1 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

2 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

3 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

4 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