Integrating the Food and Drug Administration Office of the Coordinated Outbreak Response and Evaluation Network’s foodborne illness outbreak surveillance and response activities with principles of the National Incident Management System

Abstract

The Food Safety Modernization Act mandates building a national Integrated Food Safety System, which represents a seamless partnership among federal, state, local, territorial, and tribal agencies. During multistate foodborne illness outbreak investigations, local and state partners, the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA), or the United States Department of Agriculture Food Safety Inspection Service, depending on the regulated food product, become engaged and assist in coordinating the efforts between partners involved and determine the allocation of resources. The FDA Center for Food Safety and Applied Nutrition (CFSAN) Office of the Coordinated Outbreak Response and Evaluation (CORE) Network coordinates foodborne illness outbreak surveillance, response, and post-response activities related to incidents involving multiple illnesses linked to FDA-regulated human food, dietary supplements, and cosmetic products. FDA has implemented the National Incident Management System (NIMS) Incident Command System (ICS) principles across the agency to coordinate federal response efforts, and CORE has adapted NIMS ICS principles for the emergency management of multistate foodborne illness outbreaks. CORE’s implementation of ICS principles has provided several benefits to the operational cycle of foodborne illness outbreak investigations, including establishing a consistent, standardized, and transparent step-by-step approach to outbreak investigations. ICS principles have been instrumental in the development of a national platform for rapid and systematic laboratory, traceback, and epidemiologic information sharing, data analysis, and decision-making. This allows for partners across jurisdictions to reach a consensus regarding outbreak goals and objectives, deploy resources, and take regulatory and public health actions.

BACKGROUND: FOODBORNE ILLNESS OUTBREAK INVESTIGATIONS

A foodborne illness outbreak is defined as two or more cases of a similar illness resulting from ingestion of a common food. Roughly 800 foodborne illness outbreaks are reported in the United States every year, resulting in approximately 15,000 illnesses, 800 hospitalizations, and 20 deaths,¹ which are a subset of the approximately 9.4 million illnesses annually in the United States caused by known foodborne illness pathogens.² When a foodborne illness outbreak is detected, public health and regulatory officials collaborate to find out what is causing the outbreak and take the appropriate actions to prevent additional illnesses.^3,4

Briefly, during outbreak investigations, state and local partners collect three types of data to determine a common food consumed by case patients: epidemiologic, traceback, and laboratory. Several investigative tools can be used to collect and analyze data, which provide evidence that informs regulatory action (Figure 1). State and local partners and the Centers for Disease Control and Prevention (CDC) identify outbreaks and potential foods causing the illnesses through public health surveillance and epidemiologic evidence. The United States Food and Drug Administration (FDA), state and local partners conduct traceback investigations to examine the food supply chain to determine the origin of the potential foods identified by the epidemiologic investigations. Finally, FDA, state and local partners may use tools such as product and environmental sampling followed by laboratory analyses to further confirm the suspect food as the outbreak source. The analysis of data, the development of evidence, and the decision-making that follows require representation from federal, state, and local partners. Through a combination of epidemiologic, laboratory, and traceback evidence, a product may be implicated as the source of an outbreak. FDA, CDC, state and local partners provide communications to inform the public of outbreaks and share guidance on how to protect themselves from illness. Based on investigational data, FDA may use certain regulatory tools to remove contaminated product from the market (such as recalls) or to deny entry into the country (such as increased port of entry screenings or import alerts). These investigative and regulatory tools are used concurrently to stop outbreaks and protect public health.

Figure 1.

Foodborne illness outbreak surveillance and response data, evidence developed, and vehicle status designation during incident movement through FDA CORE. Potential vehicle status in each stage may vary depending on the specific outbreak. Investigational evidence can be received and coordinated at every stage of the outbreak progression.

THE FOOD SAFETY MODERNIZATION ACT AND THE INTEGRATED FOOD SAFETY SYSTEM

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 to better protect public health by strengthening the food safety system. FSMA mandates building a national Integrated Food Safety System (IFSS), which represents a seamless partnership among federal, state, local, territorial, and tribal agencies to achieve the public health goal of a safer food supply.⁵ An IFSS leverages and optimizes the participation, coordination, resource allocation, and authorities of all regulatory partners to protect the food supply. Through an IFSS, partners can plan and prioritize work by using outbreak data to inform food safety policies and programs; implement efficient and prevention-focused, risk-based inspections and sample collection; promote use of compliance and enforcement tools to achieve adherence to food safety laws and regulations; and improve coordination and data sharing with public health partners and the public. A constraint that shapes the collaboration and coordination dynamics between federal, state, and local partnerships is the fact that foodborne illness outbreak investigations are subject to state and local laws, and within each state, there are unique relationships between state and local agencies.⁶ Local or state public health or food-regulatory agencies conduct most investigations of foodborne illness outbreaks, following their own policies and procedures, and serve as the first responders to any given incident that originates within their state.⁷ In some situations, a network of state-based Rapid Response Teams (RRTs), comprised of multiagency and multidisciplinary teams that operate by the principles of the Incident Command System (ICS)/National Incident Management System (NIMS), can respond to human and animal food emergencies and is an essential part of the IFSS.^5,8,9 In the case of a multistate outbreak investigation, the CDC, the FDA, or the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS), depending on the suspected or implicated regulated food product, collaborate with the states involved, assist in coordinating their efforts, and determine the appropriate allocation of federal resources.

We have seen that an organized response is crucial to controlling and effectively responding to emergency incidents and saving lives.^10–15 The ICS is a fundamental component of the NIMS that serves as a management tool, implemented during disasters and emergency responses to organize and coordinate response efforts.¹⁶ At FDA, NIMS implementation and training are led by the Office of Emergency Management (OEM), which helps ensure that the agency is incorporating NIMS into emergency response plans, procedures, and policies.¹⁷ Here we show how the FDA Office of the Coordinated Outbreak Response and Evaluation (CORE) Network has adapted ICS principles for the specific purposes of coordinating FDA response efforts and allocation of resources to investigate and resolve multiple concurrent multistate foodborne illness outbreaks and protect public health.

THE CORE NETWORK ORGANIZATIONAL STRUCTURE

As a result of FSMA and its promotion of an IFSS, FDA CORE, located in the Center for Food Safety and Applied Nutrition (CFSAN), in College Park, Maryland, was established in 2011 to manage outbreak surveillance, response, and post-response activities related to incidents involving multiple illnesses linked to FDA-regulated human food, dietary supplements, and cosmetic products.⁴ It is comprised of a Signals and Surveillance Team (SST), multiple CORE Response Teams (CRTs), an Outbreak Evaluation Team (OET), and an Outbreak Analytics Team (OAT). In addition, a dedicated CORE Communications Team works across all activities, coordinating public communications, and outreach efforts on outbreaks.

CORE is the coordination focal point for all FDA resources during foodborne illness investigations and provides a platform for all involved partners to exchange and analyze information aimed at timely decision-making.¹⁸ As is the case with any organization that uses ICS, the organizational structure used by CORE is scalable in a modular fashion according to the size and complexity of the incident. As the incident complexity increases, the structure expands from top down as responsibilities are delegated.⁶ CORE has found it beneficial to use ICS principles to respond to outbreaks, large or small, and as a result, investigative partners engage in a standardized process with consistent communication pathways and expected outcomes throughout the duration of the response efforts.

CORE staff have multidisciplinary backgrounds, comprised of epidemiologists, microbiologists, environmental health officers, consumer safety officers, veterinary medical officers, chemists, health communication specialists, and scientific writers. Staff are trained in basic NIMS ICS principles, including ICS-100, ICS-200, ICS-300, ICS-400, ICS-700, and ICS 800,¹⁹ ICS position-specific training, and internal CORE-specific applications of ICS for outbreak investigations. In any given foodborne illness outbreak investigation, CORE engages with partners from within FDA, other federal agencies, and state and local authorities (Table 1).

Table 1.

CORE partners and their roles and responsibilities during foodborne illness outbreak surveillance and response activities

Partners	Roles and responsibilities
FDA ORA Divisions and Laboratories	Serve as the eyes and ears of the agency through inspections of firms and plants producing FDA-regulated products; investigations of consumer complaints, emergencies, and criminal activity; enforcement of FDA regulations; sample collection and analysis; review of imported products31
FDA CFSAN Program Offices	Provide microbiological, chemical, epidemiologic, medical, veterinary, compliance, legal, or other expertise, analyze data, and assist with decision-making32
FDA Office of the Commissioner	Provide legal and agency guidance33
CDC Outbreak Response and Prevention Branch	Collaborate with epidemiologists and other public health officials who investigate clusters of foodborne, waterborne, zoonotic, and other enteric illnesses in the United States and works to ensure rapid and coordinated surveillance, detection, and response to multistate outbreaks caused by enteric bacteria34
State partners and RRTs	Provide state-specific insight, information, and jurisdictional authority, responsibilities, and actions6 RRTs have built food safety infrastructure and integrated rapid response for all-hazards food emergencies5,35
USDA FSIS	Participate in dual jurisdiction product investigations36
Industry Stakeholders and Trade Organizations	Provide industry-specific insight, information, and expertise that helps determine potential outbreak vehicles37

An outbreak is comprised of three phases: signals and surveillance, response, and post-response. The process begins with the SST, who focuses on early detection that will limit or prevent illness linked to dietary supplements, cosmetics, or human foods regulated by the FDA. Team members look for information and trends that could be an early warning of an outbreak. When an outbreak that is suspected to be related to an FDA-regulated product is identified and requires coordination of additional resources, responsibility is transferred to a CRT, whose goal is to control and stop the outbreak by finding its source and ensuring it is removed from the market. CRTs work with FDA Office of Regulatory Affairs (ORAs) Emergency Response Coordinators, laboratories, field investigators and staff, subject matter experts from CFSAN, CDC, USDA, and state and local partners to develop a national response strategy, coordinate investigative activities, and facilitate information sharing. When appropriate and necessary, collaborative efforts are pursued with the World Health Organization, the International Food Safety Authorities Network, foreign government’s public health and regulatory agencies, and other international partners. When the active response to an outbreak is complete, OET assesses all aspects of the outbreak, including historical outbreaks, to identify trends that may lead to regulatory and public health actions to prevent future outbreaks. The OAT conducts predictive data analysis of outbreaks to recommend preventive measures to reduce the frequency and impact of future outbreaks of foodborne illness.

ICS AND THE INITIATION OF OUTBREAK RESPONSE ACTIVITIES

The SST evaluates information on a continuing basis for signals that an outbreak is potentially linked to an FDA-regulated product. Assessing this information involves weighing a combination of factors to determine whether an outbreak investigation warrants transferring the incident to a CRT for further coordination. Some factors that are considered in this assessment include, but are not limited to, the following: an FDA-regulated product has been identified as the suspect vehicle, history of the pathogen/commodity pair, vulnerable population impacted, hazard severity, whether an incident is ongoing or growing, multistate illnesses, strain commonality and history, product shelf-life, if traceback, sampling or firm investigations are required, whether significant coordination between multiple internal and/or external partners is required, dual (FDA and USDA) jurisdiction establishments are involved, public messaging is warranted, and the international significance. An incident that is deemed actionable is transferred from the SST to a CRT during an Incident Transfer Briefing and an alert notification is shared with partners throughout FDA, thus initiating the sequence of meetings that comprise the ICS Planning P, adapted to the needs of CORE (Figure 2).

Figure 2.

The Planning P, as modified and implemented by FDA CORE for foodborne illness outbreak surveillance and response activities.

INCIDENT ROLES AND RESPONSIBILITIES

Outbreak investigations may range in size, scope, and complexity, and these variables are considered in CRT roles and responsibilities. NIMS identifies ICS as a standardized method for “on-scene incident management.”²⁰ However, as a headquarters-based coordination group, CORE does not deploy resources at the field level, but is responsible for the development of a national foodborne illness outbreak response strategy within FDA. This responsibility led to CORE’s adaptation of the traditional primary ICS roles: Incident Commander, Operations Section Chief, Planning Section Chief, Logistics Section Chief, and Public Information Officer (Table 2).

Table 2.

Standard versus FDA CORE ICS roles and responsibilities during foodborne illness outbreak response activities

Standard	FDA CORE
Incident Commander Leads the response and allocates and designates the use of resources.	Incident Lead Coordinator The main point of contact and coordinator for all FDA headquarter offices, as well as the point of contact for external agencies, such as CDC, USDA, and state partners, when applicable. This role facilitates meetings, reviews web posts, drafts executive summaries for leadership, and ensures appropriate delegation of responsibilities.
Operations Chief Managing the staff and operations to complete objectives for mission. Determine additional resource needs.	Operations Chief Coordinates all ongoing field operations, including investigations and inspections at firms impacted by the incident, serves as the focal point for all traceback investigational activities, tracks incident objectives, and communicates the status of each objective to the entire incident group.
Planning Chief Maintains proper documentation of information reported by all section chiefs.	Planning Chief Coordinates information sharing between the myriad of agency offices participating in the investigation and ensures proper documentation and CORE-specific resource allocation.
Logistics Section Chief Coordinates and assigns resources to complete objectives.	Logistics Section Absorbed through administrative channels and is managed by existing ORA field offices to complete assigned objectives.
Public Information Officer Drafts and submits public communications of an incident and is the main point of contact for media outlets	CORE Communication Specialist Drafts and coordinates clearance of communications for the public about an outbreak. Consolidates and distributes all modified ICS 209 forms (daily reports) to investigational partners and leadership.

INCIDENT COMMAND SYSTEM DOCUMENTATION

Documentation is a critical aspect of any organized outbreak response and is used to maintain situational awareness, sustain consistency, and provide easy to identify forms for interoperability.²⁰ FDA has adapted ICS forms, and of those, CORE utilizes an Incident Action Plan that is comprised of the ICS 201 and ICS 202, as well as a daily report that serves as a modification of the ICS 209. Through incident evaluation, CORE has identified these forms as the most pertinent documents in communicating a common operating picture and FDA objectives among incident partners during outbreak investigations.²¹ The ICS 201 is developed by the SST to provide information to CRTs that has already been collected for a detected outbreak and includes a map of states with known cases, brief epidemiologic summary, information about when the outbreak was detected, or when FDA was notified, historical information about the suspect vehicle and pathogen strain, proposed objectives and structure for an incident response, background on preliminary traceback, sampling activities and firms of interest, a point of contact list, and the rationale for transfer. After transfer to a CRT, an ICS 202 is updated for each operational period. A rolling summary of all completed tasks is listed in the general situational awareness section of the document.

ICS DURING RESPONSE OPERATIONS

Following the incident transfer to a CRT, the CRT coordinates the response, organizes information collected from all partners, and sets the pace of the response by proposing the length of the operational period. Command and General Staff Meetings are held to review the incident information, set operational objectives, discuss which tasks need to be completed for the outbreak, including, but not limited to, laboratory and traceback investigations, resource allocation, drafting the ICS 202, and proposing the length of the operational period.

The draft ICS 202 containing the proposed objectives for the upcoming operational period is shared with the entire incident group, comprised of all pertinent responders to the outbreak, during a CRT-led Tactics Meeting. During the Tactics Meeting, the objectives of the operational period are presented, discussed, and refined, as necessary. Important investigational information is shared, including epidemiologic, laboratory, traceback investigation updates, and potential communication updates for the public. Each partner responsible for the completion of an objective develops their own plan according to their own resource availability and need. CORE is responsible for ensuring all United States government agencies involved in the outbreak response efforts are informed of the situation, including state and local partners, in an effort to eliminate duplication of response efforts. A Planning Meeting is held among CRT members, since CORE is accountable only for its own resources, to adjust and finalize the objectives based on information gathered at the Tactics Meeting and finalize the ICS 202. Once the objectives have been finalized, an operations briefing email, which marks the start of the new operational period, is distributed to the entire incident group to communicate incident updates and share finalized operational period objectives. Smaller, Special Purpose Tactics Meetings can be held on occasion to accomplish, develop, or refine time-critical objectives and FDA strategy. CORE is responsible for ensuring that FDA leadership has all the evidence required to support appropriate action.

As an incident develops, the cycle of meetings will occur for each subsequent operational period. As with all uses of ICS, the operational period can be established for every few hours²² or more.²³ CORE has adapted the use of ICS to have operation periods lasting from days to weeks, depending on the rate with which information is obtained, illnesses are reported, and public health actions can be taken.

PUBLIC COMMUNICATIONS

The Communications Team members are the Public Information Officers of an outbreak and communicate outbreak information, including recommendations and advice for consumers and other stakeholders, through web posts, social media, and other media platforms. This team also serves as the focal point for outbreak-related inquiries from Congress and the media, and regularly collaborates with CDC, other federal agencies, state, local, and international partners to coordinate outbreak communications. Between CORE’s establishment in 2011 and February 2020, the CORE Communications Team issued 95 outbreak advisories and several subsequent updates, resulting in over 400 posts to the FDA.gov website. Issuing public communications aligns with CORE’s mission to control and stop outbreaks by providing FDA stakeholders with the most relevant information regarding ongoing outbreaks.

EXAMPLES OF FOODBORNE ILLNESS OUTBREAK INVESTIGATIONS AND USE OF ICS

CORE was activated in August 2011 and began responding to foodborne illness outbreaks immediately. Initial steps toward quickly establishing a consistent and robust process to respond were a feat that CORE navigated while being faced with several notable national foodborne outbreaks.^24,25 Broaching unchartered areas of information sharing, standardization of intra- and interagency coordination, and crafting communications did not impede CORE from taking the appropriate public health actions. Soon after activation, CORE established an ICS workgroup, comprised of CORE, ORA, and OEM representatives, tasked with implementing ICS principles. Since 2014, when CORE established formal processes for using ICS structure consistently for every outbreak transferred to a CRT, the office has coordinated an average of approximately 24 foodborne outbreaks a year, with a total of approximately 1,120 cases of illness, while simultaneously conducting multiple traceback, laboratory, and environmental investigations, taking regulatory action, and releasing public communications to protect public health.

In 2015, federal, state and local partners investigated an outbreak of Salmonella Poona infections linked to contaminated cucumbers imported to the United States from Mexico.²⁶ A total of 907 illnesses were reported from 40 states. CORE was engaged in the response of this incident for approximately seven months. The response phase included 11 operational periods ranging from one day at the peak of activities to three weeks toward the end of the incident. The CRT included an Incident Lead Coordinator, a Planning Chief, an Operations Chief, and three Deputy Operations Chiefs. The incident required extensive collaboration from seven different CFSAN program offices, five ORA headquarters offices, 18 district offices, five regional offices, three ORA laboratories, CDC, four offices from the Department of Defense, and eight state departments of health and/or agriculture and their affiliated laboratories. In total, CORE completed 11 operational periods, coordinating over 41 unique objectives and hosted a 50-state conference call to inform state partners of the latest developments. Epidemiologic and traceback investigations identified the supply of cucumbers from a single distributor sourced from a single grower in Mexico which led to a recall in September 2015. A laboratory investigation resulted in 19 positive samples that yielded the outbreak strain. CORE Communications issued nine web postings, alerting the public about the outbreak and subsequent recalls.²⁷

In 2016, federal, state and local partners investigated an outbreak of Shiga toxin-producing Escherichia coli O121 and O26 infections linked to contaminated flour.²⁸ A total of 56 illnesses were reported from 24 states. CORE was engaged in the response of this incident for five months. The response phase included 13 operational periods ranging from a day at the peak of activities to two weeks toward the end of the incident, completing at least 40 unique objectives. The CRT included an Incident Lead Coordinator, a Planning Chief, and an Operations Chief. The incident response included representatives from 10 different CFSAN program offices, five ORA headquarters offices, 10 district offices, four regional offices, one ORA laboratory, CDC, eight different state departments of health or agriculture and their respective laboratories, and two activated RRTs. Federal, state and local partners conducted an epidemiologic and traceback investigation that identified flour as the source of this outbreak, which led to a voluntary recall in May 2016. Initial testing of the flour collected from the homes of case patients did not identify the outbreak strain. However, CORE Tactics Meetings served as a real-time forum to exchange pertinent laboratory information between federal microbiologists regarding making appropriate adjustments to the sample analysis method. FDA and state partners modified their testing protocols for additional samples of flour, and in June 2016, they detected the presence of E. coli O121 that matched clinical cases by genetic analysis. In addition, E. coli O26 was also recovered from flour samples, prompting an expanded recall. CORE Communications issued seven web postings in an effort to advise the public to throw away the recalled flour and to warn consumers to not eat raw flour products as a general practice.²⁹

These examples illustrate the complexity of responding to foodborne illness outbreaks and the benefits of adopting ICS principles that include the ability to coordinate across multiple jurisdictions, rapid information flow, accurate data transmission, communication of key findings, and coordination of public messaging.

ICS BENEFITS AND CHALLENGES

The adaptation of ICS by CORE has demonstrated that a modular and adaptable system for all outbreak response efforts, regardless of etiology, can be employed by any organization.³⁰ CORE’s use of ICS has provided several benefits to the operational cycle of foodborne illness outbreak investigations. After implementing ICS principles, CORE has been able to provide a consistent, standardized, and transparent step-by-step approach to any given outbreak investigation. Federal, state and local partners were able to engage and participate in standard meetings and anticipate consistent outcomes during set periods of time. ICS has been instrumental in the development of a platform for rapid laboratory, traceback, and epidemiologic information sharing, data analysis, and decision-making. This allows for participants to reach a consensus regarding goals and objectives, efficient deployment of resources, and taking appropriate regulatory and public health actions. Outbreak response requires flexibility and adaptability to continuous evolving situations, and ICS allows CORE to employ a framework to facilitate consistent operational functions by the participating agencies. CORE can respond to multiple outbreaks at the same time and if needed expand its capacity to respond to incidents regardless of scale or predicted impact.

Adopting ICS principles for a newly created entity within a federal agency has not been without challenges. Implementation of a new system across diverse jurisdictions, both internally and externally to FDA, created some confusion that required appropriate training, education, and outreach. Partners unfamiliar with ICS required basic information so they could be informed of the expectations of their participation in the process. On the other hand, the consistency inherent in ICS principles allowed many of our scientific and regulatory subject matter experts to contribute to the mission without requiring extensive and in-depth emergency management training. In addition to developing appropriate educational material, it is important to develop training opportunities specific to outbreak response efforts. Tabletop exercises are a critical component of any organization dealing with response efforts, which help optimize the process and develop knowledge and experience for its roster. CORE has been a regular participant in RRT-led tabletop exercises and has been in the process of developing CORE-specific scenarios aimed at improving emergency preparedness.

IMPLICATIONS

Developing a flexible yet robust ICS structure for CORE has streamlined coordination of FDA’s response related to foodborne illness outbreaks since its implementation. Through the use of ICS, CORE has been able to bring together pertinent stakeholders, create a set of objectives and goals, develop the appropriate tactics, ensure the allocation of FDA resources, track the progress of federal and state partners in accomplishing their assigned tasks, review the plan and ensure its continued validity, communicate the goals, objectives, and expectations to participants, and establish accountability, all on a consistent basis. FDA and external partner participation and contributions were incorporated and streamlined into the overall structure to allow for easier and more organized communication flow. Decentralized offices were empowered to function under ICS and develop their own processes to manage and accomplish assigned tasks. The implications of establishing the ICS structure for CORE also include the rapid analysis and dissemination of large amounts of data and information, a forum for multidisciplinary subject matter experts to share expertise and interests leading to confident and consistent decision-making, and ultimately the protection of public health. As a result of ICS implementation, CORE has established a standard of performance that partners have come to expect from every outbreak investigation regardless of complexity and magnitude.