CONTROLLING CHEMICAL and BIOHAZARDS ASSOCIATED WITH BT-WMD INCIDENTS Philip G. Hauck, MS, MSHS CIH, SM(NRM) 6/2005 Controlling Microbial Hazards This presentation will address safety issues associated with Bioterrorism agents, and how to protect personnel taking samples in the field and processing samples in the laboratory. As part of the overall process of investigation, environmental samples have to be taken at several points in the investigation process. Final clearance also has to be established before a space is reoccupied. There may be human culture specimens that have come into the lab for evaluation. THESE AGENTS ARE PRESUMABLY HOT– HOW DO WE HANDLE THESE MATERIALS SAFELY? Risk Assessment Risks of Exposure to BT Agents: – Aerosolized Agents – Sprays / Splatters – Infected Individuals / animals – Direct contact with deposited material – Direct contact with contaminated articles We can use the Industrial Hygiene Paradigm!! Source - Pathway - Receiver We Can select proper PPE We Can use vaccines, antibiotics We Can surround and Contain the Hazard CATEGORY A and B Bacterial Agents: • Yersinia pestis • Bacillus anthracis • Brucella abortis; B. canis, B.suis • Burkholderia mallei • Francisella tularensis • Chlamidia psittaci • Coxiella burnetti Viral Agents: • Variola major (smallpox) • Viral hemorrhagic fevers • Viral encephalitis viruses • Emerging viruses (Hanta, Nipah, Hendra, • Hantavirus, SARS) http://www.bt.cdc.gov/agent/agentlist-category.asp CATEGORY A and B Fungal Agents: • Coccidioides immitis • Histoplasma capsulatum (NOT ON LIST) Toxins: • Anthrax toxin(s) • Botulinum Toxin • Tetanus Toxin • Epsilon Toxin • Ricin • Staphylocoocal Enterotoxin B • Endotoxin (gram negative bacteria) Water-Borne Agents (CATEGORY B’s): • Salmonella typhi, Vibrio cholera, Food-Borne Agents (CATEGORY B’s): • E. coli toxigenic strains 1. Engineering Controls The following are engineered devices used to control, or contain and remove dangerous agents away from the individual handling these materials. “ Biological Safety Cabinets (BSCs) are among the most effective and the most commonly used primary containment devices in laboratories working with infectious agents.” BMBL 4th Edition; page 200. - Class I, II, III BSCs; Class Is have little utility today, IIs and IIIs are preferred for Biosafety applications - Class II Type A; Type B1; Type B2; Type B3 (Type A / B3) BSCs; These are the workhorses of biosafety - Class III BSC’s; Most protective of all the BSCs - All use HEPA Filters – the “magic” of BSCs Biosafety Cabinet Type II A / B3 A. front opening B. sash C. exhaust HEPA filter D. rear plenum E. supply HEPA filter F. blower Source: CDC / Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets; 2nd Edition Class II, Type B2 Biological Safety Cabinet A. front opening, B. sash, C. exhaust HEPA filter, D. supply HEPA filter, E. negative pressure exhaust plenum, F. filter screen Note: The carbon filter in the building exhaust system is not shown. The cabinet exhaust needs to be connected to the building exhaust system. Class III Biological Safety Cabinet A. glove ports with O-ring for attaching arm-length gloves to cabinet. B. sash, C. exhaust HEPA filter, D. supply HEPA filter, E. double - ended autoclave or pass-through box. Note: A chemical tank may be installed which would be located beneath the work surface of the BSC with access from above. The cabinet exhaust needs connection to the building exhaust system. HEPA Filters and ULPA Filters are challenged with a 0.3 micron, monodisperse DioctylPhthalate (DOP) aerosol, that mimics particles in the breathable zone. Note that capture efficiency is high on both sides of the curve Almost all breathable hazards are eliminated by BSC use - the HEPA filter effectively removing particulates (but not gases!!) Source: The Baker Co. BMBL: Comparison of Biological Safety Cabinets Face velocity Type Class I * (lfpm) Airflow Pattern Radionuclides/ Biosafety Product Toxic Chemicals Level(s) Protection 75 In at front; out thru rear and top through HEPA filter No 2,3 No 75 70% recirculated through HEPA; exhaust through HEPA No 2,3 Yes 100 30% recirculated through HEPA; exhaust Yes 2,3 Yes open front Class II Type A Type B1 via HEPA and hard ducted (Low levels/ volatility) Type B2 100 No recirculation; total exhaust via HEPA and hard ducted Yes 2,3 Yes Type B3 100 Same as IIA, but plena under negative pressure Yes 2,3 Yes Yes 3,4 Yes to room and exhaust air is ducted Class III NA Supply air inlets and exhaust through 2 HEPA filters *Glove panels may be added and will increase face velocity to 150 lfpm; gloves may be added with an inlet air pressure release that will allow work with chemicals/radionuclides Engineering Controls: (continued) a. Engineered Laboratory Space: i. Ventilation(Directional, 100% In / 100% Out) ii. Negative Pressure within Lab Spaces (0.05-0.1” W.G.)** iii. Safety Interlocks (double-door entry) iv. Special floor/ wall surfaces b. Other Safety Devices: i. Screw Cap Tubes ii. Bucket enclosures / rotor enclosures on centrifuges iii. Pipettors iv. Vacuum line safety flasks / line filter devices v. Autoclaves **1.0 “ W.G. = 250 Pa(scals); range is 12.5 to 25 Pa vacuum inside space 2. Administrative Controls These are practice-based controls that control hazards through established activities based on knowledge gained from working with infectious agents. a. Standard Laboratory Practices: i. Direct contact control-“Good Housekeeping” and spill management ii. Aerosol control-limiting activities that can generate aerosols iii. “Sharps” control iv. Waste decontamination and disposal v. Surface disinfection 2. Administrative Controls: ( continued ) b. Vaccinations: there are a limited number of vaccines available c. The CDC Biological Safety Levels: recommended practices and equipment (go to: www.cdc.gov/od/ohs; BMBL) i. BSL 1 ii. BSL 2 iii. BSL 3 iv. BSL 4 d. The NIH Risk Groups: implied practices and equipment (have to use Appendix G in the NIH Guidelines) * i. Risk Group 1 ii. Risk Group 2 iii. Risk Group 3 iv. Risk Group 4 *http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html BMBL Section III Summary of Recommended Biosafety Levels for Infectious Agents BSL Agents Practices Safety Equipment (Primary Barriers) 1 Not known Standard None required to consistently Microbiological top sink required cause disease in Practices Facilities (Secondary Barriers) Open bench healthy adults 2 Associated with human BSL-1 plus: Primary barriers = Class I or disease, practice Limited access II BSCs or other physical hazard = percutaneous injury, Biohazard warning signs containment devices used ingestion, "Sharps" precautions for all manipulations mucous membrane exposure Biosafety manual of agents that cause defining any needed splashes or aerosols waste decontamination of infectious materials; or medical surveillance PPEs: laboratory coats; policies gloves; face protection as needed BSL-1 plus: Autoclave available Summary of Recommended Biosafety Levels for Infectious Agents BSL Agents Practices Safety Equipment (Primary Barriers) 3 Facilities (Secondary Barriers) Indigenous or exotic agents BSL-2 practice plus: Primary barriers = BSL-2 plus: with potential for aerosol Controlled access Class I or II BCSs Physical separation from transmission; disease may Decontamination of all waste or other physical access corridors Self-closing, have serious or lethal Decontamination of lab containment devices double-door access consequences clothing before laundering used for all open Exhausted air not recircul- Baseline serum manipulations of agents; ated Negative airflow into PPEs: protective lab clothing; laboratory gloves; respiratory protection as needed 4 Dangerous/exotic agents BSL-3 practices plus: Primary barriers = All procedures BSL-3 plus: which pose high risk of life- Clothing change before conducted in Class III BSCs Separate building or threatening disease, entering or Class I or II BSCs isolated zone aerosol-transmitted lab Shower on exit in combination with Dedicated supply and exhaust, infections; or related agents All material decontam full-body, air-supplied, vacuum, and decon systems with unknown risk of -inated on exit from positive pressure personnel suit transmission facility NIH Guidelines: Basis for the Classification of Biohazardous Agents by Risk Group (RG) Risk Group 1 (RG1) Risk Group 2 (RG2) Risk Group 3 (RG3) Risk Group 4 (RG4) Agents that are not associated with disease in healthy adult humans Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk) Source: NIH Guidelines: http://www4.od.nih.gov/oba/rdna.htm APPENDIX B. CLASSIFICATION OF HUMAN ETIOLOGIC AGENTS ON THE BASIS OF HAZARD Appendix B-I. Risk Group 1 (RG1) Agents Appendix B-II. Risk Group 2 (RG2) Agents Appendix B-II-A. Risk Group 2 (RG2) - Bacterial Agents Including Chlamydia Appendix B-II-B. Risk Group 2 (RG2) - Fungal Agents Appendix B-II-C. Risk Group 2 (RG2) - Parasitic Agents Appendix B-II-D. Risk Group 2 (RG2) - Viruses Appendix B-III. Risk Group 3 (RG3) Agents Appendix B-III-A. Risk Group 3 (RG3) - Bacterial Agents Including Rickettsia Appendix B-III-B. Risk Group 3 (RG3) - Fungal Agents Appendix B-III-C. Risk Group 3 (RG3) - Parasitic Agents Appendix B-III-D. Risk Group 3 (RG3) - Viruses and Prions Appendix B-IV. Risk Group 4 (RG4) Agents Appendix B-IV-A. Risk Group 4 (RG4) - Bacterial Agents Appendix B-IV-B. Risk Group 4 (RG4) - Fungal Agents Appendix B-IV-C. Risk Group 4 (RG4) - Parasitic Agents Appendix B-IV-D. Risk Group 4 (RG4) - Viral Agents Appendix B-V. Animal Viral Etiologic Agents in Common Use Appendix B-V-1. Murine Retroviral Vectors Emergency Management Issues ( Post-Incident) If you / your organization is involved in making a response….. Who are the players*? – Local Incident Command / Emergency Preparedness Group (IC/EPG) for your Facility (Don’t have one-get one!!) – NYPD – 911 (and FDNY if fire/ explosion is involved OCT2900) – FBI (NYPD will notify) – NYC Health Department – (311) or 788-9830 (days); 764-7667 after-hours – NYS Health Department – 518 – 473 – 1730(d); 518-465-9720 (a-h) – CDC ( Local and State Health Authorities will call) What needs to be in place? – A Written, Response and Emergency Procedure identifying the “who, how, what, where and when” of each procedure, in detail, not outline form. Scope and Limitations of activity must be defined – Contact numbers and names of key officials in the agencies listed above are located in specific areas for First Responder use. Key Hospital / Laboratory Officials who will interact with youry Representatives. Local NYPD Precinct Commanders / Bioterrorism Liaison officer(s; EMS; Disaster Response Names of NYC health officials handling Chemical/ bioterrorism emergencies. Training in the actual procedures used to initiate and follow the Response and Emergency Response Plan (RERP). a. Your staff must know beforehand: – What constitutes a Chem / BT Incident? – What degree of response will you participate in? b. Client Institutional Officials must develop official policies. – How will cases be recognized? Handled? Who responds? c. NYC Health Dept. Guidance; NYSDOH, CDC – What protective equipment will your Health Professionals use in handling / treating cases? – What practices for Protective Isolation will be used to quarantine BT-Agent infected cases from other patients? d. Safety and Health Personnel have plans developed. – How will all equipment, instruments, clothing and PPE be decontaminated, cleaned/discarded, re-used? – Infection Control, Chemical exposure control; develop policies/procedures. Have an Incident Command System in place http://www.osha.gov/SLTC/etools/ics/index.html Client Organization’s RERP must overlap with your RERP re: Who, What, When, and Where; Who is responsible? In charge? for what? When?Etc. Clear definition of what is expected, scope of operations, limitations IH IH Securing An Incident Location – – – – – – – – ACTIVATE your Facility RERP - Notify Your IC/EPG! COMMUNICATE with external agency officials* EVACUATE the victims from the release area DECONTAMINATE the victims (see 5. below!) VACATE the incident site and secure it ISOLATE the victims; control access to them EVALUATE the victims, primary / secondary contacts ISOLATE the incident site; seal-off and lock-out access to the area – INVESTIGATE the incident site (Outside Agencies*) – DECONTAMINATE the incident site - only if told and when, to do so! – DOCUMENT(ate) all activities, ie. Phone logs, lists of people on premises, agencies, etc Collecting / Preserving Evidence – Protecting Health and Safety of Victims is first!! – Collecting Personal Clothing and Effects – evidence!! - agent may be present on these items Need to contact NYPD at the beginning of the incident-they have to establish chain-of-custody for collecting and holding evidence incident scene = crime scene! – Try to obtain information about the incident as to “who; what; when; where” was in the area. Note: This is probably better left to the NYPD or FBI w/re: their investigation. You may need to know this information in order to determine if more than one release / one site is involved on your premises for decontamination purposes. – Limit Access to Agency representatives who have to investigate the victims / incident site FRP . . . at a glance What is it? Signed agreement among 27 Federal departments and agencies, including the American Red Cross, that: Provides the mechanism for coordinating delivery of Federal assistance and resources to augment efforts of State and local governments overwhelmed by a major disaster or emergency Supports implementation of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, as amended (42 U.S. Code 5121, et seq.), as well as individual agency statutory authorities Supplements other Federal emergency operations plans developed to address specific FRP . . . at a glance In anticipation of a significant event likely to result in a need for Federal assistance In response to an actual event requiring Federal assistance under a Presidential declaration of a major disaster or emergency Federal Response Plan http://www.fema.gov/pdf/rrr/frp/frp2003.pdf a. FEMA http://www.fema.gov/ b. DofJustice http://www.dhs.gov/dhspublic/ and http://www.usdoj.gov/jmd/ps/dojepm.htm c. FBI* http://www.fbi.gov/ (LFA) d. CDC / USDA www.cdc.gov and www.usda.gov e. EPA www.epa.gov (clean-up activities, FIFRA) f. Homeland Security http://www.dhs.gov/dhspublic/ (LFA) g. OSHA www.osha.gov *http://www.fbi.gov/anthrax/amerithraxlinks.htm State of NY Role: (Regional Authority) NYS Police http://www.troopers.state.ny.us/ b. NYSDoH http://www.health.state.ny.us/home.htm l c. NYS Emergency Management Office http://www.nysemo.state.ny.us C. NYC Role: a. Mayor’s Office – Office of Emergency Management (OEM) http://www.nyc.gov/html/fdny/pdf/pr/2004/strategic_plan/ goal_1.pdf – Department of Health www.nyc.gov/health. Or 311 http://www.nyc.gov/html/doh/pdf/bt/bt-emergencyguideemployers.pdf c. NYPD - 911 d. FDNY - OCT-2900 Personal Protective Equipment PPE must protect the following: –Eyes –Nose and Mouth –Respiratory Tract –Skin Personal Protective Equipment PPE is: –Respiratory Protection –Eye Protection (i.e. goggles, glasses, face shields) –Boots –“Bunny” and “Moon” Suits Saranax - coated coveralls + Full enclosure suits –Gloves PPE Know your PPE: Level A Combination [RG-3,4]: Airtight / Gastight Totally covering suit with SCBA, Hoseline or oxygen-generating rebreather. Level B Combination [RG2,3; +/- 4]: Chemically resistant suit, with SCBA, Hoseline or oxygen-generating rebreather. Sometimes PAPR’s used. Level C Suit [RG-2,3]: Chemically resistant suit with an Air Purifying Respirator(APR), Powered Air Purifying Respirator (PAPR). Source: Lab Safety Supply Source: ILC Dover,Inc. Respirator Types Air – Purifying Respirators Atmosphere – Supplying Respirators Source: NIOSH Small Scale Operations (Room size clean-ups) Basically we can borrow from available remediation technology. Who handles respirable particles @ 5 u in length? Asbestos removers! http://www.ci.nyc.ny.us/html/dep/pdf/asbestos.pdf Plastic Drapes (6 mil), HEPA (Micro-) traps, Access Enclosures, walk-through tanks, glove bags, HEPA vacuums - all of these can be adapted to small scale decontamination procedures. Personal Protective Equipment must be selected in order to protect users in the “Hot Zone” or containment area. Usually designed for Particulates…can protect against aerosols, too! Disinfectants are available for decontaminating the space - have to know what is effective as a space disinfectant and what is a surface active disinfectant. Some common Disinfectants used: Disinfectants Paraformaldehyde and water in electric skillets (aka Formaldehyde) Vaporized Hydrogen Peroxide Chlorine Dioxide Glutaraldehyde Ethylene Oxide Sodium Hypochlorite Fabrication of Containment Structures and Aerosol Control External Clean-ups Basically we can borrow from available remediation technology. The “Occupational Safety and Health Guidance Manual for Hazardous Waste Activities” NIOSH/OSHA/USCG/EPA is a good model for setting up a site for remediation: www.cdc.gov/niosh/85-115.html –Establish an over-all control of the site with respect to controlling access, operational activities, site emergencies, clearance criteria and turn-over of the site to owners. The size of the incident will actually dictate who/which agency has overall control over the site. –Firmly establish specific boundaries between zones, who is allowed into what zones, under what conditions and with what training/PPE. –Know what / How much PPE to have on site. http://www.bt.cdc.gov/DocumentsApp/Anthrax/Protective/Protective.asp. –Know what disinfectants to use, and order in sufficient quantity to do the job. –Establish a clearance level if none of the agencies involved has a clearance level. http://www.cdc.gov/ncidod/EID/vol8no10/02-0398.htm http://www.phppo.cdc.gov/nltn/pdf/LRN99.pdf Follow-Up Testing Several Agencies may set a clearance criteria or value for a given agent: Follow CDC recommended testing procedures if the agent has been evaluated by the CDC. Follow EPA recommended testing procedures if the agent has been evaluated by the EPA. Clearance criteria can come from several Gov’t Agencies.…USDA, OSHA, FEMA, etc. Laboratory Response Network http://www.bt.cdc.gov/lrn http://www.bt.cdc.gov/lrn/pdf/lrn-overview-presentation.pdf http://www.bt.cdc.gov/lrn/ppt/lrn-overview-presentation.ppt The CDC and several agencies have developed a Laboratory Response Network to identify Biological and Chemical agents in the event of a BT/CT attack. The websites above detail the interplay between the CDC, Homeland Security and the EPA. Laboratory Response Network Conclusion By using a combination of engineering controls and administrative controls, biohazardous agents can be contained safely. Unless genetically modified, the Risk Group assessments and Biosafety levels used for the naturally-occurring agent will also work for the BT-WMD. Work with biohazardous agents can proceed within a flexible practice schedule that can be modified to address the hazards and risks associated with the agent NIH Risk Groups and CDC BSL’s can be used to perform risk assessments and establish safe work practices with a given agent Both Risk Group 4 and BSL-4 Practices are most protective against unknown agents.