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

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. 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. 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. 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. 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. 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. 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. 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. 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