Product Tracing in the Food Supply Chain Roger Clemens, DrPH Horn, Chief Scientific Officer IFT President (2011-12) Adjunct Professor, USC School of Pharmacy September 12, 2013

Food Production Chain Contamination in Production Contamination in Processing Contamination in Distribution Contamination in Preparation http://www.cdc.gov/outbreaknet/investigations/production_chain.html Accessed September 1, 2013

Why Product Tracing? Center for Disease Control and Prevention (CDC) estimates 48 million cases of food borne illness 128,000 hospitalized 3,000 deaths Foodborne illness source attribution 70% 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 tracing Epidemiological investigations Traceback investigations Recalls

Definition: Product Tracing Traceback is NOT Recall How 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! Traceback Recall Product 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.

Bioterrorism Act of 2002 Established recordkeeping requirements Manufacturers/processors Record shipment and receipt information Capture incoming lot numbers as possible Link ingredients to finished product to extent practical Non-manufacturers Contact information for who it came from and went to Exemptions at supply chain ends “1 up / 1 down” redundant system Form of recordkeeping not specified Combinations 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

Food 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.

IFT’s History in Product Tracing FDA contract since 1999 Competitively awarded, 5 year contracts Task orders focused on food safety and defense In 2008, IFT began product tracing task for FDA Big report: “state of the industry” Technical and cost evaluation reports June 2009, mock tomato traceback Coined the terms KDE and CTE National Center for Food Protection & Defense (NCFPD) Traceability Project initiated in 2010 IFT Traceability Improvement Initiative Held three traceability research summits in 2011 ~50 participants per summit, a lot of industry participation Summit proceeding and white papers published on ift.org KDEs- critical information for product tracing CTEs- critical points in the product’s history/movement through the supply chain at which KDEs need to be captured NCFPD= National Center for Food Protection and Defense. Goals of the project are to: Compare and contrast the capabilities of traceability solutions Opportunities and challenges to interoperability KDEs - Key Data Elements; critical information for product tracing CTEs - Critical Tracking Events; critical points in the product’s history/movement through the supply chain at which KDEs need to be captured

IFT Task Order- FSMA Pilots Statement of Work identify and gather information on methods to improve product tracing of foods in the supply chain explore and evaluate methods to rapidly and effectively track and trace food Task issued September 2011 Final report submitted June 2012 2 Pilots Produce Item Processed Food / Ingredients Collaboration Platform Cost/Benefit Analysis

General Approach Solicit Stakeholder input Products, collaboration platform, use of existing systems, initiatives, cost data sources Baseline study- What is the process for traceback investigations, what makes them difficult/easy, where are the hang-ups in an investigation Qualitative- discussions with traceback investigators Quantitative- evaluation of previous investigations Solicit participants Conduct mock traceback pilots Evaluate results and cost Input 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 systems The 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

Tomato Pilot Tomatoes Associated with significant outbreaks from 2005-2010 Short shelf-life Some commingling Participants Growers – US and Mexico Repackers/processors Distributors & Wholesalers Retail Foodservice Scenarios Start at retail level where tomatoes may be implicated product FDA chose the products for both pilots. Many stakeholders, including those within the produce industry, thought that tomatoes would be a good choice for the pilots All 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

Complexity of Pilot Studies The purpose of having this slide is to show the complexity and number of the participants in the pilots This 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 = Grower Light blue = Ingredient supplier Dark blue = Manufacturer Orange = Warehouse Yellow = Distribution Center Red = Retail

Complexity of Pilot Studies Green = Grower Light blue = Ingredient supplier Dark blue = Manufacturer Orange = Warehouse Yellow = Distribution Center Red = Retail The purpose of having this slide is to show the complexity and number of the participants in the pilots This 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.

Processed Foods / Ingredients Pilot “Kung Pao Chicken” Ingredients associated with significant outbreaks from 2005-2010 Peanuts Red Pepper Chicken Includes many ingredients, includes USDA Participants Importer Ingredient suppliers Co-manufacturers Manufacturers Warehouse and distribution Retailers Additions: peanut butter, dry kung pao dish Scenarios Peanut butter jar tested was violative Shoppers card information Illnesses from frozen/dry product This 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)

Complexities of Pilot Studies Green = Grower Light blue = Ingredient supplier Dark blue = Manufacturer Orange = Warehouse Yellow = Distribution Center Red = Retail Retail 2 and 7 are the same company Peanut suppler 4 and 5 are the same company This is the supply chain diagram for the processed food/ingredients pilot. Scenarios PA and PB involved the peanut butter product Scenario PC involved the frozen and dry kung pao dishes Scenario PD involved an imported kung pao dish from Thailand.

Collaboration Platform Definition – from stakeholders, not FDA Data analysis system which could be used by FDA to share and analyze data collected during outbreak investigations Used 10 different systems from technology providers in the pilots Goals Feed data from pilot participants into collaboration platforms to determine how a system could be useful in traceback scenarios Identify key system attributes IFT did NOT to endorse or select one technology for FDA The 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.

Collaboration Platform Tested the concept of Key Data Elements and Critical Tracking Events KDEs - critical information for tracing CTEs - critical points in the product’s history at which KDEs need to be captured Non-participants given opportunity for input Many systems designed for unique use and could not be adapted easily for the pilots Non 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.

Cost Benefit Evaluation Benefits Public health and social benefits For example – lives saved, illnesses prevented, gains in productivity FDA operational benefits responsiveness, reputation, resource allocation Industry benefits increased brand reputation, increased consumer confidence, improved recall scope, improved supply chain management Costs FDA operational costs Analytical and Field FTE’s and associated costs; training New System Implementation (Implementation and Maintenance) Compliance Industry implementation costs Software; Capital expenditures Change to current processes

Evaluation of the Pilots Based Upon: Baseline results Traceback pilot data including: Speed to convergence/resolution Mapping speed of analysis to current practices Assessing speed of analysis when industry uses a template Collaboration platform results Cost/benefit analysis Final recommendations for FDA based on above Mapping 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.

Typical Food Supply Chain Further Processors Processors Wholesalers Distributors Producers Retailers Food Service Ag Suppliers Customers

IFT 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.

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Center Partners Mars Inc. National Fisheries Institute Produce Marketing Association University of Guelph Walmart Cargill Food Marketing Institute GS1 US International Association for Food Protection Intertek Group Lyngsoe Systems