Overview Principle of Biosafety

Transcription

1 Overview Principle of Biosafety Dr. Tassanee Eamkamon, Biosafety Specialist USAMC-AFRIMS Objectives Principle of Biosafety Overview of Biosafety Levels (BSL) Risk Group (RG) BSL&RG Influenza A(H7N9) Virus and Biosafety Level (Canada Model) 2 1

2 Principles of Biosafety A fundamental objective of any biosafety program is the containment of potentially harmful biological agents The purpose of containment is to reduce or eliminate exposure of follows to potentially hazardous agents - Laboratory workers - Other persons - Outside environment 3 Principles of Biosafety The term "containment" is used in describing: - Safe methods (Practices) - Safety Equipment (Primary Barriers and Personal Protective Equipment) - Facilities Design and Construction (Secondary Barrier) 4 2

3 Biosafety Level? CDC-NIH pdf Biosafety Level (BSL) Safety Equipment Safe Practice Facility Design Combination 4 Levels Each level is specifically appropriate for: - Operations performed - Risk Group and documented or suspected routes of transmission of the infectious agents 6 3

4 BSL 1 Safety Equipm ent Safe Practice Facility Design Appropriate for: Undergraduate and secondary educational training and teaching laboratories Laboratories in which work is done with defined and characterized strains of viable microorganisms not known to consistently cause disease in normal, healthy humans Example - Mouse malaria 7 Appropriate for: BSL 2 Safety Equipm ent Safe Practice Facility Design Clinical, diagnostic, teaching, and other laboratories Lab work with a broad spectrum of indigenous moderaterisk agents that are present in the community and associated with human disease of varying severity Lab work with any human-derived blood, body fluids, tissues, or primary human cell lines where the presence of an infectious agent may be unknown Example -Hepatitis B virus - P. faciparum -Salmonellae -H1N1 4

5 BSL 3 Safety Equipm ent Safe Practice Facility Design Appropriate for: Clinical, diagnostic, teaching, research, or production facilities Lab work with indigenous or exotic agents: -with a known potential for aerosol transmission -may cause serious and potentially lethal infection Example -Mycobacterium tuberculosis -Chikungunya 9 BSL 4 Safety Equipm ent Safe Practice Facility Design Appropriate for: Lab work with dangerous and exotic agents which: -- pose a high individual risk of life-threatening disease -- may be transmitted via the aerosol route -- there is no available vaccine or therapy Example - Ebola virus - Hendra and Nipah virus 10 5

6 WHO 2004: Laboratory Biosafety Manual BSL 1 BSL 2 Control Standard Microbiological Practices Special Practices Safety Equipment (Primary Barriers & PPE) Laboratory Facilities (Secondary Barriers) BSL 3 WHO 2004: Laboratory Biosafety Manual 6

7 Risk Group? Risk Group (RG) Risk classification based on: Pathogenicity Modes of transmission Host range Availability of effective preventive measures Availability of effective treatment 7

8 Risk Group (RG) 1. WHO (2004) 2. NIH Recombinant DNA Guidelines (USA, 2002) 3. Australian/New Zealand Standard (2002) 4. Canadian Laboratory Safety Guidelines (2004) 5. European Economic Community (2000) RISK GROUP CLASSIFICATION NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES 2002 WORLD HEALTH ORGANIZATION LABORATORY BIOSAFETY MANUAL 3RD EDITION 2004 Risk Group 1 Agents that are not associated with disease in healthy adult humans. Bacillus subtilis or Bacillus licheniformis A microorganism that is unlikely to cause human or animal disease. (No or low individual and community risk) Risk Group 2 Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available. Campylobacter coli, Salmonella, P. falciparum, Hepatitis viruses A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. (Moderate individual risk; low community risk) 8

9 RISK GROUP CLASSIFICATION Risk Group 3 NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES 2002 Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available M. tuberculosis, R. tsutsugamushi, Japanese encephalitis virus, HIV WORLD HEALTH ORGANIZATION LABORATORY BIOSAFETY MANUAL 3RD EDITION 2004 A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. (High individual risk; low community risk) Risk Group 4 Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available Ebola virus, Tick-borne encephalitis virus complex, Herpesvirus simiae (Herpes B or Monkey B virus) A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available. (High individual and community risk) available. 9

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11 Biosafety Level & Risk Group WHO 2004: Laboratory Biosafety Manual Table 2 relates but does not equate risk groups to the biosafety level of laboratories designed to work with organisms in each risk group. 11

12 Influenza A(H7N9) Virus and Biosafety Level (Canada Model) Influenza A(H7N9) virus Joint Biosafety Advisory - Influenza A(H7N9) virus This advisory is based on currently available scientific evidence as of April 9, 2013 and is subject to review and change as new information becomes available. As of April 9, 2013, the influenza A(H7N9) virus recently identified in China: 24 confirmed cases 7 deaths 14 severe cases 3 mild cases. April 12, cases-china.htm 43 Confirmed 11 Deaths Flu-like symptoms, which progressed to respiratory illness. Source, reservoir, route of infection, and mode of transmission of the virus are unknown Investigations are underway to determine these factors. Human-to-human transmission has not been reported. As of April 9, 2013, no cases had been reported outside of China. 12

13 Influenza A(H7N9) virus This influenza A(H7N9) virus is currently considered a Foreign Animal Disease (FAD) agent as there may be consequences if this pathogen becomes prevalent in the wild bird or poultry populations in Canada. The Risk Group (RG) of influenza A(H7N9) virus is RG3 ((high individual risk, low community risk). Any pathogen that usually causes serious human disease, or can result in serious economic consequences but does not ordinarily spread by casual contact from one individual to another, or that causes disease treatable by antimicrobial or antiparasitic agents). Joint Biosafety Advisory - Influenza A(H7N9) virus Influenza A(H7N9) virus & Biosafety Level Sample Type and Activity Additional Requirements Non-Proliferative Clinical/Diagnostic Activities (processing specimens for packaging and distribution to laboratories, diagnostic testing activities (excluding culturing), molecular testing using noninfectious material, etc.) Work Involving Known/likely Positive Cultures (culturing of specimens likely to contain agent, processing positive cultures for packaging and distribution to laboratories, culture of the agent, known infectious material, etc.) Minimum Containment Level Requirements CL2 CL3 CL4 In Vivo Work (Ag) Joint Biosafety Advisory - Influenza A(H7N9) virus 13

14 Influenza A(H7N9) virus & Biosafety Level Non-Proliferative Clinical/Diagnostic Activities Additional Requirements All manipulations with infectious materials (e.g. nucleic acid extraction, transfers, aliquotting, etc.) must be conducted in a Biological Safety Cabinet (BSC). Additional respiratory protection (N95 mask or equivalent) is not required when working with primary specimens in a BSC. For activities conducted outside a primary containment device, eye and respiratory protection (N95 or equivalent) must be worn in accordance with the risk of exposure. A solid-front gown with tight-fitting wrists must be worn when infectious materials are directly handled and must be removed after completion of work and kept by the dedicated work area. Personnel must have demonstrated proficiency in microbiological practices and techniques applicable to the select pathogen. Leak-proof containers must be used to transport infectious material within the laboratory. Centrifugation of infectious materials must be carried out in closed containers placed in sealed safety cups or rotors that are unloaded in a BSC. Joint Biosafety Advisory - Influenza A(H7N9) virus Influenza A(H7N9) virus & Biosafety Level Non-Proliferative Clinical/Diagnostic Activities Additional Requirements Pathogen-specific disinfection and decontamination procedures must be in place. Infectious agents stored outside of the containment zone must be kept locked in leakproof containers. Emergency response procedures are to take into account the existence of such infectious agents outside of the containment laboratory. In the event of a non-negative human sample, it is strongly recommended that all work with the sample stops and the sample be transferred to the National Microbiology Laboratory (NML). In the event that a veterinary diagnostic laboratory detects a non-negative sample, the work is to be stopped and the sample be transferred to the National Centre for Foreign Animal Disease (NCFAD) as per the policy in the Foreign Animal Disease Diagnostic Laboratory Containment Standard. Joint Biosafety Advisory - Influenza A(H7N9) virus 14

15 Influenza A(H7N9) virus & Biosafety Level Work Involving Known/likely Positive Cultures and Subsequent In Vivo Work Additional Requirements It is strongly recommended that all manipulations with human samples be conducted at the National Microbiology Laboratory (NML). All manipulations with positive animal samples are to be conducted at the National Centre for Foreign Animal Disease (NCFAD), as per the policy in the Foreign Animal Disease Diagnostic Laboratory Containment Standard Respirators are to be worn as there is a risk of exposure to infectious aerosols that can be transmitted through the inhalation route. Special Requirements for All Sample Types and Activities Additional Requirements Manipulations involving growth of the influenza A(H7N9) virus are not to be performed in the same laboratory that is simultaneously culturing material that may contain human influenza virus. Personnel are not to come in contact with susceptible animal species for a period of 5 days after handling samples containing influenza A(H7N9), as per standard foreign animal disease protocols. Joint Biosafety Advisory - Influenza A(H7N9) virus References American Biosafety Association CDC-NIH BMBL 5th edition WHO, Laboratory Biosafety Manual. Public Health Agency of Canada, Joint Biosafety Advisory - Influenza A(H7N9) virus 15

16 Thank You and Questions? 16