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Running Header: SHORT FALLS IN BIOLOGICAL DEFENSE

Department of Homeland Security Short falls in Biological defense

MSA 570 Homeland Security Defense & Administration

13 May 2013

Steve McNally

Southwestern College Professional Studies

Abstract
Concern for the use biological agents by terrorist has risen in importance over the past decade. The issue took center stage in 2001 when, shortly after the 9/11 attack, anthrax was distributed through the postal service. During a time of elevated tensions the Department of Homeland Security (DHS), undertook efforts to protect the nation. Millions of dollars went out to develop and obtain the capabilities needed to deal with threats that endangered the United States.

Result needed to be rapid and 80% solutions appear adequate enough to meet the national needs. Yet as the dusk settle on the emotional high and testing of this apparatus was conducted, the issues became apparent. Detection and countermeasures were among the areas this race to produce fell short. Sensors that have high false alarm are costing the taxpayers needlessly and demising public confidence. The DHS’s effort has been to obtain massive quantities instead of a wider variety of countermeasures.

Now after over a decade of effort and 4 billion dollars, the eyes are looking at what we got for our money. With spending become more scrutinized the effort need take on a more solid direction. This needs to be the increase in the different types of vaccines and medicines we have to respond a biological attack. Also expand the capabilities of sensing the presence of biological agents, while reducing the false alarm rate.

Introduction

Leading up to the event of September 11, 2001, the idea of rogue states and terrorist attacking that United States (U.S.) was only in the movies. The fear of such an event had only been felt in the U.S. when the Imperial Japanese Navy struck the naval base at Pearl Harbor on December 7 1941. With the passing of time the fear created from being attacked passed and were lost to history. However, as history shows us, each generation will have to deal with manmade disaster. Over the past decades it would appear that the quantity of violence and the lethality appears to be increasing.

The attack on the world trade center in 1993, though destructive, it did not create national hysteria. However, less than a decade later the September 11th 2001, the airplane attacks and the destruction that was achieved did create the fear. This fear was compounded shortly after with the release of the biological agent anthrax (Johnston, 2007). From these compounded events the Department of Homeland Security (DHS) was finally established.

This newly formed cabinet level office, among the vast efforts of the DHS is the effort to prevent and respond to the terrorist use of chemical and biological agents. Since this effort has been undertaken, billions of dollars have been spent to guard against the use of these dangerous pathogens. This endeavor is not the sole undertaking of the DHS but multiple federal agencies. The point could be argued that the effort has been successful as there has not been a mass attack using biological agents. However this is not a valid assumption to the state of preparedness for the nation. The only valid test will come when either a large scale biological agents is used against the U.S.
Background

Though President Bush created the Department of Homeland Security (DHS) in the mist of these events the idea of such an agency was not new. The origins for a collective effort for coordination and cooperation of multiple government departments have been around over a decade prior. The Presidential Decision Directive /NSC-39 enacted under President Clinton outline roles and responsibilities for counter terrorism efforts. The highest priority identified involves prevent, detecting and responding to terrorist use of weapons or material that can cause mass destruction (Presidential Decision Directive/NCS-39, 1995). The US intelligence community is directed to carry out studies, examining the types of genetically engineered ‘bugs’ terrorists could be working on to mount an attack.”

Fast forward a decade after the formation of the DHS and we see the culmination of these efforts. DHS merged 22 federal agencies under the one department. This brought a vast amount of federal resources together to safeguard the nation from a terrorist event, with the worst possible event being the use of Nuclear, Biological or Chemical (NBC) weapons. This creates fear of the use of nuclear devices which bring on visions of the aftermath of Nagasaki and Hiroshima form WWII. Also the graphic images of the WW I battlefields following the use of chemical agents or hospital wards filled with a multitude of patients suffering from biological pathogens.

Building a strategy to protect the United States from the use of such material must be comprehensive and realistic. The plan need must present confidence and maintain the public’s trusts. Additionally, the effort must address more than the delivery of weaponized hazardous agents. The potential for a terrorist organization to acquire, transport, store and employ such material is relatively low in comparison more practical effort. Though not as powerful as the military grade forms, many such materials are used throughout industrial and medical operations. The use of which would not have the potency of state sponsored material, but none the less would still cause harm and create panic among the population.


Organizational Requirement

The effort to safeguard the United States from the intentional use of chemical and biological agents is complicated and confusing. Multiple agencies are conducting independent and overlapping efforts with minor collaboration. The current administrations strategy for combating the use of weapons with ability to create mass destruction use, is based on counter proliferation strategy developed in the 1990s which centers on military grade weapons (Mauroni, 2010). Under this strategy the Department of Defense (DoD) was the lead agency until the National Security Council (NSC) elevated the consequence management effort as an independent line of effort and Office of Homeland Security assumed the role of domestic prevention and response.

Under the effort of the Bush administration to win the war on terror, the directive of denying terrorist organization access to biological agents was addressed. The National Security Strategy for countering terrorism highlighted six key areas with regards to WMD (National Security Strategy, 2006). The DHS efforts that have been taken are to detect and respond. President Obama revealed the National Security Strategy in 2010, where in the issue of “counter biological threats” was addressed as a line of effort that must be pursued (White House, 2010). The DHS echoed this objective in the Quadrennial Homeland Security Review Report (QHSRR), also in 2010 (Department of Homeland Security, 2010).

Under the five stated missions of the QHSRR, there is direct relevance to the effort of the use by terrorist of biological agents. Found in the first mission identified under the title of “Preventing Terrorism and Enhancing Security”, several goals are laid forth. Here in goal 1.2 the DHS has identified the effort of preventing the use of biological agents. The QHSRR states that under this effort a strategic outcome is that “any release of high-consequence biological weapons is detected in time to protect populations at risk from the release.”

Additionally the QHSRR addresses the response efforts should an event occur. Under the fifth mission, “ensuring resilience to disaster”, the DHS works with other government agencies both before and after an incident. Goal 5.2 is to enhance preparedness through enhancing capabilities of public health and mass care.

The ability for a private organization to develop biological agent is far from impossible. With the World Wide Web knowledge of how it can be accomplished is available. The Japanese cult Aum Shynrki was responsible for conducting attacks in Tokyo with chemical agents in 1995. They additionally pursued the developing biological agents such as Q fever, Anthrax, Botulin and Ebolo (Fletcher, 2012).

More recently and closer to home, we have seen incidents of the use of Rican. This is a toxin that is form as a byproduct from extracting the oil from the Castor bean. Because of the ease of production, Rican is often cited as being a suitable weapon for terrorist. However, the use to achieve a mass effect is not practical due to high dose needed to be deadly when it is inhaled or ingested (Baker, 2008). However, the psychological effect of a biological weapon will still be achieved. This is evident in the most recent Rican event in the United States (Weisman, 2013). The lacing of letters with the toxin was able to travel hundreds of miles through the U.S. Postal Service before being detected. Though detected finally in Maryland, how many hands did it pass through and how far could cross contamination have taken the toxin.

Gap in detection effort

The directed effort by the DHS is to prevent and respond to the use of chemical and iological by terrorist. There is the perception that the American tax-payer has of what the DHS is prepared to detect and respond to. With all of the money spent in the research and development they expect to see a return on their investment. However, due to the nature of the effort it does not appear that a quantifiable standard can be established. This is due to the vast number of variables associated with biological agents. This is due to some of these biological pathogens occurring nature in less threatening forms.

The Science and Technology (S&T) directorate is responsible for the development of the new material solutions. Under the directorate is the Science and Technology Chemical and Biological Defense Division (S&T CBD). This element works to understand various aspects of threats from the use of biological and chemical agents. Their efforts include “pre-event assessment, discovery, and interdiction capabilities as well as capabilities for warning, notification, and analysis of incidents” (Chemical and Biological Defense Division, 2013).

Additionally the efforts of the S&T CBD are the “Detect to Protect (D2P)” program. The development of early warning networks is needed to enable a rapid response. The effects of such a system of sensors go beyond the response to the event. The public is able to carry on with their daily activities with some semblance of security, due to confidence in a system designed to detect biological agents. During the event the faster the biological agent is detected the greater the opportunity available to the response and restoration operation. This will equate to saving lives and reduce the overall impact of the event.

During the 2003 state of the union address, President Bush explained to the nation, an effort to protect the people and the homeland from terrorist efforts to use germ warfare commenced (Williams, 2013). This effort was named the “BioWatch program. Under the program the DHS works in concert with the Center for Disease Control (CDC) and other local, state and federal agencies to “detect and respond” to such events. Part of the effort is to use air samplers to filter the air for Anthrax, Small Pox and other potentially deadly biological agents. Once every 24 hours the filters are analyzed to determine if there is a presence of pathogens.

Biological agents are more deadly than chemical due to the smaller quantities need and the diverse DNA (Greenwood, 2007). Among the largest efforts that they have conducted was the testing of biological sensors in the Boston Massachusetts Subway in 2012. (Department of Homeland Security Science and Technology, 2012). This was done to fulfill the requirement for a real world scenario to assess the sensors used to detect a biological agent. This test used killed Bacillus to determine how they would spread throughout a vast underground environment. The test also included an assessment of the latest biological sensors which were designed to as the next generation sensor. When the results are released they sill show how our sensors performed in the most realistic scenario we were able to replicate. Additionally, this test will yield valuable information on the spread of such agents in an underground environment.

This is where the gap lines within the DHS efforts to detect. The expectations of the congress and the public are that after $4 billion dollars and nearly a decade that a reliable system for detecting be established. The implied task has always been to build confidence in the public and that has not occurred. After all the resources that have been expended against this effort, the level of preparedness is lacking. Across the U.S. there are less than thirty cities with biological detectors (Mauroni, 2010). Additionally, the time for determining the detection along with false positives has considerably diminished the confidence of citizens in the effort. Many would argue that exposure for an entire day before notification is too long.

These sensors perceived reliability have been diminished due to the rate of false alarms. There were 56 false alarms that have affected federal agencies up to 2008 (Willman, 2012). Such a rate of false alarms is very expensive and waste time. The idea of “little boy who cried wolf” resonated with many Americans and the confidence in the system is lessened.

The reason for the high rate of false alarms is due to naturally occurring similar organisms that have the properties of the identified pathogens. These near relative’s meat the threshold for notification and send the response efforts into motion. The effort undertaken to confirm and report the false alarm is extensive as evident in the following example.

The DoD commissioned the RAND corporation to conduct a study of the response procedures. The report identified three incidents of biological alarm detection. One occurred in a private business, when the sensor in the mail room of a Falls Church Virginia office complex, which housed several governmental organizations to include the Department of Defense, was activated. The alarm was interpreted falsely as an indication of the presence of Anthrax and the alert went out. The result is for a complete deployment of the hazardous material (HAZMAT) response unit, this preventive action is required for all biological alarms (RAND, 2006). A unified command was established the samples were taken to determine what had set off the alarms. These tests were not able to rule out a biological pathogen. For precautionary efforts the Strategic National Stockpile (SNS) was alerted and provide antibiotic treatments for Anthrax to the workers. The following day the officials discontinued the effort due to being unable to confirm the presence of the Anthrax bacteria at the site.

This illustrates but one of many false alarms that have been plagued the U.S detection efforts. There can be an argument made that such efforts increase the experience of the response elements and the knowledge and interoperability forged during these events will strengthen the overall readiness. However, the truth is that these incidents cost money and resources. Such resources that need to maintained at level of readiness and money that can be used in other areas. Monies are set aside for training and exercises, which are more comprehensive and less intrusive on the public.


Recommendations

Additional research is needed to develop the detection apparatus. The increase in capability needs to decrease the false alarm rate along with expanding the coverage. This does not, at this time need to be the smartest most sophisticated sensor as cost will also factor into the next generation sensors. Conceptually the idea of a network of less sophisticated sensor is one of the greatest efforts that will increase the reliability.

The future efforts will be constrained by price, power consumption rates and maintainability. The efforts are underway to craft the ideal sensor, one that is inexpensive, requires minimal power and is maintainable with minimal effort. Additionally, this next generation will need to have a greater reliability while decreasing the false alarm rate. Currently, the Lincoln Laboratory at the Massachusetts Institute of Technology (MIT) is working such an effort (Norige, Thornton, Schiefelbein & Rudzinski, 2009).

The research is working to build a net of simple sensors that will are linked to encompass an area. The ability to couple the information from multiple individual sensors will allow for more reliability in the detection. Requiring multiple sensors to be tripped before declaring an alarm is more efficient. This is similar to intrusion detection networks where multiple sensors must be activated to confirm there is a breach in security. Additionally, these unsophisticated sensors will be less expensive and smaller. This will decrease the price as well as the power consumption. This new strategy will also provide information on the spread of the threat and allow for predictive analysis of the contaminated areas.


Gap in the response effort

The United State Code (USC) holds the DHS along with the CDC, responsible for maintaining a Strategic National Stockpile (42 USC § 247d–6b). The U.S. Congress established it to resupply local and state level supplies in the event of manmade CBRN event or natural disaster. The USC requires the stockpile(s), “to maintain adequate quantities of, drugs, vaccines and other biological products” which is determined by the Secretary of Health and Human Services (SHHS). Consideration for the appropriate and practicable amounts must take into account when securing and storing such countermeasures. Also concern must be given to the needs of other public health efforts, such as emergency health stock age that will be required in the event of a bioterrorist attack. Lower level response efforts need to have on hand certain variety and quantities for the immediate response.

The types and amount of medicines that will be maintained is directed to DHS in coordination with the SHHS. Assessments will be ongoing to determine current and emerging threats. Specific consideration to “chemical, biological, radiological, and nuclear agents” is directed to determine if they are adequate to affect the security of the nation. Qualified countermeasures for threats with be developed and stockpiled. These countermeasures are defined as products that:

“…diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security”



42 USC § 247d–6a
For countermeasures that are not available, either in quantities or existence the DHS is able to issue a call for development. This can be through the public or private sector to create the needed product. Additionally, the procurement of adequate levels is authorized to be secured. These new products, in the case of an emergency are not required to follow the standard path for approval as other medications (42 USC § 247d–6a). The declaration of an emergency was to allow liability protection to manufacturers for the production of countermeasures, including anthrax vaccine and other countermeasures, for the SNS (Rempfer, 2009). This is not a license to not be prepared nor should the DHS wait until an event to research and develop countermeasures for pathogens that we are not prepared for. The American people expect more from their government and better direction needs to be taken.

There must be a reasonable effort to obtain the vaccines that are not currently available. Among the top twelve biological threats that the DHS has determined to be potentially used, the SNS only maintains countermeasures for two (Muroni, 2009). Relying on the emergency functions is dangerous and against the direct responsibility that the department is charged with. Outside of the emergency activities there are aspects that must be addressed, such variables as the research, development production and storage efforts. These certainly are not fire and forget endeavors and must be addressed to maintain readiness.

Recommendations

Relying on out dated knowledge can have adverse affects on readiness and reliance. During the late 1990s the DoD embarked on an endeavor to protect service members from the exposure to biological agent of Anthrax. There were several issues and attempts to circumvent the normal process for approval of a vaccine (Nass, 2002). Such efforts are detrimental to the process and distracts time and resources from the effort.

The time to invest is now and the DHS must expand the development and procurement of countermeasures for the recovery from a biological attack. The focus should be for the expansion of the research, decrease the quantities of stockade and develop an immunization program for first responder.

Research and development need to be expanded to respond to a greater variety of threats. The adversaries of the nation are always planning for the next event. There activity does not have to be spectacular to effectively achieve the fear they desire. Just the indication that a biological agent being used and the U.S. bio defense efforts were not ready, will create panic and insight an onslaught of questions would be launched at the entire WMD response effort.

Due to the more likely event of the use of homegrown biological agents, the potency can be logically expected to be less than the state developed and weaponized variants. Historical accounts of various organizations have demonstrated the desire for the engaging in improvised attempts to use biological or chemical agents (Rasmussen & Hafez, 2012). Working forward the efforts to research those countermeasures that will have the impact against the additional threats must ensue. Additionally, looking into even the future potential agents should begin before the event occurs.

Research and test will be needed and the development of an immunization effort for first responders must occur. Similar to the anthrax effort, protecting this primary response force must be given a priority. This effort would need to be fully tested and monitored to ensure that the intent will achieve the desired outcome. This effort must face the scrutiny of the various systems in place to ensure the trustworthiness.

Despite the continued assessment that the DHS is directed to do, to determine the current potential threats, research for the next generation biological agents must be undertaken. For years the national strategy for the proliferation of Weapons of Mass Destruction (WMD), has been fixated on the state sponsor military grade agents (Gorman & Crawford, 2008). The need to adjust to smaller less potent threats must be expanded for the future. The additional savings from the reduced quantities of the stockpile would be used to develop countermeasures that we currently are not in possession of.
Conclusion

For over a decade the DHS has been charged with standing watch over the nation. Among the extensive tasks that they have before them is to prevent and respond to the use of biological agents. Strides have been made to increase the nation’s efforts in the issue. Yet the focus has been directed at military grade agents. From the recent history we have seen that the likelihood will be for not agents of this quality but less potent variants.

Cults and extremist groups have demonstrated the desire to use such tools to achieve the state of terror in a population. The Japanese cult, Aum Shinrikyo serves as a beacon for how far these violent extremist groups will pursue their objectives. When we face such organizations that are not bound but the limits of humanity we must be prepared. Our effort must be as driven to ensure that we are ready for when a violent extremist organization is prepared to launch such an attack on the people of the U.S.

The DHS has been chartered with the mission of tackling this effort. They must not only remain vigilant to prevent the use of biological agents but be ready to respond. This requires a continuous assessment of what the current threats that exist and determining if we are prepared. Continual updates in the detection methods will continue with the improvements in technology. Incorporating a network strategy with the sensors will enhance the detection effort and maintain the public’s trust. Expanding the countermeasures we have needs to also be an enduring process. The potential for high quality biological agents is less than those of homemade strands. Changing the strategy to reflect this reality will allow for an increase overall protection of the homeland. The American public deserves the best we can muster to ensure their safety.

References:
Strategic National Stockpile and security countermeasure procurements. 42 USC § 247d–6b

Authority for use of certain procedures regarding qualified countermeasure research and development activities. 42 USC § 247d–6a


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Rempfer, T. (2009). The anthrax vaccine: A dilemma for homeland security. Homeland security affairs , V(2), Retrieved from http://www.hsaj.org/?fullarticle=5.2.3

Weisman N., (2013), Letter mailed to senator tests positive for Rican, The New York Times, Retrieved from: http://www.nytimes.com/2013/04/17/us/politics/toxic-ricin-detected-on-mail-sent-to-senator.html?_r=0

White House. (2010), National Security Strategy, Retrieved from: http://www.whitehouse.gov/sites/default/files/rss_viewer/national_security_strategy.pdf



Willman D., (2012), The biodefender that cries wolf, Los Angeles Times, Retrieved from: http://www.latimes.com/news/nationworld/nation/la-na-biowatch-20120708,0,1751272,full.story




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