Sherri Mc Garry Center For Food Safety And Applied Nutrition Fda

Framing the Issue:Framing the Issue:Framing the Issue:Framing the Issue:FDA PerspectiveFDA PerspectiveProduct Tracing Product Tracing

Sherri A. McGarrySherri A. McGarryCenter for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition

F d d D Ad i i t tiF d d D Ad i i t tiFood and Drug AdministrationFood and Drug Administration

OverviewOverviewOverviewOverview

Federal Register NoticeFederal Register NoticeFederal Register NoticeFederal Register NoticeAnatomy of outbreak investigationAnatomy of outbreak investigationP d t T i PP d t T i PProduct Tracing ProcessProduct Tracing ProcessProduct Tracing ChallengesProduct Tracing ChallengesSummarySummary

Federal Register NoticeFederal Register Notice

FDA PerspectiveFDA Perspective

ContextContextContextContext

Foods for humans & food for animalsFoods for humans & food for animalsFoods for humans & food for animalsFoods for humans & food for animalsExisting authorities and regulationsExisting authorities and regulations–– FFDCAFFDCAFFDCAFFDCA–– 21 CFR21 CFR–– Public Health Service ActPublic Health Service ActPublic Health Service ActPublic Health Service Act

Need to go beyond for faster, more Need to go beyond for faster, more targeted product tracingtargeted product tracingtargeted product tracingtargeted product tracing

Whole Chain TraceabilityWhole Chain TraceabilityWhole Chain TraceabilityWhole Chain Traceability

Considerations for EffectiveConsiderations for EffectiveSSProduct Tracing SystemsProduct Tracing Systems

Key information elementsKey information elementsKey information elementsKey information elements–– Who manufactured the productWho manufactured the product

Who’s sending forward and who’s recievengWho’s sending forward and who’s recieveng–– Who s sending forward and who s recievengWho s sending forward and who s recieveng–– Way to link info internally and externally Way to link info internally and externally

through the supply chainthrough the supply chainthrough the supply chainthrough the supply chain–– Date shipped and recdDate shipped and recd

Physical location food shipped and recdPhysical location food shipped and recd–– Physical location food shipped and recdPhysical location food shipped and recd–– Quantity, how packagedQuantity, how packaged

FDA Issues and QuestionsFDA Issues and QuestionsFDA Issues and QuestionsFDA Issues and Questions

Core Information ElementsCore Information ElementsCore Information ElementsCore Information Elements–– Lot codes or other identifierLot codes or other identifier

Shipment identifierShipment identifier–– Shipment identifierShipment identifier–– Where should info reside (packaging, records)Where should info reside (packaging, records)

At hat stages or stages in the chainAt hat stages or stages in the chain–– At what stages or stages in the chainAt what stages or stages in the chain–– Standardized set of info elementsStandardized set of info elements


RecordsRecordsRecordsRecords–– Lot code or other identifierLot code or other identifier

Who should maintain beyond currentWho should maintain beyond current–– Who should maintain beyond current Who should maintain beyond current requirementsrequirements

–– Linking record standard formatLinking record standard format–– Linking record, standard formatLinking record, standard format–– Electronic, human readableElectronic, human readable

Transmitting trace data to FDATransmitting trace data to FDATransmitting trace data to FDATransmitting trace data to FDA


Role of RiskRole of RiskRole of RiskRole of Risk

C t B fit d F ibilitC t B fit d F ibilitCosts, Benefits, and FeasibilityCosts, Benefits, and Feasibility

Outreach, education on current Outreach, education on current requirementsrequirementsqq

Anatomy of an Anatomy of an Outbreak investigationOutbreak investigation

Disease Surveillance

Epidemiological investigation

Laboratory AnalysisLaboratory Analysis

Environmental investigation

Traceback / traceforward

Source investigationg

FDA Traceback ProcessFDA Traceback Process

FDA Traceback ObjectiveFDA Traceback ObjectiveFDA Traceback ObjectiveFDA Traceback Objective

FindFind convergence or commonalityconvergence or commonalityFind Find convergence or commonalityconvergence or commonalityIdentify source and distribution of implicate Identify source and distribution of implicate food and remove from consumersfood and remove from consumersfood and remove from consumersfood and remove from consumersDetermine potential routes and/or source Determine potential routes and/or source f t i ti t t f tf t i ti t t f tof contamination to prevent future of contamination to prevent future

illnessesillnesses

Traceback processTraceback processTraceback processTraceback processBased on epidemiological data, select Based on epidemiological data, select p gp gcases/clusters to tracecases/clusters to traceCollect records at Point of Service and identify Collect records at Point of Service and identify shipments and suppliers of interestshipments and suppliers of interestshipments and suppliers of interestshipments and suppliers of interestFrom POS info, document each subsequent From POS info, document each subsequent level in supply chainlevel in supply chainEither Either narrow or expandnarrow or expand depending on:depending on:–– records available;records available;–– number of shipments in time frame of interest; andnumber of shipments in time frame of interest; andnumber of shipments in time frame of interest; andnumber of shipments in time frame of interest; and–– ability to link shipments and items within the shipment ability to link shipments and items within the shipment

forward and backforward and back

Further StepsFurther StepsFurther StepsFurther Steps

Each step identify shipments of interestEach step identify shipments of interestEach step identify shipments of interest Each step identify shipments of interest based on time frame and linking based on time frame and linking documentsdocumentsdocumentsdocumentsDevelop flow diagram and time linesDevelop flow diagram and time linesD ’t til lD ’t til lDon’t see common sources until several Don’t see common sources until several levels or at very end so no way to know levels or at very end so no way to know

l if th t ill b l il if th t ill b l iearly on if the trace will be conclusiveearly on if the trace will be conclusive

Traceback Flow Diagram Traceback Flow Diagram ExampleExample

POSPOS Di t ib t P kDi t ib t P kFarms

POSPOS Distributors PackersDistributors Packers

What’s Critical?What’s Critical?What s Critical?What s Critical?

Illness exposure information clustersIllness exposure information clustersIllness exposure information, clustersIllness exposure information, clustersRecords with date of receiptRecords with date of receiptR d th t l iblR d th t l iblRecords that are legibleRecords that are legibleRecords with an identifier or other means Records with an identifier or other means to connect next level in supply chainto connect next level in supply chainTurn around time and pattern of buyingTurn around time and pattern of buyingp y gp y gIndustry provides records in timely fashionIndustry provides records in timely fashion

Trace over the BorderTrace over the BorderTrace over the BorderTrace over the Border

Use Registration andUse Registration andUse Registration and Use Registration and Prior Notice infoPrior Notice infoFDA requests assistance FDA requests assistance qqto conduct onsite to conduct onsite investigations in investigations in cooperation with foreign cooperation with foreign governmentgovernmentOb i d lOb i d lObtain records to close Obtain records to close the link to the sourcethe link to the source

FDA Traceback ChallengesFDA Traceback Challenges

Broad Traceback ChallengesBroad Traceback ChallengesBroad Traceback ChallengesBroad Traceback Challenges

Competing prioritiesCompeting prioritiesCompeting prioritiesCompeting priorities–– H1N1H1N1

EconomicEconomic–– EconomicEconomicVarying resources and expertiseVarying resources and expertiseReluctance and timeReluctance and time–– Where’s the positive sample?Where’s the positive sample?–– Epi? What’s that?Epi? What’s that?

Source: CDC

Traceback ChallengesTraceback ChallengesTraceback ChallengesTraceback Challenges

–– an ongoing outbreak; need to act fastan ongoing outbreak; need to act fastan ongoing outbreak; need to act fastan ongoing outbreak; need to act fast–– large numbers of sporadic caseslarge numbers of sporadic cases

poor consumer recollection of consumptionpoor consumer recollection of consumption–– poor consumer recollection of consumption poor consumer recollection of consumption history and lack of specific product history and lack of specific product informationinformationinformationinformation

–– Multiple product varieties identifiedMultiple product varieties identifiedM lti l d t / lti l i di tM lti l d t / lti l i di t–– Multiple products w/multiple ingredients Multiple products w/multiple ingredients identifiedidentified

Traceback ChallengesTraceback ChallengesTraceback ChallengesTraceback Challenges

Billing address versus shipment infoBilling address versus shipment infoBilling address versus shipment infoBilling address versus shipment infoFrom DC to RetailFrom DC to Retail–– Unclear what was shipped whereUnclear what was shipped where–– TurnTurn--around at DC/warehousearound at DC/warehouse–– Ability to narrow shipments of interestAbility to narrow shipments of interest–– Connecting incoming and outgoingConnecting incoming and outgoingCo ect g co g a d outgo gCo ect g co g a d outgo g

Product Tracing ChallengesProduct Tracing ChallengesProduct Tracing ChallengesProduct Tracing Challenges

Perishable prod ctPerishable prod ct–– Perishable productPerishable product–– Lack of rapid connectivity Lack of rapid connectivity

L k f i id tifiL k f i id tifi–– Lack of unique identifier Lack of unique identifier –– Repacking and coRepacking and co--minglingmingling–– Addresses, ship and receipt datesAddresses, ship and receipt dates–– Packaging (ie. cases) gonePackaging (ie. cases) gone–– Product no longer availableProduct no longer available–– Producing states importing as wellProducing states importing as well

Date: Invoice #:5/5/2008 38947Lack of identifier

that connects thru chainSection QTY. Pack Size Description Code

454681 100 25 25# Tomato Bulk 6x6 LG 501785

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#

DATE

CUSTOMER ID

May, 4 2008

[ABC12345]

22 Loveapple Way

Toma, TO 00001

Shipping Report

Tomato Distribution Company

648055 1 10 10# Oragne Hbanero 010#648044 10 25 25# Tomato Bulk 6X6 LG692000 1 12 32OZ Mini Bag Red Potato 012@

SHIP TO BILL TO

Pallet No Size

Foodtown, USA

301-555-5923

8 Gourmet Lane 8 Gourmet Lane

Foodtown, USA

301-555-5923

The RestaurantThe Restaurant

SHIP DATE

5/3/2008

ORDER DATE ORDER NUMBER

345115/3/08

Cartons / Manifest / Product

Invoice No. 9260

Pallet No Size

2200 4X5

2289 4X5

2226 4X5

4452 4X5

2233 4X5

2698 4X588 / 2144 / Beefsteak Tomato

88 / 2186 / Beefsteak Tomato





Cartons / Manifest / Product 1985 Fruitplant Avenue To:Pick, EM 00005 Tomato Distribution Co.

22 Loveapple WayDate: April 20, 2008 Toma, TO 00001Quantity Description

. 8506

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

Shipment Date 04/25/2008DestinationEst. Arrival 04/25/2008Pallet count 7 2698 4X5

2896 4X5



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

THANK YOU FOR YOUR BUSINESS!

500 Box, Greenhouse Tomatoes, Size '35'

Order # 4421Pallet No

3300 100 Beefsteak Tomato3374 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

Whole Tomato

Product

Whole Tomato

Whole Tomato

Whole Tomato

, Pallet count 7

3380 100 Beefsteak Tomato3467 100 Beefsteak Tomato

( ) ,

5 88 (88) 5*5,3

6 88 (88) 5*5,3

7 88 (88) 5*5,3

Whole Tomato

Whole Tomato

Whole Tomato

SummarySummarySummarySummary

Food contamination events are beingFood contamination events are beingFood contamination events are being Food contamination events are being detected earlierdetected earlierA rapid and interoperable product tracingA rapid and interoperable product tracingA rapid and interoperable product tracing A rapid and interoperable product tracing system may reduce illnesssystem may reduce illnessN d f t d di d h l b llN d f t d di d h l b llNeed for a standardized approach globallyNeed for a standardized approach globallyAdvance preventive food safety policies Advance preventive food safety policies from lessons learned from these eventsfrom lessons learned from these eventsCommunication and collaboration is KeyCommunication and collaboration is Keyyy

Submit data and comment to DocketSubmit data and comment to Docket

Sherri Mc Garry Center For Food Safety And Applied Nutrition Fda

Technology

fda traceback challenges

fda traceback process

t tif d

fda traceback objective

fda issues

date of receipt records

broad traceback challenges

time lines dont d t