Department of Health and Human Services
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
FD  AS FOOD FACILITY  
 
R  
EGISTRY
 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
December 2009 
OEI-02-08-00060   
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. 
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 OIGs 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.   
   
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OBJECTIVES 
To determine the extent to which selected domestic food facilities:   
(1)  registered with the Food and Drug Administration (FDA) and  
(2)  provided complete and accurate information for FDAs food facility 
registry.             
BACKGROUND 
Each year, more than 300,000 Americans are hospitalized and 5,000 die 
after consuming contaminated foods and beverages.  In the event of an 
outbreak of a foodborne illness, FDA is responsible for finding the 
source of the contamination and helping to remove the contaminated 
food products from the food supply chain.  Recent outbreaks of 
foodborne illness involving peanut butter, peppers, and spinach have 
raised serious questions about FDAs ability to protect the Nations food 
supply. 
The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 requires certain food facilities to register with 
FDA.  The purpose of registration is to provide FDA with sufficient and 
reliable information about food facilities.  This information enables FDA 
to quickly locate facilities during an outbreak of foodborne illness and to 
locate these facilities for inspection.  
FDA requires each domestic food facility to provide information for the 
registry, including (1) contact information (i.e., name, full address, 
telephone number, and all trade names under which the facility 
conducts business); (2) contact information for the parent company;  
(3) contact information for the owner or operator of the facility; and (4) 
an emergency contact telephone number.  If there is a change in a 
facilitys information, such as a new name or address, the facility must 
provide FDA with the updated information within 60 days.  The 
information provided by facilities is stored in a database called the FDA 
Unified Registration and Listing System (hereinafter referred to as the 
registry).  
We based this study on a purposive sample of 130 selected domestic food 
facilities.  To complete our analysis, we compared information about the 
selected facilities in the registry with information obtained during 
structured interviews with the facility managers.   
  OEI-02-06-00060  FDA FOOD FACILITY REGISTRY  i   
   
E X E C U T I V E   S U M M A R Y  
 
FINDINGS 
Seven percent of selected facilities either failed to register or failed 
to cancel their registration with FDA, as required.  Specifically,               
5 percent of selected facilities (7 of 130) did not register with FDA.  For 
each of these facilities, FDA was missing critical information that could 
be used to locate the facility in an emergency.  In addition, 2 percent of 
selected facilities (2 of 130) failed to cancel their registration.  As a 
result, the registry contained information about inactive food facilities, 
which could hinder FDAs ability to accurately identify food facilities 
that may be linked to an outbreak of foodborne illness. 
Almost half of the selected facilities failed to provide accurate 
information for the registry.  Forty-eight percent (62 of 130) of selected 
facilities either failed to provide accurate information when they first 
registered or failed to provide accurate information after changes in the 
facilitys information, as required.  Specifically, 30 facilities did not 
provide accurate contact information for the facilities, 26 facilities did not 
provide an accurate emergency contact phone number, 20 facilities did 
not provide accurate contact information for the owner or operator, and 
14 facilities did not provide accurate contact information for their parent 
company.  In addition, seven facilities created multiple registrations for 
the same facility.  Facility managers most commonly reported that they 
failed to provide FDA with accurate information either because they did 
not update the information for the registry as required; they incorrectly 
entered the information during the initial registration; or the 
responsibility for maintaining the registration was transferred to another 
person who mistakenly reregistered the facility.   
FDA regulations do not ensure that the registry contains certain 
information that may be needed to locate a facility in an emergency.  
In many cases, facilities failed to provide information that may be useful 
to FDA in an emergency because certain information in the registry is 
optional.  Specifically, 23 percent of the facilities (30 of 130) did not 
provide a valid emergency contact name or a physical address for 
contacting the parent company or the owner or operator.  This lack of 
information may hamper FDAs ability to contact food facilities in an 
emergency.   
Over half of the managers at the selected facilities were unaware of 
FDAs registry requirements.  Fifty-two percent of the managers (67 of 
130) reported that they were unaware of FDAs registry requirements.  
This included 5 managers who reported that they were unaware of any 
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  ii   
   
E X E C U T I V E   S U M M A R Y  
requirements to register, as well as 62 managers who were unaware of 
the requirement to update the information in the registry within           
60 days of a change in the facilitys information. 
RECOMMENDATIONS 
To address the findings in this report, we recommend that FDA: 
Improve the accuracy of the information in the registry.  
FDA should develop strategies to systematically verify and ensure that 
the information in the registry is accurate.  FDA should seek statutory 
authority to require food facilities to reregister on a routine basis.  It 
should also consider seeking statutory authority to impose a registration 
fee to deter facilities from submitting multiple registrations.  FDA should 
also revise the registration process to allow for more checks as the data 
are entered in the registry and conduct additional checks of information 
that has already been entered.   
Consider seeking statutory authority to impose civil penalties 
through administrative proceedings against facilities that do not 
comply with the registry requirements.  FDA should consider seeking 
the authority to impose civil penalties through administrative 
proceedings against facilities that either fail to register or fail to provide 
accurate information. 
Consider making some of the optional fields within the registry 
mandatory.  To improve the usefulness of the registry, FDA should 
carefully consider what information is needed in an emergency and 
should take actionincluding seeking statutory authority, if necessary, 
and making regulatory changesto ensure that this information is 
mandatory.  Specifically, FDA should consider requiring facilities to 
identify at least one individual who can be contacted during an 
emergency.  Similarly, for the parent companys address and the address 
of the owner or operator, FDA should consider requiring facilities to 
provide physical addresses rather than mailing addresses. 
Work with the food industry to increase facilities awareness of the 
registry requirements.  FDA should work with the food industry to 
conduct additional education and outreach activities to inform food 
facilities about the registry requirements and the importance of providing 
complete and accurate information.   
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  iii   
   
E X E C U T I V E   S U M M A R Y  
 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA generally agreed with our recommendations.  FDA noted that the 
study confirms problems that the agency has encountered as well as the 
need for additional statutory authority.  FDA further noted that it 
already has in progress several efforts that respond to our 
recommendations and that provisions in proposed legislation are 
intended to address many of the problems we identified.   
FDA agreed in principal to our second recommendation to consider 
seeking statutory authority to impose civil penalties through 
administrative proceedings against facilities that do not comply with 
registry requirements.  It indicated that proposed legislation would 
create a strong incentive to ensure timely and proper registration.  We 
agree that this is a strong incentive to maintain accurate registrations.  
However, we still recommend that FDA consider seeking statutory 
authority to impose civil penalties, such as a daily fine, as an 
intermediate step before taking more severe actions.
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  iv   
   
 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Seven percent of selected facilities either failed to register                   
or failed to cancel their registration, as required . . . . . . . . . . . . . . 7
Almost half of the selected facilities failed to provide accurate  
information for the registry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
FDAs regulations do not ensure that the registry contains        
certain information that may be needed to locate a facility                
in an emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Over half of the managers at the selected facilities were  
unaware of FDAs registry requirements. . . . . . . . . . . . . . . . . . . . 10
 
R E C O MMEN D A T ION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Agency Comments and Office of Inspector General Response . . . 13
 
APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
  A:  Registration of Food Facilities Regulations . . . . . . . . . . . . . . . 14
  B:  Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
 
A C K NO WL E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  v   
   
 I N T R O D U C T I O N  
 
OBJECTIVES 
To determine the extent to which selected domestic food facilities:   
(1)  registered with the Food and Drug Administration (FDA) and  
(2)  provided complete and accurate information for FDAs food facility 
registry.             
BACKGROUND 
Each year, more than 300,000 Americans are hospitalized and 5,000 die 
after consuming contaminated foods and beverages.1  In the event of an 
outbreak of a foodborne illness, FDA is responsible for finding the source 
of the contamination and helping to remove the contaminated food 
products from the food supply chain.  Recent outbreaks of foodborne 
illness involving peanut butter, peppers, and spinach have raised serious 
questions about FDAs ability to protect the Nations food supply. 
Section 305(a) of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 requires certain food facilities to 
register with FDA.2  The purpose of registration is to provide FDA with 
sufficient and reliable information about food facilities.3  This information 
enables FDA to quickly locate facilities during an outbreak of foodborne 
illness and to locate these facilities for inspection.4   
This report is part of an ongoing body of work by the Office of Inspector 
General (OIG) on food safety.  In a 2009 report on food traceability, we 
found that only 5 of the 40 products we purchased could be traced through 
each stage of the food supply chain.5  That report also found that  
59 percent of selected food facilities did not comply with FDAs  
 
1 Paul S. Mead et al., Food-Related Illness and Death in the United States, Emerging 
Infectious Diseases, Vol. 5, 1999, pp. 607625.  Available online at 
http://www.cdc.gov/ncidod/eid/Vol5no5/mead.htm.  Accessed on April 1, 2009. 
2 P.L. No. 107-188 ' 305(a) (codified at 21 U.S.C. ' 350d).    
3 Federal Register Interim Final Rule, 68 Fed. Reg. 58894 (Oct. 10, 2003): Registration of Food 
Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (Volume 68, Number 197).  Available online at 
http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081637. htm.  
Accessed on June 22, 2009. 
4 Ibid. 
5 OIG, Traceability in the Food Supply Chain, OEI-02-06-00210, March 2009.  
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  1   
 
   
 
I N T R O D U C T I O N  
 
recordkeeping requirements.  A forthcoming study will assess the extent 
which FDA inspects domestic food facilities and identifies and addresses 
food facility violations.6 
FDAs Food Facility Registry  
As of December 2003, FDA began requiring food facilitiesboth foreign 
and domesticthat manufacture, process, pack, or hold food for 
consumption in the United States to register with FDA.7  FDA requires 
each domestic facility to provide: 
  a facility name, full address, telephone number, and all trade names 
the facility uses;8   
  a name, address, and phone number of the parent company (if 
applicable);  
  a name, address, and phone number for the owner, operator, or 
agent in charge of the facility;9 and  
  an emergency contact phone number.10  
FDA also requires each facility to provide information about the 
categories of foods handled and a statement that the information provided  
 
6 Food and Drug Administration Inspections of Domestic Food Facilities, OEI-02-08-00080 
(forthcoming). 
7 21 CFR  1.225(a) and 1.230.  Note that pursuant to 21 CFR  1.226, certain facilities (such 
as farms, restaurants, and retail food establishments) are exempt from the registration 
requirements.  Facilities that are required to register include processors, manufacturers, 
distributors, and warehouses.   
8 Notice that the regulations require the full address for the facility, but require only an 
address for the parent company and the owner or operator.  FDA provides further guidance 
on the address requirements in its Registration of Food Facilities Step-by-Step Instructions.  
These instructions specify that the address of the facility is the physical location of the 
facility being registered.  This is normally a street address, but may be some other 
physical/geographical designation used in rural locations.  Registration of Food Facilities 
Step-by-Step Instructions.  Available online at 
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFood 
Facilities/OnlineRegistration/ucm073706.htm.  Accessed on June 23, 2009. 
9 For the purposes of this report, we refer to this as the requirement to identify the owner or 
operator. 
10 Pursuant to 21 CFR  1.232, foreign facilities are required to submit the same information 
as domestic facilities, except for the emergency contact phone number.  In addition, 21 CFR  
 1.232(d) requires each foreign facility to provide the name; address; phone number; and, if no 
emergency contact is designated under 21 CFR  1.233(e), the emergency contact phone 
number of the foreign facility's U.S. agent.  Section 21 CFR  1.227(b)(13) defines a U.S. agent 
to mean a person residing or maintaining a place of business in the United States whom a 
foreign facility designates as its agent for purposes of the registration. 
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I N T R O D  U C T I O N  
is true and that the submitter was authorized to submit the 
registration.11  FDA asks each facility to provide, in addition to the 
required information, optional information, such as the name of an 
individual to contact in an emergency and a preferred mailing address, 
fax number, and email address for the facility.12  Appendix A provides 
additional information about the registry requirements.   
FDA requires facilities to provide complete and accurate information for 
each of the mandatory requirements outlined above.  If there is a change 
in a facilitys information, such as a new name or address, a facility must 
update this information within 60 days.13  Facilities are also required to 
cancel their registration within 60 days if they go out of business, cease 
providing food for consumption in the United States, or change 
ownership.14  If a facility changes ownership, the former owner must 
cancel the facilitys registration within 60 days of the change and the new 
owner must reregister the facility.15  
Failure to register a facility, failure to update required elements of a 
facility's registration, or failure to cancel a facilitys registration as 
required is a prohibited act.16  The United States can bring a civil action 
in Federal court to enjoin a person who commits a prohibited act.  The 
United States can also bring a criminal action in Federal court to 
prosecute a person who is responsible for the commission of a prohibited 
act.17   
Information provided by facilities is stored in a database called the FDA 
Unified Registration and Listing System (hereinafter referred to as the 
registry).  Facilities may submit their information through FDAs Web 
site.  If a facility does not have reasonable access to the Internet, it may 
mail or fax the registration form.  Facilities may also mail multiple 
submissions on a CD-ROM.18  As of January 2009, the registry contained 
approximately 150,000 domestic food facility registrations and 216,000 
foreign food facility registrations.19 
 
11 Ibid. 
12 21 CFR  1.233. 
13 21 CFR  1.234(a). 
14 21 CFR  1.235 and 1.234(b). 
15 21 CFR  1.234(b). 
16 21 CFR  1.241(a). 
17 Ibid. 
18 21 CFR  1.231. 
19 FDA, Compliance Information:  Registration.  January 2009. 
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  3   
   
I N T R O D U C  T I O N  
 
  Related Work  
In October 2006, FDA conducted a study to assess the accuracy of certain 
information in the registry.  Specifically, FDA evaluated the accuracy of:  
(1) the required emergency contact phone numbers, (2) the optional fax 
numbers, and (3) the optional email addresses.   The study sampled 400 
domestic food facilities in the registry and found that this information was 
inaccurate for 18.5 percent of the facilities.  To improve the accuracy of 
the information in the registry, FDA proposed, among other things, to 
increase education of food facilities and to implement additional electronic 
checks to improve data quality.   
METHODOLOGY 
Scope 
This study assesses the extent to which selected facilities registered with 
FDA and the extent to which selected facilities provided complete and 
accurate information.  This study includes only domestic food facilities.  In 
addition, the findings are limited to selected facilities and are not 
projectable to all food facilities subject to FDAs registration 
requirements.  We also limited our review to the key fields in the registry 
that would likely be needed by FDA in a food emergency.   
Sample Selection 
We based our sample on information from a previous OIG study entitled 
Traceability in the Food Supply Chain.20  In that study, we purchased  
40 food products from different retail stores around the country and 
attempted to trace these products through each stage of the food supply 
chain back to the farm or the border.21  For each of these 40 products, we 
asked facilities to identify the sources of these food products.  In addition, 
for each facility that was not a retailer, we requested information about 
the recipients of the food products.  We contacted a total of 118 facilities 
that were required by FDA to maintain records about their sources or 
recipients.  To select the sample for the current study, we identified 83 of 
the 118 facilities in our previous study that were also subject to FDAs 
registry requirements.  For each of these facilities, we randomly selected  
 
20 OIG, Traceability in the Food Supply Chain, OEI-02-06-00210, March 2009.  
21 The productsselected in consultation with FDA officialsincluded bottled water, ice, 
milk, eggs, yogurt, flour, oatmeal, tomatoes, leafy vegetables, and juice.   
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  4   
   
I N T R O D U C T I O N  
 
up to three facilities that were identified as recipients of the food 
products.  Based on this information, we identified 58 additional facilities 
that were subject to FDAs registry requirements for a total of 141 
facilities.22   
Structured Interviews 
We conducted structured telephone interviews with managers or other 
representatives (hereinafter referred to as managers) of the facilities in 
our sample.23  In total, we were able to contact the managers for 130 of 
the 141 facilities, resulting in a 92-percent response rate.   
For each facility, we asked the manager to verify key information 
contained in the registry as of February 14, 2008.  Specifically, we asked 
each manager to provide:  (1) the facility name, full address, telephone 
number, and all trade names under which the facility conducted business; 
(2) the name, address, and telephone number of the parent company (if 
applicable); (3) the name, address, and telephone number of the owner or 
operator of the facility; and (4) the emergency contact telephone number.   
If the information provided by the manager differed from the information 
in the registry, we asked the manager to explain the discrepancies.  For 
example, we asked whether the manager had failed to update the 
information for the registry or whether it was inaccurate for other 
reasons, such as a mistyped phone number or address.   
Finally, we asked managers about their familiarity with the registry 
requirements as well as their experiences updating and maintaining their 
registration.  We also asked them where they typically obtained 
information about FDA rules and regulations.  We completed these 
interviews between June and August 2008. 
Data Analysis 
We compared the data from the structured interviews to the information 
in the registry to determine:   
(1) the number of facilities that failed to register with FDA, 
(2) the number of facilities that failed to cancel their registration 
when they ceased operations, and 
 
22 Note that we were able to identify only 58 facilities primarily because not all of the  
83 facilities had recipients that were subject to the registry requirements.   
23 In several instances, the same individual or parent company registered multiple facilities.  
In these cases, we asked the managers to provide relevant information for each of the facilities 
that they were responsible for, and we counted their responses separately for each facility.   
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I N T R O D U C  T I O N  
 
(3)  the number of facilities that failed to provide accurate and                              
complete information. 
Specifically, we assessed the accuracy of (1) the required facility name, 
full address, telephone number, and all trade names the facility uses;   
(2) the required name, address, and telephone number of the parent 
company (if applicable); (3) the required name, address, and telephone 
number of the owner or operator of the facility; and (4) the required 
emergency contact telephone number.24  In addition, we determined the 
number of facilities that did not provide an optional emergency contact 
name or a physical address for contacting the owner or operator or the 
parent company.25  We also analyzed the responses from the structured 
interviews to determine managers awareness of the registry 
requirements.  
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspections approved by the Council of the Inspectors General on 
Integrity and Efficiency. 
 
24 This study does not assess compliance with the two remaining requirements, which are:  
(1) to provide a statement that the information submitted in the registry is true and accurate 
and, if the individual submitting the form is not the owner, operator, or agent, a statement 
that the submitter was authorized to submit the registration, together with information about 
the individual who authorized the submission, and (2) to provide information about certain 
categories of foods handled by the facility.   
25 The regulations require an address for the owner or operator and the parent company; 
however, the regulations do not specify that it must be the full address or physical address.  In 
addition, FDAs Registration of Food Facilities Step-by-Step Instructions provide that for the 
parent company and for the owner or operator, the address can be a physical/geographical 
location or other mailing address.    
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  6   
   
 F I N D I N G S  
F I N D I N G S  
FDA requires all food facilities to 
Seven percent of selected facilities either 
register if they manufacture, process, 
failed to register or failed to cancel their 
pack, or hold food for consumption in 
registration with FDA, as required   
the United States.  FDA also requires 
facilities to cancel their registration if they go out of business, cease 
providing food for consumption in the United States, or change ownership.   
Five percent of selected facilities failed to register with FDA    
In total, 7 of 130 facilities that we contacted did not register with FDA.  
Five of these facilities had never registered with FDA, whereas two 
facilities failed to register after a change in ownership.  As noted earlier, 
when a facility changes ownership, the new owner must register the new 
facility within 60 days of the change.  The managers at these two facilities 
confirmed that the change in ownership occurred more than 60 days prior 
to this review.  For all seven facilities, FDA was missing critical 
information that could be used to locate them in an emergency.  
Two percent of selected facilities failed to cancel their registration with FDA 
Of the 130 facilities that we contacted, 2 facilities failed to cancel their 
registration with FDA.  FDA requires facilities to cancel their registration 
if they go out of business, cease providing food for consumption in the 
United States, or change ownership.  The managers at these two facilities 
reported that changes in ownership occurred more than 60 days prior to 
this review and they had failed to cancel their registration.  As a result, 
the registry contained information about inactive food facilities, which 
could hinder FDAs ability to accurately identify food facilities that may 
be linked to an outbreak of foodborne illness. 
Forty-eight percent of selected facilities   
Almost half of the selected facilities failed  
(62 of 130) either failed to provide 
 to provide accurate information for  
accurate information when they first 
the registry 
registered or failed to provide accurate 
information after a change in the facilities information, as required.  As 
noted earlier, FDA requires each facility to provide accurate information 
for the registry.  If there is a change in a facilitys information, such as a 
new name or address, the facility must provide FDA with the updated 
information within 60 days. 
As shown in Figure 1, 30 facilities did not provide accurate contact 
information for the facilities, 26 facilities did not provide an accurate 
emergency contact phone number, 20 facilities did not provide accurate 
contact information for the owner or operator, and 14 facilities did not 
provide accurate contact information for their parent company.  In 
addition, seven facilities created multiple registrations for the same  
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  7   
   
 
facility.  Pursuant to FDA regulations, each facility should register only 
once.  However, these seven facilities created duplicate registrations 
rather than updating their existing registration, which resulted in the 
inclusion of inaccurate information in the registry. 
 
Figure 1: 
Number of Selected  40
Facilities With 
s 30
Inaccurate  e
Information in the  ciliti30 26
Registry  Fa 20
  of 20
er  14
b
um10 7
N
0
Facilities with Facilities with Facilities with Facilities with Facilities with
inaccurate inaccurate inaccurate owner inaccurate multiple
contact emergency or operator parent company registrations
information contact phone contact contact
numbers information  information
  Source:  OIG analysis of food facilities responses, 2009. 
Note:  These categories are not mutually exclusive. 
 
Facility managers most commonly reported that they failed to provide 
FDA with accurate information either because they did not update the 
information in the registry, as required; they incorrectly entered the 
information during the initial registration; or the responsibility for 
maintaining the registration was transferred to another person who 
mistakenly reregistered the facility.  
In addition, 26 percent of the managers at the facilities with inaccurate 
registrations (16 of 62) reported that they experienced technical 
difficulties when they tried to register or update information for their 
facilities.  The most common problems reported were difficulties updating 
information, navigating the Web site, and obtaining passwords for the 
Web site.  
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  8   
   
F I N D I N G  S  
 
In many cases, facilities failed to 
FDAs regulations do not ensure that the registry 
provide information that may be 
contains certain information that may be needed to 
useful to FDA in an emergency 
locate a facility in an emergency 
because certain information in the 
registry is optional.  Specifically, 23 
percent of the facilities (30 of 130) did not provide a valid emergency 
contact name or a physical address for contacting the parent company or 
the owner or operator. 
Eighteen percent of selected facilities did not provide a valid emergency 
contact name 
The emergency contact name is an optional field in the registry, and 18 
percent of facilities (23 of 130) did not provide a valid emergency contact 
name.  Eight of the facilities did not provide any emergency contact name 
for the registry, whereas 15 provided the name of a person who was either 
no longer employed at the facility, changed positions in the facility, or was 
unknown to the manager.  These inaccuracies may hamper FDAs ability 
to contact these food facilities in an emergency.   
In addition, of the facilities that did not provide a valid emergency contact 
name, eight did not identify a person responsible for the facility elsewhere 
in the registration.  These facilities did not provide the name of an 
individual as the owner or operator of the facility, but instead had 
provided the name of the facility or parent company.  Although FDAs 
guidance does not require that facilities provide the name of a specific 
individual for the registry, it may be difficult for FDA to quickly locate an 
individual responsible for a facility in an emergency if the name of an 
owner, operator, or emergency contact is not included in the registry.  
Eight percent of selected facilities did not provide a physical address for the 
owner, operator, or parent company 
Of the 130 facilities we contacted, 10 facilities provided a mailing address 
rather than physical address for the owner, operator, or parent company.  
These facilities provided a post office box where it could receive mail from 
FDA.  Although FDA does not require a physical address for the owner, 
operator, or parent company, the lack of a physical address could hinder 
FDAs ability to respond rapidly to an emergency. 
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  9   
   
F I N D I N G  S  
 
Fifty-two percent of the 
Over half of the managers at the selected facilities  
managers (67 of 130) 
were unaware of FDAs registry requirements 
reported that they were not 
aware of FDAs registry 
requirements.  This included 5 managers who reported that they were 
unaware of any requirements to register, as well as 62 managers who 
were unaware of the requirement to update the information in the 
registry within 60 days of a change in the facilitys information.   
Of the managers who were aware of the registry requirements, they most 
commonly reported that they received information about the 
requirements from FDA.  Specifically, 33 managers reported they receive 
information from FDAs emails, listserv, or Web site.  They also reported 
receiving information from other sources, such as trade publications; 
industry groups; or internal sources, such as their parent companies or 
legal departments.  
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  10   
   
 R E C O M M E N D A T I O N S  
 
 
The purpose of food facility registration is to provide FDA with accurate 
and useful information about food facilities.  This information enables 
FDA to quickly locate facilities during an outbreak of foodborne illness 
and to locate these facilities for inspection.   
Our review raises questions about the accuracy and utility of the registry.  
Specifically, we found that 7 percent of selected facilities either failed to 
register or failed to cancel their registration and almost half of the 
selected facilities failed to provide accurate information for the registry, 
as required.   In addition, we found that FDAs regulations do not ensure 
that the registry contains certain information that may be needed to 
locate a facility in an emergency.  Finally, we found that over half of the 
managers at the selected facilities were unaware of the registry 
requirements. 
To address the findings in this report, we recommend that FDA: 
Improve the accuracy of the information in the registry 
FDA should develop strategies to systematically verify and ensure that 
the information in the registry is accurate.  To accomplish this, FDA 
should: 
  Seek statutory authority to require facilities to reregister on a 
routine basis.  If FDA determines that this is not feasible, FDA 
should develop other methods to verify the information in the 
registry, such as routinely mailing the information in the registry to 
the person authorized to maintain it, so that he or she can ensure 
that the information provided is accurate. 
  Consider seeking statutory authority to impose a registration fee.  
FDA should collect a fee for each facility registration to deter 
facilities from submitting multiple registrations.  
  Revise the registration process to allow for more checks as the data 
are entered in the registry, and conduct additional checks of the 
information that has already been entered.  For example, FDA could 
implement electronic checks that would alert facilities if 
information in the registry was incomplete.  FDA could also analyze 
registry data to identify blank fields or incongruous information and 
request that the facility correct the registration.  In addition, FDA 
should consider using other data sourcessuch as FDAs database  
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  11   
   
R E C O M M  E N D A T I O N S  
 
of food facilities within its jurisdiction, called the Official 
Establishment Inventoryto verify that the information in the 
registry is complete and accurate.  
Consider seeking statutory authority to impose civil penalties through 
administrative proceedings against facilities that do not comply with the 
registry requirements 
FDA should consider seeking the authority to impose civil penalties 
through administrative proceedings against facilities that either fail to 
register or fail to provide accurate information.  Civil penalties could be 
an effective method of encouraging facilities to comply with the registry 
requirements.   
Consider making some of the optional fields within the registry mandatory  
To improve the usefulness of the registry, FDA should carefully consider 
what information is needed in an emergency and should take action
including seeking statutory authority, if necessary, and making 
regulatory changesto ensure that this information is mandatory.  
Specifically, FDA should consider requiring facilities to identify at least 
one individual that can be contacted during an emergency, such as an 
emergency contact name or the name of the individual who may be the 
owner or operator of the facility.  Similarly, for the parent companys 
address and the address of the owner or operator, FDA should consider 
requiring facilities to provide physical addresses rather than mailing 
addresses. 
Work with the food industry to increase facilities awareness of the registry 
requirements 
FDA should work with the food industry to conduct additional education 
and outreach activities to inform food facilities about the registry 
requirements and the importance of providing complete and accurate 
information.  FDA should focus its education and outreach activities on 
informing facilities about the requirement to update their information 
within 60 days of a change in the facilitys information.  FDA should 
consider using industry Web sites and trade publications, in addition to 
its Web site and listserv, to highlight this requirement.  
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  12   
   
R E C O M M  E N D A T I O N S  
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA generally agreed with our recommendations.  FDA noted that the 
study confirms problems that the agency has encountered as well as the 
need for additional statutory authority.  FDA further noted that it already 
has in progress several efforts that respond to our recommendations and 
that provisions in proposed legislation are intended to address many of 
the problems we identified.  
FDA agreed with our first recommendation to improve the accuracy of the 
information in the registry.  Specifically, FDA noted that proposed 
legislation includes provisions for either annual or biennial registration, 
and a provision for an annual registration fee.  FDA also stated that it 
had already revised the registration process to allow for more checks as 
the data are entered into the registry.  FDA further stated that it is using 
other data sources to verify the accuracy of the registration information.   
FDA agreed in principle with our second recommendation to consider 
seeking statutory authority to impose civil penalties through 
administrative proceedings.  FDA noted that proposed legislation would 
allow FDA to deem a facilitys food misbranded if that facility is not 
properly registered, and allow FDA to cancel a registration.  We agree 
that this is a strong incentive to maintain accurate registrations.  
However, we still recommend that FDA consider seeking statutory 
authority to impose civil penalties, such as a daily fine, as an 
intermediate step before taking more severe actions, such as seizures.  
FDA agreed with our third recommendation to consider making some of 
the optional fields within the registry mandatory.  FDA noted that 
proposed legislation includes a provision for mandating additional 
information as the Secretary may require.  We note that there may be 
additional revisions FDA can make that do not require statutory changes. 
FDA did not specifically state whether it agreed with our fourth 
recommendation to work with the food industry to increase awareness of 
the registry requirements.  However, FDA noted that it has conducted 
extensive outreach, and that it continues to work with trade associations.  
We ask that, in its final management decision, FDA more clearly indicate 
whether it agrees with this recommendation.    
For the full text of FDAs comments, see Appendix B. 
 
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 A P P E N D I X ~ A  
  
Registration of Food Facilities Regulations   
Title 21 of the Code of Federal Regulations, Chapter I, Subchapter A,  
Part 1, Subpart H, describes the specific information that each facility 
must submit under the Registration of Food Facilities provision of the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002.  Pursuant to 21 CFR  1.227(b)(2), a facility is: 
any establishment, structure, or structures under one ownership at 
one general physical location, or, in the case of a mobile facility, 
traveling to multiple locations, that manufactures/ processes, packs, or 
holds food for consumption in the United States.  Transport vehicles 
are not facilities if they hold food only in the usual course of business 
as carriers.  A facility may consist of one or more contiguous 
structures, and a single building may house more than one distinct 
facility if the facilities are under separate ownership.  The private 
residence of an individual is not a facility.  Nonbottled water drinking 
water collection and distribution establishments and their structures 
are not facilities.   
Pursuant to 21 CFR 1.232, each registrant must submit the following 
information:  
(a) the name, full address, and phone number of the facility; 
(b) the name, address, and phone number of the parent company, if 
the facility is a subsidiary of the parent company; 
(c)  for domestic and foreign facilities, the names, addresses, and 
phone numbers of the owner, operator, and agent in charge; 
(d) for a foreign facility, the name, address, phone number, and, if 
no emergency contact is designated under  1.233(e), the 
emergency contact phone number of the foreign facilitys U.S. 
agent; 
(e) for a domestic facility, an emergency contact phone number; 
(f)  all trade names the facility uses; 
(g) applicable food product categories as identified in  170.3 of this 
chapter, unless you check either most/all human food product 
categories, pursuant to  1.233(j), or none of the above 
mandatory categories because your facility 
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A P P E N D I X  ~ A  
 
manufactures/processes, packs, or holds a food that is not 
identified in  170.3 of this chapter; 
(h) the name, address, and phone number for the owner, operator, 
or agent in charge; 
(i)  a statement in which the owner, operator, or agent in charge 
certifies that the information submitted is true and accurate.  If 
the individual submitting the form is not the owner, operator, or 
agent in charge of the facility, the registration must also include 
a statement in which the individual certifies that the 
information submitted is true and accurate; certifies that he/she 
is authorized to submit the registration; and identifies by name, 
address, and telephone number, the individual who authorized 
submission of the registration.  Each registration must include 
the name of the individual registering the facility submitting the 
registration, and the individual's signature (for the paper and 
CD-ROM options). 
In addition, pursuant to 21 CFR  1.233, FDA encourages, but does not 
require, facilities to submit the following optional information:   
(a) fax number and email address of the facility; 
(b) preferred mailing address, if different from that of the facility; 
(c)  fax number and email address of the parent company, if the 
facility is a subsidiary of the parent company; 
(d) for a domestic facility, emergency contact name, title, and email 
address; 
(e) for a foreign facility, an emergency contact name, title, phone 
number and email address.  FDA will consider the facility's  
U.S. agent the facility's emergency contact unless the facility 
chooses to designate another person to serve as an emergency 
contact under this section; 
(f)  for a foreign facility, title, fax number, and email address of the  
U.S. agent; 
(g) type of activity conducted at the facility (e.g., manufacturing/ 
processing or holding); 
(h) food categories not identified in  170.3 of this chapter, which are 
provided in Form 3537, sections 11a (e.g., infant formula, animal 
byproducts and extracts) and 11b (e.g., grain products, amino acids); 
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A P P E N D I X  ~ A  
 
(i)  type of storage, if the facility is primarily a holding facility; 
(j)  a food product category of most/all human food product 
categories, if the facility manufactures/processes, packs, or 
holds foods in most or all of the categories identified in  170.3 of 
this chapter; 
(k) approximate dates of operation, if the facility's business is 
seasonal; 
(l)  the fax number and email address of the owner, operator, or 
agent in charge; and 
(m) the fax number and email address of the individual who 
authorized submission of the registration. 
  OEI-02-08-00060  FDAS FOOD FACILITY REGISTRY  16  A  P  PEN  D  x  B 
Agency Comments 
DEPARTMENT OF HEALTH & HUMAN SERVICES 
Food and Drug Administration 
Silver Spring, MD 20993 
DATE:  September  25,  2009 
TO:  Inspector General 
FROM:  Principal Deputy Commissioner of Food and Drugs 
SUBJECT:  FDA's General Comments to OIG's draft report titled. FDA's Food 
FaciliZy Regis/IY (OEI-02-0B-00060) 
FDA is providing the attached general comments to the Office ofInspectot General's 
draft report titled: FDA's Food Facility Registry (OEI-02-08.00060), 
FDA appreciates the opportunity to review and comment on this draft report before it is 
published, 
Joshua M. Sfiarfstein. M,D, 

Principal Deputy Commissioner of Food and Drugs 

Attachment 
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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.   
Other principal Office of Evaluation and Inspections staff from the New 
York regional office who contributed to the report include, Jonathan 
Bandel, Lucia Fort, Vince Greiber, Iris Lin, Tiffany Moore, and Bailey 
Orshan; central office staff who contributed include Ayana Everett, 
Robert Gibbons, and Sandy Khoury. 
 
 
 
 
 
 
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