UNITED STATES DEPARTMENT OF AGRICULTURE 

FOOD SAFETY AND INSPECTION SERVICE 

WASHINGTON, DC 

FSIS DIRECTIVE 8080.3 

Rev. 2 

10/27/17 

FOODBORNE ILLNESS INVESTIGATIONS 

I. PURPOSE 

This directive provides personnel from the Office of Data Integration and Food Protection 

(ODIFP), Office of Field Operations (OFO), Office of Investigation, Enforcement and Audit 

(OIEA), Office of Policy and Program Development (OPPD), Office of Public Affairs and 

Consumer Education (OPACE), and Office of Public Health Science (OPHS) the procedures 

they are to follow when investigating foodborne illnesses potentially associated with FSISregulated meat, poultry, or processed egg products. It also identifies the factors that trigger an 

FSIS foodborne illness investigation. This directive is being reissued in its entirety to reflect 

changes in organization structures and corresponding changes in responsibilities during a 

foodborne illness investigation. 

II. CANCELLATION 

FSIS Directive 8080.3, Rev. 1 Foodborne Illness Investigations, 9/4/13 

III. BACKGROUND 

A. As a public health regulatory agency, FSIS investigates reports of foodborne illness 

potentially associated with FSIS-regulated products. 

B. A foodborne illness investigation is a multi-faceted, multidisciplinary undertaking that 

includes, but is not limited to collecting and analyzing data from epidemiologic, laboratory, and 

environmental assessments. The objectives of an FSIS foodborne illness investigation are to: 

1. Determine whether reported human illness is associated with an FSIS-regulated product; 

2. Identify the source and scope, as well as the distribution, of suspect meat, poultry, or 

processed egg product; 

3. Gather information that FSIS can use to guide its response to ensure that the product 

associated with illness is not available for consumption; 

4. Develop information to guide efforts to prevent further exposure of consumers to the 

contaminated product; 

5. Collect information and evidence that can be used to support or lead to an enforcement 

action or to recommend the recall of the identified products; 

6. Identify contributing factors, including addressing potential system failures; 

7. Prepare a report on the results of the illness investigation; and 

8. Recommend actions or new policies to prevent future occurrences. 

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C. Although the focus of the directive is on foodborne illness associated with microbial hazards, 

the information is applicable for investigation of foodborne illnesses with deleterious substances 

in food. 

D. This directive is organized to reflect the general phases of an FSIS foodborne illness 

investigation. However, each investigation is unique, and the steps outlined do not always 

occur in the specified order. The flow of information and data during an investigation is 

dynamic; consequently, the phases of an investigation may occur almost simultaneously: 

Surveillance and Information 

Monitoring 

Initiating a Foodborne Illness 

Investigation 

Foodborne Illness Investigation 

Product Sampling and Laboratory 

Analysis 

Environmental Assessment and Data Analysis and Assessment 

Product Traceback and Traceforward 

Agency Action 

Close-Out and Final Assessment 

E. This directive supplements, but does not conflict with or supersede, instructions related to 

the Consumer Complaint Monitoring System (CCMS) as specified in FSIS Directive 5610.1, 

Procedures to Implement the Consumer Complaint Monitoring System. 

F. This directive supplements, but does not conflict with or supersede, instructions related to 

investigation procedures as specified in FSIS Directive FSIS Directive 8010.1, Methodology for 

Conducting In-Commerce Surveillance Activities, FSIS Directive 8010.2, Investigative 

Methodology, FSIS Directive 8010.3, Procedures for Evidence Collection, Safeguarding and 

Disposal, FSIS Directive 8010.4, Report of Investigation, and FSIS Directive 8010.5, Case 

Referral and Disposition. 

G. Some general terms used during outbreak investigations are: 

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1. Case-patient: An individual with a presumptive or confirmed foodborne illness. 

2. Cluster: Group of relatively uncommon events or illnesses in space or time in numbers 

greater than expected. A foodborne illness investigation is needed to determine whether 

the cluster represents an outbreak due to the involvement of a common exposure. 

3. Environmental assessment: Investigation of the factors in the environment, such as inplant assessments. 

4. FSIS Incident Management System (FIMS): The web-based application for managing 

the receipt, monitoring, and follow-up actions of all Incident Reports (IRs) received by 

FSIS. 

5. FSIS foodborne illness investigation: An investigation of a possible association between 

human illnesses and an FSIS-regulated product that includes epidemiologic, laboratory, 

traceback activities, and environmental assessments. 

6. FSIS foodborne illness watch: An illness cluster with a likelihood of involvement of 

FSIS-regulated product with traceable information where additional exposures have not 

been ruled out. 

7. Implicated: Evidence from epidemiologic, laboratory, and traceback information or strong 

evidence from two of the three sources of information, rendering a conclusion about a 

suspect vehicle. 

8. Intact package: A product with unopened packaging or a product that has not been 

removed from its original primary packaging, by the consumer or other party, as supplied 

by the producing establishment. 

9. Isolate: A pure culture of bacteria, such as Salmonella, Escherichia coli (E. coli) 

O157:H7, non-O157 Shiga toxin-producing E. coli, Campylobacter, or Listeria 

monocytogenes (Lm), isolated from a clinical specimen, food or environmental sample. 

10. Multiple-locus Variable-number Analysis (MLVA): A DNA-based laboratory subtyping 

method. This method, typically used to supplement pulsed-field gel electrophoresis 

(PFGE), can be useful in discriminating closely related isolates during an illness 

investigation. 

11. Non-intact package: A product with opened packaging or a product that has been 

removed from its original primary packaging, by the consumer or other party, as supplied 

by the producing establishment. 

12. Pulsed-field gel Electrophoresis (PFGE): A DNA-based laboratory method used to 

determine whether isolates are closely related genetically and therefore could originate 

from a common source. 

13. PulseNet: A national laboratory network headquartered at the Centers for Disease 

Control and Prevention (CDC) consisting of public health and food regulatory 

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laboratories that contribute isolate characterization information for sharing across public 

health and regulatory partners. 

14. Surveillance: The use of systematically collected data to monitor and detect events or 

clusters that may trigger a foodborne illness watch or investigation. 

15. Traceback: The actions taken to identify and document the flow of product back to the 

originating source from official establishments, retail stores, warehouses, distributors, 

restaurants, or other firms. 

16. Traceforward: The actions taken to identify and document product distribution from the 

originating source to official establishments, retail stores, warehouses, distributors, 

restaurants, or other firms. 

17. Whole Genome Sequencing (WGS): A molecular method that provides high resolution 

data for identifying and characterizing bacteria and other microorganisms. 

IV. ROLES AND RESPONSIBILITIES OF FSIS PERSONNEL THROUGHOUT FOODBORNE 

ILLNESS INVESTIGATIONS 

A. Office of Public Health Science (OPHS) 

1. Applied Epidemiology Staff (AES) 

a. Functions as the Agency lead and principal coordinator for foodborne illness 

investigations; 

b. Conducts surveillance and initiates the foodborne illness investigation process; 

c. Serves as an Agency point of contact for local, state, and territorial public health 

and agriculture officials; 

d. Coordinates requests for information to and from the Centers for Disease Control 

and Prevention (CDC) Outbreak Response and Prevention Branch (ORPB) and 

in coordination with the FSIS Liaison to CDC; 

e. Analyzes epidemiologic and other investigation-related information; 

f. Assists other program areas to ensure factual, technical, and scientific accuracy 

in public communications; 

g. Shares information with other program areas to facilitate effective field 

investigative activities; 

h. Coordinates follow-up and close out meetings and compiles information to 

develop a final AES report for dissemination to appropriate Agency entities; 

i. Conducts consumer complaint surveillance and investigation activities per FSIS 

Directive 5610.1; and 

j. Coordinate foodborne-related illness root cause assessment with USDA/APHIS 

as outlined in the MOU between FSIS and APHIS Veterinary Services. 

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2. Science Staff (SciS) 

a. Designs, coordinates, and leads implementation of intensified sampling or other 

related sampling activities for outbreak investigations 

b. Coordinates sample collection and transportation and analyses of FSIS samples 

c. Evaluates the chain of custody and results of samples from non-FSIS 

laboratories per FSIS Directive 10,000.1, Policy on Use of Results from NonFSIS Laboratories; 

d. Communicates and interprets sample results; and 

e. Assists other program areas to ensure factual, technical, and scientific accuracy 

in public communications 

3. Eastern Laboratory Microbial Characterization Branch (MCB) 

a. Performs laboratory testing, including subtyping analyses, of investigationassociated samples and isolates; and 

b. Coordinates requests for laboratory information to and from the CDC PulseNet in 

coordination with the FSIS Liaison to CDC. 

4. FSIS Liaison to CDC 

a. Serves as the primary Agency point of contact with the CDC; 

b. Supports FSIS-CDC interagency investigation coordination and communication; 

and 

c. Serves as a subject matter expert on foodborne diseases and foodborne illness 

investigations. 

B. Office of Investigation, Enforcement and Audit (OIEA) 

1. Conducts domestic and international traceback and traceforward activities to determine 

product source and locate product in commerce; 

2. Controls adulterated or misbranded product in commerce; 

3. Collects and submits samples of product upon request; 

4. Obtains administrative subpoenas for records, if necessary; 

5. Investigates situations that may involve criminal, civil, or administrative activities; 

6. Coordinates investigations involving alleged tampering or terrorist activities with the 

Office of the Inspector General (OIG) and other law enforcement agencies; 

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7. Coordinates investigation of foreign establishments; 

8. Serves as an Agency point of contact for local, state, and territorial public health and 

agriculture officials to coordinate traceback and traceforward activities; and 

9. Assists OFO at official establishments; participates in verification activities or product 

identification and control. 

C. Office of Field Operations (OFO) 

1. Conducts traceback and traceforward activities at official establishments; 

2. Locates and controls product that has not left the official establishment; 

3. Collects and submits product samples from official establishments; 

4. Conducts in-plant investigations and actions; 

5. Analyses, reviews, and verifies inspection-related data; and 

6. Coordinates recall activities. 

D. Office of Public Affairs and Consumer Education (OPACE) 

1. Coordinates media, consumer, trade group, and stakeholder communication; and 

2. Oversees the USDA Meat and Poultry Hotline which serves as a point of contact for the 

public to report problems or illnesses possibly associated with FSIS-regulated food 

products. 

E. Office of Policy and Program Development (OPPD) 

1. Assesses policy implications and provides policy-based recommendations; and 

2. Reviews investigation data to assess needs for policy clarification or development. 

F. Office of Data Integration and Food Protection (ODIFP) 

1. Collaborates with program areas during investigations that may involve food defense or 

emergency coordination issues; and 

2. Supports investigations by providing data or performing analyses; 

3. Coordinates the activities of the Emergency Management Committee (EMC) as outlined 

in FSIS Directive 5500.2, Significant Incident Response; 

4. Administrates and manages the FSIS Incident Management System (FIMS) which is 

used to manage and track incident reports (IRs); and 

5. Oversees and reviews the IRs that may be created due to a foodborne illness 

investigation. 

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G. Office of Outreach, Employee Education, and Training (OOEET) 

1. Provides training on FSIS strategies to address foodborne illness investigations and 

product traceback and traceforward methodology; 

2. Trains inspection workforce on importance of sample collection techniques, proper 

documentation, chain of custody, and general food safety issues including HACCP 

evaluation and product statutes and regulations; and 

3. Informs workforce of food safety and biosecurity issues and lessons learned from 

recalled FSIS-regulated products. 

V. DETERMINING THE NEED FOR A FOODBORNE ILLNESS INVESTIGATION: 

SURVEILLANCE AND INFORMATION MONITORING 

A. FSIS conducts foodborne illness investigations in response to situations in which an FSISregulated product may be associated with human illness. FSIS may become aware of a 

potential association between an FSIS-regulated product and human illnesses from the 

following sources: 

1. Notification from local, state, territorial, national, tribal, or international public health 

officials. If public health officials identify a potential association between human illness 

and an FSIS-regulated product through surveillance, they typically notify FSIS to report 

the identified association or to request FSIS assistance with the investigation; 

2. If CDC identifies a potential association between human illness and an FSIS-regulated 

product, either through surveillance or interaction with public health officials, CDC 

officials inform the OPHS AES Senior Epidemiologist embedded in the CDC Outbreak 

Response and Prevention Branch (ORPB), FSIS Liaison to CDC, or designee; or 

3. If other federal agencies, specifically the Food and Drug Administration (FDA), identify a 

potential association between human illness and an FSIS-regulated product when 

conducting their own foodborne illness investigations, a member of the Coordinated 

Outbreak Response and Evaluation (CORE) Network, including the FDA Liaison to 

CDC, notifies AES. 

B. OPHS conducts its own monitoring and surveillance activities driven by the CDC Epi-X 

system, CDC PulseNet, foodborne illness reporting listservs, and illness clusters involving 

isolates from positive FSIS laboratory sampling. Surveillance of consumer complaints by CCMS 

is carried out using procedures outlined in FSIS Directive 5610.1. 

C. FSIS may become aware of potential associations between human illness and FSISregulated product through media reports and other information sources. 

D. AES is responsible for evaluating surveillance data or other information gathered by public 

health officials that points to a potential association between human illness and an FSISregulated product. 

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E. If a public health official outside of FSIS contacts FSIS personnel who work in an office other 

than AES to report information on a potential association between human illness and an FSISregulated product, that office is to inform the AES Director or AES Senior Epidemiologist 

embedded in the CDC ORPB. An AES investigator contacts the public health official, in 

coordination with CDC ORPB, to gather information about the illness and the affected product. 

Foodborne illness can also be reported to FoodborneDiseaseReports@fsis.usda.gov. 

F. When AES investigators receive information about a potential association between human 

illness and an FSIS-regulated product, they assess the strength of the epidemiologic data to 

determine whether there is a plausible basis to support the association and initiate an FSIS 

foodborne illness investigation. At this preliminary stage, information will be classified as an 

FSIS foodborne illness investigation or watch by AES depending on the strength of the potential 

association. When AES investigators are evaluating the information, they are to consider the 

following factors: 

1. Does the available information suggest a link between FSIS-regulated product and 

human illness? 

2. Are the surveillance, investigative, and laboratory methods being used likely to produce 

scientifically valid results? 

3. Are the preliminary epidemiologic findings plausible? 

4. Are the preliminary laboratory and environmental findings consistent with the preliminary 

epidemiologic findings? 

5. Do the published literature and past experiences of the Agency support the preliminary 

findings? 

G. If, after considering the factors described above, AES investigators determine that the 

reported human illness may be associated with an FSIS-regulated product, they initiate a 

foodborne illness investigation using the instructions in section VI. 

H. When AES initiates a foodborne illness investigation, the AES Director or designee 

designates an AES lead investigator who will be responsible for the overall coordination of the 

investigation. 

I. Even if AES decides not to initiate an FSIS foodborne illness investigation, the Agency may 

provide technical assistance, investigative support, and guidance to public health officials or 

other food safety agencies. 

VI. ACTIONS TO BE TAKEN WHEN A FOODBORNE ILLNESS INVESTIGATION IS 

INITIATED 

A. After AES initiates an FSIS foodborne illness investigation, and if one does not already exist, 

the AES lead investigator will create an IR in FIMS unless determined otherwise by OFO, OIEA, 

or OPHS Assistant Administrators. The AES lead investigator will enter information about the 

investigation into the IR. The AES lead investigator should ensure that data from the OPHS 

investigation record database is added to the IR. 

B. The AES Senior Epidemiologist embedded in the CDC ORPB or designee is to determine 

whether to issue an e-mail alert. Alerts provide early notification of foodborne illness 

investigations that will likely necessitate additional Agency resources or action. The e-mail is 

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sent to an established network of program area contacts selected by program area 

management. It will provide the name and contact information of the AES lead investigator in 

addition to the IR number. The AES lead investigator is to post the alert to the IR in FIMS. 

C. Information in the e-mail alert is confidential and is not to be released outside of FSIS. 

Health, confidential business, proprietary, and establishment-specific information is to be 

carefully reviewed before any further dissemination. 

D. The AES lead investigator is to send update alerts using e-mail when there are relevant 

developments in a foodborne illness investigation. The updates are to be distributed to the 

same network of FSIS program area contacts designated to receive alerts. These contacts are 

responsible for communicating relevant information about an investigation to their program area 

management, EMC representative, and other appropriate personnel. The AES lead investigator 

is to post this information to the IR in FIMS. 

E. If an FSIS foodborne illness investigation requires involvement of the EMC, AES will follow 

the procedures of FSIS Directive 5500.2. A significant incident, as discussed in FSIS Directive 

5500.2, presents a grave, or potentially grave, threat to public health or threat to the safety of 

FSIS-regulated product. An example includes life-threatening or widespread human illnesses 

potentially associated with FSIS-regulated product that led to a foodborne illness investigation. 

F. If at any time, the AES lead investigator or any other FSIS personnel suspect that the 

situation may involve intentional product tampering or criminal violations, they are to notify the 

OIEA Compliance and Investigations Division (CID) Director or designee immediately. OIEA will 

determine if the OIG should be involved as per FSIS Directive 8030.1. 

G. If at any time the AES lead investigator or any other FSIS personnel suspect a potential preharvest link, they are to notify the AES Director or designee so that a determination could be 

made regarding coordination of root cause assessment with the USDA Animal and Plant Health 

Inspection Service (APHIS) as outlined in the MOU between FSIS and APHIS Veterinary 

Services. 

VII. PRODUCT SAMPLING AND LABORATORY ANALYSIS 

A. Determining whether to submit case-patient or retail product samples for laboratory analysis: 

1. AES investigators are to meet with the OPHS SciS and Eastern Laboratory MCB 

investigators on a weekly basis and whenever there are new developments in a 

foodborne illness investigation to discuss issues regarding laboratory analyses. 

2. To decide whether to sample and test case-patient or retail products potentially 

implicated in an FSIS foodborne illness investigation, AES and SciS are to consider the 

answers to the questions presented below in consultation with MCB: 

a. Do the epidemiologic investigation data, including the reported food history, 

support a link between illness and FSIS-regulated product? 

b. Do the laboratory findings support a link between illness and FSIS-regulated 

product? 

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c. Does the environmental assessment support a link between illness and FSISregulated product? 

d. Is there product available to test that meets FSIS criteria for product identity, 

chain of custody, and product handling as outlined in the decision criteria of FSIS 

Directive 10,000.1, Policy on Use of Results from Non-FSIS Laboratories? If not, 

are there reasons for testing product that may not meet all of these criteria? 

e. Has product already been tested by a non-FSIS laboratory with reliable 

methodology? 

f. Can testing be carried out by or in conjunction with FSIS? 

3. The AES and SciS lead investigators are to consider whether FSIS should analyze nonintact package product samples obtained in commerce or from a consumer’s home. To 

determine whether to submit a non-intact package product sample for laboratory 

analysis, AES and SciS are to consider the following factors to assess the validity and 

utility of findings: 

a. Was the non-intact package product directly handled by the case-patient? If so, 

when and under what circumstances was it handled? 

b. Was the non-intact package product stored properly to avoid cross-contamination 

and minimize temperature abuse? 

c. Are packaging materials and product labels that identify the non-intact package 

product available? Does the case-patient have a shopper loyalty card or receipt 

that would assist with product identity? Was traceback successful in determining 

the product identity? 

d. Is the product from an official establishment that has recently been part of a 

voluntary recall? If yes, was the product produced outside the scope of the 

recall? 

4. If, after considering the factors described in sections VII.A.2. and VII.A.3. above, AES, 

SciS, and MCB determine that product sampling and laboratory testing are needed to 

determine whether there is an association between illness and an FSIS-regulated 

product, the SciS lead investigator is to: 

a. Confer with the SciS Director or designee to make a science-based 

recommendation regarding the types and quantities of samples to be collected 

and the specific analyses to be performed to maximize the chance of generating 

data that can inform decision-making. 

b. SciS is to fill out the “Outbreak-Associated Sample Request” form. This form 

describes the number and types of samples, the number of test portions, the 

proposed analyses, and the priority and urgency of laboratory analyses. 

B. Investigative sampling: If it is determined that FSIS should conduct investigative sampling at 

an implicated establishment or at a retail location, SciS will coordinate development of a 

sampling plan and work with the Laboratory Quality Assurance Staff (LQAS) to develop a 

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laboratory contract; SciS will develop and implement the sampling in coordination with OFO, 

OIEA, and OPPD. 

C. Collecting, preparing, and shipping product samples: 

1. Information regarding product sampling and subsequent laboratory results will be posted 

to the IR in FIMS. 

2. OIEA/CID investigators and OFO personnel responsibilities. When collecting, preparing, 

and shipping product samples for laboratory analyses as part of a foodborne illness 

investigation, personnel are to refer to procedures in FSIS Directive 8010.3. 

3. OFO program personnel and OIEA/CID investigators are to contact the SciS lead 

investigator if they have any questions on how they are to collect, prepare, or ship 

product samples collected as part of a foodborne illness investigation. 

4. OFO district office personnel are to notify the affected establishment of the Agency’s 

collection of product samples for laboratory analyses prior to sampling. 

NOTE: If samples are taken from product that has not moved into commerce, and positive 

results support that product is adulterated, OFO district office personnel notify the establishment 

that the sampled lot of product cannot enter commerce. This approach is consistent with the 

Agency’s policy and procedures that require establishments to hold or control product pending 

certain FSIS test results. 

5. OIEA/CID investigators are to notify the affected retail firm when a product sample in 

commerce is collected for laboratory analyses. 

6. OIEA/CID investigators may coordinate with state or local public health personnel to 

assist with the collection of samples from a case-patient’s residence. 

7. OFO district office personnel will notify the official federal establishment when a product 

sample is collected for laboratory analysis at a retail setting or from a case-patient’s 

home. 

8. When samples cannot be collected and shipped by FSIS personnel, the SciS lead 

investigator is to coordinate shipment directly from the state, local, or other collecting 

agency to the appropriate laboratory. 

D. Results from non-FSIS laboratories: 

1. During foodborne illness investigations, non-FSIS laboratories may test FSIS-regulated 

product. If AES and SciS determine that SciS should review the methodology and 

results of an analysis conducted by a non-FSIS laboratory, the AES lead investigator is 

to provide the SciS lead investigator with contact information for the appropriate 

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laboratory personnel. SciS is to use the methodology in FSIS Directive 10,000.1 in 

evaluating whether to accept the laboratory results. 

2. If SciS determines that the method chosen by the non-FSIS laboratory is not 

appropriate, or that the sensitivity or specificity is not similar to the FSIS method, SciS 

may recommend sending samples or isolates to an FSIS laboratory for further analysis. 

SciS will communicate with non-FSIS laboratory personnel to ensure that they follow 

acceptable shipping procedures and that they maintain the appropriate chain of custody. 

SciS will also coordinate with the MCB personnel to ensure that they are aware of 

samples being sent to FSIS for analysis. 

E. Reporting FSIS laboratory results: When analysis is complete and the release of the results 

is authorized, laboratory staff are to send a report to an established distribution list, including the 

AES lead investigator, as well as to the FSIS staff who submitted the samples. SciS will compile 

data from intensified sampling. OPHS is to post this information to the IR in FIMS. 

F. Testing capabilities: If FSIS laboratories do not have the testing capability for the pathogen 

of concern, the SciS lead investigator and MCB Chief may arrange for testing in a government 

or university research laboratory that SciS and MCB have determined has the capability to 

produce scientifically valid results with appropriate chain of custody procedures in place. 

G. CDC PulseNet: All microbiological analysis, including MLVA, PFGE, and WGS data derived 

from FSIS foodborne illness investigations and recall related samples by MCB are to be 

transferred to PulseNet by MCB staff. All requests for data from the PulseNet are to be 

coordinated by MCB staff. 

VIII. ENVIRONMENTAL ASSESSMENT AND PRODUCT TRACEBACK AND 

TRACEFORWARD 

A. General 

1. Throughout the foodborne illness investigation, the AES lead investigator is to assess 

whether the expertise of other FSIS programs, such as OIEA or OFO, is needed to 

assist with the investigation. 

2. OFO and OIEA personnel are to work in coordination with one another and with local, 

state, and territorial health, environmental health, or agriculture department personnel 

during domestic traceback investigations. It is imperative that information be shared 

regularly and promptly to avoid duplicative communication. 

3. OFO and OIEA personnel are to conduct traceback and traceforward activities and 

contribute to the overall decision-making process. They are to promptly notify the AES 

lead investigator and others working on the investigation of new developments via 

upload of the information to the IR in FIMS. 

4. Information collected during an investigation that contains personal identifiers that can 

be linked back to case-patients is to be considered confidential and not released to 

parties outside of FSIS. All case-patient personally identifiable information (PII) should 

be redacted. 

B. OIEA activities during foodborne illness investigations 

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1. The AES and SciS Directors or designees are to request that OIEA/CID assist with a 

foodborne illness investigation if more information is needed about product that has 

been distributed in commerce. For example, OIEA/CID may need to collect traceback or 

traceforward information about a product, locate or detain the product in commerce, 

submit investigative samples of product in commerce for laboratory analysis, or conduct 

other activities to help determine whether there is an association between the product 

and human illness. 

2. If the foodborne illness investigation suggests a link to product imported into the United 

States, the OIEA/CID Director or designee will coordinate with the OFO Import 

Operations Branch and OPPD Import and Export Policy Development Staff; the Office of 

International Coordination will work and communicate with foreign governments. 

3. The OIEA/CID assigned investigator or designee will develop and post an investigative 

plan and timeline for OIEA activities to the IR in FIMS within 12 hours of the IR approval 

and include “Investigative Plan was developed and published in the IR” in the comment 

field of the IR. The Investigative Plan will include the name and contact information of 

the OIEA/CID investigator assigned to assist with the investigation as described in FSIS 

Directive 8010.2. The investigative plan and timeline will be updated with information 

throughout the investigation and posted to the IR in FIMS. 

4. When conducting activities during a foodborne illness investigation, OIEA/CID 

investigators are to follow the investigative methodologies described in FSIS Directive 

8010.1, FSIS Directive 8010.2, FSIS Directive 8010.3, FSIS Directive 8010.4, and FSIS 

Directive 8010.5. They are to contact the AES lead investigator for any questions or 

clarification they may need about the investigation and provide investigation status 

updates, as needed, to the OIEA/CID Regional Director (RD), Director, or designee. 

C. OFO activities during foodborne illness investigations 

1. The AES Director or designee is to request assistance from OFO if more information is 

needed about product under the control of an official establishment. The request should 

include the rationale and how the findings will be used in the investigation. For example, 

AES may need OFO to obtain traceback and traceforward information about a product, 

obtain information about the establishment’s suppliers, or locate like- or same-coded 

intact package product that has not left the establishment, submit product samples for 

laboratory analyses, collect information about production practices in the plant, or 

conduct other activities to determine whether there is an association between product 

and illness. OFO may identify the need to perform a public health risk evaluation, 

(PHRE) and/or food safety assessment (FSA), which may yield information relevant to 

the investigation. 

2. The OFO Recall Management and Technical Analysis Division (RMTAD) Director, 

District Manager (DM), or designee is to provide the AES Director, AES lead 

investigator, and OIEA investigators with the names and contact information of the OFO 

personnel assigned to assist with the investigation and inform the AES and OIEA of the 

status of OFO personnel’s activities. The names of the OFO personnel, designated by 

the OFO DM or designee, assigned to assist with the investigation will be included in the 

Investigative Plan that is posted to the IR in FIMS. 

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3. The RMTAD Director, DMs, or designee is to communicate a status back within 24 hours 

of the initial request confirming the decision to provide assistance. If the RMTAD 

Director, DMs or their designee has questions concerning a request for OFO to assist in 

a foodborne illness investigation, they are to immediately contact the AES Director or 

designee to discuss the request. 

4. When conducting activities during a foodborne illness investigation, OFO personnel are 

to follow the procedures in FSIS Directive 5100.3, Administrative Enforcement Reporting 

(AER) System, to document their findings. The AES lead investigator is to work with the 

RMTAD Director, DMs, or designees of the appropriate districts to ensure that relevant 

documents are posted to the IR in FIMS. 

5. The RMTAD Director or designee is to be included in all email communication between 

OFO and other internal and external stakeholders. 

IX. DATA ANALYSIS AND ASSESSMENT 

A. Data collection, analysis, and assessment of findings are ongoing and occur throughout the 

entire investigation. 

B. During the course of a foodborne illness investigation, the AES lead investigator, in 

consultation with other FSIS investigators, is to assess the entire range of investigative data, 

including epidemiologic, laboratory, and environmental assessment findings, as they become 

available, to determine whether there is credible evidence to support an association between an 

FSIS-regulated product and human illness. 

NOTE: Conclusions may be based solely on the strength of the epidemiologic data. 

C. When an association is established between human illness and an FSIS-regulated product, 

FSIS may have a basis for concluding that there is reason to believe that the product is 

adulterated because it contains a pathogen or is otherwise harmful to human health. Although 

not limited to these situations, findings that are likely to establish a link between human illness 

and an FSIS-regulated product produced by a specific establishment may include: 

1. A clearly delineated food history, accounting for time series and environmental 

assessment findings, that demonstrates an association between human illness and 

FSIS-regulated product produced by a specific establishment or establishments under 

one corporate umbrella; 

2. Findings from a traceback or traceforward investigation of products consumed by ill 

persons that provide evidence of a common production source at an official 

establishment; 

3. Environmental findings from an in-plant assessment suggestive of product contamination 

events; 

4. Subtyping analyses from an accepted authority that supports an epidemiological link 

between clinical specimens and food samples from a product produced by the specific 

establishment; or 

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5. An appropriately designed epidemiologic study that demonstrates an association 

between human illness and FSIS-regulated product produced at a specific 

establishment. 

NOTE: Findings may also establish a link between human illness and an FSIS-regulated 

product from a retail location. 

X. AGENCY ACTION 

A. If there is a basis to conclude that FSIS-regulated product contains a pathogen or is 

otherwise harmful to human health, and the investigation has identified a specific product that 

FSIS could recommend be recalled, the AES Director or designee is to contact the RMTAD 

Director or designee and provide the investigative findings. 

NOTE: OIEA provides decision memos as part of the decision making process. 

B. The RMTAD Director or designee is to convene the Recall Committee to discuss the 

investigative findings and to determine whether the Agency should recommend a recall to 

prevent further human exposure to the product. The Recall Committee is to consider the factors 

described in FSIS Directive 8080.1, Recall of Meat and Poultry Products, to determine whether 

there is a basis for recommending a product recall. 

C. If, after reviewing the AES investigative findings, the AES Director or designee believes that 

there is a basis for FSIS to conclude that an FSIS-regulated product contains a pathogen or is 

otherwise harmful to human health, but the investigation has not identified a specific product 

that FSIS could recommend be recalled (e.g., human illnesses have been linked to the 

consumption of ground beef but the investigation did not identify a specific brand or company 

name), OPHS may recommend that a public health alert be issued. If appropriate, the situation 

is to be referred to the EMC as provided in FSIS Directive 5500.2. If the situation is referred to 

the EMC, the EMC is to decide whether FSIS should issue a public health alert or carry out 

other activities. 

D. The other possible Agency actions taken in response to the findings of a foodborne illness 

investigation will depend on the evidence collected, and how strongly human illness is linked to 

an FSIS-regulated product. Examples of Agency actions other than recommending a product 

recall or public health alert that may result from a foodborne illness investigation include, but are 

not limited to: 

1. Increased or enhanced inspection activities; 

2. Investigation at a firm in commerce per FSIS Directive 8010.2; 

3. Increased frequency of microbial testing (intensified sampling); 

4. Conduct a PHRE as described in FSIS Directive 5100.4; 

5. Performing an in-plant FSA per FSIS Directive 5100.1, Enforcement, Investigations, 

and Analysis Officer (EIAO) Comprehensive Food Safety Assessment Methodology or 

intensified verification testing (IVT) per FSIS Directive 10,300.1, IVT Protocol for 

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Sampling of Product, Food Contact Surfaces and Environmental Surfaces for Listeria 

monocytogenes; 

6. Conducting an Incident Investigation Team (IIT) review as described in FSIS Directive 

5500.3; Incident Investigation Team Reviews; 

7. Effectuating a regulatory product control action, withholding action, or suspension (9 

CFR 500.3 and 500.4); 

8. Detaining or seizing product per FSIS Directive 8410.1; Detention and Seizure; or 

9. Initiating a criminal, civil, or administrative action per FSIS Directive 8010.5. 

E. During and following Agency actions, AES investigators are to continue surveillance and 

information monitoring to ensure that actions are sufficient in scope to prevent additional 

exposure and human illness. When AES determines that further illness is not being reported, it 

is to initiate procedures to close out the investigation, including a written request to close out the 

IR in FIMS if one was created for the investigation. OIEA/CID will also provide a written request 

to close out the IR following an AES recommendation. 

F. AES investigators are to communicate Agency actions to public health officials in affected 

local, state, and territorial health, environmental health, and agriculture departments through 

established channels, such as the FSIS Resources for Public Health Partners webpage. 

Release of information specific to an inspected establishment will be cleared by OFO prior to its 

release outside of FSIS. 

G. OPACE is to lead public communications efforts as described in FSIS Directive 1240.1, 

Communicating with External Entities. 

XI. CLOSE OUT AND FINAL ASSESSMENT 

A. Following the completion of each foodborne illness investigation, AES is to convene a group 

that includes FSIS program area representatives active in the investigation. AES is to invite 

other public health agencies on a case-by-case basis. 

1. The group is to analyze what occurred to cause the human illness and the corrective and 

preventive actions taken. 

2. The group is to assess whether there are changes that the Agency could make in its 

inspection or enforcement procedures, regulations, other Agency documents, or some 

other aspect of its regulatory approach that would reduce the possibility of a recurring 

circumstance that led to foodborne illnesses and subsequent Agency action. 

3. The AES lead investigator is to address any investigative data gaps that remain. 

4. The AES lead investigator is to coordinate an FSIS close out call that may include public 

health partners involved with investigation. The CDC may coordinate close out calls with 

public health partners in multistate investigations in which they are the lead agency. 

AES investigators will participate on these calls to provide FSIS updates. 

5. An After Action Review (AAR) may be conducted on a case-by-case basis to analyze 

and assess the investigation to validate best practices, inform process improvements, 

and provide recommendations for actions that can be implemented immediately and in 

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subsequent investigations. The AES Director is to designate an AES facilitator to plan 

and conduct the AAR in addition to developing an AAR report. Factors that may trigger 

an AAR include: 

a. Issues identified that had an impact on the outcome of the investigation; 

b. Questions that arose during the investigation that were not addressed by existing 

protocols or procedures; 

c. An unusually complex or difficult investigation or one that was associated with 

unforeseen challenges; or 

d. New procedures that were implemented during the investigation. 

B. The AES lead investigator is to develop a final written summary, including potential policy 

implications, for each foodborne illness investigation and provide the summary to the AES 

Director or designee, other program areas involved in the investigations, and other FSIS entities 

upon request. The AES lead investigator is to post a copy of the final written summary to the IR 

in FIMS if one was created for the investigation. 

C. On a quarterly basis or when the OPPD Risk and Innovations Management Staff (RIMS) 

determines that it is necessary, OPPD/RIMS staff, in coordination with OPHS, are to lead an 

assessment of the events leading to a foodborne illness investigation, as well as the FSIS 

response, to assess whether the Agency can improve its policies and investigation procedures. 

1. OPPD/RIMS is responsible for coordinating the assessment meeting. Participants in the 

meeting may include, but are not limited to, FSIS program area representatives involved 

in the foodborne illness investigation. 

2. When conducting the assessment, meeting participants are to consider pertinent 

information within and across program areas such as, but not limited to: 

a. PHRE or FSA results from the establishment; 

b. Enforcement history of the establishment; 

c. Historical sampling results, including repetitive positive sampling results; 

d. Reports of consumer illness; and 

e. Any other pertinent information collected during the foodborne illness 

investigation. 

3. After the close of the assessment meeting, OPPD/RIMS is to draft a written summary 

focusing on the circumstances that led to the investigation and suggesting areas where 

new policy or policy clarification may be needed. The official who drafted the report is to 

provide a copy to the RIMS and AES Directors along with the attendees from the 

assessment meeting. 

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XII. CONTINUOUS, ONGOING ACTIVITIES—WEEKLY INVESTIGATIONS MEETING; 

TRACKING AND REPORTING; COORDINATION AND COMMUNICATION 

A. FSIS Weekly investigations meeting 

1. AES conducts weekly investigations meetings in which representatives from OPHS and 

other program areas, such as ODIFP, OFO, OIEA, OPACE, and OPPD, are invited to 

share information about new and ongoing FSIS foodborne illness watches and 

investigations. Representatives from the USDA Food and Nutrition Service (FNS), 

Agricultural Marketing Service (AMS), and APHIS are invited to participate. 

2. Representatives from each FSIS program area are to participate in the weekly meeting 

and are to inform their program area management of relevant investigation updates and 

other pertinent information about new or ongoing investigations prior to the meeting. 

3. The AES moderator for the weekly investigations meeting is to develop an agenda 

outlining foodborne illness watches and investigations to be discussed and will distribute 

by e-mail to all of the weekly meeting participants. 

4. The AES moderator for the weekly investigations meeting is to develop, for each 

investigation, a list of action items identified during the meeting and is to organize these 

items by program area. Following the meeting, AES is to distribute the action item list by 

e-mail to all of the weekly meeting participants. 

5. AES is to formally close out all completed foodborne illness investigations in the weekly 

investigations meeting. 

B. CDC-FDA-FSIS tri-agency meeting 

1. Representatives from OPHS participate in a weekly meeting with CDC and FDA to 

discuss and review clusters and outbreaks that are of interest to the agencies. 

C. Tracking sheets and recordkeeping 

1. AES investigators are to maintain foodborne illness investigation data in the investigation 

record database, which is used to create a weekly foodborne illness investigations report 

spreadsheet. 

a. The weekly report spreadsheet is to include information on all open foodborne 

illness watches and investigations; 

b. AES is to distribute the weekly report spreadsheet to OPHS management by email; 

2. To track the progress of all FSIS foodborne illness investigations, AES investigators are 

to maintain and include in the IR, if one was created for the investigation, line list of 

case-patients, brief summaries, and other relevant information, such as laboratory 

testing data. 

D. Coordination and communication during an FSIS foodborne illness investigation 

1. As the coordinator for an FSIS foodborne illness investigation, the AES lead investigator 

serves as the primary point of contact for external public health officials and for other 

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FSIS program areas that have been assigned to assist with an investigation; the AES 

lead investigator should be kept abreast of all activities associated with the investigation. 

OPACE is the primary point of contact for inquiries about foodborne illness investigations 

from consumers, media, and other stakeholders. 

2. Coordination with local, state, and territorial public health officials. 

a. After initiating a foodborne illness investigation, the AES lead investigator is 

responsible for contacting local, state, and territorial public health officials to 

gather information and to keep those officials informed of FSIS activities related 

to the investigation. The AES lead investigator is to maintain contact with local, 

state, or territorial public health officials throughout the course of the 

investigation. 

b. To facilitate communication, Agency personnel assisting with a foodborne illness 

investigation may communicate directly with local, state, and territorial public 

health officials and each other. However, FSIS personnel outside of AES are to 

include the AES lead investigator of any planned or ongoing direct 

communications with public health officials outside FSIS to avoid duplication of 

effort. 

3. Coordination with CDC 

a. The AES Senior Epidemiologist embedded in the CDC ORPB serves as the 

primary Agency point of contact with the CDC ORPB. The AES lead investigator 

continues to be responsible for the overall coordination of the FSIS foodborne 

illness investigation. The FSIS Liaison to CDC serves as the primary Agency 

point of contact with the CDC. 

b. The AES Senior Epidemiologist embedded in the CDC ORPB is to facilitate FSIS 

involvement in multi-jurisdictional investigations conducted by CDC and is to 

serve as the primary coordinator during conference calls. 

c. The AES lead investigator is to inform the FSIS Liaison to CDC and the AES 

Senior Epidemiologist embedded in the CDC ORPB of FSIS activities during a 

foodborne illness investigation. The AES lead investigator may present 

information about FSIS activities during conference calls with state or local public 

health officials. 

d. CDC-Agency for Toxic Substances and Disease Registry (ATSDR) may 

participate in an FSIS-led in-plant assessment when epidemiologic data is the 

key evidence implicating illness to products produced by an establishment and/or 

when CDC-ATSDR expertise would enhance the assessment as described in 

the MOU between FSIS and CDC-ATSDR Regarding Foodborne Health Hazard 

Assessments Associated with FSIS-Regulated Product. 

4. Coordination with other Federal agencies 

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a. FDA, USDA/FNS, USDA/AMS, Department of Defense, and other federal 

partners. The AES Director or designee is to serve as the primary point of 

contact with other Federal agencies. 

b. USDA APHIS. Coordinate foodborne-related illness root cause assessment with 

USDA/APHIS as outlined in the MOU between FSIS and APHIS Veterinary 

Services. 

c. OIEA CID Director or designee will notify OIG per FSIS Directive 8030.1 if 

intentional product tampering is suspected. 

5. Notification of industry and industry associations 

a. The OFO, OIEA, or OPHS Assistant Administrators or their designees are to 

inform individual establishments about their potential association with illnesses. 

They are to notify establishments when the investigation has determined a 

potential implication of products produced by the establishment. A summary of 

the meeting will be posted to the IR in FIMS. 

i. The OFO AA or designee is also to notify the appropriate OFO district 

office. 

ii. The producing establishment is to be informed of its potential association 

with illnesses or public health risk and be prepared to make available all 

relevant documents which can assist with traceback and traceforward 

activities related to the foodborne illness investigation. It is to be notified 

when FSIS personnel are planning to be dispatched to the establishment. 

iii. When epidemiologic data is the key evidence linking illness to products 

produced by the establishment, the AES Senior Epidemiologist 

embedded at CDC ORPB and the FSIS Liaison to CDC will work with 

CDC and OFO to coordinate conference calls with industry in addition to 

ensuring proper FSIS representation at the meeting. A summary of the 

meeting will be posted in the IR in FIMS. 

b. Factors that may trigger early industry notification include: 

i. An FSIS-regulated product from the producing establishment has been 

collected for testing by state or local public health partners as part of the 

foodborne illness investigation. 

ii. Preliminary traceback identified multiple producing establishments from 

the same corporation. 

E. FSIS personnel are to refer to procedures in FSIS Directive 1450.1 if there is a FOIA request 

regarding a foodborne illness investigation. 

XIII. EVALUATION 

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The foodborne illness investigation record database referenced in sections VI and XII is used to 

create a weekly foodborne illness investigations report spreadsheet. AES is to analyze the data 

contained in the foodborne illness investigation record database. The analysis is to confirm that 

investigations are closed, final statistics are presented, and data are entered correctly. AES will 

document the completion of this analysis quarterly and yearly. Additionally, AES is to provide 

annual briefings to the Data Coordinating Committee (DCC) and other FSIS personnel and post 

reports to the DCC and AES SharePoint websites. 

XIV. QUESTIONS 

Refer questions regarding this directive to the Risk, Innovations, and Management Staff 

through askFSIS or by telephone at 1-800-233-3935. When submitting a question, use the 

Submit a Question tab, and enter the following information in the fields provided: 

Subject Field: Enter FSIS Directive 8080.3 

Question Field: Enter question with as much detail as possible. 

Product Field: Select General Inspection from the drop-down menu. 

Category Field: Select Sampling - General from the drop-down menu. 

Policy Arena: Select Domestic (U.S.) Only from the drop-down menu. 

When all fields are complete, press Continue and at the next screen press Finish Submitting 

Question. 

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting 

questions. 

Assistant Administrator 

Office of Policy and Program Development 

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