Foodborne Outbreak Response Coordinating Group (FORCG)

U.S. Department of Agriculture	Department of Health and Human Services	Environmental Protection Agency	Department of Defense

Outbreak Response and Coordination
for Federal and State Agencies
During Multi-State Foodborne Illness Outbreaks

December 2000

Outbreak Response and Coordination for Federal and State Agencies During Multi-State Foodborne Illness Outbreaks

OVERVIEW

1. PURPOSE: The purpose of this document is to guide federal agencies, state, or local health officials, and state food regulatory officials involved in food or waterborne outbreaks on procedures for coordinating responses during a multi-state outbreak of food or waterborne illness. (Although this document refers to foodborne disease outbreaks, the public health purposes for and approach to foodborne and waterborne disease outbreaks are the same, and the information in this document will be relevant for outbreaks transmitted by either food or water.)

2. BACKGROUND: The President's Food Safety Initiative recommended establishment of an intergovernmental Foodborne Outbreak Response Coordinating Group (FORCG) comprised of representatives from federal agencies and members of state and local agencies charged with responding to foodborne illness outbreaks. This report was undertaken at the request of FORCG to outline the standard operating procedures for the rapid exchange and release of data and information during multi-state outbreaks of foodborne illness.

   FORCG has the following goal, mission, and objectives:

   1. It is the goal of FORCG to improve the approach to interstate outbreaks of foodborne illness by federal, state, and local agencies charged with responding to such outbreaks.

   2. Toward this goal, it is the mission of FORCG to include federal, state, and local agencies with outbreak response duties in the development of a national comprehensive and coordinated foodborne illness outbreak response system.
   3. FORCG's mission will include the following tasks:

   1. The review and evaluation of outbreak responses by the federal agencies, including cooperation among federal agencies and between state and local agencies and affected industries. FORCG will identify areas where effectiveness and/or efficiency can be gained in responding to foodborne illness outbreaks and make specific recommendations for improvement. The Co-Chairs of FORCG will be presented with the final analysis of the outbreak response with recommendations for their review and approval. FORCG will work with federal, state, and local governments, the food industry, health professionals, and consumer advocates to implement beneficial changes.

   2. Development of standard operating procedures for the rapid exchange of data and information associated with foodborne illness outbreaks between involved agencies, and for dissemination to the public. The procedures for coordination and communication will cover the exchange of data and information associated with an outbreak and will complement systems established for exchange of information about day-to-day occurrences of foodborne illness. (This document addresses item II B 3b in the FORCG Memorandum of Understanding.)

   3. A nationwide survey to catalog existing state and local food safety program infrastructures for those state and local agencies involved in responding to foodborne illness outbreaks.

   4. Establishment of working groups to develop recommended procedures for outbreak response coordination between federal and state agencies, and between state and local agency levels to better coordinate response to interstate outbreaks.

3. MANAGEMENT: the Assistant Secretary for Health and Surgeon General of HHS and the Undersecretary for Food Safety of USDA are the co-chairs of FORCG. The co-chairs will alternate chairing each of the FORCG meetings. The Executive Secretariat will rotate on a fiscal year basis.

STATE AND LOCAL AGENCIES

1. ROLE: Responsibility for responding to foodborne disease outbreaks is shared among local, state, and federal governments. Local and state governments are often the first to detect the occurrence of an outbreak and, when appropriate, to initiate an investigation.

   Prevention of foodborne illness is an important activity of local public health agencies. A 1997 survey by the National Association of County and City Health Officials (NACCHO) showed that 84 percent have food safety programs. Their activities include educating food managers and handlers, educating consumers, providing technical assistance to food facilities, inspecting retail food establishments, responding to public complaints, and investigating potential foodborne illnesses. The FDA Food Code is the basis for inspection and regulatory compliance activities. Local public health agencies typically also have their own specific local enforcement authorities granted by state and/or local statute. Public health agencies are the frontline in protecting the public from foodborne illness associated with improper handling of food or poor hygienic practices in retail food establishments.

   It is important to note that many episodes of foodborne illness are addressed exclusively at the local level. It is quite common for local public health agencies to receive complaints of possible foodborne illness alleged to be from a local restaurant. In many local jurisdictions, the complaint immediately leads to an on-site investigation at the restaurant and an epidemiologic investigation, both conducted by local public health agency staff. All inspections, interviews, food and human sample collection, physician contact, laboratory results reporting, and media interactions are coordinated at the local level. While state officials are informed, they typically are not directly involved other than by providing consultative guidance and public health laboratory services. Currently, federal agencies are rarely involved and rarely informed of such outbreaks, other than through their requirements for reporting communicable diseases. Federal agencies may participate in the investigation under certain circumstances. In addition, the private sector may play an important role in an outbreak response, including the initial detection of a problem or rapid effective recall of implicated food products.

   The states play a major role in outbreak surveillance and investigations. State departments of health, agriculture, and environment may be involved in outbreak surveillance, investigation and response, depending on the state. State health departments typically receive and analyze routine surveillance reports, coordinate surveillance among the local health departments, and provide epidemiological consultation and support during surveillance and outbreak investigations. In addition the states provide laboratory support for clinical, food and environmental samples. State laboratories have the capability of performing secondary testing of microbial agents, which can bevery helpful in linking samples.

2. NOTIFICATION: State and local agencies should promptly notify surrounding states and appropriate federal agencies in the following situations:
1. The foodborne illness outbreak involves an unusual or serious disease.
2. The foodborne illness outbreak appears to have the potential to affect a large number of people.
3. Cases of illness, or the potential for cases of illness to occur across state jurisdictions, potentially linked to the same food are identified in two or more states which raises concern about consistent communication.
4. The implicated food product is widely distributed or is within a special program such as the school lunch program.
5. The foodborne illness outbreak is likely to attract regional or national media attention.
6. The foodborne illness outbreak involves chemical contaminants, food additives, or pesticides.

FEDERAL AGENCIES

1. ROLE: In most instances, state and local resources are sufficient to identify an outbreak, determine its cause and mode of transmission, and interrupt transmission to protect the public's health. The role of the federal agencies in larger or more complex multi-state outbreaks is to assist the state and local agencies in preventing additional cases from occurring and preventing future outbreaks. In most instances that require federal assistance, a single federal agency will provide the necessary help, and FORCG will not be called into action.

When a federal agency receives information about a multi-state outbreak of foodborne illness that meets one or more of the criteria identified in part II. B., their federal regulatory agency designated FORCG contact should be informed. The FORCG agency contact will in turn notify the co-chairs of FORCG. The co-chairs will determine if FORCG should be convened.

2. AGENCY FUNCTIONS:

   Listed below are the functions of the various federal agencies with responsibility for food safety and foodborne disease prevention and response.

   Department of Agriculture

   USDA - The Department of Agriculture (USDA) has several components with responsibilities related to food safety. The responsibilities of the Food Safety and Inspection Service are described below. In addition, under the Federal Response Plan, the USDA's Food and Nutrition Service (FNS) is the Federal agency assigned lead responsibility to manage and coordinate Emergency Support Function 11 (ESF-11). In addition, the Office of Food Safety mobilizes, at the request of the Under Secretary for Food Safety, the USDA Food Emergency Rapid Response and Evaluation Team (FERRET) to facilitate a prompt, effective and coordinated USDA response to food emergencies.

   FSIS - The Food Safety and Inspection Service (FSIS) in the U.S. Department of Agriculture is responsible for assuring that meat, poultry, and egg products are not adulterated or misbranded. FSIS has the regulatory authority to coordinate a voluntary recall of meat, poultry or egg products linked to outbreaks of foodborne disease. During foodborne illness outbreaks, FSIS is available to assist state or local agencies in their investigation. FSIS has eight regional field-based epidemiology officers who carry out FSIS' investigation and outbreak response activities. These officers assist in tracing the origin and distribution of meat, poultry, and egg products and can provide laboratory assistance to identify the contaminant(s) in the implicated product. FSIS has experience in working with state health departments and knowledge of production practices of meat, poultry, and egg products. FSIS can provide coordination, laboratory support, technical consultation, regulatory support, and assistance with media relations.

   FSIS's main objective is to quickly remove from commerce any product known to be contaminated with harmful agents. To that end, FSIS seeks to verify the association with an FSIS-regulated product, identify the source of the product and the extent of the product's distribution and prevent further public exposure to the adulterated product. When necessary, FSIS will take appropriate regulatory action.

   If illnesses are associated with meat, poultry, or egg products, health department officials should contact the Human Health Sciences Division at 202-690-6409, 7:30 a.m. to 4:30 p.m., Monday through Friday (excluding federal holidays); after hours, contact the epidemiologist on call by beeper 1-800-759-7243 (pin #120-2473).

   Department of Health and Human Services

   HHS - The Department of Health and Human Services (HHS) has several divisions and components with responsibilities related to food safety and foodborne disease prevention and response. The responsibilities of the Food and Drug Administration and the Centers for Disease Control and Prevention are detailed below. In addition, HHS' Office of Emergency Preparedness mobilizes, at the request of the Assistant Secretary for Health, the National Disaster Medical System and other Department resources to assist State and local health authorities respond to the public health and health care consequences of an overwhelming foodborne disease outbreak. The Department's Regional Health Administrators assist in coordinating the response.

   FDA - The Food and Drug Administration (FDA) regulates the safety of all foods, including shell eggs that move in interstate commerce, except for meat, poultry and egg products regulated by FSIS. FDA's objectives in outbreak investigation and response are verification of the association with a regulated product, identification of the source of the product and extent of its distribution, prevention of any further exposure to the contaminated product, and initiation of regulatory action as indicated. Also, it is critical to determine contributing factors to avoid similar problems in the future. FDA has the regulatory authority to coordinate a voluntary recall of FDA-regulated products that are linked to outbreaks of foodborne disease. FDA works with other federal agencies as well as state and local agencies to assure efficient and expeditious investigation and response. FDA can provide coordination, field investigators, laboratory support, technical consultation, regulatory support, and media relations. FDA's Center for Food Safety and Applied Nutrition (CFSAN) provides policy, technical, and scientific support to these investigations. CFSAN scientists and consumer safety officers provide technical and scientific advice and support to field investigators during an outbreak investigation.

   Twenty District Offices located in five Regions carry out FDA's investigation and outbreak response activities. The FDA District Offices are the primary points of contact for state and local government agencies and the food industry. FDA's outbreak response is coordinated by the Division of Emergency and Investigational Operations (DEIO). DEIO can be contacted 24 hours a day, seven days a week at 301-443-1240.

   CDC - The Centers for Disease Control and Prevention (CDC) works closely with state and local public health epidemiologists and laboratorians to identify illnesses and clusters of illness that may be foodborne, to conduct the rapid epidemiologic investigations needed to implicate foods or other sources of infection, determine risk factors for illness, and develop prevention and control strategies. CDC does this by epidemiologic consultation with the state and local epidemiology office, on-site emergency assistance in epidemiologic investigations, provision of reference diagnostic support to the state public health laboratory, and development and application of subtyping protocols for foodborne pathogens. CDC is not a regulatory agency, but works with regulatory agencies during outbreak investigations to determine the origins of contaminated food and the reasons for the contamination. Epidemiologists and microbiologists in state public health departments have phone, FAX, and e-mail addresses for their routine CDC contacts. In an emergency, the CDC may be contacted 24 hours a day at 404-639-2888.

   DOD - The Department of Defense (DOD) has defined functions impacting public health through food safety and foodborne disease prevention within DOD. The United States Army Veterinary Service, the United States Army Center for Health Promotion and Preventive Medicine, the United States Air Force Biomedical Science Corps, and other military agencies conduct training in public health, including food safety and epidemiology; inspect and test food production/ processing facilities and delivered food products; and coordinate these programs with other military and federal agencies. Preventive Medicine/Environmental Health Officers conduct outbreak investigations based upon clinical symptoms of illness worldwide. Veterinary Officers conduct food item traceback investigations internationally and support two veterinary public health laboratories, one in San Antonio, Texas, and one in Germany. DOD also manages a food and non-prescription drug recall system coordinated with the USDA/FSIS and FDA to reach all military installations and facilities in the United States and overseas as well as US Naval ships at sea. DOD has officers trained in public health, environmental health, epidemiology, microbiology, toxicology, pathology, and food technology capable of providing coordination and support in outbreak investigations. DOD also contributes to food safety through research and surveillance on pathogens associated with food production and consumption.

   EPA - The U.S. Environmental Protection Agency (EPA) maintains a capability to respond to waterborne disease outbreaks. Generally, a state or county health department identifies these outbreaks, and they in turn contact the state environmental agency and CDC. If CDC agrees that the disease may be associated with drinking water, it or the state or both will contact EPA to request assistance in identifying the causes of the outbreak.

   EPA has established a coordination system for responding to waterborne outbreaks. The National Risk Management Research Laboratory (NRMRL) in the EPA's Office of Research and Development (ORD) should be contacted (513-569-7689: Dr. McKinnon). The NRMRL is responsible for staffing responses to outbreaks and through their Water Supply and Water Resources Division (WSWRD) provides a field response team and laboratory analytical capabilities, either directly or through support contract. Also, contact should be made with the EPA's Office of Ground Water and Drinking Water (202-260-5543 or 7096) to allow a coordinated outbreak response.

   In addition, WSWRD and other parts of ORD will respond to requests from Regional Offices, municipalities, and state agencies if there are water quality problems at individual water utilities. Frequently, these water quality problems are associated with violations of the Maximum Contaminant Levels under the Safe Drinking Water Act but have not been categorized as waterborne outbreaks.

   EPA's Office of Prevention, Pesticides & Toxic Substances administers the Toxic Substances Control Act, the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA), and the Pollution Prevention Act and has a system of criminal and civil penalties to enforce these statutes. Through cooperative enforcement agreements, all but one state has assumed primary enforcement responsibilities for pesticide violations under FIFRA (subject to EPA oversight). Through this system, EPA ensures that pesticides used on crops/food are registered, used according to label directions and that food is not adulterated. Investigations are done on pesticide incidents and incidents of chemical contamination. In cases of pesticide incidents or emergencies, Frank Davido (703-305-7576) in the Office of Pesticide Programs (OPP) should be contacted; he is both the OPP emergency response contact and Pesticide Incident Response Officer.

ASSESSMENTS

The primary objective of the early response to an outbreak of foodborne disease is to acquire information of sufficient quality and quantity to control the outbreak and limit illness and death. As previously noted, local and state public health and regulatory officials generally meet this objective, with or without federal assistance. The strength of the data needed for regulatory and nonregulatory outbreak responses depends on the circumstances of the outbreak and the severity of the disease. FORCG communication will include but is not limited to data resulting from the following activities:

1. EPIDEMIOLOGIC AND LABORATORY: Sometimes during investigations of outbreaks of foodborne disease, an epidemiologic association is established between illness and consumption of a specific food but laboratory confirmation of product contamination is not available. When a state or local health department believes that a federal agency should conduct a product traceback or recall based on epidemiologic data alone, the following information should be provided to the appropriate regulatory agency and CDC:

• A brief description of the outbreak, including its location; clinical characteristics of illness; diagnosis (if known) and diagnostic criteria; number of people ill, laboratory confirmed, and hospitalized; number of fatal cases; dates of first and last known onset of symptoms (provisional epidemic curve, if available).

• Case definition used in the investigation.

• Method of laboratory confirmation, identity and location of the diagnostic laboratory.

• Method of selection of controls (e.g., next age/gender matched ER patient without GI symptoms, well neighbors, unmatched random selection from the community) and number of controls.

• An epidemiologic/statistical analysis demonstrating the strength of association between illness and a specific food.

• A description of the implicated food that includes the brand name, producer, production codes and place and date of purchase.

The initial submission does not have to be lengthy or complete, but this information is important for the deliberations of the Rapid Assessment Team at CDC, and forms the scientifically credible basis for regulatory action. The Rapid Assessment Team is composed of the following:

1. a state epidemiologist in the affected states(s);
2. two consultant state epidemiologists;
3. CDC branch chief or expert in area of concern;
4. appropriate Associate Director for Science of involved CDC Center; and
5. other senior CDC staff with experience in outbreak assessment (2 or more).

The Rapid Assessment Team consultants can include a state laboratory director or designee, and representatives of regulatory agencies (FDA, FSIS, and EPA). The functions of the Rapid Assessment Team are to: 1) rapidly review available data and determine the type of additional information needed, if any, before control measures are put in place that may have national implications, and 2) assess quality of data and make recommendations for regulatory actions or other control measures. If the regulatory agency takes legal action based on epidemiologic data, additional information or documentation may be required.

2. ENVIRONMENTAL: An assessment at the location of the outbreak is needed to evaluate whether the contamination occurred locally or at some other point in the implicated product(s) distribution. The federal regulatory agencies will request the following information from the environmental assessment:

   • Identification of suspected agents and food vehicles.

   • Other possible sources of agents (e.g. drinking water).

   • Existence of leftover, potentially implicated food.

   • Data on food workers including determination of recent illness, questionnaires, specimen collection.

   • Food preparation methods and possibility of cross contamination, temperature abuse.

   • Original food container and label, container type, manufacturer, distributor, and/or importer.

   • Records of sale/shipment - invoices, freight bills, quantities, date(s) received.

   • Product lot number(s), size, color, grade, or codes of implicated food.

   • Remaining food from suspect meals.

   • Sufficient sample of implicated food for pathogen enumeration or chemical contaminant identification for dose-response determination.

3. TRACEBACKS: During an investigation of a foodborne illness outbreak, it is sometimes important to trace the implicated food vehicle backward toward its source. The traceback may be important for epidemiologic or regulatory purposes, and the approach used depends on the purpose of the traceback and the legal regulatory requirements that might form the basis of legal action. An epidemiologic traceback is conducted to help establish an association between a food and illness; to determine which of two or more possible vehicles could have caused the illnesses; and to determine the source of contamination and contributing factors that led to contamination.

   Regulatory tracebacks usually are initiated when the potential for a regulatory or administrative action could result (e.g., seizure or recall of product, injunction of firms). Inasmuch as regulatory tracebacks could always lead to potential legal action, they have more rigorous administrative and record-keeping requirements than epidemiologic tracebacks. They require more human resources and may be abandoned if it is determined that the resulting information will not be useful for legal purposes.

   A traceback that begins for epidemiologic purposes can quickly develop into a regulatory investigation if appropriate evidence is obtained. Therefore, it is desirable that the regulatory agency conduct the tracebacks even if it appears that the investigation is unlikely to uncover useful legal data.

   CDC, FSIS, and FDA all have traceback expertise that state and local agencies can call upon in investigating outbreaks of foodborne disease. This federal expertise is especially important for investigations of multi-state foodborne outbreaks that require FORCG coordination. The kind of information that a traceback investigation will obtain includes the following:

   Point of service establishment (where the implicated food product was prepared and served):

   • Product identifying information (including packaging, container type, size, color, grade, labeling, FSIS plant ID number, if applicable, and lot numbers, if available).

   • Production or pull dates.

   • Origin of the product.

   • Product preparation and use including storage conditions.

   • Receipt of product at establishment - records for all shipments that were usable at the time of the event causing the outbreak should be collected. These records would include invoice number, date, and quantities received, date of receipt, name and address of shipper(s), and lot number or codes involved.

   • Method of shipment including shipping record(s), airway or freight bill numbers and dates.

   Distributor(s):

   • Records of shipment of product to point of service establishment or next distributor.

   • Maximum shelf life of product (period of time it would be usable and salable) - records would need to be collected for the receipt of all product during the shelf life period, i.e. if the shelf life is 15 days, then records covering the shipment of the product for the 15 days previous to the day of the event causing the outbreak would be collected.

   Procedures for storage and distribution of product, including inventory procedures and records, records of stock rotation.

   • Ordering practices and historical use patterns.

   • Times of delivery from suppliers.

   • Invoice numbers, dates and quantities received from all suppliers, names and addresses of all suppliers, lot number(s) or codes received, method of shipment including shipping record(s), airway or freight bill numbers and dates.

   • For imported product(s), records should also be collected documenting importer (broker) name and address with port of entry if available; importer's invoice, airway or freight bill(s), plant ID number (if applicable) and dates of shipment; entry number used for customs clearance.

   • Sample collection of implicated product if available, or same type of product, if requested.

   Manufacturer, processor, or producer:

   • Manufacturing or production conditions or ingredients that may contribute to product contamination.

   • Dates of production.

   • Amount of product produced.

   • Finished product samples, if available.

   • Samples of ingredients used in the manufacture or production.

   Additional samples:

   • If the same product is available at the point of service that was the same as the implicated product, samples should be collected immediately for analysis.

   • If no product is available and similar product from the same source is available; sample collection may also be warranted.

MEETINGS OF FORCG

Members of FORCG will be convened by conference call as soon as possible after the decision of the Co-Chairs. FORCG members will discuss what is known about the multi-state foodborne disease outbreak and in those situations where this call is held before a food vehicle has been identified, decide if there is a need for a single federal point of contact for communication about the outbreak.

FORCG members will determine the appropriate frequency of conference calls and thenecessary participants to provide an opportunity for informationsharing about the multi-state outbreak. Inquiries about the outbreak within a state should be handled by the respective state; however, federal agencies will provide assistance to assure consistent messages among states.

When epidemiologic data or laboratory analysis links a specific food product to an outbreak, the regulatory agency responsible for the inspection of that commodity will lead the discussions and will become the single federal point of contact. The federal agency with regulatory responsibility for the implicated product will coordinate any public information releases about actions against the product. If the food product is contaminated by a substance or source regulated by another federal agency, the other federal agency will participate in developing and releasing information to the public.

It should be kept clearly in mind that the purpose of the FORCG conference calls is to facilitate information sharing among the involved public health and regulatory agencies. These calls will enhance outbreak response by providing a scheduled time and place for information sharing and a single source of official information dissemination. FORCG conference calls, therefore, should eliminate the need for most additional update calls to federal, state, and local personnel who are already busy responding to the food safety emergency, and should minimize the dissemination of out-dated, fragmentary, and conflicting information from multiple sources within multiple agencies.

COMMUNICATION

When several state and federal agencies are involved in an investigation of a foodborne illness outbreak and the criteria in part II B are met, FORCG will coordinate the release of information to the media about the investigation. Lack of coordination can result in confusing, conflicting, and inaccurate messages to the public. Moreover, one of the goals of the food safety initiative and FORCG is to strengthen collaboration among agencies.

At the outset of multi-state foodborne illness outbreaks that will involve FORCG, FORCG should discuss the need for informing the public about the outbreak and the investigation. Public affairs staff from each relevant agency should be part of such discussions. When information is preliminary, a great deal of skill is necessary to craft a message that will not mislead, confuse, and unnecessarily alarm consumers, but will assist in preventing additional illnesses or allow for early treatment of an illness.

Even when outbreaks of foodborne disease do not rise to the level of FORCG involvement, federal agencies' public affairs staff are available to assist state and local agencies. They can help in choosing effective strategies for informing the public, including language for press releases.

Coordination regarding content and timing of press releases is critical, especially when multiple local, state, and federal agencies are involved in outbreak response. When a press release is being prepared for a foodborne illness outbreak that meets the criteria identified in part II B, FORCG conference calls can help federal and state agencies involved in their discussions of the following factors:

• Which agency (ies) will issue a press release?

• If only one agency is to issue a release, it should be considered the lead media contact on the investigation.

• If more than one agency needs to issue a release, the facts and main public health message should be consistent with each other, even if the public health or regulatory mandates of the various agencies preclude identical press releases.

• How much information about the outbreak and the investigation is releasable?

• What is the advice to consumers?

• Who will be the media points of contact? This is particularly important if more than one agency will speak to reporters about the investigation.

• Will agencies do on-camera interviews for television and on-the-record interviews for newspapers, or background interviews only? If on-camera and on-the-record interviews are done, the agency spokesperson should be determined.

Before a press release is issued, the agency points of contact will share a draft of their press release with all federal agencies involved in the investigation. The federal agency with regulatory authority over the product should always be notified before a press release is issued. The sharing of press releases before they are issued will give other agencies an early alert if they get media calls. It also gives them an opportunity to correct any errors in the release or make suggestions on how to more effectively communicate to the public about the investigation.

After a press release is issued, all involved agencies should discuss any additional media follow-up that may be needed. All agencies should receive draft copies before any more press releases are issued.

David Satcher, M.D., Ph.D. Assistant Secretary for Health and Surgeon General U.S. Department of Health and Human Services	Catherine E. Woteki, Ph.D., R.D. Under Secretary for Food Safety U.S. Department of Agriculture
Patrick D. Sculley Major General, U.S. Army Deputy Surgeon General
Susan H. Wayland Acting Assistant Administrator Office of Prevention, Pesticides & Toxic Substances U.S. Environmental Protection Agency	Charles J. Fox Assistant Administrator Office of Water U.S. Environmental Protection Agency