Testimony of:  
Daniel R. Levinson  
Inspector General  
Office of Inspector General, U.S. Department of Health and Human Services  
_________________________________________________________________________________  
 
 
Good morning, Madam Chairwoman and Members of the Subcommittee.  I am Daniel Levinson, 
Inspector General for the U.S. Department of Health and Human Services.   
 
Recent outbreaks of foodborne illness involving peanut butter, peppers, and spinach have raised 
serious questions about the Food and Drug Administrations (FDA) ability to protect the Nations 
food supply.  The Office of Inspector General (OIG) has identified FDA oversight of food, drugs, 
and medical devices as a top management challenge, and has conducted several reviews on FDAs 
oversight of food safety over the past decade.  I recognize your leadership on this and other important 
issues related to FDA and appreciate the opportunity to appear before you today to discuss OIGs 
most recent work on the traceability of the food supply. 
 
In short, our most recent work, being released today and now available on our Web site at 
http://oig.hhs.gov, found that only 5 of the 40 products we purchased could be traced through each 
stage of the food supply chain back to the farm or border.  The ability to trace the remaining food 
products through each stage of the food supply chain was limited because:  (1) food facilities often 
did not maintain lot-specific information, (2) some products were not labeled with lot-specific 
information, and (3) a number of food facilities mixed raw food products from a large number of 
farms.  In addition, more than half of the facilities that handled these food products failed to meet 
FDA requirements to maintain records about their sources, recipients, and transporters of food.  A 
quarter of food facilities reported that they were not even aware of these requirements.  These factors 
affect FDAs ability to identify the source of a contamination and remove unsafe food products from 
the food supply chain.  
 
ROLE AND RESPONSIBILITIES OF OIG   
 
Our office was created in 1976 as the first statutory OIG in the Federal Government.  Two years 
later, the Inspector General Act of 1978 established OIGs at other Cabinet-level departments of the 
Federal Government, as well as at some independent Government agencies.  Congress created OIGs 
to be independent and objective units within Federal departments and agencies for the purposes of:  
(1) conducting audits and investigations of programs and operations; (2) coordinating and 
recommending policies to promote economy, efficiency, and effectiveness in the administration of 
programs; (3) preventing and detecting fraud and abuse; and (4) keeping the department Secretary or 
agency administrator and Congress informed about the necessity for corrective action. 
  
To achieve these important objectives, our office reviews programs to identify systemic 
vulnerabilities; makes recommendations to improve programs economy, efficiency and 
effectiveness; investigates instances of potential fraud or abuse and takes appropriate enforcement 
actions; audits specific payments, providers, and programs to identify and recommend recovery of 
overpayments; and promotes voluntary compliance by issuing guidance to industry. 
 
1  House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies:  Hearing March 26, 2009. 
  BACKGROUND  
 
Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming 
contaminated foods and beverages.1  FDA is responsible for ensuring the safety of about 80 percent 
of the Nations food supply, including $417 billion in domestic food and $49 billion in imported 
food.2  In a food emergency, FDAs responsibilities include finding the source of the contamination 
and helping to remove unsafe food products from retail shelves.  FDAs ability to fulfill its duties 
largely depends upon whether it can follow a food products movement through each stage of the 
food supply chain, a process referred to as traceability.  The food supply chain typically starts on 
farms and involves many different types of facilitiesincluding processors, packers, distributors, 
transporters, and retail storesbefore finally reaching the consumer.    
 
Beginning in 2005, FDA required facilities that manufacture, process, pack, transport, distribute, 
receive, hold, or import food to establish and maintain records.3  The purpose of these records is to 
help FDA trace a food product through each stage of the food supply chain if FDA has a reasonable 
belief that a food product presents a serious health threat.  Pursuant to the regulations, these records 
must include contact information for all sources, recipients, and transporters.4  Some of these 
facilitiesspecifically processors, packers, and manufacturersmust also record what is known as 
lot-specific information to the extent that this information exists.5  Other facilitiesincluding 
distributors, storage facilities, and retailersare not required to record any lot-specific information.  
Lot-specific information distinguishes one production batch from another; it can be a number printed 
on the packaging or some other identifier, such as a best if used by date.  Lot-specific information 
can help FDA trace a specific batch of food products through each stage of the food supply chain. 
 
PURPOSE OF OUR REVIEW  
 
Our review had two objectives:  (1) to assess the traceability of selected domestic food products; and 
(2) to determine the extent to which selected food facilities maintain information about their sources, 
recipients, and transporters, as required by FDA.  This review provides important information about 
FDAs ability to ensure the safety of our Nations food supply.  Our findings and recommendations 
are based on a traceability exercise of 40 selected food products, a review of the records maintained 
by the food facilities that handled these products, and structured interviews with managers at these 
facilities.  For this exercise, we purchased 40 food products from retail stores around the country.6  
We then requested that each of the facilities that handled these food products provide information 
 
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 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.   
3 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 made 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 to establish and maintain records.  
4 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. 
5 21 CFR  1.337(a)(4) and  1.345(a)(4).  
6 We purchased 10 food products in each of the following four Metropolitan Statistical Areas:  New York City, Chicago,  
San Francisco, and Washington, DC.  The productsselected in consultation with FDA officialsincluded bottled water, ice, 
milk, eggs, yogurt, flour, oatmeal, tomatoes, leafy vegetables, and juice.   
2  House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies:  Hearing March 26, 2009. 
  about the products sources, recipients, and transporters.  We used this information to try to trace 
each product through the food chain back to the farm or border.7   
 
Based upon the information we received from the facilities, 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; (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 handled the 
products could not be identified.  Additionally, we determined the extent to which facilities 
maintained information required by FDA and were aware of these requirements. 
 
TRACEABILITY OF FOOD PRODUCTS 
 
Only 5 of the 40 products we purchased could be traced through each stage of the food supply chain.  
In these cases, every facility that handled these products was able to link the product we purchased to 
lot-specific information in their records.  In a food emergency, if FDA is able to trace the product 
through each stage of the food supply chain, then it can more easily pinpoint the source of a 
contamination and target the products that need to be removed from retail shelves.   
 
For 31 of the 40 products, we were unable to trace these products through each stage of the food 
supply chain; instead, we were only able to identify facilities that likely handled the products.  Many 
of the facilities that handled these products did not maintain lot-specific information and, as a result, 
could only estimate a range of deliveries (from one or more facilities) that likely included the product 
we purchased.  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 only able to identify those facilities that likely handled a food 
product, it may not be able to quickly or accurately pinpoint the source of a contamination or target 
which products need to be removed from the food supply. 
 
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.  In a food emergency, there could be serious health consequences if 
FDA cannotat a minimumidentify the facilities that potentially handled a contaminated food 
product.   
 
FACTORS THAT AFFECT TRACEABILITY  
 
We identified three factors that limited the traceability of food products.  If FDA encounters any one 
of these three factors during a food emergency, it would also likely affect how quickly FDA could 
trace food products through the food supply chain.   
 
First, food facilities did not always maintain lot-specific information.  Although processors, packers, 
and manufacturers are required to maintain lot-specific information, 2 of the 38 in our review did not 
 
7 Our review only assessed traceability within the U.S. food supply.  For eight of the products, the beginning of the food supply 
chain was a public or private water source.  For the purposes of our review, these sources are referred to as farms.  
3  House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies:  Hearing March 26, 2009. 
  do so.  In addition, most distributors, wholesalers, and storage facilities in our review did not 
maintain lot-specific information.  Note that these facilities are not required to do so by FDA; 
however, the lack of lot-specific information limits the ability to trace food products through each 
stage of the food supply chain back to the farm or border. 
 
Second, some food products were not labeled with lot-specific information, which is not required by 
FDA.  Six of the products we purchased had no lot-specific information on the product label or 
packaging.  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.  None 
of the facilities that handled these products could link them to lot-specific information in their 
records. 
 
Third, a number of facilities received and mixed raw food products from a large number of farmsa 
process known as commingling.  For example, a single production batch of flour we purchased 
contained wheat from more than 100 farms.  If this bag of flour were implicated in a foodborne 
illness, FDA would need to contact more than 100 farms to identify the source of the contamination.  
 
RECORDS REQUIREMENTS  
 
In addition to conducting the traceability exercise, we also assessed compliance with FDAs 
requirements to maintain contact information about sources, recipients, and transporters.8  Of the 
facilities that were required to maintain these records, 59 percent did not maintain the contact 
information required by FDA about its sources, recipients, and transporters.  Facilities reported that 
they could not provide all of the required contact information for several reasons.  In some cases, 
managers had to look through large numbers of recordsmany of them paper, as opposed to 
electronicfor the required information.  Additionally, some facilities did not have integrated 
recordkeeping systems that linked sources and recipients to specific shipments of products, and 
managers had to search multiple recordkeeping systems for the required information.  In addition, a 
quarter of the food facilities reported that they were not aware of FDAs records requirements.  A 
lack of compliance with these records requirements affects FDAs ability to trace food products 
through the food supply chain.  
 
RECOMMENDATIONS  
 
Based on these findings, we made six recommendations to FDA to improve traceability of the food 
supply.  We recommended that FDA: 
 
  Seek statutory authority, if necessary, to strengthen the existing records requirements 
regarding lot-specific information.  Specifically, FDA should require processors, packers, and 
manufacturers to create lot-specific informationand maintain itif it does not exist.  FDA 
also should extend the requirements to include facilities that are currently not required to 
maintain this information.   
 
  Consider seeking additional statutory authority to require food facilities to further strengthen 
the traceability of food products.  This could include a variety of approaches such as 
requiring facilities that handle food products to maintain records about every facility or farm 
 
8 These requirements apply to facilities that manufacture, process, pack, transport, distribute, receive, hold, or import food. 
4  House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies:  Hearing March 26, 2009. 
  that handled the product, or requiring facilities to use certain information technologies to help 
facilitate recordkeeping.  
 
  Work with the food industry to develop guidance on traceability.   
 
  Address issues related to mixing raw food products from a large number of farms. 
 
  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.  With this added authority, FDA could verify that facilities 
are complying with its records requirements during its food facility inspections.   
 
  Conduct education and outreach activities to inform all segments of the food industry about 
its records requirements.   
 
CONCLUSION 
In conclusion, 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 the event of an outbreak of a foodborne illness, FDA needs to be able to 
quickly identify the source of a contamination and remove unsafe products from retail shelves.  Our 
review found that several factors limit traceability and that a significant proportion of food facilities 
are not in compliance with FDAs records requirements.  We also found that these requirements are 
not sufficient to ensure traceability.  Taken together, these findings demonstrate that more needs to 
be done to protect public health and to ensure that FDA has the necessary resources and tools to 
respond to a food emergency.  
OIG recognizes the importance of ensuring the safety of the food supply and will continue our work 
in this area.  We are currently conducting a review that assesses the extent to which food facilities 
have registered with FDA, as required.  We are also reviewing FDAs inspections of food facilities 
and the extent to which FDA follows up on violations.  Finally, we are conducting several audits 
evaluating FDAs authority and procedures for recalls. 
This concludes my testimony.  I welcome your questions. 
5  House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies:  Hearing March 26, 2009.