# Presentation: 618861

## 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**

## History

**                ****09/11/01****	****	****	**** 09/18/01 & 10/09/01**

## History

**10/26/2001**
**U**niting and **S**trengthening **A**merica by **P**roviding **A****ppropriate ****T**ools **R**equired to **I****ntercept **and **O**bstruct **T**errorism
**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”.

## 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

## 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

## 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

## 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

## 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**

## 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**

## 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***

## 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)

## 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**

## 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)

## 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

## 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**

## Group II - Re-emerging Pathogens 

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

## 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.**

## 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. **

## 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. **

## 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**

## 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

## 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)

## 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 entity’s 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.

## 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.

## Animal and Plant Health InspectionService (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 entity’s 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;

## 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.

## Other applicable Reg’s

- 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.

## 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

## 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

## 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?

## Our Checklist

- Used to generate Incident Action Plan

## Slide 32

## Slide 33

## Slide 34

## 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 1:10 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

## 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 1:10 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

## 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).

## Incident Response Inspection Checklist

## Any Questions?

## 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