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

1. Framing the Issue:
FDA Perspective
Product Tracing
Sherri A. McGarry
Center for Food Safety and Applied Nutrition
Food d Drug Ad i i t ti
F d and D Administration

2. Overview
Federal Register Notice
Anatomy of outbreak investigation
Product T i P
P d t Tracing Process
Product Tracing Challenges
Summary

3. Federal Register Notice
FDA Perspective

4. Context
Foods for humans & food for animals
Existing authorities and regulations
– FFDCA
– 21 CFR
– Public Health Service Act
Need to go beyond for faster, more
targeted product tracing
Whole Chain Traceability

5. Considerations for Effective
Product Tracing S
Systems
Key information elements
– Who manufactured the product
– Who s sending forward and who’s recieveng
Who’s who s
– Way to link info internally and externally
through the supply chain
– Date shipped and recd
– Physical location food shipped and recd
– Quantity, how packaged

6. FDA Issues and Questions
Core Information Elements
– Lot codes or other identifier
– Shipment identifier
– Where should info reside (packaging, records)
– At what stages or stages in the chain
hat
– Standardized set of info elements

7. FDA Issues and Questions
Records
– Lot code or other identifier
– Who should maintain beyond current
requirements
– Linking record standard format
record,
– Electronic, human readable
Transmitting trace data to FDA

8. FDA Issues and Questions
Role of Risk
Costs, Benefits, and F
C t B fit d Feasibility
ibilit
Outreach, education on current
requirements
q

9. Anatomy of an
Outbreak investigation
Disease Surveillance
Epidemiological investigation
Laboratory Analysis
Environmental investigation
Traceback / traceforward
Source investigation
g

10. FDA Traceback Process

11. FDA Traceback Objective
Find convergence or commonality
Identify source and distribution of implicate
food and remove from consumers
Determine potential routes and/or source
of contamination to prevent future
f t i ti t tf t
illnesses

12. Traceback process
Based on epidemiological data, select
p g
cases/clusters to trace
Collect records at Point of Service and identify
shipments and suppliers of interest
From POS info, document each subsequent
level in supply chain
Either narrow or expand depending on:
– records available;
– number of shipments in time frame of interest; and
– ability to link shipments and items within the shipment
forward and back

13. Further Steps
Each step identify shipments of interest
based on time frame and linking
documents
Develop flow diagram and time lines
Don’t
D ’t see common sources until several
til l
levels or at very end so no way to know
early on if th t
l the trace will b conclusive
ill be l i

14. Traceback Flow Diagram
Example Farms
POS Distributors
Di t ib t Packers
P k

15. What’s Critical?
What s
Illness exposure information clusters
information,
Records with date of receipt
Records th t are l ibl
R d that legible
Records with an identifier or other means
to connect next level in supply chain
Turn around time and pattern of buying
p y g
Industry provides records in timely fashion

16. Trace over the Border
Use Registration and
Prior Notice info
FDA requests assistance
q
to conduct onsite
investigations in
cooperation with foreign
government
Obtain
Ob i records to close
d l
the link to the source

17. FDA Traceback Challenges

18. Broad Traceback Challenges
Competing priorities
– H1N1
– Economic
Varying resources and expertise
Reluctance and time
– Where’s the positive sample?
– Epi? What’s that?

19. Source: CDC

20. Traceback Challenges
– an ongoing outbreak; need to act fast
– large numbers of sporadic cases
– poor consumer recollection of consumption
history and lack of specific product
information
– Multiple product varieties identified
– M lti l products w/multiple i
Multiple d t / lti l ingredients di t
identified

21. Traceback Challenges
Billing address versus shipment info
From DC to Retail
– Unclear what was shipped where
– Turn-around at DC/warehouse
Turn-
– Ability to narrow shipments of interest
– Connecting incoming a d outgo g
Co ect g co g and outgoing

22. Product Tracing Challenges
– Perishable prod ct
product
– Lack of rapid connectivity
– L k of unique id tifi
Lack f i identifier
– Repacking and co-mingling
co-
– Addresses, ship and receipt dates
– Packaging (ie. cases) gone
– Product no longer available
– Producing states importing as well

23. Date: Invoice #:
Lack of identifier 5/5/2008 38947
that connects thru chain
Section QTY. Pack Size Description Code
454681 100 25 25# Tomato Bulk 6x6 LG 501785
Date Invoice #
Shipping Report
5/5/08 89000
SECTION QTY PACK SIZE DESCRIPTION
615444 6 50 50# Yellow Onion Med 050# Tomato Distribution Company
602588 6 50 50# White Onion Med 050# 22 Loveapple Way DATE May, 4 2008
645879 2 16 3# Bag White Onion 016@ Toma, TO 00001 CUSTOMER ID [ABC12345]
648055 1 10 10# Oragne Hbanero 010# SHIP TO The Restaurant BILL TO The Restaurant
648044 10 25 25# Tomato Bulk 6X6 LG 8 Gourmet Lane 8 Gourmet Lane
692000 1 12 32OZ Mini Bag Red Potato 012@ Foodtown, USA Foodtown, USA
301-555-5923 301-555-5923
ORDER DATE ORDER NUMBER SHIP DATE
Invoice
5/3/08 34511 5/3/2008
No. 9260
Pallet No Cartons / Manifest / Produc t Size
1985 Fruitplant Avenue To:
ORDER NUMBER 2200 88 / 2144 / Beefsteak Tomato 4X5
Shipper: Pick, EM 00005 Tomato Distribution Co.
. 8506 2289 88 / 2144 / Beefsteak Tomato 4X5
Fruit Haulers R Us 22 Loveapple Way
2226 88 / 2144 / Beefsteak Tomato 4X5
Consignee: Shipment Date 04/25/2008
Date: April 20, 2008 Toma, TO 00001
Fruit Growers, Co. Destination 4452 88 / 2144 / Beefsteak Tomato 4X5
Quantity Desc ription 2233 88 / 2186 / Beefsteak Tomato 4X5
1985 Fruitplant Ave. Est. Arrival 04/25/2008
Pick, EM 00005
, Pallet count 7 2698 88 / 2144 / Beefsteak Tomato 4X5
500 Box, Greenhouse Tomatoes, Size '35'
2896 88 / 6144 / Beefsteak Tomato 4X5
Pallets Box es Produc t Size
1 88 Whole Tomato
Order # 44215*5,3
(88) Please contact Customer Service at [Phone] with any questions or comments.
2 88 Whole Tomato
Pallet No Cases
(88) 5*5,3 / Produc t THANK YOU FOR YOUR BUSINESS!
3 88 Whole Tomato 3300 100(88) 5*5,3
Beefsteak Tomato
4 72 Whole Tomato 3374 100(72) 5*5,3
( ) Beefsteak Tomato
,
5 88 Whole Tomato 3380 100(88) 5*5,3
Beefsteak Tomato
6 88 Whole Tomato 3467 100(88) 5*5,3
Beefsteak Tomato
7 88 Whole Tomato (88) 5*5,3

24. Summary
Food contamination events are being
detected earlier
A rapid and interoperable product tracing
system may reduce illness
Need for
N d f a standardized approach globally
t d di d h l b ll
Advance preventive food safety policies
from lessons learned from these events
Communication and collaboration is Key y
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