Planning for Biological Emergencies on the NIH Campus

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Planning for Biological Emergencies on the NIH
Campus

• Assistant Chief Thomas Gibson
• Master Firefighter Brian Wagner
• National Institutes of Health
• Division of Fire Rescue Services

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History
09/11/01 09/18/01 10/09/01
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History

• 10/26/2001
• Uniting and Strengthening America by Providing
  Appropriate Tools Required to Intercept and
  Obstruct Terrorism
• USA PATRIOT ACT
• Ensures that only those person who have a lawful
  purpose for possessing, using and /or
  transporting such agents are permitted to work
  with these agents.
• Established penalties for certain Restricted
  individuals who are in possession of such agents.

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History

• 03/06/2002
• DHHS Secretary Tommy G Thompson delivers a
  Memorandum requesting the implementation of
  Security Protocols for laboratories working with
  Select Agents
• 12 Point Plan established to immediately
  implement department-wide security requirements
  in keeping with the PATRIOT Act
• The complete list of Select Agents classified
  Secret by the Secretary, DHHS
• Background Investigation
• Security cameras
• Inventory procedures

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History

• 06/12/2002
• Public Health Security and Bioterrorism
  Preparedness and Response Act 2002, Title II
• (Bioterrorism Act)
• Set forth the requirements for possession use and
  transfer of Select Agents and Toxins
• The aim of the Act is "To improve the ability of
  the United States to prevent, prepare for, and
  respond to bioterrorism and other public health
  emergencies."
• These Select Agents are identified in the final
  rules

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History

• 02/07/03
• Select Agents new rules go into effect
• 42 CFR Part 73
• 7 CFR Part 331
• 9 CFR Part 121
• 09/12/03
• Dateline to incorporate all the Select Agent
  Program measures

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History

• 04/18/2005
• Select Agent Final rules are published
• 42 CFR part 73
• Possession, Use and Transfer of Select Agents and
  Toxins
• 7 CFR Part 331 9 CFR Part 121
• Agricultural Bioterrorism Protection Act of 2002
  Possession, Use and Transfer of Biological Agents
  and Toxins

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What defines a Select Agent?

• Select Agent
• Biological agents that HHS considers to have the
  potential to pose a severe threat to human health
• Y. pestis, Monkeypox virus
• High Consequence Livestock Pathogen
• Biological agents that the USDA considers to have
  the potential to pose a severe threat to animal
  or plant health, or to animal or plant products.
• Newcastle virus (velogenic), Avian Influenza
  (High Path.)
• Overlap Agent
• Biological agents that post a severe threat to
  animal health, animal products and also public
  health.
• B. anthracis

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Select Agent Characteristics

• Long Term Effects
• Route of Exposure
• Degree of Pathogenicity
• Acute Morbidity
• Acute Mortality
• Communicability
• Developed for Use as a Bioweapon
• Ability to Genetically Manipulate/Alter
• Available Treatment
• Vulnerable populations
• Status of Immunity
• Ease of Production

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HHS SELECT AGENTS AND TOXINS

• Abrin
• Cercopithecine herpesvirus (Herpes B virus)
• Coccidioides posadasii
• Conotoxins
• Crimean-Congo haemorrhagic fever virus
• Diacetoxyscirpenol
• Ebola Viruses
• Lassa fever virus
• Marburg virus
• Monkeypox virus
• Reconstructed replication competent forms of the
  1918 pandemic influenza virus containing any
  portion of the coding regions of all eight gene
  segments (Reconstructed 1918 Influenza virus)
• Ricin
• Rickettsia prowazekii
• Rickettsia rickettsii

• Saxitoxin
• Shiga-like ribosome inactivating proteins
• South American haemorrhagic fever viruses
• Flexal
• Guanarito
• Junin
• Machupo
• Sabia
• Tetrodotoxin
• Tick-borne encephalitis complex (flavi) viruses
• Central European tick-borne encephalitis
• Far Eastern tick-borne encephalitis
• Kyasanur forest disease
• Omsk hemorrhagic fever
• Russian spring and summer encephalitis
• Variola major virus (Smallpox virus)
• Variola minor virus (Alastrim)
• Yersinia pestis

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USDA Select Agents and Toxins

• African horse sickness virus
• African swine fever virus
• Akabane virus
• Avian influenza virus (highly pathogenic)
• Bluetongue virus (Exotic)
• Bovine spongiform encephalopathy agent
• Camel pox virus
• Classical swine fever virus
• Cowdria ruminantium (Heartwater)
• Foot-and-mouth disease virus
• Goat pox virus
• Japanese encephalitis virus
• Lumpy skin disease virus

• Malignant catarrhal fever virus (Alcelaphine
  herpesvirus type 1)
• Menangle virus
• Mycoplasma capricolum/ M.F38 /M. mycoides
  capri(contagious caprine pleuropneumonia
• Mycoplasma mycoides mycoides (contagious bovine
  pleuropneumonia)
• Newcastle disease virus (velogenic)
• Peste des petits ruminants virus
• Rinderpest virus
• Sheep pox virus
• Swine vesicular disease virus
• Vesicular stomatitis virus (Exotic)

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Overlap Select Agents and Toxins

• Bacillus Anthracis
• Botulinum neurotoxins
• Botulinum neurotoxin producing species of
  Clostridium
• Brucella abortus
• Brucella melitensis
• Brucella suis
• Burkholderia mallei (formerly Pseudomonas mallei)
  
• Burkholderia pseudomallei (formerly Pseudomonas
  pseudomallei)
• Clostridium perfringens epsilon toxin

• Coccidiodes immitis
• Coxiella burnetii
• Eastern Equine Encephalitis virus
• Francisella tularensis
• Hendra virus
• Nipah Virus
• Rift Valley fever virus
• Shigatoxin
• Staphylococcal enterotoxins
• T-2 toxin
• Venezuelan Equine Encephalitis virus

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USDA Plant Pathogens

• Candidatus Liberobacter africanus
• Candidatus Liberobacter asiaticus
• Peronosclerospora philippinensis
• Ralstonia solanacearum race 3, biovar 2
• Schlerophthora rayssiae var zeae
• Synchytrium endobioticum
• Xanthomonas oryzae pv. oryzicola
• Xylella fastidiosa(citrus variegated chlorosis
  strain)

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Categorized Select Agents

• Group I - Pathogens Newly Recognized in the Past
  Two Decades
• Group II - Re-emerging Pathogens
• Group III - Agents with Bioterrorism Potential
• Category A
• Category B
• Category C

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Group I - Pathogens Newly Recognized in the Past
Two Decades

• Acanthamebiasis
• Australian bat lyssavirus
• Babesia, atypical
• Bartonella henselae
• Ehrlichiosis
• Encephalitozoon cuniculi
• Encephalitozoon hellem
• Enterocytozoon bieneusi

• Helicobacter pylori
• Hendra or equine morbilli virus
• Hepatitis C
• Hepatitis E
• Human herpesvirus 8
• Human herpesvirus 6
• Lyme borreliosis 
• Parvovirus B19

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Group II - Re-emerging Pathogens

• Enterovirus 71
• Clostridium difficile
• Mumps virus
• Streptococcus, Group A
• Staphylococcus aureus 

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Group III - Agents with Bioterrorism Potential

• Category A
• The U.S. public health system and primary
  healthcare providers must be prepared to address
  various biological agents, including pathogens
  that are rarely seen in the United States.
  High-priority agents include organisms that pose
  a risk to national security because they
• can be easily disseminated or transmitted from
  person to person
• result in high mortality rates and have the
  potential for major public health impact
• might cause public panic and social disruption
• and require special action for public health
  preparedness.

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Group III - Agents with Bioterrorism Potential

• Category B
• Second highest priority agents include those that
• are moderately easy to disseminate
• result in moderate morbidity rates and low
  mortality rates and
• require specific enhancements of CDC's diagnostic
  capacity and enhanced disease surveillance.

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Group III - Agents with Bioterrorism Potential

• Category C
• Third highest priority agents include emerging
  pathogens that could be engineered for mass
  dissemination in the future because of
• availability
• ease of production and dissemination and
• potential for high morbidity and mortality rates
  and major health impact.

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Category A Agents

• Bacillus anthracis (anthrax)
• Clostridium botulinum toxin (botulism)
• Yersinia pestis (plague)
• Variola major (smallpox) and other related pox
  viruses
• Francisella tularensis (tularemia)
• Viral hemorrhagic fevers

• Arenaviruses
• LCM, Junin virus, Machupo virus, Guanarito virus
• Lassa Fever
• Bunyaviruses
• Hantaviruses
• Rift Valley Fever
• Flaviruses
• Dengue
• Filoviruses
• Ebola
• Marburg

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Category B Agents

• Burkholderia pseudomallei
• Coxiella burnetii (Q fever)
• Brucella species (brucellosis)
• Burkholderia mallei (glanders)
• Chlamydia psittaci (Psittacosis)
• Ricin toxin (from Ricinus communis)
• Epsilon toxin of Clostridium perfringens
• Staphylococcus enterotoxin B
• Typhus fever (Rickettsia prowazekii)
• Food- and Waterborne Pathogens
• Bacteria
• Diarrheagenic E.coli
• Pathogenic Vibrios
• Shigella species
• Salmonella
• Listeria monocytogenes
• Campylobacter jejuni
• Yersinia enterocolitica)

• Viruses (Caliciviruses, Hepatitis A) Protozoa
• Cryptosporidium parvum
• Cyclospora cayatanensis
• Giardia lamblia
• Entamoeba histolytica
• Toxoplasma
• Fungi
• Microsporidia
• Additional viral encephalitides
• West Nile Virus
• LaCrosse
• California encephalitis
• VEE
• EEE
• WEE
• Japanese Encephalitis Virus
• Kyasanur Forest Virus

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Category C Agents

• Emerging infectious disease threats such as Nipah
  virus and additional hantaviruses.
• NIAID priority areas
• Tickborne hemorrhagic fever viruses
• Crimean-Congo Hemorrhagic fever virus
• Tickborne encephalitis viruses
• Yellow fever
• Multi-drug resistant TB
• Influenza
• Other Rickettsias
• Rabies
• Prions
• Chikungunya virus
• Severe acute respiratory syndrome associated
  coronavirus (SARS-CoV)

• Antimicrobial resistance, excluding research on
  sexually transmitted organisms
• Research on mechanisms of antimicrobial
  resistance
• Studies of the emergence and/or spread of
  antimicrobial resistance genes within pathogen
  populations
• Studies of the emergence and/or spread of
  antimicrobial-resistant pathogens in human
  populations
• Research on therapeutic approaches that target
  resistance mechanisms
• Modification of existing antimicrobials to
  overcome emergent resistance
• Antimicrobial research, as related to engineered
  threats and naturally occurring drug-resistant
  pathogens, focused on development of
  broad-spectrum antimicrobials
• Innate immunity, defined as the study of
  nonadaptive immune mechanisms that recognize, and
  respond to, microorganisms, microbial products,
  and antigens
• Coccidioides immitis (added February 2008)
• Coccidioides posadasii (added February 2008)

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What exactly is required for Emergency Response?

• The requirements are described in
• 42 CFR 73.14 Incident response
• An individual or entity required to register
  under this part must develop and implement a
  written incident response plan.
• The incident response plan must be coordinated
  with any entity-wide plans, kept in the
  workplace, and available to employees for review.
• The incident response plan must fully describe
  the entitys response procedures for
• theft, loss, or release of a select agent or
  toxin,
• Inventory discrepancies,
• security breaches (including information
  systems),
• Severe weather and other natural disasters,
• workplace violence,
• bomb threats, suspicious packages,
• Emergencies such as fire, gas leak, explosion,
  power outage, etc.
• The response procedures must account for hazards
  associated with the select agent and toxin and
  appropriate actions to contain such select agent
  or toxin.

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42 CFR 73.14

• The incident response plan must also contain the
  following information
• (1) The name and contact information (e.g., home
  and work) for the individual or entity (e.g.,
  responsible official, alternate responsible
  official(s), biosafety officer, etc.),
• (2) The name and contact information for the
  building owner and/or manager,
• (3) The name and contact information for tenant
  offices, where applicable,
• (4) The name and contact information for the
  physical security official for the building,
  where applicable,
• (5) Personnel roles and lines of authority and
  communication,
• (6) Planning and coordination with local
  emergency responders,
• (7) Procedures to be followed by employees
  performing rescue or medical duties,
• (8) Emergency medical treatment and first aid,
• (9) A list of personal protective and emergency
  equipment, and their locations,
• (10) Site security and control,
• (11) Procedures for emergency evacuation,
  including type of evacuation, exit route
  assignments, safe distances, and places of refuge
• (12) Decontamination procedures.
• The plan must be reviewed annually and revised as
  necessary.

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Animal and Plant Health InspectionService
(APHIS)7 CFR Part 331

• 331.14 Incident response.
• An individual or entity required to register
  under this part must develop and implement a
  written incident response plan.
• The incident response plan must be coordinated
  with any entity-wide plans, kept in the
  workplace, and available to employees
• for review. The incident response plan must
  fully describe the entitys response procedures
  for
• the theft, loss, or release of a select agent or
  toxin
• inventory discrepancies
• security breaches (including information
  systems)
• severe weather and other natural disasters
• workplace violence
• bomb threats and suspicious packages
• emergencies such as fire, gas leak, explosion,
  power outage, etc.
• The response procedures must account for hazards
  associated with the select agent or toxin and
  appropriate actions to contain such agent or
  toxin.
• The incident response plan must also contain the
  following information
• The name and contact information (e.g., home and
  work) for the individual or entity (e.g.,
  responsible official, alternate responsible
  official(s), biosafety officer, etc.)
• The name and contact information for the building
  owner and/or manager, where applicable
• The name and contact information for tenant
  offices, where applicable

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7 CFR Part 331

• The name and contact information for the physical
  security official for the building, where
  applicable
• Personnel roles and lines of authority and
  communication
• Planning and coordination with local emergency
  responders
• Procedures to be followed by employees performing
  rescue or medical duties
• Emergency medical treatment and first aid
• A list of personal protective and emergency
  equipment, and their locations
• Site security and control
• Procedures for emergency evacuation, including
  type of evacuation, exit route assignments, safe
  distances, and places of refuge
• Decontamination procedures.
• The plan must be reviewed annually and revised as
  necessary.
• Drills or exercises must be conducted at least
  annually.
• The plan must be reviewed and revised, as
  necessary, after any drill or exercise and after
  any incident.

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Other applicable Regs

• Must develop and implement an emergency response
  plan that meets the requirements of OSHA
  Hazardous Waste Operations and Emergency Response
  (HAZWOPER) standard at 29 CFR part 1910.120.
• With respect to these OSHA standards, paragraph
  (a) addresses scope, application, and definitions
  and paragraph (q) addresses emergency responses
  to hazardous substance releases.
• The provisions of 40 CFR part 311 make 29 CFR
  part 1910.120 applicable to State and local
  government employees.
• The OSHA regulations also reference 29 CFR part
  1910.38 which concerns the development and
  implementation of an emergency action plan.

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Considerations

• Plan to plan
• Begin with the institute and Directors for
  specific agent guidance
• Pre-plan each incident as specified in 42 CFR
  73.14
• Determine the who, what, when, where and why
• Decon solutions, Special procedures, etc.
• Determine who will be responding
• In-house HAZMAT team
• Local jurisdiction HAZMAT Team
• Or is the Fire Department ultimately responsible
• And will make appropriate notifications for
  assistance

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Considerations

• Work diligently with the Fire Department and/or
  HAZMAT personnel
• Assign an intermediary
• Someone who speaks fire service lingo and can
  interpret to directors and supervisors the fire
  service wants and wishes.
• Our representative comes to us from our
  Occupational Safety and Health
• Sometimes procedure gets written for you in the
  form of a failed table-top exercise or drill
• The exercises and drills will make any problem or
  blockage very clear!
• Learn from the mistakes! Make changes
  accordingly and run exercise again

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Considerations

• Even in an emergency your select agent must be
  accounted for as specified in 42 CFR 73.14 and 7
  CFR 331
• Accountability for the emergency responders who
  enter the lab
• Accountability for the agent amounts
• Very difficult to know if only one person is
  working in lab
• What if that one person is the person who is
  having the medical emergency?
• Who will secure the agent?
• Who will stand watch on the lab until the agent
  can be secured?

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Our Checklist

• Used to generate Incident Action Plan

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General Response Procedures

• For a spill in a BSC
• 1. Verify appropriate PPE is donned
• 2. Cover the spilled material with a paper towel
• 3. Saturate the paper towels with a 110 dilution
  of sodium hypochlorite, beginning at the outside
  and working toward center of the covered spill
• 4. Allow for a 30 min contact time
• 5. Dispose of soiled towels in an autoclave bag,
  add 50 ml. water, close with plastic tie,
  generously spray bag with disinfectant, and
  remove to autoclave for decontamination
• 6. Discard autoclaved materials into MPW waste
  stream

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General Response Procedures

• For a spill outside the BSC
• 1. All personnel safely exit the laboratory and
  inform PI /NIH SAP
• 2. Allow any potential aerosols created to
  dissipate (approx. 30 min 1 hr)
• 3. Don appropriate PPE after consultation with
  NIH SAP 4. Cover the spill with paper towels
• 5. Saturate the paper towels with a 110 dilution
  of sodium hypochlorite, beginning at the outside
  and working toward center of the covered spill
• 6. Allow for a 30 min contact time
• 7. Dispose of soiled towels in an autoclave bag,
  add 50 ml. water, close with plastic tie,
  generously spray bag with disinfectant, and
  remove to autoclave for decontamination
• 8. Discard autoclaved materials into MPW waste
  stream
• 9. Contact NIH SAP for further instructions

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General Response Procedures

• For a spill outside the laboratory
• The chance of a spill occurring during transport
  can be minimized by taking proper precautions in
  packaging.
• In case of accidental release outside the
  laboratory, clear the area immediately and notify
  the NIH Fire Department by dialing 911 (on
  campus) or 9-911 (off campus).

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Incident Response Inspection Checklist
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• Any Questions?

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Helpful Links

• General Information
• http//www.selectagent.gov
• Resource Templates
• http//www.selectagents.gov/securitydoc.htm
• CDC Occupational Health and Safety
• http//www.cdc.gov/od/ohs