1. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 1 Product Tracing Challenges: FDA Perspective Ellen F. Morrison Director, Office of Crisis Management Food and Drug Administration

2. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 2 Product Tracing Challenges: FDA Perspective Definition A traceback investigation is the method FDA uses to determine and document the distribution and production chain, and the source(s) of a product that has been implicated in a foodborne illness investigation.

3. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 3 Product Tracing Challenges: FDA Perspective Starting Points A traceback investigation starts with the consumer or the point-of-purchase and traces the distribution of the product back to the source/farm. This is the process used in response to a foodborne illness outbreak. A traceforward investigation begins with the source/farm or manufacturer/distributor and traces forward to the consumer. This process is used for a product recall and it can also be useful in outbreak investigations.

4. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 4 Product Tracing Challenges: FDA Perspective Traceback Investigations May be conducted to: 1) identify the source and distribution of implicated food and remove contaminated product from marketplace, 2) distinguish between two or more implicated food products and 3) determine potential routes and/or sources of contamination in order to prevent future illnesses.

5. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 5 Product Tracing Challenges: FDA Perspective Traceback Challenges FDA faced a number of challenges while conducting traceback investigations of fresh produce including: –an ongoing outbreak –large numbers of sporadic cases –poor consumer recollection of consumption history (e.g. multiple days consumption of same produce) and lack of specific product information –multiple product varieties identified –multiple products w/multiple ingredients identified

6. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 6 Product Tracing Challenges: FDA Perspective Traceback Challenges Specific to Produce Consumer level –Lack of packaging/labels –Lack of consumers’ ability to distinguish the type of produce especially when sliced, chopped or served in dishes such as salsa and guacamole Distribution level –Lack of consistent product descriptions on records –Co-mingling of produce from multiple sources –Lack of lot numbers, lack of integrity of lot numbers

7. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 7 Product Tracing Challenges: FDA Perspective Traceback Challenges Specific to Produce Distribution level (cont’d) –Co-mingling & loss of source identity –Co-ops –Records - Inability to determine specific source, farm/fields, harvesting information by shipment or production day –Large numbers of possible sources contributing to specific “lots” –Lot number not carried through on subsequent distribution records

8. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 8 Example of a Conclusive Traceback

9. Public Meeting – Product Tracing Systems for Food Washington, D.C. December 9-10, 2009 9 Distributor F Grower E U.S. Grower D Foreign Country Distributor B Point of Service A Distributor N Point of Service B Point of Service C Distributor ADistributor E Grower B U.S. Grower C U.S. Distributor M Distributor CDistributor G Distributor O Grower A U.S. Broker A Distributor R Distributor S Distributor T Point of Service D Distributor D Distributor L Distributor K Distributor I Distributor H Grower Q Foreign Country Distributor J Grower F Foreign Country Distributor P Grower P Foreign Country Grower G Foreign Country Grower H Foreign Country Distributor Q Grower J Foreign Country Grower K U.S. Grower O U.S. Grower N Foreign Country Grower I Foreign Country Grower L U.S. Grower M U.S. Example of Inconclusive Traceback