Fruit & Vegetable Industry 

Advisory Committee

Food Safety Working Group

Thomas A. Hill, MPH, CP-FS, RS, DAAS

Captain, US Public Health Service

Food & Drug Administration

Center for Food Safety & Applied Nutrition

5100 Paint Branch Pkwy 

HFS-015

College Park, MD 20740

(301) 436-2152

thomas.hill@fda.hhs.gov
Anatomy of an 

outbreak investigation

Disease Surveillance

Epidemiological investigation

Laboratory analysis

Environmental investigation

Traceback / Traceforward

Manufacturer / Processor / Farm investigation
2 or more 

States 

(Outbreak)
FDA Traceback Process

 Traceback Investigations

FDA Guide to Traceback of

Fresh Fruits and Vegetables 

Implicated in 

Epidemiological Investigations

(Updated June 2006)

http://www.fda.gov/ora/inspect_ref/igs/epigde/epigde.h

tml
FDA Traceback Objective

 Find convergence or commonality

 Identify source & distribution of 

implicated food & remove from 

commerce

 Determine potential routes and/or 

source of contamination to prevent 

future illnesses
Traceback process

 Based on epidemiological data, select 

cases/clusters to trace

 Collect records at Point of Service & identify 

shipments & suppliers of interest

 From Point of Service, document each 

subsequent level in supply chain

 Either narrow or expand depending on:

• records available;

• number of shipments in time frame of interest; &

• ability to link shipments & items within the shipment 

forward & back
Traceback Flow Diagram

 POS Distributors Packers

Farms
International Traceback

 Use Registration and Prior Notice 

information

 FDA makes requests to conduct on-site 

investigations in cooperation with the 

foreign government

 Obtain records to close the link to the 

source
FDA Traceback 

Challenges
Typical Timeline of 5 to 28 days 

for Reporting Cases

Salmonella

E. Coli O157:H7
Traceback Challenges

• If an ongoing outbreak; need to 

act fast

• Large numbers of sporadic cases

• Poor consumer recall of food 

history & lack of specific product 

information

• Multiple product varieties 

identified

• Multiple products w/multiple 

ingredients identified
Product Tracing Challenges

• Lack of rapid connectivity 

• Lack of unique identifier 

• Repacking and co-mingling

• Addresses, ship and receipt 

dates may be confusing

• Packaging discarded

• Product no longer available
Date Invoice #

5/5/08 89000

SECTION QTY PACK SIZE DESCRIPTION

615444 6 50 50# Yellow Onion Med 050#

602588 6 50 50# White Onion Med 050#

645879 2 16 3# Bag White Onion 016@

648055 1 10 10# Oragne Hbanero 010#

648044 10 25 25# Tomato Bulk 6X6 LG

692000 1 12 32OZ Mini Bag Red Potato 012@

Date: Invoice #:

5/5/2008 38947

Section QTY. Pack Size Description Code

454681 100 25 25# Tomato Bulk 6x6 LG 501785

DATE

CUSTOMER ID

SHIP TO BILL TO

Pallet No Size

2200 4X5

2289 4X5

2226 4X5

4452 4X5

2233 4X5

2698 4X5

2896 4X5

Foodtown, USA

301-555-5923

8 Gourmet Lane 8 Gourmet Lane

Foodtown, USA

301-555-5923

The Restaurant

May, 4 2008

[ABC12345]

22 Loveapple Way

Toma, TO 00001

The Restaurant

88 / 2144 / Beefsteak Tomato 

88 / 6144 / Beefsteak Tomato 

SHIP DATE

5/3/2008

88 / 2186 / Beefsteak Tomato 

88 / 2144 / Beefsteak Tomato 

88 / 2144 / Beefsteak Tomato 

ORDER DATE

88 / 2144 / Beefsteak Tomato 

88 / 2144 / Beefsteak Tomato 

ORDER NUMBER

5/3/08 34511

Cartons / Manifest / Product 

Shipping Report

Tomato Distribution Company

Please contact Customer Service at [Phone] with any questions or comments.

THANK YOU FOR YOUR BUSINESS!

Invoice

 No. 9260

1985 Fruitplant Avenue To:

Pick, EM 00005 Tomato Distribution Co.

22 Loveapple Way

Date: April 20, 2008 Toma, TO 00001

Quantity Description

500 Box, Greenhouse Tomatoes, Size '35'

Order # 4421

Pallet No

3300 100 Beefsteak Tomato

3374 100 Beefsteak Tomato

3380 100 Beefsteak Tomato

3467 100 Beefsteak Tomato

Cases / Product 

Pallets Boxes Size

1 88 (88) 5*5,3

2 88 (88) 5*5,3

3 88 (88) 5*5,3

4 72 (72) 5*5,3

5 88 (88) 5*5,3

6 88 (88) 5*5,3

7 88 (88) 5*5,3

. 8506

ORDER NUMBER

Whole Tomato 

Whole Tomato 

Whole Tomato 

Whole Tomato 

Product 

Whole Tomato 

Whole Tomato 

Whole Tomato 

Shipper:

 Fruit Haulers R Us

Consignee:

 Fruit Growers, Co.

 1985 Fruitplant Ave.

 Pick, EM 00005

Shipment Date 04/25/2008

Destination

Est. Arrival 04/25/2008

Pallet count 7

Lack of a unique identifier that connects 

the links of the chain
Key Areas for Improvements

 Product Connectivity / Linkages

 Documentation

 Speed

An inter-operable system to rapidly link product 

(or ingredient) from farm / manufacturer to fork
Product Trace Policy 

and Initiatives
• Auditors attempted to 

trace 40 food products 

from retail to the farm

• Only 5 were fully 

traceable

• Problems included 

lack of lot specific 

information and 

commingling

2009 HHS Inspector General Report
Product Tracing for Foods

 Priority for the Administration

• President’s Food Safety Work Group

 Reportable Food Registry – Sep 09

 2 IFT Reports released in Dec 09:

Industry “best practices” and tomato 

traceback exercise 

 FDA & USDA held public meetingDec 09

• docket for comments closed Mar 2010
Product Trace Public Meetings

 2008 - Two Public Meetings - PRODUCE

 2009 – joint Public Meeting by FDA and 

USDA - ALL FOODS

• Purpose was to stimulate and focus 

efforts on mechanisms to enhance 

product tracing

• Substantive comments received from 

speaker panels and the public
• Electronic recordkeeping is essential. In the event 

of a recall, the FDA needs the ability to rapidly 

retrieve detailed records of product movement and 

transformation (ingredient in another food). 

• Each participant in the supply chain is responsible 

for capturing in electronic format their product 

movements and transformations (or using a third 

party), and submitting them to the FDA in the event 

of a recall. 

• A standardized, global nomenclature for key data 

elements (such as product name, lot number, date, 

locations) is required.

• A company's ability to trace and record in 

accordance with these guidelines should be part of a 

third-party audit. 

IFT Recommendations in a Nutshell...
IFT White Paper Jan 2011

• Clarifies the concepts of 

Critical Tracking Events (CTE) 

and Key Data Elements (KDE)

• The paper provides 

examples and an analogy to 

HACCP

• Has very practical 

applications for those looking 

to build their product tracing 

plans

• Open for comment through 

March 1, 2011 
Critical Tracking Events (CTEs)

Key Data Elements (KDEs)
US Food Safety Policies

 FDA Food Safety Modernization Act

• FDA to conduct additional pilot studies

• FDA has been continuously gathering data 

on industry practices

 FDA is assessing requirements 

under the new Act and prioritizing 

efforts and resources
111TH CONGRESS

 2D SESSION

S. 510

____________

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act 

with respect to the safety of the food supply.

This Act may be cited as the

 ‘‘FDA Food Safety Modernization Act’’.
TITLE II—IMPROVING CAPACITY TO DETECT 

AND RESPOND TO FOOD SAFETY PROBLEMS

Sec. 201. Targeting of inspection resources for domestic 

facilities, foreign facilities, and ports of entry; annual report.

Sec. 202. Laboratory accreditation for analyses of foods.

Sec. 203. Integrated consortium of laboratory networks.

Sec. 204. Enhancing tracking and tracing of 

food and recordkeeping.

Sec. 205. Surveillance.

Sec. 206. Mandatory recall authority.

Sec. 207. Administrative detention of food.

Sec. 208. Decontamination and disposal standards and plans.

Sec. 209. Improving the training of State, local, territorial, 

and tribal food safety officials.

Sec. 210. Enhancing food safety.

Sec. 211. Improving the reportable food registry.
FDA Food Safety Modernization Act

Specific FDA actions related to the 

enhanced tracking and tracing of food 

include:

• The establishment of pilot projects in coordination 

with the food industry to explore and evaluate methods 

to rapidly and effectively identify recipients of food to 

mitigate a foodborne illness outbreak;

• subsequent establishment of a product tracing 

system;

• feasibility and cost analyses associated with the use 

of product tracing technologies;

• the establishment of record keeping requirements.
Prevention

Government and Industry 

Working Together
Food Safety Programs and Auditing 

Protocol for the Fresh Tomato 

Supply Chain

aka 

The Tomato Safety Metrics
Commodity Specific Food Safety Guidelines for 

the Fresh Tomato Supply Chain - 2nd Edition

July 2008

FDA is posting this industry information as a 

service to industry, consumers, the media, and 

other interested parties.

The document is available in English PDF (472KB) and en 

Español (Spanish) PDF (405KB).

 

Special thanks to all of the companies, agencies, trade 

associations and individuals who helped in developing the 2nd 

edition of this guidance.
Summary

 Food contamination events are being 

detected earlier

 A rapid and inter-operable product 

tracing system may reduce illness if 

we can identify the source faster

 Need a standardized approach

globally

 Advance preventive food safety 

policies from lessons learned from 

these events
Thank you!
Questions

Thomas A. Hill, MPH, RS, DAAS

Captain, US Public Health Service

(301) 436-2152

thomas.hill@fda.hhs.gov

Food & Drug Administration

Center for Food Safety & Applied Nutrition

5100 Paint Branch Pkwy 

HFS-015

College Park, MD 20740