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Biodefense Research: Can Secrecy and Safety Coexist?
by Laura H. Kahn, MD, MPH, MPP
Over the next 10 years, the United States will spend $6 billion to develop countermeasures against biological and chemical weapons. Much of this research on highly virulent pathogens will be done in academic settings around the country. This article explores the challenges in ensuring secrecy to protect national security while accommodating the right of local communities to have access to safety information regarding select agents and laboratory-acquired infections. Secrecy has been defended as being vital for protecting national security.
Problems with secrecy can include the misinterpretation of intentions, particularly in laboratories located in nuclear weapons design facilities, and the restricted access to information relevant to public health and safety. While federal select agent legislation requires laboratories to have emergency plans in place with first responders, these plans do not necessarily include public health professionals, who will be responsible for any future public health action, such as quarantine, surveillance, or mass vaccinations, in the unlikely event that a laboratory acquired infection spreads into a community. Laboratory-acquired infections do occur, even with the best safety mechanisms in place; however, the epidemiology of the incidence and severity of these infections are not known since there is no national surveillance reporting system.
Evidence suggests that many of these infections occur in the absence of an actual laboratory accident. The best emergency plans and surveillance systems are only as good as the participation and vigilance of the laboratory workers themselves. Thus, laboratory workers have a responsibility to themselves and others to report all laboratory accidents and spills, regardless how minor. In addition, they should have a lower threshold than normal in seeking medical attention when feeling ill, and their physicians should be aware of what pathogens they work with to reduce the risk of a delay in diagnosis.
In February 2003, the Bush Administration announced Project BioShield, in which an estimated $6 billion over 10 years will be available to researchers to develop countermeasures to biological and chemical weapons.1 [Note: As we go to press, the U.S. House of Representatives has passed the bill, but it is still under consideration in the Senate.] Since 1969, and until recently, research on highly virulent pathogens was unclassified and done in high-security biocontainment laboratories in government facilities such as those at the Centers for Disease Control and Prevention (CDC) and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).2
Much of the proposed biodefense research will be conducted in biosafety level (BSL) 2, 3, and 4 laboratories in academic settings around the country.3 Although the expansion of this research from a few government laboratories to many academic laboratories around the nation may have merit, advocacy groups, such as The Sunshine Project of Austin, Tex, and the Council on Responsible Genetics in Boston, Mass, are opposed to having high-security containment laboratories in their communities.4 They cite concerns about the problems of secrecy surrounding biodefense research and about the potential risks of laboratory accidents. This article examines the challenges of balancing secrecy to protect national security with the right of local communities to have access to safety information regarding “select agents” and laboratory-acquired infections.5
The Argument for Secrecy
In 1995, Larry Wayne Harris, a microbiologist with ties to a white-supremacist group, ordered Yersinia pestis from American Type Culture Collection (ATCC, Manassas, Va). The company that sent him the vials became suspicious after a telephone conversation revealed that his research was to counteract “Iraqi rats carrying supergerms.” One week later, federal and local law enforcementofficials obtained a search warrant and found three vials of pathogens in his car and explosives in his home. At the time, there were no laws prohibiting the possession of such agents, and Harris was sentenced to 18 months’ probation for wire fraud.6 This event contributed to the passage of the Antiterrorism and Effective Death Penalty Act of 1996 (Select Agent Legislation), which tightened regulatory controls on the transfer, packaging, and acquisition of pathogens. All laboratories transferring select agents were then required to be registered with the CDC.7
The anthrax attacks of 2001 sickened 22 individuals and killed 5;8 no perpetrator has yet been found.9 This event, and the 9/11 terrorist attacks, led to the passage of two pieces of legislation: the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of October 2001 (USA PATRIOT Act) and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Response Act). The USA PATRIOT Act makes it illegal for anyone in the U.S. to possess any biological agent for an inappropriate reason, and the Bioterrorism Response Act requires, among other things, the establishment of a national database of the location and nature of select agents as well as the identities of those in possession of them.7 Access to this database is restricted. In response to this federal legislation, Maryland has so far been the only state to pass legislation that establishes its own Biological Agents Registry.10 This law essentially duplicates the federal mandate and requires that all individuals in possession of select agents in Maryland must register with its state database in addition to the federal one.
The Challenges of Secrecy
Although secrecy is considered important in protecting national security, there are problems associated with it. First, secrecy can invite misinterpretation of intentions, not only by a nation’s citizens but also by its international allies. While there is no indication that the research associated with Project BioShield will be classified, there is evidence that some government agencies, such as the Central Intelligence Agency and the Defense Department,are conducting secret biodefense programs that may be pushing the limits of the 1972 Biological Weapons Convention (BWC), which could lead to a diplomatic disaster.11 For example, in the late 1990s, the CIA developed a project named “Clear Vision,” which sought to develop Soviet-style germ bomblets, and the Defense Department’s Defense Threat Reduction Agency (DTRA) developed “Project Bacchus,” which built a small-scale germ facility at the Nevada Test Site.11 The BWC bans developing, producing, acquiring, retaining, or stockpiling a weapon or other means of delivering germ agents “for hostile purposes or in armed conflict.” These projects, while not undertaken with hostile intent, did result in products that could arguably be prohibited by this treaty.
Furthermore, high-security containment biological laboratories being built at highly classified nuclear weapons design sites at Lawrence Livermore National Laboratory in California and Los Alamos National Laboratory in New Mexico are creating concern about the U.S.’s biodefense efforts at these facilities.12 Since there is a fine line between offensive and defensive biological research, conducting research on highly virulent pathogens in a facility that designs nuclear weapons could invite international suspicion and threaten future multinational negotiations involving biological weapons. In addition, these facilities have had a history of problems involving security lapses and environmental contamination.12 In February 2001, the Department of Energy’s (DOE) Inspector General issued a report faulting the DOE laboratories for insufficient organization, coordination, and direction in activities which could increase the risk to workers and others from exposure to biological select agents.13
Second, secrecy can interfere with access to information relevant to public health and safety. In November 2003, Dr. Marcelle Layton, Assistant Commissioner for the Bureau of Communicable Diseases at the New York City Department of Health and Mental Hygiene, spoke about the conduct of sensitive research from a public health perspective in a symposium at the New York Academy of Sciences. Dr. Layton stated that, in the absence of an emergency, state and local government officials are not able to get access to information regarding what select agent research is being done in their jurisdictions because of the federal select agent legislation. She stated that this information would be useful to have ahead of time so that her agency could better prepare for the possibility of a laboratory accident that spreads to the general community.14
While the Select Agent Rule requires that laboratories have an emergency response plan that includes planning and coordination with outside parties, there is no specification that public health or medical professionals be included in these plans.15 “First responders” are usually defined as emergency medical technicians, firefighters, hazardous materials response teams, and law enforcement officials. In cases involving potentially dangerous pathogens, first responders should also include public health professionals and physicians, because the consequences associated with accidents involving these agents are potentially of public health or medical importance.
Public Health Versus Occupational Risk
The public health (i.e., the general population) risk of exposure to dangerous pathogens varies depending on the type of research being done. For example, offensive research involving open-air testing of pathogens poses considerable public health risk. A smallpox outbreak in Aralsk, Kazakhstan, in 1971 has been attributed to the open-air testing of “weaponized smallpox” conducted at a nearby Soviet research facility on Vozrozhdniye Island.
This smallpox outbreak sickened 10 individuals, 3 of whom died. The public health response required vaccinating the entire population of Aralsk (approximately 36,276 people), daily house-to-house visits for surveillance of fevers and rashes, and quarantine measures.16 In contrast to the public health risk of offensive biological research involving open-air testing, the public health risk involved in peacetime or defensive research is minimal under normal conditions. There is a theoretical potential for infections to spread to the surrounding community for example, through deliberate terrorism using stolen laboratory pathogens. But under normal circumstances, there have been no outbreaks of disease originating from laboratories to the general public other than a sporadic few ill laboratory workers who inadvertently exposed family members.17 However, a few reported cases in which secondary spread was of potential concern are described below.
In 1978, a photographer working in the Birmingham University Medical School in the United Kingdom became ill with a fever and rash. She was admitted to the hospital 13 days later and subsequently was diagnosed with smallpox.18 Approximately 40 close contacts were identified, vaccinated, and placed under surveillance. Two contacts were hospitalized but were later determined not to have smallpox. At the time, the Birmingham University Medical School was one of the two laboratories in the UK known to be holding variola virus.18
Recently, the Severe Acute Respiratory Syndrome (SARS) virus infected 2 medical researchers in Taiwan and Singapore who were working in BSL-4 and BSL-3 laboratories, respectively.19 In the BSL-4 laboratory, liquid waste had spilled into a transporting chamber, and the researcher likely became infected after opening the chamber to clean it.19 After being exposed, the Taiwanese researcher traveled to a conference in Singapore before becoming ill; this event resulted in the quarantining of 90 people in both countries. In the second case, the BSL-3 laboratory in Singapore was faulted for poor safety practices after a researcher, working with West Nile virus, became infected with a SARS-contaminated specimen.20 The need to quarantine contacts was not reported in this case.
Fortunately, none of these incidents resulted in secondary cases; however, 2 did require public health responses: vaccination, surveillance, and quarantine. In contrast to the theoretical public health risk of biodefense research, the occupational (i.e., individual) risk for laboratory-acquired infections is considerable. There have been many reported cases of laboratory-acquired infections involving dangerous pathogens.
One example highlights the importance of the physician’s role in rapidly identifying the infectious, causative agent. In March 2000, a 33-year-old microbiologist working at USAMRIID developed tender axillary lymph nodes and a fever. He had been working for 2 years with Burkholderia mallei (glanders), had diabetes mellitus, and did not routinely wear gloves. His symptoms persisted for 10 days despite treatment with antibiotics and worsened over the next several weeks. In May, he was admitted to the hospital when his condition worsened to the point of needing life support. A CT scan showed multiple liver and spleen abscesses, and a culture from one of the liver abscesses yielded B. mallei. Once the organism was identified, he was treated with the appropriate antibiotics for 6 months and subsequently did well. The researcher did not recall a laboratory accident or break in his skin, but the delay in diagnosis was nearly fatal.21
Much has been done to improve laboratory safety over the past 2 decades. The CDC and the National Institutes of Health (NIH) have published guidelines for biosafety standards and practices in work performed on infectious agents and recombinant DNA molecules, respectively.17,22 These guidelines were developed to protect both the public and laboratory workers from dangerous research pathogens and laboratory-acquired infections. However, the exact frequency of laboratory-acquired infections in the U.S. is not known, because there is no national surveillance system to monitor them.23 Harding and Byers have conducted the most recent survey of symptomatic and asymptomatic laboratory-acquired infections by reviewing 206 worldwide publications from 1979 to 1999.24 Clinical, research, teaching, public health, and production facility laboratories were included in this survey. They found a total of 1,267 cases and 22 deaths (5 were aborted fetuses) from laboratory-acquired infections during this 20-year period. The most common causative pathogens included mycobacterium tuberculosis, Q fever, hantavirus, and arboviruses. Research laboratories constituted approximately half (644 of 1,267) of the laboratories where these infections were acquired.24
In addition, the authors found that only a small proportion of laboratory-acquired infections resulted from actual accidents; most were acquired by simply working in the laboratory or by exposure to infected animals. 24 Although a decrease in the number of laboratory-acquired infections is expected because of the improvements made in safety equipment and training, laboratory design, and safety awareness, without a knowledge of the total population at risk nor the total number of infections, it will be extremely difficult to know with certainty if the increase in biodefense research laboratories working on dangerous pathogens will increase the risk for severe laboratory-acquired infections. Collecting information on these infections would be extremely difficult without a national surveillance system and a mandate. Harding and Byers write that accurately quantifying these infections would be difficult because there is “an indifference to and, frequently, an unwillingness to report these incidents.”24
National Security And Local Safety
The challenge of protecting national security is to ensure safety without jeopardizing important information that local health officials will need to prepare for possible future public health actions. While traditional first responders may participate in keeping law and order during mass quarantines, treatments, or vaccinations during a public health emergency, the responsibility will fall squarely on local public health officials to lead and manage these actions. Therefore, public health officials should have access to the nature and location of select agents within their jurisdictions before an emergency occurs. This could be accomplished by amending the select agent legislation to provide local health officials secure access to this information. In addition, laboratory directors who are required to have emergency plans should share these plans not only with traditional first responders but also with local public health officials.
Rather than an accident, the more likely scenario requiring public health action is one in which a laboratory worker develops a laboratory-acquired infection from an unrecognized exposure. In such a case, the researcher might start to feel ill at some unspecified time, not necessarily related to work. The severity of the illness could influence whether or not the worker seeks medical attention. Assuming that work with more virulent pathogens will lead to a greater incidence of severe laboratory-acquired infections, one can argue that a national database could help to prove or disprove that biodefense work is inherently more dangerous, even with considerable safety measures in place. While this surveillance system may not be of immediate, obvious benefit to local health officials, national and local epidemiologic data on laboratory-acquired infections would provide an important baseline for monitoring the incidence and severity of such infections.
Of course, the best emergency plans and surveillance systems are only as good as the participation and vigilance of the laboratory workers themselves. Workers who do not report accidents (however minor) or who ignore early signs of illness pose a potential risk to themselves and others.25 Individuals who work with virulent agents should have a lower threshold in seeking medical attention when they feel ill. In addition, if they are seeing a physician who is unfamiliar with their medical history or occupation, they should inform him or her of the nature of their work and the agents they study. This information should also be highlighted in their medical records in addition to known serious allergies.
In its effort to build up an enormous biodefense program, the federal government has the challenge of protecting the public’s health and safety while maintaining control of security. Balancing these needs will not be easy. Secrecy, while justified in certain cases, poses problems, not only in terms of limiting important information for those who need it, but also in potentially fostering misinterpretation of intent and activities. Research being done in nuclear weapons design facilities poses the greatest danger in this regard.
Secrecy is not beneficial in emergency preparedness. Although laboratory accidents and infections are relatively rare, they do occur and preparations to confront them are best made with as much information and preparation as possible. In terms of public health preparedness, local health officials should be informed of what agents are being studied in their jurisdictions so they can prepare for any unlikely future events. A national surveillance system of laboratory-acquired infections would help to provide important information on the frequency and risks of this occupational hazard. Individual researchers themselves have a key role to play in ensuring safety, not only for themselves but for those they encounter when they are ill. An indifference or unwillingness to disclose accidents or illness should not be acceptable in this era of terrorism.
1. The White House News and Policies. Accessed on
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3. National Institute of Allergy and Infectious Disease News. Accessed on 12/11/03: http://www.niaid.nih.gov/newsroom/releases/nblscorrect21.htm.
4. Council for Responsible Genetics. Accessed 12/11/03 http://gene-watch.org/press/bubiolab-093003.html; The Sunshine Project. Accessed 12/11/03: http://www.sunshineproject. org/.
5. “Select agent” refers to specifically regulated pathogens and toxins in Code of Federal Regulations Title 42 Part 73.
6. Kellman B. Biological terrorism: Legal measures for preventing catastrophe. Harv J Law Public Policy 2001;24: 449–55.
7. National Academy of Sciences. Biotechnology Research in an Age of Terrorism: Confronting the “Dual Use”Dilemma. Washington, DC: National Academies Press; 2004; 43–78.
8. Jernigan DB, Raghunathan PL, Bell BP, et al. Investigation of bioterrorism-related anthrax, United States, 2001 epidemiologic findings. Emerg Infect Dis October 2002;8:1019–28.
9. Cole LA. The Anthrax Letters: A Medical Detective Story. Washington, DC: National Academies Press; 2003:42–6.
10. Maryland Code, Title 17, Sections 601–605.
11. Miller J, Engelberg S, Broad W. Germs. BiologicalWeapons and America’s Secret War. New York: Simon & Schuster; 2001:288–300.
12. Kelley M, Coghlan J. Mixing bugs and bombs. Bull At Sci Sept/Oct 2003;59:25–31.
13. Office of Inspector General, Department of Energy. Inspectionof Department of Energy Activities Involving BiologicalSelect Agents. IG-0492. February 2, 2001. (Last Accessed April 9, 2004 at: http://www.ig.doe.gov/igreports.htm#cal2004).
14. Layton M. National Security and Conduct of Sensitive BiologicalResearch: Public Health Perspectives. Speechgiven at the New York Academy of Science, November 11,2003.
15. Code of Federal Regulations, Title 42, Sections 73.12,73.13.
16. Tucker JB, Zilinskas RA. The 1971 Smallpox Epidemic inAralsk, Kazakhstan, and the Soviet Biological WarfareProgram. Occasional Paper No. 9. Monterey, Calif: MontereyInstitute of International Studies; July 2002.
17. Centers for Disease Control and Prevention. Biosafety inMicrobiological and Biomedical Laboratories. Section I.4th ed. Accessed on 12/11/03: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.
18. World Health Organization. Smallpox surveillance. Wkly Epidemiol Rec 1978;53:265–6. Accessed on 12/8/03:http://whqlibdoc.who.int/wer/WHO_WER_1978/WER1978_53_261–268%20(N°35).pdf.
19. Normile D. Second lab accident fuels fears about SARS.Science 2004;303:26.
20. Enserink M. Singapore lab faulted in SARS case. Science2003;301:1824.
21. Srinivasan A, Kraus CN, DeShazer D, et al. Glanders in amilitary research microbiologist. N Engl J Med 2001;345:256–8.
22. NIH Guidelines for Research Involving RecombinantDNA Molecules. Section IV-B-2-a-(1). April 2002.
23. Personal communication, Jan. 15, 2004, Dr. Janet Nicholson, Assistant Director for Laboratory Science, NCID, CDC.
24. Harding AL, Byers KB. Epidemiology of laboratory-associated infections. In: Fleming DO, Hunt DL, eds. Biological Safety: Principles and Practices, 3rd ed. Washington, DC: ASM Press; 2000.
25. Barry M, Russi M, Armstrong L, et al. Treatment of a laboratory-acquired Sabia virus infection. N Engl J Med 1995;333:294–6.
Laura H. Kahn, MD, MPH, MPP
Program on Science and Global Security
Woodrow Wilson School of Public and
Posted with kind permission of Mary Ann Liebert, Inc.
Originally published in Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 2, Number 2, 2004
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
© Mary Ann Liebert, Inc.
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