Federal Oversight of Food Safety
High-Risk Designation Can Bring Attention to Limitations in the Government's Food Recall Programs Gao ID: GAO-07-785T April 24, 2007Each 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.
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.
GAO-07-785T, Federal Oversight of Food Safety: High-Risk Designation Can Bring Attention to Limitations in the Government's Food Recall Programs
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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.
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