Federal Oversight of Food Safety: High-Risk Designation Can Bring
Attention to Limitations in the Government's Food Recall Programs
(24-APR-07, GAO-07-785T).					 
                                                                 
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.	 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-785T					        
    ACCNO:   A68708						        
  TITLE:     Federal Oversight of Food Safety: High-Risk Designation  
Can Bring Attention to Limitations in the Government's Food	 
Recall Programs 						 
     DATE:   04/24/2007 
  SUBJECT:   Consumer protection				 
	     Contaminated foods 				 
	     Food industry					 
	     Food inspection					 
	     Food supply					 
	     Health hazards					 
	     Product recalls					 
	     Product safety					 
	     Public health					 
	     Safety standards					 
	     Voluntary compliance				 
	     Government agency oversight			 
	     E. coli Bacteria					 
	     GAO High Risk Series				 
	     Salmonella Enteritidis Bacteria			 

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GAO-07-785T

   

     * [1]GAO's High-Risk Series Raises the Priority and Visibility of
     * [2]Fragmented Federal Oversight of Food Safety Led to High-Risk
     * [3]Limitations in Federal Agencies' Recall Programs Heighten th
     * [4]Contact and Staff Acknowledgments
     * [5]GAO's Mission
     * [6]Obtaining Copies of GAO Reports and Testimony

          * [7]Order by Mail or Phone

     * [8]To Report Fraud, Waste, and Abuse in Federal Programs
     * [9]Congressional Relations
     * [10]Public Affairs

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

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.^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.^2

1GAO, High-Risk Series: An Update, [11]GAO-07-310  (Washington, D.C.:
January 2007).

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

           o involved public health or safety, service delivery, national
           security, national defense, economic growth, or privacy or
           citizens' rights; or
           o could result in significantly impaired service, program failure,
           injury or loss of life, or significantly reduced economy,
           efficiency, or effectiveness.

^2GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food, [12]GAO-05-51 (Washington, D.C.: Oct.
6, 2004).

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.^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:

           o 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?
           o How can agencies more strategically manage their portfolio of
           tools and adopt more innovative methods to contribute to the
           achievement of national outcomes?

^3GAO, Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce
Overlapping Inspections and Related Activities, [13]GAO-05-549T
(Washington, D.C.: May 17, 2004).

^4GAO, 21st Century Challenges: Reexamining the Base of the Federal
Government, [14]GAO-05-325SP  (Washington, D.C.: February 2005).

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
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.

^5GAO, Food Safety: Federal Oversight of Shellfish Safety Needs
Improvement, [15]GAO-01-702 (Washington, D.C.: July 9, 2001).

^6Institute of Medicine, Ensuring Safe Food from Production to
Consumption, Washington, D.C.: National Academy Press, 1998.

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.

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

           o require a company to notify the agency when it has distributed a
           potentially unsafe product,
           o order a recall,
           o establish recall requirements, and
           o impose monetary penalties if a company does not cooperate.

^7GAO, Food Safety and Security: Fundamental Changes Needed to Ensure Safe
Food, [16]GAO-02-47T  (Washington, D.C.: Oct. 10, 2001).

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:

           o 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.
           o 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.

           o 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.

^8The statute requires that this be adjusted annually for inflation. We
have not adjusted the $100,000 figure for inflation.

^9 [17]GAO-05-51 .

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
[email protected]. Key contributors to this statement were Jose Alfredo
Gomez, Bart Fischer, Terrance N. Horner, Alison O'Neill, Beverly Peterson,
and Rebecca Yurman.

(360838)

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

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For more information, contact Lisa Shames at (202) 512-3841 or
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Highlights of [25]GAO-07-785T , a testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, House of
Representatives

April24, 2007

FEDERAL OVERSIGHT OF FOOD SAFETY

High-Risk Designation Can Bring Needed Attention to Limitations in the
Government's Food Recall Programs

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.

[26]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.

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.

References

Visible links
  11. http://www.gao.gov/cgi-bin/getrpt?GAO-07-310
  12. http://www.gao.gov/cgi-bin/getrpt?GAO-05-51
  13. http://www.gao.gov/cgi-bin/getrpt?GAO-05-549T
  14. http://www.gao.gov/cgi-bin/getrpt?GAO-05-325SP
  15. http://www.gao.gov/cgi-bin/getrpt?GAO-01-702
  16. http://www.gao.gov/cgi-bin/getrpt?GAO-02-47T
  17. http://www.gao.gov/cgi-bin/getrpt?GAO-05-51
  25. http://www.gao.gov/cgi-bin/getrpt?GAO-GAO-07-785T
*** End of document. ***