Chapter 10 covers the administrative and legal aspects of biosecurity, which include international treaties, laws, statutes, regulations, and government directives aimed at reducing the threat due to the biological agents and enabling enforcers to deal with those that use them with ill intentions. These administrative measures have helped define programs and strengthen biodefense and biosecurity all over the globe. The aim of this chapter is to discuss the most relevant documents in hopes that the reader will appreciate the authority and framework given to officials by these measures. The chapter is not written for legal professionals. Rather, it is written for emergency management and public health professionals that may have to apply the rules of law in everyday situations. Care should be taken to consult a legal professional before utilizing any of the concepts related to public health law.
New construction of biosafety level 3 (BSL-3) laboratories in the United States has increased in the past decade to facilitate research on potential bioterrorism agents. The Centers for Disease Control and Prevention inspect BSL-3 facilities and review commissioning documentation, but no single agency has oversight over all BSL-3 facilities. This article explores the extent to which standard operating procedures in US BSL-3 facilities vary between laboratories with select agent or non-select agent status. Comparisons are made for the following variables: personnel training, decontamination, personal protective equipment (PPE), medical surveillance, security access, laboratory structure and maintenance, funding, and pest management. Facilities working with select agents had more complex training programs and decontamination procedures than non-select agent facilities. Personnel working in select agent laboratories were likely to use powered air purifying respirators, while non-select agent laboratories primarily used N95 respirators. More rigorous medical surveillance was carried out in select agent workers (although not required by the select agent program) and a higher level of restrictive access to laboratories was found. Most select agent and non-select agent laboratories reported adequate structural integrity in facilities; however, differences were observed in personnel perception of funding for repairs. Pest management was carried out by select agent personnel more frequently than non-select agent personnel. Our findings support the need to promote high quality biosafety training and standard operating procedures in both select agent and non-select agent laboratories to improve occupational health and safety.
Computational models describing bacterial kinetics were developed for inhalational anthrax in New Zealand white (NZW) rabbits following inhalation of Ames strain B. anthracis. The data used to parameterize the models included bacterial numbers in the airways, lung tissue, draining lymph nodes, and blood. Initial bacterial numbers were deposited spore dose. The first model was a single exponential ordinary differential equation (ODE) with 3 rate parameters that described mucociliated (physical) clearance, immune clearance (bacterial killing), and bacterial growth. At 36 hours postexposure, the ODE model predicted 1.7×10⁷ bacteria in the rabbit, which agreed well with data from actual experiments (4.0×10⁷ bacteria at 36 hours). Next, building on the single ODE model, a physiological-based biokinetic (PBBK) compartmentalized model was developed in which 1 physiological compartment was the lumen of the airways and the other was the rabbit body (lung tissue, lymph nodes, blood). The 2 compartments were connected with a parameter describing transport of bacteria from the airways into the body. The PBBK model predicted 4.9×10⁷ bacteria in the body at 36 hours, and by 45 hours the model showed all clearance mechanisms were saturated, suggesting the rabbit would quickly succumb to the infection. As with the ODE model, the PBBK model results agreed well with laboratory observations. These data are discussed along with the need for and potential application of the models in risk assessment, drug development, and as a general aid to the experimentalist studying inhalational anthrax.
Increasing threats of bioterrorism and the emergence of novel disease agents, including the recent international outbreaks of H7N9 influenza and MERS-CoV, have stressed the importance and highlighted the need for public health preparedness at local, regional, and national levels. To test plans that were developed for mass prophylaxis scenarios, in April 2013 the Cook Country Department of Public Health (CCDPH) and the Triple Community (TripCom) Medical Reserve Corps (MRC) executed a full-scale mass prophylaxis exercise in response to a simulated anthrax bioterrorism attack. The exercise took place over 2 days and included the TripCom Point-of-Dispensing (POD) Management Team, volunteers from the TripCom MRC, and neighboring public health departments and MRCs. Individuals from the community volunteered as actors during the exercise, while local municipal, police, and fire personnel coordinated their responses to create the most realistic simulation possible. The exercise was designed to test the capacity of TripCom and CCDPH to implement plans for organizing municipal staff and volunteers to efficiently distribute prophylaxis to the community. Based on results from POD clinic flow, accuracy of prophylaxis distribution, and observations from evaluators, the exercise was successful in demonstrating areas that were operationally efficient as well as identifying areas that can be improved on. These include improvements to the just-in-time training for POD staff, the health screening and consent forms handed out to patients, the physical setup of the POD, and the command structure and communication for the management of POD operations. This article demonstrates the need for full-scale exercises and identifies gaps in POD planning that can be integrated into future plans, exercises, and emergency response.
This study presents data showing the performance of 6 commercial detection assays against ricin around concentrations specified as detection limits by the producers. A 2-fold dilution series of 20 ng/ml ricin was prepared and used for testing the lateral-flow kits: BADD, Pro Strips™, ENVI, RAID DX, Ricin BioThreat Alert, and IMASS™ device. Three of the 6 tested field assays (IMASS™ device, ENVI assay, and the BioThreat Alert assay) were able to detect ricin, although differences in the measured detection limits compared to the official detection limits and false-negative results were observed. We were not able to get the BADD, Pro Strips™, and RAID assays to function in our laboratory. We conclude that when purchasing a field responder assay, there is large variation in the specificity of the assays, and a number of in-house tests must be performed to ensure functionality.
In 2005 and 2009, the Pentagon Force Protection Agency (PFPA) staged deliberate releases of a commercially available organic pesticide containing Bacillus amyloliquefaciens to evaluate PFPA's biothreat response protocols. In concert with, but independent of, these releases, the Department of Homeland Security sponsored experiments to evaluate the efficacy of commonly employed air and surface sampling techniques for detection of an aerosolized biological agent. High-volume air samplers were placed in the expected downwind plume, and samples were collected before, during, and after the releases. Environmental surface and personal air samples were collected in the vicinity of the high-volume air samplers hours after the plume had dispersed. The results indicate it is feasible to detect the release of a biological agent in an urban area both during and after the release of a biological agent using high-volume air and environmental sampling techniques.
In 2011, President Obama addressed the United Nations General Assembly and urged the global community to come together to prevent, detect, and fight every kind of biological danger, whether a pandemic, terrorist threat, or treatable disease. Over the past decade, the United States and key international partners have addressed these dangers through a variety of programs and strategies aimed at developing and enhancing countries' capacity to rapidly detect, assess, report, and respond to acute biological threats. Despite our collective efforts, however, an increasingly interconnected world presents heightened opportunities for human, animal, and zoonotic diseases to emerge and spread globally. Further, the technical capabilities required to develop biological agents into a weapon are relatively low. The launch of the Global Health Security Agenda (GHSA) provides an opportunity for the international community to enhance the linkages between the health and security sectors, accelerating global efforts to prevent avoidable epidemics and bioterrorism, detect threats early, and respond rapidly and effectively to biological threats. The US Department of Defense (DoD) plays a key role in achieving GHSA objectives through its force health protection, threat reduction, and biodefense efforts at home and abroad. This article focuses on GHSA activities conducted in the DoD Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense.
Promoting global health security as an international priority is a challenge; the US Centers for Disease Control and Prevention (CDC) in its Global Health Security Agenda has articulated the importance of accelerating progress toward a world safe and secure from infectious disease threats. The goals are to (1) prevent and reduce the likelihood of outbreaks—natural, accidental, or intentional; (2) detect threats early to save lives; and (3) respond rapidly and effectively using multisectoral, international coordination and communication. Foundational to this agenda is the World Health Organization (WHO) Revised International Health Regulations (IHR) of 2005, which provide the legal framework for countries to strengthen their health systems in order to be able to respond to any public health emergency of international concern. This article proposes leveraging the distributed structure of the US-managed Laboratory Response Network for Biological Threats Preparedness (LRN-B) to develop the core capacity of laboratory testing and to fulfill the laboratory-strengthening component of the Global Health Security Agenda. The LRN model offers an effective mechanism to detect and respond to public health emergencies of international concern.
The terrorist attacks of September 11 and the anthrax mailings a month later prompted a sweeping response by the federal government to improve the preparedness of the US to meet the potential threat posed by a terrorist using a biological agent. This response transcended traditional interagency boundaries, creating new opportunities while producing unique fiscal and leadership challenges. The National Interagency Confederation for Biological Research has made significant progress over the past 12 years because of its ability to adapt to the need for interagency cooperation and overcome many of these challenges. As construction of the National Interagency Biodefense Campus at Fort Detrick nears completion, the US has the capability to pursue a unique whole-of-government approach to the development of medical measures to counter the threat of bioterrorism. In addition to the high-level support of many in the federal government, the key success factors for this effort have been (1) a critical mass of leaders with the right leadership characteristics, (2) development of a compelling vision and accompanying narrative understood and articulated by all partnering organizations, and (3) recognition of the need for a partnership office to do the important communication and collaboration work in the organization to synchronize the information available to all the partners. The major barrier to interagency cooperative efforts of this kind is the inability to comingle funds from different appropriations.
On the morning of June 9, 2009, an explosion occurred at a manufacturing plant in Garner, North Carolina. By the end of the day, 68 injured patients had been evaluated at the 3 Level I trauma centers and 3 community hospitals in the Raleigh/Durham metro area (3 people who were buried in the structural collapse died at the scene). Approximately 300 employees were present at the time of the explosion, when natural gas being vented during the repair of a hot water heater ignited. The concussion from the explosion led to structural failure in multiple locations and breached additional natural gas, electrical, and ammonia lines that ran overhead in the 1-story concrete industrial plant. Intent is the major difference between this type of accident and a terrorist using an incendiary device to terrorize a targeted population. But while this disaster lacked intent, the response, rescue, and outcomes were improved as a result of bioterrorism preparedness. This article discusses how bioterrorism hospital preparedness planning, with an all-hazards approach, became the basis for coordinated burn surge disaster preparedness. This real-world disaster challenged a variety of systems, hospitals, and healthcare providers to work efficiently and effectively to manage multiple survivors. Burn-injured patients served as a focus for this work. We describe the response, rescue, and resuscitation provided by first responders and first receivers as well as efforts made to develop burn care capabilities and surge capacity.
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and ScienceVol. 12, No. 6 Letter to the EditorsRe: Optimization of Interventions in EbolaViroj WiwanitkitViroj WiwanitkitSearch for more papers by this authorPublished Online:3 Dec 2014https://doi.org/10.1089/bsp.2014.1031AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Re: Optimization of Interventions in Ebola." Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, 12(6), p. 373FiguresReferencesRelatedDetails Volume 12Issue 6Dec 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Viroj Wiwanitkit.Re: Optimization of Interventions in Ebola.Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.Dec 2014.373-373.http://doi.org/10.1089/bsp.2014.1031Published in Volume: 12 Issue 6: December 3, 2014PDF download
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and ScienceVol. 12, No. 6 CommentaryPrioritizing the Defense Department's Response to Biological Warfare Threat AgentsW. Seth Carus and Noreen A. HynesW. Seth CarusSearch for more papers by this author and Noreen A. HynesSearch for more papers by this authorPublished Online:3 Dec 2014https://doi.org/10.1089/bsp.2014.0054AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 12Issue 6Dec 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:W. Seth Carus and Noreen A. Hynes.Prioritizing the Defense Department's Response to Biological Warfare Threat Agents.Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.Dec 2014.370-372.http://doi.org/10.1089/bsp.2014.0054Published in Volume: 12 Issue 6: December 3, 2014Online Ahead of Print:October 17, 2014PDF download
In today's global society, infectious disease outbreaks can spread quickly across the world, fueled by the rapidity with which we travel across borders and continents. Historical accounts of influenza pandemics and contemporary reports on infectious diseases clearly demonstrate that poverty, inequality, and social determinants of health create conditions for the transmission of infectious diseases, and existing health disparities or inequalities can further contribute to unequal burdens of morbidity and mortality. Yet, to date, studies of influenza pandemic plans across multiple countries find little to no recognition of health inequalities or attempts to engage disadvantaged populations to explicitly address the differential impact of a pandemic on them. To meet the goals and objectives of the Global Health Security Agenda, we argue that international partners, from WHO to individual countries, must grapple with the social determinants of health and existing health inequalities and extend their vision to include these factors so that disease that may start among socially disadvantaged subpopulations does not go unnoticed and spread across borders. These efforts will require rethinking surveillance systems to include sociodemographic data; training local teams of researchers and community health workers who are able to not only analyze data to recognize risk factors for disease, but also use simulation methods to assess the impact of alternative policies on reducing disease; integrating social science disciplines to understand local context; and proactively anticipating shortfalls in availability of adequate healthcare resources, including vaccines. Without explicit attention to existing health inequalities and underlying social determinants of health, the Global Health Security Agenda is unlikely to succeed in its goals and objectives.
The Centers for Disease Control and Prevention recommends using open points of dispensing (PODs) and alternative modalities, such as closed PODs, for mass dispensing of medical countermeasures. However, closed POD existence has not been assessed. In 2013 we sent an online questionnaire to US Cities Readiness Initiative (CRI) and non-CRI public health disaster planners. Chi-square tests were used to determine differences between CRIs and non-CRIs when comparing having at least 1 closed POD, and to compare having a closed POD and perceived mass dispensing preparedness. A total of 301 disaster planners participated. Almost all (89.3%, n=218) jurisdictions have considered establishing a closed POD, and three-quarters (74.2%, n=181) currently have at least one. CRIs were more likely than non-CRIs to have a closed POD (85.0% vs 58.5%, X(2)=21.3, p<.001). Those with 1 or more closed PODs were more likely to believe their jurisdiction could distribute medical countermeasures within 48 hours compared to those without a closed POD (78.5% vs 21.5%; X(2)=10.8, p=.001). Half had a written plan and/or written standing orders (59.1% and 52.5%, respectively). Almost half (42%, n=72) have done no preevent training for POD staff in the past 2 years; almost 20% (18%, n=32) do not plan to offer any just-in-time training. Nearly 40% (n=70) have conducted no exercises in the past year. Closed PODs contribute to community preparedness; their establishment should be followed by development of written plans, worker training, and exercises.
In 2011, an EF5 tornado hit Joplin, MO, requiring complete evacuation of 1 hospital and a patient surge to another. We sought to assess the resilience of healthcare workers in these hospitals as measured by number reporting to work, willingness to work, personal disaster preparedness, and childcare responsibilities following the disaster. In May 2013, a survey was distributed to healthcare workers at both Joplin hospitals that asked them to report their willingness to work and personal disaster preparedness following various disaster scenarios. For those with childcare responsibilities, scheduling, costs, and impact of hypothetical alternative childcare programs were considered in the analyses. A total of 1,234 healthcare workers completed the survey (response rate: 23.4%). Most (87.8%) worked the week following the Joplin tornado. Healthcare workers report more willingness to work during a future earthquake or tornado compared to their pre-Joplin tornado attitudes (86.2 vs 88.4%, t= -4.3, p<.001; 88.4 vs 90%, t= -3.1, p<.01, respectively), with no change during other scenarios. They expressed significantly higher post-tornado personal disaster preparedness, but only preevent preparedness was a significant predictor of postevent preparedness. Nearly half (48.5%, n = 598) had childcare responsibilities; 61% (n = 366) had childcare needs the week of the tornado, and 54% (n = 198) required the use of alternative childcare. If their hospital had provided alternative childcare, 51% would have used it and 42% felt they would have been more willing to report to work. Most healthcare workers reported to work following this disaster, demonstrating true resilience. Disaster planners should be aware of these perceptions as they formulate their own emergency operation plans.
Antiviral medications can decrease the severity and duration of influenza, but they are most effective if started within 48 hours of the onset of symptoms. In a severe influenza pandemic, normal channels of obtaining prescriptions and medications could become overwhelmed. To assess public perception of the acceptability and feasibility of alternative strategies for prescribing, distributing, and dispensing antivirals and disseminating information about influenza and its treatment, the Institute of Medicine, with technical assistance from the Centers for Disease Control and Prevention (CDC), convened public engagement events in 3 demographically and geographically diverse communities: Fort Benton, MT; Chattanooga, TN; and Los Angeles, CA. Participants were introduced to the issues associated with pandemic influenza and the challenges of ensuring timely public access to information and medications. They then discussed the advantages and disadvantages of 5 alternative strategies currently being considered by the CDC and its partners. Participants at all 3 venues expressed high levels of acceptance for each of the proposed strategies and contributed useful ideas to support their implementation. This article discusses the key findings from these sessions.
In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.
The biosurveillance capabilities needed to rapidly detect and characterize emerging biological threats are an essential part of the Global Health Security Agenda (GHSA). The analyses of the global public health system's functioning during the 2009 H1N1 pandemic suggest that while capacities such as those identified in the GHSA are essential building blocks, the global biosurveillance system must possess 3 critical capabilities: (1) the ability to detect outbreaks and determine whether they are of significant global concern, (2) the ability to describe the epidemiologic characteristics of the pathogen responsible, and (3) the ability to track the pathogen's spread through national populations and around the world and to measure the impact of control strategies. The GHSA capacities—laboratory and diagnostic capacity, reporting networks, and so on—were essential in 2009 and surely will be in future events. But the 2009 H1N1 experience reminds us that it is not just detection but epidemiologic characterization that is necessary. Similarly, real-time biosurveillance systems are important, but as the 2009 H1N1 experience shows, they may contain inaccurate information about epidemiologic risks. Rather, the ability of scientists in Mexico, the United States, and other countries to make sense of the emerging laboratory and epidemiologic information that was critical—an example of global social capital—enabled an effective global response. Thus, to ensure that it is meeting its goals, the GHSA must track capabilities as well as capacities.
The function of public health rapid response teams (RRTs) is to quickly identify, investigate, and control an outbreak before it can spread. The Central America Regional Office in Guatemala provided assistance to the Guatemalan Ministry of Health and Social Assistance (MSPAS) to develop RRT manuals at the district and regional levels. The manuals are divided into 4 sections: background, activity lists, standard operating procedures, and annexes. The manuals outline Guatemala's RRT members' responsibilities and will be tested in the near future through tabletop exercises. The development of the manuals is a concrete and significant step toward the attainment of Guatemala's IHR goals and should be integrated into a larger emergency management system to promote "a world safe and secure from global health threats posed by infectious diseases."
The Global Health Security Agenda (GHSA) was launched in February 2014 by the US government in partnership with more than 25 other governments, the World Health Organization (WHO), the World Organisation for Animal Health, and the Food and Agriculture Organization of the United Nations. The GHSA aims to accelerate progress toward a world prepared to counter major infectious disease threats and to focus greater political attention on the need to promote global health security as an international priority. Many nations have already committed to working toward specific GHSA goals. A renewed focus on these difficult problems is urgently needed. National public health capacities, as measured by the International Health Regulations (2005) criteria, are not where they should be. The IHR aims to protect against the spread of epidemics and other public health emergencies across national borders and to limit interference with travel and trade. WHO published an IHR (2005) Core Capacity Monitoring Framework and the IHR Monitoring Tool so that nations could self-assess their progress in 9 core capacities that address the aims of the IHR, including surveillance, response, preparedness, and risk communication. Yet, only 16% of nations reported by the June 2012 deadline that they have achieved these obligations. Ideally, even if the capacity goals are met, these obligations would be the floor, not the ceiling, of nations’ commitments. In addition to the IHR measurements, there is also evidence that many nations are not prepared to prevent, detect, and respond to infectious disease threats. At the time of this writing, an Ebola outbreak has spread across several West African countries, with more than 1,300 cases and 700 deaths. Healthcare workers are sacrificing their lives to treat the sick and to try to limit this outbreak. But like a wildfire out of control, this Ebola tragedy will require an extraordinary effort to extinguish. Other outbreaks in recent times also underscore the critical public health capacities that must be in place to prevent future epidemics. SARS in 2003, H1N1 in 2009, and, as current and ongoing challenges, H5N1, MERSCoV, and H7N9. The increasing threat of antibiotic resistant bacteria and food safety lapses such as the E. coli outbreak in Germany that killed 50 people and made 4,000 others ill are further vivid examples of why all nations need strong public health capacities—and why we all benefit from those increased capacities. There is also the potential for deliberate or accidental events that could lead to lethal disease outbreaks. The GHSA is meant to address all disease threats, regardless of their origin. In this issue of Biosecurity and Bioterrorism, we feature a number of articles that describe how the GHSA should be implemented, how it complements already existing international regulations, and the role of different sectors and disciplines in the GHSA objectives. While this issue is
