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Module7Chapter12Slides.pptx

Biosecurity & Bioterrorism: Containing and Preventing Biological Threats

Chapter 12

Biosecurity Programs and Assets

Learning Objectives

Relate recent initiatives in biosecurity to the four phases of emergency management.

Discuss the goals and objectives of the BioShield project.

Define the phrase dual-use research of concern and discuss the role of the National Scientific Advisory Board for Biosecurity.

Discuss how mass prophylaxis caches affect a nation’s preparedness and ability to respond to a major disease outbreak.

Discuss the Cities Readiness Initiative.

Discuss the goals and objectives of the BioWatch program and how it provides early warning and detection capabilities for biothreat pathogens.

Discuss the goals and objectives of the BioSense program.

Discuss the role of the Laboratory Response Network and the function of its three tiers.

Describe the mission of the FBI Hazardous Materials Response Unit.

Describe the mission of the National Guard’s WMD Civil Support Teams.

Key Terminology

Mass Prophylaxis

Mitigation

Overt

Preparedness

Recovery

Response

Strategic National Stockpile

WMD Civil Support Team (CST)

Australia Group

BioSense initiative

BioShield project

BioWatch program

Covert

Dual-use Research of Concern

Hazardous Materials Response Unit (HMRU)

Laboratory Response Network

Covert Attack

Silent releases of a biological agent into a population, which later would correspond to many patients presenting to clinics and hospital emergency departments with a similar clinical syndrome.

In this setting, syndromic surveillance is of paramount importance.

Indicators of Bioterrorist Attack

Large number of cases appearing at the same time, particularly in a discrete population

Many cases of a rare disease or those that fall within HHS Category A or B

More severe cases than typical for a given disease

Disease related to unusual route of exposure (anthrax & inhalation)

Disease that is unusual in a given place or is out of season

Multiple simultaneous outbreaks of the same disease or different diseases

Unusual disease strains or uncommon antibiotic resistance to an organism

Overt Attack

The release of a biological agent with corresponding notification of the release by the perpetrator.

Local fire, law enforcement, and emergency management would arrive on the scene within a few minutes to manage the incident.

If an isolated incident, Federal and state agencies would join local authorities within a few hours to take charge of the scene

Critical Thinking

The 2001 Amerithrax incident was both covert and overt. Covertly, anthrax spores were sent to the AMI building in Boca Raton, Florida, without obvious notification that the act had taken place. The incident led to two cases of inhalation anthrax. The letters sent to government officials and media moguls contained a note that informed the victims that they had been attacked with “anthrax.” Why did the perpetrator act first covertly and then overtly about a week later?

Mitigation

Establishing Policy and Oversight

The Australia Group

Project BioShield

National Science Advisory Board for Biosecurity

The Australia Group

Formed in 1985 by the government of Australia as an informal body aimed at reducing the proliferation of chemical and biological weapons.

Strives to support the objectives of the Biological and Toxin Weapons Convention (BWC), which has been in force since 1975.

Group’s main objective has been to enhance the effectiveness of national export licensing measures for specific chemical and biological agents.

Established export controls, which have been modified over the years to address emerging threats and challenges.

Project BioShield

Secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics.

Authorized $5.6 billion in funding over 10 years for the advanced development and purchase of priority medical countermeasures.

"Special Reserve Fund" was provided in the FY2004 Department of Homeland Security Appropriations Act and becomes available to the Secretary of Health and Human Services (HHS) for procurements following interagency and White House approval.

The Office of Public Health Emergency Countermeasures (OPHEMC) has authority for all procurement activities for Project BioShield.

Acquisitions under Project BioShield are restricted to products in development that are potentially licensable within 8 years from the time of contract award

Created by HHS in 2005

A critical component of a set of federal initiatives to promote biosecurity in life science research

Mission is to provide advice, guidance and leadership regarding biological research that has the potential for misuse and could pose a biologic threat to public health or national security

“dual use research of concern” - research that can be reasonably anticipated to “provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health, agriculture, plants, animals, the environment, or materiel”. 

Proposed a series of experimental outcomes that should be given special consideration for their “dual use” potential

Preparedness

Mass Prophylaxis Caches

Strategic National Stockpile

BioWatch

BioSense

Cities Readiness Initiative

Prophylaxis

Medical care or measures provided to individuals to prevent or protect them from disease

This medical care or protective measure may be performed to entire populations or large sectors considered to be at risk

When this becomes the objective, the campaign or program may be referred to as mass prophylaxis.

Measures include dispensing medications or implementing vaccination

Effective public health response to a large-scale outbreak hinges on the ability to recognize the outbreak, to mobilize supplies of needed materials to affected populations in a timely manner, and to provide ongoing medical care for affected individual

Strategic National Stockpile

CDC maintains the SNS and provides technical assistance on dispensing operations to local public health and emergency management planners throughout the United States

Not designed to supplant comprehensive local planning and operations for mass prophylaxis campaigns either

The ready availability of drugs and vaccines may limit the response capacity to a serious outbreak.

Composed of a number of ready-to-deploy push packs containing medical supplies to treat thousands of patients affected by CDC Category A agents.

Predesignated pharmaceutical supply caches and production arrangements, Vendor Managed Inventory (VMI), may be used for large-scale ongoing prophylaxis and/or vaccination campaigns

States, some large municipalities and a few medical facilities across the United States have developed smaller stockpiles and secure supply chains for critical antibiotics and medical material for use in an outbreak

Images courtesy of CDC

BioWatch

An early warning system for aerosolized biological agents initiated by the Department of Homeland Security.

With early detection and medical treatment, people exposed to a biological agent have a much greater chance of recovery and the consequences of such an attack can be mitigated.

Using a network of cabinets or stations, BioWatch collectors gather samples of airborne particles into a filter system.

Each day, filters are then collected manually by a technician and taken to a CDC Laboratory Response Network (LRN) facility for processing.

When sensor filters are examined, they are tested for five specific organisms.

Bacillus anthracis (anthrax)

Burkholderia mallei (glanders)

B. pseudomallei (melioidosis)

Yersinia pestis (plague)

Variola major and V. minor (smallpox virus)

Francisella tularensis (tularemia)

Image courtesy of Los Alamos National Laboratory website

BioWatch Cabinet

Critical Thinking

On September 25, 2005, low levels of Francisella tularensis (tularemia) were detected on BioWatch filters in and around the Washington, D.C., area. These positive results came one day after a war protest took place on the Capitol Mall. Department of Homeland Security officials first suspected a problem when six sensors used in the BioWatch biological agent surveillance system collected air samples that indicated tularemia might have been present on the Mall. Subsequent testing at the CDC confirmed that there were low levels of tularemia bacteria on the Mall. However, those results were not considered entirely definitive under BioWatch standards, so DHS officials did not inform local public health officials in Washington for several days to avoid a public panic. In fact, it was not until September 30 that local health officials and the public were told to watch out for symptoms of the disease, which include chills, fever, headache, muscle aches, and pneumonia. Department of Homeland Security officials announced nearly a week later that the bacteria was naturally occurring and posed no health threat (Francis, 2006). Two questions come to mind when reading this brief. First, why did it take federal government officials so long to notify local government agencies of a potential public health threat? After all, BioWatch is a system that stands for early warning and detection. Second, whenever we look for a problem, we will eventually find it, but we are looking for things that occur naturally. So, how do we sort out background levels of these natural pathogenic agents from something that truly poses a threat? The technologies being employed to detect these agents merely tell us of their existence, they do not necessarily tell us that they are viable. Diagnostic methods based on an organism’s genetic structure do not yield results equivocal to that samples ability to infect a host.

BioSense

A web-based software application designed to collect nation-wide public health data and disseminate that information to public health officials to increase situational awareness for a possible biological event.

Gathers real-time disease occurrence data from medical treatment facilities and then compares that data to historical data in order to identify trends or peaks in disease occurrence.

Aberrations of disease occurrence data may be the first indication of a potential biological terrorism incident

Developed to enable early detection and localization of possible bioterror attacks or other significant outbreak.

Goals and objectives of BioSense are to:

provide the standards, infrastructure, and data acquisition for early detection; enable near real-time reporting, analytic evaluation and implementation

provide early event detection support for state and local public health officials

An episode or spike in influenza like illnesses (ILI) during the summer may be indicative of a biological incident (pandemic influenza, plague).

Images courtesy of CDC

Cities Readiness Initiative

Created by the Department of Health and Human Services under the CDC’s Public Health Emergency Preparedness Project

Intent is to develop an increased capacity to respond to biological outbreaks and radiological incidents through the development of a Strategic National Stockpile (SNS) and a system of disseminating the SNS in the case of an emergency which includes increased planning and cooperation between all levels of government

The CRI is designed to allow for dissemination of medications to the effected population within 24-48 hours of the incident’s onset

Response and Recovery

Laboratory Response Network (LRN)

Sentinel Laboratories

Reference Laboratories

National Laboratories

FBI Hazardous Materials Response Units

National Guard WMD Civil Support Teams

A Note to Responders

In July, 2002 the Department of Health and Human Services issued the following advisory:

The U.S. Department of Health and Human Services at this time recommends against use by first responders of hand-held assays to evaluate and respond to an incident involving unknown powders suspected to be anthrax or other biological agents.

That statement has not been retracted (February, 2008).

LRN

Formed in 1999

CDC partnered with the Association of Public Health Laboratories and the Federal Bureau of Investigation

A collective body of knowledge and infrastructure needed to:

facilitate cooperation in the event of an act of terrorism or other public health emergency

enable rapid identification of a biological agent.

Has two major components:

a well-developed network of public health laboratories dealing with biological agents (Bio-LRN)

a smaller network of public health laboratories dealing with chemical agents.

A national network of approximately 150 laboratories.

Image courtesy of CDC

Sentinel Laboratories

Are the most numerous in the LRN

Made up of private and hospital laboratories that routinely process patient tests

May be the laboratories to first test or recognize a suspect organism

Conduct tests to “rule out” less harmful organisms

Refer samples to a reference laboratory, if they cannot rule out that the sample is a bioterror agent

Image courtesy of CDC

Reference Laboratories

Have specialized equipment and trained personnel

Perform tests to detect and confirm the presence of a bioterror agent

Are capable of producing conclusive, confirmatory results

Include more than 100 local, state, and federal laboratories

National Laboratories

Include CDC, the U.S. Army Medical Research Institute for Infectious Diseases in Maryland, and the Naval Medical Research Center, also in Maryland.

Perform highly specialized testing to identify specific disease strains and other characteristics of an investigated agent.

Test certain highly infectious agents that require special handling.

LRN Locations

Image courtesy of CDC

LRN at Work

Discussion Questions

How does the comprehensive emergency management model relate to countering the threat of biothreat agents?

Explain the process for getting samples to the LRN.

What’s wrong with performing rapid tests in the field for the detection of biothreat pathogens?

An act of bioterrorism involving pneumonic plague occurs in your town. Imagine how the situation would unfold:

How would it be recognized?

What agencies in your local community would respond?

What assets at the regional, state and federal level could you call upon to lend assistance?

Who would be the Incident Commander?

Chapter Summary

Nationals programs and assets are aimed at providing support for all four phases of the emergency management model

Mitigation comes from establishing Policy and Oversight

Preparedness comes from establishing plans and networks for massing limited response capabilities

Response and recovery comes from a flexible and highly sophisticated network of laboratories operating under common guidelines and standardized protocols to provide unparalleled detection and diagnostic capabilities

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