Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
BSL guidelines vary by national jurisdiction and critics believe that unacceptable risks have been taken in conducting experiments in labs with inadequate safety precautions (MacKenzie, 2004).
Ingegerd Kallings of the Swedish Institute for Infectious Disease Control in Stockholm and others want a meeting with the international community of scientists “to find a consensus on [lab] containment” standards (MacKenzie, 2004). The U.S. Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight made a series of recommendations that should lead to a domestic oversight framework for high-consequence labs. (see Task Force Report, July 2009)
Editors, The Baker Company, “Risks to Assess when Selecting Clean Benches and Biosafety Cabinets for Animal Research” ACUMEN. Vol. 3. Number 1. June, 2000.
- “Responsible officials have logically suggested that precautions taken when working with animals infected with viruses should not be different, or certainly not less stringent, than the precautions taken with the viruses themselves.”
- The article also gives examples of infections to humans from lab animals, and a chart describing the risks with lab equipment.
Netesov, Sergey V.; Sandakhchiev, Lev S., “The Need for Creation of the International Center in Novosibirsk, Russia for Combating Infections Diseases and Bioterrorism Threat in Asia.” STATE RESEARCH CENTER OF VIROLOGY AND BIOTECHNOLOGY NOVOSIBIRSK (RUSSIA), Sep. 2001 pp 349-357.
- “In 1992, an International Science and Technology Center (ISTC)was established as a nonproliferation-targeted program for the Newly Independent States.” p 350
- “VECTOR employees have attended dozens of international conferences and workshops using ISTC Support. Hundreds of our scientists have wisited their foreign counterparts on site. It made it possible to create an atmosphere of openness and transparency at VECTOR, which is critical to science and scientists.” p 350
- “…with BTEP it is the study of infections representing serious public health problems such as HIV/AIDS, multi-drug-resistant tuberculosis, hepatitis, measles, ect. And these investigations are being started with establishing the international ethical standards at VECTOR in accordance with international GCP regulations. p 350
- “Two very perspective projects will be started soon in the field of development of fast and very sensitive PCR-microchip detection of dangerous pathogen genomes in blood and other biological samples.” p 350
- “Very focused are also the efforts that are being planned and implemented under U.S.A. Cooperative Threat Reduction (CTR) program that relate to upgrade the physical security and biosafety systems at the maximum biocontainment facilities at VECTOR up to the highest modern standards.” p 351
- “Continuous involvement of foreign scientists in work at this ”Center”would be a powerful instrument of confidence building. It is critical, therefore, that all high containment capabilities and necessary supporting facilities be incorporated into the ”Center” to alleviate concerns over possible prohibited activity.” p 351
- “The geographical location of the Center – near the geographical center of Russia – is very suitable for the most effective collection of natural viral and bacterial strains and diagnostic procedures for the study of specimens from Asian Russia, Central Asia FSU republics, Mongolia and other neighbor countries, if needed because Novosibirsk is the largest in the area transportation hub. this location of the proposed ”International Center” would also allow us to join international efforts to control and deter potential bioterrorists.” p 352
- “The Collection of Cultures of Microorganisms available in the Center comprises over 10,000 deposit entries: various viral strains, including the national collection of variola virus strains and strains of viral BSL-4 pathogens.” p 352
- “VECTOR houses one of the two WHO Collaborating Centers (WHO Collaborating Center for orthopoxvirus diagnosis and repository for variola virus strains and DNA), supplied with all required conditions for work with human highly pathogenic viruses including variola virus.” pp 352-353
- “As a result of this research, the proposed ”International Center” can have one of its strategic scientific goals such as making prognosis, based on the data of global monitoring, of what new infections might emerge in the future. It should be noticed that the most of these infectious agents are considered to be possible bioterrorism agents, and therefore the proposed ICERID could develop the preventive research in anti-bioterrorism direction.” p 353
- “The special attention would be paid to the investigation of the unusual outbreaks of infectious diseases in the region (Asian part of Russia, Central Asian republics – members of C.I.S., possibly – another countries of the region). This investigation may be conducted using molecular epidemiology approach, which allows to determine the sero- and genotypes of infectious agents, the source of primary infection and even to help distinguishing whether it is intentional or natural outbreak … Such investigations may be made on a regular basis for a wide list of pathogens. This type of research would be extremely useful both for monitoring of the evolution and spread of infectious agents and for the investigation of possible bioterrorism cases.” pp 353-354
Shapiro, Daniel, S., & Schwartz, Donald, R., “Exposure of laboratory workers to Francisella tularensis despite a bioterrorism procedure,” J. of Clinical Microbiology, June 2002, pp. 2278-2281. PubMed http://www.ncbi.nlm.nih.gov/pubmed/12037110 last checked 12/12/11
- ”A rapidly fatal case of pulmonary tularemia in a 43-year-old man who was transferred to a tertiary care facility is presented. The microbiology laboratory and autopsy services were not notified of the clinical suspicion of tularemia by the service caring for the patient. Despite having a laboratory bioterrorism procedure in place and adhering to established laboratory protocol, 12 microbiology laboratory employees were exposed to Francisella tularensis and the identification of the organism was delayed due to lack of notification of the laboratory of the clinical suspicion of tularemia. A total of 11 microbiology employees and two persons involved in performing the patient’s autopsy received prophylactic doxycycline due to concerns of transmission. None of them developed signs or symptoms of tularemia. One microbiology laboratory employee was pregnant and declined prophylactic antibiotics. As a result of this event, the microbiology laboratory has incorporated flow charts directly into the bench procedures for several highly infectious agents that may be agents of bioterrorism. This should permit more rapid recognition of an isolate for referral to a Level B laboratory for definitive identification and should improve laboratory safety.” P. 2278.
- ”Despite the presence in the clinical microbiology laboratory of a written procedure for working with agents of bioterrorism, including F. tularensis, the identification of F. tularensis isolated from a fatal case of pulmonary tularemia was delayed, resulting in the manipulation of the organism at the bench by laboratory workers, many of whom subsequently began taking prophylactic antibiotics.” P. 2278
- ”Although tularemia is rare, with approximately 200 cases annually in the United States, in Pike’s study of 3,921 cases of laboratory-associated infections, it ranked second in the United States as a cause of laboratory-associated infections, behind only brucellosis, and third worldwide, behind brucellosis and typhoid (15).” P. 2278
- ”Although the medical service caring for this patient was concerned enough about the possibility of tularemia to give him intramuscular streptomycin, the microbiology laboratory and the autopsy service were not informed of this clinical suspicion. As a result, there was both a delay in sending the clinical isolate for definitive identification and an increased risk to the microbiology staff. Although a specific bioterrorism procedure was in place in the microbiology laboratory, it was separate from, and had not been sufficiently integrated into, the specific bench procedures for the workup of blood, respiratory, and sterile body fluid cultures. As a result, technologists working with the isolate on these benches did not suspect F. tularensis. It has been the standard procedure in our microbiology laboratory to subculture all positive blood cultures within a biological safety cabinet. This procedure, which involves a broth culture, is one that can potentially result in the production of an infectious aerosol.” P. 2280
- ”The clinical microbiology laboratory at Boston Medical Center is currently designated a Level A laboratory. This classification means that the laboratory should not attempt the identification of potential bioterrorism agents such as F. tularensis, but it does require the ability to rapidly rule out such agents and to forward those isolates which cannot be ruled out to a Level B laboratory (12, 13).” P. 2280
- ”The misidentification or preliminary identification of F. tularensis as a Haemophilus species has been noted in a number of published reports (2, 11, 18). F. tularensis is characteristically isolated as small, poorly staining gram-negative rods seen mostly as single cells which yield mostly pinpoint colonies on chocolate agar and often on sheep agar at 48 h, do not grow on either MacConkey or eosin-methylene blue agar, are oxidase negative, and have a weakly positive or a negative catalase test.” P. 2280
- ”Although Yersinia pestis and Bacillus anthracis, two agents that have been classified as a Category A critical biological agents, have only rarely been reported to cause laboratory infections, we have incorporated flow charts for the identification of these organisms into our procedures in order to prevent a delay in their identification. In the clinical virology laboratory, we have incorporated a flow chart for those situations in which cytopathic effect is seen and which is consistently demonstrated upon passage but cannot be identified with our standard laboratory procedures.” P. 2280
- ”The role of performing autopsies in the possible detection of cases of bioterrorism is an important one (14). Under ideal circumstances, autopsies in cases of suspected bioterrorism should be performed in a specially designated morgue rather than in a routine hospital-based setting to minimize the risk of transmission of exotic agents, such as those causing viral hemorrhagic fevers.” P. 2281
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)
“M” (”Michigan?”) “OSEH Occupational Safety and Environmental Health Guideline: Infectious Biological Agents and Recomninant DNA” Guide No. BLS003 July 3, 2003
Bradway, “‘Mystery Island’ is no threat to us,” NEWSDAY opinion, Oct 3, 2004 p. A56.
- argues plum island is safe, but points out some lab errors/incidents.
- mistakes in science.
MacKenzie, Debora, “Experts Fear Escape of 1918 Flu from Lab ,” New Scientist, October 21, 2004. http://www.newscientist.com/article/dn6554-experts-fear-escape-of-1918-flu-from-lab.html
- “‘The potential implications of an infected lab worker – and spread beyond the lab – are terrifying,’ says D. A. Henderson of the University of Pittsburgh, a leading biosecurity expert.”
- “‘All the virologists I have spoken to have concerns,” says Ingegerd Kallings of the Swedish Institute for Infectious Disease Control in Stockholm, who helped set laboratory safety standards for the World Health Organization.’”
- “Kallings and others are calling for international discussions to resolve the issues related to such work. ‘It is time for influenza scientists to find a consensus on containment,’ she says. John MacKenzie of the University of Queensland in Australia, who investigated how the SARS virus escaped from high-level containment labs in east Asia on three occasions after lab workers became infected, agrees. ‘A meeting would be beneficial.’”
- “The team started the work at the highest level of containment, BSL-4, at Canada’s National Microbiology Laboratory in Winnipeg. Then they decided the viruses were safe enough to handle at the next level down, and did the rest of the work across the border in a BSL-3Ag lab in Madison.”
- “The main difference between BSL-4 and BSL-3Ag is that precautions to ensure staff do not get infected are less stringent: while BSL-4 involves wearing fully enclosed body suits, those working at BSL-3Ag labs typically have half-suits.”
- “Kawaoka told New Scientist that the decision to move down to BSL-3Ag was taken only after experiments at BSL-4 showed that giving mice the antiviral drug oseltamivir (Tamiflu) in advance prevented them getting sick. This means, he says, that if all lab workers take oseltamivir ‘they cannot become infected’.”
- “Terrence Tumpey’s team at the US Department of Agriculture’s poultry research lab in Athens, Georgia, got quite different results: they found that mice given oseltamivir still got sick and 1 in 10 died. It is not clear why Kawaoka’s mice fared better.”
- “Yet Kawaoka’s decision does comply with the US National Institutes of Health guidelines for BSL-3 agents: those causing ‘serious or lethal human disease for which preventive or therapeutic interventions may be [its italics] available.’”
- “By contrast, the team in Georgia, the first to experiment with genetically engineered 1918 viruses, did all its work at BSL-3Ag. Meanwhile, Michael Katze at the University of Washington at Seattle is planning to expose monkeys to aerosols of 1918-type viruses at BSL-3, a step down from BSL-3Ag. The recent SARS escapes were from BSL-3 labs.”
- “‘We would have to do any such work at BSL-4,’ says John Wood of the UK’s National Institute for Biological Standards and Control. In the US, the differing standards applied by different groups are due to the fact that experiments on engineered viruses such as the 1918 flu are approved on a case-by-case basis by Institutional Biosafety Committees (IBCs), composed of local scientists and officials. Critics say these are free to interpret the official guidelines in a way that suits them.”
- “‘There is no effective national system to ensure consistency, responsibility and good judgement in such research,’ says Edward Hammond of the Sunshine Project, a biosecurity pressure group in Austin, Texas. In a review of IBCs published this month, he found that many would not provide minutes of recent meetings as required by law.”
- “He [Hammond] says the IBC that approved the planned 1918 flu study at the University of Washington considered only one scenario that could result in workers being exposed to airborne virus – the dropping of samples. Its solution: lab workers ‘will be trained to stop breathing.’”
Santora, Marc, “City Opens a Secure Lab To Counter Bioterrorism,” 14 July 2004, New York Times [http://query.nytimes.com/gst/fullpage.html?res=9807E4DA163AF937A25754C0A9629C8B63&scp=3&sq=bioterrorism&st=cse] Last Checked 20 February 2011.
- “Opening of a $16 million high-security laboratory to help detect and deal with future threats.”
- “Today New York faces a different kind, a more dangerous kind, of biohazard: bioterrorism.”
- “The laboratory here, which is testing for bioterrorism, also greatly upgrades our ability to test rapidly, say, for tuberculosis.'”
- “In the new lab, more than 100 technicians and scientists will be able to work at one time if required.'”
- “…secure Level 3 section. Those areas, which hold dangerous pathogens, feature filtered air, sealed doors and negative air pressure, which prevent germs from leaking out.”
- “Since Sept. 11, 2001, universities, states and the federal government have greatly expanded their financing for Level 3 facilities, raising concern about ensuring the security of the pathogens being studied.”
Bavoil, Patrik, M, “Federal Indifference to Laboratory-Acquired Infections,” Applied BIOSAFETY, 10(1) pp 5-7, 2005.
Shane, “Exposure at germ lab reignites a public health debate” NYT January 24, 2005 A13,
- critical of spending
- response increasing risk (see also Mordini, wheelis & Dando, Nature June 20, 2002)
Altman, Lawrence, K., Santora, Marc, “Risk From Deadly Flu Strain Is Called Low,” NYT, April 14, 2005.
- Lab mistake contaminated specimen with dangerous 1957 strain.
- Mistake in sending out H2N2, Level 2 microbe subject to upgrade.
KAREN T. MORR, [the Acting Assistant Secretary for Office of Information Analysis in DHS] Statement, ”HEARING BEFORE THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, SCIENCE, AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES, ONE HUNDRED NINTH CONGRESS”, FIRST SESSION JULY 12, 2005. “PROJECT BIOSHIELD: LINKING BIOTERRORISM THREATS AND COUNTERMEASURE PROCUREMENT TO ENHANCE TERRORISM PREPAREDNESS.”
- “Al-Qa’ida documents recovered from a training camp in Afghanistan show interest in a variety of biological agents and mentioned plague, anthrax, cholera and tularemia.”
- “To determine threat, we examine an actor’s capability and intent. We assess capability based on factors such as the actor’s level of skill or knowledge, their ability to acquire a biological agent, the materials necessary to grow the agent and their capacity to effectively disseminate a biological agent. For intent, in addition to the actor’s desire to simply use biological weapons, we discern which agents they are more likely to pursue, their preferred method of deployment and which targets they intend to attack.”
- “Last month one of our analysts provided some of the Committee members with a classified briefing on the specifics of the current bioterrorist threat to the Homeland. I will not be able to revisit this classified threat assessment in this open forum but we would be happy to provide this information to additional members in a closed session.”
- “On occasion, we require quick access to information that does not reside within IA. In these cases, our analysts are supported to the Biodefense Knowledge Center (BKC)—a 24×7 support cell based at Lawrence Livermore National Laboratory and sponsored by the S&T Directorate. The BKC possesses vast repositories of biological technical information and is able to access SMEs from around the country, such as the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. Army Medical Research Institute for Chemical Defense (USAMRICD), and the Armed Forces Medical Intelligence Center (AFMIC), in support of a tasking from IA. The BKC compiles the appropriate information and relays it to our analysts who integrate the information into their finished intelligence analysis.”
- “Our analysts regularly collaborate with other intelligence agencies, particularly NCTC, DIA, FBI, and CIA. We also work with experts from government, academic, and private institutions and partner with scientists who keep us abreast of their potential areas of concern and the trends they see. Interaction with outside public and private sector institutions keeps us well-informed of new and emerging technology that may be exploited or misused by malicious actors. For example, IA recently hosted a workshop on emerging biotechnologies and the future biological threat. This provided a forum for non-governmental experts to provide IA with information of which they believe we should monitor.”
- “Our analysts are broadly focused and access a wide array of information in gathering source material for our assessments. They use all-source intelligence, scientific and technical information, terrorist profiles, historical trends, and open source information such as media reports and scientific journal articles.”
- “We keep current on foreign State biological weapons program developments as these activities may have implications for future terrorist events. We look at the intent of the enemy, their capabilities, potential scenarios, and attack vectors. Working with counterterrorist experts in the Community, we develop link charts on potential associates here in the United States of operatives abroad who may have received training in WMD capabilities or have knowledge of WMD programs.”
- “we assessed the implications of the H2N2 influenza shipment in which a U.S. contractor sent a highly virulent strain of influenza to hundreds of laboratories worldwide. We also recently published an Information Bulletin advising State and local Law Enforcement officials of indicators of covert anthrax production. Generally, our products fall into two categories: threat assessments and feasibility assessments.”
- “Threat Assessments. Threat assessments are written on known actors and are based on specific intelligence. To determine threat, we examine an actor’s capability and intent. We calculate capability based on factors such as a particular actor’s level of skill or knowledge; their ability to acquire a biological agent and the materials necessary to grow the agent; and their capacity to effectively disseminate a biological agent. For intent, we consider more than just an actor’s desire to use biological weapons. We attempt to discern which agents they are more likely to pursue, their preferred method of deployment, and which targets they intend to attack.”
- “Feasibility Assessments. Intelligence is never complete or all-knowing and we cannot wait until intelligence is received in order to consider plausible scenarios or the impact of a particular technique or technology on a bioterrorist’s capability. To move beyond this limitation, IA, in partnership with S&T, conducts assessments of biological processes, emerging technologies, and techniques and determines their feasibility for use in a bioterrorism event. These assessments include indicators that will help to identify if a particular scenario begins to unfold so we can prevent or disrupt events before they occur. In conjunction with the feasibility assessment, we are producing unclassified excerpts with the indicators which are distributed widely to local, State, Federal officials as well as the private sector to enhance awareness in the field and to increase suspicious activity reporting and trigger investigations where necessary.”
- “IA also has produced several bioterrorism-specific ‘‘red team’’ products, which explore issues from a terrorist’s perspective using nongovernmental experts and creative thinkers. These topics have included terrorist use of genetically modified food and recombinant DNA technologies to damage the U.S. food supply; possible terrorist exploitation of a U.S. flu vaccine shortage; and the safety and security impacts of a pandemic influenza outbreak.”
- “Under the BioShield legislation, DHS is charged with assessing current and emerging threats of chemical, biological, radiological, and nuclear agents; and determining which of such agents present a material threat against the United States population. S&T, supported by IA, has been conducting Material Threat Assessments (MTAs) and Material Threat Determinations (MTDs) in order to guide near term BioShield requirements and acquisitions.”
- “MTAs … are speculative and represent a best estimate of how an adversary may create a high-consequence event using the agent/weapon in question. Currently, MTAs are drafted by the S&T and IA provides comments on the assessment before it is provided to HHS. In our review, we ensure that the assessment reflects what IA assesses is the general capability of terrorist groups that are pursuing biological weapons.”
- “MTAs result in an estimate of the number of exposed individuals, the geographical extent of the exposure, and other collateral effects. If these consequences are of such a magnitude to be of significant concern to our national security, the Secretary of DHS then issues a formal Material Threat Determination to the Secretary of HHS, which initiates the BioShield process. To date, one MTA has been completed for anthrax and MTAs for plague, botulinum toxin, tularemia, radiological devices and chemical nerve agents are underway and an MTA for viral hemorrhagic fevers will be initiated next month. MTDs have been approved for four agents: smallpox, anthrax, botulinum toxin, and radiological/nuclear devices.”
- “IA, in cooperation with NCTC and the FBI, is providing WMD outreach briefings around the country. These briefings outline the terrorist WMD threat, including descriptions of the types of weapons used and indicators and warnings aimed at increase awareness and reporting. In the near future, we hope to expand these briefings to other audiences such as academia and the private sector to further increase awareness and reporting.”
- “IA will be playing a key role in supplying current intelligence to the National Biosurveillance Integration System (NBIS) operations center once it begins operation later this summer. NBIS will fuse information on human, plant, and animal health with environmental monitoring of air, food, and water systems. This information will be integrated with threat and intelligence information to provide real-time situational awareness and identify anomalies or trends of concern to the Homeland Security Operations Center.”
Sharp, Phillip, “1918 Flu and Responsible Science“, Science, Volume 310. 7 October 2005, page 17.
- “The influenza pandemic of 1918 is estimated to have caused 675,000 deaths in the United States.”
- “We now have the sequence of the virus, perhaps permitting the development of new therapies and vaccines to protect against other such pandemic. The concern is that a terrorist group or a careless investigator could convert this new knowledge into another pandemic.”
- “Influenza is highly infectious, and a new strain could spread around the world in a matter of months, if not weeks. The public needs confidence that the 1918 virus will not escape from research labs.”
- “All of the described experiments were done in a Biosafety Level 3 laboratory, a high-containment environment recommended by the U.S. Centers for Disease Control and Prevention and the National Institute of Health on an interim basis, whose use should become a permanent requirement for such experiments.”
- “The dual use nature of biological information has been debated widely since September 11, 2001. In 2003, a committee of the U.S. National Academies chaired by Gerald Fink considered this issue, weighing the benefits against the risks of restricting the publication of such biological information.”
- “The U.S. National Science Advisory Board for Biosecurity (NSABB) was asked to consider these papers before publication and concluded that the scientific benefit of the future use of this information far outweighs the potential risk of misuse.”
- “Because a pandemic infection is dependent on many unknown properties, there is no certainty that the reconstructed 1918 virus is capable of causing a pandemic.”
Epstein, Gerald L., “Law Enforcement and the Prevention of Bioterrorism: Its Impact on the US Research Community,” GLOBAL NON-PROLIFERATION AND COUNTER-TERRORISM: THE IMPACT OF UNSCR 1540, Eds. Bosch, Olivia and Peter van Ham, Brookings Institution Press: 2007.
- Law enforcement aims to prosecute offenders, tighten security and increase preventitive measures for bioterrorism.
- concern over biological research use
- The AntiTerrorism and Effective Death Penalty Act of 1996: regualting transport of biological agents, prevent access for criminal use.
- imbalanced rules in science vs. law enforcement, restrictions on biological research impeding/infringing upon research creativity
- Tomas Foral, Thomas Butler, Steven Kurtz
Associated Press, “Biodefense work still banned: But university says issues cited by federal agency have been fixed,” HOUSTON CHRONICLE, Dec 27, 2007,
- Texas A&M
- mistakes in science
GAO Report, “BIOSAFETY LABORATORIES: Perimeter Security Assessment of the Nation’s Five BSL-4 Laboratories,” GAO-08-1092, September 2008.
Young, Alison, “Georgia Lab Workers Exposed to Bioterror Agent,” Atlanta Journal Constitution, January 30, 2008.
- “Hundreds of laboratory workers across the country -including 57 in Georgia- were potentially exposed to a weakened bioterrorism agent when samples were mishandled as part of a voluntary readiness test, state and federal health officials said.”
- “At 16 of Georgia’s 27 clinical labs participating in the test, workers failed to follow proper handling procedures and were potentially exposed to a vaccine strain of ”Brucella abortus RB51.””
- “So far, the CDC identified 916 workers in 254 clinical labs who were potentially exposed to Brucella during the nationwide Laboratory Preparedness Survey last fall.”
- “Twice a year, labs that voluntarily participate in the program are sent samples of various disease-causin organisms. SInce 2006, the tests have included weakened bioterrorism organisms after the labs said they needed more realistic exercises of their preparedness, CDC officials said.”
- “The testing kits included written instructions stating the samples should be handled inside a special safety cabinet and within the protective barriers of a Biosafety Level 3 lab. Despiet these instructions, some lab workers handled the samples in high risk ways, even sniffing open culture plates as they sought clues to what was growing on them, records show. Certain odors are associated with some bacteria.”
Byers, Karen, B., “Biosafety and Biosecurity: Past and Present,” Address, 2009 APHL Annual Meeting, May 5-8, 2009. http://www.aphl.org/profdev/conferences/proceedings/Documents/2009/2009_APHL_Annual_Meeting/032Byers.pdf
- Laboratory Acquired Infections.
- “There is no national reporting system; no statistical epidemiological data,” (for Laboratory acquired infections.)
- “Reports in the scientific literature tell us that laboratory-acquired infections can and do occur. Insight, but not statistics, are available from literature surveys.”
- “Clinical laboratories: 471 bacterial LAI between 1979-2004.”
- “Fatalities: 11 N. meningitidis, two Salmonella (1 one was secondary); four fetuses were fatally infected by B. melitensis.”
- Citing: “Biological Safety Principles and Practices, 4th edition.2006.Fleming, Hunt Ed. ASM Press.”
Hernandez, N., Tyson, Scott A., “Army Nearly Done with Probe of Fort Detrick,” The Washington Post, April 23, 2009.
- “Army investigators are close to closing a probe into the disappearance of deadly pathogens at Fort Detrick’s infectious disease laboratory in Frederick and have found no evidence yet of criminal misconduct, the Army’s Criminal Investigation Command said yesterday.”
- “Since last year, investigators have been trying to discover what happened to three small vials of Venezuelan equine encephalitis virus that were unaccounted for, according to Caree Vander Linden, the spokeswoman for the lab.”
- “The virus that causes Venezuelan equine encephalitis is mosquito borne and usually causes a mild flulike illness but can also cause brain inflammation and death. It has potential for use as a biological weapon but is far less lethal than some other agents the lab works with.”
- “Vander Linden said that when one scientist left the institute several years ago, he handed down his materials to another scientist, who left three years later. Last year, a successor took an inventory of the samples and found three vials missing, triggering an investigation, she said. The vials were probably missing because a freezer in which they were kept failed, destroying the batch, she said.”
- “Alan Schmaljohn, a longtime scientist at the lab who is now a professor at the University of Maryland, said he had been questioned two or three months ago as someone who once had access to the virus.”
- “Schmaljohn said he hadn’t. He said the quantity of missing material was relatively small and easy to lose, especially if one of the freezers fails, requiring the vials to be rearranged.”
Grossman, Elaine, M., “Science Groups Counter WMD Panel’s Prescription for Stemming Biological Threats,” Global Security Newswire
Health & Human Services & U.S. Department of Agriculture, Co-Chairs, “Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight,” July 2009. http://www.hhs.gov/aspr/omsph/biosafetytaskforce/index.html
- “At the October 4 , 2007, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing entitled ‘Germs, Viruses, and Secrets: The Silent Proliferation of Bio-Laboratories in the United States.’ the Department of Health and Human Services (HHS) announced the formation of the Trans-Federal Task Force on Optimizing Biosafety Oversight 9the ‘Task Force’).” p. 4.
- “The purpose of the Task Force is to propose options and recommendations to improve bioafety and biocontainment oversight of research activities at high and maximum containment research laboratories in the United States through a comprehensive review of mechanisms by which individual research 9local0 institutions and the Federal Government can ensure safe working conditions.” p. 156.
- “The Task Force envisions effective, comprehensive, local (institutional) and Federal oversight that protects laboratory workers, public health agriculture, and the environment, without hindering the progress of science.” p. 156.
- “there are four areas of concern, which include lapses in biosafety, lack of timely reporting of incidents, and lack of Federal oversight for research involving pathogens that are neither select agents nor recombinant DNA agents.” p. 4.
- “The issues of biosafety and personnel reliability, although related to laboratory biosafety and biocontainment, are not the focus of this report but are being addressed by a Federal Working Group established by Executive Order 13486, ”Strengthening Laboratory Biosecurity in the United States’” p. 5.
- “Recommendations 1.1: Identify or establish a Federal entity to coordinate biosafety and biocontainemtn activities, and to ensure comprehensive and effective Federal oversight for all high and maximum containment research facilities and activities in all sectors. …” p. 10.
- “… 2.2: Support the development of an accreditation system for biosafety/biocontainment management programs at high and maximum containment research institutions.” p. 10.
- N.B. “The term ‘high and maximum containment’ is used in this report to describe biosafety level 3 (BSL-3) and BSL-4 laboratories and equivalent containment facilities…” p. 4.
- “3.1: Establish national, position-specific training standards and core competencies in biosafety and biocontainemnt for all research, managerial, and support personnel at high and maximum containment research laboratories in all sectors.” p.11
- “4.1: Establish: (1) a new voluntary, non-punitive incident reporting system for high and maximum containment research laboratories…””
- “5.1: Develop comprehensive biocontainment guidelines comparable to those of the BMBL to cover research, including high and maximum containment research, on plant, livestock, and other agriculturally significant pests and pathogens.” p. 11.
- “6.1: Require … proper installation of and preventive and ongoing maintenance programs for biosafety and biocontainment infrastructure and equipment.” p. 12.
- “7.1: Develop and maintain a robust program of applied biosafety and biocontainemnt research to create additional and update exisiting evidence-based practices and technologies.” p. 12.
- “8.1: Develop comprehensive strategies to improve public communication, outreach, and transparency about biosafety and biocontainment issues and activities at high and maximum containment research facilities.” p. 12.
Fitzsimmons, Emma, Graves, “Researcher Had Bacteria For Plague At His Death,” NYT, A 13, Sept. 22, 2009.
- “researcher, Malcom Casadaban, 60 had a weakened strain of the bacteria Yersinia pestis in his blood when he died from an infection on Sept. 13, university officials said.”
- [He was] studying the bacteria to create a better vaccine for plague.”
- “As a precaution, though, the University of Chicago medical Center offered antibiotics to about 100 people who knew the researcher, including his family members, friends and colleagues.”
- “Plague is rare in the United States, with fewer than 15 cases reported annually, mostly in rural areas in the Southwest, according to the C.D.C. About 1,000 to 3,000 cases of plague are reported globally each year, many in Africa.”
- “Dr. Casadaban had hoped to create a better vaccine for plague in part because of concerns about its possible use in bioterrorism.”
- “Officials are investigating whether Dr. Casadaban may have become infected through breathing, through a cut in his skin, or through his eyes or mouth.”
- “… required to follow safety guidelines, including wearing gloves, a lab coat and goggles and using a biosafety cabinet, a device that has a filter to clean the air in a laboratory, according to the C.D.C.”
MacInnis, Laura and Sherman, Debra “European lab accidents raise biosecurity concerns” Reuters, March 19, 2009. http://www.reuters.com/article/idUSLJ556939
- “Bird flu and Ebola virus accidents raise biosecurity fears”
- “European states urged to improve lab accident disclosure” *”Northern Europe reports most lab-acquired infections”
- “Health authorities and industry groups reviewing European lab safety standards concluded in a new report that scientists and managers needed to be better trained in ways to prevent, handle and report such incidents.”
- “Summermatter [Biosafety Europe’s project coordinator] said greater transparency about incidents that do occur was essential to help identify and reduce risks: “It is important to learn from the experience of other laboratories.””
”’Ziff, Deborah”’; ”’Seely, Ron”’, “UW-Madison professor barred from lab for potentially dangerous experiments,” May 11, 2010, Wisconsin State Journal,[http://host.madison.com/wsj/news/local/education/university/article_bc095ae8-5d4a-11df-8e83-001cc4c03286.html] last checked 10/30/2011.
*”A UW-Madison professor who studies an infectious disease lost his laboratory privileges for five years after conducting unauthorized experiments with a potentially dangerous drug-resistant germ.”
*”One person who worked in professor Gary Splitter’s lab got brucellosis but university officials don’t know if that individual, who has since recovered, caught the strain used in the unauthorized experiments.”
*”Brucellosis is a disease that is usually found in farm animals but can spread to humans and cause flu-like symptoms or worse.”
*”The 2007 experiments, which the National Institutes of Health calls a ‘major action violation,’ in part prompted the university to beef up its biological safety oversight. The university was also fined $40,000.”
*”Splitter, a tenured professor in the School of Veterinary Medicine, won’t be allowed to work in a lab for five years because of the violation.”
*”Splitter said he was not aware of the unauthorized experiments, which he said were conducted by graduate students in his lab, and that the university did not properly educate researchers about guidelines for working with antibiotic-resistant strains.”
*”His lab created antibiotic-resistant strains of brucellosis and inserted them into mice in 2007 and possibly earlier, university officials said, without approval from local or federal agencies. The concern is that if someone contracted the antibiotic-resistant version of the disease created in the lab, treatment might have been more difficult.”
*”The university learned of the stock of antibiotic-resistant strains after a round of university-wide lab inspections by the Centers for Disease Control and Prevention. They began investigating Splitter’s lab in early 2008.
*”University officials said evidence gathered during the investigation contradicted Splitter’s claim that he was unaware of the work being done by his students.”
*”Splitter said part of the problem was understaffing in the university’s bio-safety program, which is charged with training scientists about regulations. At the time of the experiments, he said, there were only two people employed in the program and neither were trained biologists.”
*”In the past year, UW-Madison has hired five biological safety officers and a new director, said Bill Mellon, associate dean for research policy.”
*[[Brucellosis]], [[Lab Safety]], [[Misconduct]], [[Oversight]], [[CDC]], [[Academia]], [[Drug Resistance]], [[Scientist]]
”’Basken, Paul”’, “Scientist, Banned From Lab, Blames U. of Wisconsin for Biosafety Lapse,” May 19, 2010, Chronicle of Higher Education[http://www.chroniclecareers.com/article/Scientist-Banned-From-Lab/65632/], last checked 10/30/2011.
*”University of Wisconsin officials suspended a professor’s laboratory privileges over unapproved tests involving an infectious disease, and said they’ve sent a strong message about accountability for hazardous materials.”
*”The five-year ban on hands-on lab work “does not restrict other people from submitting grants; it doesn’t restrict me from being an investigator on a grant; it doesn’t restrict me from working with others on grants or on science,” Dr. Splitter, a tenured professor of pathobiological sciences and a veterinarian, told The Chronicle.”
*”The case, which dates back to a routine inspection of Dr. Splitter’s lab by federal officials nearly three years ago, has garnered national attention in the past week as an example of concerns that the government may not be doing enough to guard against accidental or intentional spreads of pandemic disease.”
*”In the case of Dr. Splitter, the work involved the pursuit of a vaccine for brucellosis, a disease that humans contract from farm animals. Its effects are usually limited to chronic flu-like symptoms, though complications make it fatal in about 3 percent of cases. The disease infects about 500,000 people a year, mostly in developing countries, where the months-long process of treatment with antibiotics can be prohibitive.”
*”Ensuing investigations, which involved interviews of Dr. Splitter’s graduate students by federal inspectors and a nine-month closure of his lab, led to an agreement with federal officials last October in which the university paid the $40,000 fine. The university disclosed this month its decision to suspend Dr. Splitter’s laboratory privileges for a five-year period, ending in 2013. (He has not been allowed in his lab since 2008 because of the investigation, so the university is counting those years as part of his suspension.)”
*”William S. Mellon, associate dean for research policy at the University of Wisconsin at Madison Graduate School, said the university acted to penalize Dr. Splitter after concluding that Dr. Splitter was aware that new federal rules imposed after the September 11, 2001, attacks on the United States required him to seek specific government approval for his work with antibiotic-resistant genes.”
*”It appears, Mr. Mellon said, that Dr. Splitter—who has spent 32 years at the University of Wisconsin and is one of only about five experts worldwide working on a vaccine for brucellosis—simply never accepted the new requirements imposed on researchers. “Those are hard transitions to make—I understand that,” Mr. Mellon said.”
*”Investigations, both by federal officials and by outside analysts hired by the university, found the campus’s Institutional Biosafety Committee ‘was an organization in disarray,’ Dr. Splitter said.”
*”Mr. Mellon said he recognized that the case highlighted some shortcomings in the university’s operations and that the university has responded, hiring five new biological-safety officers and a new director for the operation. He said it’s ‘silly,’ however, for Dr. Splitter to deny his own responsibility.”
*”One of the graduate students, discussing the case with The Chronicle on the condition he not be identified, said the case pointed out the confusion over regulations and the hassles that await him if he decides to continue working with hazardous agents.”
*”The university’s penalty against Dr. Splitter became public the same week the Proceedings of the National Academy of Sciences published an analysis suggesting that the more restrictive biosafety laws imposed after the 2001 attacks had led to far fewer published studies in the field and accelerated the rate of researchers turning to other fields of study.”
*[[Brucellosis]], [[Lab Safety]], [[Misconduct]], [[Oversight]], [[CDC]], [[Academia]], [[Drug Resistance]], [[Scientist]]
”’Bita, Natasha”’, “Checks by the TGA reveal 98 per cent of drug labs have problems,” The Australian,[http://www.theaustralian.com.au/news/nation/checks-by-the-tga-reveal-98-per-cent-of-drug-labs-have-problems/story-e6frg6nf-1225893662606] July 19, 2010.
*” Deficiencies have been uncovered at 98 per cent of the pharmaceutical laboratories audited by the drugs regulator in the past year.”
*”The federal government’s Therapeutic Goods Administration yesterday revealed that only three of the 139 labs it audited last financial year were problem-free.”
*”But the TGA is now investigating the cause of discolouration affecting some multi-dose vials of Panvax — a problem it became aware of only after the FDA blew the whistle during its own audit of CSL in April. The TGA has proclaimed Panvax to be safe, even though it still does not know the cause of the discolouration.”
*”The TGA is conducting a separate inquiry into CSL’s seasonal flu shot — a world-first combination of swine and seasonal flu strains in a single vaccine.”
*[[Vaccination]], [[Oversight]], [[Lab Safety]], [[Australia]]
”’Soroka, Stephen D., et. al.”’, “A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials,” The International Association for Biologicals, Elsevier, Microbial Pathogenesis and Immune Response (MPIR) Laboratory, Meningitis and Vaccine Preventable Diseases Branch, Division of Bacterial Diseases, Microbial Pathogenesis and Immune Response (MPIR) Laboratory, Meningitis and Vaccine Preventable Diseases Branch, Division of Bacterial Diseases, Accepted September 2, 2010.
*”A two-stage, multilevel assay quality control (QC) system was designed and implemented for two high stringency QC anthrax serological assays; a quantitative anti-PA IgG enzyme-linked immunosorbent assay (ELISA) and an anthrax lethal toxin neutralization activity (TNA) assay.”
*”A total of 57,284 human serum samples were evaluated by anti-PA enzyme-linked immunosorbent assay (ELISA) and 11,685 samples by anthrax lethal toxin neutralization activity (TNA) assay. The QC system demonstrated overall sample acceptance rates of 86% for ELISA and 90% for the TNA assays respectively.”
*”The purpose of the data generated by the Anthrax Vaccine Research Program (AVRP) was to inform significant public health decisions on the use and distribution of the only licensed anthrax vaccine in the US. The wide ranging impact of these decisions on vaccination and emergency preparedness policies, together with the long duration of the study, required that the biological assays used for primary and secondary endpoint determination were precise, accurate, sensitive, specific and validated [5e7].”
*”The overall performance of the ELISA Positive control concen- trations and the TNA assay reference standard ED50 demonstrated high precision and accuracy for both assays over time (Table 3).”
*”The system established in our laboratory for the monitoring assay performance provided an increased measure of confidence in the AVRP data obtained from these serological assays.”
*”The quality control system established here is an adaptable system for other types of serological assays and has since been applied effectively for use with influenza serological assays as part of the pandemic H1N1 emergency response in 2009 (Hancock, K., personal communication).”
*[[Anthrax]], [[Lab Safety]], [[Flu]]