Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

 

Daniel R. Levinson 

Inspector General 

March 2009 

OEI-02-06-00210 

 

TRACEABILITY IN THE FOOD 

SUPPLY CHAIN 
Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities. 

Office of Inspector General 

http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS. 
ΔEXECUTIVE SUMMARY EXECUTIVE SUMMARY 

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 chain—from a retail 

shelf back to a farm—if 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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EXECUTIVE SUMMARY 

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 

product—a bag of flour—the 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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EXECUTIVE SUMMARY 

Fifty-nine percent of the food facilities did not meet FDA’s 

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 

records—some of them paper based—for 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 FDA’s 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 FDA’s records 

requirements. Specifically, 50 percent of the managers at retail facilities 

were not aware of FDA’s 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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EXECUTIVE SUMMARY 

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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EXECUTIVE SUMMARY 

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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 O E I - 0 2 - 0 6 - 0 0 2 1 0 T RACEABILITY IN THE F OOD S UPPLY CHAIN vi

EXECUTIVE SUMMARY 

We support FDA’s 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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EXECUTIVE SUMMARY .....................................i

INTRODUCTION ........................................... 1

FINDINGS ................................................. 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

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Δ TABLE OF CONTENTS 

ii
 

Δ INTRODUCTION 

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 FDA’s 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 chain—from a retail shelf back to 

a farm—if 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 Nation’s 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 facilities—including 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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INTRODUCTION 

transporters, and retail stores—before finally reaching the consumer. 

Figure 1 below shows an example of a food supply chain. 

Figure 1: Example of a food supply chain 

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. 

Storing and 

transporting 

processed 

and 

manufactured 

goods

Distributing 

goods to 

wholesale and 

retail 

establishments 

Selling 

goods to 

consumers 

Processing 

and manufacturing raw 

commodities

Storing and 

transporting 

raw 

commodities

Growing 

and 

harvesting 

agricultural 

products

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

2 

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 FDA’s 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. §§ 341–350d. 

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INTRODUCTION 

3 

h 

the Nation’s 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 healt

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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INTRODUCTION 

“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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INTRODUCTION 

Table 1: Selected Food Products

Market Sector Food Product Number of 

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 

Market Sectors: 4 

Total Types of Food 

Products: 10 

Total Number of Food Products 

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. 

5 

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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INTRODUCTION 

(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 

6 

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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INTRODUCTION 

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 

Facility Type 

Total 

Number of 

Facilities 

Number of 

Facilities Included 

in Analysis 

Number of 

Facilities 

Interviewed 

Retailers 40 28 21 

Distributors/ Wholesalers/ 

Storage Facilities 45 45 44 

Processors/ Packers/ 

Manufacturers 45 45 38 

Brokers 6 0 0 

Farms 84 0 0 

Total 220 118 103 

Source: 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 

7 

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. 

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INTRODUCTION 

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 President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

 O E I - 0 2 - 0 6 - 0 0 2 1 0 T RACEABILITY IN THE F OOD S UPPLY CHAIN 8 
 

Δ FINDINGS 

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.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 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 

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 

9 

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. 

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FINDINGS 

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 product—a bag of flour—the 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 products—a tomato, a bag of ice, a bottle of fruit juice, and a 

bottle of water—at 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 

cannot—at a minimum—identify the facilities that potentially handled 

a contaminated food product. 

Several factors limited our 

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. 

Several factors prevented us from tracing the 

specific 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. 

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FINDINGS 

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 

FDA’s 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 FDA’s 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 FDA’s ability to trace a specific product through 

the food supply chain. 

Three of the six products were unpackaged whole tomatoes. Another 

three of these products—a package of tomatoes, a bag of lettuce, and a 

bag of ice—were 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 FDA’s ability to trace a 

specific product through the food supply chain. 

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FINDINGS 

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 

maintain contact information 

about their sources, recipients, 

and transporters.26 This contact 

information helps to identify the 

source of contamination and remove the products from retail shelves. 

Fifty-nine percent of the food facilities 

did not meet FDA’s 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 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. 

12 

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. 

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FINDINGS 

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. 

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FINDINGS 

Figure 2: 

Percentage of Food 

Facilities That Did 

Not Provide Required 

Information 

* Excludes retailers. 

Source: OIG analysis of food facility responses, 2008. 

Did not provide 

all required 

information 

 about recipients 

N=90* 

Did not provide 

 all required 

information 

about transporters

N=118 

Did not provide 

all required 

information 

about sources

N=118

100%

80%

60%

40%

20%

0%

46%

52%

20%

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 

14 

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). 

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FINDINGS 

cases, managers had to look through large numbers of records—some of 

them paper based—to 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. 

15 

re 

he 

Twenty-five percent (26 of 104) of 

the managers who responded to 

our questions were not aware of 

FDA’s 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 we

not aware of FDA’s records requirements, compared to 21 percent of t

One-quarter of the food facilities were 

not aware of FDA’s records requirements; others 

highlighted practices designed to improve traceability 

28 Of the 118 facilities in our traceability exercise, 104 facilities responded to this question. 

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FINDINGS 

managers at distributor, wholesale, and storage facilities and 13 percent 

of the managers at processing, packing, and manufacturing facilities. 

Figure 3: 

Percentage of 

Managers Who 

Reported Not 

Being Aware of 

FDA Records 

Requirements, 

by Facility Type 

Source: OIG analysis of food facility responses, 2008. 

Note: This information is based on 104 of the 118 facilities that responded to this question. 

100%

80%

13%

21%

50%

0%

20%

40%

Retailers 

N=26

Distributors, 

Wholesalers, and 

Storage Facilities

N=38

Processors, 

Packers, and 

Manufacturers

N=40

60%

Many facilities reported making changes to their recordkeeping practices to 

meet FDA’s 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 driver’s 

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 

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FINDINGS 

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. 

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Δ RECOMMENDATIONS 

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 Nation’s 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 FDA’s requirements to maintain 

records about their sources, recipients, and transporters. We also found 

that one-quarter of the food facilities were not aware of FDA’s 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. 

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RECOMMENDATIONS 

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. 

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RECOMMENDATIONS 

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. 

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RECOMMENDATIONS 

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 FDA’s 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 FDA’s comments, see Appendix C. 

 

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ΔRECOMMENDATIONS APPENDIX~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); 

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APPENDIX~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.”

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Selection of Retail Facilities 

We purchased 10 products in four areas based on the U.S. Census 

Bureau’s 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. 

24 

Table 1: MSAs in Our Traceability Exercise 

MSA ZIP Code County State Population 

07059 Somerset New Jersey 14,219 New York-Northern New 

Jersey-Long Island, New 

York-New JerseyPennsylvania 07001 Middlesex New Jersey 14,188

Washington-Arlington- 20851 Montgomery Maryland 13,038

Alexandria, Washington, DCVirginia-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-OaklandFremont, California 94608 Alameda California 24,572

Source: U.S. Census Bureau, 2000.

Δ APPENDIX~B 

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Δ APPENDIX~C 

Agency Comments 

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APPENDIX ~ C 

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APPENDIX ~ C 

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APPENDIX ~ C 

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Δ ACKNOWLEDGMENTS 

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.