Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

 

FDA’S FOOD FACILITY 

REGISTRY 

 

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 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. 
 

 INTRODUCTION EXECUTIVE SUMMARY 

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 FDA’s 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 FDA’s ability to protect the Nation’s 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 

facility’s 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. 

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EXECUTIVE SUMMARY

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 FDA’s 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 

facility’s 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 FDA’s ability to contact food facilities in an 

emergency. 

Over half of the managers at the selected facilities were unaware of 

FDA’s registry requirements. Fifty-two percent of the managers (67 of 

130) reported that they were unaware of FDA’s registry requirements. 

This included 5 managers who reported that they were unaware of any 

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EXECUTIVE SUMMARY 

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 facility’s 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 action—including seeking statutory authority, if necessary, 

and making regulatory changes—to 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 company’s 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. 

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EXECUTIVE SUMMARY

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.

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 TABLE OF CONTENTS 

EXECUTIVE SUMMARY .....................................i

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

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

FDA’s 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 FDA’s registry requirements. . . . . . . . . . . . . . . . . . . . 10

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Agency Comments and Office of Inspector General Response . . . 13

APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

 A: Registration of Food Facilities Regulations . . . . . . . . . . . . . . . 14

 B: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

v 
 

 INTRODUCTION 

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 FDA’s 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 FDA’s ability to protect the Nation’s 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 FDA’s 

1 Paul S. Mead et al., “Food-Related Illness and Death in the United States,” Emerging 

Infectious Diseases, Vol. 5, 1999, pp. 607–625. 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. 

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INTRODUCTION

recordkeeping requirements. A forthcoming study will assess the extent 

which FDA inspects domestic food facilities and identifies and addresses 

food facility violations.6

FDA’s Food Facility Registry 

As of December 2003, FDA began requiring food facilities—both foreign 

and domestic—that 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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INTRODUCTION

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 addre

fax number, and email address for the facility.

ss, 

gistry requirements. 

12 Appendix A provides 

additional information about the re

FDA requires facilities to provide complete and accurate information for 

each of the mandatory requirements outlined above. If there is a change 

in a facility’s 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 facility’s 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 facility’s 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 FDA’s 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. 

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INTRODUCTION 

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 FDA’s 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 FDA’s 

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 products—selected in consultation with FDA officials—included bottled water, ice, 

milk, eggs, yogurt, flour, oatmeal, tomatoes, leafy vegetables, and juice. 

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INTRODUCTION 

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 FDA’s 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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INTRODUCTION 

(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, FDA’s 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.” 

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FINDINGS 

 

 FINDINGS

Seven percent of selected facilities either 

failed to register or failed to cancel their 

registration with FDA, as required 

FDA requires all food facilities to 

register if they manufacture, process, 

pack, or hold food for consumption in 

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 FDA’s ability to accurately identify food facilities that may 

be linked to an outbreak of foodborne illness. 

Forty-eight percent of selected facilities 

(62 of 130) either failed to provide 

accurate information when they first 

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 facility’s 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 

Almost half of the selected facilities failed 

 to provide accurate information for 

the registry 

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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 

Facilities With 

Inaccurate 

Information in the 

Registry 

30

26

20

14

7

0

10

20

30

40

Facilities with

inaccurate

contact

information

Facilities with

inaccurate

emergency

contact phone

numbers

Facilities with

inaccurate owner

or operator

contact

information 

Facilities with

inaccurate

parent company

contact

information

Facilities with

multiple

registrations

Number of Facilities

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. 

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FINDINGS 

FDA’s 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. 

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 FDA’s 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 FDA’s 

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 

FDA’s ability to respond rapidly to an emergency. 

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FINDINGS 

Over half of the managers at the selected facilities 

were unaware of FDA’s registry requirements 

Fifty-two percent of the 

managers (67 of 130) 

reported that they were not 

aware of FDA’s 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 facility’s 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 FDA’s 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. 

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 RECOMMENDATIONS 

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 FDA’s 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 sources—such as FDA’s database 

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RECOMMENDATIONS 

of food facilities within its jurisdiction, called the Official 

Establishment Inventory—to 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 changes—to 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 company’s 

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 facility’s information. FDA should 

consider using industry Web sites and trade publications, in addition to 

its Web site and listserv, to highlight this requirement. 

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RECOMMENDATIONS 

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 facility’s 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 FDA’s comments, see Appendix B. 

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 APPENDIX~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 facility’s 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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APPENDIX~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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APPENDIX~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. 

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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: 

FROM: 

SUBJECT: 

Inspector General 

Principal Deputy Commissioner of Food and Drugs 

FDA's General Comments to OIG's draft report titled. 

FaciliZy Regis/IY (OEI-02-0B-00060) 

FDA's Food 

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 

OEI·02·08·00060 FDA's FOOD FACILITY REGISTRY 17 
 

APPENDIX ~ B 

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APPENDIX ~ B 

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APPENDIX ~ B 

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APPENDIX ~ B 

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APPENDIX ~ B 

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 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. 

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.