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

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Agent Summary Statements – Viral Agents inhalation of virus from aerosols generated by infecting animals or by aspirating, dispensing, mixing, centrifuging or otherwise manipulating virus-infected samples. In addition, laboratory infection can result from direct inoculation of mucus membranes through virus contaminated gloves following handling of tissues, feces or secretions from infected animals. Genetic manipulation has the potential for altering the host range, pathogenicity, and antigenic composition of influenza viruses. The potential for introducing influenza viruses with novel genetic composition into humans is unknown. Containment Recommendations BSL-2 facilities, practices and procedures are recommended for diagnostic, research and production activities utilizing contemporary, circulating human influenza strains (e.g., H1/H3/B) and low pathogenicity avian influenza (LPAI) strains (e.g., H1-4, H6, H8-16), and equine and swine influenza viruses. ABSL-2 is appropriate for work with these viruses in animal models. All avian and swine influenza viruses require an APHIS permit. Based on economic ramifications and source of the virus, LPAI H5 and H7 and swine influenza viruses may have additional APHIS permit-driven containment requirements and personnel practices and/or restrictions. NON-CONTEMPORARY HUMAN INFLUENZA (H2N2) STRAINS Non-contemporary, wild-type human influenza (H2N2) strains should be handled with increased caution. Important considerations in working with these strains are the number of years since an antigenically related virus last circulated and the potential for presence of a susceptible population. BSL-3 and ABSL-3 practices, procedures and facilities are recommended with rigorous adherence to additional respiratory protection and clothing change protocols. Negative pressure, HEPA-filtered respirators or positive air-purifying respirators (PAPRs) are recommended for use. Cold-adapted, live attenuated H2N2 vaccine strains may continue to be worked with at BSL-2. 1918 INFLUENZA STRAIN Any research involving reverse genetics of the 1918 influenza strain should proceed with extreme caution. The risk to laboratory workers is unknown at the present time, but the pandemic potential is thought to be significant. Until further risk assessment data are available, the following practices and conditions are recommended for manipulation of reconstructed 1918 influenza viruses and laboratory animals infected with the viruses. These practices and procedures are considered minimum standards for work with the fully reconstructed virus. • BSL-3 and ABSL-3 practices, procedures and facilities. • Large laboratory animals such as NHP should be housed in primary barrier systems in ABSL-3 facilities. 224
Agent Summary Statements – Viral Agents • Rigorous adherence to additional respiratory protection and clothing change protocols. • Use of negative pressure, HEPA-filtered respirators or PAPRs. • Use of HEPA filtration for treatment of exhaust air. • Amendment of personnel practices to include personal showers prior to exiting the laboratory. HIGHLY PATHOGENIC AVIAN INFLUENZA (HPAI) Manipulating HPAI viruses in biomedical research laboratories requires similar caution because some strains may pose increased risk to laboratory workers and have significant agricultural and economic implications. BSL-3 and ABSL-3 practices, procedures and facilities are recommended along with clothing change and personal showering protocols. Loose-housed animals infected with HPAI strains must be contained within BSL-3-Ag facilities (See Appendix D). Negative pressure, HEPAfiltered respirators or positive air-purifying respirators are recommended for HPAI viruses with potential to infect humans. The HPAI are agricultural Select Agents requiring registration of personnel and facilities with the lead agency for the institution (CDC or USDA-APHIS). An APHIS permit is also required. Additional containment requirements and personnel practices and/or restrictions may be added as conditions of the permit. OTHER INFLUENZA RECOMBINANT OR REASSORTANT VIRUSES When considering the biocontainment level and attendant practices and procedures for work with other influenza recombinant or reassortant viruses, the local IBC should consider but not limit consideration to the following in the conduct of protocol-driven risk assessment. • The gene constellation used. • Clear evidence of reduced virus replication in the respiratory tract of appropriate animal models, compared with the level of replication of the wildtype parent virus from which it was derived. • Evidence of clonal purity and phenotypic stability. • The number of years since a virus that was antigenically related to the donor of the hemagglutinin and neuraminidase genes last circulated. If adequate risk assessment data are not available, a more cautious approach utilizing elevated biocontainment levels and practices is warranted. There may be specific 225
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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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Agent Summary Statements - Arboviru
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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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Agent Summary Statements - Toxins L
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Agent Summary Statements - Toxins e
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Agent Summary Statements - Toxins o
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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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