The United States is underprepared for biological threats. The Nation lacks the leadership, coordination, collaboration, and innovation necessary to respond. The Blue Ribbon Study Panel on Biodefense was established in 2014 to assess gaps and provide recommendations to improve U.S. biodefense. This Panel (through public meetings, targeted interviews, and extensive research) examined the national state of defense against biological attacks and emerging and reemerging infectious diseases, of the order that could cause catastrophic loss of life, societal disruption, and loss of confidence in our government.
“We scrutinized the status of prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation – the spectrum of activities deemed necessary for biodefense . We identified substantial achievements, but we also found serious gaps and inadequacies that continue to leave the Nation vulnerable to threats from nature and terrorists alike.”
“Our intent is to help remedy the correctable shortfalls by identifying specific short-, medium-, and long-term programmatic, legislative, and policy actions in this report. We urge those in leadership positions to implement our recommendations with utmost haste. Lives are in the balance.”
The need for leadership in achieving coordination
“Biodefense necessitates complex and sophisticated multi-disciplinary efforts, successful navigation of which requires coordination among government, academia, and industry. Centralized effective leadership is necessary to align these efforts.” The Nation lacks a single leader to control, prioritize, coordinate, and hold agencies accountable for working toward common national biodefense.
The lack of coordination at the highest levels impacts a variety of downstream areas of critical importance, including: intelligence activities; full consideration of the interrelationships among animal, environmental, and human health; coordination of medical countermeasure development; attribution of bioterrorist acts; and environmental decontamination and remediation.
These critical areas demand better integration and clear prioritization, aligned with funding and investment, in order to inform stakeholders across the biodefense spectrum and enable them to execute a strategy once it is developed.
“The Department of State (DOS) assesses that China, Iran, North Korea, Russia, and Syria continue to engage in dual-use or biological weapons-specific activities and are failing to comply with the BWC. Caches of incompletely destroyed or buried biological weapons materials from old state programs can now be accessed again by new state programs, and then smuggled to other regions for use in today’s wars and by today’s terrorists. ” Weapons that once consumed a great deal of time and resources to make now take far less, and it is reasonable to believe that what the United States could accomplish more than 40 years ago, others can accomplish now.
The Islamic State of Iraq and the Levant (also known as ISIL and Da’esh) is devastating the Middle East while espousing the value of biological weapons for their ability to cause massive loss of life.
The resources necessary to produce biological weapons are more easily obtained by states and terrorists than in years past. Additionally, terrorist organizations, domestic militia groups, and lone wolves have expressed intent to use and shown some capacity to develop biological weapons.
Globalization has led to the rapid spread of emerging diseases.
Naturally occurring threats such as influenza, Ebola, and Chikungunya are bypassing borders to emerge in nations oceans away, and exact a continued toll. The Pandemic and highly pathogenic influenzas challenge the globe every year and result in the loss of thousands of human and frequently millions of animal lives, respectively.
Globally prevalent diseases for which countermeasures have already been developed are mutating and defeating what little we have to treat them. Emerging diseases – such as Dengue fever and Chikungunya – are occurring with greater frequency, spreading throughout the United States, and lack treatments. Naturally occurring diseases can also devastate livestock, crops, and dairy or produce supplies, harming millions of people and producing a debilitating effect on the U.S. economy.
Scientific advances and synthetic biology
“It’s easier than ever to create deadly and dangerous biological weapons, for which we have no known treatment. Advances in science have led to a convergence of biology and chemistry, and an ability (through synthetic biology) to create and combine agents. All of this has expanded the number and types of potential biological weapons and made it more difficult to fully comprehend the enormity of the threat.”
Insufficient Biosecurity and Biosafety
Accidents can also result in the release of harmful pathogens. Some laboratory leaders have paid insufficient attention to the details necessary to ensure laboratory biosafety and have inadvertently contributed to the biological threat.
Poor biosafety resulted in the unintended release of anthrax from Russian laboratories in 1979, anthrax from a U.S. military laboratory at Dugway Proving Grounds in 2015, and Burkholderia pseudomallei from a Tulane University research center in 2014
Poor biosecurity also increases the biological threat. Even our highest level government laboratories have fallen short in this regard. For example, in 2001, anthrax was illicitly removed from the U.S. Army Medical Research Institute on Infectious Disease and used in the perpetration of the anthrax attacks that year.
Biodefense touches many aspects of society, falling within the purview of national security, homeland security, public health security, and economic security. As such, it requires an enterprise approach – eliminating stovepipes; transcending agency-centric activity; drawing upon stakeholders throughout government, academia, and the private sector; and recognizing the extraordinary breadth of the challenge – to provide flexible solutions that address the full spectrum of the threat.
Develop, implement, and update a comprehensive national biodefense strategy.
A single, comprehensive, and harmonized National Strategy for Countering Biological Threats is needed that provide a foundation for federal biodefense activities and that needs to be implemented in a coherent, prioritized, and unitary fashion.
“The National Security Council should collate all extant biodefense policies, laws, and treaties that promulgate defense responsibilities against intentionally introduced, accidentally introduced, and naturally occurring biological threats. There is need to develop plans to address weaponized pathogens based on recently declassified information from the U.S. biological weapons program.”
“Develop a gap analysis based on this comprehensive strategy. Congress should direct the Government Accountability Office (GAO) to analyze gaps in resources mapped against the requirements of the National Biodefense Strategy and estimate resource requirements for small-, medium-, and large-scale events.”
Unifying the biodefense budget
Additionally, a unified approach to budgeting is a vital part of any strategic interagency effort, and this is lacking as well. This undoubtedly means that spending is redundant in some areas and deficient in others.
A unified approach to budgeting would enhance congressional oversight and allow the White House to better determine whether ongoing programs are aligned with the President’s priorities. Additionally, many biodefense activities would greatly benefit from multiyear funding. The biodefense enterprise is no different from the national defense enterprise, which receives multiyear funding for a variety of its programs.
Improving intelligence community efforts
The IC is addressing the biological threat, but overall, the Community is unable to adequately collect and analyze intelligence due to insufficient resource allocation. The priority level placed on addressing the threat is not high enough to warrant the reallocation of resources (including human) necessary for increased collection, analysis, and distribution. IC should develop intelligence collection strategies that address bystanders, who may be able to provide useful information.
Recognizing and institutionalizing the one health concept
Sixty percent of infections due to emerging infectious diseases are leaping into the human population via animals (with 72 percent of these coming from wildlife) and at an accelerating rate.
Divisions between human and animal health are artificial, since most pathogens of concern often affect both. Viewing them as parts of a whole is what defines a One Health approach to healthy populations. Together, human, animal, and environmental health comprise a dynamic and interconnected system that requires leadership and a strategic and coordinated approach to pull together traditionally fragmented divisions of expertise, responsibility, and authority while working effectively at the human-animal interface.
To ensure that Animal health and environmental health agencies are identified and assigned responsibility, and that their activities are fully aligned and coordinated with other biodefense activities and are current with respect to new science and evidence.
Coordinating medical countermeasure efforts
Federally-funded scientific investigators are more likely to engage in early stage research, rather than to use the more private sector approach of focusing on specific product goals and end-user needs. This is one reason that Ebola MCM were not available when they were needed.
Need to Prioritize and align investments in medical countermeasures among all federal stakeholders.
Establishing an attribution apparatus
The ability to attribute crimes to their perpetrators is a necessary component of effective prosecution. Attribution is a challenge in any context, and becomes increasingly difficult with the involvement of numerous investigators and when unusual or novel weapons are used to execute crimes. This is the case with biocrimes, biological terrorism, and biological warfare. When biological agents are used for attacks, not only must crimes be attributed to particular perpetrators, but the pathogens and their sources must also be correctly identified. The United States has yet to fully establish this capability due to the inherent challenges associated with microbial forensic techniques and related analysis
Establish a national biological attribution decision-making apparatus. They should inform this apparatus with: 1) standards/ burdens of proof in the U.S. criminal justice system; 2) evidence, information, and intelligence regarding the source; 3) accuracy, reliability, timeliness, credibility and defensibility of that evidence, information, and intelligence; and 4) national security considerations. This apparatus should be exercised to inform decisions and to ensure that these decisions are defensible.
Taking charge of decontamination and remediation
Environmental remediation is the application of countermeasures to eliminate an agent from a geographically defined area. Additional research is needed to develop standards and protocols for the elimination or reduction of new infections caused by pathogens hiding in a particular environment.
“Natural environments are not pristine and often contain microbes at low levels tolerated by humans. Returning an environment to its baseline level after an event cannot be accomplished without first having measured the baselines and this has not been systematically attempted.”
The Nation must be able to decontaminate and remediate affected environments in a coordinated, predictable fashion. This national capacity must be sufficient to address accidents, bioterror threats, and emerging infectious diseases.
Achieving an integrated biosurveillance and biodetection capability
“Surveillance and detection are the means by which we achieve the earliest possible situational awareness for biological events that affect people, animals, the food supply, and the environment. They are fundamental capabilities that enable us to prevent or mitigate the consequences of these events. They also enable protection of national and local critical infrastructure, and support response and recovery operations. ”
Optimal surveillance and detection require a nationwide array of sensors and detectors at many levels, interconnected and working in parallel. This system must be expansive and address many aspects of disease spread, including human health (e.g., clinical, diagnostic), animal health (e.g., livestock, wildlife, companion), and sociocultural events (e.g., mass gatherings, burials).
Surveillance and detection systems need to work quickly, indicating the presence of an agent in hours, not days or weeks. Such a capability can usefully inform rapid response operations, saving lives and other resources. Along with this capability, methods for information sharing between surveillance and biodefense partners are also needed. Many stakeholders could benefit from improved communication and real-time awareness
Animal health surveillance should not be segregated from the model of comprehensive biosurveillance described. What if, instead of simply identifying the location of an insidious zoonotic outbreak, one could identify its reservoir, the place in the animal world where it is hiding?
Sensitive and specific biosurveillance can be attained only through a distributed network of activities. Medical records, clinical laboratory data, food recall data, human and animal pharmaceutical consumption, food and animal health surveillance, and water and air quality monitoring are examples of existing troves of data that could be shared with National Biosurveillance Integration System (NBIS) with the necessary leadership, correct approach, and comprehensive agreements. In return, the data owners could receive aggregated NBIS data, analyses, or other incentives.
The plan must identify information required by decision makers (federal, state, local, territorial, tribal, private sector) to manage a biological event; these requirements should then be used to determine needed data sources, technology, and operational processes to achieve situational awareness and response capabilities. The plan should encourage and incentivize private sector input.
Supporting emergency preparedness
The Emergency Services Sector is a critical infrastructure sector that is the Nation’s first line of defense for preventing, preparing for, responding to, and recovering from incidents of many kinds, including biological threats. This sector consists of law enforcement, fire and emergency services, emergency management, emergency medical services, and public works.
The Nation must also demonstrate support for emergency services through improved training, enhanced personal protection, and better intelligence sharing. Provide emergency service providers with the resources they need to keep themselves and their families safe. This will fulfill the Nation’s commitment to these professionals while also helping to ensure their participation in the event of a biological emergency.
Threat information insufficiently shared with emergency services
Emergency service providers might be able to better target their efforts to address biological threats and protect themselves if they had more information regarding the threat, relevant vulnerabilities, and potential consequences. Yet much of the available information about current and potential biological threats is often classified.
Creating incentives for hospital preparedness
“We must commit reasonable and sustained levels of financial support to state, local, territorial, and tribal health departments. The federal government must also increase support to hospitals, through tighter management of Hospital Preparedness Program funds, development of Centers for Medicare and Medicaid Services incentives, and accreditation of select hospitals as biodefense specialty centers.”
A stratified hospital system similar to that utilized for Ebola and other specialized pathologies (e.g., trauma, stroke, cardiac care, burns, pediatrics) is needed for infectious diseases. Such a system would require all hospitals to attain the ability to assess patients in order to recognize bioterror agents, as well as emerging and reemerging infectious diseases. All hospitals would also be able to stabilize patients within 48 hours, and then refer patients quickly to higher-level hospitals for more definitive care. Other levels of hospitals would be able to provide increasingly specialized care, depending on the status of these patients.
Lead the way toward establishing a functional and agile global public health response capacity and build international threat awareness reach consensus on priorities, improve regional and cross-border surveillance, and increase regional MCM stockpiling and distribution plans.
Dealing with cyber threats to Pathogen security
While a cyber attack on any health-related system could have enormous consequences to health security and care delivery, an area of particular relevance to biodefense and biosecurity is the vulnerability of pathogen-related data. Such information is commonly shared via the cloud or non-secure networks during the course of scientific business.
Senator Sheldon Whitehouse told the Panel, “There is a considerable bank of information on biological warfare dating back to the biological warfare planning of the United States and the Soviet Union fifty years ago…Unlike a nuclear warhead, that information can travel very readily, and in the hands of terrorists or others who wish us harm, it can be very dangerous. So how do we control the proliferation of that bank of information our countries built back in those days?”
Not only does this historical information still pose a risk, but so does the body of knowledge about pathogens that has expanded since that time. Genetic sequences of pathogens (including those of the most serious threat agents) may be shared. The databases that contain this kind of information are as vulnerable to hacking as any other, and adversaries could use their contents to gather intelligence on U.S. defensive capabilities, or even to engineer bioweapons.
Theft, misuse, or tampering with pathogen data should be considered a national security matter. If cloud-based data sharing, storage, and analysis are to be used for disease research, detection, and characterization, technical and non-technical security measures must be developed and implemented to ensure that no data stored or shared in the cloud are inappropriately manipulated or destroyed. A strategy for sharing information regarding cyber threats, securing pathogen data, and preventing national security breaches is needed.
Reengaging with the biological and Toxin weapons convention
The BWC is a legally binding treaty that entered into force in 1975. Signatory nations agree to never “develop, produce, stockpile or otherwise acquire or retain microbial or other biological agents or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.”
To date, 173 nations have become parties to the convention, but at least five of these countries (China, Iran, North Korea, Russia, and Syria) are suspected of engaging in biological weapons activities despite BWC ratification.
The BWC does not absolutely prohibit the use of biological agents or toxins, but instead prohibits their use as or in biological weapons. The BWC allows these agents and toxins to be used for peaceful purposes, including research and the development of MCM, protective equipment, and detection systems. Such peaceful work can cross the line into offensive work, and a well-known shortcoming of the BWC is that it lacks a verification system to sufficiently restrain countries from engaging in offensive biological weapons programs.
Implement military-civilian collaboration for biodefense
DOD has significant knowledge that it could transfer to the civilian sector in the way of planning, logistics, response, operating in contaminated environments, science, technology, and many other matters.
Despite the importance of DOD’s role in providing support to civilian authorities in response to domestic bioincidents, doctrinal clarity for this role is lacking. DOD has not established strong interfaces with the federal, state, local, territorial, and tribal agencies that would be involved in responding to a major biological attack against the United States
DOD force protection and projection are imperiled by the threat of both bioweapons and naturally occurring infectious diseases. Yet U.S. warfighter preparedness for and protection against biological attacks is inadequate.
DOD assets and force readiness overseas and within the homeland could be dangerously compromised by a major biological event. Scant consideration has been given to how operations would be conducted in biologically contaminated environments caused by a biological attack or by exposure to infectious disease when engaging in combat or providing humanitarian assistance.
The need for leadership in driving innovation
“Our leaders must give priority to innovative approaches to engaging industry and others toward needed solutions in areas like diagnostics, detection, biosurveillance informatics, personal and collective protection, remediation, and attribution.”
The report recommends Incentivizing Civilian Medical Countermeasure Development, Leaping Ahead to a Modern State of Biodetection, Removing Select Agent Program Impediments to Innovation, and Implementing New Approaches to Global Health Response
Implementing novel approaches to Global health response
International cooperation is a key element in implementing global health strategies. U.S. activities include establishing emergency operations centers, strengthening laboratory biosecurity in developing nations, partnering with international animal health authorities to rapidly detect and manage animal diseases, and implementing and strengthening the International Health Regulations and OIE reporting capacities.
Nowhere is the fragility of the human-animal disease boundary more pronounced than in developing nations, from where the majority of new infectious agents are emerging. Urban areas are nucleation points for infectious disease risk and their populations are dramatically increasing in many of these countries. Because these nations often lack both public health and animal health infrastructures, their capacity for early and effective surveillance and mitigation efforts is challenged
Dramatic improvements are within our reach if we follow a national blueprint for biodefense, establish leadership, and engage in major reform efforts that build on the good work that is already in place.