Ellen Morrison Director, Office Of Crisis Management Fda

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

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Ellen Morrison Director, Office Of Crisis Management Fda

  1. 1. Product Tracing Challenges: FDA Perspective Ellen F. Morrison Director, Director Office of Crisis Management Food and Drug Administration Public Meeting – Product Tracing Systems for Food 1 Washington, D.C. December 9-10, 2009
  2. 2. Product Tracing Challenges: FDA Perspective Definition • A traceback investigation is the method FDA acebac es ga o s e e od 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. Public Meeting – Product Tracing Systems for Food 2 Washington, D.C. December 9-10, 2009
  3. 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 f t forward t the consumer. This process i d to th Thi is used for a product recall and it can also be useful in outbreak investigations. Public Meeting – Product Tracing Systems for Food 3 Washington, D.C. December 9-10, 2009
  4. 4. Product Tracing Challenges: FDA Perspective Traceback Investigations • May be conducted to: 1) identify the source and distribution of implicated f d and remove f i li d food d contaminated product from marketplace, 2) di ti distinguish b t i h between t two or more i li t d implicated food products and 3) determine potential routes and/or sources of contamination in order to prevent future illnesses. illnesses Public Meeting – Product Tracing Systems for Food 4 Washington, D.C. December 9-10, 2009
  5. 5. Product Tracing Challenges: FDA Perspective Traceback Challenges • FDA faced a number of challenges while conducting traceback investigations of fresh p produce including: g – 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 Public Meeting – Product Tracing Systems for Food 5 Washington, D.C. December 9-10, 2009
  6. 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 consumers produce especially when sliced, chopped or served in dishes such as salsa and guacamole • Distribution level – Lack of consistent product descriptions on records –CCo-mingling of produce f i li f d from multiple sources li l – Lack of lot numbers, lack of integrity of lot numbers Public Meeting – Product Tracing Systems for Food 6 Washington, D.C. December 9-10, 2009
  7. 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 , g y p production day – Large numbers of possible sources contributing to specific “lots” lots – Lot number not carried through on subsequent distribution records Public Meeting – Product Tracing Systems for Food 7 Washington, D.C. December 9-10, 2009
  8. 8. Example of a Conclusive Traceback Multi-state outbreak Cluster #1 Cluster #2 Cluster #3 Cluster #4 Dist A Dist B Dist C Dist D Dist E Farm A Farm C Public Meeting – Product Tracing Systems for Food 8 Washington, D.C. December 9-10, 2009
  9. 9. Example of Inconclusive Traceback Grower B Point of Distributor A Distributor E U.S. Service A Grower C Grower G U.S. Foreign Country Distributor M Grower H Foreign Country Point of Distributor B Distributor F Service B Grower D Grower I Foreign Country Foreign Country Grower J Grower E Distributor Q Foreign U.S U S. Cou t y Country Grower K U.S. Point of Distributor N Distributor R Service C Distributor C Distributor G Grower L U.S. Broker A Distributor S Grower M U.S. Grower A Distributor T Grower N U.S. Distributor O Foreign Country Distributor H Distributor J Grower O G Point of Grower F U.S. Distributor D Foreign Country Service D Distributor Distributor K P Grower P Foreign Country Distributor I Distributor L Grower Q G Foreign Country Public Meeting – Product Tracing Systems for Food 9 Washington, D.C. December 9-10, 2009

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