Federal Oversight of Food Safety
High-Risk Designation Can Bring Needed Attention to Fragmented System Gao ID: GAO-07-449T February 8, 2007Each year, about 76 million people contract a foodborne illness in the United States; about 325,000 require hospitalization; and about 5,000 die. While the recent E. coli outbreaks highlighted the risks posed by accidental 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) need to address federal oversight of food safety as a 21st century challenge. This work is based on previously issued reports.
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. 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. 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 other food. In many previous reports, GAO found that this fragmented system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources. For example, existing statutes give agencies different regulatory and enforcement authorities. Under current law, thousands of USDA inspectors must examine all slaughtered carcasses and visit all processing facilities at least once during each operating day. However, federal law does not mandate the frequency of inspection for foods that are under FDA's jurisdiction. Food recalls are generally voluntary. While USDA and FDA provide guidance to companies for carrying out voluntary recalls, they do not know how promptly and completely companies carry out recalls and do not promptly verify that recalls have reached the entire distribution chain. In addition, they use procedures that may not be effective to alert consumers to a recall. Federal agencies are spending resources on overlapping food safety activities. USDA and FDA both inspect shipments of imported food at 18 U.S. ports of entry but do not share inspection resources at these ports. Integrating the fragmented federal food safety system is a significant challenge for the 21st century, particularly in light of the nation's current deficit and growing structural fiscal imbalance. To help Congress review and reconsider the base of federal spending, GAO framed illustrative questions for decision makers to consider in 21st Century Challenges: Reexamining the Base of the Federal Government. Among these questions are how agencies can integrate and share accountability for their activities on crosscutting issues and how they can adopt more innovative methods to contribute to the achievement of national outcomes. While framing these questions, GAO specifically cited the myriad of food safety programs managed across several federal agencies.
GAO-07-449T, Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System
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Testimony:
Before the Subcommittee on Agriculture, Rural Development, FDA, and
Related Agencies, Committee on Appropriations, House of
Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 1:00 p.m. EST:
Thursday, February 8, 2007:
Federal Oversight Of Food Safety:
High-Risk Designation Can Bring Needed Attention to Fragmented System:
Statement of David M. Walker Comptroller General of the United States:
GAO-07-449T:
GAO Highlights:
Highlights of GAO-07-449T, a testimony before the Subcommittee on
Agriculture, Rural Development, FDA, and Related Agencies, Committee on
Appropriations, 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. While the recent E. coli outbreaks highlighted the risks posed by
accidental 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) need to address federal
oversight of food safety as a 21st century challenge. This work is
based on previously issued reports.
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. 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.
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 other food. In many
previous reports, GAO found that this fragmented system has caused
inconsistent oversight, ineffective coordination, and inefficient use
of resources. For example:
* Existing statutes give agencies different regulatory and enforcement
authorities. Under current law, thousands of USDA inspectors must
examine all slaughtered carcasses and visit all processing facilities
at least once during each operating day. However, federal law does not
mandate the frequency of inspection for foods that are under FDA‘s
jurisdiction.
* Food recalls are generally voluntary. While USDA and FDA provide
guidance to companies for carrying out voluntary recalls, they do not
know how promptly and completely companies carry out recalls and do not
promptly verify that recalls have reached the entire distribution
chain. In addition, they use procedures that may not be effective to
alert consumers to a recall.
* Federal agencies are spending resources on overlapping food safety
activities. USDA and FDA both inspect shipments of imported food at 18
U.S. ports of entry but do not share inspection resources at these
ports.
Integrating the fragmented federal food safety system is a significant
challenge for the 21st century, particularly in light of the nation‘s
current deficit and growing structural fiscal imbalance. To help
Congress review and reconsider the base of federal spending, GAO framed
illustrative questions for decision makers to consider in 21st Century
Challenges: Reexamining the Base of the Federal Government. Among these
questions are how agencies can integrate and share accountability for
their activities on crosscutting issues and how they can adopt more
innovative methods to contribute to the achievement of national
outcomes. While framing these questions, GAO specifically cited the
myriad of food safety programs managed across several federal agencies.
What GAO Recommends:
While many of GAO‘s recommendations to promote the safety of the
nation‘s food supply have been acted upon, others that are not yet
addressed could help Congress and the executive branch transform the
federal oversight of food safety. For example, GAO recommended that
Congress enact comprehensive, uniform, and risk-based food safety
legislation, and analyze alternative organizational food safety
structures. GAO also recommended that the executive branch reconvene
the President‘s Council on Food Safety to facilitate interagency
coordination. Finally, the development of a governmentwide performance
plan could help ensure agencies‘ goals are complementary.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-449T].
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 o section]
Madam Chairwoman 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. 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. In addition, 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 government can
more efficiently and effectively protect our nation's food supply. As a
result, we added the federal oversight of food safety to our list of
programs needing urgent attention and transformation in order to ensure
that our national government functions in the most economical,
efficient, and effective manner possible.[Footnote 1]
Our high-risk status reports are provided at the start of each new
Congress to help in setting congressional oversight agendas and to help
in raising the priority and visibility of government programs needing
transformation. 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 this regard, I recently provided
congressional leadership with a set of recommendations based on GAO's
work, including work on some areas we have designated as high risk, for
its consideration in developing the oversight agenda of the 110th
Congress.[Footnote 2] Together, the high-risk update and the
recommendations for oversight can help congressional decision makers
focus on the programmatic challenges facing the nation.
Because of your continuing interest in the effective use of food safety
resources, 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) the need to address
federal oversight of food safety as a 21st century challenge. My
testimony is based on published GAO products that were developed in
accordance with generally accepted government auditing standards.
Appendix I includes highlights of selected reports.
GAO's High-Risk Series Raises the Priority and Visibility of the Need
to Transform Federal Oversight of Food Safety:
Overall, our High-Risk Series has served to identify and help 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. With that in mind, we designated the federal oversight of food
safety as a high-risk area to raise the priority and visibility of the
need to transform the federal government's oversight system.
Since 1990, GAO has reported on government operations that we
identified as high risk and has periodically reported on the status of
progress to address high-risk areas and updated our high-risk list.
Historically, high-risk areas have been so designated because of
traditional vulnerabilities related to their greater susceptibility to
fraud, waste, abuse, and mismanagement. As our high-risk program has
evolved, we have increasingly used the high-risk designation to draw
attention to areas needing broad-based transformations to achieve
greater economy, efficiency, effectiveness, accountability, and
sustainability of selected key government programs and operations.
In determining whether a government program or operation is high risk,
we consider whether it has national significance or a management
function that is key to performance and accountability. Further, we
consider qualitative factors, such as whether the risk:
* involves 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.
We remove a high-risk designation when legislative and agency actions,
including those in response to our recommendations, result in
significant and sustainable progress toward resolving a high-risk
problem. Key determinants include a demonstrated strong commitment to
and top leadership support for addressing problems, the capacity to do
so, a corrective action plan, and demonstrated progress in implementing
corrective measures. The sustained attention and commitment by Congress
and agencies to resolve serious, long-standing high-risk problems have
paid off; because of sufficient progress, we were able to remove the
high-risk designation from 18 areas--more than half of our original
list. As we have with areas previously removed from the high-risk list,
we will continue to monitor these programs, as appropriate, to ensure
that the improvements we have noted are sustained.
For areas that remain on our high-risk list for 2007, there has been
important--but varying levels of--progress. Top administration
officials have expressed their commitment to ensuring that high-risk
areas receive adequate attention and oversight. The Office of
Management and Budget (OMB) has led an initiative to prompt agencies to
develop detailed action plans for each area on our high-risk list.
These plans are intended to identify specific goals and milestones that
address and reduce the risks we identified within each high-risk area.
Further, OMB has encouraged agencies to consult with us regarding the
problems our past work has identified and the many recommendations for
corrective actions we have made. While progress on developing and
implementing plans has been mixed, concerted efforts by agencies and
ongoing attention by OMB are critical.
In addition to the programs that remain on the list, we recently
designated three new areas as high risk, including the need to
transform federal oversight of food safety. For these recently added
areas, along with those remaining on the list, we expect that continued
perseverance will ultimately yield significant benefits. To begin 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 also 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:
For several years, we have reported on issues that suggest that food
safety could be designated as a high-risk area because of the need to
transform the federal oversight framework to reduce risks to public
health as well as the economy. Specifically, the patchwork 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 the integrity of the
nation's food supply. This challenge 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.
An accidental or deliberate contamination of food or the introduction
of disease to livestock, poultry, and crops could undermine consumer
confidence in the government's ability to ensure the safety of the U.S.
food supply and have severe economic consequences. 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. The value of U.S. agricultural exports exceeded
$68 billion in fiscal year 2006. 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 exports. Similarly, food contamination, such as the
recent E. coli outbreaks, can harm local economies. For example,
industry representatives estimate losses from the recent California
spinach E. coli outbreak to range from $37 million to $74 million.
While 15 agencies collectively administer 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
foods. Among other agencies with responsibilities related to food
safety, the National Marine Fisheries Service (NMFS) in the Department
of Commerce conducts voluntary, fee-for-service inspections of seafood
safety and quality; the Environmental Protection Agency (EPA) regulates
the use of pesticides and maximum allowable residue levels on food
commodities and animal feed; and the Department of Homeland Security
(DHS) is responsible for coordinating agencies' food security
activities.
The food safety system is further complicated by the subtle differences
in food products that dictate which agency regulates a product as well
as the frequency with which inspections occur. For example, 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). Although there are
no differences in the risks posed by these products, USDA inspects
wholesale manufacturers of open-face sandwiches sold in interstate
commerce daily, while FDA inspects manufacturers of closed-face
sandwiches an average of once every 5 years.
This 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 fragmented federal food
safety system and reported that the system has caused inconsistent
oversight, ineffective coordination, and inefficient use of resources.
Our most recent work demonstrates that these challenges persist.
Specifically:
* Existing statutes give agencies different regulatory and enforcement
authorities. For example, food products under FDA's jurisdiction may be
marketed without the agency's prior approval. On the other hand, food
products under USDA's jurisdiction must generally be inspected and
approved as meeting federal standards before being sold to the public.
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]
* Federal agencies are spending resources on overlapping food safety
activities.[Footnote 4] USDA and FDA both inspect shipments of imported
food at 18 U.S. ports of entry. However, these two agencies do not
share inspection resources at these ports. For example, USDA officials
told us that all USDA-import inspectors are assigned to, and located
at, USDA-approved import inspection facilities and some of these
facilities handle and store FDA-regulated products. USDA has no
jurisdiction over these FDA-regulated products. Although USDA maintains
a daily presence at these facilities, the FDA-regulated products may
remain at the facilities for some time awaiting FDA inspection. In
fiscal year 2003, USDA spent almost $16 million on imported food
inspections, and FDA spent more than $115 million.
* 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 provide guidance to companies for carrying out
voluntary recalls. We reported that USDA and FDA can do a better job in
carrying out their food recall programs so they can quickly remove
potentially unsafe food from the marketplace.[Footnote 5] These
agencies do not know how promptly and completely companies are carrying
out recalls, do not promptly verify that recalls have reached all
segments of the distribution chain, and use procedures that may not be
effective to alert consumers to a recall.
* The terrorist attacks of September 11, 2001, have heightened concerns
about agriculture's vulnerability to terrorism. The Homeland Security
Act of 2002 assigned DHS the lead coordination responsibility for
protecting the nation against terrorist attacks, including
agroterrorism. Subsequent presidential directives further define
agencies' specific roles in protecting agriculture and the food system
against terrorist attacks. We reported that in carrying out these new
responsibilities, agencies have taken steps to better manage the risks
of agroterrorism, including developing national plans and adopting
standard protocols.[Footnote 6] However, we also found several
management problems that can reduce the effectiveness of the agencies'
routine efforts to protect against agroterrorism. For example, there
are weaknesses in the flow of critical information among key
stakeholders and shortcomings in DHS's coordination of federal working
groups and research efforts.
* More than 80 percent of the seafood that Americans consume is
imported. We reported in 2001 that FDA's seafood inspection program did
not sufficiently protect consumers.[Footnote 7] For example, FDA tested
about 1 percent of imported seafood products. We subsequently found
that FDA's program has improved: More foreign firms are inspected, and
inspections show that more U.S. seafood importers are complying with
its requirements.[Footnote 8] Given FDA officials' concerns about
limited inspection resources, we also identified options, such as using
personnel in the National Oceanic and Atmospheric Administration's
(NOAA) Seafood Inspection Program to augment FDA's inspection capacity
or state regulatory laboratories for analyzing imported seafood. FDA
agreed with these options.
* In fiscal year 2003, four agencies--USDA, FDA, EPA, and NMFS--spent a
total of $1.7 billion on food safety-related activities.[Footnote 9]
USDA and FDA together were responsible for nearly 90 percent of federal
expenditures for food safety. However, these expenditures were not
based on the volume of foods regulated by the agencies or consumed by
the public. 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.
Federal Oversight of Food Safety Should Be Addressed as a 21st Century
Challenge:
We have cited the need to integrate the fragmented federal food safety
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 10] The traditional incremental approaches to
budgeting will need to give way to more fundamental reexamination of
the base of government. While prompted by fiscal necessity, such a
reexamination can serve the vital function of updating programs to meet
present and future challenges within current and expected resource
levels. To help Congress review and reconsider the base of federal
spending, we framed illustrative questions for decision makers 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. We
have identified such opportunities. For example, as I already
mentioned, USDA and FDA spend resources on overlapping food safety
activities, and we have made recommendations designed to reduce this
overlap. Similarly, regarding FDA's seafood inspection program, we have
discussed options for FDA to use personnel at NOAA to augment FDA's
inspection capacity.
Many of our recommendations to agencies to promote the safety and
integrity of the nation's food supply have been acted upon.
Nevertheless, as we discuss in the 2007 High-Risk Series, a fundamental
reexamination of the federal food safety system is warranted. Such a
reexamination would need to address criticisms that have been raised
about USDA's dual mission as both a promoter of agricultural and food
products and an overseer of their safety. 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.
To that end, 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 11] 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.
These actions can begin to address the fragmentation in the federal
oversight of food safety. 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
decision makers balance trade-offs and compare performance when
resource allocation and restructuring decisions are made.
As I have discussed, GAO designated the federal oversight of food
safety as a high-risk area that is in need of a broad-based
transformation to achieve greater economy, efficiency, effectiveness,
accountability, and sustainability. The 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. GAO stands ready to provide professional, objective,
fact-based, and nonpartisan information and thereby assist Congress as
it faces tough choices on how to fundamentally reexamine and transform
the government. Lasting solutions to high-risk problems offer the
potential to save billions of dollars, dramatically improve service to
the American public, strengthen public confidence and trust in the
performance and accountability of our national government, and ensure
the ability of government to deliver on its promises.
Madam Chairwoman, 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 Erin
Lansburgh, Bart Fischer, Alison O'Neill, and Beverly Peterson.
[End of section]
Appendix I: Highlights of Selected GAO Food Safety Reports:
GAO Highlights:
Highlights of GAO-05-213, a report to congressional requesters:
Why GAO Did This Study:
GAO has documented many problems resulting from the fragmented nature
of the federal food safety system and recommended fundamental
restructuring to ensure the effective use of scarce government
resources. In this report, GAO (1) identified overlaps in food safety
activities at USDA, FDA, EPA, and NMFS; (2) analyzed the extent to
which the agencies use interagency agreements to leverage resources;
and (3) obtained the views of stakeholders.
What GAO Found:
Several statutes give responsibility for different segments of the food
supply to different agencies to ensure that the food supply is safe.
The U.S. Department of Agriculture (USDA) and the Food and Drug
Administration (FDA) within the Department of Health and Human Services
(HHS) have the primary responsibility for regulating food safety, with
the Environmental Protection Agency (EPA) and the National Marine
Fisheries Service (NMFS) also involved. In carrying out their
responsibilities, with respect to both domestic and imported food,
these agencies spend resources on a number of overlapping activities,
such as inspection/enforcement, training, research, or rulemaking. For
example, both USDA and FDA conduct similar inspections at 1,451 dual
jurisdiction establishments”facilities that produce foods regulated by
both agencies. Under authority granted by the Bioterrorism Act of 2002,
FDA could authorize USDA inspectors to inspect these facilities, but it
has not done so. Furthermore, USDA and FDA maintain separate training
programs on similar topics for their inspectors that could be shared.
Ultimately, inspection and training resources could be used more
efficiently.
Common Elements of UDSA and FDA Inspections:
[See PDF for image]
[End of figure]
GAO identified 71 interagency agreements that the agencies entered into
to better protect public health and to coordinate their food safety
activities. However, the agencies have weak mechanisms for tracking
these agreements that, in some cases, lead to ineffective
implementation. Specifically, USDA and FDA are not fully implementing
an agreement to facilitate the exchange of information about dual
jurisdiction establishments, which both agencies inspect. In addition,
FDA and NMFS are not implementing an agreement designed to enable each
agency to discharge its seafood responsibilities effectively.
GAO spoke with selected industry associations, food companies, consumer
groups, and academic experts, and they disagree on the extent of
overlap and on how best to improve the food safety system. Most of
these stakeholders agreed that laws and regulations should be
modernized to more effectively and efficiently control food safety
hazards, but they differed about whether to consolidate food safety
functions into a single agency.
What GAO Recommends:
Recognizing the statutory constraints under which the agencies operate,
GAO, among other things, recommends that (1) if cost effective, FDA use
available authority to enter into an agreement to commission USDA
inspectors at jointly regulated facilities; (2) USDA and FDA consider
joint training programs; and (3) USDA, FDA, EPA and NMFS inventory,
evaluate, and update active interagency agreements. USDA generally did
not appear to agree with GAO‘s recommendations but recognized the
benefits of joint training for food inspectors. HHS (FDA) agreed with
GAO‘s recommendations to inventory, evaluate, and update the
interagency agreements and with GAO‘s recommendation to use USDA‘s
foreign country evaluations, but it disagreed with others. NMFS agreed
with GAO‘s recommendations, and EPA took no position.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-213].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Robert A. Robinson at
(202) 512-3841 or robinsonr@gao.gov.
[End of Highlights for GAO-05-213]
GAO Highlights:
Highlights of GAO-05-51, a report to congressional requesters:
Why GAO Did This Study:
Two large food recalls completed in 2003 were associated with 8 deaths
and nearly 100 serious illnesses in at least 16 states. Manufacturers
voluntarily recall potentially unsafe food by notifying their customers
to return or destroy it. The U.S. Department of Agriculture (USDA), for
meat, poultry, and egg products, and the Food and Drug Administration
(FDA), for other food, have programs to monitor voluntary food recalls,
verify that companies contact their customers, and maintain recall
data. GAO (1) examined the recall programs and procedures USDA and FDA
use to protect consumers from unsafe foods and (2) compared their food
recall authority with the authority of agencies to recall other
consumer products.
What GAO Found:
Weaknesses in USDA‘s and FDA‘s food recall programs heighten the risk
that unsafe food will remain in the food supply and ultimately be
consumed. Specifically, USDA and FDA do not know how promptly and
completely the recalling companies and their distributors and other
customers are carrying out recalls, and neither agency is using its
data systems to effectively track and manage its recall programs. For
these and other reasons, most recalled food is not recovered and
therefore may be consumed. GAO‘s analysis of recalls in 2003 showed
that about 38 percent and 36 percent of recalled food was ultimately
recovered in recalls overseen by USDA and FDA, respectively. These
agencies also told GAO of instances in which companies were slow to
reveal where they had distributed the food or provided inaccurate
customer lists. That distribution information is critical because
USDA‘s and FDA‘s primary role in recalls is to monitor the
effectiveness of a company‘s recall actions. To do so, the agencies
contact a sample of the distribution chain from these lists to verify
that customers in the food distribution chain received notice of the
recall, and that they located the food and removed it from the
marketplace. However, the methodology that the agencies use for
selecting the customers to check can result in entire segments of
complex distribution chains being overlooked. Moreover, GAO found that
the agencies did not complete verification checks for some recalls
before the shelf life of the food expired. In addition, consumer groups
and others question the usefulness of USDA‘s and FDA‘s efforts to
communicate with the public, suggesting alternatives such as posting
notices in grocery stores and direct notification of consumers.
Agencies responsible for the safety of products, such as toys, heart
pacemakers, and automobiles, have specific recall authority not
available to USDA and FDA for food. This includes the authority to (1)
require a company to notify the agency when it has distributed a
potentially unsafe product, (2) order a recall, (3) establish recall
requirements, and (4) impose monetary penalties if a company violates
recall requirements. For example, by law, companies must promptly
notify the Consumer Product Safety Commission after learning that a
product may pose an unreasonable risk of serious injury or death, or
face penalties of up to $1.65 million. Likewise, FDA has recall
authority for unsafe biological products, medical devices, radiation
emitting electronic products, and infant formula. Moreover, in contrast
to its inability to penalize a company that is slow to conduct a food
recall, FDA can impose penalties of up to $100,000 per day for a
company that fails to recall a defective biological product, such as a
vaccine.
What GAO Recommends:
GAO proposes that Congress consider legislation requiring a company to
notify USDA or FDA if it discovers it has distributed unsafe food and
giving agencies authority to order food recalls, and recommends that
the agencies take actions to ensure prompt, complete recalls and better
recall monitoring. USDA said the report was generally accurate and its
May 2004 directive will address weaknesses GAO found. FDA did not
believe its system lengthened recalls or its processes reduced
recovery. FDA disagreed with some recommendations. GAO continues to
believe its recommended actions are needed to protect consumers.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-51].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Lawrence J. Dyckman at
(202) 512-3841 or dyckmanl@gao.gov.
[End of Highlights for GAO-05-51]
GAO Highlights:
Highlights of GAO-05-214, a report to congressional requesters:
Why GAO Did This Study:
U.S. agriculture generates more than $1 trillion per year in economic
activity and provides an abundant food supply for Americans and others.
Since the September 11, 2001, attacks, there are new concerns about the
vulnerability of U.S. agriculture to the deliberate introduction of
animal and plant diseases (agroterrorism). Several agencies, including
the U.S. Department of Agriculture (USDA), the Department of Homeland
Security (DHS), the Department of Health and Human Services (HHS), the
Environmental Protection Agency (EPA), and the Department of Defense
(DOD), play a role in protecting the nation against agroterrorism. GAO
examined (1) the federal agencies‘ roles and responsibilities to
protect against agroterrorism, (2) the steps that the agencies have
taken to manage the risks of agroterrorism, and (3) the challenges and
problems that remain.
What GAO Found:
After the terrorist attacks of September 11, 2001, federal agencies‘
roles and responsibilities were modified in several ways to help
protect agriculture from an attack. First, the Homeland Security Act of
2002 established DHS and, among other things, charged it with
coordinating U.S. efforts to protect against agroterrorism. The act
also transferred a number of agency personnel and functions into DHS to
conduct planning, response, and recovery efforts. Second, the President
signed a number of presidential directives that further define
agencies‘ specific roles in protecting agriculture. Finally, Congress
passed legislation that expanded the responsibilities of USDA and HHS
in relation to agriculture security.
In carrying out these new responsibilities, USDA and other federal
agencies have taken a number of actions. The agencies are coordinating
development of plans and protocols to better manage the national
response to terrorism, including agroterrorism, and, along with several
states, have conducted exercises to test these new protocols and their
response capabilities. Federal agencies also have been conducting
vulnerability assessments of the agriculture infrastructure; have
created networks of laboratories capable of diagnosing animal, plant,
and human diseases; have begun efforts to develop a national veterinary
stockpile that intends to include vaccines against foreign animal
diseases; and have created new federal emergency coordinator positions
to help states develop emergency response plans for the agriculture
sector.
However, the United States still faces complex challenges that limit
the nation‘s ability to respond effectively to an attack against
livestock. For example, USDA would not be able to deploy animal
vaccines within 24 hours of an outbreak as called for in a presidential
directive, in part because the only vaccines currently stored in the
United States are for strains of foot and mouth disease, and these
vaccines need to be sent to the United Kingdom (U.K.) to be activated
for use. There are also management problems that inhibit the
effectiveness of agencies‘ efforts to protect against agroterrorism.
For instance, since the transfer of agricultural inspectors from USDA
to DHS in 2003, there have been fewer inspections of agricultural
products at the nation‘s ports of entry.
Burning Carcasses during the 2001 U.K. Outbreak of Foot and Mouth
Disease:
What GAO Recommends:
To enhance the agencies‘ ability to reduce the risk of agroterrorism,
GAO recommends, among other things, that (1) USDA examine the costs and
benefits of developing stockpiles of ready-to-use vaccines and (2) DHS
and USDA determine the reasons for declining agricultural inspections.
USDA, DHS, and HHS generally agreed with our recommendations. DOD and
EPA made technical comments but took no position on the report‘s
recommendations.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-214].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Robert Robinson, 202-512-
3841, Robinsonr@gao.gov.
[End of Highlights for GAO-05-214]
GAO Highlights:
Highlights of GAO-04-246, a report to congressional requesters
Why GAO Did This Study:
More than 80 percent of the seafood that Americans consume is
imported. The Food and Drug Administration (FDA) is responsible for
ensuring that imported seafood is safe and produced under sanitation
and safety systems comparable to those of the United States. Since GAO
reported in 2001 that FDA‘s seafood inspection program did not
sufficiently protect consumers, additional concerns have arisen about
imported seafood containing banned substances, such as certain
antibiotics. In this review, GAO was asked to evaluate (1) FDA‘s
progress in implementing the recommendations in the 2001 report and
(2) other options to enhance FDA‘s oversight.
What GAO Found:
Since GAO‘s January 2001 report, FDA‘s imported seafood safety program
has shown some improvement. FDA inspects more foreign firms, and its
inspections show that more U.S. seafood importers are complying with
its requirements. FDA also slightly increased the number of seafood
products it tests at U.S. ports of entry to just over 1 percent.
However, FDA still has not established equivalence agreements with
seafood exporting countries as GAO recommended in its 2001 report.
Equivalence agreements that commit U.S. trading partners to maintain
comparable food safety systems are an efficient way to ensure imported
seafood safety. Unlike the U.S. Department of Agriculture, FDA is not
legally required to certify that countries exporting food products to
the United States have equivalent food safety systems. According to a
panel of nationally recognized experts that GAO convened to address
this and other issues, establishing these types of agreements would
shift some of FDA‘s burden for ensuring seafood safety to foreign
governments. This shift, in turn, would allow FDA to focus its limited
resources on seafood products from countries with less advanced food
safety systems.
FDA also made little progress regarding the recommendation GAO made in
2001 that FDA communicate to U.S. port-of-entry personnel serious
deficiencies identified during inspections so that potentially
contaminated imported seafood is examined before it enters the United
States. GAO found that FDA continues to experience long delays between
finding deficiencies and taking action. For example, GAO‘s review of
foreign firm inspection records found that it took an average of 348
days for FDA to alert port-of-entry personnel about serious safety
problems identified at six foreign firms. Moreover, GAO found that FDA
does not prioritize enforcement actions when violations that pose the
most serious public health risk occur or have an automated system to
track the time involved in documenting, reviewing, and processing
enforcement actions.
FDA officials acknowledged some of the problems that GAO identified
regarding FDA‘s current imported seafood inspection program, but they
also raised concerns about limited inspection resources and competing
priorities, such as the recent need to implement provisions of the
Bioterrorism Act of 2002. GAO identified several options that FDA
could consider to augment its resources and enhance its current
program, including (1) commissioning seafood inspectors from the
National Oceanic and Atmospheric Administration‘s (NOAA) Seafood
Inspection Program, (2) using state regulatory laboratories and/or
private laboratories to augment FDA‘s testing of imported seafood, and
(3) developing a program to use third-party inspectors to augment its
program.
What GAO Recommends:
GAO recommends that FDA (1) work toward developing a memorandum of
understanding with NOAA to use NOAA‘s resources; (2) make it a
priority to establish equivalence or other agreements, starting with
countries having high-quality food safety systems; (3) develop a
system to track the time involved in processing enforcement actions;
(4) give enforcement priority to violations posing the most serious
risks; (5) consider accrediting private laboratories; and (6) explore
the potential for certifying third-party inspectors. FDA generally
agreed with all but the recommendation on making it a priority to
establish equivalence or other agreements.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-04-246].
To view the full product, including the scope and methodology, click
on the link above. For more information, contact Lawrence J. Dyckman
at (202) 512-3841 or dyckmanl@gao.gov.
[End of Highlights for GAO-04-246]
[End of section]
Related GAO Products:
Homeland Security: Management and Coordination Problems Increase the
Vulnerability of U.S. Agriculture to Foreign Pests and Disease. GAO-06-
644. Washington, D.C.: May 19, 2006.
Oversight of Food Safety Activities: Federal Agencies Should Pursue
Opportunities to Reduce Overlap and Better Leverage Resources. GAO-05-
213. Washington, D.C.: March 30, 2005.
Food Safety: Experiences of Seven Countries in Consolidating Their Food
Safety Systems. GAO-05-212. Washington, D.C.: February 22, 2005.
Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food. GAO-05-51. Washington, D.C.:
October 6, 2004.
Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to
Address Risk to Humans from Antibiotic Use in Animals. GAO-04-490.
Washington, D.C.: April 22, 2004.
School Meal Program: Few Instances of Foodborne Outbreaks Reported, but
Opportunities Exist to Enhance Outbreak Data and Food Safety Practices.
GAO-03-530. Washington, D.C.: May 9, 2003.
Food-Processing Security: Voluntary Efforts Are Under Way, but Federal
Agencies Cannot Fully Assess Their Implementation. GAO-03-342.
Washington, D.C.: February 14, 2003.
Meat and Poultry: Better USDA Oversight and Enforcement of Safety Rules
Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902. Washington,
D.C.: August 30, 2002.
Genetically Modified Foods: Experts View Regimen of Safety Tests as
Adequate, but FDA's Evaluation Process Could Be Enhanced. GAO-02-566.
Washington, D.C.: May 23, 2002.
Food Safety: Improvements Needed in Overseeing the Safety of Dietary
Supplements and "Functional Foods." GAO/RCED-00-156. Washington, D.C.:
July 11, 2000.
FOOTNOTES
[1] GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.:
January 2007).
[2] GAO, Suggested Areas for Oversight for the 110th Congress, GAO-07-
235R (Washington, D.C.: Nov. 17, 2006).
[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, Oversight of Food Safety Activities: Federal Agencies Should
Pursue Opportunities to Reduce Overlap and Better Leverage Resources,
GAO-05-213 (Washington, D.C.: Mar. 30, 2005).
[5] 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).
[6] GAO, Homeland Security: Much Is Being Done to Protect Agriculture
from a Terrorist Attack, but Important Challenges Remain, GAO-05-214
(Washington, D.C.: Mar. 8, 2005).
[7] GAO, Food Safety: Federal Oversight of Seafood Does Not
Sufficiently Protect Consumers, GAO-01-204 (Washington, D.C.: Jan. 31,
2001).
[8] GAO, Food Safety: FDA's Imported Seafood Safety Program Shows Some
Progress, but Further Improvements Are Needed, GAO-04-246 (Washington,
D.C.: Jan. 30, 2004).
[9] 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, 2005).
[10] GAO, 21st Century Challenges: Reexamining the Base of the Federal
Government, GAO-05-325SP (Washington, D.C.: February 2005).
[11] GAO, Food Safety and Security: Fundamental Changes Needed to
Ensure Safe Food, GAO-02-47T (Washington, D.C.: Oct. 10, 2001).
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