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• Ready or Not: Protecting the Public's Health from Diseases, Disasters and Bioterrorism 2019

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  "One lesson from recent events is that emergencies happen. And happen often. From disease outbreaks to natural disasters to man-made crises, the stakes are high: Americans face serious health risks and even death with increasing regularity. Therefore, as a nation, it's critical to ask, 'Are we prepared?' The public health emergencies of the past year--an unusually severe flu season, confounding cases of acute flaccid myelitis, two major hurricanes, and the deadliest fire season in California's history--reinforce the need for every jurisdiction to be vigilant about preparing for emergencies in order to safeguard the public's health. 'The Ready or Not: Protecting the Public's Health from Diseases, Disasters and Bioterrorism' series from Trust for America's Health (TFAH) has tracked public health emergency preparedness in the United States since 2003. The series has documented significant progress in the nation's level of preparedness as well as those areas still in need of improvement."

  Trust for America's Health

  2019-02
• Congressional Budget Office Cost Estimate: H.R. 6378: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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  "H.R. 6378 would authorize funding for certain activities to support national preparedness for public health emergencies (PHEs) and widespread medical emergencies, including acts of bioterrorism. Using information from affected federal agencies, CBO [Congressional Budget Office] estimates that implementing the act would cost about $11.9 billion over the 2019-2023 period, assuming appropriation of the authorized amounts. The Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (Public Law 115-245), included funding of $3.1 billion in fiscal year 2019 for similar activities. H.R. 6378 also would allow medical professionals in the National Disaster Medical System (NDMS) to participate in the Public Safety Officers' Benefits (PSOB) Program. CBO estimates that provision would increase direct spending by less than $500,000 over the 2019-2028 period. Because the act would affect direct spending, pay-as -you-go procedures apply. Enacting H.R. 6378 would not affect revenues."

  United States. Congressional Budget Office

  2018-12-06
• Evaluation of Electrostatic Sprayers for Use in a Personnel Decontamination Line Protocol for Biological Contamination Incident Response Operations

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  From the executive summary: "This project supports the mission of the U.S. Environmental Protection Agency's (EPA's) Homeland Security Research Program (HSRP) of the Office of Research and Development's National Homeland Security Research Center (NHSRC) by providing vital scientific data that can inform decisions for EPA emergency responders. The focus of this study was to provide information relevant to the decontamination of personnel and personal protective equipment (PPE) after responding to an act of bioterrorism. To minimize worker exposure and to prevent the spread of potentially hazardous materials beyond the original areas of contamination, work zones will be established to allow workers to move between the non-contaminated Support Zone (SZ), the Contamination Reduction Zone (CRZ) where personnel decontamination takes place, and the Exclusion Zone (EZ) or area of contamination. A well-established decontamination line is essential for ensuring that potentially hazardous residues (chemical, biological or radiological) on worker PPE do not transfer into the SZ. Traditional electric backpack sprayers or handheld manual sprayers are often used to distribute a liquid decontaminant over the surfaces of worker PPE, but this process can generate a large volume of waste and may not always provide decontamination efficacy. Therefore, improved decontamination line strategies must be investigated to minimize the spread of contamination and reduce waste disposal costs."

  United States. Environmental Protection Agency; National Homeland Security Research Center (U.S.)

  Archer, John

  2018-09
• Congressional Budget Office Cost Estimate: S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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  "S. 2852 would amend the Public Health Service Act and the United States Code to authorize funding for certain activities to support national preparedness for public health emergencies (PHEs) and widespread medical emergencies, including acts of bioterrorism. Using information from affected federal agencies, CBO [Congressional Budget Office] estimates that implementing the bill would cost about $13 billion over the 2019-2023 period, assuming appropriation of the authorized amounts. The Consolidated Appropriations Act, 2018, included funding of about $3 billion in fiscal year 2018 for similar activities."

  United States. Congressional Budget Office

  2018-08-03
• Bridging the Gap: To What Extent Do Socioeconomic Barriers Impede Response to Emerging Public Health Threats?

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  From the thesis abstract: "It is crucial for public health emergency planners and responders to realize and account for socioeconomic barriers and the challenges they pose when faced with a bioterrorism, infectious disease, or other emerging public health threat impacting the homeland. The study design of this research incorporated two particular paradigms, investigative and predictive. The researcher found that social and economic factors account for nearly 40 percent of health outcomes in the United States. Public health and its response partners need to plan for emergencies using a '60/40' lens. He discovered that at least 40 percent of populations may not receive the critical health care they require in emergencies because of socioeconomic status or related factors. This thesis investigated the language, culture and historical trauma barriers--and affiliated challenges, such as fear and distrust--that exist throughout the country. Given these findings, this thesis provides both policy- and strategy-level recommendations to assist public health and healthcare practitioners in their efforts to 'bridge the gap' that exists within and between community populations in the United States. Disciplines that consider implementing these recommendations will help minimize significant, and perhaps avoidable, consequences that follow health-related emergencies or varied disasters impacting the homeland."

  Naval Postgraduate School (U.S.); Naval Postgraduate School (U.S.). Center for Homeland Defense and Security

  Neuert, Donald L.

  2017-03
• Position Paper: Bioterrorism Preparedness & Response, A Proposed Model for Bioterrorism Response: Initial Operations and Characterization

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  "This paper presents the position of the InterAgency Board (IAB) on an approach to developing a national bioterrorism response capability. The IAB proposes a model for a biothreat response capability that brings together public safety jurisdictions, federal resources, processes, standards, and doctrine to support the creation of a network of locally owned and operated validated bioterrorism response teams. Under this model, responder organizations that meet eligibility requirements can apply to operate through contracts as approved bioterrorism response organizations within their own jurisdictions. These teams would be trained and equipped to meet a set of national standards and would work collaboratively with the Federal Bureau of Investigation (FBI) and the Centers for Disease Control and Prevention (CDC) Laboratory Response Network (LRN) in bioterrorism incident responses. The model described herein defines proposed equipment, training, and capability requirements and recommends establishing equipment and training standards. A model for funding this national program is also outlined. By implementing this model, all stakeholders in the biothreat response enterprise will be able to confidently make decisions on courses of action to assure public safety and consistently address threats or the perception of them."

  InterAgency Board

  2017-01
• Assessing the Threat of Infectious Disease to the Biosecurity of the United States

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  From the thesis abstract: "There are four significant variables that must be considered when assessing the biosecurity threat of infectious disease to the US. Climate change, globalization, bioterrorism and policy all have a variance of impact that must be considered to prevent an outbreak of disease. Diseases such as Ebola, Zika, anthrax, and measles, have all had recent impact on the biosecurity of the US. Climate change is having an effect upon the habitat of many arthropod vectors of disease. Global travel and human migration are increasing the ranges of many infectious diseases of global significance. After the attacks of September 11th, 2001, the US has increased efforts to identify and combat bioterrorism. Health policies that address vaccinations have come under scrutiny. When diseases are assessed against the four variables, the vulnerability of public health prevention and response efforts can be assessed and identified as 'gaps.' Once identified, gaps in biosecurity can be mitigated to prevent or lessen the impact of future outbreaks of infectious disease."

  U.S. Army Command and General Staff College

  Lopez, John M

  2016-06-10
• Biodefense: The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurveillance, Statement of Chris Currie, Director, Homeland Security and Justice, Testimony Before the Committee on Homeland Security and Governmental Affairs, U.S. Senate

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  "The nation's biodefense enterprise is the whole combination of systems at every level of government and the private sector that can contribute to protecting the nation and its citizens from potentially catastrophic effects of a biological event. It is composed of a complex collection of resources, programs, and initiatives, designed for different purposes and dedicated to mitigating various risks, both natural and intentional. In an era of rapid transit and global trade, the public health and agricultural industries, as well as natural ecosystems including native plants and wildlife, face increased threats of naturally occurring outbreaks of infectious disease and accidental exposure to biological threats. Also, threats of bioterrorism, such as anthrax attacks, highlight the continued need for biosurveillance systems that provide early detection and warning about biological threats to humans. This statement summarizes GAO's [Government Accountability Office] work on challenges to building and maintaining the nation's biodefense and biosurveillance. This statement is based on GAO work issued from December 2009 through March 2016 on various biodefense and biosurveillance efforts. GAO also reviewed the 2015 report of the Blue Ribbon Study Panel on Biodefense for updates, but has not independently assessed the entirety of the conclusions, recommendations or methods. To conduct the prior work, GAO reviewed relevant laws, presidential directives, policies, strategic plans, and other reports; surveyed states; and interviewed federal, state, and industry officials, among others."

  United States. Government Accountability Office

  Currie, Chris

  2016-04-14
• Serial No. 114-41: Defending Against Bioterrorism: How Vulnerable is America? Hearing Before the Committee on Homeland Security, House of Representatives, One Hundred Fourteenth Congress, First Session, November 3, 2015

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  This is the November 3, 2015 hearing on "Defending Against Bioterrorism: How Vulnerable is America?" held before the House of Representatives Committee on Homeland Security. From the opening statement of Michael T. McCaul: "Particularly on this issue of biodefense, the threat from weapons of mass destruction may have faded from public view since 9/11, but the dangers have not diminished, and terrorists in rogue states are as committed as ever to obtaining weapons-of-mass destruction capabilities to intimidate our people and to inflict unspeakable harm. Unfortunately, our level of readiness has not kept pace with the growing risk. Last year, the Ebola crisis showed us that we are not fully prepared to confront biological threats. We learned that the Federal Government did not have the systems in place to address the situation and lacked clear lines of authority. We learned that many front-line health care workers did not have the skills or basic training needed. We learned that officials lacked a plan for communicating the Government's response to the public, including reassuring the American people that it could keep the contagion from spreading through international air travel. Fortunately, we kept the virus from spreading, but there were important lessons to be learned." Statements, letters, and materials submitted for the record include those of the following: Thomas J. Ridge, Joseph I. Lieberman, and Leonard A. Cole.

  United States. Government Publishing Office

  2016
• Serial No. 114-52: Improving the Department of Homeland Security's Biological Detection and Surveillance Programs, Hearing Before the Subcommittee on Emergency Preparedness, Response, and Communications of the Committee on Homeland Security, U.S. House of Representatives, One Hundred Fourteenth Congress, Second Session, February 11, 2016

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  This testimony compilation is from the February 11, 2016 hearing, "Improving the Department of Homeland Security's Biological Detection and Surveillance Programs" before the U.S. House of Representatives Subcommittee on Emergency Preparedness, Response, and Communications of the Committee on Homeland Security. In her opening statement, chairwoman Martha McSally stated that the purpose of meeting is to improve DHS's detection and surveillance programs to address bioterrorism threats, and that it should be a top national security priority to "mitigate the impacts of all types of biological events." Statements, letters, and materials submitted for the record include those of the following: Kathryn Brinsfield, Reginald Brothers, and Chris P. Currie.

  United States. Government Publishing Office

  2016
• Defending Against Bioterrorism: How Vulnerable is America? Hearing Before the Full Committee on Homeland Security, U.S. House of Representatives, One Hundred Fourteenth Congress, First Session, November 3, 2015

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  This is a testimony compilation of the November 3, 2015 hearing "Defending Against Bioterrorism: How Vulnerable is America?" held before the Full House Committee on Homeland Security. From the opening statement of Chairman Michael McCaul: ""Over the course of the past year, their Study Panel hosted a number of meetings to address the full spectrum of the bioterror threat, and their final report provides a thorough review of the challenges we face on that front. It makes 33 recommendations on a number of topics including leadership, strategy, intelligence gathering and dissemination, medical countermeasures, and response. It comes as no surprise to me that one of your main findings is the lack of federal leadership and coordination at the highest level of the executive branch. With a dozen agencies playing a role in the biodefense space, we must have a senior individual coordinating these efforts. Indeed, one of the main questions I asked during the Ebola response was 'Who is in charge?' Unfortunately, that would still be an open question today. That is why I have advocated for the reinstatement of the Special Assistant to the President for Biodefense. Your report calls for the designation of the Vice President as the responsible official, along with the development of a White House Biodefense Coordination Council. I look forward to discussing this recommendation and why you believe the Vice President would be in the best position to address this threat. We are also particularly interested in your assessment of the responsibilities of the Department of Homeland Security in this space." Statements, letters, and other materials submitted for the record include those of the following: Thomas J. Ridge, Joseph I. Lieberman, and Leonard A. Cole.

  United States. Congress. House. Committee on Homeland Security

  2015-11-03
• Assessing the Implications of Advances in Science and Technology for the Biological Weapons Convention [PASCC Research in Progress]

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  "In recent years, there have been rapid advances in life sciences that promise significant contributions to health, food, and energy policy outcomes. Yet, there are concerns that the science and technology (S&T) that enables these benefits may also be used to develop new bioweapons or facilitate bioterrorism. These advances present fundamental challenges to national and international institutions focused on preventing the misuse of S&T. This project assesses new developments in S&T and their potential biosecurity implications. Through collaboration among several scientific organizations, the project will reach a broad audience of international security and S&T professionals in advance of the Eighth Review of the Biological Weapons Convention (BWC) in 2016 in Geneva." This document has been added to the Homeland Security Digital Library in agreement with the Project on Advanced Systems and Concepts for Countering WMD (PASCC) as part of the PASCC collection. Permission to download and/or retrieve this resource has been obtained through PASCC.

  Naval Postgraduate School (U.S.). Center for Contemporary Conflict; National Academy of Sciences (U.S.)

  Bowman, Katherine

  2015-05
• Serial No. 114-14: Strategic Perspectives of the Bioterrorism Threat, Hearing Before the House Subcommittee on Emergency Preparedness, Response, and Communications, One Hundred Fourteenth Congress, First Session, April 22, 2015

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  This is the April 22, 2015 hearing on "Strategic Perspectives of the Bioterrorism Threat," held before the House Subcommittee on Emergency Preparedness, Response, and Communications. From the opening statement of Martha McSally: "This morning, the Subcommittee on Emergency Preparedness, Response, and Communications will continue its examination of preparedness for the CBRN [Chemical, Biological, Radiological, and Nuclear] attacks to the homeland, with a focus on the threat of bioterrorism. It is what I hope will be the first conversation of many that this subcommittee will hold on biodefense. I intend for us to really dig into all aspects of biopreparedness, both for terrorism and pandemics or other emerging infectious diseases." Statements, letters, and materials submitted for the record include those of the following: Jim Talent, Charles B. Cairns, and Marisa Raphael.

  United States. Government Publishing Office

  2015
• Examining Medical Product Development in the Wake of the Ebola Epidemic, Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, Second Session, November 19, 2014

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  This is the November 19, 2014 hearing on "Examining Medical Product Development in the Wake of the Ebola Epidemic," held before the House Committee on Energy and Commerce. From the opening statement of Anthony S. Fauci: "Years ago, we made the decision that not only would we need to be prepared for deliberate attacks in the form of bioterror but for the natural emergence and reemergence of these infectious diseases, so the biodefense agenda was merged into an agenda for naturally emerging and reemerging infections, and so the NIH [National Institute of Health] put on a multifaceted effort that ranged from fundamental basic research through clinical research and the provision of resources for academic investigators and industries, with the result in mind of ultimately developing countermeasures in the form of diagnostics, therapeutics, and vaccines. And, as represented on this committee, what we had was a variety of agencies synergizing with each other. The NIH doing the concept and early product development, advanced development on the part of BARDA [Biomedical Advanced Research and Development Authority], which you will hear from Dr. Robinson soon, the commercial manufacturing, and finally the regulatory guidance and review by the FDA. Using this framework, we have products now that are in the various stages of the process of development." Statements, letters, and materials submitted for the record include those of the following: Anthony S. Fauci, Luciana Borio, Stephen C. Redd, and Robin A. Robinson.

  United States. Government Publishing Office

  2015
• Protecting U.S. Agriculture from Bioterrorism

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  "The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) works to ensure the continued health, welfare, and value of our Nation's agriculture and natural resources. As part of this safeguarding mission, we help protect U.S. animal and plant health by overseeing the possession, use, and transfer of potentially damaging biological agents and toxins, which we refer to as 'select agents.' APHIS' Agriculture Select Agent Services (AgSAS) carries out this work in our agency's security and bioterrorism preparedness efforts. Along with the Division of Select Agents and Toxins (DSAT), a parallel program through the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention (CDC), we make up the Federal Select Agent Program (FSAP). AgSAS also regulates the import and interstate transport of other infectious organisms and agents (non-select agents) that can carry and pass on animal disease."

  United States. Department of Agriculture; United States. Animal and Plant Health Inspection Service

  2014-09
• Report on the Potential Exposure to Anthrax

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  "The Centers for Disease Control and Prevention (CDC) conducted an internal review of an incident that involved an unintentional release of potentially viable anthrax within its Roybal Campus, in Atlanta, Georgia. On June 5, 2014, a laboratory scientist in the Bioterrorism Rapid Response and Advanced Technology (BRRAT) laboratory prepared extracts from a panel of eight bacterial select agents, including 'Bacillus anthracis' ('B. anthracis'), under biosafety level (BSL) 3 containment conditions. These samples were being prepared for analysis using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry, a technology that can be used for rapid bacterial species identification. […] This was a serious event that should not have happened. Though it now appears that the risk to any individual was either non-existent or very small, the issues raised by this event are important. CDC has concrete actions underway now to change processes that allowed this to happen, and we will do everything possible to prevent a future occurrence such as this in any CDC laboratory, and to apply the lessons learned to other laboratories across the United States."

  Centers for Disease Control and Prevention (U.S.)

  2014-07-11
• Progress Towards Developing The 'Pathogen Toolkit'

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  "Microbial forensics is an emerging field that is very important for public safety, yet it presents enormous challenges to both the scientific and legal communities. Microbes have developed a number of mechanisms for generating natural genetic variation, such as high mutation and high recombination rates. Recombinant DNA technologies can also be employed to rapidly combine novel genetic elements conferring new biological, and presumably pathogenic, properties to microbial 'super bugs' with potentially devastating effects. One major goal of microbial forensics is to use this genetic variation to identify the source of a pathogen used to commit crimes or acts of bioterrorism. Rapid pathogen evolution invalidates the use of DNA 'fingerprinting' techniques. Instead, phylogenetic methods are ideally suited because they can explicitly model genetic change through time in order to identify pathogen source populations. While phylogenetic analysis of nucleotide variation within individual genes has been used in previous forensic studies, several drawbacks exist. First, much genomic information is ignored, including gene presence or absence, insertion and deletion events, and structural rearrangements. Second, forensic studies based on the phylogenetic analysis of only a few genes may not reflect the true evolutionary history of that organism. Differences between gene trees and true organismal trees can result from biological processes such as recombination, laboratory engineering through recombinant techniques, and/or analytical difficulties (e.g., misleading signal due to convergent evolution)."

  National Institute of Justice (U.S.)

  Andersen, John; Nelson, Bradley J.; Kshatriya, Priyanka . . .

  2014-05
• Safe Drinking Water Act (SDWA): A Summary of the Act and Its Major Requirements [February 5, 2014]

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  "This report summarizes the Safe Drinking Water Act (SDWA) and its major programs and regulatory requirements. It excerpts, with several additions, the SDWA chapter of CRS Report RL30798, 'Environmental Laws: Summaries of Major Statutes Administered by the Environmental Protection Agency', which provides summaries of the principal environmental statutes administered by the Environmental Protection Agency (EPA). This report includes the drinking water security provisions added to the SDWA by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), and lead reduction provisions as amended by P.L. 111-380. It also outlines amendments made in December 2013 by P.L. 113-64 (H.R. 3588) to explicitly exempt fire hydrants from coverage under the act's lead plumbing restrictions. The SDWA, Title XIV of the Public Health Service Act, is the key federal law for protecting public water supplies from harmful contaminants. First enacted in 1974 and substantially amended in 1986 and 1996, the act is administered through programs that establish standards and treatment requirements for public water supplies, control underground injection of wastes, finance infrastructure projects, and protect sources of drinking water. The 1974 law established the current federal-state arrangement in which states may be delegated primary implementation and enforcement authority for the drinking water program. The state-administered Public Water Supply Supervision (PWSS) Program remains the basic program for regulating the nation's public water systems, and 49 states have assumed this authority."

  Library of Congress. Congressional Research Service

  Tiemann, Mary

  2014-02-05
• Serial No. 113-51: Bioterrorism: Assessing the Threat, Hearing Before the Committee on Homeland Security, Subcommittee on Emergency Preparedness, Response, and Commications, House of Representatives, One Hundred Thirteenth Congress, Second Session, February 11, 2014

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  This is the February 11, 2014 hearing, "Bioterrorism: Assessing the Threat" before the House Subcommittee on Emergency Preparedness, Response, and Communications of the Committee on Homeland Security. From the opening statement of Susan W. Brooks: "Today's hearing is part of the oversight work this Subcommittee has and will be conducting on bioterrorism and the Department of Homeland Security's biosurveillance capabilities. [...] At the request of Ranking Member Payne and myself, as well as the Chairman and Ranking member of the full Committee, the Government Accountability Office (GAO) is conducting a review of the National Biosurveillance Integration Center (NBIC) to determine whether the NBIC is working to its potential, providing value to Federal participants, and worthy of our vital security dollars. [...] The Subcommittee is also continuing its oversight of the BioWatch Program, the Office of Health Affairs' flagship program designed to detect aerosolized bioterror agents. BioWatch is at a crossroads. Members may recall that this Subcommittee requested a GAO review of the program in the 112th Congress, which was released in September 2012. [...] As the foundation of this future work, we are meeting today to receive an update on the bioterrorism threat. And we know the threat is real." Statements, letters, and materials submitted for the record include those of the following: Susan W. Brooks, Robert P. Kadlec, Tom Inglesby, and Leonard A. Cole.

  United States. Government Printing Office

  2014
• Serial No. 113-56: Continuing Concerns over BioWatch and the Surveillance of Bioterrorism: Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, First Session, June 18, 2013

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  This is from the June 18, 2013 hearing, "Continuing Concerns over BioWatch and the Surveillance of Bioterrorism," before the U.S. House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. From the opening statement of Tim Murphy: "We will be examining the effectiveness and efficiency of BioWatch, a Department of Homeland Security (DHS) program that relies heavily on the Centers for Disease Control and Prevention (CDC), and the state and local public health laboratories that are members of the CDC Laboratory Response Network. BioWatch is an early warning system designed to detect a large-scale, covert attack that releases anthrax or other agents of bioterrorism into the air. BioWatch is an early warning system designed to detect a large-scale, covert attack that releases anthrax or other agents of bioterrorism into the air. The program was launched in January 2003 as this country was preparing for war, and it was intended to protect against threats of state-sponsored programs that may have had anthrax, smallpox, and botulinum. BioWatch deploys collectors in 34 of the largest U.S. metropolitan areas in outdoor locations, with indoor deployments in three sites, and special event capacity. These collectors hold filters that gather air samples. Every 24 hours, a government worker goes to these collectors, manually retrieves the filters, and takes them to a state or local laboratory for analysis and testing. If the lab testing shows a positive result, called a BioWatch Actionable Result, or BAR for short, government officials review other evidence and information to decide if it is an actual attack, or just the detection of a bacteria in the environment that has similar DNA to the pathogen of concern. Since the program started, there have been 149 BARs, none of them being an actual attack. BioWatch costs about $85 million a year to operate, with over $1 billion spent since 2003." Statements, letters, and materials submitted for the record include those of the following: Tim Murphy, Michael Walter, and Toby L. Merlin.

  United States. Government Printing Office

  2014
• Serial No. 113-70: BioWatch: Lessons Learned and the Path Forward: Hearing Before the Subcommittee on Emergency Preparedness, Response, and Communications of the Committee on Homeland Security, House of Representatives, One Hundred Thirteenth Congress, Second Session, June 10, 2014

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  This hearing testimony is from the June 10, 2014 hearing on "BioWatch: Lessons Learned and the Path Forward" held before the House Committee on Homeland Security. From the opening statement of Susan W. Brooks: "The BioWatch program was established in 2003 in the aftermath of the anthrax attacks that killed five people and sickened more than 20 others. The program is a system of detectors deployed to more than 30 U.S. cities to scan for a number of aerosolized biothreat agents. Recognizing the limitations of the current system, in 2008 the Department's Office of Health Affairs began the process to acquire a next generation detector, known as Gen-3. After a series of missteps spanning two administrations, six years and millions of dollars later, Secretary Johnson cancelled that acquisition on April 29, 2014. We know, through this Subcommittee's biothreat hearing in February and a subsequent classified briefing, that the threat of bioterrorism is real. In fact, in its BioWatch analysis of alternatives performed for the Department, the Institute for Defense Analysis noted that the bioterrorism threat has not changed since 2001. […] As we consider what is next for BioWatch, we must be mindful of what went wrong with Gen-3 so we learn from those mistakes. Unfortunately, this is not the first failed acquisition in the Department's history. SBI-Net [Secure Border Initiative-Net], the A-S-P program, e-Merge, and TASC [The Analytic Sciences Corporation] all suffered from management shortcomings, be it requirements setting, or a failure to follow proper acquisition protocols, such as the completion of alternatives analyses or cost benefit analyses." Statements, letters, and materials submitted for the record include those of the following: Kathryn Brinsfield, Reginald Brothers, Chris Cummiskey, Chris Currie, and Deena S. Disraelly.

  United States. Government Printing Office

  2014
• Science Needs for Microbial Forensics: Initial International Research Priorities

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  "Microbial forensics is a scientific discipline dedicated to analyzing evidence from a bioterrorism act, biocrime, or inadvertent microorganism or toxin release for attribution purposes. This emerging discipline seeks to offer investigators the tools and techniques to support efforts to identify the source of a biological threat agent and attribute a biothreat act to a particular person or group. Microbial forensics is still in the early stages of development and faces substantial scientific challenges to continue to build capacity. The unlawful use of biological agents poses substantial dangers to individuals, public health, the environment, the economies of nations, and global peace. It also is likely that scientific, political, and media-based controversy will surround any investigation of the alleged use of a biological agent, and can be expected to affect significantly the role that scientific information or evidence can play. For these reasons, building awareness of and capacity in microbial forensics can assist in our understanding of what may have occurred during a biothreat event, and international collaborations that engage the broader scientific and policy-making communities are likely to strengthen our microbial forensics capabilities. One goal would be to create a shared technical understanding of the possibilities - and limitations - of the scientific bases for microbial forensics analysis." Note: This document has been added to the Homeland Security Digital Library in agreement with the Project on Advanced Systems and Concepts for Countering WMD (PASCC) as part of the PASCC collection. Permission to download and/or retrieve this resource has been obtained through PASCC.

  National Academies Press (U.S.)

  2014
• Implementing the National Framework for a Biothreat Field Response Mission Capability

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  From the thesis abstract: "Since the 2001 anthrax attacks, communities have been responding to a sample surge of suspicious mailings. Each event has the potential to be an act of bioterrorism involving a deadly pathogen and, thus, requires a timely response in order to evaluate the risk to public safety. Stakeholders from federal and state governments and industry have recognized the need to develop a mission capability for responding to these suspicious events. The framework for a biothreat field response mission capability advocates the use of innovative detection technology in support of a risk assessment concept of operation. Implementing the framework will require federal and state collaboration and will establish local certification training standards, field-based proficiency and competency assessment exercises, and state response plans that reflect national guidance. This research describes the critical elements of a bioresponse framework, the current status of framework adoption at the state level, and recommendations for a three-phased implementation model."

  Naval Postgraduate School (U.S.). Center for Homeland Defense and Security; Naval Postgraduate School (U.S.)

  Marsh, Bryon

  2013-09
• Responsible Official Guidance Document

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  "This document has been prepared to assist a registered entity and its Responsible Official (RO) to plan and develop policies and procedures that comply with federal select agent regulations promulgated under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The regulatory requirements for a RO are found in Section 9 of the select agent regulations. Each registered entity that possesses, uses, or transfers biological select agents and toxins (i.e., select agents and toxins) is required to designate an individual as their RO and submit that person's name to the Federal Select Agent Program (either the Centers for Disease Control and Prevention (CDC) or the Animal and Plant Health Inspection Service (APHIS)) for approval. While compliance with the select agent regulations is ultimately the responsibility of the registered entity, the RO plays a key role to ensure that his or her entity is in compliance with the select agent regulations and serves as the main point of contact for all select agent registration, reporting, and compliance issues."

  Centers for Disease Control and Prevention (U.S.). Division of Select Agents and Toxins; United States. Animal and Plant Health Inspection Service

  2013-07-05
• Guidance for Industry: What You Need to Know About Administrative Detention of Foods Small Entity Compliance Guide, Final Guidance

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  "This guidance document provides updated information pertaining to the Food and Drug Administration's (FDA) authority to order the administrative detention of human or animal food under section 304(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 334(h)]. Congress originally established this authority in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and amended it in January 2011 as part of the FDA Food Safety Modernization Act (FSMA). FDA prepared this guidance to restate the legal requirements in section 304(h) of the FD&C Act. Previously, this guidance restated the legal requirements for FDA's administrative detention regulation at 21 CFR Part 1, Subpart K, implementing section 304(h) of the FD&C Act. This guidance also served as FDA's Small Entity Compliance Guide (SECG) for 21 CFR Part 1, Subpart K in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). However, as explained above, section 304(h) was amended by FSMA in 2011. Accordingly, in October 2011, FDA updated this document to provide guidance intended to help any entity comply with the requirements of section 304(h) of the FD&C Act, including the amendments to section 304(h) of the FD&C Act made by section 207 of FSMA. This update clarifies that this document continues to serve as FDA's SECG for 21 CFR Part 1, Subpart K."

  United States. Food and Drug Administration

  2013-03
• Remarks at Tufts University During a Panel Discussion on Biosecurity and Bioterrorism: How Significant a Threat?

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  "The Centers for Disease Control and Prevention defines a bioterrorism attack as, ' the deliberate release of viruses, bacteria, or other germs (agents) used to cause illness or death in people, animals, or plants' and in the National Strategy for Countering Biological Threats the Obama Administration stated, 'Biological weapons and their use or proliferation by States or non-State actors (biological threats) present a significant challenge to our national security.' The United States Government recognizes that bioterrorism is a significant threat not only to the United States, but to the entire world. Biological agents do not acknowledge international borders and sovereign nations. It is important when addressing the threat posed by bioterrorism to note that the mechanisms we use to address it are equally applicable to emerging infectious diseases. This 'dual benefit' to our efforts to counter bioterrorism means that it is absolutely imperative that we work together across the health and security communities as we address biological threats, no matter the cause."

  United States. Department of State

  Jenkins, Bonnie D.

  2013-02-23
• Serial No. 112-117: BioWatch Present and Future: Meeting Mission Needs for Effective Biosurveillance? Joint Hearing Before the Subcommittee on Emergency Preparedness, Response, and Communications and the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies of the Committee on Homeland Security, House of Representatives, One Hundred Twelfth Congress, Second Session, September 13, 2012

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  This is the September 13, 2012 joint hearing on "BioWatch Present and Future: Meeting Mission Needs for Effective Biosurveillance?," held before the U.S. House Committee on Homeland Security, Subcommittee on Emergency Preparedness, Response, and Communications, Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies. From the opening statement of Gus M. Bilirakis: "The joint hearing of the Committee on Homeland Security Subcommittee on Emergency Preparedness, Response, and Communications and the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies will come to order. The subcommittees are meeting today to receive testimony on the Department of Homeland Security's biosurveillance efforts and particularly the BioWatch program. I now recognize myself for my own statement. Established in 2003 in the wake of the anthrax attacks that killed five people, the BioWatch program was the first Nationally-deployed system designed to detect an aerosol attack with anthrax and other agents of bioterrorism. Now very near the 11th, of course the 11th anniversary of the attacks that prompted the program's development, it is time to take a step back and ask what Gen--2 has accomplished for us, what it has not achieved, and how we can better understand its relevancy to an overall biodetection architecture that must be dynamic and capable of meeting evolving threats." Statements, letters, and materials submitted for the record include those of the following: Gus M. Bilirakis, Laura Richardson, Daniel E. Lungren, Yvette D. Clarke, Bennie G. Thompson, Alexander G. Garza, Rafael Borras, William O. Jenkins, Jr., and Frances Phillips.

  United States. Government Printing Office

  2013
• Terrorism and Security Issues Facing the Water Infrastructure Sector [November 28, 2012]

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  "The September 11, 2001, attacks on the World Trade Center and the Pentagon have drawn attention to the security of many institutions, facilities, and systems in the United States, including the nation's water supply and water quality infrastructure. These systems have long been recognized as being potentially vulnerable to terrorist attacks of various types, including physical disruption, bioterrorism/chemical contamination, and cyber attack. Damage or destruction by terrorist attack could disrupt the delivery of vital human services in this country, threatening public health and the environment, or possibly causing loss of life. Further, since most water infrastructure is government-owned, it may serve as a symbolic and political target for some. This report presents an overview of this large and diverse sector, describes security-related actions by the government and private sector since 9/11, and discusses additional policy issues and responses, including congressional interest."

  Library of Congress. Congressional Research Service

  Copeland, Claudia

  2012-11-28
• National Biosurveillance Integration Center Strategic Plan

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  "The 2010 Department of Homeland Security (DHS) Quadrennial Homeland Security Review states 'ultimately Homeland Security is about effectively managing risks to the Nation's security.' With risk defined as the likelihood and consequences of potential unwanted events, managing risks from naturally-occurring, accidental, or deliberate biological events such as emerging infectious disease or bioterrorism is difficult to accomplish through activities that attempt to reduce these events' likelihood of occurrence. Although much is being done to prevent these types of events, such events could and do still occur. Instead, activities that mitigate these risks largely focus on reducing, managing, or limiting the consequences of biological events once they begin to occur. Surveillance plays an import role in early detection of such events, allowing an early response, limiting the spread and effects of such events. Doing this effectively requires the earliest possible warning that an event is occurring, as well as continuing shared situational awareness throughout the event, to enable effective decision making regarding what actions should be taken. The mission of the National Biosurveillance Integration Center (NBIC) is fundamentally about the integration of biosurveillance information to enable early warning and shared situational awareness, and disseminate it to the appropriate people in a timely fashion. The National Biosurveillance Integration Center Strategic Plan first provides an overview of national biosurveillance in general, as well as current NBIC activities and operations, then outlines the goals and objectives required to achieve the NBIC's mission over the next five years. These strategic goals, objectives, and activities represent a balance of efforts that enable early warning and shared situational awareness through information ingestion and analysis; synthesis of existing government, private non-governmental, open-source, and classified information; and innovating advanced analytics and models, all in collaboration with federal partners and state, local, territorial, tribal, private, and international stakeholders. NBIC's goals and objectives outlined in this plan include these stakeholders and will be measured for success against specific milestones developed in collaboration with them."

  United States. Department of Homeland Security

  2012-11
• Safe Drinking Water Act (SDWA): A Summary of the Act and Its Major Requirements [October 25, 2012]

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  "This report summarizes the Safe Drinking Water Act (SDWA) and its major programs and regulatory requirements. It excerpts, with several additions, the SDWA chapter of CRS [Congressional Research Service] Report RL30798, 'Environmental Laws: Summaries of Major Statutes Administered by the Environmental Protection Agency', which provides summaries of the principal environmental statutes administered by the Environmental Protection Agency (EPA). This report includes the drinking water security provisions added to the SDWA by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188). The SDWA, Title XIV of the Public Health Service Act, is the key federal law for protecting public water supplies from harmful contaminants. First enacted in 1974 and substantially amended in 1986 and 1996, the act is administered through programs that establish standards and treatment requirements for public water supplies, control underground injection of wastes, finance infrastructure projects, and protect sources of drinking water. The 1974 law established the current federal-state arrangement in which states may be delegated primary implementation and enforcement authority for the drinking water program. The state-administered Public Water Supply Supervision (PWSS) Program remains the basic program for regulating the nation's public water systems, and 49 states have assumed this authority."

  Library of Congress. Congressional Research Service

  Tiemann, Mary

  2012-10-25