Department of Health and Human Services
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
TRACE  ABILITY IN THE FOOD 
 
S C  
UPPLY  HAIN
 
 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
March 2009 
OEI-02-06-00210 
   
Office of Inspector General 
http://oig.hhs.gov 
 
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amended, is to protect the integrity of the Department of Health and Human Services 
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enforcement authorities. 
   
 E X E C U T I V E   S U M M A R Y  
E X E C U T I V E   S U M M A R Y  
OBJECTIVES 
1.  To assess the traceability of selected food products.  
2.  To determine the extent to which selected food facilities maintain 
information required by the Food and Drug Administration (FDA) in 
a food emergency. 
BACKGROUND 
Beginning in 2005, FDA required certain food facilities to maintain 
records identifying the sources, recipients, and transporters of food 
products.  The purpose of these records is to allow FDA to trace an 
article of food through each stage of the food supply chainfrom a retail 
shelf back to a farmif FDA has a reasonable belief that a food product 
is adulterated and presents a serious health threat. 
Traceability is the ability to follow the movement of a food product 
through the stages of production, processing, and distribution.  
Traceability includes both traceback and trace forward.  Traceback is 
the ability to trace a food product from the retail shelf back to the farm.  
Conversely, trace forward is the ability to trace a food product from the 
farm forward to the retail shelf.  Traceability is often needed to identify 
the sources of food contamination and the recipients of contaminated 
food in product recalls and seizures.  This study refers to such a 
situation as a food emergency.  
This study is based on two primary data sources:  (1) a traceability 
exercise of 40 selected food products and (2) structured interviews with 
the managers at the food facilities that handled the selected food 
products.  For the traceability exercise, we purchased 40 food products 
from different retail stores and attempted to trace them through each 
stage of the food supply chain back to the farm(s) or the border.  We 
asked the facilities that handled the food product for information about 
their sources, recipients, and transporters, which we used in an effort to 
trace the product.   
 
 
 
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E X E C U T I V E   S U M M A R Y  
FINDINGS 
We were able to trace 5 of the 40 products through each stage of the 
food supply chain; for most of the other products, we could identify 
the facilities that likely handled them.  Not all facilities are required       
to maintain lot-specific information in their records, and those that are 
required to maintain lot-specific information are required to maintain it 
only if it exists.  As a result, we were able to trace five of the specific 
products through each stage of the food supply chain.  The facilities that 
handled each of these products were able to provide information about 
the specific product we purchased or were able to link that product to 
lot-specific information in their records.   
For 31 of the 40 products, we were able to identify the facilities that 
likely handled the products.  Most facilities that handled these products 
did not maintain lot-specific information in their records and could only 
estimate a range of deliveries (from one or more facilities) that may 
have included the product we purchased.  As a result, we were not able 
to trace these specific products through each stage of the food supply 
chain.  In addition, these estimates may have included more facilities 
than those that actually handled the product or may not have included 
all of the facilities that handled the product.  For example, for one 
producta bag of flourthe storage facility did not know the exact 
farms that contributed to the product and, therefore, had to give us 
information about every farm that provided wheat during the previous 
harvest season. 
For the remaining four products, we could not even identify the facilities 
that likely handled them.  In these cases, at least one facility in the food 
supply chain failed to provide any information about the potential 
sources of the products.   
Several factors prevented us from tracing the specific products 
through the food supply chain.  Several factors limited our ability to 
trace the specific food products through each stage of the food supply 
chain.  These factors included:  (1) processors, packers, and 
manufacturers not always maintaining lot-specific information, as 
required; (2) other types of facilities not maintaining lot-specific 
information because it is not required; (3) retailers receiving products 
not labeled with lot-specific information; and (4) the mixing of products 
from a large number of farms.  These factors also affect the speed with 
which FDA can trace specific food products through the food supply 
chain. 
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E X E C U T I V E   S U M M A R Y  
Fifty-nine percent of the food facilities did not meet FDAs 
requirements to maintain records about their sources, recipients, 
and transporters.  Fifty-nine percent (70 of 118) of the food facilities in 
our traceability exercise did not provide all of the required contact 
information about their sources, recipients, and transporters.  Twenty 
percent did not provide all of the required information about their 
sources, 52 percent did not provide all of the required information about 
their recipients, and 46 percent did not provide all of the required 
information about their transporters.   
Facilities could not provide all required contact information for several 
reasons.  In some cases, managers had to look through large numbers of 
recordssome of them paper basedfor contact information.  
Additionally, some facilities did not have integrated recordkeeping 
systems that linked sources and recipients to specific shipments or to 
transporters, and managers had to search separate systems to obtain 
the contact information. 
One-quarter of the food facilities were not aware of FDAs records 
requirements; others highlighted practices designed to improve 
traceability.  Twenty-five percent (26 of 104) of the managers who 
responded to our questions were not aware of FDAs records 
requirements.  Specifically, 50 percent of the managers at retail facilities 
were not aware of FDAs records requirements, compared to 21 percent of 
the managers at distributor, wholesale, and storage facilities and           
13 percent of the managers at processing, packing, and manufacturing 
facilities.  
Over half of the managers (43 of 78) who were aware of the FDA records 
requirements reported making changes to their recordkeeping practices 
to meet these requirements.  These changes included switching from 
paper-based to electronic recordkeeping systems, improving their 
existing electronic systems, and improving their facilities ability to 
maintain lot-specific information.   
RECOMMENDATIONS 
To address the findings in this report, we recommend that FDA: 
Seek statutory authority, if necessary, to strengthen existing records 
requirements regarding lot-specific information.  FDA should seek 
statutory authority, if necessary, to require all processors, packers, and 
manufacturers to create and maintain lot-specific information for food 
products.  FDA should also extend the requirements regarding  
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E X E C U T I V E   S U M M A R Y  
 
lot-specific information to other types of facilities, such as distributors, 
storage facilities, and retailers, in order to further strengthen the 
traceability of food products.   
Consider seeking additional statutory authority to improve 
traceability.  FDA should consider seeking additional statutory 
authority requiring food facilities to further strengthen the traceability 
of food products.   
FDA should consider a variety of different approaches, such as 
expanding current requirements stipulating that facilities maintain 
information only for their immediate sources, recipients, and 
transporters.  FDA may instead require each facility that handles a food 
product to maintain records about every facility or farm that handled 
the product, along with the relevant lot-specific information.  This may 
allow FDA to more quickly and accurately trace food products during a 
food emergency.  In addition, FDA should consider requiring facilities to 
use certain information technologies to help facilitate recordkeeping, 
such as interoperable recordkeeping systems.  These interoperable 
systems, which would allow for information to be exchanged among all 
facilities in the food supply chain, may also allow FDA to more quickly 
and accurately trace food products during a food emergency.   
Work with the food industry to develop additional guidance to 
strengthen traceability.  FDA should work with the food industry to 
develop additional guidance on traceability.  Among other things, this 
guidance could encourage facilities to assign a point person to be 
responsible for responding to food emergencies, conduct mock recalls, 
and contract with independent third-party auditors to monitor 
recordkeeping systems. 
Address issues related to mixing raw food products from a large 
number of farms.  FDA should work with the food industry to develop 
standards for mixing raw food products from a large number of farms.  
This would address a serious vulnerability in the traceability of the food 
supply chain. 
Seek statutory authority to conduct activities to ensure that facilities 
are complying with its records requirements.  FDA should seek 
statutory authority to request facilities records at any time, as opposed 
to its current authority to request records only when FDA has a 
reasonable belief that an article of food presents a serious health threat.  
FDA should use this authority to conduct traceability exercises or other 
checks on facilities to ensure that they are complying with its records 
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E X E C U T I V E   S U M M A R Y  
 
requirements.  With this added authority, FDA would be able to include 
a component in its food facility inspections to verify as a matter of 
course whether facilities are complying with its records requirements. 
Conduct education and outreach activities to inform the food industry 
about its records requirements.  FDA should develop education 
activities that focus on appropriate and reliable recordkeeping systems.  
These activities could include informational meetings, mailings, and 
other initiatives.  FDA should use these efforts to clearly explain the 
specific types of information that must be maintained, such as 
transporter contact information.  FDA should also target outreach 
efforts to facilities that have less familiarity with the records 
requirements, namely retailers, distributors, wholesalers, and storage 
facilities.  
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA stated that it will consider our recommendations regarding 
seeking enhanced statutory authority, and it described its efforts in 
response to our recommendations to work with the food industry and to 
conduct education and outreach.  FDA did not specifically state whether 
it concurred with these latter two recommendations. 
FDA stated that it will consider our three recommendations to seek 
additional statutory authority to (1) strengthen existing records 
requirements, (2) improve traceability, and (3) ensure that facilities are 
complying with its records requirements, as well as our 
recommendation to address issues relating to mixing raw food products.  
FDA noted that it continues to work closely with its food safety partners 
to strengthen its ability to protect Americans from foodborne illness, 
which includes determining whether additional statutory authority is 
needed to better protect public health.   
In response to our recommendation to work with the food industry, FDA 
stated it is continuing to work with the food industry and other 
stakeholders to develop additional guidance to strengthen traceability.  
Finally, in response to our recommendation to conduct education and 
outreach activities, FDA stated that it will continue to work with 
industry and trade association groups to communicate the requirements 
of the rule to stakeholders. 
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E X E C U T I V E   S U M M A R Y  
We support FDAs ongoing efforts to improve the traceability of the food 
supply and to ensure that it has the tools needed to better protect the 
public health in the event of a food emergency.  We ask that, in its final 
management decision, FDA more clearly indicate whether it concurs 
with our recommendations to work with the food industry and to 
conduct education and outreach.   
 
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 T A B L E   O F   C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
 
 
I N T RO DUC T IO N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
 
 
F I N D IN G S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
  We traced 5 of the 40 products; for most of the other products,          
we identified facilities that likely handled them. . . . . . . . . . . . . . . 9
Several factors prevented us from tracing specific products. . . . . 10
  Fifty-nine percent of facilities did not meet requirements . . . . . . 12
  One-quarter of facilities were not aware of requirements. . . . . . . 15
 
 
R E C O MMEN D A T ION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
         Agency Comments and Office of Inspector General Response. . . . 20
 
 
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
  A:  The Establishment and Maintenance of Records  
               Regulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
  B:  Selection of Retail Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
  C:  Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
 
 
A C K NO WL E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 
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 I N T R O D U C T I O N  
OBJECTIVES 
1.  To assess the traceability of selected food products.  
2.  To determine the extent to which selected food facilities maintain 
information required by the Food and Drug Administration (FDA) in 
a food emergency.  
BACKGROUND 
Each year, more than 300,000 Americans are hospitalized and 5,000 die 
after consuming contaminated foods and beverages.1  In a food 
emergency, FDA is responsible for finding the source of the 
contamination and helping to remove the food products from the food 
supply chain.  Recent food contaminations involving peppers, spinach, 
and peanut butter have demonstrated the importance of FDAs role and 
the challenge of quickly finding and removing unsafe food products from 
retail shelves. 
Beginning in 2005, FDA required certain food facilities to maintain 
records on the sources, recipients, and transporters of food products.2  
The purpose of these records is to allow FDA to trace an article of food 
through each stage of the food supply chainfrom a retail shelf back to 
a farmif FDA has a reasonable belief that a food product is 
adulterated and presents a serious health threat.3  This study refers to 
such a situation as a food emergency.  
This study assesses the traceability of selected food products and 
determines the extent to which selected food facilities can provide 
information required by FDA about their sources and recipients.  Food 
traceability is essential to ensuring the safety of our Nations food 
supply and to enabling FDA to identify problems, respond quickly, and 
protect the public health. 
Traceability in the Food Supply Chain 
The food supply chain typically starts on farms and involves many 
different types of facilitiesincluding processors, packers, distributors, 
 
1 Centers for Disease Control and Prevention, National Center for Infectious Diseases.  
Available online at http://www.cdc.gov/ncidod/diseases/food/.  Accessed April 16, 2008. 
2 21 CFR  1.337 and 1.345.   
3 Federal Food, Drug, and Cosmetic Act,  414(a), 21 U.S.C.  350c(a), as amended by the 
Public Health Security and Bioterrorism Act of 2002, P.L. No. 107-188, 306. 
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I N T R O D U C T I O N  
transporters, and retail storesbefore finally reaching the consumer.  
Figure 1 below shows an example of a food supply chain. 
Figure 1:  Example of a food supply chain 
Growing  Storing and  Processing  Storing and  Distributing  Selling 
and  transporting  and manufac- transporting  goods to  goods to 
harvesting  raw  turing raw  processed  wholesale and  consumers 
agricultural  commodities  commodities  and  retail 
products  manufactured  establishments 
goods
 
Source:  Based on a graphic from Terrorist Threats to Food:  Guidance for Establishing and Strengthening Prevention and Response       
Systems, Food Safety Department, World Health Organization, 2002.   
 
Traceability is the ability to follow the movement of a food product 
through the stages of production, processing, and distribution.4  
Traceability includes both traceback and trace forward.  Traceback is 
the ability to trace a food product from the retail shelf back to the farm.5  
Conversely, trace forward is the ability to trace a food product from the 
farm to the retail shelf.  Traceability is often needed to identify the 
sources of food contamination and the recipients of contaminated food in 
product recalls and seizures. 
FDA and the Bioterrorism Act   
FDA is responsible for ensuring the safety of almost all food products 
sold in the United States, with the exception of meat, poultry, and some 
egg products, which are regulated by the U.S. Department of 
Agriculture.  The Federal Food, Drug, and Cosmetic Act gives FDA the 
authority to regulate food safety.6 
The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Act) is intended to improve the ability of the 
United States to prevent, prepare for, and respond to bioterrorism and 
other public health emergencies affecting a number of areas, including 
 
4 Codex Alimentarius Commission, Procedural Manual, Seventeenth Edition, 2007.  The 
Codex Alimentarius Commission was created in 1963 by the Food and Agriculture 
Organization (FAO) and the World Health Organization (WHO) to develop food standards 
and guidelines.  Available online at:  ftp://ftp.fao.org/docrep/fao/010/a1472e/a1472e.pdf.  
Accessed October 6, 2008.  In this study, traceability is defined as the ability to trace a food 
product through the domestic supply chain, which is different from the ability to trace a 
food product to its country of origin.   
5 FDAs Center for Food Safety and Applied Nutrition, Guidance for Industry:  Guide to 
Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 1998. 
6 Federal Food, Drug, and Cosmetic Act, Chapter IV, 21 U.S.C.  341350d. 
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the Nations food supply.7  The Act makes a number of significant 
amendments to the Federal Food, Drug, and Cosmetic Act.  One of these 
amendments, the Maintenance and Inspection of Records provision, 
stipulates that FDA promulgate regulations to require persons who 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food (hereinafter referred to as food facilities) to establish and 
maintain records.8  It also allows FDA to inspect those records if there 
is a reasonable belief that an article of food presents a serious health 
threat.9   
In December 2004, FDA promulgated regulations authorized by the 
Maintenance and Inspection of Records provision.10  The regulations 
require food facilities to maintain records on the sources and recipients 
of food products.  The regulations also require food facilities to maintain 
records on the transporters of both incoming and outgoing shipments of 
food products.11  These records must include contact information  
(i.e., complete names, addresses, and phone numbers whether domestic 
or foreign) for all sources, recipients, and transporters.  In addition, the 
records must include the dates, quantities, and a description of the type 
of food and its packaging.  The regulations do not apply to farms or to 
foreign entities operating outside the United States.12 
Food manufacturers, processors, and packers must also record  
lot-specific information (i.e., a lot number, a code number, or another 
identifier) to the extent that this information exists.13  Lot-specific 
information distinguishes one production batch from another and can be 
a number printed on the packaging or some other identifier, such as a 
 
7 P.L. No. 107-188. 
8 P.L. No. 107-188,  306(a) amending  414(b) of the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C.  350c(b).  The Federal Food, Drug, and Cosmetic Act at 21 U.S.C.  321(e) defines 
a person to include an individual, partnership, corporation, and association.  This study 
refers to persons as food facilities. 
9 Public Law 107-188,  306(a), (b) amending  414(a) and  704(a) of the Federal Food, 
Drug, and Cosmetic Act, 21 U.S.C.  350c(a) and  374(a).  The technical standard is a 
reasonable belief that an article of food is adulterated and presents a threat of serious 
adverse health consequences or death to humans or animals. 
10 69 Fed. Reg. 71562 (Dec. 9, 2004), corrected 70 Fed. Reg. 8726 (Feb. 23, 2005); codified at 
21 CFR pt. 1, subpart J. 
11 The regulations refer to sources as nontransporter immediate previous sources;, to 
recipients as nontransporter immediate subsequent recipients;, and to transporters as 
transporter immediate previous sources and transporter immediate subsequent 
recipients. 
12 21 CFR  1.327.   
13 21 CFR  1.337(a)(4) and  1.345(a)(4).  
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II NN TT RR OO DD UU CC TT II OO NN   
  
best if used by date.14  Finally, the records must be available for 
inspection and copying as soon as possible, but not to exceed 24 hours 
from the receipt of an official request.15  See Appendix A for a more 
detailed description of the records requirements.   
All food facilities were required to comply with the records        
maintenance provision by December 2006.  Retailers with 10 or fewer 
full-time-equivalent employees are exempt from the records 
requirements; however, they are not exempt from the requirement to 
provide FDA with any records that they maintain, if requested.16  
METHODOLOGY 
Scope 
This study assesses the traceability of selected food products and 
determines the extent to which food facilities maintain the required 
information about their sources, recipients, and transporters.  It is 
based on two primary data sources:  (1) a traceability exercise of           
40 selected food products and (2) structured interviews with the 
managers at the food facilities that handled the selected food products.  
This study includes only domestic food facilities.  
Traceability Exercise  
We purchased 40 food products from different retail stores and 
attempted to trace them through each stage of the food supply chain 
back to the farm(s) or the border.  We selected 10 different products for 
the study in consultation with FDA officials, and purchased these         
10 food products in each of the following four Metropolitan Statistical 
Areas (MSA):  New York City, Chicago, San Francisco, and Washington, 
DC.17  Table 1 lists the food products that we selected.  Appendix B 
provides more detailed information about how we selected the retail 
facilities and the products in each area. 
 
14 The preamble to this rule states that FDA acknowledges that most firms use lot or code 
numbers to identify specific batches of their products.  However, some may use other 
technologies such as barcodes.  The term other identifier is intended to capture any other 
methods that the food industry may be using to identify specific lots of product.  
69 Fed. Reg. 71600. 
15 21 CFR  1.361. 
16 21 CFR  1.327(f). 
17 MSAs are areas designated by the Office of Management and Budget that include major 
cities and the suburban areas surrounding them.  
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Table 1:  Selected Food Products 
 
Number of 
Market Sector  Food Product 
Products Purchased 
 
Bottled water  4 
Beverage 
  Manufactured ice  4 
Whole milk  4 
 
Dairy  Carton of eggs  4 
  Plain yogurt  4 
Milled unbleached flour  4 
  Grains 
Plain oatmeal  4 
  Tomatoes, fresh whole  4 
Produce  Bag of fresh-cut leaf vegetable  4 
 
Fruit juice  4 
 Total Number of  Total Types of Food  Total Number of Food Products 
Market Sectors:  4  Products:  10  Purchased:  40 
 
For each of the 40 products, we provided the retailer with a description 
of the food product, including any information available on the 
packaging.  We then requested that the retailer identify the source(s) of 
the food product and the transporter(s) from which the retailer received 
the food product.  For each source, we specifically requested:  (1) the 
name, address, and phone number of the source and the transporter;    
(2) the date when the retailer received the product; (3) the quantity of 
the product that the retailer received; and (4) a description of the 
product as it was received by the retailer.  Note that three retailers did 
not respond to our request, and in these cases, we repurchased the food 
products from other retailers.18 
To continue the traceability exercise, we then contacted the facility that 
the retailer identified as the source of the food product.  As we did with 
the retailers, we provided these facilities with a description of the food 
product and requested that they provide us with product and contact 
information for the source(s) and transporter(s) of the food product.   
We continued the process of moving backward through the food supply 
chain until:  (1) we reached the farm(s) at the beginning of the chain,19 
 
18 Because we could not determine whether these retailers had 10 or fewer                        
full-time-equivalent employees and were, therefore, exempt from the records requirements, 
we did not include them in our study.  Instead, we repurchased the food products from other 
retailers.   
19 For eight of the food products, the beginning of the food supply chain was a public or 
private water supply.  For the purposes of this report, these sources are referred to as 
farms. 
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(2) we reached the border, or (3) we ended the exercise because a facility 
(other than the retailer) did not provide information about its 
source(s).20  When we reached the farm(s), we asked them to verify the 
information given to us by the facility that listed them as a source.  We 
did not ask them to provide us with any additional information, as 
farms are exempt from the records requirements.  
In addition, for each facility that was not a retailer, we requested 
information about the recipient(s) of its food product.  Specifically, we 
requested contact information for all recipient(s) of the food product and 
the transporter(s) that delivered it.  We used this information to 
determine whether each facility could provide information about its 
recipients.  We did not use this information to trace the product forward 
through the food supply chain.  
Analysis of the Traceability Exercise  
We contacted a total of 220 facilities that handled the 40 selected food 
products.  We analyzed the facilities responses to assess the traceability 
of the 40 selected food products.  To conduct this analysis, we 
categorized the 40 food products into three groups:  (1) products that 
could be traced through each stage of the food supply chain, meaning 
that every facility that handled the product could provide information 
that was specific to the product we purchased and that 10 or fewer 
farms contributed to the lot of food product;21 (2) products that could not 
be traced but the facilities that likely handled the products could be 
identified; and (3) products that could not be traced and the facilities 
that likely handled the products could not be identified.   
As noted earlier, not all facilities are required to maintain lot-specific 
information in their records, and those that are required to maintain 
lot-specific information are required to maintain the information only if 
it exists.  This may have contributed to facilities not being able to 
provide information specific to either the product or the lot of product 
that we purchased.   
Analysis of the Records Maintenance Requirement    
Of the 220 facilities we contacted, we included in our analysis  
118 facilities that were required by FDA to maintain records.  As shown 
 
20 Note that if a facility identified more than five sources, we randomly selected and 
contacted only five of those sources.   
21 For retailers, we considered lot-specific information to mean that there was lot-specific 
information on the product we purchased or the retailers maintained lot-specific 
information in their records. 
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I N T R O D U C T I O N  
in Table 2, we excluded 84 farms because they were exempt from the 
records requirements.  Similarly, we excluded 12 retailers that provided 
information about their sources but had 10 or fewer full-time-equivalent 
employees.22  Finally, we excluded six brokers because brokers were not 
consistently identified as sources by facilities.23 
 
 
Table 2:  Facilities From Traceability Exercise  
 
  Total  Number of  Number of 
 
Facility Type  Number of  Facilities Included  Facilities 
Facilities  in Analysis  Interviewed 
 
Retailers  40  28  21 
  Distributors/ Wholesalers/ 
45  45  44 
Storage Facilities 
 
Processors/ Packers/ 
45  45  38 
Manufacturers 
 
Brokers  6  0  0 
 
Farms  84  0  0 
 
  Total  220  118  103 
  S ource:  OIG analysis of food facility responses, 2008.   
We then determined how many of the 118 facilities were unable to 
provide the information required by FDA.  We considered a facility as 
having failed to provide the required source information if it did not 
provide a complete address and phone number for each source that it 
identified.  We used the same criterion to determine whether a facility 
failed to provide the required recipient and transporter information.   
Structured Telephone Interviews 
We conducted structured telephone interviews with managers or senior 
representatives (hereinafter referred to as managers) at each of the 
facilities.  As shown in Table 2, we were able to contact managers at   
103 of the 118 facilities, resulting in an 87-percent response rate.  Our 
questions focused on facilities recordkeeping practices and the types of 
 
22 Retailers with 10 or fewer full-time-equivalent employees are exempt from the records 
requirements; however, they are not exempt from the requirement to provide FDA with any 
records that they maintain, if requested.  See 21 CFR  1.327(f).  Twelve retailers with 10 or 
fewer full-time-equivalent employees provided information that we used in the traceability 
exercise, however, we did not include these 12 retailers in our analysis of the records 
maintenance requirements.   
23 A broker is a firm or an individual that is commissioned to negotiate sales of food 
products on behalf of food facilities.  In many cases, brokers are required by FDA to 
maintain records.  
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  7   
   
I N T R O D U C T I O N  
 
information they maintained about the selected food products.  These 
interviews provided additional information about the traceability of the 
food products, as well as about facilities experiences in implementing 
the records requirements.  We completed these interviews between 
April and September 2007.   
Limitations 
Although the selected food products reflect a broad range of food types, 
our results are not generalizable to the entire food supply.  In addition, 
we were not able to verify whether a facility provided a complete list of 
all of its sources, recipients, or transporters.  The statements in this 
report are therefore based on the sources, recipients, and transporters 
that the facilities identified.  
Standards   
This review was conducted in accordance with the Quality Standards 
for Inspections issued by the Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  8   
   
 F I N D I N G S  
 
Not all facilities are required       
We were able to trace 5 of the 40 products through 
to maintain lot-specific 
each stage of the food supply chain; for most of the 
information in their records, and 
other products, we could identify the facilities that  those that are required to 
likely handled them  maintain lot-specific information 
are required to maintain it only if 
it exists.24  As a result, we were able to trace 5 of the 40 specific 
products through each stage of the food supply chain.  For another 31 of 
the 40 products, we could identify the facilities that likely handled 
them.  For the remaining four products, we could not identify the 
facilities that likely handled them. 
We could trace 5 of the 40 products through each stage of the food supply 
chain 
We were able to trace five products through each stage of the food supply 
chain.  The facilities that handled each of these products were able to 
provide information about the specific product we purchased or were able 
to link that product to lot-specific information in their records.  These 
products were three cartons of eggs, a container of yogurt, and a bottle of 
water.  For all three cartons of eggs, the food supply chain included only a 
retailer and a farm.  In contrast, the supply chain for the container of 
yogurt included four facilities and four farms.  The facilities that handled 
these five products were able to provide us with information that allowed 
us to trace the path these products took from the farm to the retail shelf.   
 
For 31 of the 40 products, we could identify the facilities that likely handled 
the products  
As noted earlier, not all facilities are required to maintain lot-specific 
information in their records, and those that are required to maintain      
lot-specific information are required to maintain it only if it exists.  
Therefore, many facilities were not able to provide information that was 
specific to the products we purchased.   
For 31 of the 40 products, we were able to identify the facilities that 
likely handled the products.  Most facilities that handled these products 
did not maintain lot-specific information in their records and could only 
estimate a range of deliveries (from one or more facilities) that may 
have included the product we purchased.  As a result, we were not able 
to trace these specific products through each stage of the food supply 
 
24 As noted earlier, FDA requires only processors, packers, and manufacturers to maintain  
lot-specific information in their records to the extent this information exists.   
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  9   
   
F I N D I N G S  
 
chain.  In addition, for many of these products, these estimates may 
have included more facilities than those that actually handled the 
product or may not have included all of the facilities that handled the 
product.  For example, for one producta bag of flourthe storage 
facility did not know the exact farms that contributed to the product 
and, therefore, had to give us information about every farm that 
provided wheat during the previous harvest season. 
If FDA is not able to trace a specific product through each stage of the 
food supply chain, it may have difficulty identifying the source of 
contamination or targeting which products need to be removed from 
retail shelves. 
For 4 of the 40 products, we could not identify the facilities that likely 
handled them  
For four productsa tomato, a bag of ice, a bottle of fruit juice, and a 
bottle of waterat least one facility in the food supply chain failed to 
provide any information about the potential sources of the products.  
This prevented us from tracing these four products through each stage 
of the food supply chain back to the farm(s) or the border and from 
identifying all of the facilities that likely handled the products.  In a 
food emergency, there could be serious health consequences if FDA 
cannotat a minimumidentify the facilities that potentially handled 
a contaminated food product. 
 
Several factors prevented us from tracing the  Several factors limited our 
specific products through the food supply chain  ability to trace the food products 
through each stage of the food 
supply chain.  These factors included:  (1) processors, packers, and 
manufacturers not always maintaining lot-specific information, as 
required; (2) other types of facilities not maintaining lot-specific 
information because it is not required; (3) retailers receiving products 
not labeled with lot-specific information; and (4) the mixing of products 
from a large number of farms.  These factors also affect the speed with 
which FDA can trace products through the food supply chain. 
Processors, packers, and manufacturers did not always maintain  
lot-specific information  
FDA requires processors, packers, and manufacturers to maintain  
lot-specific information in their records to the extent this information 
exists.  Of the 38 facilities we interviewed that were required to 
maintain this information, 2 failed to comply.   
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  10   
   
F I N D I N G S  
These facilities labeled the food product with lot-specific information; 
however, they did not maintain this information in their records.  
Further, two additional facilities did not maintain lot-specific 
information because it did not exist.  One of these facilities, an ice 
manufacturer, did not establish lots that would allow it to distinguish 
one production batch from another.  Although these facilities were in 
compliance with the records requirements because lot-specific 
information did not exist, the lack of lot-specific information can limit 
FDAs ability to trace a specific product through each stage of the food 
supply chain.   
Other types of facilities did not maintain lot-specific information  
FDA does not require distributors, wholesalers, storage facilities, and 
retailers to maintain lot-specific information.  However, this 
information could improve FDAs ability to identify the source of food 
contamination and help remove specific food products from retail 
shelves.   
The distributors, wholesalers, storage facilities, and retailers that we 
interviewed did not commonly maintain lot-specific information.  Of 
these facilities, 30 of the 44 distributors, wholesalers, and storage 
facilities and all of the 21 retailers did not maintain lot-specific 
information in their records.   
Some retailers received products that were not labeled with lot-specific 
information 
Six of the forty food products that we purchased were not labeled with 
any lot-specific information.  The lack of lot-specific information on the 
packaging can hinder FDAs ability to trace a specific product through 
the food supply chain.   
Three of the six products were unpackaged whole tomatoes.  Another 
three of these productsa package of tomatoes, a bag of lettuce, and a 
bag of icewere packaged products.  For the packaged tomatoes, as well 
as two of the unpackaged tomatoes, the processors or packers labeled 
the cases of the product rather than the individual products available on 
the retail shelf.  None of the six retailers, however, could link the 
purchased products to any lot-specific information.   
Facilities sometimes mixed raw food products from a large number of farms  
The mixing of raw products from a large number of farms, a process 
that is often called commingling, can also limit FDAs ability to trace a 
specific product through the food supply chain.   
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  11   
   
F I N D I N G S  
Thirty-seven facilities in our traceability exercise received raw food 
products directly from farms.  Of these, 15 facilities mixed raw products 
from more than 10 farms.25  These facilities processed flour, juice, milk, 
and yogurt, and almost half of these facilities mixed raw products from 
100 or more farms.  Because of the large number of farms that 
contributed to these finished products, FDA may have difficulty 
identifying the source of food contamination and helping to remove the 
contaminated products from retail shelves.  According to an estimate 
from a manager at a grain storage facility, if grain from one farm were 
contaminated, millions of bags of flour would be at risk and might have 
to be removed from retail shelves. 
The remaining 22 facilities received raw food products from 10 or fewer 
farms.  Several of these facilities that handled the eggs, leaf vegetables, 
and tomatoes received information from farms, such as expiration dates, 
the location of the field where the product was grown, and the date the 
product was harvested.  In these cases, FDA would be able to more 
easily trace a contaminated food product through the food supply chain.  
   
FDA requires certain facilities to 
Fifty-nine percent of the food facilities  
maintain contact information 
did not meet FDAs requirements  
about their sources, recipients, 
to maintain records about their  
and transporters.26  This contact 
sources, recipients, and transporters  
information helps to identify the 
source of contamination and remove the products from retail shelves.    
Fifty-nine percent (70 of 118) of the food facilities in our traceability 
exercise did not provide all of the required information.  Six of the  
118 facilities did not provide any of the required information.  The 
remaining 64 facilities provided some but not all of the required 
information.    
 
25 The four oatmeal chains are excluded because they ended at the U.S. border before 
reaching the beginning of the chain.   
26 FDA requires only certain facilities to meet these requirements.  The facilities required 
to maintain contact information about their sources, recipients, and transporters include 
those that manufacture, process, pack, transport, distribute, receive, hold, or import food in 
the United States.  See Appendix A for more detailed information about the types of 
facilities subject to these requirements and the information they are required to maintain. 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  12   
   
F I N D I N G S  
Twenty percent of facilities did not provide all of the required contact 
information about their sources 
FDA requires certain food facilities to maintain the names, addresses, 
and telephone numbers of the sources of their food products.   
Twenty percent (24 of 118) of the facilities in our traceability exercise 
did not provide all of the required information about their sources.  See  
Figure 2 on the following page for the percentage of facilities that did 
not provide the different types of required information.  Six facilities did 
not provide any information about their source(s); the remaining  
18 facilities did not provide some of the required information, such as a 
complete address or telephone number.   
The six facilities did not provide any information about their sources for 
several reasons.  One of the facilities, a produce distributor, bought its 
tomatoes from different vendors and did not maintain any records 
documenting these purchases.  Another facility, an ice manufacturer, 
was not able to provide the information because it went out of business 
shortly after we purchased the product.  In addition, one water bottler 
reported that it would be too difficult to provide the information because 
it did not include lot-specific information in its records.  Three other 
facilities responsible for handling a bottle of juice did not provide any 
information about their sources or about why they did not provide this 
information.   
The facilities that did provide information about their sources may have 
been able to do so because they typically had only one source.     
Seventy-two percent of all facilities had only one source for the selected 
food product.  These facilities may not have had to look through large 
numbers of records or multiple recordkeeping systems to find the 
information.  In several cases, managers noted that they did not have to 
look at records at all because they knew the one source of the product 
from memory.     
 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  13   
   
F I N D I N G S  
Figure 2:  100% 
Percentage of Food 
Facilities That Did 
Not Provide Required  80% 
Information 
60% 
52%
46%
40% 
20%
20% 
0% 
Did not provide  Did not provide   Did not provide 
all required  all required   all required 
information   information  information  
about sources  about recipients  about transporters
N=118  N=90*  N=118 
   
 
* Excludes retailers. 
Source:  OIG analysis of food facility responses, 2008. 
 
Fifty-two percent of facilities did not provide all of the required contact 
information about their recipients 
FDA also requires certain food facilities to maintain the names, 
addresses, and telephone numbers of the recipients of their food 
products.  Fifty-two percent (47 of 90) of the facilities did not provide all 
of the required information about their recipients.27  Six facilities did 
not provide any information about their recipients.  These facilities were 
the same ones that did not provide any information about their sources.   
The remaining 41 facilities did not provide some of the required 
information, such as a complete address or telephone number.  
Facilities may have had difficulty in providing all of the required 
information about their recipients because they typically had more than 
one recipient.  Specifically, 62 percent of the 90 facilities in our 
traceability exercise had more than one recipient.  In several of these 
 
27 FDA does not require retailers to provide information about their recipients if the 
recipients are consumers.  Therefore, this requirement did not apply to the 28 retailers in 
our traceability exercise.   See 21 CFR  1.327(e). 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  14   
   
FF II NN DD II NN GG SS   
 
cases, managers had to look through large numbers of recordssome of 
them paper basedto identify recipients.  A number of managers 
specifically reported that their facilities kept the contact information for 
recipients in a system separate from the one used to track incoming 
shipments, making it burdensome to provide the contact information for 
the selected food products. 
Forty-six percent of facilities did not provide all of the required contact 
information about their transporters 
FDA requires certain food facilities to maintain the names, addresses, 
and telephone numbers for the transporters of both their incoming and 
outgoing shipments.  Forty-six percent of food facilities (54 of 118) did 
not provide all of the required information about their transporters.  
Specifically, 27 facilities did not provide all of the information about 
their transporters of outgoing shipments, whereas 10 facilities did not 
provide all of the information about their transporters of incoming 
shipments.  An additional 17 facilities did not provide all of the 
information about the transporters of either their incoming or outgoing 
shipments.   
Facilities had difficulty in providing all of the required information 
about their transporters for several reasons.  Several managers 
indicated that they did not keep records that identified their 
transporters when the transportation was arranged by either their 
source or their recipient.  Several other managers reported that they 
kept the transporter information in a separate recordkeeping system 
that was not integrated with their system that tracked shipments.  
Some managers further noted that identifying the transporter 
associated with a particular incoming or outgoing shipment was very 
burdensome because they needed to manually search a large number of 
paper records.   
Twenty-five percent (26 of 104) of 
One-quarter of the food facilities were  
the managers who responded to 
not aware of FDAs records requirements; others 
our questions were not aware of 
highlighted practices designed to improve traceability   FDAs records requirements.28  
The percentage of managers who 
were not aware of the requirements varied by the type of facility.  As 
shown in Figure 3, 50 percent of the managers at retail facilities were 
not aware of FDAs records requirements, compared to 21 percent of the 
 
28  Of the 118 facilities in our traceability exercise, 104 facilities responded to this question. 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  15   
   
F I N D I N G S  
managers at distributor, wholesale, and storage facilities and 13 percent 
of the managers at processing, packing, and manufacturing facilities.  
Figure 3:  100% 
Percentage of 
Managers Who  
Reported Not   80% 
Being Aware of  
FDA Records 
Requirements,   60% 
50%
by Facility Type 
40% 
21%
20% 
13%
0% 
Processors,  Distributors,  Retailers 
Packers, and  Wholesalers, and  N=26 
Manufacturers Storage Facilities  
N=40  N=38 
 
  Source:  OIG analysis of food facility responses, 2008. 
Note:  This information is based on 104 of the 118 facilities that responded to this question.  
 
Many facilities reported making changes to their recordkeeping practices to 
meet FDAs records requirements 
Over half of the managers (43 of 78) who were aware of the FDA records 
requirements reported making changes to their recordkeeping practices 
to meet these requirements.  For example, a number of these managers 
reported switching from paper-based to electronic recordkeeping 
systems or reported improving their existing electronic systems.  
Additionally, eight managers noted that they had developed or 
improved their facilities ability to maintain lot-specific information.  
One of these managers purchased software to more easily keep track of 
products, whereas another began recording lot-specific information in a 
paper-based system. 
Additionally, several managers reported making other types of changes.  
For example, eight managers reported making improvements to their 
transporter records.  One manager began photocopying the drivers 
licenses of transporters, whereas another added the transporters names 
and addresses to the receipts documenting the delivery of transported 
products.  A few other managers noted that their facilities now  
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  16   
   
F I N D I N G S  
designate a point person to respond to food emergencies or hire a     
third-party auditor to monitor their recordkeeping systems.  A few 
others noted that they had started to keep their records for a longer 
period of time. 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  17   
   
 R E C O M M E N D A T I O N S  
 
 
The traceability of food products and the ability of food facilities to 
provide information about their sources, recipients, and transporters 
are essential to ensuring the safety of our Nations food supply.  In a 
food emergency, this information allows FDA to identify the source of 
contamination and help remove unsafe food products from retail 
shelves. 
Based on our review, we were able to trace 5 of the 40 specific products 
we purchased.  For 31 of the 40 products, we were able to identify the 
facilities that likely handled them.  For the remaining four products, we 
could not identify the facilities that likely handled them.  Several 
factors prevented us from tracing the specific products through each 
stage of the food supply chain.  These factors included:  (1) processors, 
packers, and manufacturers not always maintaining lot-specific 
information, as required; (2) other types of facilities not maintaining  
lot-specific information because it is not required; (3) retailers receiving 
products not labeled with lot-specific information; and (4) the mixing of 
products from a large number of farms.   
In addition, we found that 59 percent of the food facilities in our 
traceability exercise did not meet FDAs requirements to maintain 
records about their sources, recipients, and transporters.  We also found 
that one-quarter of the food facilities were not aware of FDAs records 
requirements, whereas others highlighted practices designed to improve 
traceability. 
To address the findings in this report, we recommend that FDA: 
Seek statutory authority, if necessary, to strengthen existing records 
requirements regarding lot-specific information                                
FDA should seek statutory authority, if necessary, to require all 
processors, packers, and manufacturers to create and maintain  
lot-specific information for food products.  FDA should also extend the 
requirements regarding lot-specific information to other types of 
facilities, such as distributors, storage facilities, and retailers, in order 
to further strengthen the traceability of food products.   
Consider seeking additional statutory authority to improve traceability  
FDA should consider seeking additional statutory authority requiring 
food facilities to further strengthen the traceability of food products.   
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  18   
   
R E C O M M E N D A T I O N S  
FDA should consider a variety of different approaches, such as 
expanding current requirements stipulating that facilities maintain 
information only for their immediate sources, recipients, and 
transporters.  FDA may instead require each facility that handles a food 
product to maintain records about every facility or farm that handled 
the product, along with the relevant lot-specific information.  This may 
allow FDA to more quickly and accurately trace food products during a 
food emergency.  In addition, FDA should consider requiring facilities to 
use certain information technologies to help facilitate recordkeeping, 
such as interoperable recordkeeping systems.  These interoperable 
systems, which would allow for information to be exchanged among all 
facilities in the food supply chain, may also allow FDA to more quickly 
and accurately trace food products during a food emergency.   
Work with the food industry to develop additional guidance to 
strengthen traceability                                                                                                    
FDA should work with the food industry to develop additional guidance 
on traceability.  Among other things, this guidance could encourage 
facilities to assign a point person to be responsible for responding to 
food emergencies, conduct mock recalls, and contract with independent 
third-party auditors to monitor recordkeeping systems. 
Address issues related to mixing raw food products from a large 
number of farms                                                                                        
FDA should work with the food industry to develop standards for 
mixing raw food products from a large number of farms.  This would 
address a serious vulnerability in the traceability of the food supply 
chain. 
Seek statutory authority to conduct activities to ensure that facilities 
are complying with its records requirements                         
FDA should seek statutory authority to request facilities records at any 
time, as opposed to its current authority to request records only when 
FDA has a reasonable belief that an article of food presents a serious 
health threat.  FDA should use this authority to conduct traceability 
exercises or other checks on facilities to ensure that they are complying 
with its records requirements.  With this added authority, FDA would 
be able to include a component in its food facility inspections to verify as 
a matter of course whether facilities are complying with its records 
requirements. 
 
 
 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  19   
   
R E C O M M E N D A T I O N S  
 
Conduct education and outreach activities to inform the food industry 
about its records requirements                                                                    
FDA should develop education activities that focus on appropriate and 
reliable recordkeeping systems.  These activities could include 
informational meetings, mailings, and other initiatives.  FDA should 
use these efforts to clearly explain the specific types of information that 
must be maintained, such as transporter contact information.  FDA 
should also target outreach efforts to facilities that have less familiarity 
with the records requirements, namely retailers, distributors, 
wholesalers, and storage facilities. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA stated that it will consider our recommendations regarding 
seeking enhanced statutory authority, and it described its efforts in 
response to our recommendations to work with the food industry and to 
conduct education and outreach.  FDA did not specifically state whether 
it concurred with these latter two recommendations.  
FDA stated that it will consider our three recommendations to seek 
additional statutory authority to (1) strengthen existing records 
requirements, (2) improve traceability, and (3) ensure that facilities are 
complying with records requirements, as well as our recommendation to 
address issues relating to mixing raw food products.  FDA noted that it 
continues to work closely with its food safety partners to strengthen its 
ability to protect Americans from foodborne illness, which includes 
determining whether additional statutory authority is needed to ensure 
that it has the requisite tools to better protect public health.   
In response to our recommendation to work with the food industry, FDA 
stated it is continuing to work with the food industry and other 
stakeholders to develop additional guidance to strengthen traceability.  
FDA noted that it is meeting with the food and feed industry and 
technology firms to better understand industry product tracing 
activities and technologies.  FDA also stated that it has held two public 
meetings to stimulate discussions on enhancing product tracing 
systems, and has recently awarded a contract for a study on traceability 
in food systems.  FDA also noted its plan to host a workshop to review 
the results of a traceability study being conducted by the European 
Union, which will allow FDA to learn from the findings and incorporate 
them into its decisionmaking.   
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  20   
   
R E C O M M E N D A T I O N S  
In response to our recommendation to conduct education and outreach 
activities, FDA stated that it is the responsibility of those providing food 
for American consumers to be aware of and comply with all laws and 
regulations that apply to their activities.  FDA further noted that it had 
conducted extensive outreach activities in 2005 and had continued to 
provide assistance to the industry by developing a series of Question 
and Answer guidance documents, and that it will continue to work with 
industry and trade association groups to communicate the requirements 
of the rule to stakeholders. 
We support FDAs ongoing efforts to improve the traceability of the food 
supply and to ensure that it has the tools needed to better protect the 
public health in the event of a food emergency.  We ask that, in its final 
management decision, FDA more clearly indicate whether it concurs 
with our recommendations to work with the food industry and to 
conduct education and outreach.   
For the full text of FDAs comments, see Appendix C. 
   
 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  21   
   
R E C O M M E N D A T I O N S  
 A P P E N D I X ~ A  
The Establishment and Maintenance of Records Regulations  
Title 21 of the Code of Federal Regulations, Part 1, Subpart J, describes 
the specific information to be maintained under the Maintenance and 
Inspection of Records provision of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 for all persons, 
except transporters, who are subject to the Federal recordkeeping 
requirements.  A person includes an individual, a partnership, a 
corporation, and an association (21 CFR  1.328).  Pursuant to                   
21 CFR  1.337, facilities must establish and maintain the following 
records for food they receive: 
  The name of the firm, address, telephone number and, if 
available, the fax number and e-mail address of the 
nontransporter immediate previous source, whether domestic or 
foreign; 
  An adequate description of the type of food received, to include 
brand name and specific variety (e.g., brand x cheddar cheese, not 
just cheese; or romaine lettuce, not just lettuce); 
  The date you received the food; 
  For persons who manufacture, process, or pack food, the lot or 
code number or other identifier of the food (to the extent this 
information exists); 
  The quantity and how the food is packaged (e.g., 6-count bunches, 
25-pound (lb) carton, 12-ounce (oz) bottle, 100-gallon (gal) tank); 
and 
  The name of the firm, address, telephone number, and, if 
available, the fax number and e-mail address of the transporter 
immediate previous source (the transporter who transported the 
food to you). 
Additionally, pursuant to 21 CFR  1.345, facilities must establish 
and maintain the following records for food they release:  
  The name of the firm, address, telephone number, and, if 
available, the fax number and e-mail address of the 
nontransporter immediate subsequent recipient, whether 
domestic or foreign; 
  An adequate description of the type of food released, to include 
brand name and specific variety (e.g., brand x cheddar cheese, not 
just cheese; or romaine lettuce, not just lettuce); 
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  22   
   
A P P E N D I X ~ A  
  The date you released the food; 
  For persons who manufacture, process, or pack food, the lot or 
code number or other identifier of the food (to the extent this 
information exists); 
  The quantity and how the food is packaged (e.g., 6-count bunches, 
25-lb carton, 12-oz bottle, 100-gal tank); 
  The name of the firm, address, telephone number, and, if 
available, the fax number and e-mail address of the transporter 
immediate subsequent recipient (the transporter who transported 
the food from you ); and 
  Your records must include information reasonably available to 
you to identify the specific source of each ingredient used to make 
every lot of finished product.
  OEI-02-06-00210  TRACEABILITY IN THE FOOD SUPPLY CHAIN  23   
   
 A P P E N D I X ~ B  
 
Selection of Retail Facilities 
We purchased 10 products in four areas based on the U.S. Census 
Bureaus Metropolitan Statistical Areas (MSA).  In each MSA, we 
purchased 10 food products, each from a different retail facility, for a 
total of 40 food products.  We selected retail facilities in the two  
ZIP Codes with populations closest to the median population, or, if 
necessary, in a bordering ZIP Code.  We purchased different brand 
names for each of the 40 products and, when possible, we selected lesser 
known brands.   See Table 1for a list of the MSAs and the targeted ZIP 
Codes. 
 
 
Table 1:  MSAs in Our Traceability Exercise  
 
MSA   ZIP Code  County  State  Population 
New York-Northern New 
07059  Somerset  New Jersey  14,219 
Jersey-Long Island, New 
York-New Jersey-
07001  Middlesex  New Jersey  14,188 
Pennsylvania  
Washington-Arlington- 20851  Montgomery  Maryland  13,038 
Alexandria, Washington, DC-
Virginia-Maryland  20187  Fauquier  Virginia  12,886 
60093  Cook  Illinois  19,528 
Chicago-Naperville-Joliet, 
Illinois-Indiana-Wisconsin 
60448  Will  Illinois  19,476 
94947  Marin  California  24,724 
San Francisco-Oakland-
Fremont, California 
94608  Alameda  California  24,572 
  Source:  U.S. Census Bureau, 2000. 
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Agency Comments 
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 A C K N O W L E D G M E N T S  
 
This report was prepared under the direction of Jodi Nudelman, 
Regional Inspector General for Evaluation and Inspections in the     
New York regional office, and Meridith Seife, Deputy Regional Inspector 
General.   
Vincent Greiber served as the team leader for this study.  Other 
principal Office of Evaluation and Inspections staff from the New York 
regional office who contributed to the report include Judy Bartlett and 
Lucia Fort; other central office staff who contributed include          
Ayana Everett, Robert Gibbons, Talisha Searcy, and Sandy Khoury. 
 
 
 
 
 
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