Sherri Mc Garry Center For Food Safety And Applied Nutrition Fda
Post on 31-May-2015
1092 Views
Preview:
DESCRIPTION
Transcript
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
FDA Issues and QuestionsFDA Issues and QuestionsFDA Issues and QuestionsFDA Issues and Questions
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
FDA Issues and QuestionsFDA Issues and QuestionsFDA Issues and QuestionsFDA Issues and Questions
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
88 / 2144 / Beefsteak Tomato
88 / 2144 / Beefsteak Tomato
88 / 2144 / Beefsteak Tomato
88 / 2144 / 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
88 / 2144 / Beefsteak Tomato
88 / 6144 / Beefsteak Tomato
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
top related