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Distribution/Trace Forward Improving Product Tracing of Food

Public Meeting, 12/9-10/09

David K. Elder

Director, Office of Regional Operations

Office of Regulatory Affairs

U.S. Food and Drug Administration

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Expectations• To reduce consumer exposure to unsafe

products, FDA expects regulated firms to have an accurate and documented system to trace product through the full distribution chain and to retrieve it rapidly if necessary– Prepare and exercise plans/procedures for

conducting an effective recall– Use sufficient product coding– Maintain distribution records – Fully understand the distribution and use of their

products – Know suppliers as well as customers

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Challenges• Globalization:

– imported ingredients and finished products– exports (known and presumed)

• The distribution system is as strong as its weakest link and the full distribution chain is often complex

• Paper-based systems do not facilitate rapid or accurate traceability

• Certain products (e.g. poorly coded, perishable) are often more difficult to fully trace than others

• Ingredient-driven issues:– an unsafe ingredient used in various finished products

significantly raises the difficulty level for risk control in the full distribution chain

– Recent examples: peanut butter, pet food

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Opportunities/Enhancements• Standardization among distribution systems –

electronic, interconnected• Better use of retail purchasing information

through consumer shopper cards• Track and trace; current feasibility of RFID?• Clear and meaningful product coding• Rapid alert systems that provide clear, accurate,

and meaningful information through the full distribution chain (that is acted upon as needed)

• Real-time efforts to determine the effectiveness of a recall, with intervention as needed