Biosecurity

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Center for Biosecurity UPMC http://www.upmc-biosecurity.org/index.html

  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.”
  2. “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.”
  3. “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 http://www.bepstate.net/

  1. “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. “
  2. “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.

  1. “Labs in the United States and Russia keep samples under lock and key; whether anyone else has it is the crucial question.”
  2. “No longer found in nature, smallpox can’t be made in a lab and would probably require a suicidal carrier to deliver it.”
  3. “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.”
  4. “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.”
  5. “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.”
  6. “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.”
  7. “…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

  1. “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)
  2. “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)
  3. “Therefore, risk assessment becomes the responsibility of the clinical microbiologist, infection control personnel, hospital risk management office, and infectious disease physicians.” (Pg. 3)
  4. “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, JohnBioSecurity 2003: Keynote Address on National Preparedness,Office of Science and Technology Policy:Executive Office of the President.

  1. “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.”
  2. “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.”
  3. “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.”

Biosecurity, Project Bioshield, Bioterrorism

 

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

  1. “As of May 2003 globally there was 7,700 cases of SARS and 643 deaths.
  2. “The epidemic in the United States was controlled by methods of isolation and quarantine.”
  3. “Furthermore active monitoring done by health officials on people exposed to SARS have been occurring in hospitals or at their homes.”
  4. “Communication has been critical at the local and state levels”
  5. “We have learned from SARS that the United States can respond quickly to define the virus, develop tests, and sequence it.”
  6. “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.”
  7. “Containment of SARS has been successful even in developing countries.”
  8. “The perceived weakest link is that SARS could spread so entire public health system needs to be strengthened.”

Biosecurity, Developing Countries, SARS, Quarantine

 

Atlas, Ronald, “National Security and the LabMedical Laboratory Observer, Volume 35, Issue 9. 52. September 2003.

  1. ”The aftermath of anthrax attacks following the horrific 9/11 events increased fear that terrorists could acquire deadly pathogens from legitimate U.S. laboratories, which led to a series of laws and regulations directly impacting clinical microbiology laboratories.” – page 52
  2. ”Enhancement of clinical and public health laboratories is key to the nation’s biodefense capabilities, so the American Society for Microbiology (ASM) worked with the Centers for Disease Control and Prevention (CDC) to develop protocols for diagnostic laboratories to recognize and handle major biothreat agents.” – page 52
  3. ”Since clinical labs have been the sources of the agents used in prior acts of bioterrorism or biocrimes, (e.g., the 1989 use of salmonella by the Rajneesh cult in Dalles, OR), they must exercise appropriate oversight as to who is given access to any pathogen which can be misused to cause harm.” – page 52
  4. ”Clinical labs wishing to retain select agents as clinical specimens or reference standards must meet all of the registration requirements of the Biopreparedness Act, including imposing strict biosecurity procedures and obtaining Department of Justice clearance for all individuals with access to the select agents.” – page 52
  5. ”The CDC and USDA must maintain accurate tracking of the acquisition, transfer and possession of these select agents, and must establish safeguards and biosecurity procedures to be followed by institutions possessing select agents.” – page 52
  6. ”The FBI is responsible for conducting security risk assessments of individuals seeking access to listed agents and toxins, and individuals or entities seeking to register under the Act.” – page 52
  7. ”The Biopreparedness Act, a new regulatory burden, should have minimal impact. The greatest impact is likely to be on the labs in the western United States where plague, tularemia, and coccidioidomycoses occur.” – page 52

Public Health, Lab Security, Anthrax, Salmonella, Tularemia, Plague, CDC, Bioterrorism, Biodefense, Biosecurity

2004

Elizabeth K. Leffel, Douglas S. Reed, “Marburg and Ebola Viruses as Aerosol Threats,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, 2004;2(3):186-191.

  1. “Although transmission during naturally occurring outbreaks is believed to occur from close personal contact with blood or other body fluids, or the failure to practice proper medical hygiene as relates to blood-borne pathogens, in the past 10 years several publications have indicated that filoviruses possess a number of properties that would make them suitable as biological weapons.”
  2. “While the possibility of aerosol exposure cannot be ruled out in some cases, it is clear that direct contact is the primary means of transmission.”
  3. “The high mortality rates, coupled with the knowledge that these viruses possess properties considered desirable in biological weapons, explains the considerable concern about their potential use.”
  4. “Without data there can be little understanding of the level of threat that filoviruses present. For example, it is not clear from the available data whether filoviruses would cause large-scale infections and deaths if disseminated by aerosol over a city without extensive preparation or modification (“weaponization”).”

Ebola, Biosecurity, Bioterrorism, Biosafety, Biodevelopment

2005

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

  1. “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.”
  2. “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.”
  3. “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, Flu, Pandemic, Biosafety, Dual Use, Biosecurity

 

Editors, “PATIENT DECONTAMINATION RECOMMENDATIONS FOR HOSPITALSEMSA. July 2005.
http://www.calhospitalprepare.org/sites/epbackup.org/files/resources/DecontaminationRecommendationsforHospitals_0.pdf

  1. “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)
  2. “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)
  3. “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)
  4. “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)
  5. “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)
  6. “Disposable fluid-repelling gowns should be worn to protect skin and clothing” (Pg. 18)
  7. “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)
  8. “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, et al,”Fast neutron inspection of sea containers for the presence of ‘‘dirty bomb’’Science Direct. April 21, 2007. http://144.206.159.178/ft/788/580871/12281760.pdf Last checked February 27, 2013

  1. “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.”
  2. “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.”
  3. “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.”
  4. “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.”
  5. “At the moment, inspectors examine less than 10% of containers and often only after containers have already traveled hundreds of miles.”
  6. “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.”
  7. “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.”
  8. “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”
  9. “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 Unconventional Weapon,” NYT, A 11, Dec. 1, 2008. http://www.preventwmd.gov/report/

  1. “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.”
  2. “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.”
  3. “The report is the result of a six month study by the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism.”
  4. “[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.”
  5. “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

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. http://oba.od.nih.gov/biosecurity/NSABB_3rd_Roundtable_Presentation/Nino%20(Dual)1_Chakhava.pdf

  1. “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 alEuropean Perspective of 2-Person Rule for Biosafety Level 4 Laboratories,Emerging Infectious Diseases, P. 1858, Vol. 15, No. 11, November 2009.

  1. ”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.”
  2. ”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.”
  3. ”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.”
  4. ”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.”
  5. ”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.

  1. “Compared with other potential biological agents, anthrax spores are stable in the environment and the aerosolized form has a high mortality rate.” (Pg. 1)
  2. “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)
  3. “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)
  4. “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)
  5. “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)
  6. “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.

  1. “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.”
  2. “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.”
  3. “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.”
  4. “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.”
  5. “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.”
  6. “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.”
  7. “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”
  8. “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.”
  9. “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.”
  10. “Currently, the U.S. lacks a coordinated and sustained federal research program in biological decontamination.”
  11. “The federal government does not have the human resources to carry out a decontamination response on its own, even for a small biological event.”
  12. “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.”
  13. “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)
  14. “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)
  15. “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)
  16. “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

 

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.

  1. “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.”
  2. “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.”
  3. “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.”
  4. “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.”
  5. “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.”
  6. “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.”
  7. “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”
  8. “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.”
  9. “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.”
  10. “Currently, the U.S. lacks a coordinated and sustained federal research program in biological decontamination.”
  11. “The federal government does not have the human resources to carry out a decontamination response on its own, even for a small biological event.”
  12. “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.”
  13. “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)
  14. “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)
  15. “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)
  16. “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 http://www.nti.org/e_research/e3_malaysia_export_control_law.html Last Checked 1 August 2011.

  1. “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.”
  2. “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.”
  3. “Economic prosperity and development have tended to trump concerns about potential illicit trafficking issues in Malaysia, and elsewhere in Southeast Asia.”
  4. “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.”
  5. “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.”
  6. “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.
  7. “Malaysia—along with most Southeast Asian states—submitted its national report to the 1540 Committee in 2004.”
  8. “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.”
  9. “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.”
  10. “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.”
  11. “The limited implementation of UNSCR 1540 in Southeast Asia and elsewhere derives from insufficient financial and technical resources.”
  12. “Malaysia long perceived export and transshipment control requirements as largely negative, potentially resulting in lessened economic progress and development.”
  13. “[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.”
  14. “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.”
  15. “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.”
  16. “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.”
  17. “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.”
  18. “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.”
  19. “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.”
  20. “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.”
  21. “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, Malaysia

 

Matishak, Martin, “House Lawmakers Look to Strengthen Security at U.S. Biolabs“, 11 June 2010, Global Security Newswire, http://gsn.nti.org/gsn/nw_20100611_4895.php, Last Checked 7 October 2010

  1. “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.”
  2. “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.”
  3. “‘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.’”
  4. “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.”
  5. “The Homeland Security Secretary would be charged with producing biennial ‘bioterrorism risk assessments’ that identify and assess evolving biological risks to the country.”
  6. “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.”
  7. “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.”
  8. “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, Bioterrorism, Biosecurity, Biotechnology

 

EditorBill seeks to bolster U.S. ability to fight bioterror.”, Homeland Security Newswire, 24 June 2010 http://homelandsecuritynewswire.com/bill-seeks-bolster-us-ability-fight-bioterror Last Checked 9/26/2010

  1. “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.”
  2. “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…”
  3. “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”
  4. “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.”
  5. “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, Biodefense, WMD, Bioterrorism, Biosecurity, Biosurveillance

 

Luedtke, Patrick and Becker, Scott J. “RE: Comments on the changes to the list of select agents and toxinsMemo to Centers for Disease Control and Prevention Division of Select Agents and Toxins. Atlanta, GA. August 30, 2010 http://www.selectagents.gov/resources/Association%20of%20Public%20Health%20Laboratories.pdf

  1. “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:
    1. Coccidioides posadasii/Coccidioides immitis
    2. Rickettsia rickettsii
    3. Monkeypox virus
    4. Cercopithecine herpesvirus 1 (Herpes B virus)
    5. Saxitoxin
    6. Shiga-like ribosome inactivating proteins
    7. Shigatoxin; T-2 toxin
    8. Tetrodotoxin
    9. Conotoxins
    10. Diacetoxyscirpenol
    11. Clostridium perfringens epsilon toxin.”
  2. “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.”
  3. “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 BiosecurityRequirements” Presentation to the Federal Experts Security Advisory Panel. American Society for Microbiology. August 31, 2010 http://www.asm.org/asm/images/pdf/Policy/asmtiering8-31-10.pdf

  1. “The ASM believes that biosecurity requirements, including personnel clearance requirements, could be stratified to be commensurate with risk.”
  2. “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.”
  3. “…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.”
  4. “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.”
  5. “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

 

EditorPentagon shifts $1 billion from WMD-defense efforts to vaccine development“, Homeland Security Newswire, 1 September 2010 http://homelandsecuritynewswire.com/pentagon-shifts-1-billion-wmd-defense-efforts-vaccine-development Last Checked 9/19/2010

  1. “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.”
  2. “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.’”
  3. “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.”
  4. “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 protective clothing for military personnel entering toxic areas.”
  5. “‘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.”
  6. “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…”

Homeland Security, Biodetection, Biosecurity, WMD

 

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

  1. “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.”
  2. “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.”
  3. “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.”
  4. “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.’”
  5. “The 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.”

Project Bioshield, Biosecurity

 

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

  1. “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…”
  2. “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…”
  3. “Fauci’s BARDA counterpart did not comment on the proposed organization, raising questions among experts over which agency would oversee the group.”
  4. “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…”
  5. “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…”
  6. “The new entity would address development of materials similar to those emphasized by the existing development agency: antimicrobial agents, diagnostic instruments and production equipment.”
  7. “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.”
  8. “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 BodyGlobal Security Newswire, October 5 2010

  1. “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…”
  2. “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.”
  3. “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.”
  4. “‘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.”
  5. “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.”
  6. “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.”
  7. “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.”

Biosecurity, Biodetection

 

Low, Donald E. and McGeer, Allison., “Pandemic (H1N1) 2009: Assessing the Response.” Canadian Medical Association Journal, November 2010. http://www.docstoc.com/docs/70230222/Pandemic-%28H1N1%29-2009-assessing-the-response

  1.  “Research published by Viboud and colleagues suggests that the first waves of the 2009 pandemic may have been more severe than is widely perceived.”
  2. “…the estimate number of years of life lost was 25% greater than duing a usual influenza season.”
  3. “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.”
  4.  “…uncertainty and limited communication about vaccine supply hampered local and provincial coordination of delivery.”
  5. “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, Adjuvants

 

Department of Health and Human Services, “Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA”. October 2010. http://www.phe.gov/Preparedness/legal/guidance/syndna/Pages/default.aspx

  1. “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.”
  2. “Following the Guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations”
  3. “…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.”
  4. “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.”
  5. “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.”
  6. “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.

  1. “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.”
  2. “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.”
  3. “‘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.’”
  4. “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.”
  5. “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 http://gsn.nti.org/gsn/nw_20101123_8958.php Last Checked 20 February 2011.

  1. “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.”
  2. “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…”
  3. “‘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..”
  4. “‘We don’t want terrorist groups to do the same thing that the Soviet weapons program did,’ according to Weber…”
  5. “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.”
  6. “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.”
  7. “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.”
  8. “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 http://orise.orau.gov/emi/scapa/files/Highlights/2010Dec16.pdf

  1. “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.”
  2. “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.”
  3. “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 http://www.washingtonpost.com/wp-dyn/content/article/2011/02/15/AR2011021506504.html, Last Checked 20 February 2011.

  1. “For the FBI, the case of the anthrax killer is an investigation that never seems to end.”
  2. “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.”
  3. “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).”
  4. “The report ‘shows that the science is not necessarily a slam-dunk.”< /span>
  5. “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.”
  6. “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.”
  7. “‘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.”
  8. “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.”
  9. “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.”
  10. “…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.”
  11. “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, http://www.dod.gov/dodgc/olc/docs/testParker04132011.pdf Last checked October 4, 2012

  1. “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.”
  2. “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.”
  3. “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.”
  4. “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.”
  5. “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.”
  6. “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.”
  7. “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.”
  8. “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.”
  9. “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.”
  10. “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.”
  11. “The Transformational Medical Technologies program addresses novel threats, biologically engineered pathogens, or emerging infectious diseases by developing new detection and therapeutic capabilities.”
  12. “The Medical Countermeasures Initiative encompasses two components: science and technology, and advanced development and manufacturing.”
  13. “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.”
  14. “Ultimately, the Medical Countermeasures Initiative will coalesce to provide a “one-stop“ shop for all future DoD medical countermeasure development.”
  15. “We are putting more emphasis on biodefense, particularly medical biodefense, leveraging the rapid growth in new technologies for our purposes.”

Biosecurity, Biodetection, Biotechnology, Biosurveillance, Biodefense

 

Schnirring, Lisa, “GAO’s federal duplication report cites problems in public health,” March 3, 2011, CIDRAP News http://www.cidrap.umn.edu/cidrap/content/fs/food/news/mar0311duplication2.html, Last Checked 5 March 2011.

  1. “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.”
  2. “Congress passed a law last year ordering the GAO to produce annual duplication reports as a tool to help it reduce the federal deficit.”
  3. “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.”
  4. “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.”
  5. “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, http://the-diplomat.com/flashpoints-blog/2011/06/21/the-importance-of-unscr-1540/ Last Visited 3 August 2011.

  1. “[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.”
  2. “The Council also decided to implement a formal comprehensive review on the status of the resolution’s implementation after five years.”
  3. “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.”
  4. “The Committee’s last comprehensive update, dubbed the Heller report after former 1540 chairman Claude Heller, was released in December 2010.”
  5. “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.”
  6. “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.”
  7. “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).”
  8. “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.”
  9. “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.”
  10. “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

 

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