Framing the Issue:
     FDA Perspective
     Product Tracing
             Sherri A. McGarry
Center for Food Safety and App...
Overview
Federal Register Notice
Anatomy of outbreak investigation
Product T i P
P d t Tracing Process
Product Tracing Cha...
Federal Register Notice

     FDA Perspective
Context
Foods for humans & food for animals
Existing authorities and regulations
– FFDCA
– 21 CFR
– Public Health Service ...
Considerations for Effective
    Product Tracing S
                    Systems
Key information elements
– Who manufactured...
FDA Issues and Questions
Core Information Elements
– Lot codes or other identifier
– Shipment identifier
– Where should in...
FDA Issues and Questions
Records
– Lot code or other identifier
– Who should maintain beyond current
  requirements
– Link...
FDA Issues and Questions
Role of Risk

Costs, Benefits, and F
C t B      fit     d Feasibility
                         ib...
Anatomy of an
Outbreak investigation

      Disease Surveillance

   Epidemiological investigation

       Laboratory Anal...
FDA Traceback Process
FDA Traceback Objective
Find convergence or commonality
Identify source and distribution of implicate
food and remove from...
Traceback process
Based on epidemiological data, select
            p         g
cases/clusters to trace
Collect records at...
Further Steps
Each step identify shipments of interest
based on time frame and linking
documents
Develop flow diagram and ...
Traceback Flow Diagram
             Example      Farms
POS      Distributors
         Di t ib t      Packers
             ...
What’s Critical?
         What s
Illness exposure information clusters
                 information,
Records with date of ...
Trace over the Border
Use Registration and
Prior Notice info
FDA requests assistance
        q
to conduct onsite
investiga...
FDA Traceback Challenges
Broad Traceback Challenges
Competing priorities
– H1N1
– Economic
Varying resources and expertise
Reluctance and time
– Wh...
Source: CDC
Traceback Challenges
– an ongoing outbreak; need to act fast
– large numbers of sporadic cases
– poor consumer recollectio...
Traceback Challenges
Billing address versus shipment info
From DC to Retail
– Unclear what was shipped where
– Turn-around...
Product Tracing Challenges

– Perishable prod ct
             product
– Lack of rapid connectivity
– L k of unique id tifi...
Date:                    Invoice #:
   Lack of identifier                                                                 ...
Summary
Food contamination events are being
detected earlier
A rapid and interoperable product tracing
system may reduce i...
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Sherri Mc Garry Center For Food Safety And Applied Nutrition 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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Sherri Mc Garry Center For Food Safety And Applied Nutrition Fda

  1. 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. 2. Overview Federal Register Notice Anatomy of outbreak investigation Product T i P P d t Tracing Process Product Tracing Challenges Summary
  3. 3. Federal Register Notice FDA Perspective
  4. 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. 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. 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. 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. 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. 9. Anatomy of an Outbreak investigation Disease Surveillance Epidemiological investigation Laboratory Analysis Environmental investigation Traceback / traceforward Source investigation g
  10. 10. FDA Traceback Process
  11. 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. 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. 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. 14. Traceback Flow Diagram Example Farms POS Distributors Di t ib t Packers P k
  15. 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. 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. 17. FDA Traceback Challenges
  18. 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. 19. Source: CDC
  20. 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. 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. 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. 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. 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 Submit data and comment to Docket
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