Biosecurity

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Status Brief

History/Origins:


Developmental Milestones/Developments to Date:


Current Assessment/State of the Field:


Problems/Challenges:


Proposals:

Organizations/Groups/Government

"Center for Biosecurity" UPMC-Biosecurity.org [[1]]

  • "The United States faces unprecedented risks to national security in the 21st century posed by the clear and growing danger of bioterrorism or a destabilizing infectious disease pandemic. Our nation’s vulnerability to biothreats is so severe simply because most of the vaccines and medicines that will be needed to protect our citizens during and after such events do not now exist, and will likely require several years and several hundred million dollars each to successfully develop and produce."
  • "Bioterrorism is an urgent and growing threat to U.S. national security, and the lethality of biological weapons mirrors that of nuclear weapons. A covert biological attack on U.S. civilians could potentially cause tens of thousands of casualties and immense social and economic disruption. Furthermore, there are no significant technical barriers to prevent the development and use of biological weapons, and tactical warning of a biological attack is unlikely."
  • "The Alliance for Biosecurity works to promote a stronger, more effective partnership between government and the BioPharma industry to better develop critically needed medical countermeasures. The Alliance also seeks to usher in a new era in the prevention and treatment of severe infectious diseases that present global security challenges. This new era will be characterized by the capacity to rapidly develop, produce, and stockpile medical countermeasures for the country. The Center for Biosecurity and BioPharma members of the Alliance are striving to create a long-term national security vision for achieving and sustaining defenses against a range of current and future biothreats."


"US Department of State Biosecurity Engagement Program" bepstate.net [[2]]

  • "The anthrax attacks of 2001 and the recent outbreaks of SARS and highly pathogenic avian influenza have demonstrated that infectious disease—whether natural or manmade—poses a significant and growing threat to international peace, security and stability. Perhaps the most important trend influencing the biological threat is the expansion of public and private bioscience worldwide. Advancing biotechnology, while improving the health and well being of millions, also increases the risk that bioscience could be intentionally misused. "
  • "The Biosecurity Engagement Program (BEP) is committed to developing cooperative international programs that promote the safe, secure and responsible use of biological materials that are at risk of accidental release or intentional misuse."
  • State Department, Biosecurity



2002

Barry, John et. al, "Assessing the Threat", Newsweek, Vol. 140 Issue 16, p52, 14 October 2002.

  • "Labs in the United States and Russia keep samples under lock and key; whether anyone else has it is the crucial question.”
  • “No longer found in nature, smallpox can't be made in a lab and would probably require a suicidal carrier to deliver it."
  • "The notion of a black market in smallpox keeps the Bush administration up at night. Homeland Security czar Tom Ridge points to "credible information within the international community at large that some of our enemies have smallpox." Vice President Dick Cheney thinks so, too.”
  • “When bioweapons inspectors visited Iraq in the mid-1990s they found no smoking gun, but they did find a disturbing sliver of evidence. They saw the word "smallpox" written in Arabic on a freeze-dryer that could have been used to weaponize the virus; Iraq claimed the dryer was used to make vaccines.”
  • “When Hussein Kamel, Saddam's son-in-law and his bioweapons director, defected temporarily to Jordan in 1995, he disclosed much about Iraq's bioweapons, but he denied any effort to weaponize smallpox."
  • "The simplest delivery vehicle would be an infected soldier or terrorist with a hacking cough riding the crowded subways or buses of an American city. Whereas that might initially infect dozens of people, an aerosol bomb that sprayed a virus-laden mist would reach hundreds.
  • “Iraq and several other countries have the capability of making aerosols."
  • "...last month started vaccinating frontline health-care workers. Some Israeli bioweapons experts are convinced that Iraq poses a smallpox threat and advocate vaccinating the entire population. Britain and Australia have been buying vaccines."
  • Russia, Iraq, Smallpox, Biosecurity, Vaccination


2003

Snyder, James, "Role of the Hospital-Based Microbiology Laboratory in Preparation for and Response to a Bioterrorism Event" Journal of Clinical Microbiology. pg. 1-4, Vol. 41, No.1. Jan. 2003

  • "The main role of the hospital-based clinical microbiology laboratory in support of a biothreat, biocrime, or act of bioterrorism is to "raise suspicion" when a targeted agent is suspected in a human specimen."(Pg. 1)
  • "These plans include the following: (i) criteria for distinguishing the type of bioterroism event; (ii) information regarding access to and utilization of the LRN, including diagnostic testing protocols; (iii) safety guidelines; (iv) communication and notification protocols..." (Pg. 1)
  • "Therefore, risk assessment becomes the responsibility of the clinical microbiologist, infection control personnel, hospital risk management office, and infectious disease physicians." (Pg. 3)
  • "The laboratory, preferably the laboratory director, must establish and include in the laboratory bioterrorism response plan a notification policy that is enacted when a suspicious isolate cannot be ruled out and must be referred to the next higher level laboratory for confirmation of the organism's identity." (Pg. 3)
  • Public Health, Bioterrorism, CDC, Lab Safety, Biodetection, Biodefense, Biosafety, Biosecurity, Decontamination, Personnel Reliability


Marburger, John "BioSecurity 2003: Keynote Address on National Preparedness," Office of Science and Technology Policy:Executive Office of the President.

  • "Following as they did the terrorist attacks of 9/11, the anthrax incidents the following month sent two unambiguous messages: our society is vulnerable to bioterrorism, and we are not prepared. We did not anticipate the potential for delivery of a biological weapon through the U.S. Postal Service. During the intervening two years, important steps have been taken, not only to make the mail safe, but also to protect and prepare the nation for a much broader range of threats. Much remains to be done, but a substantial framework has been created that will make further action easier, and clear directions have been established to guide the next steps."
  • "To encourage the development of countermeasures that might not otherwise be commercially viable, Project BioShield guarantees a market for any viable countermeasure developed in the public and private sector. It does so by purchasing these countermeasures for the Strategic National Stockpile. In order to increase national preparedness, the Department of Health and Human Services,and the Department of Homeland Security, are authorized to purchase drugs, vaccines, biological products, medical devices and other supplies in such number and amounts as may be necessary to ensure national preparedness."
  • "In addition to registration, the law requires that facilities provide physical security measures based on a site-specific threat assessment and risk analysis that takes into account the nature of the biological agents and their containment requirements, the need for access and type of research in which they will be employed, the actual physical plant and its location, and other environmental considerations. Individuals who are deemed to have a legitimate need for access to select agents will need to undergo a

"security risk assessment," which is a database background check conducted under the aegis of the Attorney General."


Gerberding, Julie L., "SARS: How effective is the state and local response?", Hearing before the Permanent Subcommittee on Investigations, May 2003, pgs 10-12.

  • "As of May 2003 globally there was 7,700 cases of SARS and 643 deaths.
  • "The epidemic in the United States was controlled by methods of isolation and quarantine."
  • "Furthermore active monitoring done by health officials on people exposed to SARS have been occurring in hospitals or at their homes."
  • "Communication has been critical at the local and state levels"
  • "We have learned from SARS that the United States can respond quickly to define the virus, develop tests, and sequence it."
  • "The question is are we quick enough to contain it if we end up having a highly infectious person who sets off a cascade of transmission."
  • "Containment of SARS has been successful even in developing countries."
  • "The perceived weakest link is that SARS could spread so entire public health system needs to be strengthened."
  • Developing Countries

2005

Kaiser, Jocelyn, “Resurrected Influenza Virus Yields Secrets of Deadly 1918 Pandemic”, Science, Vol. 310, 7 October 2005, page 28-29.

  • “The research grows out of Armed Forces Institute of Pathology (AFIP) pathologist Jeffery Taubenberger’s efforts, begun in 1995, to sequence the genome of the 1918 flu virus. Working mainly with tissue from a victim found in permafrost in Alaska, he and others have been piecing together the virus’s eight genes and characterizing their protein products.”
  • “Because of the sensitive nature of the work, the Centers for Disease Control and Prevention (CDC) lab’s safety precautions received unusual scrutiny, says Tumpey, including review by several biosafety committees. Workers followed biosafety level 3 (BSL-3) practices, with additional enhancements for instance, wearing battery-powered air purifiers with face shields and showering when leaving the lab.”
  • “A new federal biosecurity board gave the paper an unusual last-minute review to make sure the merits of its publication outweighed the risks of releasing potentially dangerous knowledge. The board’s green light is a relief to scientists who have worried about a clampdown on scientific information following the anthrax attacks.”
  • “Science decided to publish the 1918 flu paper because it ‘could help prevent another global flu pandemic,’ says Editor-in-Chief Donald Kennedy.”
  • 1918 Flu, Biosafety, Dual Use, Biosecurity, Pandemic


Editors, "PATIENT DECONTAMINATION RECOMMENDATIONS FOR HOSPITALS". EMSA. July 2005. [3]

  • “In the case of a medical radiation emergency, response and recovery radiation exposure limits should be established to preserve lifesaving capabilities while taking into consideration risk to staff and facility operation.” (Pg. 13)
  • “After removal of contaminated clothing, patients should be instructed (or assisted if necessary) to immediately shower with soap and water. Potentially harmful practices, such as bathing patients with bleach solutions, are unnecessary and should be avoided” (Pg. 17)
  • “Patient clothing should be handled only by personnel wearing appropriate personal protective equipment, and placed in an impervious bag to prevent further environmental contamination.” (Pg. 17)
  • “Gloves should be worn when contact with blood or body fluids is anticipated. Gloves should be removed immediately, without touching non-contaminated surfaces, as soon as the patient care task is complete.” (Pg. 17- 18)
  • “Facial protection should be worn when performing patient care tasks likely to generate splashing or spraying of blood and body fluids onto the mucous membranes of the face.” (Pg. 18)
  • “Disposable fluid-repelling gowns should be worn to protect skin and clothing” (Pg. 18)
  • “Hospitals should plan for decontamination operations that will not exceed their capacity, but should also develop a contingency plan for mass decontamination when patient numbers do exceed their capacity.” (Pg 19)
  • "Ensure large quantities of water are available for decontamination in order to dilute the agent as much as possible. Direct excess waste water to the sanitary sewer and immediately notify the POTW and/or MS4.” (PG. 21)
  • Decontamination, Public Health, Quarantine, Nuclear, Biosecurity, Biosafety, Biotechnology, CDC, Bioterrorism, Biodefense


2007

V. Valkovic´a,D. Sudac a,S. Blagus a,K. Nada, J. Obhodasˇa,B. Vekic´a,G. Nebbia b, S. Pesente b,"Fast neutron inspection of sea containers for the presence of ‘‘dirty bomb’’" Science Direct. April 21, 2007. [4] Last checked February 27, 2013

  • "The risk of nuclear terrorism carried out by terrorist groups should be considered not only in construction and/or use of nuclear devices, but also in possible radioactive contamination of large urban areas."
  • "The RDD could then be placed in or near a target facility and detonated, spreading the radiological material through the force of the explosion and in the smoke of

any resulting fires."

  • "Probably the best way to move these materials around the globe is by using sea containers. This is because a container offers criminals the same benefits as those enjoyed by ocean carriers and shippers: efficiency and security."
  • "In addition, every day over 15 millions of containers are being moved over the seas or on land, or standing in yards waiting to be delivered."
  • "At the moment, inspectors examine less than 10% of containers and often only after containers have already traveled hundreds of miles."
  • "A straightforward application of the proposed approach is the coupling of the inspection by tagged neutron beams to a commercial imaging device based on either X-ray or gamma ray radiography that performs a fast scan of the container, identifies a ‘‘suspect’’ region and provides coordinates of the suspicious object to the neutron based device for the final ‘‘confirmatory’’ inspection."
  • "In order to investigate different scenarios of illicit trafficking of explosive and radioactive materials, the experimental setup with a 3 m long section of the real container has been installed in the neutron laboratory."
  • "The evaluation of the performance of the proposed two sensor instrumental portal has shown that simultaneous presence of both explosive and fissile material, hidden inside the container, could be detected"
  • "The detection of the explosive within a suspicious volume element inside the container is performed by gamma detection produced by the tagged neutron bombardment of the volume element"

Container Security, Nuclear, Biosecurity, Radiological Surveillance

2008

Schmitt, Eric, "Panel Fears Use of Unconventioanl Weapon," NYT, A 11, Dec. 1, 2008.

  • "An independent commission has concluded that terrorists will most likely carry out an attack with biological, nuclear or other unconventional weapons somewhere in the world in the next five years unless the United States and its allies act urgently to prevent that."
  • "the Congressionally mandated panel found that with countries like Iran and North Korea pursuing nuclear weapons programs, and with the risk of poorly secured biological pathogens growing, unconventional threats are fast outpacing the defenses arrayed to confront them."
  • "The report is the result of a six month study by the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism."
  • "[recommendations include] improved bioforensic capabilities, and strengthening international organizations, like the International Atomic Energy Agency, to address the nuclear threat. It also calls for a comprehensive approach for dealing with Pakistan."
  • "The report calls for conducting a major review of the program to secure dangerous pathogens and tighten oversight of high-containment laboraties."
  • Bioterrorism, WMD, Biosecurity, Nonproliferation, Iran, North Korea, Pakistan, [5]

2009

Chakhava, George; Kandelaki, Nino. "Progress in the Life Sciences in Georgia Strategies for Managing Dual Use Research of Concern". Center for Strategic Development and Research in Medical Education at TSMU and the ethics of science: Georgian Association of Medical Specialties. March 27, 2009. [6]

  • "Three types of ethics committees exist currently in Georgia: National Council on Bioethics, research and clinical (medical) ethics committees. Schematically outlines all these chematically ethics committees and the legal basis for their establishment and functioning."
  • Georgia, Dual Use, Biosafety, Biosecurity


Ippolito, Giuseppe, et al “European Perspective of 2-Person Rule for Biosafety Level 4 Laboratories,” Emerging Infectious Diseases, P. 1858, Vol. 15, No. 11, November 2009.

  • ”Recently, the directors of Biosafety Level 4 (BSL-4) laboratories in the United States published their views of the requirement of having ≥2 persons present at all times while biological work is undertaken in a BSL-4 laboratory.”
  • ”we support the authors’ initiative and broadly agree with their position. The consensus among European BSL-4 experts is that, in the interest of safety, standard practice should be for all laboratories to perform a risk assessment before any activity is undertaken.”
  • ”They concluded that safety and security would be better assured in some situations by video monitoring systems rather than by the presence of a fellow scientist.”
  • ”A 2-person rule is inappropriate simply because the best approach is not to have inflexible rules that are not objectively assessed according to laboratory-specific circumstances.”
  • ”Surveillance video monitoring and data storing have their place in protecting laboratory facilities from unauthorized access and theft of materials, but their effectiveness for ensuring proper handling of pathogens is quite limited.”
  • Lab Security, Biosecurity, Personnel Reliability, Europe

2010

Nyamathi, Adeline, "Computerized Bioterrorism Education and Training for Nurses on Bioterrorism Attack Agents” SLACK Incorporated. 2010.

  • “Compared with other potential biological agents, anthrax spores are stable in the environment and the aerosolized form has a high mortality rate.” (Pg. 1)
  • “ Achieving the goal of bioterrorism preparedness is directly linked to comprehensive education and training that enables first-line responders, such as nurses, to diagnose infectious agents rapidly and assess and deal with risks appropriately to avoid widespread contamination, illness, and death. In the same way that the threat of biological attack is continuous and constantly evolving, bioterrorism education and training must take advantage of newer technologies and must be sustained and not limited to occasional seminars or a one-time symposium” (Pg. 2)
  • “Fewer than 50% of the nurses were able to correctly differentiate anthrax from an upper respiratory infection or smallpox from chickenpox. Furthermore, nurses scored lower than physicians on all 12 of the knowledge-based questions. Of the respondents, only 20% reported having previous bioterrorism training and fewer than 15% believed that they could respond efficiently to a bioterrorism event.” (Pg. 2)
  • “In a larger study of 651 physicians, an online program was used to train participants to diagnose and manage cases of smallpox, anthrax, botulism, and plague (Cosgrove, Perl, Song, & Sisson, 2005). Pretest/posttest scores for correct diagnosis increased from 47% to 79%, whereas scores for correct management increased from 25% to 79%. Thus, web-based, case-oriented programs were effective in educating physicians about agents of bioterrorism. (Pg. 2)
  • “This didactic module, which was adapted for nurses, included a background on bioterrorism, encompassing a brief history of bioterrorism and the reasons why biological agents could be used as weapons and an overview of the category A bioterrorism agents, including the differential diagnosis, diagnostic methods, and treatment.” (Pg. 4)
  • “Participants in the computerized bioterrorism education and training program were more likely to solve the cases critically without reliance on expert consultants. However, participants in the standard bioterrorism education and training program reduced the use of unnecessary diagnostic tests” (Pg. 10)
  • Public Health, Anthrax, Smallpox, Emergency Response, Bioterrorism, Biosecurity


Bouri, Nidhi & Franco, Crystal, "Environmental Decontamination Following a Large-Scale Bioterrorism Attack: Federal Progress and Remaining Gaps," Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, Volume 8, Number 2, 2010. April 7, 2010.

  • "The process of environmental decontamination is a key step in a successful response to a large-scale attack involving a biological agent. Costs for the decontamination response following the 2001 anthrax attacks were estimated in the hundreds of millions of dollars, and some facilities could not be reopened for more than 2 years."
  • "However, a large-scale biological attack would likely result in an even greater amount of contamination, more areas that need to be cleaned and made safe, and a much greater cost to the American public."
  • "The Select Biological Agents (biological organisms of particular concern) can be categorized along a continuum of decontamination difficulty, ranging from not problematic to very problematic, with a range of difficulty in between. Factors influencing the difficulty of decontamination for a particular agent following a biological attack would include both the natural stability of the agent in the environment and added man-made stability through weaponization."
  • "Bacillus anthracis, the causative agent of anthrax, is considered to be the most problematic agent of concern. Anthrax is both a threat to human health and extremely hardy in the environment. Thus, anthrax requires extensive environmental decontamination following a release."
  • "The main purpose of this analysis is to identify the gaps in decontamination policy and technical practice at the federal level, including safety standards, that must be addressed in order to facilitate a successful response to a large-scale attack involving a biological agent."
  • "The U.S. intelligence community, including the Central Intelligence Agency (CIA), the Defense Intelligence Agency (DIA), the Department of State, the National Intelligence Council, and the Defense Science Board, has assessed the threat of an attack on the U.S. using biological weapons, and they have determined that the threat of a biological attack on the U.S. is current and real.14 Yet, as noted by the Com- mission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (the Commission) in their World at Risk report released in December 2008, the U.S. remains vulnerable and unprepared to deal with such an attack."
  • "Decontamination is the process of removing or inactivating a hazardous substance (in this case, a biological agent) from contaminated environments or surfaces, including skin, clothing, buildings, air, and water, in order to prevent adverse health events from occurring. Remediation fol- lowing an attack with a biological weapon will involve a number of different phases of response, including: Sampling, Testing, and Analysis; Containment and Mitigation; Decontamination, Confirmatory Sampling, and Testing"
  • "Although efforts are underway and advancements have been made in the field of biological agent decontamination, there are a number of high-level policy and scientific questions that have not yet been resolved. These gaps will be major stumbling blocks to a successful decontamination response following a large bioterrorism attack. Gaps include challenges in leadership, research coordination, funding, and decontamination response."
  • "Numerous federal agencies have responsibility for portions of the decontamination response to a bioterrorism attack. Yet, federal plans do not sufficiently delineate decontamination leadership roles and responsibilities."
  • "Currently, the U.S. lacks a coordinated and sustained federal research program in biological decontamination."
  • "The federal government does not have the human resources to carry out a decontamination response on its own, even for a small biological event."
  • "The nation must be ready to effectively and efficiently respond to and recover from a large-scale bioterrorism attack, and the federal government must take steps now to ensure that the U.S. has the technical and operational capabilities necessary to re- cover after an attack."
  • “The DOD Chemical and Biological Defense Program (CBDP) strives to develop capabilities for decontamination research and response ‘‘that enable the quick restoration of combat power, maintain/recover essential functions that are free from the effects of CBRN hazards, and facilitate the return to pre-incident operational capability””(Pg. 3)
  • “Investment now in biological decontamination research to improve technologies and methods has the potential to save the country tens of billions of dollars in clean-up costs for the next event” (Pg. 5)
  • “The risks of secondary aerosolization are important to understand, because they will greatly affect decontamination methods and standards, as well as policy decisions surrounding evacuation, transportation, and population movement” (Pg. 6)
  • “The federal government does not have the human resources to carry out a decontamination response on its own, even for a small biological event” (Pg. 7)
  • Decontamination, Anthrax, Biodefense, Biosafety, Bioterrorism, Emergency Response, Public Health, Biosecurity, Quarantine,


Lieggi, Stephanie; Sabatini, Richard, “Malaysia's Export Control Law: A Step Forward, But How Big?,” 10 May 2010, NTI [7] Last Checked 1 August 2011.

  • “In April 2010 . . . the Malaysian government announced that it had enacted the Strategic Trade Act, intended to strengthen Kuala Lumpur's ability to curb the export and transshipment of WMD related materials.”
  • “Critics have consistently accused Malaysia of giving insufficient attention to its nonproliferation-related trade controls. This is a serious problem because proliferating states and non-state actors are known to seek out and take advantage of weak links in the global security chain in order to procure sensitive WMD-related technologies. Inadequate strategic trade controls can provide states and terrorist organizations ample opportunity to acquire components used in chemical, biological and nuclear weapons with little risk of being caught.”
  • “Economic prosperity and development have tended to trump concerns about potential illicit trafficking issues in Malaysia, and elsewhere in Southeast Asia.”
  • “The popularity of Malaysian ports noticeably increased after the port of Dubai in the UAE—previously the transit point of choice for Iranian and Pakistani based traffickers—increased its transshipment controls under pressure from the United States and other international partners.”
  • “Iranian entities in particular appeared to be transshipping sensitive goods through Malaysia as a means to route them to Tehran without arousing the suspicion of the original supplier.”
  • “Malaysia has been far from alone in its reluctance to impose stronger nonproliferation-related trade controls. Throughout Southeast Asia, attempts to implement UN Security Council Resolution (UNSCR) 1540 have met resistance or lukewarm interest.
  • "Malaysia—along with most Southeast Asian states—submitted its national report to the 1540 Committee in 2004.”
  • “The Malaysian report showed a weak and disjointed system without a significant unifying law, and little understanding of the importance of transshipment and brokering controls.”
  • “The report also stated that Malaysia lacked a comprehensive WMD export control system and that export control laws and regulations were primarily "based on economic reasons."
  • “Despite strong international concern regarding the overall efficiency and effectiveness of its trade control system at the time, Malaysia's 1540 report did not reference any weaknesses within its system. Specifically, Malaysia asserted in its initial report that it "does not require assistance in implementing" UNSCR 1540 but indicated a willingness to consider requests from other states for assistance.”
  • “The limited implementation of UNSCR 1540 in Southeast Asia and elsewhere derives from insufficient financial and technical resources.”
  • “Malaysia long perceived export and transshipment control requirements as largely negative, potentially resulting in lessened economic progress and development.”
  • “[I]n the last few years, Malaysia has shown more interest in cooperating internationally on strategic trade controls. Malaysia and the United States have worked through the State Department administered Export Control and Related Border Security Assistance (EXBS) to help Malaysian officials draft effective regulations and establish a workable licensing system.”
  • “Malaysia has also been a regular participant in the Japanese government sponsored Asian Export Control Seminar. In 2008, the German Federal Office of Economics and Export Control, which implements the European Commission's assistance projects related to export controls, identified Malaysia as an important partner within its outreach program.”
  • “Despite this interaction with foreign partners, Malaysia's new export control system was slow to get up to speed. Highlighting the continued problem of lax transshipment controls in the Malaysian system, allegations of illegal Malaysian involvement in exports of sensitive dual-use items to Iran emerged in 2008.”
  • “Since taking office last year, Malaysian Prime Minister Najib Razak has sought to create warmer relations with the United States and recognized that Malaysia's lax nonproliferation-related trade controls was a serious impediment to bilateral relations.”
  • “The new Strategic Trade Act outlaws the shipment of weapons of mass destruction related materials through Malaysian territory and represents a significant step towards fuller compliance with UNSCR 1540.”
  • “The new legislation, which was drafted with the support of U.S. experts and officials, was one of the numerous "house gifts" that countries brought to Washington during the summit showing their support for President Obama's efforts in this area.”
  • “The law authorizes the appointment of a Strategic Trade Controller to establish and coordinate a more unified licensing system for trade in strategic materials. The law further extends the control of the system over strategic items being transshipped through Malaysian ports, and creates a basis for controlling brokering activities of Malaysian entities.”
  • “Under the Strategic Trade Act, prison sentences of no less than five years and considerable fines have been set for those designated as violators of the law.”
  • “Given the critical importance of exports of high-tech goods to Malaysia's economy, many within the domestic system will remain reluctant to block shipments without clear proof that the goods in question are destined for a weapons purpose—a very difficult standard to meet.”
  • Export Control, UNSCR 1540, WMD, Biosecurity


Matishak, Martin, "House Lawmakers Look to Strengthen Security at U.S. Biolabs", 11 June 2010, Global Security Newswire, [8], Last Checked 7 October 2010

  • “Members of the U.S. House Homeland Security Committee yesterday unveiled their version of legislation aimed at overhauling security at the country's biological research facilities and enhancing federal efforts against the threat posed by weapons of mass destruction.”
  • “That panel concluded that an attack involving a weapon of destruction is likely to occur somewhere in the world by 2013 in the absence of significant security improvement. It further determined a biological strike was more likely to occur than a nuclear or chemical attack because of the prevalence of deadly pathogens and other disease materials around the globe.”
  • “‘Our legislation concerns all weapons of mass destruction threats but will give special emphasis to the emerging threat of biological weapons,’ Representative Bill Pascrell (D-N.J.), one of the bill's co-sponsors, said during a press conference on Capitol Hill. He said the proposal ‘offers an extensive blueprint to address the greatest catastrophic risk we face.’”
  • “Pascrell said panel members had consulted with scientists from U.S. laboratories as well as others in the biodefense field and concluded that the Agriculture and Health and Human Services departments are the best equipped to perform inspections and evaluations of disease research facilities.”
  • “The Homeland Security Secretary would be charged with producing biennial ‘bioterrorism risk assessments’ that identify and assess evolving biological risks to the country.”
  • “The National Intelligence Director would receive the authority to coordinate with other federal offices to develop and implement strategies for countering biological and other WMD threats and expand efforts to create a ‘national cadre’ of experts to support biodefense efforts.”
  • “The Health and Human Services Department would be required to develop and implement a national strategy for distributing medical countermeasures in the event of a WMD crisis.”
  • “The Secretary of State must work to address biosecurity in international forums such as the United Nations, the World Health Organization and the Biological Weapons Convention. Specifically, officials should support sharing of information among nations regarding biological attacks and events with major health consequences.”
  • Biodefense, WMD, Biosecurity, Biotechnology


Editor "Bill seeks to bolster U.S. ability to fight bioterror.", Homeland Security Newswire, 24 June 2010 [9] Last Checked 9/26/2010

  • "Representatives Peter King (R-New York) and Bill Pascrell (D- New Jersey) last week introduced HR 5498 — the Weapons of Mass Destruction Prevention and Preparedness Act of 2010 — described as a “comprehensive approach to improving America’s biodefense capabilities” — to bolster the U.S. defenses against future bioterror attacks."
  • "Nick Rees writes that a house panel was told last week by experts on biological agents that efforts made by the government to allow information sharing and interagency collaboration as a means of addressing bioterrorism has failed to date. HR 5498 aims to reverse that trend by, in part, requiring the director of national intelligence to produce and administer a National Intelligence Strategy for Countering the Threat from WMD..."
  • "This bill addresses the full-range of homeland security considerations associated with the WMD threat — it not only authorizes programs to enhance our nation’s prevention, deterrence, and preparedness capabilities but also bolsters our diction, attribution, response and recovery capabilities"
  • "Biosecurity and biodefense stakeholders would see their relevant intelligence and information sharing techniques integrated nationally by DHS under the legislation. Additionally, DHS would be called on to coordinate with other federal agencies to create biennial bioterrorism risk assessments."
  • "Participation in the National Biosurveillance Integration Center, which currently only carries voluntary interagency participation, would become mandatory under the bill, bringing together disparate agencies from the medical, public health and environmental fields, among many others.This participation would ensure that data on biothreats would be made available to not only federal but also local agencies."
  • Homeland Security, Biosecurity , WMD


Luedtke, Patrick and Becker, Scott J. Memo to Centers for Disease Control and Prevention Division of Select Agents and Toxins. “ RE: Comments on the changes to the list of select agents and toxins” Atlanta, GA. August 30, 2010 [10]

  • “Upon careful review of the current list of select agents, APHL does not recommend that any additional agents or toxins be added to the HHS list. However, we recommend eliminating the following agents from the list due to their wide distribution in nature, lack of ease of production and limited pathogenicity: Coccidioides posadasii/Coccidioides immitis; Rickettsia rickettsii; Monkeypox virus; Cercopithecine herpesvirus 1 (Herpes B virus); Saxitoxin; Shiga-like ribosome inactivating proteins; Shigatoxin; T-2 toxin; Tetrodotoxin; Conotoxins; Diacetoxyscirpenol; Clostridium perfringens epsilon toxin.”
  • “ APHL supports a tiered HHS select agent list commensurate with the risk that a particular agent could be misused to cause significant harm to public health. However, we do not support any tiering categorization that would result in an increase in biosecurity for any select agents.”
  • “Increased biosecurity requirements would be damaging to public health laboratories storing limited quantities of select agents used during response to public health emergencies and would compromise laboratory preparedness and the ability of the United States to detect and respond to bioterrorism or naturally occurring diseases caused by select agents.”
  • Personnel Reliability, Biosecurity


Atlas, Ronald and Shoemaker, Janet. “Tiering/Reducing the Select Agent List and Biosecurity Requirements”. Presentation to the Federal Experts Security Advisory Panel. American Society for Microbiology. August 31, 2010 [11]

  • “The ASM believes that biosecurity requirements, including personnel clearance requirements, could be stratified to be commensurate with risk.”
  • “The ASM recommends that the select agent regulations be tiered so that biosecurity requirements are commensurate with the risk that a particular agent could be misused to do significant harm.”
  • “…tiering and reducing the number of agents requiring the highest levels of biosecurity could increase the likelihood for international harmonization that would greatly increase biosecurity.”
  • “...reduced levels of security requirements for personnel and facilities should be strongly considered for the agents designated as Tier 3 to the degree that such reductions are consistent with existing federal legislation.”
  • “The legislation that led to the select agent regulations recognizes that some select agents may pose a greater threat to the public health and safety than others and specifically states that security requirements should be “commensurate with the risk of the agent and toxin, including the risk of use in terrorism.””
  • Personnel Reliability, Biosecurity


Editor "Pentagon shifts $1 billion from WMD-defense efforts to vaccine development", Homeland Security Newswire, 1 September 2010 [12] Last Checked 9/19/2010

  • "The U.S. Defense Department has shifted more than $1 billion out of its nuclear, biological, and chemical defense programs to underwrite a new White House priority on vaccine development and production to combat disease pandemics, according to government and industry officials."
  • "The planned funding reduction 'terminates essential CBRN [chemical, biological, radiological and nuclear] defense programs … required to meet high priority service needs, prevent casualties and protect against CBRN incidents.'"
  • "An additional $442 million was trimmed through efficiency reductions mandated by Defense Secretary Robert Gates, for a total of $1.5 billion cut from the counter-WMD account over the five-year period, according to the draft memo."
  • "Defense Department projects under the budget-cutting ax include the development and acquisition of biological and chemical detection systems; gear to decontaminate skin and equipment after exposure; systems to coordinate military operations in a chem-bio environment; and protectiBive clothing for military personnel entering toxic areas."
  • "'By diverting $1 billion from nonmedical [chem-bio] defense programs to this medical vaccine facility on top of the OSD efficiency cuts, Weber threatens to return the military forces to a state of unpreparedness that we haven’t seen since 1996,' said one longtime defense analyst, referring to the Office of the Secretary of Defense."
  • "the memo reportedly has since been superseded by another, more limited plea, which instead seeks restoration of less than one-third of the eliminated WMD-defense funds. The subsequent document also omits mention of the high-priority White House vaccine project, sidestepping what might be regarded as implicit internal criticism of the Obama funding priority on the Medical Countermeasures Initiative..."


FDA Week, "White House Eyes Bioshield, Flu Funds For Countermeasures Initiatives." FDA Week, Newsletter; Vol. 16 No. 35, September 3, 2010.

  • "The White House is proposing to strip $170 million from existing pandemic flu funding for FDA and up to $400 million from Project Bioshield procurement funds to support new medical countermeasures initiatives."
  • "A fiscal 2011 budget amendment, submitted to Congress on Aug. 20 by President Barack Obama, requests that 'necessary changes' be made to appropriations language to support the MCM report."
  • "It would also specifically authorize the transfer of $200 million from the Bioshield SRF to the Department of Defense to establish a Technical Center of Excellence for Advanced Development and Manufacturing, while another $200 million will create a strategic investment corporation."
  • "According to FDA, $170 million would be allocated to the agency for fiscal 2010 and 2011 from funds provided to HHS in 2009 omnibus appropriations and 2010 consolidated appropriations bills. The 2011 budget amendment states that the flu funding would be used to 'support research to modernize regulatory science and enhance the safety, quality, and performance of medical countermeasures against chemical, biological, radiological, and nuclear threats and emerging infectious diseases.'"
  • "he initiatives outlined in the report will allow FDA to establish a science program focused on MCM that includes development of new tools and standards to help assess the performance of products and strengthen the evaluation of countermeasures, according to FDA."

Bioshield, Biosecurity


Matt Korade, "New Biodefense Office, Existing Agency Could Cover Same Ground", Global Security Newswire, National Journal Group, September 24, 2010.

  • "An Obama administration plan to establish a "strategic investment firm" for promoting development of biological-weapon and other disease countermeasures could raise questions over division of responsibilities with a Health and Human Services Department agency..."
  • "Unlike the existing Biomedical Advanced Research and Development Authority, which addresses development of medical countermeasures, the proposed entity would seek to certify the financial stability of small biotechnology firms competing for biodefense contract..."
  • "Fauci's BARDA counterpart did not comment on the proposed organization, raising questions among experts over which agency would oversee the group."
  • "The existing agency aims to help disease countermeasures make it past the latter part of the development process and ready for sale. It has funded work on treatments for anthrax, smallpox, radiation exposure and other health threats in recent years..."
  • "The office wields authority to fund vaccine or drug development proposals that have not undergone the time-consuming peer review process, whereas the National Institutes of Health lacks that power..."
  • "The new entity would address development of materials similar to those emphasized by the existing development agency: antimicrobial agents, diagnostic instruments and production equipment."
  • "The new firm, though, would receive more funding. The entity's initial allotment is projected to fall around $200 million, whereas BARDA funds for core studies totaled $10 million in the current fiscal year."
  • "Anne Oplinger, NIAID spokeswoman, noted that biodefense development funding for her office had increased from roughly $53 million in 2001 to almost $1.64 billion in 2008, setting a precedent for the agency to oversee such money..."

Biosecurity Biodetection


Editor, "Bill would establish Global Biosecurity Body", Global Security Newswire, October 5 2010

  • "U.S. Representative Brad Sherman (D-Calif.) last week introduced a bill aimed at establishing a new international body charged with bolstering global preparations for biological threats..."
  • "The new "International Biosecurity Initiative" would seek to improve biological threat detection and response efforts in other countries through education and other programs, according to the think tank. The bill calls for a State Department report on international legal arrangements with regard to biological threats, and it seeks the formation of an expert panel with representatives from various nations to advise the new initiative."
  • "House Foreign Affairs Terrorism, Nonproliferation and Trade Subcommittee staffers said they have discussed with their Homeland Security Committee counterparts possible inclusion of the bill's content in the WMD Prevention and Preparedness Act of 2010, a proposal awaiting a House floor vote."
  • "'Biological risks extend beyond biological weapons developed or used by foreign countries and also include intentional release of harmful biological agents by nonstate groups or individuals, harmful outcomes through unintentional release or unforeseen consequences of biological research and experimental biological agents, and natural disease outbreaks,' according to the bill."
  • "The International Biosecurity Initiative would advance the objectives of the President Obama's National Strategy for Countering Biological Threats in part by seeking worldwide standards for securing sensitive biological materials and laboratories."
  • "Such standards would be created and routinely updated in cooperation with multilateral entities with private-sector input, and the rules would be "based on international needs and domestic lessons learned," the bill states. The cooperative effort would also aim to advance relevant codes of ethics, emergency reporting and response procedures and training programs."
  • "In addition, the proposed initiative would seek to "ensure a strong legal regime for biosecurity" by strengthening criminal penalties in various countries, improving related law enforcement cooperation between governments and by working to bolster enforcement of the Biological Weapons Convention."
  • Biodetection, Biosecurity


Low, Donald E. and McGeer, Allison., “Pandemic (H1N1) 2009: Assessing the Response.” Canadian Medical Association Journal, November 2010. [13]

  • “Research published by Viboud and colleagues suggests that the first waves of the 2009 pandemic may have been more severe than is widely perceived.”
  • “…the estimate number of years of life lost was 25% greater than duing a usual influenza season.”
  • “The vaccine could not be made quickly enough to protect Canadians from the second wave, the complexity of delivering vaccine was badly underestimated, and attempts to deliver rapid public education about vaccination with an adjuvant vaccine failed.”
  • “…uncertainty and limited communication about vaccine supply hampered local and provincial coordination of delivery.”
  • “Last year’s events clearly show that our current methods of vaccine production are too slow for an adequate response to a pandemic.”
  • Flu, Vaccination, Pandemic, Emergency Response, Biosecurity, Public Health, Adjuvant


Department of Health and Human Services, “Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA”. October 2010. [14]

  • “Synthetic biology is not constrained by the requirement of using existing genetic material and this has great potential to be used to generate organisms, both currently existing and novel, including pathogens that could threaten public health, agriculture, plants, animals, the environment, or material.”
  • “Following the Guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations”
  • “…synthesis obviates the need for access to the naturally occurring agents or naturally occurring genetic material from these agents, thereby greatly expanding the potential availability of these agents.”
  • “Providers should establish a comprehensive and integrated screening framework that includes both customer screening and sequence screening, as well as follow-up screening when customer and/pr sequence screening raises concern.”
  • “ The ongoing development of best practices in this area is commendable and encouraged, particularly in light of the continued advances in DNA sequencing and synthesis technologies and the accelerated rate of sequence submissions to public databases such as the National Institutes of Health’s GenBank. However, due to the complexity of determining pathogenicity and because research in this area is ongoing and many such agents are not currently encompassed by regulations in the U.S., generating a comprehensive list of such agents to screen against is not currently feasible and hence is not provided in this Guidance.”
  • "Many DNA sequences encode genes that are required to maintain normal cellular physiology, otherwise know as "house-keeping genes." These "house-keeping genes" are highly conserved between pathogenic and non-pathogenic species. Screening methodologies that recognize highly conserved sequences such as "house-keeping genes" as positive "hits" for "sequences of concern" offer little biosecurity benefit and may impede the screening efforts. Such methodologies would produce a larger number of "hits" adding extra burden for screeners and potentially resulting in actual "sequences of concern" being overlooked. Additionally, such a system may hamper scientific research by falsely assigning sequences from closely related microbes as "sequences of concern"."
  • Personnel Reliability, Biosecurity, Synthetic Biology, Drug Resistance


Editors, "Lugar Touts U.S. Effort to Safeguard Disease Materials," NTI, Global Security Newswire, November 9, 2010.

  • "U.S. Senator Richard Lugar (R-Ind.) described in an address yesterday how the nation's Cooperative Threat Reduction program was seeking to secure potential biological-weapon ingredients beyond the former Soviet Union."
  • "he Nunn-Lugar program has already helped to shutter biological weapons capabilities in one-time Soviet states, but deadly biological agents including Ebola, Marburg and anthrax remained largely unprotected at research facilities in Africa. Lugar is set to travel with Defense Department experts to examine scientific facilities in Burundi, Kenya and Uganda."
  • "'The footprint of weapons-producing laboratories and the size of today’s strategic weapons grow smaller every day," he said. "A delivery system may be as mundane as a commercial cargo carrier. In the case of infectious pathogens, the delivery system could be an individual human being.'”
  • "As we look to the future of the Nunn-Lugar program, biological threat reduction is an area that is rapidly increasing in importance. The work of securing dangerous pathogens, building central reference laboratories and establishing disease surveillance and monitoring is critically needed in many parts of the world."
  • "Nunn-Lugar biological engagement directly serves vital U.S. interests, including safeguarding the welfare of our troops overseas, preventing terrorist use of deadly pathogens, and detecting emerging infectious diseases and pandemics before they threaten the American people."
  • Lab Security, Biodefense, Biosecurity


Matishak, Martin, “U.S Will Expand Biosecurity Work to Africa, Official Says,” 23 November 2010, Global Security Network [15] Last Checked 20 February 2011.

  • "The U.S. Cooperative Threat Reduction initiative will work to secure deadly pathogens in Africa to prevent their use as tools of bioterrorism, a key Defense Department official said yesterday."
  • "The Nunn-Lugar program has effectively safeguarded biological weapons facilities in the former Soviet Union but deadly disease materials, such as Ebola and anthrax, remain for the most part unprotected at research institutions in East Africa…"
  • "'I've been to a lot of the former bioweapons laboratories in the Soviet Union territory and if you look at the diseases that they weaponized, the pathogen samples originated in Africa,’ he said during a global health and security conference.."
  • "'We don't want terrorist groups to do the same thing that the Soviet weapons program did,’ according to Weber..."
  • "The program is on track to receive roughly $523 million in fiscal year 2011, once the annual spending bills are approved by both houses of Congress and sewn together in conference."
  • "Weber said recently the program was likely to provide several million dollars to African states to improve security at laboratories that store dangerous pathogens. He added yesterday that "big thrust and focus" of the initiative's biological engagement work in Africa would be to improve biosafety and biosecurity at research institutions."
  • "Biosafety is often defined as measures intended to prevent the release of infectious agents within a laboratory or the outside environment. Biosecurity involves active methods to avert biological terrorism or other disease breakouts."
  • "The decision to expand the threat reduction program into Africa rather than other regions was based on several priorities, including: the prevalence of endemic disease, the presence of terrorist groups with intent to use biological agents; and the level of existing infrastructure and capacity and the impact the effort could have on improving that, according to Weber."
  • "’Unfortunately, there's terrorism in East Africa, as well as the South Asia region. So yes, we need to work in both; we need to prioritize. A lot of what I described should be a global effort but we can't start everywhere at the same time,’ he told GSN."
  • Biosecurity, Biosafety, Bioterrorism, Anthrax, Ebola


Subcommittee on Consequence Assessment and Protective Actions (SCAPA). Highlights SCAPA Teleconference 10-05. October 21, 2010 [16]

  • “The Federal Experts Security Advisory Panel (FESAP) working groups were convened by NIH and the United States Department of Agriculture (USDA) to follow up on Executive Order 13546, “Optimizing the Security of Biological Select Agents and Toxins (BSAT) in the United States,” signed by President Obama in July 2010… The recommendations of these working groups are not yet final, but it can be generally said that recommendations from the working groups will not be radically out of line with DOE/NNSA practices for PR and physical/cyber security programs.”
  • “Tier 1 bio-agents will have the highest PR requirements. Tier 1 will be a select group of bacterial and viral agents. However, it is unsure how much loosening of recommendations may occur for Tier 2. Compliance with the new guidelines should be easy for national laboratories but will be much harder for the academic/university laboratories. Of particular difficulty for them is the issue on how to handle medical and psychological information collected to reduce the insider threat. They need to worry about compliance with HIPAA requirements and how to fund the costs associated with an enhanced PR program.”
  • “On the PR working group, there are a lot of heavy hitters who know a great deal about establishing PR programs at various federal agencies. The PR program for biosafety at LANL is based on the PR program established for the nuclear program. It includes medical assessment, a psychological evaluation, etc.”
  • Personnel Reliability, Biosecurity, Executive Order

2011

Markon, Jerry, “Anthrax report casts doubt on scientific evidence in FBI case against Bruce Ivins,” 16 February 2011, The Washington Post [17], Last Checked 20 February 2011.

  • “For the FBI, the case of the anthrax killer is an investigation that never seems to end.”
  • “A report from the National Research Council questioned the strength of genetic testing that the government said had conclusively linked the anthrax-infested letters that killed five people to a flask of lethal bacteria belonging to Bruce E. Ivins.”
  • “For years, the FBI has claimed scientific evidence for its conclusion that anthrax spores found in the letters were linked to the anthrax bacteria found in Dr. Ivins's lab,’ said Sen. Charles E. Grassley (R-Iowa).”
  • “The report ‘shows that the science is not necessarily a slam-dunk.”
  • “The spore-laden letters…triggered a massive FBI probe that has suffered missteps, including the public naming of a [person of interest] who was never charged.”
  • "But Tuesday's report questioned a critical piece of evidence: the link between the anthrax spores in a flask - labeled RMR-1029 - stored in Ivins's lab at Fort Detrick, Md., and the anthrax from the attacks.”
  • “‘The scientific link between the letter material and flask number RMR-1029 is not as conclusive as stated in the DOJ Investigative Summary,’ said the $1.1 million report, which was commissioned by the FBI.”
  • "The document added, however, that the ‘genetic evidence is consistent with and supports an association between the RMR-1029 flask’ and the anthrax used in the attacks.”
  • “The 190-page document by the research arm of the National Academy of Sciences praised the FBI's energetic pursuit of emerging science in the investigation. But it offered another possible explanation for the apparent link between the letters and the Ivins flask: that some of the mutations identified in the letters could have arisen independently, through a process known as "parallel evolution."
  • “ …the government was satisfied that its science would have met the standard of proof in federal court.. ..’The standard is not beyond all doubt,’ the official said.”
  • “The report said that the tests turned out to be negative but that the evidence was inconsistent, and it called for further review.”
  • Biosecurity, Bioterrorism, Anthrax


Parker, Gerald W., "Homeland Security Threat Countermeasures," April 13, 2011, FDCH Congressional Testimony, [18] Last checked October 4, 2012

  • "Our national security is challenged to both accurately identify and rapidly respond to an attack or naturally occurring outbreak with countermeasures that limit impacts and loss of life."
  • "DoD is responding to this challenge by building an end-to-end, integrated capability to respond to the threat through enhanced diagnostics, detection, and biosurveillance; and through innovative industrial capacity for advanced development and adaptive manufacture of medical countermeasures for rapid response.”
  • "The events of the 2009 H1N1 pandemic, along with the ongoing challenges and costs associated with development of chemical, biological, radiological, and nuclear medical countermeasures, revealed major gaps in advanced development and access to domestic surge manufacturing capacity.”
  • "Factors that have limited progress for developing biodefense vaccines include the inability to leverage the expertise and capabilities of larger, experienced biopharmaceutical companies due to the high opportunity costs of entering the limited chemical, biological, radiological, and nuclear medical countermeasure market.”
  • "The result is a reliance on small biotechnology firms that are engines of innovation and critical for discovery and early development of medical countermeasure candidates, but they have limited advanced development and regulatory experience and limited manufacturing capabilities. This is a costly, inefficient, and risky approach to meet critical biodefense and public health needs.”
  • "It is crucial that we close the vaccine, antimicrobial and antiviral drug gaps. We cannot afford to take the average 12 to 15 years to develop a medical countermeasure against a single threat, nor can we afford to use the traditional and costly ``one bug-one drug`` development paradigm.”
  • "Detection capabilities are a priority for DoD and include pursuit of research, development, and acquisition of medical diagnostics, environmental detection, and data fusion, management, and decision tools.”
  • "One diagnostic capability currently fielded with our forces in over 300 locations worldwide is the Joint Biological Agent Identification and Diagnostic System. It is capable of rapidly identifying multiple biological agents, such as anthrax, plague, and avian influenza.”
  • "Within DoD, a new laboratory information and communications system, the Electronic Integrated Disease Surveillance System, can link together the different levels of a national disease surveillance network within a country providing near real time information flow that can be disseminated to the appropriate organizations in a timely manner."
  • "By the end of 2012 there will be 10 Homeland Response Force units capable of responding within hours in each of the FEMA regions to provide more life saving capabilities faster using the same approximately 18,000 personnel assigned to this mission.”
  • "The Transformational Medical Technologies program addresses novel threats, biologically engineered pathogens, or emerging infectious diseases by developing new detection and therapeutic capabilities.”
  • "The Medical Countermeasures Initiative encompasses two components: science and technology, and advanced development and manufacturing.”
  • "One of the innovation drivers will be the ability to manufacture medical countermeasures in a flexible fashion to include ``on-demand`` surge capacity for specific products in the event of a national security emergency or change manufacturing runs on different products as the need arises.”
  • "Ultimately, the Medical Countermeasures Initiative will coalesce to provide a ``one-stop`` shop for all future DoD medical countermeasure development.”
  • "We are putting more emphasis on biodefense, particularly medical biodefense, leveraging the rapid growth in new technologies for our purposes.”
  • Biosecurity, Biodetection, Biotechnology, Biosurveillance

Schnirring, Lisa, “GAO’s federal duplication report cites problems in public health,” March 3, 2011, CIDRAP News [19], Last Checked 5 March 2011.

  • “In the first of an expected annual series of reports to Congress on duplication in federal government goals and activities, the US Government Accountability Office (GAO) cites problems in three areas of public health: food safety, biodefense, and communications.”
  • “Congress passed a law last year ordering the GAO to produce annual duplication reports as a tool to help it reduce the federal deficit.”
  • “In its assessment of the government's biodefense efforts, the GAO echoed other expert groups in pointing out that more than two dozen presidential appointees and numerous federal agencies have some responsibility for biodefense. 'However, there is no individual or entity with responsibility, authority, and accountability for overseeing the entire biodefense enterprise,' the group wrote.”
  • “Multiple federal agencies have biodefense responsibilities in each of four areas: threat awareness, prevention and protection, surveillance and detection, and response and recovery, according to the GAO. In the past, it has described fragmentation in biosurveillance activities.”
  • “The agency recommended that the Homeland Security Council consider establishing a focal point to coordinate all federal biodefense activities. It added that the nation's biodefense system would benefit from strategic oversight mechanisms—such as a national coordinator and strategy—to ensure efficient, effective, and accountable results.”
  • Biosecurity, Biodefense


Berkshire, Miller J., “The Importance of UNSCR 1540,” 21 June 2011 The Diplomat, [20] Last Visited 3 August 2011.

  • “[T]he UN Security Council adopted an important resolution (UNSCR 1977) this spring extending the mandate of UNSCR 1540 an additional 10 years until 2021.”
  • “The Council also decided to implement a formal comprehensive review on the status of the resolution’s implementation after five years.”
  • “South African Ambassador to the United Nations Baso Sanqu chairs the 1540 Committee, which has a mandate to report on the implementation status of the resolution.”
  • “The Committee’s last comprehensive update, dubbed the Heller report after former 1540 chairman Claude Heller, was released in December 2010.”
  • “The report recommended that the Security Council extend 1540 for an additional 10 years, with a potential to review every five years . . . [m]odeled . . . after the Nuclear Non-Proliferation Treaty, which has a review conference every five years.”
  • “Heller also advocated that the Committee focus greater attention on biological weapons proliferation, an area that has thus far been marginalized compared with nuclear and chemical weapons prevention.”
  • “It seems at first glance that Heller’s recommendations have been adopted by the UNSC, but the proposal on the review conference has yet to be institutionalized (despite the decision to hold one in 2016).”
  • “Moreover, the new resolution doesn’t provide a tangible mandate for increased attention to biological weapons. Despite this, Interpol has recently stressed it will commit more resources to fighting bioterrorism.”
  • “A great deal of effective work has been done since 2004 in response to the resolution’s unprecedented requirements. The ‘G-8 Global Partnership Against the Spread of Weapons and Materials of Mass Destruction has effectively contributed a tremendous amount of state-to-state assistance in preventing terrorist acquisition of WMD and related materials through the provision of expertise and financial backing of projects in areas such as nuclear security, chemical weapons destruction and biological weapons non-proliferation.”
  • “The International Atomic Energy Agency and the Organization for the Prohibition of Chemical Weapons have also continued to help out by providing capacity building programs to developing countries, which often have abysmal infrastructures protecting such sensitive materials.”
  • UNSCR 1540, WMD, Nonproliferation, Biosecurity, Nuclear, Chemical


Editors , “Fact Sheet: Global Health Security” The White House. Sept. 22, 2011. [21]

  • ““We will focus on the health of mothers and children. And we must come together to prevent, detect, and fight every kind of biological danger – whether it is a pandemic like H1N1, a terrorist threat, or a treatable disease. This week, America signed an agreement with the World Health Organization to affirm our commitment to meet this challenge.””
  • “This week President Obama addressed the United Nations General Assembly and urged the global community come together to prevent, detect, and fight every kind of biological danger, whether it is a pandemic, terrorist threat, or treatable disease.’”
  • “Improving capacities to detect, report and respond to infectious diseases quickly and accurately lies at the heart of the global community’s ability to address all infectious disease threats”
  • “The BWC Revcon offers an important opportunity to revitalize international efforts against these threats, helping to build global capacity to combat infectious diseases, prevent biological weapons proliferation and bioterrorism, and bring security, health, and scientific communities together to raise awareness of evolving biological risks and develop practices to manage them.”
  • Public Health, Bioterrorism, Biodefense, Biosecurity, Developing Countries, Executive Order, Pandemic, Emergency Response


Editors, “U.S. Biodefesne Improve, But New Threats Develop,” 30 September 2011, Global Security Newswire [22] Last Checked 30 September 2011.

  • “Biodefense officials in the United States are concerned about the implications of evolving synthetic biology capabilities even as they note the significant strides the nation has made in the last decade in preparing for a potential disease-based attack.”
  • “Synthetic biology is the growing field in which genetic material, including pathogens, is created in a laboratory from scratch.”
  • “Substantial benefits are predicted to come from the field, including advancements in agriculture, medicine and energy. However, biodefense experts also see the possibility of bad actors creating and modifying dangerous bacteria and viruses to make them more virulent, resilient and deadly with the intent of using the augmented pathogens in biological attack.”
  • “‘We are certainly better prepared than we were 10 years ago,’ said Eric Toner of the Center for Biosecurity at the University of Pittsburgh Medical Center. ‘But there is still a lot of work to be done.’”
  • “Toner warned that major reductions to public health agencies could reverse gains made in biodefense preparedness.”
  • “In the last three years, 29,000 positions at local health agencies have been eliminated, according to the National Association of County and City Health Officials.”
  • Biodefense, Biosecurity


Matishak, Martin, "Experts Offer Measures to Save Lives After Nuclear Explosion". NTI. September 28, 2011. [23]

  • “The Rad Resilient City plan includes a seven-point checklist composed by an expert panel that communities can implement to better protect residents from radioactive fallout after an atomic blast.”
  • “It lays out actions cities and regions can take, starting with obtaining broad community support for nuclear incident preparedness; conducting an ongoing public education campaign on the effects of an atomic detonation and how people can protect themselves; having all building owners or operators assess the level of fallout protection given by different types of structures; and building local capacity to deliver public warnings following an incident. The plan also calls for establishing a rapid system for mapping and monitoring radioactive fallout; developing strategies and logistics for a large-scale, phased evacuation of a municipality; and then testing all the elements of the preparedness plan.”
  • “"The bottom line is the only way for us to be prepared is to know what to do in advance," Tammy Taylor”
  • “Today there is enough fissile material in the world to fuel roughly 120,000 nuclear weapons, Tom Inglesby, chief executive officer and director of the Center for Biosecurity told the audience.”
  • Biosecurity, Nuclear, Public Health, Al-Qaeda, Emergency Response, Pandemic, Biodetection


Barnett, Jim and Ahlers, Mike, “Bioterrorism Report Card: U.S. Unprepared,” 12 October 2011, CNN [24] Last Checked 14 October 2011.

  • “Ten years after an anthrax attack killed five people and awakened the nation to the dangers of bioterrorism, the United States remains largely unprepared for a large-scale bioterrorism attack or deadly disease outbreak, according a new report from the WMD Terrorism Research Center.”
  • “The report, released Wednesday, gives the country mostly B's and C's for its ability to handle small-scale events, such as the anthrax letter attack of 2001, and failing grades for its ability to handle large-scale events, like the global epidemic depicted in the movie ‘Contagion.’”
  • “Notably, the report gives the country a ‘D’ across the board for the country's ability to develop and quickly approve medical countermeasures such as diagnostic tools and vaccines, which are crucial in outbreaks of all sizes.”
  • “In its report, the center says the U.S. has spent more than $65 billion on bio-defense during the past decade, but still has holes that leave it vulnerable.”
  • “The threat isn't simply hypothetical, the report says. Ayman Zawahiri, the presumed leader of al Qaeda following the death of Osama bin Laden, is a medical doctor with a known interest in bioterrorism, having started a bio-weapons program in Afghanistan and Malaysia in 1999, the report notes.”
  • “The report's authors say they recognize that budget constraints are preventing governments from addressing all of the shortcomings in current bio-terror preparedness. They recommend focusing on potential large-scale outbreaks, saying such preparations would automatically improve preparedness for smaller outbreaks.”
  • “Such a strategy will mean improving detection and diagnosis of large-scale diseases and attacks, improving the development of medical countermeasures such as vaccines, and developing methods of dispensing those countermeasures to large populations.”
  • Bioterrorism, Biosecurity


Editors, "Libyan chemical weapons stockpile intact: inspectors". Reuters. Nov. 4th, 2011. [25]

  • “An OPCW inspection team found that the full stockpile of sulfur mustard and ingredients for making chemical weapons were intact at the Ruwagha depot, in southeast Libya, it said”
  • “The abandonment or disappearance of some Gaddafi-era weapons has caused international concern that such firepower could erode regional security if it falls into the hands of Islamist militants or rebels active in North Africa. Some fear they could be used by Gaddafi loyalists to spread instability in Libya”
  • “U.N. Secretary-General Ban Ki-moon Wednesday said the United Nations would send experts to Libya to help ensure nuclear material and chemical weapons did not fall into the wrong hands.”
  • Biosecurity, Biodefense, Bioterrorism, Nuclear, Organizations/Groups, Chemical, Developing Countries, Biosafety, WMD


Warrick, Joby, "IAEA Says Foreign Expertise Has Brought Iran to Threshold of Nuclear Capability", Washington Post. 6 November 2011. [26]

  • "Intelligence provided to U.N. nuclear officials shows that Iran’s government has mastered the critical steps needed to build a nuclear weapon, receiving assistance from foreign scientists to overcome key technical hurdles, according to Western diplomats and nuclear experts briefed on the findings."
  • information on "a former Soviet weapons scientist who allegedly tutored Iranians over several years on building high-precision detonators of the kind used to trigger a nuclear chain reaction."
  • Iran said to have conducted weapons related research post 2003
  • intent to gather all ingredients to build a weapon if they so choose
  • claim to info gathered/purpose in order to generate electricity
  • "Albright said IAEA officials, based on the totality of the evidence given to them, have concluded that Iran “has sufficient information to design and produce a workable implosion nuclear device” using highly enriched uranium as its fissile core."
  • obtained design info on the "R265 generator. The device is a hemispherical aluminum shell with an intricate array of high explosives that detonate with split-second precision. These charges compress a small sphere of enriched uranium or plutonium to trigger a nuclear chain reaction"
  • Iran, Bioterrorism, Biosecurity, Nonproliferation, Nuclear, WMD


Editors, "Survey to compile detailed radiation map in Fukushima begins". Mainichi Daily News. Nov. 8th 2011. [27]

  • “Measurements will be taken by unmanned helicopters around woodland and rivers, while monitoring vehicles will travel along roads in residential areas, it said.”
  • “The survey is "the first step of decontamination work by the government," said Soichiro Seki, a senior Environment Ministry official."We will try hard to restore normal conditions in Fukushima, keeping in mind that Fukushima cannot be revitalized without decontamination."”
  • Chemical, Decontamination, Public Health, Nuclear, Biodetection, Biosafety, Biodefense, Biosecurity


Editors, "OPCW Monitors to Inspect Undeclared Libyan Chemical Arms" Google. Nov. 11, 2011. [28]

  • “"We also hope to keep a small group of inspectors on the ground, to liaise with the government on security arrangements."”
  • “Countries in the chemical weapons treaty "have had different kinds of forces on the ground and they have been focused on certain things such as keeping eyes in the sky on the chemical weapons out on the desert, making sure there is a semblance of security," Luhan said.”
  • “The OPCW "will set what we feel would be a reasonable deadline, to keep pressure on the government to address this but also give enough latitude as it is becoming a new government," the spokesman said”
  • Biosecurity, CWC, Biodefense, Biosafety, Chemical, Bioterrorism


Greenfieldboyce, Nell, “Scientists Worry about Impact of Bird Flu Experiment,” National Public Radio, November 17, 2011 [29] Last Checked December 3, 2011

  • “Scientist recently have been altering the genes of H5N1 to make the virus spread more easily between lab animals- raising concerns about biosafety and how this research is regulated.”
  • “At a flu conference one scientist said he’d done a lab experiment that resulted in bird flu virus becoming highly contagious between ferrets, the animal model used to study human infection.”
  • “Thomas Inglesby, bioterrorism expert and director of the Center for Biosecurity at the University of Pittsburgh Medical Center said, ‘It's just a bad idea for scientists to turn a lethal virus into a lethal and highly contagious virus. And it's a second bad idea for them to publish how they did it so others can copy it.’”
  • “The scientist who presented the results of this study is Ron Fouchier, of the Erasmus Medical Center in the Netherlands.”
  • “NPR has learned that his work is now under scrutiny by a committee called the National Science Advisory Board for Biosecurity.”
  • “That's a committee of independent experts that the U.S. government set up to give advice on how to deal with biological research that's legitimately important to science, but that also could be misused. It can make recommendations about things like whether or not to publish.”
  • Flu, Scientist, Biosafety, Biosecurity, Dual Use, Drug Resistance, Biosurveillance


Editors, “Australia Could Support Bioweapon Vaccine Development,” Global Security Newswire, November 22, 2011 [30] Last Checked November 25, 2011

  • “The United States has requested support from the government operator of a newly opened biological defense laboratory in Australia to develop vaccines for potential bioterrorism agents.”
  • “The Australian Animal Health Laboratory is expected to study deadly agents such as the Ebola virus.”
  • “Research personnel at the Biosecurity Level 4 facility are expected to collaborate with overseas counterparts.
  • “‘They want to develop anti-biological warfare options, which could include vaccines, or better equipment such as face masks for their troops, particularly after the anthrax scare.”
  • Biodefense, Vaccination, Australia, Biosecurity, Ebola


Editors, “Saudi may join nuclear arms race: ex-spy chief”, Yahoo News. Dec. 5th 2011. [31]

  • “Saudi Arabia may consider acquiring nuclear weapons to match regional rivals Israel and Iran, its former intelligence chief Prince Turki al-Faisal said on Monday.”
  • “Israel is widely held to possess hundreds of nuclear missiles, which it neither confirms nor denies, while the West accuses Iran of seeking an atomic bomb, a charge the Islamic republic rejects.”
  • “Abdul Ghani Malibari, coordinator at the Saudi civil nuclear agency, said in June that Riyadh plans to build 16 civilian nuclear reactors in the next two decades at a cost of 300 billion riyals ($80 billion).”
  • Nuclear, Biosecurity, Bioterrorism, Biodefense, Biosafety, Public Health


Editors, “North Korea making missile able to hit U.S.”, The Washington Times. Dec 5th, 2011. [32]

  • “New intelligence indicates that North Korea is moving ahead with building its first road-mobile intercontinental ballistic missile, an easily hidden weapon capable of hitting the United States, according to Obama administration officials.”
  • ““We believe this new intelligence reiterates the need for the administration to correct its priorities regarding missile defenses, which should have, first and foremost, the missile defense of the homeland.””
  • “Mobile missiles are difficult for tracking radar to locate, making them easier to hide. They also can be set up and launched much more quickly than missiles fired from silos or launchpads.”
  • ““North Korea has three paths to building ICBMs. One is using the Taepodong-2, with a range of up to 9,300 miles, as its main strategic missile. A second way is to further develop the ranges of existing missiles like the Musudan, and last is to “use the very large launch facility that is being constructed on the west coast of North Korea to launch a very large missile,” the cable said.”
  • “North Korea also has a new solid-fueled short-range missile called the Toksa, with a range of 75 miles, and has sold a number of shorter-range Musudan missiles to Iran, the report said.”
  • “Pressed for details, he said, “I don’t think it’s an immediate threat, no. But on the other hand, I don’t think it’s a five-year threat.””
  • ““They are developing a road-mobile ICBM. I never would have dreamed they would go to a road-mobile before testing a static ICBM. It’s a huge problem. As we’ve found out in a lot of places, finding mobile missiles is very tough”
  • Nuclear, Biosecurity, Biodefense, Bioterrorism, Biotechnology, Emergency Response, Military, Public Health, CWC, Russia, North Korea, Homeland Security, Biodetection


Editors, “France admits lapses after breach of nuke reactor security” CNN. Dec. 6th,2011. [33]

  • “Interior Minister M. Claude Gueant said there have been lapses in the nuclear plant's security system and has ordered a search of all nuclear plants, a spokesman for the ministry told CNN.”
  • “"This action shows how vulnerable the French nuclear centrals are: Peaceful activists have managed with a few means, to reach the heart of the nuclear central!”
  • Biosecurity, Biodefense, Public Health, Law Enforcement

2012

Epstein, Gerald, “Biosecurity 2011: Not a Year to Change Minds,” Bulletin of the Atomic Scientists, January 2012 vol. 68 no. 1 29-38.

  • “The WMD Center’s Bio-Response Report Card [34] provides a sobering assessment of the challenge involved in defense against biological attack.”
  • “Grades range from ‘B’ in many response categories for small-scale attacks, to ‘D’ for most categories for large-scale attacks, to ‘F’s practically across the board for the most devastating contingencies. In no category are US capabilities getting worse, but five out of eight show no progress being made.”
  • “Contrary to those who might assume that poor grades in such public policy assessments are the fault of incompetent government bureaucrats, the 'D's and 'F's on this chart typically result from extraordinarily daunting technical challenges, such as the expense, time, and scientific uncertainties involved as well as the logistical difficulties that come with distributing millions of doses of medicine quickly enough to forestall disease.”
  • “Those downplaying the threat would not argue that the grades are wrong, but rather irrelevant, and that resources devoted to improving these grades would be better spent on public health, or at least in ways that both benefit public health and prepare for a biological attack.”
  • “Those who cannot so easily dismiss the risk of a bioterrorist attack, however, draw different conclusions: First, many of the actions that need to be taken to prepare for an attack would not draw on a bolstered public health system; such responses require dedicated biodefense funding and—like other security investments—may not necessarily provide benefit against other public health threats. Second, to the extent that certain response categories build on others, an effective response in one category may be limited by deficiencies in another. Third, although the scorecard shows that it is much harder to defend against a large attack than a small one, a terrorist group capable of conducting a small attack does not face a comparable challenge in scaling up its ambitions. After all, a large attack may simply be a series of small attacks, repeated in multiple locations or over time. Fourth, though successful efforts to prevent bioterrorist attacks would obviate the need for response, preventive measures can never be guaranteed 100 percent effective.”
  • Biosecurity, Biosurveillance


Bronwyn, Parry, "Domesticating Biosurveillance: ‘Containment’ and the Politics of Bioinformation" Health & Place, July 2012 vol. 18 no. 4; 718-725.

  • "In the US, the term biosurveillance is used to refer to practices that involve the development of what can be thought of as ‘panoptical’ (or all-seeing) systems of population-wide surveillance used to detect ‘causes of disease, outbreaks of disease and environmental conditions that pre-dispose to disease.’"
  • "The febrile ‘post-terror state’ consciousness of US government policy makers has recently fuelled and legitimised a dramatic expansion of the biosurveillance agenda, its requisite infrastructure, and legal framework."
  • ". . .a much wider constituency of information providers and sources of information (including corporate professionals, military personnel, electronic medical records, and retail sales data) has subsequently been enroled in the service of this wider biopolitical strategy."
  • "Despite this, it is still argued that such systems process only anonymised, or unidentifiable meta-level or population-wide data."
  • "In the UK the term biosurveillance has been employed to describe practices that involve the active surveillance of individuals through the collection and analysis of what is described as their ‘person-specific biological information’."
  • "The emphasis here is not on elaborating and analysing population wide epidemiological or environmental data but rather on acquiring specific, distinguishing bioinformation from single individuals that can then be employed to track or trace their movements through a given environment, be it a crime scene, airport or other ‘high risk’ zone, as a means of securitizing the State."
  • "A recent report completed by the Nuffield Council in the UK (Nuffield Council on Bioethics, 2007: 9) confirms that the British state is (perhaps counter-intuitively) much more committed to the project of individual biosurveillance than are their US allies as evidenced by the fact that 6% of the total UK population have now had their bioinformation accessioned to the National DNA Database compared to only 0.5% of the US population."
  • "…the political impulse for ‘containment’ of biosecurity ‘events’ as evidenced on both sides of the Atlantic during the recent HINI pandemic has induced both a compulsion, and an opportunity, to seamlessly meld the two registers of biosurveillance together in ways that create ever more robust and finely calibrated systems of individual surveillance and, in the process, ever more complex and far reaching regimes of biological governmentality."
  • "What is disturbing about the BioSense RODS, Biowatch and other ‘co-opted’ epidemiological and public health surveillance systems is not only their globality but also their relative opacity—the subject is oblivious to the fact that when they call an ‘anonymous’ health line or buy some cold or flu remedy at the chemist that a ubiquitous, albeit entirely hidden surveillance system is simultaneously, ever so amiably, politely, civilly, mining the most intimate orders of information about their body and health behaviour."
  • Biosurveillance, Biosecurity


Lungren, Dan, "BioWatch Present and Future: Meeting Mission Needs for Effective Biosurveillance?" Committee on Homeland Security, September 13, 2012, [35], Last checked October 16, 2012

  • "We know from our oversight and from a lot of good work from the GAO that DHS, other federal agencies, and states and localities have taken many steps to improve biosurveillance. But truly integrated surveillance is still lacking. Efforts to establish a working National Biosurveillance and Integration Center, while not without flaws, have at least demonstrated where some of our capability gaps remain."
  • "We have heard over the years from many constituencies about the successes and challenges of the deployed BioWatch system, Generation 2. The good news is that through this program, many U.S. localities have been able to partner with the federal government and with each other to enhance their biosurveillance capabilities. BioWatch, in fact, depends on the very important contributions from state and local public health laboratories, and their service to this program is essential."
  • "To meet some of Gen-2`s lack of capacity, OHA has proposed BioWatch Generation 3, an advanced automated detection system undergoing DHS acquisition."
  • "The GAO will tell us today that DHS did not fully develop critical information for decision making on this major acquisition, with lifecycle cost estimates now approaching $6 billion. Furthermore, delays now put full deployment, if approved, at 2022."
  • "GAO has offered several recommendations for how DHS can self- correct this acquisition. DHS agreed with GAO`s recommendations and plans to implement them - but is, nevertheless, pushing forward with the acquisition process to avoid further delays."
  • "We`ve already spent more than $100 million on Gen-3. The House has not provided funds for FY 13. Shouldn`t an acquisition of this size have a cost-benefit analysis, at the very least?"
  • "We also need to understand all of the opportunities to protect human life from a bio-attack before we adopt a specific path forward. We can only do this with a thorough analysis of alternatives, which should include proposals to refine and improve the Gen-2 system before pushing forward on the next generation."
  • "...we need to refine our focus on defining the problem, and then determining the total architecture – from hardware to software to the human element – that can best meet that challenge."
  • Biosurveillance, Biodetection, Biotechnology, Biosecurity


Garza, Alexander, G., "Biosurveillance Outlook" Congressional Testimony, September 13, 2012 [36], Last checked November 15, 2012

  • " In accordance with the President’s July 2012 National Strategy for Biosurveillance, the BioWatch Program is strengthening local partnerships and building capacity to improve biosurvelliance, enabling rapid, well-informed decision-making.”
  • "The current detection capabilities used by the BioWatch Program consist of outdoor aerosol collectors whose filters are manually retrieved for subsequent analysis in a state or county public health laboratory that is a member of the CDC Laboratory Response Network (LRN).”
  • "The results are generally received 8-10 hours after sample delivery to the laboratory.”
  • "To be clear, a BioWatch Actionable Result (BAR) does not mean a terrorist attack has occurred, a viable agent has been released, or that people have been exposed. Additional information is needed to determine if an attack has occurred and if there is a risk to public health. A BAR simply means that targeted DNA is present.”
  • "Each BioWatch jurisdiction has a BioWatch Advisory Committee (BAC) made up of state, local and federal partners who operate the program and are responsible for leading response efforts.”
  • "When a BAR has been declared, the BAC is informed within one hour and a national conference call is generally conducted within two hours.”
  • "While the current BioWatch system is extremely beneficial, it is labor intensive and results may not be available until 12-36 hours after the release of a biological agent has occurred.”
  • "As the National Strategy for Biosurveillance states, we must foster innovation to facilitate new biosurveillance activities- including new detection technologies.”
  • "DHS implemented the Gen-3 acquisition, which aims to reduce the time between potential exposure and confirmation of a potential biological attack through automated detection.”
  • "Automated detection will eliminate the need for manual filter retrieval and is intended to provide continuous collection and analysis of samples within the unit.”
  • "With Gen-3, the time to detect could be reduced to 4-6 hours”
  • "Phase I testing for the Gen-3 acquisition, which was completed in June 2011, assessed the maturity and technical capability of the biodetection technology market against a robust set of system requirements. To accomplish this goal, Phase I included assay/characterization testing and field testing of candidate Gen-3 detectors.”
  • "We are currently preparing to enter Phase II, which will allow us to test a small number of production level units to ensure they meet performance standards.”
  • "I appreciate the Government Accountability Office’s (GAO) draft report on the status of the Gen-3 acquisition and we are currently working to develop, revise, and update the requisite acquisition documentation as appropriate and in line with current Departmental acquisition directives”
  • "The Acquisition Decision Authority (ADA) gave contingent approval for the BioWatch Program to release the solicitation for an analysis of alternatives (AoA) and the RFP for Gen-3 Phase II Stage 1, which provides for performance testing of a small number of detector units from each competitively selected vendor.”
  • "As a result of the guidance provided in the last IRB, we are in the process of updating the Mission Need Statement, commissioning an independent organization to conduct the AoA, which will include a cost-benefit analysis, and updating all the required documents to ensure they comply with the current Departmental guidance for acquisitions as outlined in Management Directive 102-01.”
  • Biosurveillance, Biodetection, Emergency Response, Biosecurity, Biotechnology


Editors, "DTRA Seeks Next Generation Sequencing for Biothreat Agents" October 1, 2012, Global Biodefense, [37], Last checked October 4, 2012

  • "The Defense Threat Reduction Agency (DTRA) has issued a Request for Information to identify sources with the capability to amplify, sequence, and assemble sequence data for biothreat agents into high-quality genomes."
  • "The Next Generation Sequencing (NGS) effort is specifically looking to identify sources that can perform these pathogen characterization tasks for a large volume of samples on a yearly basis, with little or no government investment in instruments or infrastructure."
  • "Information gathered in response to this RFI will be used to support the development of a strategic plan for notional future DTRA investments in genomics and NGS."
  • "This RFI is targeted to mature organizations and institutions that have demonstrated the ability to comprehensively perform end-to-end NGS in such environments"
  • "The responses from companies will be used to inform a strategic plan for notional future DTRA investments in genomics and NGS."
  • Biodefense, Biodetection, Biosecurity, Biosurveillance, Biotechnology


Editors, "DHS Expands Secure The Cities Program To LA/Long Beach Region" October 16, 2012, Homeland Security Today, [38], Last checked October 17, 2012

  • "The Department of Homeland Security (DHS) Monday announced the expansion of the Domestic Nuclear Detection Office’s (DNDO) Securing the Cities (STC) program to the Los Angeles/Long Beach area."
  • "Los Angeles/Long Beach area will receive a direct grant of $1 million and an additional $500,000 in training support, and will be eligible to receive additional funding pending congressional appropriations to build a region-wide, robust nuclear detection capability."
  • "DNDO will partner with the City of Los Angeles Mayor’s office to develop a regional structure of law enforcement and first responder organizations to identify, prevent and respond to potential nuclear or radiological threats."
  • "DNDO will also assist regional partners in conducting training and exercises to further their nuclear detection capabilities and coordinate these with federal operations."
  • "STC has provided more than 8,500 pieces of detection equipment, trained nearly 13,000 personnel, and conducted more than a hundred drills."
  • Biodetection, Biosecurity, Biosurveillance


Roos, Robert, “Experts differ on HHS select-agent proposal for H5N1,” CIDRAP News, December 26, 2012, available at [39] last checked December 31, 2012. See also: [40] [41] [42]

  • ”Some professional groups and scientists think it's a good idea to classify highly pathogenic avian (HPAI) H5N1 influenza viruses as ‘select agents’ requiring special research precautions, while others say the step is unnecessary and would impede research, according to comments they have filed with the US Department of Health and Human Services (HHS).”
  • ”For example, the Infectious Diseases Society of America (IDSA), a physician organization, says H5N1 viruses should be in the select agent category, whereas the American Society for Microbiology (ASM) argues against the idea, noting that circulating H5N1 viruses have poor transmissibility in humans.”
  • ”Several vaccine manufacturers recommend that the attenuated H5N1 strains used to make vaccines should not be included in any select agent designation, because that could slow vaccine development if an H5N1 strain gained greater human transmissibility.”
  • ”Because of the threat they pose to poultry, HPAI H5N1 viruses are already listed as select agents in the US Department of Agriculture's (USDA's) Select Agent Program. But the viruses are not on HHS's select agent list.”
  • ”HHS's request for comments followed a determination by a federal interagency committee that H5N1 viruses may pose a severe threat to human health and safety. The finding came from the Centers for Disease Control and Prevention's (CDC's) Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC), which includes members from various HHS and USDA agencies and the departments of Homeland Security and Defense.”
  • ”The committee considered the findings concerning the transmissibility of genetically modified H5N1 viruses among ferrets, along with the virus's virulence and the low level of immunity in the population.”
  • "’It is crucial that extensive biosafety and biosecurity measures be taken to prevent accidental release or an act of bioterrorism,’ IDSA President David A. Relman, MD, wrote in the comments. Noting that the USDA already regulates H5N1 as a select agent, he said an HHS designation would ensure that the impact on human health is considered.”
  • ”Relman also recommended that HHS consider "more extensive" biosafety and biosecurity requirements for work with H5N1 strains that have been lab-modified to increase their pathogenicity or transmissibility. Research on such strains is currently done in enhanced biosafety level 3 (BSL-3) conditions, according to previous reports.”
  • ”In contrast to the IDSA, the ASM voiced opposition to regulating H5N1 as an HHS select agent. ‘Due to the extremely limited number of human illnesses seen despite widespread circulation of the virus and very poor transmissibility, it is hard to argue that currently circulating viruses represent a severe threat to public health and safety,’ the group wrote.”
  • ”Because H5N1 is on the USDA's select agent list, "HPAI H5N1 already falls under the safety, security, and handling provisions of the select agent rule," the ASM said. "Adding HPAI H5n1 viruses to the HHS select agent list will not add any additional protections or oversight.’"
  • ”The group also said it ‘strongly disagrees’ with the idea of making HPAI H5N1 a ‘Tier 1’ select agent—a new HHS category that requires additional physical and personnel security precautions beyond those required for other select agents.”
  • "’Such a designation would inhibit important research activities related to these viruses,’ the ASM said.”
  • ”A Sanofi Pasteur official urged that lab-attenuated H5N1 strains used to make vaccines should be exempt from any HHS select agent designation. He did not comment on whether HPAI H5N1 strains should be treated as select agents.
  • ”If attenuated strains were classified as select agents, the additional regulatory burdens would delay vaccine development if a pandemic H5N1 strain emerged, Hosbach wrote. Similar views were expressed by two other vaccine makers, MedImmune and Novartis Vaccines and Diagnostics.”

Biosecurity, Open Science, Flu, Biosafety, Pharma, Lab Safety, Public Health


Tinder, Paul, "Navy participates in national and global biosurveillance strategy", BioPrep Watch, December 31, 2012 [43] Last checked February 27, 2013

  • "The United States Navy is conducting advanced research and coordinating resources on the national and global level as part of an effort to prevent attacks involving biological agents, infectious diseases and food-borne illnesses."
  • "The Navy also has research units in North Africa, the Pacific, Latin America and elsewhere that support biosurveillance development."
  • "Recently, NAMRU-2 helped Cambodia’s Ministry of Health to respond to an outbreak of enterovirus 71 that killed more than 50 children."
  • "In countries with limited resources, the NAMRU constructs biosurveillance systems to ensure a more secure global response to diseases. The NAMRU also supports large scale biosurveillance in resource rich countries."
  • Biosurveillance, Biosecurity, Biodefense

2013

Fouchier, Ron, García-Sastre, Adolfo, Kawaoka, Yoshihiro et al., “Transmission Studies Resumefor Avian Flu,” Science Express – Letters, January 23, 2013 [44] last checked January 24, 2013.

  • ”In January 2012, influenza virus researchers from around the world announced a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals. We declared a pause to this important research to provide time to explain the public-health benefits of this work, to describe the measures in place to minimize possible risks, and to enable organizations and governments around the world to review their policies (for example on biosafety, biosecurity, oversight, and communication) regarding these experiments.”
  • ”The World Health Organization has released recommendations on laboratory biosafety for those conducting this research, and relevant authorities in several countries have reviewed the biosafety, biosecurity, and funding conditions under which further research would be conducted on the laboratory-modified H5N1 viruses. Thus, acknowledging that the aims of the voluntary moratorium have been met in some countries and are close to being met in others, we declare an end to the voluntary moratorium on avian flu transmission studies.”
  • ” The controversy surrounding H5N1 virus transmission research has high-lighted the need for a global approach to dealing with dual-use research of concern.”
  • ”Because H5N1 virus transmission studies are essential for pandemic preparedness and understanding the adaptation of influenza viruses to mammals, re-searchers who have approval from their governments and institutions to conduct this research safely, under appropriate biosafety and biosecurity conditions, have a public-health responsibility to resume this important work.”
  • ”Scientists should not restart their work in countries where, as yet, no decision has been reached on the conditions for H5N1 virus transmission research. At this time, this includes the United States and U.S.-funded research conducted in other countries.”
  • ”Scientists should never conduct this type of research without the appropriate facilities, oversight, and all necessary approvals. We consider biosafety level 3 conditions with the considerable enhancements (BSL-3+) outlined in the referenced publications as appropriate for this type of work, but recognize that some countries may require BSL-4 conditions in accordance with applicable standards (such as Canada).”
  • ”We fully acknowledge that this research—as with any work on infectious agents—is not without risks. However, because the risk exists in nature that an H5N1 virus capable of transmission in mammals may emerge, the benefits of this work outweigh the risks.”
  • Scientific Self-Governance, Dual Use, Flu, Biosafety, Biosecurity, WHO, Open Science, Oversight, Public Health, Canada, Risk, BSL, Pandemic


Basaraba, Nicole, "Explosive breakthrough in research on molecular recognition published in Nature", University of Alberta, January 30, 2013 [45] Last checked February 21, 2013

  • "Seonghwan Kim, Dongkyu Lee, and Xuchen Liu, with Research Associate, Charles Van Neste, visiting Professor, Sangmin Jeon from the Pohang University of Science and Technology (South Korea), and Professor Thomas Thundat, has found a method of using receptor-free nanomechanical infrared spectroscopy to increase recognition of chemical molecules in explosive mixtures."
  • "The nanomechanical infrared spectroscopy used by the research team provides higher selectivity in molecular detection by measuring the photothermal effect of the absorbed molecules."
  • ". . .the spectroscopy looks at the physical nature of the molecule and said, 'even if there are mixed molecules, we can detect specific molecules using this method.'"
  • "Using this method, a few trillionths of a gram of explosive molecules can now be detected in a complex mixture even if there is a concentration of other interfering molecules is high."
  • "The research team’s current work looks at detecting biomolecules and hydrocarbons in the oil industry and nerve gas stimulants (DMMP), which can be found in household radiators, gasoline, and fabric softeners, for example. The team also hopes to develop a handheld device for chemical detection that could be utilized in fields such as security, healthcare and environmental protection."
  • Biodetection, Biosecurity, Biotechnology


Kirkup, James, "Biological attacks 'getting easier for terrorists'" March 26, 2013, Telegraph. [46] Last Checked April 1, 2013

  • "Charles Farr, the Director of the Office for Security and Counter-Terrorism, said that extremists have ever greater access to the information and technology required to create and spread germ agents or other biological weapons."
  • "The Home Office has published an annual report on its Contest counter-terrorism strategy, which warned that Islamic terrorist threats are now spread more widely across the world, requiring “very significant resources” to combat."
  • "“Biological will get easier from a terrorist point of view,” Mr Farr said."
  • "Factors facilitating such attacks include the availability of formulae and other information on the internet; increasing teaching of biological sciences at universities, and “greater availability of technology,” he said."
  • "Mr Farr also revealed that even as officials prepare for such attacks, the counter-terrorism budget is coming under pressure to make cuts."
  • "Security and intelligence agencies are having to “find savings” to fund the battle against al-Qaeda, he said. In some cases, that means reducing manpower."
  • "“The terrorist threats we face are now more diverse than before, dispersed across a wider geographical areas, and often in countries without effective governance,” it said."
  • "“This poses significant challenges to our national security and to the security and intelligence agencies and departments working on counter-terrorism: operating in these areas is difficult and dangerous, requires very significant resources and is complicated and at times made impossible by the breakdown of governance and law and order.”"
  • "The Home Office report also warned that British Muslims fighting in Syria’s civil war could return home to carry out terrorist attacks."
  • Bioterrorism, Biosecurity, U.K.


Editors, "Potential Treatments For Ebola And Other Deadly Viruses" March 25, 2013, MNT [47] Last Checked April 1, 2013

  • "Illnesses caused by many of the world's most deadly viruses cannot be effectively treated with existing drugs or vaccines."
  • "Many viruses that cause human diseases are nonsegmented, negative-strand (NNS) RNA viruses, which include the highly lethal Ebola virus and other pathogens mentioned above.
  • "In contrast to the many antibiotics that work against a wide range of bacteria, there are currently no highly effective or safe broad-spectrum drug treatments for viral diseases."
  • "To address this need, John Connor and John Snyder of Boston University and their team screened thousands of diverse compounds for small molecules that showed strong antiviral activity against multiple NNS viruses."
  • "The most potent of these compounds turned off NNS viral genes by blocking transcription. "Because our antiviral targets such a critical step in virus replication, we may be able to develop it into a therapeutic that could be used against many different types of viral infections," Filone says."
  • Ebola, Biosecurity


Schneidmiller, Chris , “Lab Prepares New Bioagent Infection Detector” Global Security Newswire. April 12, 2013 [48] Last checked April 15, 2013

  • ”The Sandia National Laboratories in New Mexico is preparing a hand-held device that hospitals could one day use to quickly test patients for infection by anthrax, ricin or other potential bioterror agents.”
  • ”The enhanced version of the SpinDx device would allow emergency room doctors to analyze blood samples to determine within 15 minutes whether a person had been exposed to a potentially lethal disease material, said Anup Singh, senior manager for the Energy Department facility's biological science and technology group in California.”
  • ”"There's an urgent need to have screening devices in case there is a bioterrorism incident,'… Currently such responders in ERs are not prepared to deal with very large numbers of people all showing at the same time."”
  • ”The U.S. National Institutes of Health in late 2012 provided $4 million over four years for further development of the device, which would be able to test small amounts of blood for up to 64 disease agents or toxins at one time, Singh said.”
  • ”While a "mature prototype" is expected to be ready in about one year, the testing process to prepare the technology for FDA licensing is likely to take four to five years, Singh said. That last hurdle would be carried out by the company selected to market the instrument.”
  • Biodefense, Biosecurity, Emergency Response, Anthrax, Ricin


Milburn, John, “Obama proposes $714M for Kansas biodefense project” San Antonio Express News. April 10, 2013. [49] Last Checked April 15, 2013

  • ”The budget proposal President Barack Obama sent to Congress on Wednesday includes $714 million to build a new federal biosecurity lab in Kansas, the largest proposed federal expenditure for the project to date.”
  • ”Republican Sen. Pat Roberts of Kansas said the recommendation signals the administration's support for building the $1.15 billion lab, which will study large animal diseases and develop measures to protect the nation's food supply.”
  • ”"After almost a decade of work by a whole bunch of folks, this is certainly good news," Roberts said. "We're not there yet, but it's a milestone””
  • ”Roberts said spending and debt issues haven't changed, nor have federal across-the-board cuts of some $85 billion, but he was confident the administration was behind getting the new lab built.”
  • ”The entire complex will be adjacent to Kansas State's Biosecurity Research Institute, which already conducts research on deadly plant and animal disease that are of a lower level threat than the diseases contemplated to be researched in the federal labs. Officials have contemplated transferring some of the research ongoing at Plum Island to the existing lab in coming years.”
  • Biodefense, Biosecurity, Executive


Barnes, Diane, "Homeland Security Agency Vacillates on ‘False’ Bioweapon Warnings", Global Security Newswire, June 20, 2013 [50] Last checked September 28, 2013

  • "WASHINGTON -- If a proposed multibillion-dollar biological attack warning system alerted U.S. authorities to a microbe that turned out to be harmless, could the warning be considered “false?” The Obama administration still has not made up its mind, a U.S. official said on Tuesday."
  • "An existing biological-weapon network raised more than 50 such alarms in six years, but the Homeland Security Department has rejected use of the word “false” to describe them. Last year, a DHS official instead called the warnings “actionable results” for state and local leaders to consider in assessing the need for an emergency response."
  • "The parsing of words could take on crucial significance as lawmakers consider the push to acquire and deploy a third generation of detection gear for the Biowatch network. In more than 30 U.S. cities, Biowatch sensors routinely sample the air for organisms that could alert officials to the spread of a deadly disease agent."
  • "Technology for the system has cost more than $1 billion since 2003. Congressional auditors estimate that the new equipment would require nearly six times that amount to roll out and maintain over a decade, according to a House committee briefing document."
  • "Citing one source of prior warnings, Walters said the system previously could not distinguish innocuous forms of tularemia bacteria from “subtypes of these organisms that actually cause the disease.”"
  • "The government has begun using filters capable of identifying certain strains as harmless, a top official for the Centers for Disease Control and Prevention said at a Tuesday hearing of the House Energy and Commerce Oversight and Investigations Subcommittee."
  • "The “Biowatch Generation 3” sensor technology would be designed to automatically conduct routine air sampling for dangerous organisms like tularemia and anthrax. As things stand, laboratories must regularly remove and analyze filters from Biowatch sensors, producing time lags that Homeland Security officials believe could delay a response to an actual biological strike."
  • "House appropriators cited Generation 3 procurement delays when they moved this month to slash Biowatch funding $11.1 million below the Obama administration’s $90.6 million request for fiscal 2014."
  • Biosurveillance, Biosecurity, Biodetection, Biotechnology, Biowatch


Barnes, Diane, "Scientists Aim to Mutate Avian Flu in Lab to Better Understand its Spread" Global Security Newswire, August 8, 2013, [51] Last checked September 28, 2013

  • "WASHINGTON -- Nearly two dozen virologists from around the world on Wednesday said they want to modify an emerging form of avian influenza in ways that could produce more contagious, virulent or drug-resistant forms of the disease."
  • "The studies would aim to shed light on how the so-called H7N9 virus could threaten humans as it mutates in nature, the 22 researchers wrote in a letter published in the journals Science and Nature."
  • " Their announcement came one day after scientists said a Chinese woman appeared to have caught the virus directly from her father, ultimately killing both in what might be first case of the germ leaping directly between humans."
  • "When diseases mutate and take on new capabilities -- such as the emerging transmission of avian flu from one human to another -- scientists typically seek to study that mutation's “gain of function.” Such analyses aim to develop a fuller understanding of the mutation as a first step toward fighting it."
  • "The proposal has already provoked questions from experts doubtful that any scientific benefits from such experiments would outweigh the risk of a modified virus escaping -- or being stolen -- from a laboratory."
  • "In an interview with Science, Princeton University molecular biologist Adel Mahmoud said the proposal’s scientific rationale “is very flimsy, to put it mildly." He added: “The claims that it will lead to anything useful are lightweight.""
  • "Studies should take place under stringent “Biosafety Level 3 enhanced” conditions, involving safeguards used in handling potentially lethal diseases, the researchers said in an accompanying document. Personnel should undergo “relevant background checks” before being cleared to work with modified agent, they said."
  • "H7N9 produces its most severe human symptoms after taking root in the lungs, but virus particles can also cause localized infections on “any mucous membrane,” including in the mouth, eyes and upper respiratory tract, said Amesh Adalja, a senior associate with the Center for Health Security at the University of Pittsburgh Medical Center."
  • "Bioterrorism came up only “occasionally” in discussions among officials and researchers, and at no point was there any high-profile look at “the risk of deliberate release by an insider,” he wrote in April’s edition of the Bulletin of the Atomic Scientists."
  • "Officials and independent experts have generally advised giving laboratory managers considerable freedom in how they decide whom to entrust with high-risk pathogens. The approach, he wrote, “would be deemed … naïve and utterly inadequate” had more people died as a result of the 2001 anthrax attacks controversially blamed on a U.S. Army microbiologist."
  • "Without addressing whether flu-modification experiments should be continued, Culp said federal and state legislators could alter privacy statutes to “permit more intrusive screening and monitoring” of individuals who handle dangerous biological agents."
  • Lab Security, Lab Safety, Biosecurity, Biodefense, Bioterrorism

Editors, "Dutch Court Upholds Rule Requiring Permission to Publish Avian Flu Data" Global Security Newswire. September 27, 2013. [52] Last checked September 28, 2013

  • "A court in the Netherlands ruled in favor of a Dutch regulation mandating government permission be granted before sensitive research into dangerous diseases such as the avian flu is disseminated to the public, the Center for Infectious Disease Research and Policy reported on Thursday."
  • "Virologist Ron Fouchier of the Erasmus Medical Center had filed an appeal to the Dutch government's decision last year requiring him to obtain an export permit before he could publish research results in the journal Science. The findings showed how only a few genetic alterations were needed to change the H5N1 avian flu into a disease that more easily could be transmitted by air from one mammal to another."
  • "H5N1 bird flu has killed the majority -- nearly 60 percent -- of the hundreds of people it has infected in the last decade."
  • "Advocates of publishing the Erasmus research contended it would help spur public health and pharmaceutical understanding about the way the disease could evolve in the future. Biodefense analysts, however, argued that bad actors could seize upon the data to develop a more lethal disease targeting humans."
  • "The Dutch government said prior-permission to publish the research was mandated by 2009 European Union rules intended to limit the proliferation of weapons of mass destruction. The regulations cover serous flu strains and accompanying technical information."
  • "The court ruled that scientists do not have the authority to determine whether their own scientific projects constitute basic research."
  • Biosecurity, Biodefense, Dual Use

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