United States Government Accountability Office

GAO Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, House of Representatives

FEDERAL OVERSIGHT OF 

FOOD SAFETY 

High-Risk Designation Can 

Bring Attention to 

Limitations in the 

Government’s Food Recall 

Programs 

Statement of Lisa Shames, Acting Director 

Natural Resources and Environment 

For Release on Delivery

Expected at 9:30 a.m. EDT

Tuesday, April 24, 2007

 

GAO-07-785T 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

April 24, 2007

FEDERAL OVERSIGHT OF FOOD SAFETY

High-Risk Designation Can Bring Needed 

Attention to Limitations in the 

Government’s Food Recall Programs 

Highlights of GAO-07-785T, a testimony 

before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, House of Representatives

Each year, about 76 million people 

contract a foodborne illness in the 

United States; about 325,000 

require hospitalization; and about 

5,000 die. The outbreaks of E. coli

in spinach and Salmonella in 

peanut butter, along with 

contamination in pet food, have 

highlighted the risks posed by 

accidental food contamination.

The attacks of September 11, 2001, 

heightened awareness that the food

supply could also be vulnerable to 

deliberate contamination. This 

testimony focuses on the (1) role

that GAO’s high-risk series can play

in raising the priority and visibility

of the need to transform federal 

oversight of food safety, (2) 

fragmented nature of federal 

oversight of food safety, and (3) 

limitations in federal food recall 

programs. 

What GAO Recommends

While many of GAO’s 

recommendations to promote the 

safety of the nation’s food supply 

have been acted upon, others have 

not yet been addressed. For

example, GAO recommended that

the executive branch reconvene the 

President’s Council on Food Safety 

to facilitate interagency

coordination. GAO also proposed 

that Congress enact

comprehensive, uniform, and riskbased food safety legislation; 

analyze alternative organizational

food safety structures; and 

consider legislation giving agencies

authority to order food recalls. 

GAO’s High-Risk Series is intended to raise the priority and visibility of 

government programs that are in need of broad-based transformation to 

achieve greater economy, efficiency, effectiveness, accountability, and 

sustainability. These reports also help Congress and the executive branch 

carry out their responsibilities while improving the government’s 

performance and enhancing its accountability for the benefit of the 

American people. In January 2007, as part of our regular update of this series 

for each new Congress, GAO designated the federal oversight of food safety 

as a high-risk area for the first time. 

We designated federal oversight of food safety as a high-risk area because of 

the need to transform this system to reduce risks to public health as well as 

the economy. While this nation enjoys a plentiful and varied food supply that 

is generally considered to be safe, the federal oversight of food safety is 

fragmented, with 15 agencies collectively administering at least 30 laws

related to food safety. The two primary agencies are the U.S. Department of 

Agriculture (USDA), which is responsible for the safety of meat, poultry, and 

processed egg products, and the Food and Drug Administration (FDA), 

which is responsible for virtually all other food. We have identified 

examples where the federal government’s resources and enforcement 

activities can better align with the risks of food contamination. For example, 

the majority of federal expenditures for food safety inspection were directed 

toward USDA’s programs for ensuring the safety of meat, poultry, and egg 

products; however, USDA is responsible for regulating only about 20 percent 

of the food supply. In contrast, FDA, which is responsible for regulating 

about 80 percent of the food supply, accounted for only about 24 percent of 

expenditures. 

Among the reasons we designated federal oversight of food safety as a highrisk area is that limitations in the federal government’s food recalls heighten 

the risk that unsafe food will remain in the food supply and ultimately be 

consumed. 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 FDA’s authority to require a recall for infant formula. 

USDA and FDA provided guidance for companies to carry out voluntary 

recalls. We have reported that USDA and FDA could do a better job carrying 

out their food recall programs so they can quickly remove potentially unsafe 

food from the marketplace. At the time of our review, these agencies did not 

know how promptly and completely companies were carrying out recalls, 

did not promptly verify that recalls had reached all segments of the 

distribution chain, and used procedures that may not have been effective to 

alert consumers to a recall. 

www.gao.gov/cgi-bin/getrpt?GAO-07-785T.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Lisa Shames at 

(202) 512-3841 or ShamesL@gao.gov. 
Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today to discuss the designation of federal 

oversight of food safety as a high-risk area in the January 2007 update to 

our High-Risk Series and, specifically, the limitations in the government’s 

food recall programs. Let me state at the outset that this nation enjoys a 

plentiful and varied food supply that is generally considered to be safe. 

However, each year, about 76 million people contract a foodborne illness 

in the United States; about 325,000 require hospitalization; and about 5,000 

die, according to the Centers for Disease Control and Prevention. Further, 

as the population grows older and more vulnerable to foodborne illness, 

food safety will become increasingly important. The recent outbreaks of E. 

coli in spinach and Salmonella in peanut butter, for example, along with 

contamination in pet food, have highlighted the risks posed by accidental

food contamination. 

Ensuring the safety of the nation’s food supply is even more urgent since 

the terrorist attacks of September 11, 2001 heightened awareness of 

agriculture’s vulnerabilities to terrorism, such as the deliberate 

contamination of food or the introduction of disease to livestock, poultry,

and crops. Agriculture, as the largest industry and employer in the United 

States, generates more than $1 trillion in economic activity annually, or 

about 13 percent of the gross domestic product. An introduction of a 

highly infectious foreign animal disease, such as avian influenza or footand-mouth disease, would cause severe economic disruption, including 

substantial losses from halted agricultural exports, which exceeded $68 

billion in fiscal year 2006. 

We added the federal oversight of food safety to our list of high-risk 

programs needing urgent attention and transformation to ensure that our 

federal government functions in the most economical, efficient, and 

effective manner possible.1

 As we have repeatedly reported, our 

fragmented food safety system has resulted in inconsistent oversight, 

ineffective coordination, and inefficient use of resources. With 15 agencies

collectively administering at least 30 laws related to food safety, the 

patchwork nature of the federal food safety oversight system calls into 

question whether the federal government can more efficiently and 

effectively protect our nation’s food supply. In addition, food recalls are 

voluntary, and the U.S. Department of Agriculture (USDA) and the Food 

 1

GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007).

Page 1 GAO-07-785T 
and Drug Administration (FDA), which have primary responsibility for 

food safety, have no authority to compel companies to carry out most 

recalls, except for FDA’s authority to require a recall for infant formula. 

Instead, USDA and FDA provide guidance for companies to carry out 

voluntary recalls. We have reported that USDA and FDA could do a better 

job in carrying out their food recall programs so they can quickly remove 

potentially unsafe food from the market place.2

Because of your responsibility for oversight of federal agencies, I will 

focus on three key points: (1) the role of GAO’s High-Risk Series in raising 

the priority and visibility of the need to transform federal oversight of food 

safety, (2) the fragmented nature of federal oversight of food safety, and

(3) limitations in federal food recall programs. My testimony is based on 

published GAO products that were developed in accordance with 

generally accepted government auditing standards. 

We designated the federal oversight of food safety as a high-risk area to 

raise the priority and visibility of the need to transform this system. 

Overall, our High-Risk Series has identified and helped resolve serious 

government weaknesses in areas that involve substantial resources and 

provide critical services to the public. Since we began reporting on highrisk areas, the government has taken high-risk problems seriously and has 

made long-needed progress toward correcting them. 

In designating federal oversight of food safety as high risk, we considered 

whether it had national significance or a management function that was 

key to performance and accountability. Further, we considered qualitative 

factors, such as whether food safety 

GAO’s High-Risk 

Series Raises the 

Priority and Visibility 

of the Need to 

Transform Federal 

Oversight of Food 

Safety 

• involved public health or safety, service delivery, national security, 

national defense, economic growth, or privacy or citizens’ rights; or 

• could result in significantly impaired service, program failure, injury or 

loss of life, or significantly reduced economy, efficiency, or 

effectiveness. 

 2

GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls

of Potentially Unsafe Food, GAO-05-51 (Washington, D.C.: Oct. 6, 2004). 

Page 2 GAO-07-785T 
Clearly, these factors weighed heavily into our deliberations to place the 

federal oversight of food safety on our high-risk list. For example, food 

contamination, such as the recent E. coli outbreaks, can have a 

detrimental impact on public health and the local economy. According to

FDA, the outbreak resulted in 205 confirmed illnesses and three deaths. In

addition, industry representatives estimate losses from the recent 

California spinach E. coli outbreak to range from $37 million to $74 

million. 

To address the weaknesses in federal oversight of food safety, executive 

agencies can start by implementing our recommendations intended to 

improve the problems we previously identified. Further, continued 

congressional oversight, including today’s hearing, and additional 

legislative action will be key to achieving progress, particularly in 

addressing challenges in the broad-based transformation needed to 

promote the safety and integrity of the nation’s food supply.

The fragmented nature of the federal food oversight system calls into 

question whether the government can plan more strategically to inspect 

food production processes, identify and react more quickly to outbreaks of

contaminated food, and focus on promoting the safety and integrity of the 

nation’s food supply. While 15 agencies collectively administer at least 30 

laws related to food safety, two agencies have primary responsibility––

USDA, which is responsible for the safety of meat, poultry, and processed 

egg products, and FDA, which is responsible for virtually all other foods. 

Fragmented Federal 

Oversight of Food 

Safety Led to HighRisk Designation 

The food safety system is further complicated by the subtle differences in

food products that dictate which agency regulates a product. For example, 

which agency is responsible for ensuring the safety of frozen pizzas 

depends on whether or not meat is used as a topping. USDA inspects 

manufacturers of frozen pepperoni pizza, while FDA inspects 

manufacturers of frozen cheese pizza. In other instances, how a packaged

ham and cheese sandwich is regulated depends on how the sandwich is 

presented. USDA inspects manufacturers of packaged open-face meat or 

poultry sandwiches (e.g., those with one slice of bread), but FDA inspects 

manufacturers of packaged closed-face meat or poultry sandwiches (e.g.,

those with two slices of bread). 

We have identified examples where the federal government’s resources 

and enforcement activities can better align with the risks of food 

contamination. For example, the majority of federal expenditures for food 

safety inspection have been directed toward USDA’s programs for 

Page 3 GAO-07-785T 
ensuring the safety of meat, poultry, and egg products; however, USDA is 

responsible for regulating only about 20 percent of the food supply. In 

contrast, FDA, which is responsible for regulating about 80 percent of the 

food supply, accounted for only about 24 percent of expenditures. Also, 

under current law, thousands of USDA inspectors maintain continuous 

inspection at slaughter facilities and examine all slaughtered meat and 

poultry carcasses. They also visit each processing facility at least once 

during each operating day. For foods under FDA’s jurisdiction, however, 

federal law does not mandate the frequency of inspections.3

 FDA has 

jurisdiction over the food products involved in the recent food 

contamination outbreaks I mentioned today. 

The federal regulatory system for food safety, like many other federal 

programs and policies, evolved piecemeal, typically in response to 

particular health threats or economic crises. During the past 30 years, we 

have detailed problems with the current federal food safety system and 

reported that the system has caused inconsistent oversight, ineffective 

coordination, and inefficient use of resources. We have cited the need to

integrate this fragmented system as a significant challenge for the 21st 

century, to be addressed in light of the nation’s current deficit and growing 

structural fiscal imbalance.4

To help decisionmakers update programs to meet present and future 

challenges within current and expected resource levels, we framed 

illustrative questions for them to consider. While these questions can apply 

to other areas needing broad-based transformation, we specifically cited 

the myriad of food safety programs managed across several federal 

agencies. Among these questions are the following: 

• How can agencies partner or integrate their activities in new ways, 

especially with each other, on crosscutting issues, share accountability 

for crosscutting outcomes, and evaluate their individual and 

organizational contributions to these outcomes? 

• How can agencies more strategically manage their portfolio of tools 

and adopt more innovative methods to contribute to the achievement 

 3

GAO, Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping 

Inspections and Related Activities, GAO-05-549T (Washington, D.C.: May 17, 2004). 

4

GAO, 21st Century Challenges: Reexamining the Base of the Federal Government, 

GAO-05-325SP (Washington, D.C.: February 2005). 

Page 4 GAO-07-785T 
of national outcomes? 

Integration can create synergy and economies of scale and can provide 

more focused and efficient efforts to protect the nation’s food supply. 

Further, to respond to the nation’s pressing fiscal challenges, agencies may 

have to explore new ways to achieve their missions. 

Many of our recommendations to agencies to promote the safety and 

integrity of the nation’s food supply have been acted upon. For example, 

we recommended that FDA adopt a risk-based approach to overseeing 

states’ shellfish safety programs.5

 In response to our recommendation, 

FDA designed a risk-based approach to reviewing the states’ shellfish 

safety programs and incorporated it into their fiscal year 2003 to 2005 

compliance program, which FDA’s shellfish specialists use to evaluate

state programs. 

Nevertheless, as we discuss in the 2007 High-Risk Series, a fundamental 

reexamination of the federal food safety system is warranted. Taken as a 

whole, our work indicates that Congress and the executive branch can and 

should create the environment needed to look across the activities of 

individual programs within specific agencies and toward the goals that the

federal government is trying to achieve. Others have also called for 

fundamental changes to the federal food safety system overall. In 1998, the 

National Academy of Sciences concluded that the system is not well 

equipped to meet emerging challenges.

6

Going forward, to build a sustained focus on the safety and the integrity of 

the nation’s food supply, Congress and the executive branch can integrate 

various expectations for food safety with congressional oversight and 

through agencies’ strategic planning processes. The development of a 

governmentwide performance plan that is mission-based, is resultsoriented, and provides a cross-agency perspective offers a framework to 

help ensure agencies’ goals are complementary and mutually reinforcing. 

Further, this plan can help decisionmakers balance trade-offs and 

compare performance when resource allocation and restructuring 

decisions are made. 

 5

GAO, Food Safety: Federal Oversight of Shellfish Safety Needs Improvement, GAO-01-702

(Washington, D.C.: July 9, 2001). 

6

Institute of Medicine, Ensuring Safe Food from Production to Consumption, Washington,

D.C.: National Academy Press, 1998. 

Page 5 GAO-07-785T 
We have recommended, among other things, that Congress enact 

comprehensive, uniform, and risk-based food safety legislation and 

commission the National Academy of Sciences or a blue ribbon panel to 

conduct a detailed analysis of alternative organizational food safety 

structures.7 Members of this subcommittee and others have introduced 

food safety legislation, none of which has been enacted thus far. We also 

recommended that the executive branch reconvene the President’s 

Council on Food Safety to facilitate interagency coordination on food 

safety regulation and programs. According to documents on the council’s 

Web site, the current administration has not reconvened the council. 

These actions can begin to address the fragmentation in the federal 

oversight of food safety.

Among the reasons we designated federal oversight of food safety as a 

high-risk area is that limitations in the federal government’s food recalls 

heighten the risk that unsafe food will remain in the food supply and 

ultimately be consumed. Food recalls are largely voluntary, and federal 

agencies responsible for food safety have no authority to compel 

companies to carry out recalls in these cases, with the exception of FDA’s 

authority to require a recall for infant formula. Specifically, USDA does not 

have authority to issue a mandatory recall order for meat, poultry, and 

processed egg products. Similarly, FDA, which is responsible for virtually 

all other foods, does not have recall authority beyond infant formula. 

Limitations in Federal 

Agencies’ Recall 

Programs Heighten 

the Risk that Unsafe 

Food Will Reach 

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 agencies have 

the authority to 

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

potentially unsafe product, 

• order a recall, 

• establish recall requirements, and 

 7

GAO, Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food, 

GAO-02-47T (Washington, D.C.: Oct. 10, 2001). 

Page 6 GAO-07-785T 
• 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 $1.825 million if a company does not inform 

the commission promptly about an unsafe product. Furthermore, the 

National Highway Traffic Safety Administration has the authority to 

establish recall requirements to require companies to directly notify the 

purchasers of vehicles with defects and to remedy the defects. Likewise, 

FDA has authority to order recalls of unsafe biological products and 

medical devices—and it has used this authority in the past. In addition, 

FDA can impose penalties of up to $100,000 per day on companies that do 

not recall unsafe biological products, such as vaccines.8

Even in the context of their limited recall authority, we reported in 

October 2004 that USDA and FDA could do a better job in carrying out 

their food recall programs so they could quickly remove potentially unsafe 

food from the marketplace.9

 Specifically: 

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

were carrying out recalls. The agencies were not using their data 

systems to effectively monitor and manage their recall programs. They 

did not track important dates to calculate how long companies take to 

carry out recalls and the percentage of food that is recovered. 

Furthermore, managers did not receive routine reports on the progress 

of ongoing recalls to target program resources. Moreover, neither 

agency’s guidance provided time frames for how quickly companies 

should initiate and carry out recalls. Consequently, companies may 

have had less impetus to notify downstream customers and remove 

potentially unsafe food from the marketplace. 

• USDA and FDA did not promptly verify that recalls had reached all 

segments of the distribution chain, yet monitoring the effectiveness of 

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

For the 10 USDA recalls in 2003 we examined in depth, USDA staff 

 8

The statute requires that this be adjusted annually for inflation. We have not adjusted the 

$100,000 figure for inflation. 

9

GAO-05-51. 

Page 7 GAO-07-785T 
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. 

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

press releases and Web postings—may not have been 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. 

We have proposed 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. Congress has not enacted legislation granting agencies 

general mandatory recall authority. We have also recommended 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. 

According to agency officials, USDA and FDA are taking actions to 

address some of our recommendations. Specifically, they are currently 

updating their recall data systems. In addition, USDA amended a directive 

in order to improve its recall effectiveness checks and how it 

communicates information about recalls. FDA is also conducting a quality 

management review of its food recall system with a goal of providing a 

documented, uniform, and streamlined recall process. We have not 

reviewed these actions to determine if they adequately address our 

recommendations. 

The recent outbreaks of E. coli in spinach and Salmonella in peanut 

butter, along with outbreaks of contaminated pet food, underscore the 

need of a broad-based transformation of the federal oversight of food 

safety to achieve greater economy, efficiency, effectiveness, 

accountability, and sustainability. GAO’s high-risk designation raises the 

priority and visibility of this necessary transformation and thus can bring 

needed attention to address the weaknesses caused by a fragmented 

system. Among the reasons we designated the federal oversight of food 

safety as a high-risk area is that USDA and FDA have limited recall 

authority. Even within this limited authority, we found that these agencies 

could have done better in carrying out their food recall programs. 

Positively, agency officials are taking actions intended to improve their 

Page 8 GAO-07-785T 
food recall programs. However, we have not reviewed these actions to 

determine if they adequately address our recommendations. 

Mr. Chairman, this concludes my prepared statement. I would be pleased

to respond to any questions that you or other Members of the 

Subcommittee may have. 

Contact points for our Offices of Congressional Relations and Public 

Affairs may be found on the last page of this statement. For further 

information about this testimony, please contact Lisa Shames, Acting 

Director, Natural Resources and Environment at (202) 512-3841 or 

ShamesL@gao.gov. Key contributors to this statement were José Alfredo 

Gómez, Bart Fischer, Terrance N. Horner, Alison O’Neill, Beverly 

Peterson, and Rebecca Yurman. 

Page 9 GAO-07-785T 

Contact and Staff 

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