Facts, Assumptions, and Critical Considerations

The following information represents key facts, assumptions, and critical considerations that inform biological incident response and recovery planning and related activities. The importance of each will vary depending on the incident scope, scale, characteristics, and complexity.

Facts and Assumptions

The following represent the highlights of more detailed discussion regarding general facts and assumptions governing biological incident response and recovery planning presented in the BIA. 

• Authorities: SLTT governmental public health agencies have primary responsibility and authority for the public health response to biological incidents within their jurisdictions and can implement isolation, quarantine, and movement restrictions that may vary, based on the specifics of the situation, from federal guidance issued by HHS CDC. Determining authorities and responsibilities of SLTT agencies ahead of time and identifying lead agencies for different areas of preparedness and response in line with the legal authorities of individual local agencies will result in more effective and efficient plans. Ideally, planners must understand how prevailing laws, regulations, and/or ordinances may empower or limit government personnel in responding to an emergency and how SLTT elected political leaders or other decision makers may adapt plans to address unique aspects of the incident.
• Situational Awareness: At first, full information on the biological threat may not be available. Information on the incident will unfold over the course of the incident, ranging from hours (e.g., declaration of an attack/accident or triggering of an environmental monitoring system), days (e.g., surges of patients reporting to the medical system, pathogen identification, delineation of exposed areas and/populations), or months (e.g., determination of transmission rates, agent lethality, and susceptibility to countermeasures for new agents). Incident cause and/or disease origin may not be readily apparent. Response actions will require many decisions to be made without complete information.
• Incident Coordination: Planning and decision-making coordination should occur between SLTT emergency managers, public health officials, healthcare coalitions (HCCs), and community stakeholders (e.g., NGOs) to ensure aligned response activities (e.g., protective measure guidance, positioning of MCM, security, and public messaging).

• Disease Transmission: Transmissible pathogens (or infectious diseases) present a threat to response and recovery depending on whether the disease is spread through direct contact (e.g., human-to-human or animal-to-human contact) or indirect contact (e.g., contact with contaminated objects, water, and vector-borne diseases) and whether MCMs exist for the specific pathogen (e.g., diagnostic tests, prophylaxis, therapeutics).
• Epidemiological Investigations: Public and animal health epidemiological investigations will use information from various sources (e.g., public health surveillance systems, laboratory testing, patient interviews) to identify the causative agent, source of the agent, mode of transmission, and populations at risk. Investigations will be performed by local public health investigators, with potential involvement by federal experts (e.g., HHS CDC), as appropriate.
• Criminal Investigations: During intentional or alleged intentional biological incidents, the DOJ FBI may coordinate joint criminal and epidemiological investigative activities with appropriate SLTT law enforcement partners and other federal agencies.
• Animal Population Impacts: While the focus of this document is human disease, some pathogens affecting people may also affect animal health. As discussed further in the FAIA, zoonotic diseases, where a pathogen may move from animal to human communities, require additional collaboration and coordination between multiple agencies for response and recovery. Animal disease may affect a broad range of species including wildlife, zoo, livestock, service, and companion animals, requiring infection control through MCMs (e.g., vaccines) and NPIs (e.g., isolation or depopulation).
• Environmental Persistence: Generally speaking, most pathogens rapidly become harmless in the environment (with the exception of waterborne pathogens); however, some select pathogens are environmentally persistent and may require specific decontamination methods.
• Differential Diagnosis: Many illnesses have similar initial symptoms and may be undiagnosed or improperly diagnosed until the disease progresses, more cases accumulate, or there is laboratory confirmation of the biological agent involved.
• Non-Pharmaceutical Interventions (NPIs) and Medical Countermeasures (MCMs): Non-pharmaceutical interventions (or community mitigation strategies) are measures that limit the spread of a pathogen, without the use of MCM, and can be applied at the individual or community level. MCMs have been identified and stockpiled to reduce the health impacts of specific, identified biological threats.

Critical Considerations

Critical considerations represent additional key elements of information that planners should take into account when developing a plan. The following represent the highlights of more detailed discussion regarding critical considerations for biological incident response and recovery planning presented in the BIA. 

• Incident Detection: Capabilities for incident detection may be limited depending on the nature of the biological agent involved and the existence or availability of diagnostic tests for the specific pathogen. Detection strategies are more likely to be through passive recognition systems/surveillance (e.g., monitoring for symptoms), while certain agents may be detected through active systems (e.g., water/air monitoring systems).
• Malicious Acts: A suspected or actual intentional biological threat, including a suspected terrorist threat, will require close coordination between the public health and law enforcement communities, and potentially the counterterrorism community, as the threat or incident evolves.
• Authorities: During a response where federal or SLTT authorities conflict or intersect, critical legal and policy decisions will be required and may be elevated to higher levels of government for resolution (e.g., movement restrictions, prioritization of distribution for personal protective equipment [PPE], civil order). Planning efforts also should consider the fact that specific authorities at the state and local level, as well as specific legal relationships between state and local governments, vary greatly across jurisdictions within the U.S.
• Public Information: During an incident, there will be a time-sensitive demand for guidance and other information from the public and from partners. Top priorities will be communication of risk of exposure, exposure guidance, signs and symptoms, availability of MCMs, and protective actions. Communications must synthesize complex medical and health information to promote public compliance with government guidance.
• Behavioral and Mental Health Impacts: Behavioral and mental health impacts (e.g., depression, anxiety, post-traumatic stress disorder) due to stress, restrictions, and messaging may be significant and should be anticipated. Negative perception of individuals, families, ethnic/racial groups, or certain professions may also become associated with the incident via media/social media and other sources of reporting. The public’s response to a biological incident may be quite different than after other types of natural disasters (in which communities naturally often come together) because of the ongoing hazard posed by transmissible agents.
• Disproportionate Responder and Receiver Community Impacts: Depending on the agent and the nature of the incident, responders and first receivers may be disproportionately impacted physically and mentally due to increased exposure, frequent changes in operational environment, limited resource availability, working conditions, concerns about exposed or ill family members, childcare challenges, and increased demand for services.
• Vulnerable Populations: Vulnerable populations may experience disproportionate harm from a biological incident, including increased risk of infection or disease burden, loss of income, etc., and may face barriers to implementing disease prevention/mitigation measures. These increased risks may stem from use of multi-generational or public housing, lack of access to medical or behavioral health treatment, employment type, and public transport use.

• Continuity of Operations (COOP)/Continuity of Government (COG): The implementation of COOP planning and COG activities may vary depending on the pathogen’s impact on the workforce, essential services, etc.
• Economic Impacts: A communicable disease may impact local economies through business closures, capacity limitations, workforce reductions, or resource competition. A large-scale incident may affect national and global markets, supply chains, and production capacities.
• Medical Countermeasure (MCM) Development, Production, and Distribution: MCM availability, overwhelming public demand, and requests beyond impacted areas may complicate MCM distribution. For pathogens with limited or no available pharmaceutical MCMs, MCM development and production may take considerable time.
• Significant Resource Shortfalls: The size, scope, and/or complexity of a biological incident may overwhelm existing local capabilities and resources. Mutual aid agreements with neighboring jurisdictions can provide support prior or in addition to federal resource engagement. Resources may be limited regardless of pathogen. Competition between various jurisdictional levels of government and the private sector may occur in the absence of proper coordination to promote judicious resource distribution.
• Decontamination: While most biological agents are inactivated in the environment via natural processes, some pathogens are environmentally persistent and specialized decontamination processes are required to eliminate the threat they pose. Decontamination of buildings or public spaces from such agents could require their long-term or permanent closure.
• Public Safety: Authorities must consider public safety and security during implementation of response and recovery measures (e.g., security at MCM-dispensing areas and at healthcare and public health critical infrastructure).
• Waste Management: Agent identity and pathogen type may have an impact on available/approved waste processing and disposal options; disposal of large quantities of hazardous biological waste will prove challenging and will likely tax existing resources.
• Fatality Management: Standard mechanisms used to process hazardous human remains may be overwhelmed by incidents that result in a large number of fatalities. Additionally, evidence from human remains may need to be recovered and preserved as part of ongoing law enforcement investigations. Planning must also account for hazardous animal remains and any related special considerations.
• Achieving Recovery Outcomes: Recovery of the impacted populations and environments may take an extended amount of time and involve restoring critical infrastructure, rebuilding public trust, supporting economic recovery, and disposing of hazardous waste, among other priorities.