appendix A Proper maintenance of ca
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Appendix A declined. However, in ma
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Appendix A It is possible to exhaus
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Appendix A 4. The Class II, Type A2
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Appendix A prohibited. Furthermore,
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Appendix A plastic wrappers, pipett
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Appendix A touch-plate microburners
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Appendix A SECTION VI FACILITY AND
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Appendix A Development of Containme
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Appendix A C. Airflow Smoke Pattern
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Appendix A TABLES Table 1. Selectio
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Appendix A Table 3. Field Performan
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Appendix A FIGURES Figure 1. HEPA f
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Appendix A Figure 3. The Class II,
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Appendix A Figure 5B. The Class II,
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Appendix A Figure 8. The Class III
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Appendix A Figure 9B. The vertical
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Appendix A Figure 11. A typical lay
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Appendix A REFERENCES 1. Centers fo
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Appendix B Decontamination and Disi
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Appendix B surfaces are contaminate
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Appendix B TABLE 1 DESCENDING ORDER
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Appendix B dioxide gas exits the ge
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Appendix B d The effectiveness of a
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Appendix C Transportation of Infect
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Appendix C 1600 Clifton Road, N.E.,
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Appendix C disease in humans or in
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Appendix C Biological specimen, Cat
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Appendix D Agriculture Pathogen Bio
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Appendix D simultaneous opening of
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Appendix D 14. Pathological inciner
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Appendix D Wastes and other materia
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Appendix D Camelpox virus b a, b, c
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Appendix D SPECIAL ISSUES The impor
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Appendix D required by the USDA and
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Appendix D depression, anorexia, an
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Appendix D laboratory with enhancem
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Appendix D five day period of conta
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Appendix D slaughterhouses or indus
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Appendix D virus does not cause any
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Appendix D NDV is classified in the
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Appendix D movement permit is requi
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Appendix D Spring Viremia of Carp V
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Appendix D REFERENCES 1. Hess WR. A
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Appendix D 37. Alexander DJ. Newcas
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Appendix E Arthropod Containment Gu
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Appendix F Select Agents and Toxins
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Appendix G IPM issues and requireme
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Appendix H Working with Human, NHP
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Appendix I Guidelines for Work with
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decontaminated periodically, for ex
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0.25N, and/or sodium hypochlorite (
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k Irradiation causes a dose-depende
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7. Morin R, Kozlovac J. Biological
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Appendix J NIH Oversight of Researc
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Appendix K Resources for Informatio
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Appendix K E-mail: http://www2.gsu.
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Appendix K and http://www.who.int/c
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Appendix L HEPA High Efficiency Par
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credits bmbl December 7 '06.doc - Central Michigan University

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