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

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Agent Summary Statements – Arboviruses and Related Zoonotic Viruses The recommendations for viruses listed in Table 2 that require BSL-3 containment are based on multiple criteria. SALS considered the laboratory experience for some viruses to be inadequate to assess risk, regardless of the available information regarding disease severity. In some cases, SALS recorded overt LAI transmitted by the aerosol route in the absence or non-use of protective vaccines, and considered that the natural disease in humans is potentially severe, life threatening, or causes residual damage. 1 Arboviruses also were classified as requiring BSL-3 containment if they caused diseases in domestic animals in countries outside of the United States. Laboratory Hazards The agents listed in this group may be present in blood, CSF, urine, and exudates, depending on the specific agent and stage of disease. The primary laboratory hazards are exposure to aerosols of infectious solutions and animal bedding, accidental parenteral inoculation, and contact with broken skin. Some of these agents (e.g., VEE virus) may be relatively stable in dried blood or exudates. Containment Recommendations BSL-3 practices, containment equipment, and facilities are recommended for activities using potentially infectious clinical materials and infected tissue cultures, animals, or arthropods. A licensed attenuated live virus is available for immunization against yellow fever. It is recommended for all personnel who work with this agent or with infected animals, and those entering rooms where the agents or infected animals are present. Junin virus has been reclassified to BSL-3, provided that all at-risk personnel are immunized and the laboratory is equipped with HEPA-filtered exhaust. SALS also has reclassified <strong>Central</strong> European tick-borne encephalitis (CETBE) viruses to BSL-3, provided all at-risk personnel are immunized. CETBE is not a registered name in The International Catalogue of Arboviruses (1985). Until the registration issue is resolved taxonomically, CETBE refers to the following group of very closely related, if not essentially identical, tick-borne flaviviruses isolated from Czechoslovakia, Finland and Russia: Absettarov, Hanzalova, Hypr, and Kumlinge viruses. While there is a vaccine available that confers immunity to the CETBE group of genetically (>98%) homogeneous viruses, the efficacy of this vaccine against Russian spring-summer encephalitis (RSSE) virus infections has not been established. Thus, the CETBE group of viruses has been reclassified as BSL-3 when personnel are immunized with CETBE vaccine, while RSSE remains classified as BSL-4. It should be noted that CETBE viruses are currently listed as Select Agents and require special security and permitting considerations (See Appendix F). Investigational vaccines for eastern equine encephalomyelitis (EEE) virus, Venezuelan Equine Encephalitis (VEE), western equine encephalomyelitis (WEE) virus, and Rift Valley fever viruses (RVFV), may be available in limited quantities and 248
Agent Summary Statements – Arboviruses and Related Zoonotic Viruses administered on-site at the Special Immunization Program, USAMRIID. Details are available at the end of this section. The use of investigational vaccines for laboratory personnel should be considered if the vaccine is available, initial studies have shown the vaccine to be effective in producing an appropriate immunologic response, and the adverse effects of vaccination are within acceptable parameters. The decision to recommend vaccines for laboratory personnel must be carefully considered and based on an risk assessment which includes a review of the characteristics of the agent and the disease, benefits versus the risk of vaccination, the experience of the laboratory personnel, laboratory procedures to be used with the agent, and the contraindications for vaccination including the health status of the employee. If the investigational vaccine is contraindicated, does not provide acceptable reliability for producing an immune response, or laboratory personnel refuse vaccination, the use of appropriate personal protective equipment may provide an alternative. Respiratory protection, such as use of a PAPR, should be considered in areas using organisms with a well-established risk of aerosol infections in the laboratory, such as VEE viruses. Any respiratory protection equipment must be provided in accordance with the institution’s respiratory protection program. Other degrees of respiratory protection may be warranted based on an assessment of risk as defined in Chapter 2 of this manual. All personnel in a laboratory with the infectious agent must use comparable personal protective equipment that meets or exceeds the requirements, even if they are not working with the organism. Sharps precautions as described under BSL-2 and BSL-3 requirements must be continually and strictly reinforced, regardless of whether investigational vaccines are used. Non-licensed vaccines are available in limited quantities and administered on-site at the Special Immunization Program of USAMRIID, located at Ft. Detrick, Frederick MD. As IND vaccines are administered under a cooperative agreement between the U.S. Army and the individual’s requesting organization. Contact the Special Immunization Program by telephone at (301) 619-4653. Enhanced BSL- 3 Containment Situations may arise for which enhancements to BSL-3 practices and equipment are required. An example would be when a BSL-3 laboratory performs diagnostic testing on specimens from patients with hemorrhagic fevers thought to be due to dengue or yellow fever viruses. When the origin of these specimens is Africa, the Middle East, or South America, such specimens might contain etiologic agents, such as arenaviruses, filoviruses, or other viruses that are usually manipulated in a BSL-4 laboratory. Examples of enhancements to BSL-3 laboratories might include 1) enhanced respiratory protection of personnel against aerosols; 2) HEPA filtration of dedicated exhaust air from the laboratory; 3) personal body shower. Additional appropriate training for all animal care personnel should be considered. 249
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Biosafety in Microbiological and Bi
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SECTION VIII-H: Prion Diseases 299
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Forward Biosafety in Microbiologica
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Editors: L. Casey Chosewood, MD Dir
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Guest Editors: Matthew J. Arduino,
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Charles B. Millard, PhD Lieutenant
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Robert Bull Karen B. Byers Jane Cap
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Thomas L. Miller Douglas M. Moore M
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Robert Yarchoan Uri Yokel Lisa Youn
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Introduction laboratories chose not
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Introduction RISK CRITERIA FOR ESTA
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Introduction BMBL includes an impor
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Section II Biological Risk Assessme
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Biological Risk Assessment informat
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Biological Risk Assessment The NIH
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Biological Risk Assessment effectiv
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Biological Risk Assessment Third, m
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Biological Risk Assessment 14. Oxma
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Principles of Biosafety Safety equi
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Principles of Biosafety Often an in
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Principles of Biosafety Four standa
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Principles of Biosafety 4. Centers
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Laboratory Biosafety Level Criteria
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Section V Vertebrate Animal Biosafe
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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-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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