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

2. Food Production Chain Contamination in Production
Contamination in Processing
Contamination in Distribution
Contamination in Preparation
Accessed September 1, 2013

3. 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

4. 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.

5. 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

6. 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.

7. 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

8. 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

9. 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

10. Tomato Pilot
Tomatoes
Associated with significant outbreaks from
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

11. 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

12. 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.

13. Processed Foods / Ingredients Pilot
“Kung Pao Chicken”
Ingredients associated with significant outbreaks from
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)

14. 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.

15. 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.

16. 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.

17. 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

18. 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.

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

20. 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.

21. Global Food Traceability Center
Center Pillars
Research
Global Food Traceability Center
Protocols & Standards
Education & Training
Technology Transfer
Reduce duplication by industry and government
Ensure practical solutions that provide real benefit to stakeholders
Provide tangible facilities and applied services (research, marketing, commercialization, education)

22. 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