This is the accessible text file for GAO report number GAO-07-785T 
entitled 'Federal Oversight of Food Safety: High-Risk Designation Can 
Bring Attention to Limitations in the Government's Food Recall 
Programs' which was released on April 24, 2007. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as part 
of a longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov. 

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. 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. 

Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 

GAO: 

For Release on Delivery Expected at 9:30 a.m. EDT: 

Tuesday, April 24, 2007: 

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: 

GAO-07-785T: 

GAO Highlights: 

Highlights of GAO-07-785T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives 

Why GAO Did This Study: 

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 Found: 

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 
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 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. 

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 risk-based food safety legislation; analyze 
alternative organizational food safety structures; and consider 
legislation giving agencies authority to order food recalls. 

[Hyperlink, http://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. 

[End of section] 

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 foot-and-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.[Footnote 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 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.[Footnote 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. 

GAO's High-Risk Series Raises the Priority and Visibility of the Need 
to Transform Federal Oversight of Food Safety: 

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 high-risk 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: 

* 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. 

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. 

Fragmented Federal Oversight of Food Safety Led to High-Risk 
Designation: 

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. 

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 
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.[Footnote 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.[Footnote 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 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.[Footnote 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.[Footnote 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 results-oriented, 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. 

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.[Footnote 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. 

Limitations in Federal Agencies' Recall Programs Heighten the Risk that 
Unsafe Food Will Reach Consumers: 

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. 

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: 

* 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.[Footnote 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.[Footnote 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 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 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 and Staff Acknowledgments: 

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. 

FOOTNOTES 

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

[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). 

[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). 

[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. 

[7] GAO, Food Safety and Security: Fundamental Changes Needed to Ensure 
Safe Food, GAO-02-47T (Washington, D.C.: Oct. 10, 2001). 

[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.

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site (www.gao.gov). Each weekday, GAO posts 
newly released reports, testimony, and correspondence on its Web site. 
To have GAO e-mail you a list of newly posted products every afternoon, 
go to www.gao.gov and select "Subscribe to Updates.": 

Order by Mail or Phone: 

The first copy of each printed report is free. Additional copies are $2 
each. A check or money order should be made out to the Superintendent 
of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or 
more copies mailed to a single address are discounted 25 percent. 
Orders should be sent to: 

U.S. Government Accountability Office 441 G Street NW, Room LM 
Washington, D.C. 20548: 

To order by Phone: Voice: (202) 512-6000 TDD: (202) 512-2537 Fax: (202) 
512-6061: 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 

Web site: www.gao.gov/fraudnet/fraudnet.htm E-mail: fraudnet@gao.gov 
Automated answering system: (800) 424-5454 or (202) 512-7470: 

Congressional Relations: 

Gloria Jarmon, Managing Director, JarmonG@gao.gov (202) 512-4400 U.S. 
Government Accountability Office, 441 G Street NW, Room 7125 
Washington, D.C. 20548: 

Public Affairs: 

Paul Anderson, Managing Director, AndersonP1@gao.gov (202) 512-4800 
U.S. Government Accountability Office, 441 G Street NW, Room 7149 
Washington, D.C. 20548: