Presentation on theme: "Product Tracing in the Food Supply Chain"— Presentation transcript:
1Product Tracing in the Food Supply Chain Roger Clemens, DrPHHorn, Chief Scientific OfficerIFT President ( )Adjunct Professor, USC School of PharmacySeptember 12, 2013
2Food Production Chain Contamination in Production Contamination in ProcessingContamination in DistributionContamination in PreparationAccessed September 1, 2013
3Why Product Tracing?Center for Disease Control and Prevention (CDC) estimates48 million cases of food borne illness128,000 hospitalized3,000 deathsFoodborne illness source attribution70% of investigations unresolved at the state level (CSPI)42% of outbreaks from unknown foods (CDC)7 pathogens cause 90% of illnesses, hospitalizations, and deaths due to known pathogens (CDC)Challenges and opportunities in product tracingEpidemiological investigationsTraceback investigationsRecalls
4Definition: Product Tracing Traceback is NOT RecallHow do you find points of convergence when much is unknown?A single company doesn’t have traceability – but is a critical piece of the puzzle!TracebackRecallProduct tracing (FDA said this should be the standard term, not “traceability), is the ability to follow the movement of a food product and its constituents through the stages of production, processing, and distribution, both backward and forward. This is different from recalls, where the implicated product is already known and can then be traced forward. In product tracing, the goal is to determine a converging point to find where the food may have been contaminated.
5Bioterrorism Act of 2002 Established recordkeeping requirements Manufacturers/processorsRecord shipment and receipt informationCapture incoming lot numbers as possibleLink ingredients to finished product to extent practicalNon-manufacturersContact information for who it came from and went toExemptions at supply chain ends“1 up / 1 down” redundant systemForm of recordkeeping not specifiedCombinations of paper and electronic records (even within a facility)1 up/ 1 down requires firms to capture the information from their suppliers as well as who they supply to. This is a redundant system in that trading partners should both be capturing the same information.5
6Food Safety Modernization Act- Product Tracing Pilots FSMA Section 204(A) develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses;(B) develop and demonstrate appropriate technologies, including technologies existing on the date of enactment of this Act, that enhance the tracking and tracing of food;Section 204 covers all of product tracing requirements for the FDA through the implementation of two pilots.
7IFT’s History in Product Tracing FDA contract since 1999Competitively awarded, 5 year contractsTask orders focused on food safety and defenseIn 2008, IFT began product tracing task for FDABig report: “state of the industry”Technical and cost evaluation reportsJune 2009, mock tomato tracebackCoined the terms KDE and CTENational Center for Food Protection & Defense (NCFPD) Traceability Project initiated in 2010IFT Traceability Improvement InitiativeHeld three traceability research summits in 2011~50 participants per summit, a lot of industry participationSummit proceeding and white papers published on ift.orgKDEs- critical information for product tracingCTEs- critical points in the product’s history/movement through the supply chain at which KDEs need to be capturedNCFPD= National Center for Food Protection and Defense. Goals of the project are to:Compare and contrast the capabilities of traceability solutionsOpportunities and challenges to interoperabilityKDEs - Key Data Elements; critical information for product tracingCTEs - Critical Tracking Events; critical points in the product’s history/movement through the supply chain at which KDEs need to be captured
8IFT Task Order- FSMA Pilots Statement of Workidentify and gather information on methods to improve product tracing of foods in the supply chainexplore and evaluate methods to rapidly and effectively track and trace foodTask issued September 2011Final report submitted June 20122 PilotsProduce ItemProcessed Food / IngredientsCollaboration PlatformCost/Benefit Analysis
9General Approach Solicit Stakeholder input Products, collaboration platform, use of existing systems, initiatives, cost data sourcesBaseline study- What is the process for traceback investigations, what makes them difficult/easy, where are the hang-ups in an investigationQualitative- discussions with traceback investigatorsQuantitative- evaluation of previous investigationsSolicit participantsConduct mock traceback pilotsEvaluate results and costInput was requested on every aspect of the pilots: what foods to choose, how to use a collaboration platform, what tracing systems existed currently, what product tracing initiatives existed within industry/specific firms, and where to find cost/benefit data for implementing new product tracing systemsThe baseline study was done to be able to compare what “current” product tracing maturities that firms were in compared to what could be done in the future to make these systems better
10Tomato PilotTomatoesAssociated with significant outbreaks fromShort shelf-lifeSome comminglingParticipantsGrowers – US and MexicoRepackers/processorsDistributors & WholesalersRetailFoodserviceScenariosStart at retail level where tomatoes may be implicated productFDA chose the products for both pilots.Many stakeholders, including those within the produce industry, thought that tomatoes would be a good choice for the pilotsAll mock traceback scenarios started at the retail level and involved having illnesses that were associated with tomatoes purchased over a (usually two week) date range at a specific retail location
11Complexity of Pilot Studies The purpose of having this slide is to show the complexity and number of the participants in the pilotsThis is the diagram of the tomato supply chain that the pilots involved. They are not all connected to one another, and some are standalone. This is due to the fact that the pilots themselves were completely voluntary for participants.Green = GrowerLight blue = Ingredient supplierDark blue = ManufacturerOrange = WarehouseYellow = Distribution CenterRed = Retail
12Complexity of Pilot Studies Green = GrowerLight blue = Ingredient supplierDark blue = ManufacturerOrange = WarehouseYellow = Distribution CenterRed = RetailThe purpose of having this slide is to show the complexity and number of the participants in the pilotsThis is the diagram of the tomato supply chain that the pilots involved. They are not all connected to one another, and some are standalone. This is due to the fact that the pilots themselves were completely voluntary for participants.
13Processed Foods / Ingredients Pilot “Kung Pao Chicken”Ingredients associated with significant outbreaks fromPeanutsRed PepperChickenIncludes many ingredients, includes USDAParticipantsImporterIngredient suppliersCo-manufacturersManufacturersWarehouse and distributionRetailersAdditions: peanut butter, dry kung pao dishScenariosPeanut butter jar tested was violativeShoppers card informationIllnesses from frozen/dry productThis processed food was chosen because of its inclusion of peanuts, crushed red pepper, and chicken. A dry kung pao dish was also included, although it did not have any chicken in it. Peanut butter was also used for one scenario.The scenarios varied more in the processed foods/ingredients pilot and included: having a peanut butter jar that was tested off the shelf be “violative”, having illness associated with a shopper’s card account, and having illness associated with both the frozen and dry kung pao dish (to look for convergence)
14Complexities of Pilot Studies Green = GrowerLight blue = Ingredient supplierDark blue = ManufacturerOrange = WarehouseYellow = Distribution CenterRed = RetailRetail 2 and 7 are the same companyPeanut suppler 4 and 5 are the same companyThis is the supply chain diagram for the processed food/ingredients pilot.Scenarios PA and PB involved the peanut butter productScenario PC involved the frozen and dry kung pao dishesScenario PD involved an imported kung pao dish from Thailand.
15Collaboration Platform Definition – from stakeholders, not FDAData analysis system which could be used by FDA to share and analyze data collected during outbreak investigationsUsed 10 different systems from technology providers in the pilotsGoalsFeed data from pilot participants into collaboration platforms to determine how a system could be useful in traceback scenariosIdentify key system attributesIFT did NOT to endorse or select one technology for FDAThe term “collaboration platform” was given to IFT in the statement of work from FDA without a definition. IFT used stakeholder input to determine its definition, which is the first bullet.
16Collaboration Platform Tested the concept of Key Data Elements and Critical Tracking EventsKDEs - critical information for tracingCTEs - critical points in the product’s history at which KDEs need to be capturedNon-participants given opportunity for inputMany systems designed for unique use and could not be adapted easily for the pilotsNon participating technology companies primarily had solutions that were not applicable for the pilots. Some of these were for environmental monitoring (temperature, humidity, etc.) for specific segments of industry, or had specific applications to connect consumers to the origin of the foods (farms, etc.) and the ability to notify them if they had a product that was involved in a recall.
17Cost Benefit Evaluation BenefitsPublic health and social benefitsFor example – lives saved, illnesses prevented, gains in productivityFDA operational benefitsresponsiveness, reputation, resource allocationIndustry benefitsincreased brand reputation, increased consumer confidence, improved recall scope, improved supply chain managementCostsFDA operational costsAnalytical and Field FTE’s and associated costs; trainingNew System Implementation (Implementation and Maintenance)ComplianceIndustry implementation costsSoftware; Capital expendituresChange to current processes
18Evaluation of the Pilots Based Upon: Baseline resultsTraceback pilot data including:Speed to convergence/resolutionMapping speed of analysis to current practicesAssessing speed of analysis when industry uses a templateCollaboration platform resultsCost/benefit analysisFinal recommendations for FDA based on aboveMapping speed of analysis to current practices: IFT looked at our analysis time of the data sent to us compared to the current practices that the specific firms use in doing product tracing.Some companies gave IFT data in a ‘template’ form that was specific to their company, and some other companies used a template that IFT provided to share their tracing data. IFT determined whether or not using a template of any kind made a difference in the time it took for IFT to analyze the tracing data.
19Typical Food Supply Chain Further ProcessorsProcessorsWholesalers DistributorsProducersRetailers Food ServiceAg SuppliersCustomers
20IFT Global Traceability Center Vision: To become the global resource and authoritative voice on food traceability.Business Model:Access and enhance global ideas, research and accomplishments in an efficient and affordable manner.Translate findings into practical, cost-effective traceability tools and data collaboration methods that can be used by agriculture and food stakeholders.Communicate the availability of these tools and their use to stakeholders through various channels.Publish the outcomes and benefits of its work to the public and industry.Assist with implementing solutions and transferring technologies.
21Global Food Traceability Center Center PillarsResearchGlobal Food Traceability CenterProtocols & StandardsEducation & TrainingTechnology TransferReduce duplication by industry and governmentEnsure practical solutions that provide real benefit to stakeholdersProvide tangible facilities and applied services (research, marketing, commercialization, education)
22Center Partners Mars Inc. National Fisheries Institute Produce Marketing AssociationUniversity of GuelphWalmartCargillFood Marketing InstituteGS1 USInternational Association for Food ProtectionIntertek GroupLyngsoe Systems