Presentation regarding Produce Traceability as presented to FDA & FSIS on December 9 & 10, 2009 in Washington, D.C.

1. Distribution/Trace Forward
Improving P d t T i of Food
I i Product Tracing f F d
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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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 distrib tion records
distribution
– Fully understand the distribution and use of their
products
–KKnow suppliers as well as customers
li ll t
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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
p y p
traceability
• Certain products (e.g. poorly coded, perishable) are
often more difficult to fully trace than others
y
• 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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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 i
f ll i h intervention as needed
i d d
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