fda response to foodborne disease outbreaks elisa l. elliot, ph.d. microbiologist u.s. food and drug...

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FDA Response to FDA Response to Foodborne Disease Foodborne Disease Outbreaks Outbreaks Elisa L. Elliot, Ph.D. Elisa L. Elliot, Ph.D. Microbiologist Microbiologist U.S. Food and Drug Administration U.S. Food and Drug Administration Center for Food Safety and Applied Center for Food Safety and Applied Nutrition Nutrition Office of Food Defense, Communication Office of Food Defense, Communication and Emergency Response and Emergency Response Emergency Coordination and Response Emergency Coordination and Response Team Team

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Page 1: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Response to FDA Response to Foodborne Disease Foodborne Disease

OutbreaksOutbreaks

Elisa L. Elliot, Ph.D.Elisa L. Elliot, Ph.D.MicrobiologistMicrobiologist

U.S. Food and Drug AdministrationU.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Center for Food Safety and Applied NutritionOffice of Food Defense, Communication and Office of Food Defense, Communication and

Emergency ResponseEmergency ResponseEmergency Coordination and Response TeamEmergency Coordination and Response Team

Page 2: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Response to FDA Response to Foodborne OutbreaksFoodborne Outbreaks

FDA actively works to prevent and to respond to food-related threats that can come from biological, chemical or radiological agents.

Whether contamination is unintentional or deliberate there is a need to Make a public health decision Often with limited information In a very short timeframe and Implement the appropriate level of response

with respect to the emerging incident.

Page 3: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Investigation and coordination in multi-Investigation and coordination in multi-state outbreaksstate outbreaks

Review epidemiological, lab and Review epidemiological, lab and environmental dataenvironmental data

Laboratory analysis and assistanceLaboratory analysis and assistance Alert consumersAlert consumers Establishment inspections Establishment inspections Tracebacks of implicated foodsTracebacks of implicated foods

What is FDA’s Role?What is FDA’s Role?

Page 4: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Ensure removal, if possible, of implicated Ensure removal, if possible, of implicated foods from commercefoods from commerce

Monitor recallsMonitor recalls Farm investigationsFarm investigations Other appropriate regulatory actionsOther appropriate regulatory actions Evaluate data to identify trends and Evaluate data to identify trends and

develop policy, guidance, or regulations to develop policy, guidance, or regulations to prevent future outbreaksprevent future outbreaks

What is FDA’s Role?What is FDA’s Role?

Page 5: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plansEmergency response plans Disease surveillance Disease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation RecoveryRecovery

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 6: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillance Disease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation RecoveryRecovery

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 7: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA PlansFDA Plans Crisis Management Crisis Management

PlanPlan Emergency Emergency

Response Plan (ERP) Response Plan (ERP) BSE ERPBSE ERP Chemical and Chemical and

Biological ERPBiological ERP Pandemic Influenza Pandemic Influenza

ERPERP Radiological ERPRadiological ERP

Page 8: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Plan and Plan and guidance on guidance on emergencies emergencies affecting FDA-affecting FDA-regulated regulated products:products: food defensefood defense food safetyfood safety and and cosmetics cosmetics safetysafety emergenciesemergencies

Page 9: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Interaction During a Foodborne Interaction During a Foodborne Outbreak EmergencyOutbreak Emergency

FDA Office of Regulatory Affairs

CFSANFDA Office of Crisis

Management–Office of Emergency Operations*

(EOC)

CDC

USDA

* FDA’s hub for all emergency response activities

States

Page 10: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Contacting the FDA Office of Contacting the FDA Office of Emergency Operations (OEO)Emergency Operations (OEO)

301-443-1240 (24-hour line)301-443-1240 (24-hour line)E-mail: E-mail: [email protected]

The FDA OEO serves as the Agency’s focal point The FDA OEO serves as the Agency’s focal point for all emergency response activities seven for all emergency response activities seven days a week, 24 hours a day. days a week, 24 hours a day.

Note:Note: CORE (Coordinated Outbreak CORE (Coordinated Outbreak Response and Evaluation) Network is a Response and Evaluation) Network is a new team at FDA starting new team at FDA starting today, July 18,today, July 18, and will coordinate and respond to new and will coordinate and respond to new foodborne outbreaks.foodborne outbreaks.

Page 11: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillance Disease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation RecoveryRecovery

Foodborne Outbreak Foodborne Outbreak InvestigationInvestigation

Page 12: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak SurveillanceFoodborne Outbreak Surveillance

Why do we conduct Why do we conduct surveillance and outbreak surveillance and outbreak investigations?investigations?

Prevent additional illnessesPrevent additional illnesses Identify causes / trends to prevent Identify causes / trends to prevent

future illnessesfuture illnesses

Page 13: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Disease SurveillanceFoodborne Disease Surveillance

About 48 million people (1 in 6 Americans) About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne 3,000 die each year from foodborne diseases, according to recent FoodNet and diseases, according to recent FoodNet and other data from the Centers for Disease other data from the Centers for Disease Control and Prevention (Scallen et al., Dec. Control and Prevention (Scallen et al., Dec. 2010).  2010). 

This is a significant public health burden This is a significant public health burden that is largely preventable.that is largely preventable.

Page 14: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Centers for Disease Control and Prevention

SAFER • HEALTHIER • PEOPLE

Page 15: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak SurveillanceFoodborne Outbreak Surveillance

Federal involvement by the Centers for Federal involvement by the Centers for Disease Control and Prevention (CDC)Disease Control and Prevention (CDC) National reportable diseaseNational reportable disease Multi-state outbreaksMulti-state outbreaks Unusual pathogensUnusual pathogens Unusual vehiclesUnusual vehicles

Page 16: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak SurveillanceFoodborne Outbreak Surveillance

Formal Surveillance SystemsFormal Surveillance Systems National Notifiable Disease Surveillance System National Notifiable Disease Surveillance System NORS National Outbreak Reporting SystemNORS National Outbreak Reporting System(formerly eFORS -- electronic Foodborne Outbreak (formerly eFORS -- electronic Foodborne Outbreak

Reporting System)Reporting System) PulseNetPulseNet FoodNetFoodNet EHS-NetEHS-Net

Who’s involved?Who’s involved? Local and state public health and environmental Local and state public health and environmental

health officials, laboratories, and the Feds - health officials, laboratories, and the Feds - CDC, FDA, USDA, EPACDC, FDA, USDA, EPA

Page 17: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak SurveillanceFoodborne Outbreak Surveillance

Pulsed Field Gel Electrophoresis (PFGE)

Patient 1Patien

t 2Bacteria in food

“Genetic fingerprint”

Page 18: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak SurveillanceFoodborne Outbreak Surveillance

What is the Role of PulseNet?What is the Role of PulseNet? Detect foodborne disease case clusters by pulsed-Detect foodborne disease case clusters by pulsed-

field gel electrophoresis (PFGE)field gel electrophoresis (PFGE) Facilitate early identification of common source Facilitate early identification of common source

outbreaksoutbreaks Assist epidemiologists in investigating outbreaksAssist epidemiologists in investigating outbreaks Separate outbreak-associated cases from other Separate outbreak-associated cases from other

sporadic casessporadic cases Assist in rapidly identifying the source of Assist in rapidly identifying the source of

outbreaksoutbreaks Act as a rapid and effective means of Act as a rapid and effective means of

communication between public health laboratoriescommunication between public health laboratories

Page 19: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

                                                                                                                          

EHS-Net --Environmental health specialists who collaborate with epidemiologists and laboratory scientists to identify and prevent environmental factors contributing to foodborne and waterborne illness and disease outbreaks.

Page 20: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Disease and Foodborne Disease and Outbreak SurveillanceOutbreak Surveillance

Local / State ResponseLocal / State Response

PhysiciansPhysicians Local Health DepartmentsLocal Health Departments State Health DepartmentsState Health Departments

Page 21: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak SurveillanceFoodborne Outbreak Surveillance

Informal Surveillance SystemsInformal Surveillance Systems Network of public health officials, Network of public health officials,

laboratorians, and healthcare laboratorians, and healthcare professionalsprofessionals

Report to each other unusual numbers Report to each other unusual numbers of cases, unusual vehicles or agentsof cases, unusual vehicles or agents

Page 22: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Exposure in the general population

Person becomes ill

Person seeks care

Specimen obtained

Culture confirmed case

Reported to Health Department/CDC

Lab tests for organisms

Surveillance and Reporting

Page 23: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Why does it take so long?Why does it take so long?

Page 24: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Surveillance - Outbreak Surveillance - Outbreak DetectionDetection

“ “Is an outbreak occurring?”Is an outbreak occurring?” Ongoing collection, analysis and Ongoing collection, analysis and

dissemination of informationdissemination of information Monitor changes in disease Monitor changes in disease

frequencyfrequency Establish background levels of Establish background levels of

specific diseases in a communityspecific diseases in a community Association by time, place, and or by time, place, and or

person person

Page 25: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillanceDisease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 26: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak Investigations Foodborne Outbreak Investigations – States and Local– States and Local

Epidemiological Investigation StepsEpidemiological Investigation Steps Verify diagnosis - Case interviews and Verify diagnosis - Case interviews and

laboratory confirmationlaboratory confirmation Range of onset of systems - Epi curveRange of onset of systems - Epi curve Case definitionCase definition Epi associationsEpi associations

Time, place, person associationsTime, place, person associations Has an outbreak occurred Has an outbreak occurred Hypotheses generationHypotheses generation

Page 27: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Epi curve: Epi curve: E. coliE. coli O157:H7 outbreak O157:H7 outbreak associated with fresh bagged spinachassociated with fresh bagged spinach

                                                       

CDC MMWR Dispatch 9/26, 2006 / 55(Dispatch);1-2

Page 28: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Epidemiological AssociationsEpidemiological Associations

Implicating a food vehicleImplicating a food vehicle

It’s not magic, but is based on statistical It’s not magic, but is based on statistical calculations using data from case calculations using data from case questionnairesquestionnaires

Food-specific attack ratesFood-specific attack rates Stratified analysisStratified analysis Multivariate analysis Multivariate analysis Case-control studiesCase-control studies

Page 29: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne OutbreakFoodborne OutbreakInvestigationsInvestigations

Federal food regulatory agency Federal food regulatory agency involvement (FDA and or USDA)involvement (FDA and or USDA) Interstate commerce of foodInterstate commerce of food Outbreaks associated with the same food Outbreaks associated with the same food

in multiple statesin multiple states Sporadic cases of unusual pathogens / Sporadic cases of unusual pathogens /

serotypes linked by PFGEserotypes linked by PFGE

Page 30: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Foodborne Outbreak ResponseFDA Foodborne Outbreak Response

FDA review and evaluation of the preliminary FDA review and evaluation of the preliminary epidemiological evidence, assessing the public epidemiological evidence, assessing the public health implications, and determining the extent of health implications, and determining the extent of CFSAN involvement based on the evidence available.CFSAN involvement based on the evidence available.

A food or foods may have been epidemiologically A food or foods may have been epidemiologically

associated as “suspect” in causing illness, the associated as “suspect” in causing illness, the food(s) or cases were likely to have traveled food(s) or cases were likely to have traveled interstate, and clinical laboratory testing has interstate, and clinical laboratory testing has isolated an agent. isolated an agent.

The laboratory data may include subtyping, such as The laboratory data may include subtyping, such as speciation, pulsed-field gel electrophoresis (PFGE) speciation, pulsed-field gel electrophoresis (PFGE) analysis, or phage typing.analysis, or phage typing.

Page 31: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillanceDisease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 32: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak Foodborne Outbreak Investigations: Lab testingInvestigations: Lab testing

Laboratory investigationLaboratory investigation Clinical samplesClinical samples Food samplesFood samples Environmental samplesEnvironmental samples

Match clinical results to food Match clinical results to food product and or environmental product and or environmental resultsresults

Page 33: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Lab Results: Connections to a Lab Results: Connections to a Common SourceCommon Source

Genus (Genus (SalmonellaSalmonella)) SubtypingSubtyping

Serotype - Serotype - SalmonellaSalmonella Poona, Poona, S. S. Enteritidis, Enteritidis, S.S. NewportNewport

PFGE - DNA fingerprintPFGE - DNA fingerprint MLVA - Multiple-Locus Variable number tandem MLVA - Multiple-Locus Variable number tandem

repeat Analysis –molecular typing using repeat Analysis –molecular typing using naturally occurring variation in the number of naturally occurring variation in the number of tandem repeated DNA sequences found in tandem repeated DNA sequences found in many different loci in the genome of a variety many different loci in the genome of a variety of organisms.of organisms.

Antibiotic resistance patternAntibiotic resistance pattern Gene sequencing - PCRGene sequencing - PCR

Page 34: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

PFGE Patterns of E. coli O157:H7 Isolates from Lettuce

Source

Initial Case-patient

Bag #2

Bag #1

Page 35: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Foodborne Outbreak ResponseFDA Foodborne Outbreak Response A CFSAN epidemiologist reviews summary A CFSAN epidemiologist reviews summary

epidemiological and laboratory (and environmental if epidemiological and laboratory (and environmental if available) evidence and renders a decision of available) evidence and renders a decision of support for an association or not. support for an association or not.

If epidemiologically supported and scientifically If epidemiologically supported and scientifically plausible, and there is no evidence of on-site plausible, and there is no evidence of on-site contamination at the point of purchase, then CFSAN contamination at the point of purchase, then CFSAN will conduct a situational assessment. will conduct a situational assessment.

A response strategy will be formulated by CFSAN in A response strategy will be formulated by CFSAN in cooperation with the FDA Office of Emergency cooperation with the FDA Office of Emergency Operations and OEO and Office of Regulatory Operations and OEO and Office of Regulatory Affairs (HQ and field).Affairs (HQ and field).

Page 36: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Foodborne Outbreak ResponseFDA Foodborne Outbreak Response

Risk management – control the product and limit Risk management – control the product and limit exposureexposure Conducting a traceback investigationConducting a traceback investigation Voluntary market withdrawal or recall by manufacturer or Voluntary market withdrawal or recall by manufacturer or

distributordistributor Request state embargoRequest state embargo FDA requested recall, seizure, administrative detention, FDA requested recall, seizure, administrative detention,

import alert, or other FDA regulatory actionimport alert, or other FDA regulatory action Risk communicationRisk communication

Warning consumersWarning consumers Notifying state and federal regulatory agencies, other Notifying state and federal regulatory agencies, other

federal agencies, and industryfederal agencies, and industry Providing guidance to industryProviding guidance to industry

Page 37: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Foodborne Outbreak ResponseFDA Foodborne Outbreak Response Regulatory Action-Domestic Product:Regulatory Action-Domestic Product: If epi evidence implicates a domestic product or If epi evidence implicates a domestic product or

imported product in domestic commerce, CFSAN imported product in domestic commerce, CFSAN may recommend that the manufacturer may recommend that the manufacturer

voluntarily hold the product, voluntarily hold the product, withdraw the product from the market, withdraw the product from the market, conduct a recall, conduct a recall, suggest that the firm issue a press release.suggest that the firm issue a press release.

FDA may request the state to embargo the product.FDA may request the state to embargo the product. FDA may take regulatory action, such as seizure.FDA may take regulatory action, such as seizure. New!New! Mandatory RecallMandatory Recall::  The Food Safety   The Food Safety

Modernization Act (FSMA) provides FDA with Modernization Act (FSMA) provides FDA with authority to issue a mandatory recall when a authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after company fails to voluntarily recall unsafe food after being asked to by FDA. being asked to by FDA.

Page 38: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

FDA Foodborne Outbreak ResponseFDA Foodborne Outbreak Response

Regulatory Action—Imported ProductRegulatory Action—Imported Product If epi evidence has implicated an imported If epi evidence has implicated an imported

product, CFSAN may recommend an Import product, CFSAN may recommend an Import Alert or Bulletin. Administrative detention Alert or Bulletin. Administrative detention may also be considered. may also be considered.

If epi evidence is supported by If epi evidence is supported by environmental or product lab findings, then environmental or product lab findings, then

FDA may issue an Import Alert FDA may issue an Import Alert Screening criteria for imports may be Screening criteria for imports may be

adjusted.adjusted.

Page 39: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillanceDisease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 40: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Environmental Investigation – Environmental Investigation – State / LocalState / Local

Food preparation reviewFood preparation review Interview food workersInterview food workers Determine if time, temperature abuse or Determine if time, temperature abuse or

cross-contamination occurredcross-contamination occurred Collect samplesCollect samples

Page 41: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Environmental Investigation – FederalEnvironmental Investigation – Federal

TracebackTraceback Source investigations along distribution Source investigations along distribution

chainchain identify common denominatoridentify common denominator i.e., processors, packers, farmsi.e., processors, packers, farms

Page 42: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Environmental investigation is led by the state or Environmental investigation is led by the state or local regulatory agency.local regulatory agency.

Information provided to FDA should includeInformation provided to FDA should include Summary epidemiological data suggesting an Summary epidemiological data suggesting an

association to a CFSAN regulated productassociation to a CFSAN regulated product Clinical laboratory dataClinical laboratory data Environmental investigational reportsEnvironmental investigational reports Results of environmental or product testing Results of environmental or product testing

conducted by state or local agenciesconducted by state or local agencies

Page 43: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillanceDisease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Packinghouse / farm investigationPackinghouse / farm investigation RecoveryRecovery

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 44: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Record collectionRecord collection Production lotProduction lot DistributionDistribution Bills of ladingBills of lading InvoicesInvoices

Record reviewRecord review QuantitiesQuantities Lot numbersLot numbers Ship and receipt datesShip and receipt dates

Page 45: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Date Invoice #

5/5/08 89000SECTION QTY PACK SIZE DESCRIPTION

615444 6 50 50# Yellow Onion Med 050#602588 6 50 50# White Onion Med 050#645879 2 16 3# Bag White Onion 016@648055 1 10 10# Oragne Hbanero 010#648044 10 25 25# Tomato Bulk 6X6 LG692000 1 12 32OZ Mini Bag Red Potato 012@

Date: Invoice #:

5/5/2008 38947

Section QTY. Pack Size Description Code

454681 100 25 25# Tomato Bulk 6x6 LG 501785

DATE

CUSTOMER ID

SHIP TO BILL TO

Pallet No Size

2200 4X5

2289 4X5

2226 4X5

4452 4X5

2233 4X5

2698 4X5

2896 4X5

88 / 2144 / Beefsteak Tomato

88 / 2144 / Beefsteak Tomato

ORDER NUMBER

345115/ 3/ 08

Cartons / Manifest / Product

88 / 2144 / Beefsteak Tomato

88 / 6144 / Beefsteak Tomato

SHIP DATE

5/ 3/ 2008

88 / 2186 / Beefsteak Tomato

88 / 2144 / Beefsteak Tomato

88 / 2144 / Beefsteak Tomato

ORDER DATE

The Restaurant

May, 4 2008

[ABC12345]

22 Loveapple Way

Toma, TO 00001

The Restaurant

Foodtown, USA

301-555-5923

8 Gourmet Lane 8 Gourmet Lane

Foodtown, USA

301-555-5923

Shipping Report

Tomato Distribution Company

Please contact Customer Service at [Phone] with any questions or comments.

THANK YOU FOR YOUR BUSINESS!

Invoice

No. 92601985 Fruitplant Avenue To:

Pick, EM 00005 Tomato Distribution Co.22 Loveapple Way

Date: April 20, 2008 Toma, TO 00001

Quantity Description

500 Box, Greenhouse Tomatoes, Size '35'

Order # 4421

Pallet No

3300 100 Beefsteak Tomato3374 100 Beefsteak Tomato3380 100 Beefsteak Tomato3467 100 Beefsteak Tomato

Cases / Product

Pallets Boxes Size

1 88 (88) 5*5,3

2 88 (88) 5*5,3

3 88 (88) 5*5,3

4 72 (72) 5*5,3

5 88 (88) 5*5,3

6 88 (88) 5*5,3

7 88 (88) 5*5,3

. 8506

ORDER NUMBER

Whole Tomato

Whole Tomato

Whole Tomato

Whole Tomato

Product

Whole Tomato

Whole Tomato

Whole Tomato

Shipper: Fruit Haulers R UsConsignee: Fruit Growers, Co. 1985 Fruitplant Ave. Pick, EM 00005

Shipment Date 04/25/2008DestinationEst. Arrival 04/25/2008Pallet count 7

Page 46: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Example of Traceback StepsExample of Traceback Steps First date of illness onset = Nov 27First date of illness onset = Nov 27 Shipment of lettuce lasts 2-3 days at Shipment of lettuce lasts 2-3 days at

restaurantrestaurant

What shipments to concentrate on?What shipments to concentrate on?

FDA determined that shipments between FDA determined that shipments between November 24 and 25 had highest probability November 24 and 25 had highest probability of contaminationof contamination

Records identified 2 farms as probable Records identified 2 farms as probable sources of lettuce in CAsources of lettuce in CA

Page 47: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Traceback Flow Diagram Traceback Flow Diagram ExampleExample

POSPOS Distributors PackersDistributors PackersFarms

Page 48: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied
Page 49: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillanceDisease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Origin or Packinghouse/farm Origin or Packinghouse/farm

investigationinvestigation RecoveryRecovery

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 50: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Produce: Sources and Spread of Produce: Sources and Spread of Contamination – Trend AnalysisContamination – Trend Analysis

Multiple Modes Of ContaminationMultiple Modes Of Contamination

SoilSoil WaterWater WorkersWorkers AnimalsAnimals

Page 51: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Microbial Quality of WaterMicrobial Quality of Water

PONDS

CROP SPRAY

WASH

WELLSIRRIGATION

Page 52: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Potential Sources of ContaminationPotential Sources of Contamination

Page 53: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Potential Sources of ContaminationPotential Sources of Contamination

Page 54: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Pig feces in a spinach field

Pig tracks across a spinach field

v

Potential Sources of ContaminationPotential Sources of Contamination

Page 55: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied
Page 56: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak Data Foodborne Outbreak Data GatheringGathering

Outbreak data include – epidemiology, Outbreak data include – epidemiology, environmental findings, laboratory analytical environmental findings, laboratory analytical datadata

Tracebacks Tracebacks Firm investigationsFirm investigations Farm InvestigationsFarm Investigations Laboratory dataLaboratory data

Produce surveillance assignmentsProduce surveillance assignments Firm and farm investigations Firm and farm investigations

Environmental investigations criticalEnvironmental investigations critical

Page 57: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans Emergency response plans Disease surveillanceDisease surveillance Epidemiological investigationEpidemiological investigation Laboratory analysisLaboratory analysis Environmental investigation and or Environmental investigation and or

establishment inspectionestablishment inspection Traceback / trace forwardTraceback / trace forward Origin or Packinghouse/farm Origin or Packinghouse/farm

investigationinvestigation RecoveryRecovery

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 58: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak Response: Foodborne Outbreak Response: RecoveryRecovery

Communication to stakeholders that the type(s) Communication to stakeholders that the type(s) of foods affected are now safe to consumeof foods affected are now safe to consume

consumersconsumers federal, state and local agenciesfederal, state and local agencies industryindustry health care providers, if applicablehealth care providers, if applicable

Investigational findings, laboratory analysis, and Investigational findings, laboratory analysis, and reportingreporting

Investigations to identify source of Investigations to identify source of contamination, which may include farm contamination, which may include farm investigationsinvestigations

Compliance actions and/or recommendations Compliance actions and/or recommendations initiatedinitiated

Page 59: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

The Long TermThe Long TermPublic Health Impact of Public Health Impact of

Outbreak ResponseOutbreak Response

What does FDA do after the What does FDA do after the outbreak/illness is over?outbreak/illness is over?

Page 60: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Foodborne Outbreak Response: Foodborne Outbreak Response: EvaluationEvaluation

Improvements for preparednessImprovements for preparedness Improvements to emergency response plans Improvements to emergency response plans

and proceduresand procedures Interventions to better protect public healthInterventions to better protect public health Improvements for communicationsImprovements for communications Best practicesBest practices Recommendations to modify scientific and Recommendations to modify scientific and

regulatory policy, laboratory and field regulatory policy, laboratory and field operations, and research activitiesoperations, and research activities

Page 61: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Risk Management ApproachRisk Management Approach

Emergency:outbreak

Develop policyChange existing

Reduced # illness and outbreaks

Stakeholdersimplement

Identify contributing factors

Page 62: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

A Framework for Reducing Foodborne Illness Through Prevention, Intervention and Response

Production

PreparationTransportation

Retail

Consumer

Processing

Regulations, Enforcement, and Guidance

Consumption

Distributionand

Storage

Illness

?

EducationTrainingSurveillanceResearch

Page 63: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Emergency response plans – Emergency response plans – at all levelsat all levels Disease surveillance – Disease surveillance – States submit info to CDCStates submit info to CDC Epidemiological investigation -Epidemiological investigation -

States and CDC conduct epi investigation and States and CDC conduct epi investigation and FDA reviewsFDA reviews

Laboratory analysis -Laboratory analysis -Clinical (States and CDC), food and Clinical (States and CDC), food and environmental (States and FDA)environmental (States and FDA)

Environmental investigation and or Environmental investigation and or establishment inspection – establishment inspection –

State, Local and FDAState, Local and FDA Traceback / trace forward – Traceback / trace forward –

States, FDA and industryStates, FDA and industry Packinghouse / farm investigation – Packinghouse / farm investigation – State, FDAState, FDA RecoveryRecovery

Foodborne Outbreak InvestigationFoodborne Outbreak Investigation

Page 64: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

SummarySummary FDA depends on outbreak, traceback, and FDA depends on outbreak, traceback, and

farm investigations to provide important farm investigations to provide important information to guide response and set information to guide response and set priorities.priorities. Resulting actions include changes in Resulting actions include changes in

policy, development of guidance, policy, development of guidance, targeted research, and regulatory targeted research, and regulatory action.action.

FDA continues to work with all stake- FDA continues to work with all stake- holders, including industry, government, holders, including industry, government, and academia, to prevent contamination and academia, to prevent contamination and outbreaks.and outbreaks.

Page 65: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

ConclusionsConclusions

Foodborne disease surveillance and Foodborne disease surveillance and response comprises a response comprises a network network of of physicians, local, State, and Federal physicians, local, State, and Federal public health officials, laboratory public health officials, laboratory scientists, and othersscientists, and others

Investigations require critical thinking, Investigations require critical thinking, scientific analysis, and risk- based scientific analysis, and risk- based approaches to real eventsapproaches to real events

Page 66: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

AcknowledgmentsAcknowledgments

CFSAN Emergency Coordination and Response CFSAN Emergency Coordination and Response TeamTeam

CFSAN Epidemiology TeamCFSAN Epidemiology Team CAPT Thomas Hill for slides and photos of farm CAPT Thomas Hill for slides and photos of farm

investigationsinvestigations Office of Emergency OperationsOffice of Emergency Operations

Page 67: FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied

Thank you!Thank you!