Responses to biological incidents (including naturally occurring diseases and terrorist events) start at the local, tribal, and state levels. They include the use of police, emergency medical technicians, firefighters, and National Guard assets such as WMD civil support teams and chemical, biological, radiological, nuclear, or high-yield explosive emergency response force packages. Once the incident has been identified as a pandemic or a terrorist event or has grown beyond the scope of local, tribal, and state response, federal response takes place. Actions at this level can be taken with or without a presidential Stafford Act declaration or a public health emergency declaration by the secretary of health and human services.
Excerpt from the National Response Framework Biological Incident Annex, August 2008
The objectives of the federal government's response to a biological terrorism event or to a naturally occurring disease outbreak with a known or novel pathogen are to:
The unique attributes of this response require separate planning considerations that are tailored to specific health concerns and effects of the disease (e.g., terrorism versus natural outbreaks, communicable versus noncommunicable diseases, etc.).
Detection of a bioterrorism act against the civilian population may occur in several different ways and involve several different modalities:
This appendix supports policies and procedures outlined in the National Response Framework (NRF), Emergency Support Function (ESF) #8, Public Health and Medical Services Annex; ESF #10, Oil and Hazardous Materials Response Annex; ESF #11, Agriculture and Natural Resources Annex; ESF #15, External Affairs Annex; the Terrorism Incident Law Enforcement and Investigation Annex; and the International Coordination Support Annex.
Department of Health and Human Services (DHHS) serves as the federal government's primary agency for the public health and medical preparation and planning for and response to a biological terrorism attack or naturally occurring outbreak that results from either a known or novel pathogen, including an emerging infectious disease.
The U.S. Department of Agriculture (USDA) serves as the government's primary agency for outbreaks and/or attacks that may occur in animals used in the commercial production of food and for attacks on food processing/slaughtering facilities under its regulatory purview. In the event of a food or animal event, DHHS may provide additional public health and veterinary epidemiological assistance to USDA. Wildlife events will be placed under the purview of the Department of the Interior (DOI), while those involving marine animals will be managed and monitored by the Department of Commerce.
The secretary of homeland security is the principal federal official for domestic incident management. Pursuant to the Homeland Security Act of 2002, the secretary is responsible for coordinating federal operations within the United States to prepare for, respond to, and recover from terrorist attacks, major disasters, and other emergencies, including biological incidents.
State, tribal, territorial, and local governments are primarily responsible for detecting and responding to disease outbreaks and implementing measures to minimize the health, social, and economic consequences.
The attorney general has lead responsibility for criminal investigations of terrorist acts or terrorist threats by individuals or groups inside the United States or directed at U.S. citizens or institutions abroad. Generally acting through the Federal Bureau of Investigation (FBI), the attorney general, in cooperation with other federal departments and agencies engaged in activities to protect our national security, shall also coordinate the activities of the other members of the law enforcement community to detect, prevent, pre-empt, and disrupt terrorist attacks against the United States. If any agency becomes aware of an overt threat involving biological agents or indications that disease may not be the result of natural causes, the Department of Justice must be notified through the FBI's weapons of mass destruction operations unit (WMDOU).
If the threat is deemed credible by the FBI in coordination with DHHS or USDA, the FBI, in turn, immediately notifies the National Operations Center (NOC) and the National Counterterrorism Center (NCTC). The Laboratory Response Network (LRN) is used to test samples for the presence of biological threat agents.
Once notified of a credible threat or disease outbreak, DHHS convenes a meeting of ESF #8 partners to assess the situation and determine appropriate public health and medical actions. The Department of Homeland Security (DHS) coordinates overall nonmedical support and response actions across all federal departments and agencies.
DHHS will be supported by other federal agencies, as appropriate, during the various states of a biological incident response in the preparation, planning, and/or response processes and will perform the roles described in this annex in coordination with DHS and state partners. If the incident response progresses such that it requires multiagency participation, DHS will serve as the incident coordinator. DHHS will serve as the coordinating agency for public health issues.
If there is potential for environmental contamination, DHHS collaborates with the Environmental Protection Agency (EPA) in developing and implementing sampling strategies and sharing results.
In the event of an outbreak of an agriculturally significant zoonotic disease or human foodborne pathogen, DHHS collaborates with USDA during the preparation, planning, and/or response processes.
Given the dynamic nature of a biological incident, DHHS, in collaboration with other departments and agencies, determines the thresholds for a comprehensive federal government public health and medical response.
In a biological incident, federal, state, tribal, territorial, and local officials require a highly coordinated response to public health and medical emergencies.
Disease transmission may occur from direct contact with an infected individual or animal, an environmental reservoir (includes contaminated surface or atmospheric dispersion), an insect vector, or contaminated food and water. Indirect contact transmission may also occur where contaminated inanimate objects (fomites) serve as the vehicle for transmission of the agent.
A biological incident may be distributed across multiple jurisdictions simultaneously. This could require the simultaneous management of multiple "incident sites."
The introduction of biological agents, both natural and deliberate, is often first detected through clinical or hospital presentation. However, there are other methods of detection, including environmental surveillance technologies such as BioWatch, and medical and syndromic surveillance systems.
Routine fish and wildlife health and disease surveillance, including investigation of wildlife mortality events conducted on public lands and in public laboratories, provides the opportunity for early detection of biological agents and acts of bioterrorism. Animal health surveillance in the agriculture sector provides similar opportunities.
No single entity possesses the authority, expertise, and resources to act unilaterally on the many complex issues that may arise in response to a nonroutine disease outbreak and loss of containment affecting a multijurisdictional area. The national response requires close coordination between numerous agencies at all levels of government and with the private sector.
The federal government supports affected state, tribal, territorial, and local health jurisdictions as requested or required. The response by DHHS and other federal agencies is flexible and adapts as necessary as the outbreak evolves.
The LRN provides analytical support to inform public health assessment of the potential for human illness associated with exposure and the scope of this kind of risk. The LRN also provides for definitive testing of both environmental and clinical samples, as well as limited supporting analysis of food samples that may be implicated as part of epidemiological investigations associated with incident response to cases of human illness. The Food Emergency Response Network (FERN) is a complementary system that integrates the nation's food testing laboratories at the local, state, and federal levels into a network that is able to respond to emergencies involving biological, chemical, or radiological contamination of food.
Response to disease outbreaks suspected of being deliberate in origin requires consideration of special law enforcement and homeland security requirements.
An investigation into intentional biological threats or incidents will likely require the initiation of a joint criminal and epidemiological investigation. The FBI would coordinate criminal investigative activities with appropriate state, local and federal partner agencies, such as DHS, DHHS, and USDA.
Concept of Operations
Biological agent response
The key elements of an effective biological response include (in nonsequential order):
Primary federal functions include supporting state, tribal, territorial, and local public health and medical capacities according to the policies and procedures detailed in the NRF and its annexes.
Determination of a disease outbreak
The initial indication of a biological incident may be the recognition by public health and medical authorities that a significantly increased number of people are becoming ill.
One tool to support this process is the National Biosurveillance Integration System (NBIS). NBIS leverages the individual capabilities of multiple surveillance systems by integrating and analyzing domestic and international surveillance and monitoring data collected from human health, animal health, plant health, and food and water monitoring systems. This cross-domain analysis allows for enhanced situational awareness and potentially reduced detection time, thus enabling more rapid and effective biological incident response decision making.
During the evaluation of a suspected disease outbreak, laboratory samples are distributed to appropriate laboratories. During a suspected terrorist incident, sample information is provided to the FBI for investigative use and to public health and emergency response authorities for epidemiological use and agent characterization to facilitate and ensure timely public health and medical interventions as well as environmental cleanup.
Identification (analysis and confirmation)
The samples collected and the analyses conducted must be sufficient to characterize the causative agent of the outbreak. LRN and FERN laboratories fulfill the federal responsibility for rapid analysis of biological agents. In a suspected terrorist incident, sample collection activities and testing are coordinated with the FBI and with LRN members.
Since there is no definitive/reliable field test for biological agents of concern, all potential bioterrorism samples are transported to an LRN laboratory, where expert analysis is conducted using established federal protocols/reagents. A major component of this process is to establish and maintain the law enforcement chain of custody and arrange for transport.
The following actions occur if a positive result is obtained by an LRN on an environmental sample submitted by the FBI or other designated law enforcement personnel:
Any disease outbreak suspected or identified by an agency within DHHS or through a federal, state, tribal, territorial, or local public health partner as having public health implications is brought to the immediate attention of DHHS.
Any potentially significant biological agent, disease outbreak, or suspected bioterrorism act affecting or involving animals, plant health, or wildlife should involve notifications to USDA (animals and plant health) and DOI (wildlife).
Following these initial notifications, the procedures detailed in ESF #8 are followed. Instances of disease that raise the "index of suspicion" of terrorist or criminal involvement are reported to FBI headquarters. In these instances, FBI headquarters, in conjunction with DHHS and/or USDA, examines available law enforcement and intelligence information, as well as the technical characteristics and epidemiology of the disease, to determine if there is a possibility of criminal intent. If the FBI, in conjunction with DHHS or USDA, determines that the information represents a potential credible terrorist threat, the FBI communicates the situation immediately to the NCTC and NOC, which notifies the White House, as appropriate. If warranted, the FBI, DHHS, and/or USDA and respective state, tribal, territorial, and/or local health officials will conduct a joint law enforcement and epidemiological investigation to determine the cause of the disease outbreak, the threat to public health and public safety, and the individual(s) responsible.
In the event of an environmental detection of a biological threat agent above established agency-specific thresholds, the responsible agency should contact DHHS, the FBI, and the NOC within two hours of laboratory confirmation. The FBI and DHHS, in conjunction with DHS, will convene an initial threat assessment conference call with appropriate officials to examine the public health risk posed by the detection. Coordination of assessment and response activities will involve officials from the impacted state, tribal, territorial, and local jurisdictions.
Once notified of a threat or disease outbreak that requires significant federal public health and medical assistance, DHHS requests activation of ESF #8 from the Federal Emergency Management Agency and convenes a meeting of the partner organizations to assess the situation and determine the appropriate actions.
The immediate task is to identify the affected and vulnerable population and the geographic scope of the incident. The initial public health and medical response includes the following:
If there is suspicion that the outbreak may be deliberate, the FBI may establish a joint operations center, which may be integrated into the joint field office structure, if established, to coordinate investigative and intelligence activities.
Controlling the epidemic
The following steps are required to contain and control an epidemic affecting large populations:
The governor of an affected state or territory implements isolation and/or social-distancing requirements using state/local legal authorities. The tribal leader of a recognized tribe may also order a curfew, isolation, social distancing, and quarantine under tribal legal authorities. In order to prevent the import or interstate spread of disease, DHHS may take appropriate federal actions using the authorities granted by title 42 of the U.S. Code, parts 70 and 71, and U.S. Code 21 part 1240. These measures may include state, tribal, territorial, and local assistance with the implementation and enforcement of isolation and/or quarantine actions if federal authorities are invoked.
The scope of the disease outbreak may require mass isolation or quarantine of affected or potentially affected persons. Depending on the type of event, food, animals, and other agricultural products may need to be quarantined to prevent further spread of disease. In addition, livestock or poultry may need to be vaccinated or depopulated, and the movement of animals and equipment on and off affected premises may be restricted. In this instance DHHS and USDA will work with state, tribal, territorial, and local health and legal authorities to recommend the most feasible, effective, and legally enforceable methods of isolation and quarantine.
For certain types of biological incidents (e.g., anthrax), it may be necessary to assess the extent of contamination and decontaminate victims, responders, animals, equipment, transportation conveyances, buildings, critical infrastructure, and large outdoor areas. Such decontamination and related activities take place consistent with the roles and responsibilities, resources and capabilities, and procedures contained in the ESF #8, ESF #10, ESF #11, and ESF #14, long-term community recovery annexes. (Note: Chemicals used for biological decontamination, such as those used for inactivating highly infectious biological agents such as Bacillus anthracis spores, must be registered for that purpose by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. If, during an emergency, a response entity wants to use a chemical that has not been registered for inactivating the specific biological agent(s) of concern, a request for an emergency exemption from registration must be submitted to the EPA.)
Department of Defense Responsibilities
For a list of Department of Defense responsibilities in ESF #8, Public Health and Medical Services; ESF #10, Oil and Hazardous Materials Response; ESF #11, Agriculture and Natural Resources; ESF #15, External Affairs; and ESF #14, Long-Term Community Recovery; see Chapter 5 of this handbook.