Globalizing biosecurity

A harmonized international regime that enhances biosecurity is needed to reduce the risk of bioterrorism. Like other security regimes, this will entail mutually reinforcing strands, which need to include: enactment of legally binding control of access to dangerous pathogens, transparency for sanctioned biodefense programs, technology transfer and assistance to developing countries to jointly advance biosafety and biosecurity, global awareness of the dual-use dilemma and the potential misuse of science by terrorists, and development of a global ethic of compliance. To work, this effort must be undertaken collectively, utilizing the international and regional institutions that already have a role to play in providing safety and security. Most notably, it must grow in a top-down manner from the Biological Weapons Convention accord, in which States Parties have agreed to ban the development of biological weapons, and in a bottom-up manner from the scientific and health communities, which are engaged in the research and public health efforts that must be protected against misuse-especially involving the World Health Organization.     

Using Fault Tree Analysis to Assess Bioterrorist Risks to the U.S. Food Supply

Concerns about terrorist use of biological agents have increased at state and federal levels and in the popular press. Vulnerability of U.S. agricultural assets to bioterrorism has received less attention. A bioterrorist could use the U.S. food supply system to deliver a bioagent to a human target or use a bioagent to destroy it's inputs or infrastructure. Establishing effective agriculture security programs requires condensing generalizations about such bioterrorist threats into specific attack scenarios. This paper suggests a two-stage process to achieve this: problem formulation to define and rank scenarios, then quantitative risk assessment of selected, more highly ranked, scenarios. The quantitative component is illustrated for two specific scenarios: the actual 1984 Rajneeshee incident in Oregon and a hypothetical release of oral anthrax into the food supply system. The fault tree analysis of these scenarios suggests that the food supply system may be a less than optimal bioagent delivery mechanism, particularly if the objective is a mass casualty attack, as a number of events must occur simultaneously with reasonable probability if a bioagent is likely to be deployed effectively. In addition, an environmentally stable bioagent would be required if only the food system were used to deliver it to human consumers, but early detection of an intentional release common bioagent may be difficult absent specific intelligence or “unusual” epidemiological circumstances.     

E3LSI research: an essential element of biodefense

The threat of bioterrorism has prompted the U.S. to undertake a vast biodefense initiative, including funding biodefense-related scientific research at unprecedented levels. Unfortunately, the many ethical, economic, environmental, legal, and social implications (E(3)LSI) of biodefense research and activities are not yet receiving the attention they warrant. Previously, in laudable demonstrations of foresight and responsibility, the federal government has funded research into the E(3)LSI of other recent scientific endeavors--namely, the Human Genome Project and the nanotechnology research program--through directed appropriations from their respective research budgets. This article advocates and proposes a model for a portion of biodefense funding to be similarly set aside for an E(3)LSI research program to complement biodefense research, to ensure that bioterror preparedness does not give rise to harmful or otherwise undesirable unintended consequences.     

Federal Agency biodefense funding, FY2011-FY2012

Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series have analyzed civilian biodefense funding by the federal government for fiscal years (FY) 2001 through proposed funding for FY2011. This article updates those figures with budgeted amounts for FY2012, specifically analyzing the budgets and allocations for biodefense at the Departments of Health and Human Services, Defense, Homeland Security, Agriculture, Commerce, and State; the Environmental Protection Agency; and the National Science Foundation. This article also includes an updated assessment of the proportion of biodefense funding provided for programs that address multiple scientific, public health, healthcare, national security, and international security issues in addition to biodefense. The FY2012 federal budget for civilian biodefense totals $6.42 billion. Of that total, $5.78 billion (90%) is budgeted for programs that have both biodefense and nonbiodefense goals and applications, and $637.6 million (10%) is budgeted for programs that have objectives solely related to biodefense.     

Universal influenza vaccination: the time to act is now

Annual influenza epidemics create a significant public health burden each year in the United States. That influenza continues to pose a public health threat despite being largely preventable through vaccination is indicative of continuing weaknesses in the U.S.'s public health system. Moreover, the burden of annual influenza epidemics and the fragility and instability of the capacity to respond to them underscore the U.S.'s ongoing vulnerability to pandemic influenza and highlights gaps in bioterrorism preparedness and response efforts. This article examines the burden of annual influenza epidemics in the U.S., efforts to combat that burden with vaccination, shortcomings of influenza vaccination efforts, and how those shortcomings exemplify weaknesses in pandemic influenza and bioterrorism preparedness efforts. We make the case for establishing an annual universal influenza vaccination program to assure access to influenza vaccination to anyone who can safely receive vaccination and desires it. Such a program could greatly reduce the annual burden of influenza while advancing and maintaining U.S. pandemic influenza and bioterrorism preparedness and response efforts.     

Federal agency biodefense funding, FY2012-FY2013

Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series have analyzed civilian biodefense funding by the federal government for fiscal years (FY) 2001 through proposed funding for FY2012. This article updates those figures with budgeted amounts for FY2013, specifically analyzing the budgets and allocations for civilian biodefense at the Departments of Health and Human Services, Defense, Homeland Security, Agriculture, Commerce, and State; the Environmental Protection Agency; and the National Science Foundation. As in previous years, our analysis indicates that the majority (>90%) of the "biodefense" programs included in the FY2013 budget have both biodefense and non-biodefense goals and applications-that is, programs to improve infectious disease research, public health and hospital preparedness, and disaster response more broadly. Programs that focus solely on biodefense represent a small proportion (<10%) of our analysis, as the federal agencies continue to prioritize all-hazards preparedness. For FY2013, the federal budget for programs focused solely on civilian biodefense totals $574.2 million, and the budget for programs with multiple goals and applications, including biodefense, is $4.96 billion, for an overall total of $5.54 billion.     

Designing a biocontainment unit to care for patients with serious communicable diseases: a consensus statement

In spite of great advances in medicine, serious communicable diseases are a significant threat. Hospitals must be prepared to deal with patients who are infected with pathogens introduced by a bioterrorist act (e.g., smallpox), by a global emerging infectious disease (e.g., avian influenza, viral hemorrhagic fevers), or by a laboratory accident. One approach to hazardous infectious diseases in the hospital setting is a biocontainment patient care unit (BPCU). This article represents the consensus recommendations from a conference of civilian and military professionals involved in the various aspects of BPCUs. The role of these units in overall U.S. preparedness efforts is discussed. Technical issues, including medical care issues (e.g., diagnostic services, unit access); infection control issues (e.g., disinfection, personal protective equipment); facility design, structure, and construction features; and psychosocial and ethical issues, are summarized and addressed in detail in an appendix. The consensus recommendations are presented to standardize the planning, design, construction, and operation of BPCUs as one element of the U.S. preparedness effort.     

Biodefense research: an emerging conundrum

Biodefense research creates a conundrum for the scientific community--what are the permissible limits of biodefense research and how can knowledge in the life sciences be protected against misuse? As biodefense research expands to counter the threat of bioterrorism, so does suspicion and the need for guidance to respond to these concerns.     

Billions for biodefense: federal agency biodefense funding, FY2007-FY2008

Since 2001, the U.S. government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series analyzed civilian biodefense funding by the federal government from fiscal years 2001 through 2007. This article updates those figures with budgeted amounts for fiscal year 2008, specifically analyzing the budgets and allocations for biodefense at the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, the Department of Agriculture, the Environmental Protection Agency, the Department of State, and the National Science Foundation.     

Biological threat characterization research: a critical component of national biodefense

Biological warfare (BW) threat assessments identify and prioritize BW threats to civilian and military populations. In an ideal world, they provide policymakers with clear and compelling guidance to prioritize biodefense research, development, testing, evaluation, and acquisition of countermeasures. Unfortunately, the biodefense community does not exist in an ideal world. National security professionals responsible for crafting BW threat assessments often are challenged by factors that limit the clarity and/or timeliness of those assessments. Moreover, the potential for life science advances to enhance threats enabled by state programs and the possibility that non-state actors may pursue crude but effective BW methodologies will drastically expand the scope of the perceived threat. Appropriate investment of federal biodefense funds will require some mechanism for validating and prioritizing present and future threats. Ideally, such a mechanism will incorporate empirical data targeted to elucidate actual hazards. In this regard, the Department of Homeland Security's creation of a Biological Threat Characterization Program for the technical validation of threat agents will be a valuable addition to the nation's overall biodefense strategy. This article articulates the need for a coordinated national biological threat characterization program, discusses some of the principal challenges associated with such research, and suggests a few options for their resolution.     

Bioterrorism: responding to an emerging threat

Only a few years ago bioterrorism was considered a remote concern but few today are complacent about the possibility of biological agents being intentionally used to cause widespread panic, disruption, disease and death. By its very nature, the biological weapons threat - with its close links to naturally occurring infectious agents and disease - requires a different paradigm than that for conventional terrorism, military strikes or attacks caused by other weapons of mass destruction. This evolving threat presents the medical, public health and scientific communities (importantly including biotechnology) with a set of difficult and pressing challenges. This article provides a brief overview of the threat from biological weapons, the nature of a bioterrorist attack and some of the issues that need to be addressed if we are to make meaningful progress to prevent or contain this disturbing and potentially catastrophic danger.     

Managing biosecurity threats in China

Compared to the extensive literature on bioterrorism and biosecurity in the United States, less analysis has been conducted on similar challenges in China. This article seeks to fill this void by providing an integrated and updated assessment of 3 major biosecurity threats China faces: biowarfare, bioterrorism, and biocrimes. An analysis of China's biosecurity threats and biodefense building suggest varying levels of risk associated with each threat type. First, a direct bioweapons attack on China is highly unlikely, although the threat of biowarfare cannot be simply written off. Second, potential perpetrators of bioterrorism have capabilities at their disposal for carrying out such attacks. While terrorist organizations in China do not have a strong interest in bioterrorism, the limited state capability to counter such a threat may increase the risk in the future. Third, unlike the threats of biowarfare and bioterrorism, potential perpetrators of biocrimes have both incentives and capabilities, and biocrimes can produce reactions far out of proportion to the actual number of casualties. Despite the distinct biosecurity challenges it faces, China has yet to articulate a differentiated and coherent strategy to effectively tackle the challenges. Assessing different types of biosecurity threats in terms of degrees of risk not only provides greater analytical clarity but also has important implications for the strategies required to manage the risks.     

Navigating the storm: report and recommendations from the Atlantic Storm exercise

Atlantic Storm was a tabletop exercise simulating a series of bioterrorism attacks on the transatlantic community. The exercise occurred on January 14, 2005, in Washington, DC, and was organized and convened by the Center for Biosecurity of UPMC, the Center for Transatlantic Relations of Johns Hopkins University, and the Transatlantic Biosecurity Network. Atlantic Storm portrayed a summit meeting of presidents, prime ministers, and other international leaders from both sides of the Atlantic Ocean in which they responded to a campaign of bioterrorist attacks in several countries. The summit principals, who were all current or former senior government leaders, were challenged to address issues such as attaining situational awareness in the wake of a bioattack, coping with scarcity of critical medical resources such as vaccine, deciding how to manage the movement of people across borders, and communicating with their publics. Atlantic Storm illustrated that much might be done in advance to minimize the illness and death, as well as the social, economic, and political disruption, that could be caused by an international epidemic, be it natural or the result of a bioterrorist attack. These lessons are especially timely given the growing concerns over the possibility of an avian influenza pandemic that would require an international response. However, international leaders cannot create the necessary response systems in the midst of a crisis. Medical, public health, and diplomatic response systems and critical medical resources (e.g., medicines and vaccines) must be in place before a bioattack occurs or a pandemic emerges.     

School nurses as volunteers in a bioterrorism event

Most public health departments do not have enough public health nurses to adequately respond to a bioterrorist attack or other large-scale health emergency and would need to look to volunteers to help with staffing needs in an emergency. The National Association of School Nurses supports the use of school nurses, a skilled workforce, as responders in a mass casualty event, whether it is naturally occurring or as a result of bioterrorism. This article explores the use of school nurses to supplement public health staff during an emergency. A Likert-scale survey was used to assess the preparedness and willingness of school nurses to respond to a health threat. Although school nurses are willing to respond, the findings highlight the importance of continued education on risk and personal protection.     

Risk of occupationally acquired illnesses from biological threat agents in unvaccinated laboratory workers

Many vaccines for bioterrorism agents are investigational and therefore not available (outside of research protocol use) to all at-risk laboratory workers who have begun working with these agents as a result of increased interest in biodefense research. Illness surveillance data archived from the U.S. offensive biological warfare program (from 1943 to 1969) were reviewed to assess the impact of safety measures on disease prevention (including biosafety cabinets [BSCs]) before and after vaccine availability. Most laboratory-acquired infections from agents with higher infective doses (e.g., anthrax, glanders, and plague) were prevented with personal protective measures and safety training alone. Safety measures (including BSCs) without vaccination failed to sufficiently prevent illness from agents with lower infective doses in this high-risk research setting. Infections continued with tularemia (average 15/year), Venezuelan equine encephalitis (1.9/year), and Q fever (3.4/year) but decreased dramatically once vaccinations became available (average of 1, 0.6, and 0 infections per year, respectively). While laboratory-acquired infections are not expected to occur frequently in the current lower-risk biodefense research setting because of further improvements in biosafety equipment and changes in biosafety policies, the data help to define the inherent risks of working with the specific agents of bioterrorism. The data support the idea that research with these agents should be restricted to laboratories with experience in handling highly hazardous agents and where appropriate safety training and precautions can be implemented.     

Missouri nurses' bioterrorism preparedness

Nurses are the largest group of healthcare providers and will be at the forefront during a response to a bioterrorism attack in the U.S. However, nurses' bioterrorism risk perceptions and their participation in bioterrorism preparedness activities, such as bioterrorism-related exercises or drills, have not been evaluated. We mailed a survey to all members of the Missouri Nurses Association in July 2006, consisting of 1,528 registered nurses. The instrument measured risk perception, perceived susceptibility, perceived seriousness, bioterrorism education received, participation in exercises/drills, and personal response plan thoroughness. The response rate was 31% (474/1,528). Most respondents believe that a bioterrorism attack will occur in the U.S. (82.3%; n = 390), but few (21.3%; n = 101) believe that one will occur in their community. The majority of nurses reported that they believe that a bioterrorism attack would have serious consequences (96.1%, n = 448), including having a serious impact on U.S. citizens' safety (90.7%, n = 446) and on their own safety (84.3%, n = 379). Most (60%, n = 284) reported that they had not received any bioterrorism-related education nor participated in any drills/exercises (82.7%, n = 392). Of those who had received education, most had participated in 3 or fewer programs and in only 1 drill. Few nurses (3.6%, n = 15) reported having all aspects of a personal bioterrorism response plan; approximately 20% (19.4%, n = 81) did not have any components of a plan. Most of the registered nurses in Missouri who were surveyed are not receiving bioterrorism education, participating in bioterrorism exercises, or developing thorough personal response plans. Nurses need to be aware of and encouraged to participate in the many education and training opportunities on bioterrorism and infectious disease disasters.     

Incentives for biodefense countermeasure development

Therapeutics and vaccines are available for only a fraction of biological threats, leaving populations vulnerable to attacks involving biological weapons. Existing U.S. policies to accelerate commercial development of biodefense products have thus far induced insufficient investment by the biopharmaceutical industry. In this article, we examine the technical, regulatory, and market risks associated with countermeasure development and review existing and proposed federal incentives to increase industrial investment. We conclude with several recommendations. To increase industry's engagement in biodefense countermeasure development, Congress should expand BioShield funding, giving HHS the flexibility to fund a portfolio of biodefense countermeasures whose revenues are comparable to those of commercial drugs. Congress should establish tradable priority review vouchers for developers of new countermeasures. A National Academy of Sciences or National Biodefense Science Board should formally evaluate incentive programs and a government-managed "Virtual Pharma," in which HHS contracts separate stages of research, development, and production to individual firms.     

The Microbial Rosetta Stone Database: A compilation of global and emerging infectious microorganisms and bioterrorist threat agents

Background

Thousands of different microorganisms affect the health, safety, and economic stability of populations. Many different medical and governmental organizations have created lists of the pathogenic microorganisms relevant to their missions; however, the nomenclature for biological agents on these lists and pathogens described in the literature is inexact. This ambiguity can be a significant block to effective communication among the diverse communities that must deal with epidemics or bioterrorist attacks.

Results

We have developed a database known as the Microbial Rosetta Stone. The database relates microorganism names, taxonomic classifications, diseases, specific detection and treatment protocols, and relevant literature. The database structure facilitates linkage to public genomic databases. This paper focuses on the information in the database for pathogens that impact global public health, emerging infectious organisms, and bioterrorist threat agents.

Conclusion

The Microbial Rosetta Stone is available at http://www.microbialrosettastone.com/. The database provides public access to up-to-date taxonomic classifications of organisms that cause human diseases, improves the consistency of nomenclature in disease reporting, and provides useful links between different public genomic and public health databases.     

Postal workers' perspectives on communication during the anthrax attack

In 2001, the nation experienced its first bioterrorism attack, in the form of anthrax sent through the U.S. Postal Service, and public health professionals were challenged to communicate with a critical audience, U.S. postal workers. Postal workers, the first cohort to receive public health messages during a bioterrorist crisis, offer a crucial viewpoint that can be used in the development of best practices in crisis and emergency risk communication. This article reports results of qualitative interviews and focus groups with 65 postal workers employed at three facilities: Trenton, New Jersey; New York City; and Washington, DC. The social context and changing messages were among the factors that damaged trust between postal workers and public health professionals. Lessons learned from this attack contribute to the growing body of knowledge available to guide communications experts and public health professionals charged with crisis and emergency risk communication with the public.     

生物技术的两用性及其监控措施

生物技术像一把双刃剑,它在给人类带来巨大利益的同时,也带来了消极隐患。隐患之一是如果先进的生物技术被恶意缪用或误用,就有可能产生给人类健康和社会发展带来巨大威胁的新的危险病原体。这些病原体有可能被用于发展生物武器和生物恐怖活动。本文简要介绍了近年来生物技术被恶意使用或误用的几个事例,分析了国内外生物技术两用性监控措施的现状和发展态势,提出了进一步加强生物技术监控时应思考的重要问题。