a

GAO

United States Government Accountability Office

Report to Congressional Requesters

October 2004 FOOD SAFETY

USDA and FDA Need 

to Better Ensure 

Prompt and Complete 

Recalls of Potentially 

Unsafe Food

GAO-05-51
www.gao.gov/cgi-bin/getrpt?GAO-05-51.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Lawrence J. 

Dyckman at (202) 512-3841 or 

dyckmanl@gao.gov. 

Highlights of GAO-05-51, a report to 

congressional requesters 

October 2004

FOOD SAFETY

USDA and FDA Need to Better Ensure 

Prompt and Complete Recalls of 

Potentially Unsafe Food 

Two large food recalls completed 

in 2003 were associated with 8 

deaths and nearly 100 serious 

illnesses in at least 16 states. 

Manufacturers voluntarily recall 

potentially unsafe food by notifying 

their customers to return or 

destroy it. The U.S. Department of 

Agriculture (USDA), for meat, 

poultry, and egg products, and the 

Food and Drug Administration 

(FDA), for other food, have 

programs to monitor voluntary 

food recalls, verify that companies 

contact their customers, and 

maintain recall data. GAO (1) 

examined the recall programs and 

procedures USDA and FDA use to 

protect consumers from unsafe 

foods and (2) compared their food 

recall authority with the authority 

of agencies to recall other 

consumer products. 

GAO proposes that Congress 

consider legislation requiring a 

company to notify USDA or FDA if 

it discovers it has distributed 

unsafe food and giving agencies 

authority to order food recalls, and 

recommends that the agencies take 

actions to ensure prompt, complete 

recalls and better recall 

monitoring. USDA said the report 

was generally accurate and its May 

2004 directive will address 

weaknesses GAO found. FDA did 

not believe its system lengthened 

recalls or its processes reduced 

recovery. FDA disagreed with some 

recommendations. GAO continues 

to believe its recommended actions 

are needed to protect consumers. 

Weaknesses in USDA’s and FDA’s food recall programs heighten the risk 

that unsafe food will remain in the food supply and ultimately be consumed. 

Specifically, USDA and FDA do not know how promptly and completely the 

recalling companies and their distributors and other customers are carrying 

out recalls, and neither agency is using its data systems to effectively track 

and manage its recall programs. For these and other reasons, most recalled 

food is not recovered and therefore may be consumed. GAO’s analysis of 

recalls in 2003 showed that about 38 percent and 36 percent of recalled food 

was ultimately recovered in recalls overseen by USDA and FDA, 

respectively. These agencies also told GAO of instances in which companies 

were slow to reveal where they had distributed the food or provided 

inaccurate customer lists. That distribution information is critical because 

USDA’s and FDA’s primary role in recalls is to monitor the effectiveness of a 

company’s recall actions. To do so, the agencies contact a sample of the 

distribution chain from these lists to verify that customers in the food 

distribution chain received notice of the recall, and that they located the 

food and removed it from the marketplace. However, the methodology that 

the agencies use for selecting the customers to check can result in entire 

segments of complex distribution chains being overlooked. Moreover, GAO 

found that the agencies did not complete verification checks for some recalls 

before the shelf life of the food expired. In addition, consumer groups and 

others question the usefulness of USDA’s and FDA’s efforts to communicate 

with the public, suggesting alternatives such as posting notices in grocery 

stores and direct notification of consumers. 

Agencies responsible for the safety of products, such as toys, heart 

pacemakers, and automobiles, have specific recall authority not available to 

USDA and FDA for food. This includes the authority to (1) require a 

company to notify the agency when it has distributed a potentially unsafe 

product, (2) order a recall, (3) establish recall requirements, and (4) impose 

monetary penalties if a company violates recall requirements. For example, 

by law, companies must promptly notify the Consumer Product Safety 

Commission after learning that a product may pose an unreasonable risk of 

serious injury or death, or face penalties of up to $1.65 million. Likewise, 

FDA has recall authority for unsafe biological products, medical devices, 

radiation emitting electronic products, and infant formula. Moreover, in 

contrast to its inability to penalize a company that is slow to conduct a food 

recall, FDA can impose penalties of up to $100,000 per day for a company 

that fails to recall a defective biological product, such as a vaccine. 
Page i GAO-05-51 Food Recall Programs

Contents

Letter 1

Results in Brief 4

Background 7

Weaknesses in USDA’s and FDA’s Recall Programs Heighten the Risk 

That Unsafe Food Will Reach Consumers 13

Other Government Agencies Have Recall Authority Not Available to 

USDA and FDA for Food That May Better Protect Consumers 25

Conclusions 30

Matters for Congressional Consideration 31

Recommendations for Executive Action 31

Agency Comments and Our Evaluation 32

Appendixes

Appendix I: Objectives, Scope, and Methodology 36

Appendix II: Federal Actions Associated with the Discovery of an Animal 

in the United States Infected with BSE 39

Beef Recall Was Triggered by a BSE-Positive Sample from

One Cow 39

Recall Begun in December 2003 Was Completed in March 2004 39

Recall Was Complicated by Inaccurate Distribution Lists and Mixing 

of Potentially Contaminated and Noncontaminated Beef 40

FDA’s Role in USDA’s Recall 44

USDA and FDA Worked Together on the Recall 45

Appendix III: Information on a 2002 Recall of Ground Beef by a ConAgra 

Plant in Greeley, Colorado 48

Appendix IV: USDA and FDA Actions on the Recommendations We Made in 

2000 50

Appendix V: Information on the 20 Food Recalls We Examined for 2003 52

Appendix VI: Recall Authority of Selected Government Agencies 54

USDA’s Food Safety and Inspection Service 54

FDA’s Center for Food Safety and Applied Nutrition 55

FDA’s Center for Biologics Evaluation and Research 56

FDA’s Center for Devices and Radiological Health 57

FDA’s Center for Drug Evaluation and Research 59

FDA’s Center for Veterinary Medicine 60

Consumer Product Safety Commission 60

Department of Transportation’s National Highway Traffic Safety 

Administration 61
Contents

Page ii GAO-05-51 Food Recall Programs

Canadian Food Inspection Agency 62

Appendix VII: Comments from the U.S. Department of Agriculture 64

GAO Comments 67

Appendix VIII: Comments from the Food and Drug Administration 70

GAO Comments 74

Appendix IX: GAO Contacts and Staff Acknowledgments 76

GAO Contacts 76

Staff Acknowledgments 76

Tables Table 1: USDA and FDA Verification Rates for 20 Selected Class I 

Recalls in 2003 21

Table 2: Recall Authority of Selected Government Agencies 27

Table 3: Detailed Timeline of USDA, FDA, and Company Actions 

Related to the Discovery of an Animal Infected with 

BSE 45

Table 4: USDA and FDA Actions on GAO’s Recommendations to 

Modify Recall Data Systems 50

Table 5: Selected Information on the 20 Class I Food Recalls We 

Examined 52

Figures Figure 1: USDA and FDA Recalls by Risk Classification, 2003 8

Figure 2: Downstream Distribution Chain May Include Multiple 

Levels of Distributors, Processors, and Retailers before 

the Food Reaches Consumers 10

Figure 3: Number of Days after Production When Recall Occurred 

and Expected Shelf Lives for Four Recalls 17

Figure 4: USDA’s Recall Verification Checks by Location and 

Customer Type for Meat Associated with the Animal 

Infected with BSE 43
Contents

Page iii GAO-05-51 Food Recall Programs

Abbreviations

BSE bovine spongiform encephalopathy

CFIA Canadian Food Inspection Agency

CPSC Consumer Product Safety Commission

FDA Food and Drug Administration

FSIS Food Safety and Inspection Service

NHTSA National Highway Traffic Safety Administration

USDA U.S. Department of Agriculture

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately.
Page 1 GAO-05-51 Food Recall Programs

United States Government Accountability Office

Washington, D.C. 20548

A

October 6, 2004 Letr

The Honorable Tom Harkin

Ranking Democratic Member

Committee on Agriculture, Nutrition, and Forestry

United States Senate

The Honorable Marcy Kaptur

Ranking Minority Member

Subcommittee on Agriculture, Rural Development, 

Food and Drug Administration, and Related Agencies

Committee on Appropriations

House of Representatives

When food companies discover that they may have distributed food that is 

contaminated with disease-causing bacteria or that contains allergens that 

can cause serious illness or death, they will usually conduct a voluntary 

recall. That is, they will contact their customers and instruct them to 

contact the wholesalers, retailers, and others in the food’s distribution 

chain and ask them to return or destroy the potentially unsafe food. Recalls 

may not always prevent serious health problems. In fact, two large recalls 

completed in 2003 were associated with foodborne illness outbreaks 

involving nearly 100 hospitalizations or serious illnesses, 8 deaths, and 3 

miscarriages in at least 16 states, according to the U.S. Department of 

Agriculture (USDA).

In recent years, the volume of food that companies recalled in the United 

States increased substantially; for meat and poultry alone, the amount 

recalled increased from nearly 6 million pounds in 1988 to about 36 million 

pounds in 2003. Concerns that contaminated food could reach consumers 

have also intensified because of the potential susceptibility of food to 

deliberate contamination. In January 2004, the President identified the U.S. 

food system as vulnerable to intentional acts of terrorism.1

Food recalls are voluntary and federal agencies responsible for food safety 

have no authority to compel companies to carry out recalls—with the 

exception of the Food and Drug Administration’s (FDA) authority to 

require a recall for infant formula. USDA provides guidance to companies 

1

Homeland Security Presidential Directive/HSPD-9, Defense of United States Agriculture 

and Food (Jan. 30, 2004).
Page 2 GAO-05-51 Food Recall Programs

for carrying out voluntary recalls of meat, poultry, and egg products and 

monitors those recalls. FDA provides guidance to companies for carrying 

out voluntary recalls of other foods and monitors those recalls.

In August 2000, we reported that while USDA and FDA believed companies 

carried out timely recalls, the two agencies did not have data to support 

their views.2

 We recommended that, among other things, USDA and FDA 

provide specific guidance to companies, including time frames for quickly 

initiating and carrying out recalls, and that the agencies maintain key 

dates—such as when the recall started, when customers in the distribution 

chain were notified, and when the recalls were completed—in their recall 

data systems to allow the agencies to assess whether companies do indeed 

carry out timely recalls.

As part of their recall programs, both USDA and FDA classify recalls on the 

basis of their severity, with Class I recalls presenting the greatest risk to 

human health. Class I recalls may involve food contaminated with diseasecausing bacteria, such as Listeria monocytogenes (listeria) and 

Escherichia coli (E. coli), or food containing ingredients not identified on 

the label (e.g., nuts or eggs) that could cause severe illness or death to 

someone allergic to that ingredient. Class II and Class III recalls involve 

foods that present little or no risk of adverse health consequences. For 

example, in FDA’s case, these foods may cause medically reversible 

adverse consequences, such as seasoned popcorn containing a color 

additive not listed on the label that can cause mild allergic reactions.

In their guidance to companies for voluntary recalls, both USDA and FDA 

have procedures for companies to notify their downstream customers—

such as processors, wholesalers, distributors, institutions, and retailers in 

the distribution chain—as well as procedures for returning or disposing of 

the food (referred to as “recovery”). 

Both USDA and FDA also have guidance for their respective field staff with 

procedures for monitoring the progress of the recall, ensuring that the 

public is notified through press releases and Web postings, carrying out 

verification checks to confirm that the company has notified its 

downstream customers, and documenting certain agency and company 

2

GAO, Food Safety: Actions Needed by USDA and FDA to Ensure That Companies 

Promptly Carry Out Recalls, GAO/RCED-00-195 (Washington, D.C.: Aug. 17, 2000).
Page 3 GAO-05-51 Food Recall Programs

recall activities in their respective recall databases—Recall Web for USDA, 

and Recall Enterprise System for FDA.

In contrast to the voluntary food recall programs at USDA and FDA, other 

agencies have authority to issue mandatory recall orders: the National 

Highway Traffic Safety Administration’s recall authority for motor vehicles; 

the Consumer Product Safety Commission’s recall authority for many 

consumer goods; and FDA’s recall authority for infant formula, biological 

products, medical devices, and radiation-emitting electronic products. At 

the time of our previous study, legislation had been introduced that would 

have given mandatory authority to USDA and FDA for food recalls. Similar 

legislation was introduced in the current Congress.3

As you requested, this report (1) examines the recall programs and 

procedures USDA and FDA use to protect consumers from unsafe foods 

and (2) compares USDA’s and FDA’s authority for food recalls with the 

recall authority of agencies responsible for the safety of other consumer 

products, such as toys, medical devices, and automobiles. In addition, 

information you requested on USDA’s and FDA’s efforts to identify and 

recall food from a cow slaughtered in Washington State that had bovine 

spongiform encephalopathy (BSE), otherwise known as mad cow disease, 

is presented in appendix II. You also requested information on a 2002 recall 

of ground beef by a ConAgra plant in Greeley, Colorado, which is presented 

in appendix III.

For the purpose of this report, the term “food” refers to food intended for 

human consumption, the term “customer” refers to any company in the 

downstream distribution chain of the company conducting the recall, and, 

with respect to recall authority, the term “order” includes the authority to 

order or to require a recall. To examine the recall programs and procedures 

USDA and FDA use to protect consumers from unsafe foods, we analyzed 

in depth 20 Class I recalls that were ongoing in fiscal year 2003—10 from 

USDA and 10 from FDA. We discussed these recalls with officials from the 

recalling companies and with the agencies’ district offices that monitored 

the recalls. These recalls represented a range of foods, contaminants, and 

geographical locations. In addition, we examined the reliability of 

3

See, for example, the SAFER Meat, Poultry, and Food Act (H.R. 3547) and the Consumer 

Food Safety Act of 2003 (H.R. 1496). In addition, legislation was introduced to provide 

USDA with authority to order recalls for food served in the school meals programs (S. 506/ 

H.R. 1551).
Page 4 GAO-05-51 Food Recall Programs

information from USDA and FDA recall data systems for that year. We also 

obtained views on USDA’s and FDA’s recall programs from representatives 

of trade and consumer organizations, such as the American Meat Institute, 

the Center for Science in the Public Interest, and the Consumer Federation 

of America. To compare USDA’s and FDA’s authority for food recalls with 

recall authority available to federal agencies responsible for the safety of 

other consumer products, we compared statutes and regulations and 

discussed these recall programs with agency officials. This report also 

provides information on, but does not evaluate, the Canadian Food 

Inspection Agency’s recall program. The Canadian agency has the authority 

to order food recalls. Appendix I discusses our objectives, scope, and 

methodology in detail. We conducted our review between May 2003 and 

August 2004 in accordance with generally accepted government auditing 

standards. 

Results in Brief Even in the context of their limited recall authority, USDA and FDA can do 

a better job in carrying out their food recall programs. Weaknesses in these 

agencies’ systems for monitoring food recalls heighten the risk that unsafe 

food will remain in the food supply and ultimately be consumed. 

Specifically: 

• USDA and FDA do not know how promptly and completely companies 

are carrying out recalls. Neither agency’s guidance provides time frames 

for companies on how quickly to initiate and carry out recalls. 

Consequently, companies may have less impetus to notify downstream 

customers and remove potentially unsafe food from the marketplace. 

Moreover, USDA and FDA are not using their data systems to effectively 

monitor and manage their recall programs. They do not track important 

dates to calculate how long companies take to carry out recalls and the 

percentage of food that is recovered. Furthermore, managers do not 

receive routine reports on the progress of ongoing recalls to target 

program resources. Finally, we found that FDA’s food recall program 

staff maintain a recall data system that is separate from FDA’s official 

recall data system. FDA uses information from this other data system to 

report to Congress because, according to program staff, the system 

maintained by the program staff contains the most accurate data. 

Moreover, the two systems do not contain consistent information, which 

brings into question the validity and reliability of FDA’s official system. 

• USDA and FDA do not promptly verify that recalls have reached all 

segments of the distribution chain, yet monitoring the effectiveness of a 
Page 5 GAO-05-51 Food Recall Programs

company’s recall actions is the agencies’ primary role in a food recall. 

For the 10 USDA recalls we examined in depth that occurred in 2003, 

USDA staff averaged 38 days to complete verification checks, and for 

the 10 FDA recalls we examined in depth, FDA staff averaged 31 days. 

These time frames exceeded the expected shelf life for some perishable 

foods that were recalled, such as fresh ground beef and fresh-cut bagged 

lettuce. Moreover, the agencies’ procedures for selecting the sample of 

companies to check do not ensure that all segments of a food 

distribution chain are included. In May 2004, USDA issued new 

procedures to its staff with time frames for completing verification 

checks—within 13 days for Class I recalls—and with a methodology 

designed to reach all segments of the distribution chain. If implemented, 

these procedures should provide reasonable assurance that recalls are 

effective.

• The procedures USDA and FDA use to alert consumers to a recall—

press releases and Web postings—may not be effective. According to 

consumer groups and others, relatively few consumers may see that 

information. They identified additional methods to notify the public, 

such as posting recall notices in grocery stores and directly notifying 

consumers using “shoppers’ club” information. 

In contrast to the limited, or lack of, authority that federal food safety 

agencies have to order food recalls, agencies responsible for the safety of 

certain other consumer products have more specific recall authority that 

may help them better protect consumers. This includes the authority to (1) 

require a company to notify the agency when it has distributed a potentially 

unsafe product, (2) order a recall, (3) establish recall requirements, and (4) 

impose monetary penalties if a company does not cooperate. For example, 

manufacturers of many consumer goods are generally required to notify the 

Consumer Product Safety Commission within 24 hours of obtaining 

information that suggests a product could create a substantial risk of injury. 

The commission has the authority to impose monetary penalties of up to 

$1.65 million if a company does not inform the commission promptly about 

an unsafe product. Likewise, FDA has authority to order recalls of unsafe 

biological products and medical devices—and it has used this authority in 

the past. Furthermore, the National Highway Traffic Safety Administration 

has used its authority to establish recall requirements to require companies 

to directly notify the purchasers of vehicles with defects and to remedy the 

defects. Finally, FDA can impose penalties of up to $100,000 per day on 

companies that do not recall unsafe biological products, such as vaccines. 
Page 6 GAO-05-51 Food Recall Programs

We are proposing that Congress consider legislation that would require 

companies to alert USDA or FDA when they discover they have distributed 

potentially unsafe food and that would give both agencies mandatory food 

recall authority. We are also recommending that USDA and FDA better 

track and manage food recalls, achieve more prompt and complete recalls, 

and determine if additional ways are needed to alert consumers about 

recalled food that they may have in their homes. 

In commenting on a draft of this report, USDA said the report was generally 

factually accurate, and the department believes that the procedures it 

adopted in late May 2004 will address most of the weaknesses we observed 

in its recall program. However, USDA disagreed with our recommendations 

regarding additional data collection and report generation. USDA believes 

that those recommendations may be a burden to the agency and industry. 

We do not believe it would be burdensome to USDA because the 

department already generally collects these data in its inspection 

paperwork but does not systematically capture them in its Recall Web 

database, which should be able to generate the management reports we 

recommend. With regard to industry, companies are already required by 

law to maintain food distribution information. Appendix VII contains 

USDA’s written comments and our detailed response. In its comments, FDA 

said we did not demonstrate that FDA recalls were lengthy because of 

system inefficiencies or that weaknesses in FDA’s recall process resulted in 

little recovery of food. FDA agreed with our recommendations regarding 

using the Recall Enterprise System to generate routine management 

reports and eliminating the duplicative recall database, but it disagreed 

with our recommendations regarding the need for specific time frames for 

companies’ actions and for recording the dates of company and agency 

actions in the Recall Enterprise System. We continue to believe that time 

frames are critical to reinforce the urgency for companies to act promptly 

to protect consumers and that tracking these dates is essential for FDA to 

effectively monitor ongoing recalls and assess actions to improve the 

timeliness of recalls. Appendix VIII contains FDA’s written comments and 

our detailed response.
Page 7 GAO-05-51 Food Recall Programs

Background Food companies, USDA, and FDA may discover that unsafe food has been 

distributed from customer complaints, routine facility investigations, 

product testing by the company or a federal or state government agency, or 

an outbreak of a foodborne illness. Depending on the food, USDA (for 

meat, poultry, and egg products) or FDA (for all other food), would 

generally monitor the recall.4

USDA and FDA classify recalls by the potential health risk that the food 

poses, as follows: 

• Class I: Recalls of food that poses a reasonable probability of causing 

serious, adverse health consequences or death, such as foods that 

contain listeria, salmonella, or E. coli O157:H7, or undeclared allergens 

such as peanuts and eggs.5

• Class II: For USDA, recalls of food that poses a remote probability of 

adverse health consequences, and, for FDA, recalls of food that presents 

a remote probability of serious adverse health consequences or may 

cause temporary or medically reversible adverse health consequences.

• Class III: For USDA, recalls of food that will not cause adverse health 

consequences. (For example, meat or poultry that contains added water 

not disclosed on the label, which USDA regulation prohibits.) For FDA, 

recalls of food not likely to cause adverse health consequences. (For 

example, food that contains mold or insects, which FDA regards as 

unfit, although the food is unlikely to pose adverse health 

consequences.)

The number of food recalls has generally increased over the past decade, 

with a record high of more than 500 in 2002.6

 In addition, for fiscal year 

2003, most recalls were Class I—for food that poses the greatest risk of 

illness or death. As figure 1 shows, Class I recalls accounted for 51 (66 

4

The Department of Defense may also coordinate recall responsibilities with respect to 

foods purchased to feed military personnel and their families.

5

USDA classifications are in the Food Safety and Inspection Service Directive 8080.1, 

Revision 4. FDA recall classifications are provided in 21 C.F.R. § 7.3(m)(2004).

6

The number of food recalls each year has ranged from 260 to 519 over the past decade, with 

an average of 335 recalls a year for that period.
Page 8 GAO-05-51 Food Recall Programs

percent) of the 77 food recalls for USDA in 2003 and 160 (54 percent) of the 

296 recalls for FDA in that year.

Figure 1: USDA and FDA Recalls by Risk Classification, 2003

USDA and FDA generally monitor a food recall when the recalling company 

alerts the agency or when the agency learns about a problem from, for 

example, routine facility inspections or product tests. Typically, recalls are 

monitored by the agencies’ district office responsible for the geographic 

area where the recalling company is located. District office inspectors 

obtain preliminary information from the company, such as the reason for 

the recall, the amount of food to be recalled, and the food’s labeling and 

packaging. For USDA, a recall committee comprised of headquarters and 

district recall staff assign the risk classification, and, for FDA, the districts 

assign a preliminary risk classification. 

Class III

(35)

Class II

(101)

Class I

(160)

Class III

(14)

Class II

(12)

Class I

(51)

12%

34% 54%

18%

16%

66%

Source: GAO analysis based on USDA and FDA recall data.

Food that poses a reasonable probability of causing serious illness or death

Food that will not cause serious adverse health consequences or that may

cause temporary or medically reversible adverse health consequences

USDA (77 recalls) FDA (296 recalls)
Page 9 GAO-05-51 Food Recall Programs

Both USDA and FDA rely on press releases and Web site postings to alert 

consumers about recalls, although there is no law requiring them to 

provide such notification. USDA’s Food Safety and Inspection Service will 

generally issue press releases for Class I and Class II recalls and post 

information on its recall Web site: 

http://www.fsis.usda.gov/fsis_recalls/index.asp. USDA’s press releases 

describe the product, including any identifying marks or codes; the reason 

for the recall; and the risk involved with consuming the product. The press 

releases also instruct consumers on what to do with any product in their 

possession and provide a name and telephone number of a company 

contact for questions.

For FDA recalls, the recalling company generally issues a press release for 

Class I recalls. FDA guidance recommends that the press release be issued 

promptly, and if the company fails to issue the press release, FDA may do 

so. FDA posts these press releases on its recalls Web site: 

http://www.fda.gov/opacom/7alerts.html, along with recalls for the other 

products that it regulates. FDA provides companies with model language 

for press releases for several different causes of Class I recalls (e.g., 

allergens, E. coli O157:H7, or salmonella), which covers, in general, the 

same information found in USDA’s press releases. In addition, USDA and 

FDA food recalls are also posted on a governmentwide recall Web site: 

http://www.recalls.gov, which is managed by the Consumer Product Safety 

Commission.

In addition, under both USDA and FDA guidelines, a recalling company is 

to alert its customers to the recall and provide them with instructions for 

recovery—return or disposal—of the food. This first level of customers—

referred to as primary—can be any number and combination of processors, 

distributors, retailers, or other customers and may also include direct-toconsumer sales. For example, some frozen food companies distribute their 

products by direct delivery to individual homes. The recalling company is 

to ask its primary customers to pass the alert to subsequent customers in 

the distribution chain (referred to as secondary and tertiary), when they 

have further distributed or sold the food. As figure 2 shows, the entire 

distribution chain can include multiple levels of downstream processors, 

distributors, and retailers before the food reaches consumers.
Page 10 GAO-05-51 Food Recall Programs

Figure 2: Downstream Distribution Chain May Include Multiple Levels of Distributors, Processors, and Retailers before the Food 

Reaches Consumers

Consumer Consumer

Consumer

D

R

C

C C

P

D

R

C

P

D

R

C

P

D

R

C

P

Processor

Distributor

Consumer

Retailer

Processor

Distributor

Processor

Recalling

company

Secondary customers

Tertiary customers

Primary customers

D = Distributor

R = Retailer

C = Consumer

P = Processor

Source: GAO.

Retailer

SALE

Retailer

Distributor
Page 11 GAO-05-51 Food Recall Programs

USDA’s and FDA’s primary role is to monitor the effectiveness of a 

company’s recall actions by verifying that customers in the food 

distribution chain receive notice of the recall, and that the food is located 

and removed from the marketplace. To carry out their verification checks, 

USDA and FDA contact a percentage of the company’s customers to 

determine whether the recall was carried out—specifically, that the 

customers were provided with recall information, and that they followed 

instructions for returning or destroying the food.7

 In addition, several states 

have agreements with USDA and FDA to coordinate verification 

responsibilities for companies in their states. States are to report the 

results of the verification checks to the monitoring agency. USDA and FDA 

may also request that recalling companies periodically submit status 

reports on their progress, including the number of customers contacted 

and the amount of the food recovered or otherwise accounted for. USDA 

and FDA inspectors should be consulted prior to the destruction of the 

food, and they may request that the company allow them to witness the 

final disposition of the food.8

Both USDA and FDA consider a recall completed when their district 

officials finish verification checks and determine that the company has 

made all reasonable efforts to recall the food. The agencies are to notify 

recalling companies in writing that no further action is necessary. At this 

point, the agencies put summary information into their respective data 

systems.

The report we issued in August 2000 provided information on several 

aspects of USDA’s and FDA’s voluntary recall programs. It was intended to 

assist congressional consideration of then-pending legislative proposals to 

give mandatory recall authority to USDA and FDA. Although such 

legislation has not been enacted, USDA and FDA do have authority to 

detain, seize through the courts, and condemn foods as part of their overall 

responsibility for food safety. Specifically:

• The Federal Meat Inspection Act, the Poultry Products Inspection Act, 

and the Egg Products Inspection Act give USDA authority to detain 

7

USDA refers to its verification checks as “effectiveness checks,” whereas FDA refers to 

them as “audit checks.”

8

Disposition of a recalled product may include actions such as relabeling, reworking (e.g., 

further cooking to sell as food or rendering to sell as fertilizer or animal feed), or destroying 

the food (e.g., disposing of food in a landfill).
Page 12 GAO-05-51 Food Recall Programs

meat, poultry, and egg products for up to 20 days when it has reason to 

believe the food is adulterated or misbranded. These acts give USDA 

authority, through the courts, to seize, condemn, and destroy unsafe 

food. USDA also may withdraw meat and poultry inspectors from 

slaughtering and processing facilities or withhold or remove the USDA 

“inspected and passed” label—both measures that require the 

production line to be shut down—if the sanitary conditions at the 

company’s facility cause food to become unsafe.

• The Federal Food, Drug, and Cosmetic Act gives FDA authority, through 

the courts, to seize, condemn, and destroy adulterated or misbranded 

food not exclusively regulated by USDA. The act also gives FDA 

authority to disseminate information about foods that are believed to 

present a danger to public health. In addition, the Public Health Security 

and Bioterrorism Preparedness and Response Act of 20029

 (commonly 

referred to as the Bioterrorism Act), authorizes FDA to detain food for 

up to 30 days without a court order, if the agency has evidence 

indicating that the food presents a threat of serious adverse health 

consequences or death to humans or animals. FDA issued its final rule 

for administrative detention on June 4, 2004.10

9

Pub. L. No. 107-188, 116 Stat. 594(2002).

10Administrative Detention of Food, 69 Fed. Reg. 31660 (June 4, 2004)(to be codified at 21 

C.F.R. §§ 1.377 et seq.).
Page 13 GAO-05-51 Food Recall Programs

The Bioterrorism Act also authorizes FDA to establish record-keeping 

requirements for companies involved in the food industry (except farms 

and restaurants) so that FDA will be better able to identify companies 

involved in the food distribution chain—that is, the immediate previous 

sources and subsequent recipients of food. In this way, the act attempts to 

address, if necessary, “credible threats of serious adverse health 

consequences or death to humans or animals.”11 As of August 2004, FDA 

had not issued final regulations to implement these record-keeping 

requirements, and the agency told us it has not determined the applicability 

of the act to food recalls.12 

Weaknesses in USDA’s 

and FDA’s Recall 

Programs Heighten the 

Risk That Unsafe Food 

Will Reach Consumers

Even recognizing the limitations in their recall authority, federal agencies 

could still better protect consumers from unsafe foods if they addressed 

weaknesses we identified in their monitoring of companies’ recalls. 

Specifically, USDA and FDA have not set time frames to encourage 

companies to act promptly, and, because the agencies do not track 

important dates and recovery rates in their recall data systems, they do not 

know how promptly and completely companies are carrying out recalls. 

Furthermore, the agencies’ procedures for conducting verification checks 

do not ensure that agency staff promptly verify that recalls have reached all 

segments of the distribution chain. Finally, consumer groups have raised 

questions about the effectiveness of the agencies’ public notification 

efforts. 

USDA and FDA Do Not 

Know How Promptly and 

Completely Companies 

Carry Out Recalls

In November 2003, FDA issued new recall guidance to companies, and, in 

May 2004, USDA also issued new guidance. However, neither agency 

included time frames for companies to initiate and carry out recalls of food 

that involve potentially serious adverse health risks, nor procedures for the 

1121 U.S.C. § 350c(b).

12In the preamble of the proposed regulations, FDA stated that it intends to make this 

process as simple as possible for both domestic and foreign facilities. FDA has proposed 

that covered entities would be required to maintain specific information in their files, but 

the form or type of records maintenance system would not be specified. The proposed 

regulations would, if finalized, require companies to provide FDA with information within 

specified time frames about the immediate previous source and subsequent recipient of all 

food. See Establishment and Maintenance of Records Under the Public Health Security and 

Bioterrorism Preparedness and Response Act of 2002, 68 Fed. Reg. 25188 (proposed May 9, 

2003)(to be codified at 21 C.F.R. §§ 1.326 et seq.).
Page 14 GAO-05-51 Food Recall Programs

companies to notify their distribution chains and alert the public. Without 

specific guidance on time frames, companies may have less impetus to 

promptly notify downstream customers and retrieve potentially unsafe 

food from the marketplace. Of particular concern are perishable foods that 

are sold and consumed within a few days. In our 2000 report, we 

recommended that the agencies include time frames to ensure that 

companies would initiate and carry out recalls without delay. Appendix IV 

provides information on the actions USDA and FDA have taken on the 

other recommendations we made to them in 2000.

Moreover, we found that, although USDA and FDA have developed new 

data systems since our 2000 report, the agencies are not using the systems 

to effectively monitor and manage their recall programs. The agencies do 

not track some critical data for assessing the timeliness and effectiveness 

of recalls. For example, USDA does not track when a company learns that 

it needs to initiate a recall or when it provides complete distribution lists. 

In addition, neither USDA nor FDA tracks when the company begins and 

finishes notifying its customers or when the agency begins and finishes its 

verification checks. Without tracking these data, the agencies do not have 

the information they need to assess how quickly the company and the 

agency have acted. Even when the agencies collect data, they do not use 

the information to generate routine reports that would help their managers 

track the progress of recalls that are ongoing or assess the effectiveness of 

their recall programs’ activities. Such reports are a key prerequisite to 

effective management of resources, as emphasized in the Government 

Performance and Results Act of 1993.13

13Pub. L. No. 103-62, 107 Stat. 285(1993).
Page 15 GAO-05-51 Food Recall Programs

We found, for example, that while both agencies record the information for 

calculating the recovery rate, they do not calculate the recovery rate for 

recalls. As a result, they did not know how much food was actually 

recovered, although both agencies told us recovery was an important 

indicator of a successful recall. Using the information in USDA’s Recall Web 

database, we calculated that the total recovery rate has generally declined 

since 1988 for recalls monitored by USDA.14 We could not similarly analyze 

recovery rates for FDA-monitored recalls for multiple years because the 

agency has not recorded recovery information in its database in a way that 

allowed us to do the calculation. That is, FDA uses inconsistent units, such 

as cases, cans, boxes, or bags of food, which prevented us from calculating 

annual recall volume. However, we calculated the average recovery rate for 

about one-half of FDA recalls in 2003 for which the agency used the same 

unit for both “quantity distributed” and “quantity recovered.”15 We found 

that companies’ recovery rates for FDA-regulated food was about 36 

percent. In a similar analysis of USDA recalls, about 38 percent of food was 

recovered.

USDA has a low expectation of recovering much food with a short shelf 

life, such as fresh meat, which moves quickly through the distribution 

chain. USDA said that the drop in its recovery rates may also be due, in 

part, to the significant number of recalls related to its E. coli O157:H7 

testing programs, which started around 1994.16 Test results take several 

days. That is, because of the delay in getting the test results, meat that 

tested positive for E. coli O157:H7 may have already been distributed, sold, 

and consumed—thus reducing the amount that may be recovered. Some 

companies told us that, to avoid recalls related to positive E. coli O157:H7 

tests taken by USDA, they have begun holding meat from distribution until 

test results are back. Another reason for low recovery rates is that USDA is 

14We calculated the total recovery rate by dividing the total pounds recovered by the total 

pounds recalled in each year. The first complete year that USDA recorded pounds recovered 

was 1988.

15To calculate the average fiscal year 2003 recovery rate, we averaged rates for individual 

recalls. For FDA, we included in our analysis 86 of the 153 recalls started in 2003 that had 

been completed by the end of February 2004 and for which FDA recorded the same unit in 

the fields for “quantity distributed” and the “quantity recovered/number of units corrected.” 

For the remaining recalls, FDA was missing data in one or both fields, or the fields had 

different units. For USDA, we were able to include in our analysis 75 of the 77 fiscal year 

2003 recalls, because USDA recorded both the quantity distributed and the quantity 

recovered in pounds.

16E. coli O157:H7 is a virulent strain of E. coli bacteria.
Page 16 GAO-05-51 Food Recall Programs

using epidemiological evidence, such as outbreaks of foodborne illnesses 

that are traced back to the food, as a basis for requesting that companies 

conduct a recall. Because traceback can be slow, recalls linked to illness 

outbreaks may have low recovery rates. 

Recovering perishable foods is particularly challenging because they may 

be subject to recall after the product’s shelf life has passed. As USDA 

pointed out, it is unlikely that much food will be recovered in these recalls. 

Figure 3 illustrates the timeline for 4 of the 20 recalls that we examined in 

depth. Of these 4 recalls, the recall for canned soup began well before the 

end of the food’s shelf life, the recall for packaged turkey sandwiches near 

the end, and the recalls for fresh-cut bagged lettuce and ground beef well 

after the recommended shelf life of the product. USDA recall officials 

pointed out that consumers could have frozen the meat or poultry, so that 

some of those products could still have been in consumers’ homes. FDA 

also pointed out that the fresh-cut bagged lettuce may have deteriorated in 

quality, but may still have been edible after its shelf life expired.
Page 17 GAO-05-51 Food Recall Programs

Figure 3: Number of Days after Production When Recall Occurred and Expected 

Shelf Lives for Four Recalls

Note: The recall of canned soup began during the soup’s shelf life. The recall of ground beef began 

after the shelf life because of the time it took to identify the source of the contamination following an 

illness outbreak. The recall of packaged turkey sandwiches began near the end of the sandwiches’ 

shelf life because the turkey used in the sandwiches was part of an expanded recall conducted by 

another company. The recall of fresh-cut bagged lettuce began after the shelf life of the lettuce 

because the food tested positive for listeria after it already had reached store shelves, and the test 

results were slow to reach the agency and the company.

We relied primarily on the agencies’ documents for our analysis. We cannot 

say with confidence that FDA’s Recall Enterprise System accurately depicts 

actions taken. At the end of our review, we learned that FDA’s Center for 

Food Safety and Applied Nutrition continues to maintain a separate food 

recall data system and uses that system—not the official Recall Enterprise 

System—to report recall information to Congress. According to center 

program staff, FDA uses information from this unofficial data system to 

report to Congress because the center’s system contains the most accurate 

data. FDA invested more than $3 million to implement the Recall 

Enterprise System, which was designed to be a valid and reliable 

0 5 10 15 20 25 30 35 40 45 50 365 730

Canned soup

(shelf life 2 years)

Packaged

turkey sandwich

(shelf life 21-25

days)

Fresh-cut

bagged lettuce

(shelf life 14-16 days)

Ground beef

(shelf life 9 days)

Foods and usable shelf life

Days after production

First day of 

production

79 days

21 days

29 days

38 days

Lettuce

Recall began well after the food's shelf life expectancy.

Recall began well before the food's shelf life expectancy.

Recall began near the end of the food's shelf life expectancy.

Source: GAO analysis based on USDA and FDA data.

Number of days from the day of production to the end

of a usable shelf life.
Page 18 GAO-05-51 Food Recall Programs

automated system for capturing information about recalls across FDA’s five 

centers. The system is accessible to FDA staff in both headquarters and 

district offices. In addition to this substantial investment and the 

duplication of effort for maintaining two separate data systems, the 

existence of a second recall data system raises several other concerns:

• The unofficial database reflects a substantial difference in the number 

of recalls over the period we examined. For example, the unofficial 

database included 296 food recalls for 2003, while the Recall Enterprise 

System shows only 207. Some of the difference can be explained 

because recall counts from the unofficial system are based on the year 

that FDA assigns a risk classification—typically at the end of the 

recall—whereas our analysis of Recall Enterprise System data used the 

year the recall began. FDA was not able to provide us with enough 

information on the recalls to resolve the differences.

• Data in the two systems were not consistent for individual recalls. For 

example, the start date and classification date for some recalls did not 

agree.

• Some fields, such as the date the company completed its recall actions, 

are in both the Recall Enterprise System and the unofficial system. This 

is one of the critical dates we recommended in our 2000 report that the 

agency should track. However, we found that this date was not entered 

into the Recall Enterprise System for a significant number of recalls—

about 20 percent of recalls in 2003.

These problems raise significant questions about the validity and reliability 

of the official Recall Enterprise System. 

USDA and FDA Do Not 

Promptly Verify That 

Recalls Reach All Segments 

of the Distribution Chain

Neither USDA nor FDA acted promptly to carry out verification checks or 

used a sound methodology for selecting the sample of a company’s 

downstream distribution chain for verification. As a result, the agencies 

could overlook entire segments of a food’s distribution chain, as they did in 

many of the recalls we examined in detail.

For the 10 USDA recalls from 2003 that we examined in detail, USDA did 

not have guidance in place with time frames for when agency staff should 

finish verifying that a company had completed its recall. In addition, USDA 

does not collect in its data system information on when agency staff begin 

and finish verification checks. Therefore, we could not calculate how long 
Page 19 GAO-05-51 Food Recall Programs

USDA took to verify all recalls for the period we reviewed. However, for the 

USDA recalls, we calculated that district staff took an average of 38 days to 

verify whether the recalling company’s customers were aware of the recall. 

That length of time exceeds the shelf life of fresh meat and poultry. 

Furthermore, it delays the agencies’ ability to identify problems with the 

recall and request corrective actions before consumers eat the recalled 

food.

USDA revised its guidance to its staff in May 2004 and included a risk-based 

goal for verification activities that considers the class of the recall.17 

Specifically:

• For Class I recalls, district offices should begin verification to determine 

whether a company carried out the recall within 3 days of the start of 

the recall and should substantially complete the verification within 10 

days thereafter.18

• For Class II recalls, verification should begin within 5 days and be 

completed within 12 days.

• For Class III recalls, verification should begin within 10 days and be 

completed within 17 days.

In contrast, FDA had guidance for beginning and finishing its verification 

checks during the recalls we reviewed. The total process is to take 20 days: 

that is, checks are to begin within 10 days of the company’s starting a recall 

and be completed no more than 10 days after checks begin.19 Because FDA, 

like USDA, does not collect information on when agency staff begin and 

finish verification checks in its Recall Enterprise System, we could not 

assess the extent to which FDA met its time frame for all recalls in 2003. 

However, we were able to make that determination for the 10 recalls we 

examined in depth. We found that FDA did not conduct verification checks 

17USDA Food Safety and Inspection Service Directive 8080.1, Revision 4, Attachment 3, May 

24, 2004.

18Had the goal for the Class I recalls been in place during 2003, USDA would have met it for 

1 of the 10 recalls that we examined for which USDA conducted checks.

19FDA’s guidance to its staff is provided in chapter 7 of its Regulatory Procedures Manual, 

March 2004 edition, effective May 6, 2004 

(http://www.fda.gov/ora/compliance_ref/rpm/default.htm). Additional industry guidance is 

also provided in regulation (21 C.F.R. §§ 7.40-7.59).
Page 20 GAO-05-51 Food Recall Programs

for 4 of those recalls. For the remaining 6 recalls, we calculated that district 

staff took an average of 31 days to complete the checks—with 3 recalls 

taking more than the targeted number of days.

In conducting their verification checks, USDA and FDA told us that they 

can be hindered in their efforts to initiate verification checks when 

companies delay in providing their distribution lists or provide imprecise 

lists. According to FDA, if every customer in a distribution chain takes 2 

days to provide its list, even with a short distribution chain, this could add 2 

weeks to the verification process. In a May 2003 proposed rulemaking 

under the Bioterrorism Act, FDA stated that the amount of time it would 

take FDA to determine where a food is located “may be increased if the 

[distribution] records are incomplete and FDA has to wait for missing 

records to be retrieved. This possible delay would be a substantial concern 

if FDA were attempting to remove [unsafe] food that presents a threat of 

serious adverse health consequences or death....”20

We also found that the agencies have not been using sound methodologies 

for selecting the sample of companies in the distribution chain for 

verification. As part of their recall activities, USDA and FDA decided on 

what percentage of the recalling company’s primary and secondary 

customers they would contact to determine whether the customers were 

aware of the recall and had removed the food from the marketplace 

according to the recalling company’s instructions. If the downstream 

customers they checked were aware and had removed the food, USDA and 

FDA generally considered the food recall effective. 

Both USDA’s and FDA’s recall procedures include methodologies for 

conducting verification checks. Although USDA revised its procedures in 

May 2004, the practice that was in effect during the recalls we reviewed 

was for district staff to contact at least 20 percent of primary customers 

and 10 percent of secondary customers. We found that the districts’ 

understanding, and therefore implementation, of that practice varied, with 

some districts saying that, for example, they were to check 10 percent of 

primary customers and others saying they were to check 20 percent. As 

table 1 shows, for the 10 Class I recalls we examined, USDA checked 

between 14 and 100 percent of primary customers.

2068 Fed. Reg. 25188, see footnote 12.
Page 21 GAO-05-51 Food Recall Programs

The procedures that FDA used are based on regulations that specify five 

different verification levels—0, 2, 10, between 10 and 100, or 100 percent.21 

However, the regulations and FDA’s procedures do not specify when to use 

different levels of verification. FDA officials told us that district staff would 

generally not do any checks when they believe the food is no longer on 

store shelves or when the company can demonstrate that it is doing the 

verification checks. Agency recall officials said that they select a level 

depending on the size of the distribution chain and the risk associated with 

the recalled product. As table 1 shows, for the 10 FDA Class I recalls we 

examined in detail, FDA checked from 0 to 100 percent of primary 

customers. In 4 recalls, FDA determined that no verification checks were 

needed. Appendix V provides USDA’s and FDA’s recall identification 

numbers for the 20 recalls we examined.

Table 1: USDA and FDA Verification Rates for 20 Selected Class I Recalls in 2003

2121 C.F.R. § 7.42(b)(3)(i)-(v)(2004).

Agency Food Reason for recall

Primary customers

Number

checked

Total

number

Percentage of

total

USDA Fresh ground beef E. coli 7 15 47

Chicken frankfurters Listeria 9 24 38

Ground beef E. coli 4 12 33

Fully cooked frozen chicken Hard piece of plastica 8 14 57

Fresh and frozen ground beef E. coli 51 84 61

Fresh and frozen ground beef E. coli 18 30 60

Frozen ground beef E. coli 41 129 32

Fresh and frozen ready-to-eat 

turkey and chicken

Listeria 103 757 14

Fresh and frozen ready-to-eat 

turkey and chicken

Listeria 47 144 33

Canned soup Cheeseb 1 1 100
Page 22 GAO-05-51 Food Recall Programs

Source: GAO summary of USDA and FDA data and documents.

a

The hard piece of plastic was considered to be foreign material.

b

The presence of a potential allergen (cheese, milk, peanuts, or eggs) was not declared on the food’s 

ingredient label.

c

FDA did not conduct checks because the recalling company recovered 100 percent of the distributed 

oregano.

d

FDA did not conduct checks because the bagged salad was 2 weeks past its expiration date, and it 

concluded that the salad was not likely to be available on store shelves.

e

FDA did not conduct checks because the recalling company documented that it visited each of its 

customers and recovered sandwiches.

f

FDA did not conduct checks because the recalling company used a third-party vendor to contact 100 

percent of the primary customers, and the company faxed timely status reports to update the agency.

USDA and FDA were limited in their ability to reasonably ensure that 

recalls were effective because their methodologies did not take into 

account the complexities of downstream distribution chains. In the recalls 

we examined, USDA and FDA generally obtained the recalling company’s 

primary distribution lists and then checked a percentage of the customers 

on those lists. The agencies then obtained customer lists only from the 

primary customers that they checked, which enabled them to identify 

secondary customers associated with the primary customers that they 

checked. Because the agencies did not usually check all primary 

customers, they were not aware of all secondary customers. As a result, the 

agencies may have overlooked whole segments of a distribution chain with 

their verification checks. That is, even when the agencies conducted the 

recommended percentage of verification checks, they may not have 

conducted enough checks across the distribution chain to be able to 

determine whether the recall was effective. 

FDA Crab cakes Milkb 22 34 65

Ice cream Peanutsb 1 1 100

Salted herring Botulinum spores 2 8 25

Oregano Salmonella 0 11 0c

Fresh-cut bagged lettuce Listeria 0 79 0d

Packaged turkey sandwiches Listeria 0 2,700 0e

Alfalfa sprouts Salmonella 14 25 56

Smoked salmon Listeria 12 107 11

Packaged breakfast pastry Eggb 0 341 0f

Chocolate milk Excessive amounts of 

vitamins A and D

4 53 8

(Continued From Previous Page)

Agency Food Reason for recall

Primary customers

Number

checked

Total

number

Percentage of

total
Page 23 GAO-05-51 Food Recall Programs

Moreover, USDA’s Office of Inspector General issued a report in June 2004 

that was critical of USDA’s verification process.22 That report 

recommended that USDA’s Food Safety and Inspection Service document 

its recall effectiveness determinations, implement controls to ensure the 

data are valid, and conduct future effectiveness checks in a timely and 

methodologically sound manner.

In the future, however, USDA’s verification checks may help the agency 

better ascertain whether a recall was effective because USDA adopted new 

verification guidance in May 2004. If properly implemented, this guidance 

will provide greater assurance that downstream customers are aware of a 

recall and have followed the recalling company’s instructions for removing 

the food from the marketplace. USDA’s new guidance provides a statistical, 

risk-based method that considers the class of recall, any illnesses 

associated with the food, and the number of customers in the distribution 

chain. Specifically, the guidance sets standards for the (1) number of 

checks to conduct, (2) method for sampling which customers to check, (3) 

method for conducting the checks (e.g., on-site visits or telephone calls), 

and (4) critical number of verification checks, finding that customers were 

not aware of the recall, beyond which USDA determines that the recall 

process was inadequate and warrants further action by the recalling 

company. In addition, the guidance provides time frames for completing 

these checks. 

For example, for a Class I recall with associated illnesses and a distribution 

chain that included 1,000 customers, USDA would select 200 customers by 

checking every fifth customer and consider the recall ineffective if it found 

any customers that were not notified of the recall or that still had food that 

could reach consumers. USDA also would begin checks within 3 days of 

the recall’s start and finish checks within 10 days thereafter. USDA’s new 

approach is similar to the one that the Canadian Food Inspection Agency 

has used since 2001. 

FDA’s verification approach also does not ensure that a reasonable number 

of downstream customers are aware of a recall and have taken the 

appropriate action. While FDA’s policy is to determine the percentage of 

downstream customers to contact on the basis of the size and the risk 

22U.S. Department of Agriculture, Office of Inspector General, Food Safety and Inspection 

Service: Effectiveness Checks for the 2002 Pilgrim’s Pride Recall, Report No. 24601-03-Hy 

(June 2004).
Page 24 GAO-05-51 Food Recall Programs

associated with the recall, we found that the agency lacks methods for 

consistently determining which level of checks—the percentage of the 

downstream customers—to use in verifying a given recall. FDA’s 

verification approach also lacks other features of a risk-based 

methodology, such as considering whether illnesses have resulted from the 

unsafe food or criteria for whether to consider the recall ineffective.

Agencies and Consumer 

Groups Differ in Their 

Views on the Effectiveness 

of Public Notification

More than 200 Class I food recalls occurred in 2003, but the procedures 

USDA and FDA use to alert consumers to a recall—press releases and Web 

postings—may not be effective. Both USDA and FDA rely on press releases 

as their main tool to alert consumers to the dangers of recalled foods. Both 

agencies also make recall press releases available on their Web sites as a 

service to consumers; the media; and other interested parties, such as state 

and local health officials. 

Views on the usefulness of the agencies’ efforts to communicate with the 

public differ, according to the officials and organizations we interviewed. 

For example, a California State health official expressed concerns that the 

frequency of recall press releases can overwhelm the public. Nevertheless, 

the official thought that press releases from a government entity are given 

more weight by consumers and the media than press releases issued by 

individual food companies; hence, that USDA-issued press releases may 

have greater impact than company-issued press releases (for FDAregulated foods).

Public interest groups presented a different view. According to the Center 

for Science in the Public Interest and the Consumer Federation of America, 

most press releases are not useful to consumers because the releases lack 

the specificity, such as store locations, that consumers need to help them 

determine whether they purchased the food that is being recalled. 

According to these officials, if industry and government want consumers to 

avoid eating a recalled food, information about the recall should be 

prominently displayed in the grocery stores that sold the food. We 

identified some stores that voluntarily provide additional information to 

help consumers, including a membership warehouse that uses member 

information from its “shoppers’ club” to directly contact its customers who 

purchased a recalled food.
Page 25 GAO-05-51 Food Recall Programs

According to USDA and FDA officials, the agencies generally do not have 

the authority to publicly name the retail stores that are selling a recalled 

food because the information is considered confidential business 

information. For example, USDA provided a distribution list of the recalled 

beef products to the California Department of Health Services during the 

December 2003 recall of beef potentially contaminated with BSE.23 

Although California could use the list to help its inspectors ensure that the 

meat was removed from store shelves, the state had to agree not to publicly 

identify the stores and restaurants where the recalled beef was sold. USDA 

and FDA officials told us that they plan to look into additional options to 

help consumers identify recalled foods in their homes.

Even if the agencies could disclose store locations, consumers may still not 

be able to identify the recalled food. As USDA pointed out, consumers may 

have difficulty identifying a recalled food because packaging may change at 

different points in the distribution chain, especially for such foods as 

ground beef, which may be mixed with other meat or further processed 

into prepared foods such as frozen lasagna, canned ravioli, or ready-to-eat 

sandwiches. In such instances, recalling companies may not know how 

their downstream customers have processed or distributed these foods.

Other Government 

Agencies Have Recall 

Authority Not Available 

to USDA and FDA for 

Food That May Better 

Protect Consumers

Government agencies that regulate the safety of other products, such as 

toys and automobile tires, have recall authority not available to USDA and 

FDA for food and have had to use their authority to ensure that recalls were 

conducted when companies did not cooperate. These recall authorities 

may facilitate faster recalls and better protect consumers. 

Agencies that have recall authority for other products include the 

following:

23According to USDA, distribution lists obtained from a firm recalling a meat or poultry 

product are considered proprietary information protected from public disclosure. However, 

a USDA regulation authorizes limited disclosure, under certain conditions, to states and 

other federal government agencies to verify removal of a recalled food. 9 C.F.R. § 

390.9(2004).
Page 26 GAO-05-51 Food Recall Programs

• FDA, for infant formula, human biological products, medical devices 

and radiation-emitting electronic products, human drugs, animal drugs, 

and medicated animal feeds;24

• the Consumer Product Safety Commission, for many consumer goods; 

and

• the Department of Transportation’s National Highway Traffic Safety 

Administration, for motor vehicles, motor vehicle equipment, child 

safety seats, and tires.

In addition, the Canadian Food Inspection Agency has recall authority for 

foods sold in Canada.25

Table 2 compares USDA’s and FDA’s food recall authority with the authority 

of agencies responsible for recall programs of other products we 

examined, and appendix VI provides additional information for the 

programs we examined.

24Some human biological products are approved for use through “new drug” applications 

and are treated as human drugs for recall purposes. Likewise, some human drugs are 

licensed under the same procedures as human biological products and are treated as human 

biological products for recall purposes.

25In April 1997, regulatory responsibility for food safety in Canada was consolidated into a 

single agency, the Canadian Food Inspection Agency.
Page 27 GAO-05-51 Food Recall Programs

Table 2: Recall Authority of Selected Government Agencies

Source: GAO analysis of applicable laws and regulations.

a

For the purposes of this report, we define a “mandatory recall order” to include the requirement to 

remove, repair, replace, or refund the cost of a defective or unsafe product.

b

Not applicable because no recall requirements exist.

c

FDA’s recall authority for licensed biological products is found in section 351(d) of the Public Health 

Service Act (42 U.S.C. § 262(d)) and has not been elaborated on in implementing regulations.

d

FDA’s authority to assess civil monetary penalties depends on the nature of the device violation. For 

example, penalties are authorized only for significant or intentional failures to file required reports. 21 

U.S.C. § 333(g)(1).

e

The Consumer Product Safety Commission’s jurisdiction does not cover tobacco, motor vehicles and 

related equipment, pesticides, firearms, aircraft, boats, food, drugs, medical devices, or cosmetics. 15 

U.S.C. § 2052(a)(1) (definition of “consumer product”).

Agency Products covered

Requirement to notify the 

agency when a company 

identifies a potentially 

unsafe product

Authority to 

issue a 

mandatory recall 

ordera

Authority to 

establish recall 

requirements or 

approve recall 

plans

Authority to 

impose monetary 

penalties or seek 

fines or 

imprisonment

USDA

Meat, poultry, egg 

products

No No No b

FDA

Foods not exclusively 

regulated by USDA

No No No b

Infant formula Yes Yes Yes Yes

Human biological 

products

Yes Yes Yesc Yes

Medical devices, 

radiation-emitting 

electronic products

Yes Yes Yes Yesd

Human drugs Yes No No Yes

Animal feed No No No b

Animal drugs, medicated 

feeds 

Yes No No Yes

Consumer 

Product Safety 

Commission

Consumer goodse Yes Yes Yesf Yes

National Highway 

Traffic Safety 

Administration

Motor vehicles, motor 

vehicle equipment, child 

safety seats, tires

Yes Yes Yesg Yes

Canadian Food 

Inspection 

Agency

Food No Yes Yesh Yes
Page 28 GAO-05-51 Food Recall Programs

f

While the manufacturer, retailer, or distributor may choose to repair, replace, or refund the cost of the 

defective product, the Consumer Product Safety Commission may require submission of a plan 

“satisfactory to the Commission, for taking action....” 15 U.S.C. § 2064(d).

g

While the manufacturer may repair, replace, or refund the cost of defective products, the National 

Highway Traffic Safety Administration may order a manufacturer to take a specific action if the 

manufacturer’s remedy is determined to be inadequate. 49 U.S.C. § 30120(e).

h

The applicable Canadian statute is general and there are no implementing regulations. This 

information is largely based on our discussions with Canadian officials.

As table 2 shows, in contrast to USDA and FDA, the other agencies we 

examined, and FDA with regard to some products, have authority to order 

recalls and to be notified about unsafe products. Specifically, they have 

authority to (1) require a company to notify the agency when it has 

distributed a potentially unsafe product; (2) order a recall; (3) establish 

recall requirements; and (4) impose monetary penalties, or seek fines or 

imprisonment, if a company violates the recall requirements. These 

authorities are discussed below:

• Requirement that a company notify the agency when the company 

identifies a potentially unsafe product. Companies manufacturing or 

selling products regulated by some of the agencies we reviewed are 

subject to stringent notification requirements. For example, companies 

that manufacture consumer products, such as toys or appliances, must 

notify the Consumer Product Safety Commission immediately, generally 

within 24 hours of obtaining information that reasonably supports the 

conclusion that a product could create an unreasonable risk of serious 

injury or death, such as a toy that poses a choking danger to children. 

Also, if a manufacturer of infant formula has information indicating that 

the formula it processed does not contain the required nutrients or is 

otherwise adulterated, the manufacturer must promptly notify FDA.
Page 29 GAO-05-51 Food Recall Programs

• Authority to order a company to conduct a recall if the company 

refuses to do so voluntarily. Several agencies can order a company to 

conduct a recall if the company refuses to do so voluntarily. For 

example, the Canadian Food Inspection Agency, after determining that 

there are reasonable grounds to believe that a product poses a risk to 

public health, can order anyone selling, marketing, or distributing the 

food to conduct a recall. The Canadian agency rarely has had to use its 

recall authority. Agency officials told us that, as of April 2004, the agency 

had used its mandatory authority for eight recalls since 1997. For the 

period of 1997 through 2003, the agency reported that Canadian 

companies had conducted 1,890 recalls.26 Likewise, FDA has authority 

to order recalls of unsafe biological products and medical devices and 

has used this authority in the past.

• Authority to establish recall requirements or approve recall plans, 

including direct notification to consumers. Some agencies we 

reviewed have authority to establish recall requirements, such as 

requiring direct notification to consumers or prescribing a recall plan if 

voluntary efforts are insufficient. For example, the National Highway 

Traffic Safety Administration may require companies to speed up a 

recall or renotify owners, purchasers, and dealers in a manner 

prescribed in regulation if it determines that the initial notice was not 

effective. FDA has authority to review the terms of a company’s recall 

plan for recalls of medical devices to ensure that the way the company 

proposes to fix the problem sufficiently addresses the risk. If FDA 

determines that the company’s recall plan is insufficient, FDA can 

prescribe a recall plan that may include repairing the device, replacing 

it, or refunding its cost. Also, if FDA determines that a device recall is 

warranted, it must specify a timetable for the recall and require periodic 

reports. In addition, for infant formula, a recalling firm must submit to 

FDA in writing an evaluation of the hazard, a recall strategy, and all 

recall communications. 

• Authority to impose monetary penalties or seek fines or 

imprisonment if a company violates recall requirements. Most 

agencies we examined have the authority to impose civil monetary 

penalties or seek fines or imprisonment when companies either refuse 

to conduct recalls or fail to follow recall requirements. For example, 

26These recall counts are for the Canadian fiscal years 1997-98 through 2002-03. The 

Canadian fiscal year runs from April 1 through March 31.
Page 30 GAO-05-51 Food Recall Programs

failure to obey an FDA order to recall a biological product that poses an 

imminent hazard to public health could result in monetary penalties of 

$100,000 or more. Similarly, the Consumer Product Safety Commission 

can impose monetary penalties of $7,000 for each product violation, up 

to $1.65 million for related violations, if a company fails to notify the 

commission promptly, in accordance with the applicable law and 

regulations. 

Officials in FDA, the Consumer Product Safety Commission, and the 

National Highway Traffic Safety Administration, as well as Canadian 

officials, told us that companies generally cooperate in recalls. 

Nonetheless, the agencies have had to use the additional authority in some 

instances to ensure that recalls are conducted promptly and completely.

USDA and FDA officials told us that while they believe companies 

generally cooperate with food recalls, they recognize that in some 

instances, recalls can be particularly challenging. For example, when the 

food company has gone out of business or when the company is located 

overseas. 

Conclusions USDA and FDA are responsible for ensuring the safety of the food supply. 

While we recognize that they have limited recall authority, we believe the 

agencies can do better in carrying out their food recall programs. 

Consumers may be vulnerable to serious illness, hospitalization, and even 

death, in part, because of weaknesses in USDA’s and FDA’s programs for 

monitoring companies’ recalls of unsafe food. Although no single weakness 

may be directly linked to serious health consequences in the recalls we 

examined, these weaknesses may have contributed to the lengthy recall of 

unsafe food and, consequently, to relatively little recovery of the food.

USDA and FDA could address these weaknesses—lack of time frames for 

company actions, ineffective use of their data systems to monitor and 

manage recalls, a verification system that does not ensure the timeliness 

and completeness of a recall, and potentially ineffective consumer 

notification—by modifying their existing programs. Indeed, with its new 

risk-based, scientific verification procedures, USDA has taken positive 

steps to improve its verification processes—the agencies’ primary method 

for ensuring an effective recall. FDA continues to rely on a flawed process.

We are also concerned about the quality of data in FDA’s Recall Enterprise 

System—its official recall data system. FDA continues to maintain 
Page 31 GAO-05-51 Food Recall Programs

information about food recalls in its unofficial data system. The two 

systems do not contain the same information, which raises questions about 

the validity and reliability of the official system and reports FDA issued to 

Congress. Moreover, FDA’s investment in developing the Recall Enterprise 

System will not be entirely realized until the agency fully implements it as 

the sole system for collecting and managing recall data.

We believe that addressing the problems we have identified could raise the 

likelihood that recalled food will be removed from the marketplace more 

promptly and completely. However, these corrective steps, while necessary, 

will still leave fundamental vulnerabilities because the agencies lack 

specific recall authority available to other agencies with consumer safety 

responsibilities. Although we did not identify any instances in which 

companies refused to carry out a food recall, such refusal is possible, as 

Canada’s experience has indicated. As in Canada, USDA and FDA may not 

need this authority for most recalls, but if enacted, it would be available 

when needed.

Matters for 

Congressional 

Consideration

To ensure that USDA and FDA have information and authority so they can 

act quickly to remove potentially unsafe food from the marketplace and 

can better protect consumers, we propose that Congress consider 

legislation that would 

• require a company to notify the responsible agency when it becomes 

aware that a food it has distributed is unsafe and 

• give USDA and FDA authority to (1) issue a mandatory recall order, (2) 

establish recall requirements, and (3) impose monetary penalties or 

seek fines or imprisonment for failing to follow food recall 

requirements.

Recommendations for 

Executive Action

To ensure that companies promptly and effectively recall foods that may 

cause serious illness or death, we are making the following five 

recommendations to the Secretary of Agriculture and the Commissioner of 

FDA: 

• revise agency guidance to recalling companies to include specific time 

frames for notifying their customers, removing recalled food from the 
Page 32 GAO-05-51 Food Recall Programs

marketplace, and providing the agencies with the names and locations 

of customers that received the food;

• use agency data systems to routinely generate reports for recall program 

managers so that they may monitor ongoing recalls and oversee recall 

timeliness and effectiveness; 

• track in their recall data systems the dates that companies (1) start and 

finish notifying their customers, (2) provide the agency with the lists of 

customers that received the food, and (3) start and finish recovering the 

recalled food;

• track in their data systems the dates that the agencies start and finish 

verification checks; and

• work jointly to determine what, if any, additional approaches are needed 

for alerting consumers about recalls.

We also make the following four recommendations to the Commissioner of 

FDA: 

• revise guidance to agency staff to include risk-based time frames for 

completing verification checks promptly;

• develop a sound methodology for district staff to verify that companies 

have quickly and effectively carried out recalls; 

• when tracking the amount of food recalled and recovered for individual 

recalls, use the same units of measure to facilitate calculations of the 

recovery rate; and 

• direct the recall staff to use FDA’s Recall Enterprise System as the sole 

data system to capture recall information, manage food recalls, and 

generate reports to Congress.

Agency Comments and 

Our Evaluation

We provided USDA and FDA with a draft of this report for review and 

comment. We also provided segments of the draft describing their 

respective recall authority and rules to the Consumer Product Safety 

Commission, the National Highway Traffic Safety Administration, and the 

Canadian Food Inspection Agency. 
Page 33 GAO-05-51 Food Recall Programs

USDA stated that the report was generally factually correct. However, it 

characterized as “alarmist” the report’s statement that “Consumers may be 

vulnerable to serious illness, hospitalization, and even death because of 

weaknesses in USDA’s and FDA’s programs for monitoring companies’ 

recalls of unsafe food.” We recognize that the cause of the illnesses, 

hospitalizations, and deaths was contaminated food not the agencies’ 

programs. However, because the public is relying on USDA and FDA to 

protect consumers from potentially unsafe food, it is important that the 

agencies’ recall programs be as effective as possible. As our report points 

out, two large recalls in 2003 were associated with nearly 100 

hospitalizations or serious illnesses and 8 deaths. Both of those recalls, 

monitored by USDA, were expanded to more and more customers and, 

therefore, it took some time to locate and recover the food. USDA’s 

Inspector General reported that during one of the two recalls, USDA’s field 

staff took longer than 4 months to complete their verification checks. The 

Inspector General’s report concluded that the department did not identify 

and correct problems with the recall to maximize recovery and take 

enforcement actions—potentially exposing consumers to unsafe meat. 

USDA further said that it believes the new procedures adopted on May 24, 

2004, will address most of the observed weaknesses we found in its food 

recall program. As our report discusses, the new procedures do provide a 

statistical, risk-based method that will provide greater assurance that 

downstream customers are aware of recalls and that they have followed 

instructions for removing food from the marketplace, and the procedures 

include time frames for USDA to complete its verification checks. While 

the new procedures should improve USDA’s verification of recalls, it is 

premature to tell whether they will address any other weaknesses we found 

in USDA’s recall program. Thus we continue to believe that our 

recommendations—for (1) time frames for recalling companies’ actions—

to encourage prompt recalls—and companies’ disclosure of the locations 

where they sent the food, (2) using routinely generated management 

reports from the official recall data system, (3) tracking critical dates, or 

(4) working with FDA on how best to alert consumers about recalls of food 

that can cause serious illnesses—are needed to further strengthen the 

safety of the food supply by providing for a more effective food recall 

system. Finally, USDA said the report implies that the Consumer Product 

Safety Commission’s and the National Highway Traffic Safety 

Administration’s recall authorities and procedures offer better protection 

to consumers but does not discuss how long those agencies work with 

companies before they announce recalls. We did not independently 

evaluate the effectiveness of the other agencies’ recall programs nor did we 

imply that they were faster or better. Our point in discussing those 
Page 34 GAO-05-51 Food Recall Programs

programs is to show that they (1) have additional recall authority not 

available to USDA and FDA for food and (2) have had to use their recall 

authority. We also note that USDA has supported, as recently as late 2000, 

proposed legislation that would have given the department the additional 

recall authority that those other agencies have at their disposal, if and 

when they need it.

FDA stated that our report did not demonstrate that FDA recalls were 

lengthy because of system inefficiencies or that weaknesses in FDA’s recall 

process resulted in little recovery of food. We believe our report accurately 

presents the current recall system’s performance. The report describes 

significant inefficiencies and weaknesses in FDA’s verification process that 

resulted in delays in identifying and correcting problems in the recalls we 

examined. For example, in 3 of the 10 recalls we examined, FDA took 

longer than its 20-day target for completion of verification checks. In 

addition, FDA noted that, “companies are encouraged to initiate action as 

soon as possible and strongly encouraged to issue press releases within 24 

hours of deciding to recall a product.” FDA further stated that its 

expectation of a recalling firm is immediate notification, timely removal, 

and timely disposal. While such statements are appropriate, we did not find 

that they were effective. Furthermore, FDA asserts that we did not present 

evidence to support our point that information in its unofficial recall 

database is inaccurate. Our concern is twofold. First, maintaining two 

separate recall databases is an inefficient use of resources, especially when 

FDA cited resource limitations as a factor for not yet incorporating routine 

management reports in its Recall Enterprise System. Second, since we 

identified inconsistencies in the information in the two systems, the 

validity and reliability of the official system is in question. FDA agreed with 

our recommendations regarding using the Recall Enterprise System to 

generate routine management reports and eliminating the duplicative recall 

database. However, it disagreed with our recommendation regarding the 

need for specific time frames for companies’ actions and noted that it 

would be difficult to specify such time frames. We believe time frames are 

critical to reinforce the urgency with which companies need to act, 

particularly for Class I recalls where even 1 day’s delay can result in 

additional serious health consequences. Also, FDA sees limited utility in 

our recommendations for recording the dates of company and agency 

actions in its Recall Enterprise System. We continue to maintain that these 

dates are essential for FDA to effectively monitor ongoing recalls and 

assess actions to improve the timeliness of recalls. 
Page 35 GAO-05-51 Food Recall Programs

USDA’s written comments and our more detailed responses to them are in 

appendix VII. FDA’s written comments and our responses are in appendix 

VIII. In addition, USDA, FDA, the Consumer Product Safety Commission, 

the National Highway Traffic Safety Administration, and the Canadian 

Food Inspection Agency provided technical comments, which we 

incorporated into the report as appropriate.

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from its 

issuance. At that time, we will send copies of this report to interested 

congressional committees, the Secretary of Agriculture, the Commissioner 

of Food and Drugs, and other interested parties. We will make copies 

available to others upon request. In addition, the report will be available at 

no charge on GAO’s Web site at http://www.gao.gov.

If you or your staff have any questions about this report, please call me at 

(202) 512-3841. Key contributors to this report are listed in appendix IX.

Lawrence J. Dyckman

Director, Natural Resources and Environment
Page 36 GAO-05-51 Food Recall Programs

Appendix I

Objectives, Scope, and Methodology ApApenednxidexiIs

This report (1) examines the extent to which the U.S. Department of 

Agriculture’s (USDA) and the Food and Drug Administration’s (FDA) recall 

programs protect consumers from unsafe foods and (2) compares USDA’s 

and FDA’s authority to conduct food recalls with the recall authority of 

agencies responsible for the safety of other consumer products, such as 

toys, medical devices, and automobiles. This report also provides 

information on USDA’s and FDA’s efforts to identify and recall foods 

associated with the December 2003 cow infected with bovine spongiform 

encephalopathy (BSE), otherwise known as mad cow disease, found in 

Washington State (see app. II) and information on a 2002 recall of ground 

beef by a ConAgra plant in Greeley, Colorado (see app. III).

To determine the extent to which USDA and FDA recall programs have 

adequately protected consumers from unsafe foods, we studied the 

agencies’ recall procedures and analyzed in depth agency actions during 20 

recent recalls—10 from USDA and 10 from FDA. The 20 we selected were 

ongoing in fiscal year 2003 and were Class I recalls—that is, those with the 

potential to cause serious illness or death. We systematically selected 

recalls in order to cover (1) a wide range of food products, (2) different 

types of contaminants, and (3) geographical locations. Priority was given to 

large recalls of foods that were widely distributed. However, recalls were 

not randomly selected and therefore are not statistically representative of 

all food recalls conducted in fiscal year 2003. In reviewing these 20 recalls, 

we examined USDA and FDA documents, including verification records, 

and interviewed company and agency officials responsible for monitoring 

them. In addition, we obtained USDA and FDA aggregate recall data for 

2003 and examined the reliability of information in those systems. We also 

analyzed data from USDA’s recall database and relied on FDA to extract 

similar data from its recall data systems. We obtained the computerized 

files for these recalls and summarized the Class I recalls by year. 

Additionally, we interviewed USDA and FDA district and headquarters 

officials responsible for maintaining their recall data systems to determine 

how they collect recall information and add it to their data systems.

To understand whether consumers are adequately informed of food recalls 

and to get perspectives on measures that could affect the timeliness and 

effectiveness of recalls, we interviewed representatives from the food 

industry; trade associations; and consumer advocacy groups, including 

Costco, the American Meat Institute, the Center for Science in the Public 

Interest, and the Consumer Federation of America. To determine the 

amount of product recovered per year for USDA, we relied on agency data 

to compare the pounds of product distributed with the pounds of product 
Appendix I

Objectives, Scope, and Methodology

Page 37 GAO-05-51 Food Recall Programs

recovered. To calculate the amount of product recovered for FDA in 2003, 

we compared the database fields for “product distributed” and “product 

recovered” for those recalls with identical units in the database fields.

To compare USDA’s and FDA’s authority to conduct food recalls with the 

recall authority of agencies responsible for the safety of other consumer 

products, such as toys, medical devices, and automobiles, we reviewed and 

compared FDA’s and other agencies’ statutes and regulations. We identified 

the agencies that have mandatory recall authority by conducting literature 

and Internet searches and by asking officials at USDA and FDA. We also 

reviewed the transcript of proceedings from the December 12, 2002, USDA 

public meeting “Food Safety and Inspection Service Public Meeting—

Improving the Recall Process.” We selected the following agencies and 

products, which account for a substantial share of major consumer goods:

• FDA, for infant formula, human biological products, medical devices 

and radiation-emitting electronic devices, human drugs, animal feed, 

animal drugs, and medicated feeds;

• Consumer Product Safety Commission, for many consumer goods; and

• Department of Transportation’s National Highway Traffic Safety 

Administration, for motor vehicles, motor vehicle equipment, child 

safety seats, and tires.

In addition, we included the Canadian Food Inspection Agency, which has 

regulatory responsibility, including mandatory recall authority, for food 

sold in Canada. We did not include the following agencies because they 

have a narrower scope: the U.S. Coast Guard, for boats, boating equipment, 

and floatation devices; the Environmental Protection Agency, for pesticides 

and emission control devices; and the Department of Housing and Urban 

Development, for manufactured housing. 

To conduct our comparison, we first focused on USDA’s and FDA’s 

authority to detain and seize unsafe food and then reviewed laws 

authorizing other agencies to require companies to take specific recall 

actions. We also examined the laws requiring manufacturers and other 

companies to notify the appropriate agency when they become aware of 

unsafe products. To gain insight on how different authorities are applied in 

practice, we interviewed agency officials, using a standard set of questions, 

from USDA’s Food Safety Inspection Service; FDA’s Centers for Food 

Safety and Applied Nutrition, Biologics Evaluation and Research, Devices 
Appendix I

Objectives, Scope, and Methodology

Page 38 GAO-05-51 Food Recall Programs

and Radiological Health, Drug Evaluation and Research, and Veterinary 

Medicine; the Consumer Product Safety Commission; the National 

Highway Traffic Safety Administration; and the Canadian Food Inspection 

Agency. We compared the results of the legal review and interviews to 

identify authority and related legal requirements of other agencies helpful 

in the administration of recalls that are not available to USDA and FDA for 

food recalls. 

To examine the voluntary recall of beef products associated with the 

December 2003 discovery of an animal infected with BSE, we analyzed the 

distribution lists USDA collected from companies and the verification 

checks it conducted to develop a diagram illustrating the location and 

volume of recalled beef that reached different levels of the distribution 

chain. We compared the distribution lists and verification checks to 

identify how many customers listed on the distribution lists did not receive 

the recalled beef and the number of customers not listed on distribution 

lists that received the recalled beef. We interviewed USDA and FDA staff 

involved with the recall to understand the timing of recall actions and the 

challenges encountered during the recall.

To develop information on the 2002 recall of ground beef by a ConAgra 

plant in Greeley, Colorado, we reviewed USDA’s recall file and other 

documents on the recall. We also met with the department’s Office of 

Inspector General and reviewed the Inspector General’s September 2003 

report.1

We conducted our review from May 2003 through August 2004 in 

accordance with generally accepted government auditing standards.

1

U.S. Department of Agriculture, Office of Inspector General, Great Plains Region Audit 

Report: Food Safety and Inspection Service: Oversight of Production Process and Recall at 

ConAgra Plant (Establishment 969), Report No. 24601-2-KC (September 2003).
Page 39 GAO-05-51 Food Recall Programs

Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE ApendxiI

On December 23, 2003, USDA announced that a cow in the state of 

Washington had tested positive for BSE—commonly referred to as mad 

cow disease. This appendix describes the actions USDA took to recall the 

meat and the actions FDA took with respect to FDA-regulated products, 

such as animal feed and cosmetics, made from rendered parts of the 

animal.

Beef Recall Was 

Triggered by a BSEPositive Sample from 

One Cow

On December 9, 2003, the recalling company slaughtered 23 cows. USDA, 

in accordance with its BSE surveillance policy at the time, took a sample of 

1 cow that was unable to walk, although the condition of the tested cow is 

now disputed. USDA did not process the sample in its Ames, Iowa National 

Veterinary Services Laboratory in an expedited manner because the cow 

did not show symptoms of neurological disorder. USDA test results 

indicated a presumptive positive for BSE on December 23, 2003.

Recall Begun in 

December 2003 Was 

Completed in March 

2004

On December 23, 2003, after learning about the positive BSE test, USDA 

headquarters notified the Boulder District Office, which is the field office 

with jurisdiction over the recalling firm. The Boulder District began 

gathering information about the recalling company’s product distribution. 

Field staff telephoned the recalling company and were on-site at 7:00 p.m. 

The Boulder District initially thought 3 days of the recalling company’s 

production would have to be recalled, but further examination of facility 

cleanup and shipping records revealed that it was only necessary to recall 1 

day of production. USDA recall staff convened at 9:15 p.m. and discussed 

the science related to BSE and whether the recalling company’s cleanup 

practices were sufficient to limit the recall to 1 day of production. 

Following USDA’s determination to conduct a Class II recall—that is, the 

beef posed a remote possibility of adverse health consequences—USDA 

contacted the recalling company to discuss recall details and the press 

release. The press release and Recall Notification Report were released 

that evening.

On December 24, 2003, USDA’s Food Safety and Inspection Service (FSIS) 

sent inspectors to the recalling company’s primary customers to obtain 

secondary customer distribution lists and product shipping records. USDA 

conducted 100 percent verification checks for this recall—it contacted 

every customer that received the recalled meat. This level of verification 

checks is well above the percentage of checks conducted by USDA district 

offices for the Class I recalls we reviewed. 
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 40 GAO-05-51 Food Recall Programs

On December 26, 2003, USDA began checking the primary and secondary 

customers of the recalling company that it was aware of, although the 

entire product distribution chain was unknown. During the checks, USDA 

tried to determine if the product was further distributed, and it used 

verification checks to acquire distribution lists for secondary and tertiary 

customers of the recalling company. 

Verification checks continued until February 25, 2004. Three USDA 

districts conducted these verification checks. The Boulder District 

coordinated the checks and assigned checks to the Minneapolis District 

Office for customers in Montana and to the Alameda District Office for 

customers in California. USDA required that 100 percent of the primary 

checks, 50 percent of the secondary checks, and 20 percent of the tertiary 

checks be conducted on-site. According to USDA, more than 50 percent of 

the secondary checks were actually conducted on-site. FDA officials 

helped conduct verification checks. According to USDA, the recall took a 

long time to complete because USDA contacted each customer at least 

twice. USDA first contacted each customer to conduct the check and again 

to verify product disposition.

On February 25, 2004, the Boulder District concluded that the recall was 

conducted in an effective manner. On March 1, 2004, USDA’s Recall 

Management Division recommended that the agency terminate the recall, 

and USDA sent a letter to the recalling company to document that USDA 

considered the recall to be complete.

Recall Was 

Complicated by 

Inaccurate Distribution 

Lists and Mixing of 

Potentially 

Contaminated and 

Noncontaminated Beef 

USDA used distribution lists and shipping records to piece together where 

the recalled product was distributed. According to USDA, one of the 

recalling company’s three primary customers was slow in providing its 

customer list. USDA could not begin verification activities for that primary 

customer without this list. Furthermore, some customers of the recalling 

company provided USDA with imprecise lists that did not specify which 

customers received the recalled product. As a consequence, USDA could 

not quickly determine the scope of product distribution and had to take 

time conducting extra research using shipping invoices to determine which 

specific customers received the product. 

Even when USDA determined the amount and location of beef, the agency 

still had trouble tracking the beef in certain types of establishments, such 

as grocery store distributors. USDA could not easily track the individual 

stores where those distributors sent the beef because of product mixing 
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 41 GAO-05-51 Food Recall Programs

and the distributors’ record-keeping practices. Generally, distributors 

purchase beef from multiple sources, mix it in their inventory, and lose 

track of the source of the beef they send to the stores that they supply. To 

deal with this problem, USDA first identified the dates when recalled beef 

was shipped to the distributors and then asked for a list of the stores that 

were shipped any beef after those dates. Consequently, some stores were 

included in the recall that may never have received recalled beef.

The recall was also complicated by repeated mixing of recalled beef with 

nonrecalled beef, thereby increasing the amount of meat involved in the 

recall. The recalling company slaughtered 23 cows on December 9, 2003, 

and shipped those and 20 other carcasses to a primary customer on 

December 10, 2003. The recalling company’s carcasses were tagged to 

identify the slaughter date and the individual cow. The primary customer 

removed the identification tags and mixed the 23 recalled carcasses with 

the 20 nonrecalled carcasses. Because the carcasses could not be 

distinguished, the recall included all 43 carcasses at the primary customer. 

After one round of processing at the primary customer, the meat from the 

carcasses was shipped to two other processing facilities. Both 

establishments further mixed the recalled meat from the 43 carcasses with 

meat from other sources. In all, the mixing of beef from 1 BSE-positive cow 

resulted in over 500 customers receiving potentially contaminated beef.

Imprecise distribution lists and the mixing of recalled beef combined to 

complicate USDA’s identification of where the product went. Specifically, 

on December 23, 2003, USDA’s initial press release stated that the recalling 

company was located in Washington State. Three days later, on December 

26, 2003, USDA announced that the recalled beef was distributed within 

Washington and Oregon. On December 27, 2003, USDA determined that one 

of the primary customers of the recalling firm distributed beef to facilities 

in California and Nevada, in addition to Washington and Oregon, for a total 

of four states. On December 28, 2003, USDA announced that some of the 

secondary customers of the recalling company may also have distributed 

the product to Alaska, Montana, Hawaii, Idaho, and Guam, for a total of 

eight states and one territory.

On January 6, 2004, over 2 weeks from recall initiation, USDA determined 

that the beef went to only six states—Washington, Oregon, California, 

Nevada, Idaho, and Montana—and that no beef went to Alaska, Hawaii, or 

Guam. To reach that conclusion, USDA used the distribution lists, shipping 

records, and sales invoices that it received from companies to piece 

together exactly where the recalled beef may have been sent. The lists 
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 42 GAO-05-51 Food Recall Programs

showed that 713 customers may have received the recalled beef; 6 of those 

may have received beef from more than one source. USDA determined that 

176 customers on the lists did not actually receive recalled beef, including 

the customers in Guam and Hawaii. USDA’s review also indicated that 

recalled beef was probably not shipped to Alaska or Utah, and USDA 

checked 2 retailers in Alaska and 3 retailers in Utah to confirm that was the 

case. In total, USDA conducted verification checks on 537 of the 713 

customers on the lists. USDA’s initial checks identified an additional 45 

customers that may have received the recalled beef that were not included 

on the distribution lists, for a total of 582 verification checks. Figure 4 

summarizes USDA’s verification efforts during the recall.
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 43 GAO-05-51 Food Recall Programs

Figure 4: USDA’s Recall Verification Checks by Location and Customer Type for Meat Associated with the Animal Infected with 

BSE

Note: USDA checked 15 primary, 40 secondary, and 526 tertiary customers plus the recalling 

company, for a total of 582 verification checks.

USDA’s press release stated that the recall involved 10,410 pounds of beef 

products, and the USDA recall coordinator for this recall told us that 

downstream processors mixed the recalled beef with nonrecalled beef, for 

a total of more than 38,000 pounds of beef that was distributed at the 

secondary customer level. According to USDA officials involved with the 

D = Distributor

R = Retailer

SF = Storage facility

P = Processor

Primary customers

(15 total)

Recalling

slaughterhouse

(WA) 1 R

(OR)

1 P

(WA) 1 P

(OR)

1 P

(OR)

11 R

(WA)

Secondary customers

(40 total)

Tertiary customers

(526 total)

1 R

(OR)

1 SF

(OR)

3 D

(OR)

3 D

(WA)

2 dual D

(OR)

59 R

(OR)

79 R

(WA)

5 R

(ID)

3 R

(UT)

4 R

(MT)

161 R

(WA)

8 R

(ID)

15 R

(OR) 2 R

(AK)

31 R

(OR) 8 R

(WA) 10 R

(NV)

5 R

(ID)

10 R

(CA)

2 R

(CA)

17 R

(OR)

5 R

(WA)

1 D

(NV)

11 R

(CA)

85 R

(NV)

3 D

(OR) 11 R

(OR)

2 D

(CA) 26 R

(CA)

2 R

(WA)

( ) Acronyms in parentheses are postal abbreviations for each state.

Source: GAO analysis of USDA verification check documents.
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 44 GAO-05-51 Food Recall Programs

recall, the precise amount of meat that was sold at the retail level is 

unknown because retailers at the tertiary level further mixed nonrecalled 

meat with potentially contaminated meat. USDA told us that more than 

64,000 pounds of beef was ultimately returned or destroyed by customers, 

and that, because of the mixing, it was not able to determine how much of 

the original 10,410 pounds of recalled beef was contained in the 64,000 

pounds that were recovered.

FDA’s Role in USDA’s 

Recall

Parts of the BSE-infected animal slaughtered on December 9, 2003, were 

not used for food, but they were sent to renderers to be separated into raw 

materials, such as proteins and blood. Rendered materials are used for 

many purposes, including cosmetics and vaccines. FDA has jurisdiction 

over renderers. 

When USDA learned of the BSE-infected cow on December 23, 2003, the 

agency immediately notified FDA. On December 24, 2003, FDA sent an 

inspection team to a renderer that handled materials from the BSE cow. 

Inspectors confirmed that the parts of the slaughtered BSE positive cow 

were on the premises. FDA later identified a second company that 

potentially rendered material from the slaughtered BSE cow. Both 

renderers agreed to voluntarily hold all product processed from the 

diseased cow and dispose of the product as directed by FDA and local 

authorities.

On January 7, 2004, 15 containers of potentially contaminated, rendered 

material (meat and bone meal) were inadvertently loaded on a ship, and on 

January 8, 2004, the ship left Seattle, Washington, for Asia. The renderer 

initiated steps to recover the shipped material, so it could be disposed of as 

directed by FDA and local authorities. The ship carrying the material 

returned to the United States on February 24, 2004, and the material was 

disposed of in a landfill on March 2, 2004.

On January 12, 2004, FDA asked both renderers to expand their voluntary 

holds to rendered materials processed from December 23, 2003, through 

January 9, 2004, because they may have rendered some recalled meat or 

trim that was recovered from retail establishments. Both renderers agreed 

to the expanded product hold. In total, FDA requested that renderers 

voluntarily hold approximately 2,000 tons of rendered material. FDA 

confirmed that none of the potentially contaminated, rendered material 

entered commerce, because FDA accounted for all rendered material. FDA 
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 45 GAO-05-51 Food Recall Programs

reported that no recall was necessary because no product was distributed 

commercially by the rendering companies.

USDA and FDA 

Worked Together on 

the Recall

USDA and FDA worked together in two ways. First, both agencies notified 

each other if their investigations yielded any information about products 

within the jurisdiction of the other agency. For instance, when conducting 

the second round of verification checks, USDA tracked the disposition of 

the product to renderers and landfills and notified FDA when the product 

went to renderers. Second, FDA officials helped conduct verification 

checks. FDA conducted 32 of the 582 verification checks (approximately 5 

percent) for the USDA recall. Officials from both agencies indicated they 

regularly interacted and shared information. Table 3 outlines the agencies’ 

actions.

Table 3: Detailed Timeline of USDA, FDA, and Company Actions Related to the Discovery of an Animal Infected with BSE

Date USDA recall actions FDA actions Company actions

12/9/03 • USDA samples cow for BSE. • BSE cow is slaughtered.

12/11/03 • Sample is sent to Ames, Iowa, for BSE 

testing.

• Recalling company sends 

carcasses to primary customer for 

processing.

12/12/03 • Primary customer sends meat 

products to two other primary 

customers for further processing.

12/12 -

12/23/03

• Other primary customers distribute 

recalled product to secondary 

customers.

• Secondary customers distribute 

recalled product to tertiary 

customers.

12/23/03 • BSE test results are presumptively 

positive.

• Recall meeting.

• Initiation of voluntary recall.

• Press release.

• FDA notified of BSE test results.

• FDA dispatches investigation teams.

12/24/03 • FDA inspects Renderer 1.

• FDA determines some rendered 

material from Renderer 1 is intended 

for Indonesia.

• FDA discovers some material may 

have been sent to Renderer 2.

• Renderer 1 agrees to hold remaining 

rendered material.

• Recalling company contacts 

primary customers.

• Primary customers contact their 

customers.
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 46 GAO-05-51 Food Recall Programs

12/25/03 • USDA receives confirmation from 

reference lab in England that cow in 

question is BSE positive.

12/26/03 • Verification checks begin

• USDA announces recalled product in 

Washington State and Oregon.

• FDA begins process of comparing 

records to ensure all products from 

Renderers 1 and 2 are accounted for.

• Renderer 2 agrees to hold all material 

that may have been derived from 

BSE cow. None of the rendered 

material has been distributed.

12/27/03 • USDA announces recalled product was 

distributed in Washington State, 

Oregon, California, and Nevada.

• FDA issues statement confirming that 

the rendering plants that processed 

all of the nonedible material from the 

BSE cow have placed a voluntary 

hold on all of the potentially infectious 

product, none of which had left the 

control of the companies and entered 

commercial distribution.

12/28/03 • USDA announces recalled product was 

distributed in Washington State, 

Oregon, California, Nevada, Montana, 

Idaho, Alaska, Hawaii, and Guam.

12/29/03 • Food Safety and Inspection Service 

determines that the recalled meat 

products were distributed to 42 

locations, with 80 percent of the 

products distributed to stores in 

Oregon and Washington State. 

12/31/03 • FDA offers assistance to USDA to 

complete recall verification checks.

1/6/04 • USDA determines recalled product 

was only distributed in Washington 

State, Oregon, California, Nevada, 

Montana, and Idaho.

1/8/04 • FDA is notified by the renderer that 

some of the rendered material on 

hold from Renderer 1 was 

inadvertently shipped to Asia. 

Renderer 1 commits to isolate and 

return the rendered material.

• Rendering company notifies FDA of 

shipment of product on hold.

(Continued From Previous Page)

Date USDA recall actions FDA actions Company actions
Appendix II

Federal Actions Associated with the 

Discovery of an Animal in the United States 

Infected with BSE 

Page 47 GAO-05-51 Food Recall Programs

Source: GAO analysis of USDA and FDA information.

1/12/04 • FDA advises Renderers 1 and 2 that 

they may have rendered meat or trim 

subject to recall from retail stores.

• FDA requests Renderers 1 and 2 to 

place all rendered material from 

December 23 to January 9 on hold.

• FDA determines neither renderer had 

shipped rendered material 

manufactured after December 23, 

2003.

2/9/04 • All rendered material was disposed of 

in landfill, except material shipped to 

Asia.

2/24/04 • Ship carrying rendered material 

returns to U.S. port.

2/25/04 • Verification checks complete.

• USDA Boulder District Office 

concludes recall is effective.

3/1/04 • Recall is closed.

3/2/04 • FDA observes disposal in landfill of 

remaining rendered material.

(Continued From Previous Page)

Date USDA recall actions FDA actions Company actions
Page 48 GAO-05-51 Food Recall Programs

Appendix III

Information on a 2002 Recall of Ground Beef 

by a ConAgra Plant in Greeley, Colorado ApendxiI

This appendix provides general information about the recall of 18 million 

pounds of ground beef and beef products because of possible 

contamination with E. coli O157:H7 by the ConAgra Beef Company 

(ConAgra) plant in Greeley, Colorado, beginning in June 2002. USDA’s 

Office of Inspector General evaluated the effectiveness of the department’s 

management and oversight of the recall, issuing a report in September 

2003.1

 As a result, we did not independently analyze the department’s 

actions during this recall.

Beginning in June 2002, at least 46 people in 16 states became ill from 

contaminated meat. An epidemiological investigation by the Colorado 

Department of Public Health and Environment and the Centers for Disease 

Control and Prevention, confirmed that about 23 of those illnesses around 

Colorado were from the same genetic strain of E. coli, which linked the 

illnesses to the same source of contamination. Later testing confirmed that 

beef from the ConAgra plant was the source of that contamination.

On June 30, 2002, ConAgra officials agreed to a voluntary recall of 354,200 

pounds of ground beef that the company identified as having been 

produced on May 31, 2002. FSIS’s subsequent review of ConAgra records 

showed that beef from the plant had been testing positive for E. coli

O157:H7 from April 12 through July 11, 2002. On July 18, the company 

decided to expand the recall to include about 18 million pounds of ground 

beef and beef trim. The expanded recall—one of the largest in U.S. 

history—included fresh and frozen ground beef products produced from 

April 12 through June 29, 2002, and beef trimmings produced from April 12 

through July 11, 2002. The Centers for Disease Control and Prevention 

reported that the extent to which the recalled meat was repackaged and 

distributed under other labels was unclear, potentially making it difficult to 

identify the affected lots of beef by looking at the package. According to 

USDA, about 3 million pounds (17 percent) of the recalled beef was 

recovered.

USDA’s Inspector General noted the following in 2003:

• USDA had imposed no specific requirements that plants keep 

production or distribution records, which increased the difficulty USDA 

had in tracking the distribution of the ground meat.

1

U.S. Department of Agriculture, Office of Inspector General, Food Safety and Inspection 

Service.
Appendix III

Information on a 2002 Recall of Ground Beef 

by a ConAgra Plant in Greeley, Colorado

Page 49 GAO-05-51 Food Recall Programs

• USDA did not review verification checks in time to maximize the 

amount of recalled food that could be recovered, and the problems 

found during those checks received limited management attention. 

• Of the 490 verification checks that USDA conducted, 67 indicated that 

companies in the downstream distribution chain had not been notified 

of the recall. Although USDA confirmed that ConAgra notified its 

primary customers of the recall, the agency took no action in the 67 

cases where it found that those customers had not notified others in the 

distribution chain. These checks notwithstanding, USDA district office 

managers determined that the recall was a success because to their 

knowledge, no one consuming unrecovered product became ill.

• USDA conducted verification checks between July and November, 2002, 

months after the recall began, with about 31 percent of checks in July, 

42 percent in August, 20 percent in September, and 7 percent in October. 

Two checks were performed in November.
Page 50 GAO-05-51 Food Recall Programs

Appendix IV

USDA and FDA Actions on the 

Recommendations We Made in 2000 ApendxiIV

As previously discussed in this report, our 2000 report1 on USDA’s and 

FDA’s food recall programs recommended that USDA and FDA provide 

guidance to companies with time frames for quickly initiating and carrying 

out food recalls that involve potentially serious adverse health risks, 

including procedures to expeditiously notify their distribution chains and 

alert the public. 

Our 2000 report also recommended that both USDA and FDA modify 

existing recall data systems to include information on the timeliness of 

companies’ recall activities so that the agencies could determine whether 

companies delay initiating and carrying out recalls. Both agencies acted on 

our recommendations by implementing new recall data systems to help 

track information about the recalls they monitor. USDA began using its 

new system—Recall Web—in January 2001, and FDA began using its new 

system—Recall Enterprise System—in November 2002. FDA’s Recall 

Enterprise System captures information on recalls of all FDA-regulated 

products, including food and other products such as medical devices and 

drugs. As table 4 shows, FDA implemented more of our recommendations 

than did USDA.

Table 4: USDA and FDA Actions on GAO’s Recommendations to Modify Recall Data Systems

Source: GAO analysis of the USDA Recall Web and the FDA Recall Enterprise System.

a

Regardless of the public notification action taken by the recalling company, FSIS will generally issue a 

press release for Class I and Class II recalls. The agency also will post them on the FSIS Web site.

b

Although FDA does not track this information in its data system, companies generally use a press 

release to notify the public, and FDA posts recall information on its Web site.

1

GAO, Food Safety: Actions Needed by USDA and FDA to Ensure That Companies 

Promptly Carry Out Recalls, GAO/RCED-00-195 (Washington, D.C.: Aug. 17, 2000).

Agency

Modify data systems to track the following dates and methods

Dates Methods

Company 

found out 

about 

problem

Agency 

requested 

company to 

initiate recall

Company 

initiated 

recall

Company 

notified 

customers

Company 

notified 

public

Company 

completed 

recall

Company 

used to 

notify 

customers

Company 

used to 

notify public

USDA No No Yes No No No Yes a

FDA Yes Yes Yes Yes Yes Yes Yes Nob
Appendix IV

USDA and FDA Actions on the 

Recommendations We Made in 2000

Page 51 GAO-05-51 Food Recall Programs

As table 4 shows, USDA did not add fields in its new data system for most 

of the fields that we recommended, but its system does record the date the 

company initiated a recall and the methods it used to notify its customers. 

According to USDA recall staff, its system was designed to create the 

letters they use to officially begin and end recalls. The system does not 

track the agency’s or company’s actions. In contrast, FDA added all but one 

of the fields we recommended.
Page 52 GAO-05-51 Food Recall Programs

Appendix V

Information on the 20 Food Recalls We 

Examined for 2003 ApendxiV

We analyzed 20 recent recalls—10 from USDA and 10 from FDA. The 20 we 

selected occurred in fiscal year 2003 and were among those with the 

greatest potential to cause serious illness or death—Class I recalls. Table 5 

presents selected information on those recalls.

Table 5: Selected Information on the 20 Class I Food Recalls We Examined

Agency

Agencyassigned recall 

number

Location

of facility

Lead

district office Recalled food Reason for recall

Approximate

amount recalled

USDA 107-2002 Ashville, NY Albany Fresh ground beef E. coli 320,000 pounds

001-2003 Bronx, NY Albany Chicken frankfurters Listeria 26,400 pounds

102-2002 Augusta, GA Atlanta Ground beef E. coli 54,000 pounds

112-2002 Elberton, GA Atlanta Fully cooked frozen 

chicken

Hard piece of 

plastica

36,000 pounds

086-2002 Milwaukee, WI Madison Fresh and frozen 

ground beef

E. coli 2,800,000 poundsb

091-2002 Milwaukee, WI Madison Fresh and frozen 

ground beef

E. coli 568,000 pounds

073-2002 Minneapolis, MN Minneapolis Frozen ground beef E. coli 717,000 pounds

090-2002 Franconia, PA Philadelphia Fresh and frozen 

ready-to-eat turkey and 

chicken

Listeria 27,400,000 

poundsb

098-2002 Camden, NJ Philadelphia Fresh and frozen 

ready-to-eat turkey and 

chicken

Listeria 4,200,000 poundsb

008-2003 Napoleon, OH Chicago Canned soup Cheesec 56,000 pounds

FDA F-474/

479-3

Trainer, PA Philadelphia Crab cakes Milkc 40,000 pounds

F-433-3 Conestoga, PA Philadelphia Ice cream Peanutsc 14,916 units

F-502-3 Brooklyn, NY New York 

Downstate

Salted herring Botulinum spores 2,025 pounds

F-398-3 Farmingdale, NY New York

Downstate

Oregano Salmonella 2,180 pounds

F-463-3 Salinas, CA San Francisco Fresh-cut bagged 

lettuce

Listeria 5,622 cases

F-207/

218-3

Mukilteo, WA Seattle Packaged turkey 

sandwiches

Listeria 285,700 

sandwiches

F-381/

383-3

Auburn, WA Seattle Alfalfa sprouts Salmonella 32,000 pounds

F-425-3 Clackamas, OR Seattle Smoked salmon Listeria 434 pounds
Appendix V

Information on the 20 Food Recalls We 

Examined for 2003

Page 53 GAO-05-51 Food Recall Programs

Source: GAO analysis of USDA and FDA data and documents.

a

The hard piece of plastic was considered to be foreign material.

b

This recall was expanded beyond the initial amount. The amount listed is the final amount of recalled 

food.

CThis item is a potential allergen that was not declared on the food’s ingredient label.

F-185-3 Battle Creek, MI Detroit Packaged breakfast 

pastry

Eggc 730,000 packages

F-482-3 Barberton, OH Cincinnati Chocolate milk Excessive amounts 

of vitamins A and D

490 

1⁄2-gallon 

containers

(Continued From Previous Page)

Agency

Agencyassigned recall 

number

Location

of facility

Lead

district office Recalled food Reason for recall

Approximate

amount recalled
Page 54 GAO-05-51 Food Recall Programs

Appendix VI

Recall Authority of Selected Government 

Agencies ApendxiVI

This appendix provides additional explanation of the information 

previously provided in table 2. It describes the requirements that 

manufacturers and other companies must follow to notify agencies of 

unsafe products and the authority of government agencies to recall 

products. The regulatory functions and products under the jurisdiction of 

each agency are discussed, followed by a description of the authority each 

agency has to recall products, including required notification of unsafe 

products.

USDA’s Food Safety 

and Inspection Service

USDA’s FSIS is responsible for protecting the public from foodborne illness 

by administering and enforcing the Federal Meat Inspection Act, Poultry 

Products Inspection Act, and Egg Products Inspection Act. FSIS’s 

jurisdiction covers beef; pork; lamb; poultry; processed eggs; and other 

products that contain meat or poultry, such as sausage, soups, stews, and 

frozen pizzas or dinners. FSIS inspects individual products as well as 

processing plants, tests for various types of food contamination, 

establishes facility sanitation requirements, maintains a system of import 

inspections and controls, prescribes labeling requirements, and develops 

consumer education programs to keep the public informed on how to 

properly prepare and store food. FSIS also monitors the effectiveness of 

voluntary recalls to remove unsafe meat, poultry, and egg products from 

interstate commerce.

FSIS does not have authority to issue a mandatory recall order or require a 

company to follow certain recall procedures during a voluntary recall. Nor 

are companies required to notify the agency when they identify a 

potentially unsafe product. However, if a company refuses to recall a 

product believed to be hazardous to the public health, FSIS may rely on its 

authority to detain and seize it. If necessary, FSIS may detain meat, poultry, 

or egg products for up to 20 days when there is reason to believe they are 

adulterated or misbranded and may be used as human food. After this 

period, a U.S. district court may be petitioned to authorize USDA to seize 

and condemn the product. To encourage cooperation with a voluntary 

recall, FSIS can withdraw inspectors or withhold the USDA “inspected and 

passed” label, effectively shutting down a manufacturer, according to the 

Secretary of Agriculture.1

1

Testimony before the House Agriculture Committee, January 21, 2004.
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 55 GAO-05-51 Food Recall Programs

FDA’s Center for Food 

Safety and Applied 

Nutrition

FDA’s Center for Food Safety and Applied Nutrition, is responsible for the 

safety of food not exclusively regulated by USDA.2

 This includes food such 

as fruits and vegetables, and infant formula. FDA shares jurisdiction with 

USDA on foods such as eggs, (FDA is responsible for shell eggs while 

USDA is responsible for egg products), sandwiches (depending on whether 

they are open-faced or close-faced) and soups (depending on the quantity 

of meat they contain). To ensure the safety of food under its jurisdiction, 

center activities include regulation of certain food production facilities and 

food labeling and the approval of food additives. The center also conducts 

facility inspections, collects and tests food samples to detect unsafe food, 

conducts research on emerging food safety issues, and educates the public 

on proper food handling. If an unsafe food under its jurisdiction enters the 

market, FDA may request a voluntary food recall and issue a press release 

about the unsafe food.

With the exception of infant formula, FDA does not have explicit authority 

to order food recalls. Instead, FDA relies on its authority to detain and seize 

adulterated or misbranded foods. While adulterated or misbranded 

products are subject to seizure through the courts with the assistance of 

the U.S. Department of Justice, FDA may detain food for up to 30 days if it 

has credible evidence or information that indicates the food presents a 

threat of serious adverse health consequences or death to humans or 

animals. FDA may also issue publicity about foods that present a danger to 

public health. According to agency officials, companies usually conduct 

voluntary recalls to avoid such adverse publicity.

For infant formula, however, FDA can require a manufacturer to conduct a 

recall if FDA determines that the formula processed by the manufacturer 

presents a risk to human health. An infant formula may present a risk to 

human health if it does not provide the required nutrients or is otherwise 

adulterated or misbranded. Manufacturers that have knowledge that 

reasonably supports the conclusion that their formula may not contain the 

required nutrients, or otherwise may be adulterated or misbranded, must 

promptly report this information to FDA, which then will determine 

whether the infant formula presents a risk to human health. Reports are 

also required if there is a reasonable possibility of a causal relationship 

between the consumption of the company’s infant formula and infant 

2

FDA’s Center for Food Safety and Applied Nutrition also has regulatory responsibility for 

cosmetics, medical foods, and dietary supplements.
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 56 GAO-05-51 Food Recall Programs

death. When a company conducts a recall, it must provide information to 

FDA by telephone about the infant formula within 24 hours. Within 14 days 

after the recall has begun, the manufacturer must provide a written report 

to FDA and at least every 14 days thereafter until the recall is terminated. 

The manufacturer also must request each retail establishment at which 

such formula is sold or is available for sale to post a notice of the recall. 

Failure to comply with the notification, reporting, or posting-request 

requirements are prohibited acts punishable by imprisonment, a fine, or 

both.

The Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 includes a number of provisions that establish new 

requirements for those engaged in the food business and gives new 

authority to FDA to take action to protect the nation’s food supply. These 

new requirements and powers include registration of food facilities, 

administrative detention of food believed to be unsafe, maintenance of and 

access to certain records, and notification of food imports prior to arrival.3

FDA’s Center for 

Biologics Evaluation 

and Research

FDA’s Center for Biologics Evaluation and Research is responsible for 

ensuring the safety and effectiveness of biological products, such as blood 

and vaccines. The center also regulates human tissue intended for 

transplant to prevent the transmission of communicable disease.4

 To 

achieve its goals, the center reviews and approves biologics for licensing, 

inspects the conditions of facilities manufacturing biological products, 

regulates biological product quality, and conducts research to support 

these programs.

3

Pub. L. No. 107-188, 116 Stat. 594, §§ 303, 305-07(2002).

4

FDA has issued regulations that apply to human tissue establishments or persons engaged 

in the recovery, screening, testing, processing, storage, or distribution of human tissue. 

Human tissue determined to be in violation of these regulations may be recalled. 21 C.F.R. § 

1270.43(2004).
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 57 GAO-05-51 Food Recall Programs

Reports of adverse events associated with biological products can help 

identify whether a recall may be necessary. Manufacturers must report to 

FDA if they become aware of adverse experiences associated with their 

products. Such information may come from a number of sources, including 

commercial marketing experience, postmarketing clinical investigations, 

and scientific literature. Vaccine manufacturers and health care providers 

are also required to report certain reactions associated with the 

administration of routinely recommended childhood vaccines.5

The Public Health Service Act authorizes FDA to issue an order to recall a 

licensed biological product after determining that it presents “an imminent 

or substantial hazard to the public health....”6

 Recalls must be carried out 

in a manner consistent with the FDA order and pertinent regulations. 

Violation of the recall requirements could result in monetary penalties of 

$100,000 or more per day of violation, fines, and imprisonment. 

FDA’s Center for 

Devices and 

Radiological Health

FDA’s Center for Devices and Radiological Health is responsible for 

ensuring the safety and effectiveness of medical devices and preventing 

unnecessary human exposure to radiation from electronic products. The 

center has regulatory jurisdiction over medical devices, such as heart 

pacemakers and electronic thermometers, as well as radiation-emitting 

electronic products, such as microwave ovens, infrared alarm systems, 

ultraviolet tanning lamps, and lasers. The center evaluates and approves 

certain devices for clinical trials and marketing, regulates manufacturing 

practices, sets performance standards, conducts postmarket surveillance 

of product performance, provides technical assistance to small 

manufacturers, and educates the public.

Medical device manufacturers and importers must report device-related 

deaths or serious injuries, as well as certain product corrections and 

market removals to FDA, and importers must report these events to the 

manufacturer(s). User facilities must report deaths that may have been 

caused by the use of a medical device to FDA and the manufacturer, if 

5

FDA has proposed to require adverse event reporting for human tissue products. See

Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based 

Products; Inspection and Enforcement, 66 Fed. Reg. 1508 (proposed Jan. 8, 2001)(to be 

codified at 21 C.F.R. pt. 1271). The agency is working on the final rule.

6

42 U.S.C. § 262(d)(1).
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 58 GAO-05-51 Food Recall Programs

known. Device-related serious injuries must be reported to the 

manufacturer or to FDA if the manufacturer is unknown.

FDA is authorized to order two types of recalls for medical devices: a 

“repair, replacement, or refund” order and a recall order.7

 The first type 

may be initiated if (1) a device presents an unreasonable risk of substantial 

harm to the public health, (2) there are reasonable grounds to believe that 

the device was not properly designed or manufactured, (3) there are 

reasonable grounds to believe that the risk is not due to improper use or 

care, and (4) notification of the risk would not be sufficient to eliminate it.

If a device meets these criteria, FDA may order the manufacturer, importer, 

or distributor, or any combination of the three, to submit a plan to repair or 

replace the device or to refund the purchase price. The plan may not 

include a charge to anyone seeking a remedy, except manufacturers, 

importers, distributors, or retailers, where there are reasonable grounds to 

believe that the person or entity in question is eligible for a remedy. It must 

also provide for reimbursement of the reasonable and foreseeable 

expenses associated with obtaining repair, replacement, or refund. If a plan 

is unsatisfactory, FDA may prescribe a plan.

If there is a reasonable probability that a device would cause serious 

adverse health consequences or death, FDA must issue an order requiring 

the appropriate parties to immediately (1) cease distribution and (2) notify 

health professionals and device user facilities of the order and instruct 

them to stop using the device. After providing an opportunity for an 

informal hearing, FDA may amend the order to require a recall of the 

device specifying a time table for completion and periodic reporting. Such 

recall orders do not include recall of devices from individuals, although 

individuals subject to the risks associated with the recalled devices are 

required to be notified.

FDA is authorized to require manufacturers to adopt a method of device 

tracking for certain medical devices. According to FDA, this authority may 

be used to facilitate recalls. Tracking orders may be issued for devices (1) 

that if they failed, would be reasonably likely to cause serious adverse 

7

Electronic products are treated separately and subject to repair, replacement, or refund if 

they have a safety defect relating to the emission of electronic product radiation or fail to 

comply with certain performance standards. Failure to comply with the applicable 

requirements may result in penalties as large as $300,000.
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 59 GAO-05-51 Food Recall Programs

health consequences, (2) that are intended to be implanted in the body for 

more than a year, or (3) that are life-sustaining or life-supporting and used 

outside a device user facility.

Failure to comply with requirements or orders could result in penalties up 

to $15,000 per violation, not to exceed $1 million for all violations in a 

single proceeding; fines; and imprisonment.

FDA’s Center for Drug 

Evaluation and 

Research

FDA’s Center for Drug Evaluation and Research is responsible for ensuring 

the availability of safe and effective prescription and over-the-counter 

drugs for the American people. To ensure that drugs are safe and effective 

before they reach the market, the center reviews new drug applications and 

establishes manufacturing, product quality, and labeling standards. The 

center also conducts postmarket drug safety surveillance, collects samples 

of and analyzes drugs to help make sure they are safe and effective, 

administers a postmarket adverse drug experience program in an effort to 

identify potentially unsafe drugs, and provides consumers with the 

information they need to use drugs appropriately and safely.

Unlike foods, drugs must go through premarket approval and must be 

determined to be safe and effective before they can be marketed. Even 

after they are marketed, questions may arise regarding their safety or 

effectiveness. FDA may become aware of such concerns through adverse 

event reporting. Generally, manufacturers and others are required to report 

serious and unexpected adverse drug events to FDA within a certain time 

frame. FDA may use this information to determine whether particular 

drugs should continue to be marketed. Those who fail to make the required 

adverse event reports are subject to fines and imprisonment.

While FDA does not have the authority to issue a recall order for drugs 

determined to be unsafe or ineffective,8

 it may immediately suspend and 

propose to withdraw the New Drug Application approval for such drugs if 

they are found to constitute an “imminent hazard.”

8

For human drugs regulated using a biologics license application, FDA has express statutory 

recall authority. However, FDA has not developed implementing regulations.
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 60 GAO-05-51 Food Recall Programs

FDA’s Center for 

Veterinary Medicine

FDA’s Center for Veterinary Medicine regulates the approval, manufacture, 

and sale of animal drugs and feeds containing animal drugs. FDA may 

become aware of information concerning the safety and effectiveness of 

animal drugs and medicated feeds through the reporting of adverse 

reactions associated with them. Manufacturers of animal drugs are 

required to report serious and unexpected adverse drug events to FDA 

within a certain time frame whether administered directly or through feed. 

Those who fail to make the required reports may be subject to fines and 

imprisonment.

FDA’s Center for Veterinary Medicine does not have authority to issue a 

recall order if any of these products are found to be unsafe or ineffective. 

However, the center may propose to withdraw marketing approval for such 

drugs or propose to revoke the license of the medicated feed manufacturer 

if certain conditions are not met. If the drug or medicated feed poses an 

imminent hazard to human health or the animals for which it is intended, 

the Secretary of Health and Human Services may immediately suspend the 

drug’s marketing approval or the feed manufacturing license.

Consumer Product 

Safety Commission

The Consumer Product Safety Commission (CPSC) is charged with 

protecting the public from unreasonable risks of serious injury or death 

from over 15,000 types of consumer goods. Consumer goods generally fall 

under the regulatory jurisdiction of CPSC, with the exceptions of motor 

vehicles and motor vehicle equipment, food, human and animal drugs, 

aircraft, boats, tobacco, firearms, cosmetics, pesticides, and medical 

devices. To help protect consumers from unsafe products, CPSC develops 

and enforces product safety standards; administers recalls—which may 

include repair, replacement, or refund—of certain hazardous products; 

evaluates the safety of products; bans unsafe products; conducts research 

on the safety of products; and educates consumers.

Companies are required to notify CPSC immediately (generally within 24 

hours) after obtaining information that reasonably supports the conclusion 

that a product violates a product safety ban or standard, the product 

contains a defect that could create a substantial product hazard or creates 

an unreasonable risk of serious injury or death. The staff verifies the defect 

or hazard and assists the company in developing a remedy. According to 

CPSC officials, virtually all recalls are conducted voluntarily without the 

need for litigation. If the commission determines that notification of the 

public about a product defect or failure is necessary, and the company does 
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 61 GAO-05-51 Food Recall Programs

not cooperate, the law provides for a hearing. After a hearing, CPSC may 

order the affected companies to give such notice publicly and through the 

mail to manufacturers, distributors, retailers, or individual consumers. 

Manufacturers also must notify CPSC if a product is the subject of three or 

more settled civil actions or adjudicated civil actions, in favor of the 

plaintiff, alleging death or grievous bodily injury—over a 2-year period. The 

company must report to CPSC within 30 days of final settlement or 

judgment in the third case. 

Companies selling goods that a CPSC technical review finds to present 

“substantial product hazards” may be ordered to conduct a recall or 

develop a plan that provides for repair, replacement, or refund for the 

product in question. CPSC is authorized to review and approve any plan. 

Products that a U.S. district court determines to be imminently hazardous 

are subject to injunction and seizure. In such cases, relief may include 

notification of the risk to purchasers, public notice, recall, repair, 

replacement, refund, or condemnation. If someone knowingly fails to 

comply with the reporting, or a notification or recall order, CPSC may 

assess civil monetary penalties of $7,000 per violation up to $1.65 million 

for a related series of violations.9

Department of 

Transportation’s 

National Highway 

Traffic Safety 

Administration

The National Highway Traffic Safety Administration (NHTSA), an agency 

within the Department of Transportation, is charged with a number of 

responsibilities, including reducing deaths and injuries resulting from 

motor vehicle traffic accidents, establishing motor vehicle safety 

standards, administering motor vehicle and highway safety grant programs, 

securing and analyzing data to learn about safety trends, and monitoring 

the recall of defective products. Its jurisdiction covers motor vehicles and 

equipment, including tires and child safety seats.

9

Maximum civil monetary penalties were last revised for inflation in 1999 and are required to 

be revised again later in 2004. See Notice of Adjusted Maximum Civil Penalty Amounts, 64 

Fed. Reg. 51963(1999); 15 U.S.C. § 2069(a)(3).
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 62 GAO-05-51 Food Recall Programs

NHTSA may become aware of problem products either through its own 

research or testing, or by notification from manufacturers or consumers. 

Manufacturers of motor vehicles or replacement equipment must notify 

NHTSA within 5 working days if the manufacturer decides that its products 

contain a defect related to motor vehicle safety or violate a motor vehicle 

safety standard.10 Owners, purchasers, and dealers must also be notified 

within a reasonable time and are entitled to remedies—which may include 

repairs, replacement, or refunds of the defective or noncompliant 

product—without charge. If there is insufficient customer response after 

the initial notification, NHTSA may order the manufacturer to send out a 

second notification in a manner prescribed by regulation. The 

manufacturer’s program to remedy the defect or noncompliance must be 

filed with NHTSA, which then makes it available to the public. If NHTSA 

decides that a manufacturer has not reasonably met the remedy 

requirements, it may order specific action. Failure to provide notification 

or a proper remedy may result in a civil monetary penalty of up to $5,000 

for each violation, up to $15 million in total for a related series of violations.

Canadian Food 

Inspection Agency

The Canadian Food Inspection Agency (CFIA), created in April 1997, is 

Canada’s science-based regulator for food safety, animal health, and plant 

protection. Its responsibilities include activities that had been divided 

among four Canadian government departments. It is responsible for the 

administration and enforcement of 13 Canadian laws and their respective 

regulations. Through the delivery of inspection and other related services, 

which include inspection of food-processing facilities, analysis of food 

samples for impurities, inspection of international food products and 

animals, and evaluation of the safety of animal feeds and vaccines, the 

agency verifies compliance with these laws. Critical to the effective 

delivery of the CFIA’s responsibilities is the ongoing design and 

development of inspection-related tools and processes, which include the 

continual review of regulations and policies and the implementation of new 

science-based inspection methodologies.

The CFIA also coordinates food recalls across Canada and posts 

publications of food recalls on its government Web site. According to 

10Manufacturers of motor vehicles or motor vehicle equipment must notify NHTSA within 5 

working days after determining to conduct a safety recall or other safety campaign in a 

foreign country on vehicles or equipment that are identical or substantially similar to ones 

sold in the United States. 49 U.S.C. § 30166(l).
Appendix VI

Recall Authority of Selected Government 

Agencies

Page 63 GAO-05-51 Food Recall Programs

agency officials, although companies are not required by statute to notify 

the CFIA when they identify potentially unsafe products, the CFIA 

encourages and assists companies in the coordination of food emergency 

responses on a 24-hour basis. The CFIA Web site also has manuals and 

checklists for companies to structure food safety emergency response 

policies.

CFIA officials told us that although companies generally cooperate in 

recalls, the CFIA has mandatory recall authority that it may use in cases 

where cooperation is not forthcoming and a recall must be done promptly 

and completely. Section 19 of the Canadian Food Inspection Agency Act

provides that the Minister of Agriculture and Agri-Food may order a recall 

of a particular product where there are reasonable grounds to believe that 

the product poses a risk to public, animal, or plant health. A recall order 

under this section applies to anyone who sells, markets, or distributes the 

product, and violation of a recall order may result in a fine of up to $50,000 

and imprisonment.11

11The applicable Canadian statute is general and there are no implementing regulations. This 

information is largely based on our discussions with Canadian officials.
Page 64 GAO-05-51 Food Recall Programs

Appendix VII

Comments from the U.S. Department of 

Agriculture ApendxiVI

Note: GAO comments 

supplementing those in 

the report text appear 

at the end of this 

appendix.

See comment 1.

See comment 2.
Appendix VII

Comments from the U.S. Department of 

Agriculture

Page 65 GAO-05-51 Food Recall Programs

See comment 3.

See comment 4.

See comment 5.

See comment 6.
Appendix VII

Comments from the U.S. Department of 

Agriculture

Page 66 GAO-05-51 Food Recall Programs

See comment 7.
Appendix VII

Comments from the U.S. Department of 

Agriculture

Page 67 GAO-05-51 Food Recall Programs

The following are GAO’s comments on the U.S. Department of Agriculture 

letter received August 31, 2004.

GAO Comments 1. USDA believes the new recall directive adopted May 24, 2004, will 

address most of the observed weaknesses we found in its food recall 

program. As the report already noted, the new directive does provide a 

statistical, risk-based method that will give greater assurance that 

downstream customers are aware of recalls and that they have 

followed instructions for removing food from the marketplace, and the 

directive includes time frames for USDA to complete its verification 

checks. However, although the directive includes general procedures 

to, among other things, determine the need for a recall and the actions 

the agency expects the company to take to ensure maximum recovery 

in the shortest amount of time, the procedures do not provide specific 

time frames as guidance to the companies. In particular, the new 

directive does not address our recommendations that USDA (1) set 

time frames for recalling companies’ actions—to encourage prompt 

recalls—including time frames for companies to disclose the locations 

where they sent the food, (2) use routinely generated management 

reports from the official recall data system, (3) track critical dates, and 

(4) work with FDA on how best to alert consumers about recalls of 

food that can cause serious illnesses. While the new directive should 

improve USDA’s verification of recalls, we believe it is premature to say 

whether it will address any other weaknesses we found in USDA’s recall 

program.

2. USDA believes that our recommendations regarding additional data 

collection and report generation may be a burden to the agency, overly 

prescriptive, and costly to industry and USDA. We continue to believe 

that our recommendation is sound. Our review of specific recalls 

disclosed that inspectors generally are already capturing the additional 

data, such as the dates that the company started and completed the 

recall, in their paperwork. Our recommendations would have USDA 

systematically capture this information and other critical information 

in its Recall Web database to help the department better manage its 

recall program. With respect to routine management reports, both 

headquarters and district offices need routine reports to carry out their 

oversight responsibilities. Now that recalls are run and coordinated 

directly from the district offices, under the May 2004 procedures, it is 

particularly important for headquarters to be able to monitor the recall 

activities of USDA’s 17 different district offices to ensure the new 
Appendix VII

Comments from the U.S. Department of 

Agriculture

Page 68 GAO-05-51 Food Recall Programs

procedures are uniformly implemented. Finally, with respect to the cost 

to industry, companies are already legally required to maintain 

distribution information. Our recommendation speaks to instances 

where USDA district staff told us they received broad customer lists 

instead of the specific locations where the recalled food was sent.

3. We recognize that USDA uses press releases and Web postings to notify 

the public after it learns about a recall. Our recommendation that USDA 

and FDA work jointly to determine what, if any, additional approaches 

are needed for alerting consumers addresses the situation in which 

consumers may not see the press release or Web posting and therefore 

may consume recalled food that is in their home.

4. We agree that the purpose of a recall is to remove potentially harmful 

food from commerce and alert consumers to potential risks of 

consumption. Consequently, the report defines “recovery” to include 

food that is returned or disposed of by firms in the distribution chain. 

That is, food that is removed from commerce. We revised the report to 

reflect that the recovery rate is an important indicator of a successful 

recall, rather than the purpose of a recall. As we note in the report, we 

remain concerned about how effectively the agencies are alerting 

consumers to potentially harmful foods that may be in their homes.

5. We recognize that the cause of the illnesses, hospitalizations, and 

deaths was contaminated food, not the agencies’ programs. However, 

because the public is relying on USDA and FDA to protect consumers 

from unsafe food, it is important that the agencies’ recall programs be 

as effective as they can. As appendix III discusses, USDA’s Inspector 

General reported that during one of the two recalls we mentioned that 

involved illnesses and deaths, USDA’s field staff took longer than 4 

months to complete their verification checks. The Inspector General’s 

report concluded that the department did not identify and correct 

problems with the recall to maximize recovery and take enforcement 

actions—thereby potentially exposing consumers to the unsafe meat. 

Therefore, we believe our report’s presentation is fair and consistent 

with the facts.

6. With respect to the recall authority of other agencies, we sought to 

show that other agencies have recall authority and have had to use that 

authority. We did not evaluate those recall programs nor did we imply 

that they were faster or better. For example, FDA currently has explicit 

recall authority for infant formula and certain other products that the 
Appendix VII

Comments from the U.S. Department of 

Agriculture

Page 69 GAO-05-51 Food Recall Programs

agency regulates and has had to use that authority. In comments on our 

August 2000 report on USDA’s and FDA’s recall programs, USDA told us 

that it has supported proposed recall legislation that specifically 

included “civil penalties, mandatory recall authority, mandatory 

notification...when contaminated meat or poultry may enter the 

market.” USDA noted that, for the most part, the voluntary system 

works but that mandatory authority would provide “an insurance policy 

guaranteeing that consumers will be protected from potentially 

dangerous meat or poultry without delay.” Moreover, because the 

President has identified the food supply as at risk for intentional 

contamination, such authority is important. Finally, USDA’s suggestion 

that mandatory recall authority could conceivably slow the recall 

process was not raised as an issue by any of the agencies we cite. 

Rather, they saw their recall authority as a useful tool—not a 

replacement for voluntary recalls—when companies are slow or 

uncooperative and consumers are at risk.

7. We revised the report to include a statement that USDA is considering 

additional options to help consumers identify recalled foods in their 

homes.
Page 70 GAO-05-51 Food Recall Programs

Appendix VIII

Comments from the Food and Drug 

Administration ApendxiVI

Note: GAO comments 

supplementing those in 

the report text appear 

at the end of this 

appendix.
Appendix VIII

Comments from the Food and Drug 

Administration

Page 71 GAO-05-51 Food Recall Programs

See comment 1.

See comment 2.

See comment 3.
Appendix VIII

Comments from the Food and Drug 

Administration

Page 72 GAO-05-51 Food Recall Programs

See comment 4.
Appendix VIII

Comments from the Food and Drug 

Administration

Page 73 GAO-05-51 Food Recall Programs

See comment 5.

See comment 6.
Appendix VIII

Comments from the Food and Drug 

Administration

Page 74 GAO-05-51 Food Recall Programs

The following are GAO’s comments on the Food and Drug Administration 

letter dated August 27, 2004.

GAO Comments 1. FDA believes that Class I recall actions were not lengthy because of 

system inefficiency, and that the relatively small percentage of recalled 

food that is recovered is not a result of weaknesses in FDA food recall 

processes. While we do not believe that these are the sole reasons why 

FDA’s recalls may be slow or result in low recovery, we do believe that 

its system and processes are contributing factors. As FDA pointed out, 

the most significant stage of a recall is the initial action the recalling 

company takes to notify the public and its customers to have the food 

removed from the marketplace, with the assistance of FDA 

investigators and/or district recall coordinators. However, FDA staff 

from several district offices told us that companies sometimes conduct 

recalls without contacting FDA and therefore without the benefit of 

FDA assistance. Our report does note that FDA encourages companies 

to initiate promptly when deciding to recall a product and that 

companies usually agree to carry out recalls. That notwithstanding, 

FDA staff told us that, in some instances, they had to place 

considerable pressure on companies before they “voluntarily” 

conducted the recall. In addition, as our report points out, FDA’s 

verification process serves a critical function in recalls—to identify and 

correct problems with recall notification and product removal—a 

process that does not consistently meet FDA’s timeliness guidelines.

2. As FDA states, the recall completion date reflects the amount of time 

that the recalling company took to complete all actions related to the 

recall effort. We agree that this time can vary significantly depending on 

the particular circumstances of the recall. However, we continue to 

believe, as we stated in our 2000 report, that it is important to 

document the completion date as an important indicator for FDA’s 

recall managers to assess the overall promptness of company actions to 

protect consumers from unsafe food in the marketplace.

3. We did not assess the reliability or validity of the unofficial database 

maintained by FDA’s Center for Food Safety and Applied Nutrition. 

However, we are concerned that the information in FDA’s official 

database—the Recall Enterprise System—was not the same as 

information in the center’s database. FDA comments state that the 

differences we found are the result of information in the pilot database 

that preceded the Recall Enterprise System. We did not compare 
Appendix VIII

Comments from the Food and Drug 

Administration

Page 75 GAO-05-51 Food Recall Programs

information in the pilot database. Rather, we compared information in 

the Recall Enterprise System and the center’s database for such dates 

as when the recalls started and when they were classified by risk. We 

continue to believe that these differences reflect potential weaknesses 

in the reliability and validity of FDA’s official recall database.

4. FDA believes that it would be difficult to specify workable time frames 

to companies, and that such time frames may serve no better purpose 

than current procedure to have recall notifications and press releases 

issued as soon as possible. We continue to believe that more specific 

time frames are needed as guidance to industry. This is particularly 

important for Class I recalls, which pose serious health risks, where 

even a day’s delay may have adverse health consequences. FDA also 

states that firms are advised about time frames via a letter. However, 

for the 10 recalls we examined in detail, FDA sent this letter between 26 

and 213 days after the company initiated the recall. According to FDA 

officials, it is commonly FDA’s practice to send the letter at the end of 

the recall. Therefore, we do not believe the letter serves as a timely 

means of instructing the recalling company to act quickly.

5. We agree that data should only be captured if they provide useful 

information to recall program managers. As FDA states, “the most 

significant stage of a recall is the initial action taken by the recalling 

[company] to notify its [customers]...of the product recall and have the 

product removed from the marketplace.” We therefore believe that the 

Recall Enterprise System should capture those critical dates so field 

staff can monitor ongoing recalls and headquarters recall managers can 

determine how much time elapses between critical steps of the recall 

process and take steps to reduce time frames, to the extent possible. 

6. FDA believes that data available on recalled food may not include 

individual product or case breakdown. While capturing details about 

the amount recalled and amount recovered may not always be possible, 

we believe that FDA field staff should be instructed to take care that, 

when such information is available, it be captured in the Recall 

Enterprise System using comparable units.
Page 76 GAO-05-51 Food Recall Programs

Appendix IX

GAO Contacts and Staff Acknowledgments ApendxiIX

GAO Contacts Lawrence J. Dyckman, (202) 512-3841

J. Erin Lansburgh, (202) 512-3017

Staff 

Acknowledgments

In addition to those named above, Terrance N. Horner, Jr.; Julian Klazkin; 

Lynn Musser; Jennifer Popovic; Julia A. Roberts; Carol Herrnstadt 

Shulman; Joseph Thompson; and Jonathan Weiss made key contributions 

to this report.

(360313)
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