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

http://www.cdc.gov/outbreaknet/investigations/production_chain.htmlAccessed September 1, 20132

Contamination in Production

Contamination in Processing

Contamination in Distribution

Contamination in Preparation

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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!

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Traceback Recall

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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)

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Food Safety Modernization Act- Product Tracing Pilots

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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;

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

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KDEs - 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

IFT Task Order- FSMA Pilots

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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

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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

Tomato Pilot

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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

Complexity of Pilot Studies

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Green = GrowerLight blue = Ingredient

supplierDark blue =

ManufacturerOrange = WarehouseYellow = Distribution

CenterRed = Retail

Complexity of Pilot Studies

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Green = GrowerLight blue =

Ingredient supplierDark blue =

ManufacturerOrange = WarehouseYellow = Distribution

CenterRed = Retail

Processed Foods / Ingredients Pilot

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“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

Complexities of Pilot Studies

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Green = GrowerLight blue = Ingredient

supplierDark blue =

ManufacturerOrange = WarehouseYellow = Distribution

CenterRed = Retail

• Retail 2 and 7 are the same company

• Peanut suppler 4 and 5 are the same company

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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

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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

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Benefits

Costs

Cost Benefit Evaluation 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

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• Compliance

Evaluation of the Pilots Based Upon:

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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

Typical Food Supply Chain

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AgSu

pplie

rsPro

ducers

Processors

FurtherProcessors

Wholesalers

Distributors

Retailers

Food Service

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 Pillars

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Global Food Traceability

Center

• 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)

Research

Education & Training

Protocols & Standards

Technology Transfer

Center Partners

Cargill Food Marketing

Institute

GS1 US

International Association for Food Protection

Intertek Group

Lyngsoe Systems

Mars Inc.

National Fisheries Institute

Produce Marketing Association

University of Guelph

Walmart22

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