Release Date: October 18, 2011
Good morning Chairman Lieberman, Ranking Member Collins, and distinguish= ed Members of the Committee. It is an honor to appear before you today to discuss the state of U.S biodefense ten years after letters containing B= acillus anthracis or “anthrax” killed five people and sickened seventeen others and to report on the biodefense portfolio within the Department of Homeland Security’s (DHS) Science and Technology Directorate (S&T). In the decade since the Amerithrax incident th= ere have been significant gains in the country’s ability to detect, respo= nd to and recover from a deliberate bioattack or a natural epidemic of infecti= ous disease.
Designing and implementing a viable biodefense is a complex
undertaking.
Since its creation in 2002, the Department of Homeland Security’s
Science and Technology Directorate (DHS S&T) has made many contribution=
s to
DHS S&T staff have been highly active participants and leaders in
numerous, ongoing Federal Interagency efforts to advance
While there are still important challenges ahead of us, these extensive efforts have resulted in a government and citizenry considerably more prepa= red to respond to and recover from a biological attack than we were a decade ago. DHS S&T has been an important part of this progress. Building upon the work started in the national labs and other federal agenc= ies, S&T has crafted a portfolio that addresses the full continuum of the threat. My testimony will provide an overview of the bioterror threat= and DHS S&T’s biodefense work.
Ten years after anthrax was mailed to members of the U.S. Congress and to media organizations, dozens of policy, intelligence, and technical reports = have affirmed the viability of terrorist groups using biological weapons to cause death, suffering, and socio-economic disruption on a calamitous scale. = ; In 2008, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism stated that it, “…is more likely th= an not that a weapon of mass destruction will be used in a terrorist attack so= mewhere in the world by the end of 2013.” S&T has worked diligently= to increase understanding of the full spectrum of potential threats and their consequences.
More than a decade ago, the Defense Science Board affirmed that, “there are no technical barriers to a large-scale bioattack.”2 We are living in the midst of a biotechnology revolution where the knowledge and tools needed to acquire and disseminate a biological weapon are increasingly accessible. It is possible today to manipulate pathogens’ characteristics (e.g. virulence, antibiotic resistance), a= nd even to synthesize viruses from scratch. These procedures will inexor= ably become simpler and more available across the globe as technology continues = to mature. Thankfully, the combination of technical expertise required and the restrictions limiting the acquisition of the materials necessary for produc= tion still make this a challenging task.
Even small-scale attacks could be highly lethal and disruptive, and as h= as been noted, there is a real possibility of a campaign of bioattacks on mult= iple targets (the “reload” phenomenon) – because these weapons= are self-replicating organisms. Moreover, it is not necessary for a nation-state to maintain a large stockpile of bioweapons to pose a signific= ant asymmetric threat as the development of a significant offensive bioattack capability could occur within weeks or months.
Understanding the biological threat and the relative risk posed by biological agents is a fundamental need for any biodefense capability. Homeland Security Presidential Directive 10: Biodefense for the 21st Century, DHS S&T has the responsibility to conduct the Biological Terro= rism Risk Assessment (BTRA) every two years. The BTRA has been developed in partnership with experts in the law enforcement and intelligence communitie= s, along with input from the scientific, medical, and public health communitie= s, and serves as a starting point for biodefense investment priorities. = ;
The BTRA is a comprehensive, strategic-level assessment designed to 1) a= id in identifying and prioritizing credible, high impact threats, 2) aid in identifying and prioritizing vulnerabilities and knowledge gaps, and 3) pro= vide a systematic, science-based, common framework for “what if” analyses. At its core, the BTRA is a model. It does not predict= the future, but provides a way to think logically, using common assumptions, ab= out more and less likely possible futures. The BTRA approach encompasses a wide variety of possible attack scenarios to ensure that the assessment outcomes are comprehensive. Consider the scope of the 2010 study which examined:
The end result is millions of enumerated scenarios of what is possible in bioterrorism. To date, S&T has conducted BTRAs in 2006, 2008 and 2010. Additionally, S&T conducts companion analyses such as= the Chemical Terrorism Risk Assessments (conducted in 2008 and 2010), the Radiological and Nuclear Terrorism Risk Assessment (conducted in 2010) and = the Integrated Terrorism Risk Assessments (conducted in 2008 and 2010). T= hese risk assessments are used by other Federal departments and agencies to guide their CBRN response planning.
The strength of the BTRA is due in large part to the work conducted by t= he National Biological Threat Characterization Center (NBTCC). This uniq= ue, national-level S&T asset was created by DHS in 2004 as part of the NBAC= C to address gaps in our knowledge related to high priority biological threat ag= ents and to help support decisions regarding biodefense resource prioritization. The NBTCC performs scientific experiments to address = the critical knowledge gaps related to acquisition, production, and disseminati= on in order to ensure an effective knowledge base for critical decision making= in biological defense.
The most significant utilization of the BTRA is its role in providing ri=
sk
input in shaping the multi-million dollar MCM investment decisions of the
HHS. The Project BioShield Act of 2004 outlines the multi-step process
utilized by DHS and HHS to ensure that the nation’s MCM research, dev=
elopment,
and acquisition activities are grounded in a risk-based process. In
summary, as identified in the BTRA, the bio-agents which present the greate=
st
risk to the
To date, DHS has issued 11 MTDs for biological age= nts, two MTDs for classes of chemical agents, one MTD for radiological materials, and one MTD for nuclear detonation effects. The MTD is a statutory requirement for procurements using BioShield funds; however the issuance of= an MTD does not guarantee that the government will pursue countermeasures agai= nst that agent. If an MCM is sought, DHS has a statutory responsibility alongside HHS in recommending to the Office of Management and Budget to rel= ease the BioShield Special Reserve Funds.
Early indication of a biological attack is very challenging due to the dual-use nature of the required knowledge and materials and the small size = of operational footprint necessary to produce the agents making detection difficult. In the absence of pre-attack interdiction, it is crucial t= hat the U.S. has the means to detect and mitigate an attack either through large-scale technology programs such as BioWatch or through enhancing the capabilities of First Responders and Public Health professionals by, for example, the creation of better methods for detecting bioagents in the fiel= d or conducting reliable lab analyses. Other S&T investments also work= to create sensors which could automatically initiate protective actions (e.g. altering a building’s airflow patterns) as well as develop rapid diagnostic capabilities as both a means of detection and a critical element= to help mitigate an attack by guiding our response.
Standard Field Protocol for Rapid Resolution of Suspicious White Powd= ers: Since 2001, responses to incidents involving suspicious “white powders” have impacted the First Responder community; these events are often costly and disruptive. S&T has invested in tools to both re= duce the cost and impacts of these responses and to standardize the responses to ensure that any real events are optimally handled.
S&T has led an interagency effort with the Center for Disease Control and Prevention (CDC), Federal Bureau of Investigation (FBI), EPA and Nation= al Institute of Standards and Technology to develop multiple standards on bulk= and swab sample collection of suspected biothreat powders and operational guidelines for initial response to a suspected biothreat agent to ensure th= at the procedures and sampling strategies used are effective and support confirmation and prosecution if a real incident were to occur. These standards were published by the American Society for Testing and Materials,= an international standards organization in 2010. These standards are increasingly being adopted by First Responders and are already in use by multiple states and the FBI.
Rapid Portable BioDetector for First Responders: S&T is developing technology intended to evaluate suspicious powders in the field = in a matter of minutes. Although laboratory confirmation is the only way to reliably determine the presence of a biological organism, this technology w= ill help emergency responders assess a threat.
Detect to Protect (D2P): Current biodetection systems are designe= d to “detect to treat”. Studies done by S&T of bioattacks and chemical attacks on subways and by DOD at the Pentagon show that bio-aeroso= ls can spread throughout a subway system or building very quickly. These investigations highlight the need for very rapid, tight connections between initial detection of a release and response actions. Such “detect to protect” systems are challenging to build, because they must balance = the need for a fast detection against the fact that fast detection sensors are prone to false alarms.
To address these difficulties, S&T is pursuing a multi-tiered bio-ae= rosol DP2 program for sensing a bioattack within metro systems, airports, buildin= gs, and stadia. Low cost, rapid “trigger” sensors when tripped immediately initiate “behind the scenes” protective actions to = slow spread of an agent, such as changing air flows within a space while turning= on a confirmation sensor. The confirmation sensors are high confidence detection technologies provide the high confidence analysis necessary to support high-impact actions such as building evacuations or warnings to she= lter in place or alerting of public health officials. Such a multi-tiered detection approach not only helps reduce the spread of the age= nt and the extent of human exposure in near-real time, but could also reduce system costs by decreasing the required number of expensive confirmer senso= rs. S&T is currently conducting operational tests and evaluations on the D2P system within the Boston Metro (Massachusetts Bay Transportation Authority – MBTA).
Assay development and standards: A key element of any successful = detection or diagnostic tool is the assay which provides the ability to discern the unique molecular signatures of an agent. DHS S&T has a hig= hly robust bioassay program that is focused on the development of improved assa= ys as well as standards and test methodologies to foster confidence in deployed detection systems. Some of the aspects of assay developme= nt currently ongoing include:
DHS S&T has led the interagency in the development of standards that guide the appropriate levels of sensitivity and specificity needed for assa= ys deployed in various environments. There are generally two levels of standards for assays, one for use by First Responders when making decisions= to evacuate buildings or close off streets, and another used by the CDC to dec= lare medical emergencies and issue medications. Working with the Associati= on of Analytical Communities and their Stakeholder Panel on Agent Detection As= says S&T developed the consensus standards for Public Safety Actionable Assa= ys (PSAA) to support the testing and validation of commercial technologies that might be used by the First Responders in the field. A much high= er standard of performance is needed for those assays designed to be used by t= he CDC LRN when making high-impact public health decisions such as the distribution of antibiotics. At the request of the White House in Fis= cal Year 2008, S&T has been working with our Interagency partners including= the CDC, DoD, State and Local public health authorities to develop the Federal Standards for Assay Performance and Equivalency (FSAPE) which specifically = aims to ensure a common standard for sensitivity and specificity for assays that will be used to make public health actionable decisions. This process= is nearing completion and has already received the buy-in from multiple stakeholders in the public health community.
Any bio-detection architecture needs to be a coordinated effort leveragi= ng multiple federal laboratories for sample analysis and public health decisions. S&T led in the establishment of the Integrated Consort= ium of Laboratory Networks (ICLN) to serve this purpose The ICLN coordina= tes a network of laboratories that, in the case of an act of bioterrorism, will= be accountable for provision of timely, credible, and interpretable data in support of surveillance, early detection, and effective consequence management. By coordinating Federal labs, the ICLN can take a risk-ba= sed approach to events and minimize capability gaps of individual labs.
Advanced Biodiagnostics: Currently, there= are no approved, point-of-care clinical diagnostic tests that physicians could = use to determine if an individual is infected with a bioterror threat agent. The traditional diagnostic approach involves blood culture anal= ysis which requires one or more days to deliver results. In situations where outcomes depend on rapid treatment after exposure, or in mass casualty situations where scarce resources must be deployed intelligently, the abili= ty to rapidly identify infected victims is a strategic necessity. DHS S&T, in partnership with the DoD Defense Threat Reduction Agency, the National Labs, and the CDC, are pursuing an effort to develop a broad-spect= rum diagnostic with the potential to identify exposure to biological agents pri= or to the onset of symptoms.
Rapid Test for Antibiotic Susceptibility: DHS S&T, in collaboration with the CDC, has developed a rapid assay to determine antibiotic susceptibility for B. anthracis and Y. pesti= s. These rapid assays reduce the timeline for answers by 50% compared to the g= old standard conventional susceptibility assay. Given that some of the biothreat agents possess very short incubation periods for disease onset and are coup= led with high mortality rates after symptomology, the need for rapid antimicrob= ial susceptibility assays is critical.
Much of our national biodefense investment focuses on detection of and medical treatment for a biological attack. However, it is equally essential to develop capabilities, protocols and technologies that support rapid attribution to identify the source of the attack as well as help an impacted area quickly and appropriately respond to and recover from an atta= ck
Bioattack response and recovery operations are complex and much work rem= ains to be done in this arena. The Environmental Protection Agency (EPA) h= as the lead in the area of environmental restoration but it is widely acknowle= dged that the EPA budget is too small to support a robust program. DHS S&T, as well as DoD, have made strategic investments in this area and several of the efforts have yielded valuable insights that I would like to bring to your attention.
Responding to an Attack: S&T’s biodef= ense investments include the development of guidance and technologies to diminish uncertainty and enhance data-driven decisions in the hours and days after an epidemic is first detected. Immediately following a bioattack there w= ill be a critical need for “situational awareness” - information leaders will need to guide the response - but reliable data will be hard to obtain quickly with current systems, technologies, biosurveillance capaciti= es and communication flows. During the initial days following a covert attack, there is likely to be significant uncertainty regarding whether the observed epidemic is natural or deliberate, the scale of the attack, where = the attack occurred; who was exposed; whether the bioagent is susceptible to sp= ecific antibiotics, whether and where the environment is contaminated, whether and where there might be additional attacks, etc.
Viable Particle Capture Device: This program is developing a low-cost deployable device that continuously samples the air a= nd collects and stores any airborne particles or pathogens in a manner that ke= eps them viable for laboratory analysis. Because of the low-cost nature of the device it can be widely deployed throughout a city as an augmentation of the BioWatch network and after an attack has been detected the additional sample points would greatly increase the knowledge of where an agent had be= en dispersed. Even more importantly, the device ensures that any agent collected during an attack is viable allowing laboratories to identify it a= nd test it for virulence and anti-biotic resistance.
Multi-Application Multiplex Technology Platform (MAMTP): The testing systems currently in use at the Laboratory Response Network labs th= at process the BioWatch samples were designed around the public health mission= and are not optimized to support a Biodefense surveillance system in terms of t= he number of agents that can be tested and throughput. The MAMTP is a technology platform that will be able to perform up to 100 tests or detect = 100 targets simultaneously within a single sample. The platform will use a standardized cartridge system to reduce costs and aid in surge capacity whi= ch will be needed to handle the thousands of samples that will be collected af= ter an attack in an effort to identify where the agent has spread.
Anthrax Re-aerosolization: A significant question with regard to anthrax attacks is whether the anthrax bacteria, which are unusual as they = are protected by an extremely hardy spore coat that makes it resistant to environmental degradation, could become “re-aerosolized” and continue to pose a health threat once it is deposited on surfaces following= the initial attack. The answer has significant implications for remediati= on strategies, but existing data is limited and contradictory. DHS S&= ;T, in partnership with DoD, EPA and the national labs, is conducting studies to understand this problem within urban areas. These studies will address gaps in our understanding and will inform key policy decisions for evacuati= on vs. shelter-in-place, distribution of medical countermeasures, clean-up, and re-occupancy.
Recovery from an Attack: It is essential that the Nation ha= ve the capability to rapidly restore buildings, public infrastructure and crit= ical utilities to full-function after an attack. This need is especially pertine= nt in the context of anthrax, because of the long-lived nature of this microbe, but understanding the extent, duration and consequences of post-attack contamination needs to be further explored.
Interagency Biological Restoration Demonstration (IBRD): Th= is interagency effort included partnerships with state and local governments in the Seattle Urban Area and was co-funded with the DoD’s Defense Threat Reduction Agency. The IBRD program developed a Seattle Region Plan for determining approaches for response and restoration activities, which serve= d as the foundation for the development of the “Interim Consequence Manage= ment Guidance for a Wide-Area Biological Attack” document that can be used= by other cities.
Mass Transit System Biological and Chemical Dispersion Studies: = ;S&T studied releases of simulated biological and chemical agents in the Boston subway and DC metro systems to determine how material would move, disperse, deposit and could be mitigated through fast acting detection systems and changes to the airflow control systems. This effort is being continued through a partnership with the Washington Area Metropolitan Transit Authori= ty to conduct simulated attacks on the Metro system to develop response protoc= ols and above-ground countermeasure requirements.
Bioforensics: In 2001, there existed numerous challenges associated with microbial forensics investigative capabilities. Among them were no biocontainment lab, staff or equipment singly dedicated to mic= robial forensic analysis and limited evidence handling processes peer-reviewed analytical methodologies, or quality guidelines. Today, S&T owns and operates a national asset for biological forensics and attribution, the National Bioforensics Analysis Center (NBFAC), which is part of NBACC, was established by HSPD10 as “the lead Federal facility to conduct and facilitate the technical forensic analysis and interpretation of materials recovered following a biological attack in support of the appropriate lead = Federal agency.” S&T owns and operates this national asset for biological forensics and attribution.
The NBFAC provides 24/7 support for biocrime and bioterror investigations for the Federal Bureau of Investigation (FBI), DHS Customs and Border Protections , the U.S. Secret Service and other government agencies w= ith dedicated staff, equipment and biocontainment laboratories designed specifically for bioforensic analysis. The NBFAC has developed sensit= ive and specific assay capabilities for more than 60 bacterial, viral and toxin agents and has processed over 8,000 samples and completed 137 cases in supp= ort of Federal Law Enforcement agencies. The NBFAC also maintains a Bioforensic Reference Repository collection of geographically and temporally diverse biological agents to support comparative forensic analyses. T= he NBFAC trains FBI examiners to safely handle biologically contaminated evide= nce and supports traditional forensic exams. As a result of NBFAC, the U.= S. can now do in days to weeks what previously required months.
S&T was charged by Congress to design and build the National Bio- and Agro-defense Facility (NBAF), a laboratory with the capac= ity to perform research and development work on large animals at the highest (BSL-4) laboratory biosafety containment levels. After an extensive t= hree year competition and evaluation, Manhattan, Kansas was selected as the site= for NBAF. Since 2009, Congress has appropriated $154 million for NBAF des= ign, site preparation and construction. The state of Kansas has pledged to contribute $110 million towards construction costs and has donated land for= the site. The total remaining cost of NBAF construction was estimated as = of 2011 to be $874 million. Construction of this facility, which is an essential part of the US biodefense infrastructure, is dependent upon conti= nued support from Congress.
For more than 50 years, the Plum Island Animal Disease Center (PIADC) has served as the primary US laboratory facility for conduct= ing vital livestock disease research. Despite its many successes, the age= of PIADC facilities, its limited capacity restricts research and is imped= ing the development of needed countermeasures. PIADC has no capacity to d= o research at the Biosafety Level 4 (BSL-4), the highest bio-safety level, which is essential to combating the most dangerous animal disease threats. Currently, the U.S. must rely on partnerships with large animal BSL-4 labs in Australia and Canada. In the event of a bioattack on agricult= ure, or an attack employing a zoonotic disease, the U.S. would be unable to do t= he research needed for response. PIADC has no surge capacity for response to wide-scale events and its island location off the coast of New = York limits operations in adverse weather conditions. Failure to build the NBAF will not only place the security of US agriculture in jeopardy, but wo= uld seriously impair U.S. scientific eminence in this important field.
Biodefense is just one of the many areas addressed by S&T’s diverse portfolio. To ensure that individual R&D projects are mee= ting the goals established by our partners in the operating components and the broader homeland security enterprise (HSE), S&T has committed to an ann= ual review of our portfolio of basic and applied R&D and all proposed “new start” projects. The review process consists of writ= ten materials, an oral presentation by the project manager, and careful analysi= s of the project’s likely impact and feasibility (or “riskiness̶= 1;) as judged against specific metrics determined by S&T with input from the operating components. These metrics are designed to address elements essential to programmatic success in the context of the DHS’s QHSR missions, namely:
A review panel of S&T leaders, the DHS Component representatives, and outside experts evaluates and rates each project. = ; By measuring all of our projects against this framework, we will provide a transparent and “shareable” view of all R&D within S&T; enable more strategic, longer-term budget decisions; ensure efficient deliv= ery to the component or end user; and nurture effective communication throughout the process. This particular review model has been used by both Feder= al and private R&D organizations, including the prize-winning Army Engineering, Research and Development Laboratory. Review is key to en= sure that S&T remains focused on the highest priority challenges in biodefen= se and ensuring that our work is complementary, not duplicative, of other agencies.
The design and implementation of a robust, cohesiv= e, and cost-effective biodefense system will be the work of a generation. Despite the significant gains made over the past decade, much work remains = to be done to deal with today’s – and tomorrow’s – challenges. As President Obama has noted, true biodefense against both deliberate and natural epidemics of infectious disease must be an internati= onal endeavor.
In the coming years, the DHS S&T Directorate intends to focus its resources on developing capacities to detect bioattacks in near-real time in order to enhance protective response actions. There will also likely be cal= ls to improve detection of a wider range of potential threat agents, including genetically altered, synthetic or unanticipated agents, and possibly to ena= ble detection of food and surface contamination. Faster, more detailed and reliable characterization of bioevents to improve situational awareness and inform response will be necessary. We must continue to develop an agi= le approach that accommodates possible epidemics of emerging disease or attacks using unforeseen bioagents or agents not addressed = by stockpiled countermeasures. Inexpensive, real-time, point-of-care diagnostics will be essential to enabling rapid identification and treatmen= t of those at risk from epidemic disease and to containing the spread of contagi= ous disease. Strategies for coping with and stopping bioterror campaigns = must be developed. Mechanisms of international cooperation in dealing with infectious disease outbreaks and collaborative approaches to financing and refining needed biodefense technologies and countermeasures must evolve.
It is critical to understand that bioscience is in a state of revolution. Advances in our understanding of living systems and our technological ability to manipulate these systems are proceeding globally at a breathtaki= ng pace. The biothreat landscape of the next ten years will not resemble today’s. The technologies, tools and capabilities being develop= ed need to be viewed not just through the lens of today’s threat agent l= ist, but from the perspective of capabilities available to our adversaries in the future.
Thank you for the opportunity to appear before you today. I am happy to answer any questions you might have.
This page was last reviewed/modified on October 18, 2011.