Federal Food Safety and Security System
Fundamental Restructuring Is Needed to Address Fragmentation and Overlap Gao ID: GAO-04-588T March 30, 2004The safety of the U.S. food supply is governed by a highly complex system of more than 30 laws administered by 12 agencies. In light of the recent focus on government reorganization, it is time to ask whether the current system can effectively and efficiently respond to today's challenges. At the request of the Subcommittee on Civil Service and Agency Organization, we reviewed and summarized our work on the safety and security of the food supply regarding (1) the fragmented legal and organizational structure of the federal food safety system, (2) the consequences of overlapping and inconsistent inspection and enforcement, and (3) options for consolidating food safety functions.
As we have stated in numerous reports and testimonies, the federal food safety system is not the product of strategic design. Rather, it emerged piecemeal, over many decades, typically in response to particular health threats or economic crises. The result is a fragmented legal and organizational structure that gives responsibility for specific food commodities to different agencies and provides them with significantly different authorities and responsibilities. The existing food safety statutes create fragmented jurisdictions between the two principal food safety agencies, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). As a result, there are inconsistencies in the frequency of the agencies' inspections of food facilities and the enforcement authorities available to these agencies. In short, which agency has jurisdiction to regulate various food products, the regulatory authorities they have available to them, and how frequently they inspect food facilities is determined by disparate statutes or by administrative agreement between the two agencies, without strategic design as to how to best protect public health. In many instances, food processing facilities are inspected by both FDA and USDA. Furthermore, federal food safety efforts are based on statutory requirements, not risk. For example, funding for USDA and FDA is not proportionate to the amount of food products each agency regulates, to the level of public consumption of those foods, or to the frequency of foodborne illnesses associated with food products. A federal food safety system with diffused and overlapping lines of authority and responsibility cannot effectively and efficiently accomplish its mission and meet new food safety challenges. These challenges are more pressing today as we face emerging threats such as mad cow disease and the potential for deliberate contamination of our food supply through bioterrorism. Therefore, fundamental changes are needed. First, there is a need to overhaul existing food safety legislation to make it uniform, consistent, and risk based. Second, consolidation of food safety agencies under a single independent agency or a single department is needed to improve the effectiveness and efficiency of the current federal food safety system. Integrating the overlapping responsibilities for food safety into a single agency or department can create synergy and economies of scale, as well as provide more focused and efficient efforts to protect the nation's food supply.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-04-588T, Federal Food Safety and Security System: Fundamental Restructuring Is Needed to Address Fragmentation and Overlap
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Testimony:
Before the Subcommittee on Civil Service and Agency Organization,
Committee on Government Reform, House of Representatives:
United States General Accounting Office:
GAO:
For Release on Delivery Expected at 3:00 p.m. EST Tuesday, March 30,
2004:
Federal Food Safety and Security System:
Fundamental Restructuring Is Needed to Address Fragmentation and
Overlap:
Statement of Lawrence J. Dyckman, Director, Natural Resources and
Environment:
GAO-04-588T:
GAO Highlights:
Highlights of GAO-04-588T, testimony before the House Subcommittee on
Civil Service and Agency Organization, Committee on Government Reform
Why GAO Did This Study:
The safety of the U.S. food supply is governed by a highly complex
system of more than 30 laws administered by 12 agencies. In light of
the recent focus on government reorganization, it is time to ask
whether the current system can effectively and efficiently respond to
today‘s challenges.
At the request of the Subcommittee on Civil Service and Agency
Organization, we reviewed and summarized our work on the safety and
security of the food supply regarding (1) the fragmented legal and
organizational structure of the federal food safety system, (2) the
consequences of overlapping and inconsistent inspection and
enforcement, and (3) options for consolidating food safety functions.
What GAO Found:
As we have stated in numerous reports and testimonies, the federal food
safety system is not the product of strategic design. Rather, it
emerged piecemeal, over many decades, typically in response to
particular health threats or economic crises. The result is a
fragmented legal and organizational structure that gives responsibility
for specific food commodities to different agencies and provides them
with significantly different authorities and responsibilities.
The existing food safety statutes create fragmented jurisdictions
between the two principal food safety agencies, the Food and Drug
Administration (FDA) and the U.S. Department of Agriculture (USDA). As
a result, there are inconsistencies in the frequency of the agencies‘
inspections of food facilities and the enforcement authorities
available to these agencies. In short, which agency has jurisdiction to
regulate various food products, the regulatory authorities they have
available to them, and how frequently they inspect food facilities is
determined by disparate statutes or by administrative agreement between
the two agencies, without strategic design as to how to best protect
public health. In many instances, food processing facilities are
inspected by both FDA and USDA. Furthermore, federal food safety
efforts are based on statutory requirements, not risk. For example,
funding for USDA and FDA is not proportionate to the amount of food
products each agency regulates, to the level of public consumption of
those foods, or to the frequency of foodborne illnesses associated with
food products.
A federal food safety system with diffused and overlapping lines of
authority and responsibility cannot effectively and efficiently
accomplish its mission and meet new food safety challenges. These
challenges are more pressing today as we face emerging threats such as
mad cow disease and the potential for deliberate contamination of our
food supply through bioterrorism.
Therefore, fundamental changes are needed. First, there is a need to
overhaul existing food safety legislation to make it uniform,
consistent, and risk based. Second, consolidation of food safety
agencies under a single independent agency or a single department is
needed to improve the effectiveness and efficiency of the current
federal food safety system. Integrating the overlapping
responsibilities for food safety into a single agency or department can
create synergy and economies of scale, as well as provide more focused
and efficient efforts to protect the nation‘s food supply.
What GAO Recommends:
GAO suggests that the Congress consider (1) enacting comprehensive,
uniform, and risk-based food safety legislation and (2) establishing a
single, independent food safety agency. Alternatively, GAO suggests
that the Congress consider modifying existing laws to designate one
current agency as the lead agency responsible for all food safety
inspection matters.
This testimony is based on dozens of GAO products issued since 1992 and
ongoing reviews related to food safety and security efforts. A list of
GAO reports and testimonies is contained in appendix III.
www.gao.gov/cgi-bin/getrpt?GAO-04-588T.
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 section]
Madam Chairwoman and Members of the Subcommittee:
I am pleased to be here today before the Committee on Government
Reform's Subcommittee on Civil Service and Agency Organization to
discuss the Subcommittee's interest in streamlining the federal
government. Today, I will discuss our work on the federal food safety
system and whether its current design provides sufficient protection
for consumers while ensuring logical and effective use of scarce
government resources. In recent testimony before this Subcommittee, the
Chairman of the National Commission on the Public Service, Mr. Paul
Volcker, recommended that government programs that are designed to
achieve similar outcomes be combined into one agency and that agencies
with similar or related missions be combined into large departments
that encourage cooperation, achieve economies of scale in management,
and facilitate responsiveness to political leadership. He noted that
important health and safety protections fail when responsibility for
regulation is dispersed among several departments, as is the case with
our federal food safety system.
At GAO we concur with this view. In his September 2003 testimony, the
Comptroller General stressed the importance of beginning to take steps
to achieve fundamental reorganization of the federal government into a
limited number of mission-related executive departments. His testimony
pointed out that redundant, unfocused, and uncoordinated programs waste
scarce resources, confuse and frustrate program customers, and limit
overall program effectiveness. Based on GAO's substantive body of work
on the federal food safety system and as we have testified in the past,
we believe that overhauling existing food safety statutes,
consolidating food safety agencies under a single independent agency or
a single department, and streamlining inspection and enforcement
efforts would improve the effectiveness and efficiency of the current
federal food safety system.
While the food supply is generally safe, each year tens of millions of
Americans become ill and thousands die from eating unsafe food. The
federal government spends about $1.3 billion annually[Footnote 1] to
ensure the safety of domestic and imported foods, and estimates that
the costs associated with foodborne illnesses are about $7 billion,
including medical costs and productivity losses from missed work. As we
have stated in previous reports and testimonies, the nation's food
safety system is a patchwork structure that hampers efforts to address
the risks of inadvertent or deliberate food contamination. Fundamental
changes are needed to correct deficiencies in the system, reduce
overlap and duplication, and ensure a safer food supply. In summary, a
system with diffused and overlapping lines of authority and
responsibility cannot effectively and efficiently accomplish its
mission and meet new food safety challenges. These challenges are more
pressing today as we face emerging threats associated with diseases
like bovine spongiform encephalopathy (BSE), better known as mad cow
disease, and the potential for the deliberate contamination of our food
supply through bioterrorism.
My testimony today provides an overview of the government's fragmented
food safety system, the consequences of overlapping and inconsistent
inspection and enforcement, and options for consolidating food safety
functions. I will also provide a brief overview of the agencies' roles
in addressing the emerging threat of a bioterrorism act against the
nation's food supply and for protecting the U.S. from mad cow disease.
This testimony draws upon our wide-ranging, ongoing, and completed work
on food safety and upon completed work and previous testimonies on
issues related to government organization and transformation. We used
updated data on agency expenditures and numbers of employees and
establishments that we obtained from the agencies. We used consumer
expenditures data from the Bureau of Labor Statistics (BLS) and
analyzed foodborne illness outbreaks data from the Centers for Disease
Control and Prevention (CDC). To assess the reliability of these data,
we reviewed existing documentation about the data and the systems that
produced them and interviewed agency officials knowledgeable about the
data; we determined that the data were sufficiently reliable for the
purposes of this testimony. We conducted our work in accordance with
generally accepted government auditing standards.
Background:
The safety and quality of the U.S. food supply is governed by a highly
complex system that is based on more than 30 laws and administered by
12 agencies. In addition, there are over 50 interagency agreements to
govern the combined food safety oversight responsibilities of the
various agencies. The federal system is supplemented by the states,
which have their own statutes, regulations, and agencies for regulating
and inspecting the safety and quality of food products. The United
States Department of Agriculture (USDA) and the Food and Drug
Administration (FDA), within the Department of Health and Human
Services (HHS), have most of the regulatory responsibilities for
ensuring the safety of the nation's food supply and account for most
federal food safety spending. Under the Federal Meat Inspection Act,
the Poultry Products Inspection Act, and the Egg Products Inspection
Act, USDA is responsible for the safety of meat, poultry, and certain
egg products. FDA, under the Federal Food, Drug, and Cosmetic Act, and
the Public Health Service Act, regulates all other foods, including
whole (or shell) eggs, seafood, milk, grain products, and fruits and
vegetables.[Footnote 2] Appendix I summarizes the agencies'
responsibilities.
Existing statutes give the 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. Although recent legislative changes have
strengthened FDA's enforcement authorities, the division of inspection
authorities and other food safety responsibilities has not changed.
As we have reported, USDA traditionally had more comprehensive
enforcement authority than FDA; however, the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 has granted FDA
additional enforcement authorities that are similar to USDA's. For
example, FDA can now require all food processors to register with the
agency so that they can be inspected. FDA can also temporarily detain
food products when there is credible evidence that the products present
a threat of serious adverse health consequences, and FDA can require
that entities such as the manufacturers, processors, and receivers of
imported foods keep records to allow FDA to identify the immediate
previous source and the immediate subsequent recipients of food,
including its packaging. This record keeping authority is designed to
help FDA track foods in the event of future health emergencies, such as
terrorism-related contamination. In addition, FDA now has the authority
to require advance notice of imported food shipments under its
jurisdiction. Despite the additional enforcement authorities recently
granted to FDA, important differences between the agencies' inspection
and enforcement authorities remain.
Finally, in addition to their established food safety and quality
responsibilities, following the events of September 11, 2001, the
federal agencies began to address the potential for deliberate
contamination of agriculture and food products. In 2001, by Executive
Order, the President added the food industries to the list of critical
infrastructure sectors that need protection from possible terrorist
attack. As a result of this Executive Order, the Homeland Security Act
of 2002 establishing the Department of Homeland Security, and
subsequent Presidential Directives, the Department of Homeland Security
provides overall direction on how to protect the U.S. food supply from
deliberate contamination. The Public Health Security and Bioterrorism
Preparedness and Response Act also included numerous provisions to
strengthen and enhance food safety and security.
Fragmented System Hampers the Efficiency and Effectiveness of Food
Safety Efforts:
As we have stated in numerous reports and testimonies, the fragmented
federal food safety system is not the product of strategic
design.[Footnote 3] Rather, it emerged piecemeal, over many decades,
typically in response to particular health threats or economic crises.
In short, what authorities agencies have to enforce food safety
regulations, which agency has jurisdiction to regulate what food
products, and how frequently they inspect food facilities is determined
by the legislation that governs each agency, or by administrative
agreement between the two agencies, without strategic design as to how
to best protect public health. It is important to understand that the
origin of this problem is historical and, for the most part, grounded
in the federal laws governing food safety. We and other organizations,
including the National Academies, have issued many reports detailing
problems with the federal food safety system and have made numerous
recommendations for change. While many of these recommendations have
been acted upon, problems in the food safety system persist, largely
because food safety responsibilities are still divided among agencies
that continue to operate under different laws and regulations. As a
result there is fragmentation, inconsistency, and overlap in the
federal food safety system. These problems are manifested in numerous
ways as discussed below.
* Federal agencies have overlapping oversight responsibilities. Agency
jurisdictions either assigned by law over time or determined by agency
agreements result in overlapping oversight of single food products. For
example, which agency is responsible for ensuring the safety of frozen
pizzas depends on whether or not pepperoni is used as a topping. Figure
1 shows the agencies involved in regulating the safety of frozen pizza.
Figure 1: Federal Agencies Responsible for Ensuring Safe Pizza:
[See PDF for image]
[End of figure]
In other instances, such as canned soups, it is the amount of a
particular ingredient contained in the food product that governs
whether it is subject to FDA or USDA inspection. As a result, canned
soup producers are also subject to overlapping jurisdiction by the two
food safety agencies.
* Overlap and duplication result in inefficient use of inspection
resources. Food processing establishments may be inspected by more than
one federal agency because they process foods that are regulated under
different federal laws or because they participate in voluntary
inspection programs. As of February 2004, FDA's records show that there
are about 2,000 food processing facilities in the United States that
may handle foods regulated by both FDA and USDA because their products
include a variety of ingredients. Multi-ingredient products that are
regulated by both FDA and USDA include pizza, canned soups, and
sandwiches. GAO found that 514 of the 8,653 FDA inspections conducted
in six states between October 1987 and March 1991, duplicated those of
other federal agencies. For example, FSIS had five inspectors assigned
full time to a plant that processed soups containing meat or poultry,
yet FDA inspected the same plant because it also processed soups that
did not contain meat or poultry. Thus, rather than having the full-time
inspectors assigned to the plant conduct inspections for all the
plant's products, additional inspectors from another agency were
required to conduct separate inspections of products as a result of the
different ingredients contained in the product.
Moreover, there is also inefficient use of federal inspection resources
dedicated to overseeing the safety of seafood products. FDA has
responsibility for ensuring the safety of domestic and imported seafood
products. However, as we reported in January 2004, the NOAA Seafood
Inspection Program also provides fee-for-service safety, sanitation,
and/or product inspections for approximately 2,500 foreign and domestic
firms annually. Thus, both FDA and NOAA's programs duplicate
inspections of seafood firms. To make more efficient use of federal
inspection resources, we have recommended that FDA work toward
developing a memorandum of understanding that leverages NOAA's Seafood
Inspection Program resources to augment FDA's inspection capabilities.
* Federal agencies' different authorities result in inconsistent
inspection and enforcement. Despite the additional enforcement
authorities granted to FDA by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, differences between
the agencies' inspection and enforcement authorities remain. For
example, when FSIS inspectors observe serious noncompliance with USDA's
food safety regulations, they have the authority to immediately
withdraw their inspection services. This effectively stops plant
operations because a USDA inspector must be present and food products
under USDA's jurisdiction generally must be inspected and approved as
meeting federal standards before being sold to the public. This ensures
more timely correction of problems that could affect the safety of meat
and poultry products. In contrast, food products under FDA's
jurisdiction may be marketed without the agency's prior approval. Thus,
while FDA may temporarily detain food products when there is credible
evidence that the products present a threat of serious adverse health
consequences, FDA currently has no authority comparable with USDA's
allowing it to stop plant operations. As a result, problems identified
during FDA inspections may take longer to correct.
* Federal agencies' different authorities to oversee imported foods
also result in inconsistent efforts to ensure safety. A significant
amount of the food we consume is imported; yet, as we have testified in
the past, the same fragmented structure and inconsistent regulatory
approach is being used to ensure the safety of imported foods. For
example, more than three-quarters of the seafood Americans consume is
imported from an estimated 13,000 foreign suppliers in about 160
different countries.[Footnote 4] As we have reported, however, FDA's
system for ensuring the safety of imported seafood does not
sufficiently protect consumers. For example, the agency inspected about
100 of roughly 13,000 foreign firms in 2002 and tested slightly over 1
percent of imported seafood products. In January 2004, we reported that
despite some improvements, FDA is still able to inspect only a small
proportion of U.S. seafood importers and visit few seafood firms
overseas yearly. As we have previously recommended, a better
alternative would be to strengthen FDA's ability to ensure the safety
of imported foods by requiring that all food eligible for importation
to the United States be produced under equivalent food safety systems.
USDA has such authority. In fact, USDA is legally required to review
certifications made by other countries that their meat and poultry food
safety systems ensure compliance with U.S. standards and USDA must also
conduct on-site inspections before those products can be exported to
the United States. At this time, 37 countries are approved to export
meat and poultry products to the United States.
* Frequency of inspections is not based on risk. Under current law,
USDA inspectors maintain continuous inspection at slaughter facilities
and examine each slaughtered meat and poultry carcass. They also visit
each processing plant at least once during each operating day. For
foods under FDA jurisdiction, however, federal law does not mandate the
frequency of inspections. The differences in inspection frequencies
are, at times, quite arbitrary, as in the case of jointly regulated
food products. For example, as we testified in 2001, federal
responsibilities for regulating the production and processing of a
packaged ham and cheese sandwich depends on whether the sandwich is
made with one or two slices of bread, not on the risk associated with
its ingredients. As a result, facilities that produce closed-faced
sandwiches are inspected on average once every 5 years by FDA, whereas
facilities that produce open-faced sandwiches are inspected daily by
FSIS.
* Federal expenditures are not based on the volume of foods regulated,
consumed, or their risk of foodborne illness. FDA and FSIS food safety
efforts are based on the respective legislation governing their
operation. As a result, expenditures for food safety activities are
disproportionate to the amount of food products each agency regulates
and to the level of public consumption of those food products. FDA is
responsible for ensuring the safety of approximately 79 percent of the
foods Americans consume annually, while its budget represented only 40
percent ($508 million) of the approximately $1.3 billion spent on food
safety oversight during fiscal year 2003. In contrast, FSIS inspects
approximately 21 percent of the foods Americans consume annually, while
its food safety budget represented 60 percent ($756 million) of the
federal expenditures for food safety in 2003. Figure 2 shows the
imbalance between the dollar amounts that the agencies spend on food
safety activities and the volume of foods Americans consume annually.
Figure 2: Comparison of Agencies' Food Safety Expenditures Versus
Consumers' Annual Food Expenditures[Footnote 5]
[See PDF for image]
[End of figure]
Perhaps more importantly, the agencies' food safety expenditures are
disproportionate to the percentage of foodborne illnesses linked to the
food products they regulate. For example, according to foodborne
illness data compiled by the CDC, USDA-regulated foods account for
about 32 percent of reported foodborne outbreaks with known sources.
Conversely, FDA-regulated foods account for about 68 percent of these
outbreaks. (See fig. 3.) Yet, USDA's food safety expenditures are about
49 percent more than FDA's.
Figure 3: Percentage of Foodborne Outbreaks Associated with Products
Regulated by FDA and USDA from 1993-1997:
[See PDF for image]
Note: Only major food categories under each agency's jurisdiction are
included.
[End of figure]
Finally, as figure 4 shows, FSIS has 9,170 employees that are, by law,
responsible for daily oversight of approximately 6,464 meat, poultry,
and egg product plants. FDA has roughly 1,900 food inspection employees
who, among other things, inspect about 57,000 food establishments.
Figure 4: FDA and USDA Fiscal Year 2003 Inspection Resources Versus
Facilities Regulated by Each Agency:
[See PDF for image]
[End of figure]
* Overlaps in egg safety responsibility compromise safety. Overlapping
responsibilities have resulted in extensive delays in the development
of a comprehensive regulatory strategy to ensure egg safety. As we have
reported, no single federal agency has overall responsibility for the
policies and activities needed to ensure the safety and quality of eggs
and egg products. Figure 5 shows the overlapping responsibilities of
multiple agencies involved in overseeing the production, processing,
and transportation of eggs and egg products.
Figure 5: Federal Oversight of Egg Production, Processing and
Transportation:
[See PDF for image]
[End of figure]
As shown in figure 5, FDA has the primary responsibility for the safe
production and processing of eggs still in the shell (known by industry
as shell eggs), whereas FSIS has the responsibility for food safety at
the processing plants where eggs are broken to create egg products.
Despite FSIS and FDA attempts to coordinate their efforts on egg
safety, more than 10 years have passed since the problem of bacterial
contamination of intact shell eggs was first identified, and a
comprehensive safety strategy has yet to be implemented. Agency
representatives serving on the President's Council on Food Safety
developed an Egg Safety Action Plan in 2000 and identified egg safety
as one component of food safety that warranted immediate federal,
interagency action. As of March 2004, comprehensive regulations to
implement the actions the agencies identified in the Action Plan have
not been published.[Footnote 6]
* Claims of health benefits for foods may be treated inconsistently by
different federal agencies. Overlaps also exist in the area of health
benefit claims associated with certain foods and dietary supplements.
FDA, USDA, and the Federal Trade Commission (FTC) share responsibility
for determining what types of health benefit claims are allowed on
product labels and in advertisements. The varying statutory
requirements among the agencies can lead to inconsistencies in labeling
and advertisements. As a result, the use of certain health benefit
claims on a product might be denied by one agency but allowed by
another. For example, the FTC may allow a health claim in an
advertisement as long as it meets the requirements of the Federal Trade
Commission Act, even if FDA has not approved it for use on a label.
Similarly, USDA reviews requests to use health claims on a case-by-case
basis, regardless of whether or not FDA has approved them. Thus,
consumers face a confusing array of claims, which may lead them to make
inappropriate dietary choices.
* Multiple agencies must respond when serious food safety challenges
emerge. Inconsistent food safety authorities result in the need for
multiple agencies to respond to emerging food safety challenges. This
was illustrated recently with regard to ensuring that animal feed is
free of diseases, such as bovine spongiform encephalopathy (BSE), or
mad cow disease. A fatal human variant of the disease is linked to
eating beef from cattle infected with BSE. As we reported in 2002, four
federal agencies are responsible for overseeing the many imported and
domestic products that pose a risk of BSE. One, the U.S. Customs and
Border Protection, screens all goods entering the United States to
enforce its laws and the laws of 40 other agencies. The second, USDA's
Animal and Plant Health Inspection Service (APHIS), protects livestock
from animal diseases by monitoring the health of domestic and imported
livestock.[Footnote 7] The third, USDA's FSIS, monitors the safety of
imported and domestically produced meat and, at slaughterhouses, tests
animals prior to slaughter to determine if they are free of disease and
safe for human consumption. Finally, FDA monitors the safety of animal
feed--animals contract BSE through feed that contains protein derived
from the remains of diseased animals. During the recent discovery of an
infected cow in Washington state, FDA investigated facilities that
might have handled byproducts from the infected animal to make animal
feed. Figure 6 illustrates the fragmentation in the agencies'
authorities.
Figure 6: Federal Government Agencies Involved in Bovine Spongiform
Encephalopathy (BSE) Oversight:
[See PDF for image]
[End of figure]
When we issued our report in 2002, BSE had not been found in U.S.
cattle. However, we found a number of weaknesses in import controls.
Because of those weaknesses and the disease's long incubation period--
up to 8 years--we concluded that BSE might be silently incubating
somewhere in the United States. Then, in May 2003, an infected cow was
found in Canada, and in December 2003, another was found in the state
of Washington. USDA's Animal and Plant Health Inspection Service
operates the surveillance program that found the infected U.S. cow,
while FDA must ensure that the disease cannot spread by enforcing an
animal feed ban that prohibits the use of cattle brains and spinal
tissue, among other things, in cattle feed. With regard to the meat
from the BSE-infected animal found in Washington state, FSIS conducted
a recall of meat distributed in markets in six states. Both USDA and
FDA have reported that meat from the cow was not used in FDA-regulated
foods. However, had the meat been used, for example, in canned soups
that contained less than 2 percent meat, FDA--not FSIS--would have been
responsible for working with companies to recall those foods. (As app.
II shows, the agencies' oversight responsibilities for food products
vary depending on the amount of beef or poultry content.) Neither FDA
nor USDA has authority under existing food safety laws to require a
company to recall food products.[Footnote 8] Both agencies work
informally with companies to encourage them to initiate a recall, but
our ongoing work shows that each agency has different approaches and
procedures. This can be confusing to food processors involved in a
recall. Overlapping responsibilities in responding to mad cow disease
highlight the challenges that government and industry face when
responding to the need to remove contaminated food products from the
market. As part of work currently underway, we are looking at USDA and
FDA food recalls--including USDA's oversight of the BSE-related recall
and FDA's oversight of the feed ban. We are also monitoring both USDA's
and FDA's BSE-response activities.
There are undoubtedly other federal food safety activities where
overlap and duplication may occur. For example, in the areas of food
safety research, public outreach, or both FDA, and USDA's Economic
Research Service, FSIS and the Cooperative State Research, Education
and Extension Service have all received funding to develop food safety-
related educational materials for the public. In addition,
responsibility for regulating genetically modified foods is shared
among FDA, USDA, and the Environmental Protection Agency (EPA).
However, we have not yet examined the extent to which these and other
areas of overlap and duplication impact the efficiency of the food
safety system.
Emerging Terrorist Threats Highlight the Need to Reorganize the Federal
Food Safety System:
The fragmented legal and organizational structures of the federal food
safety system are now further challenged by the realization that
American farms and food are vulnerable to potential attack and
deliberate contamination. As we recently reported in a statement for
the record before the Senate Committee on Governmental
Affairs,[Footnote 9] bioterrorist attacks could be directed at many
different targets in the farm-to-table continuum, including crops,
livestock, food products in the processing and distribution chain,
wholesale and retail facilities, storage facilities, transportation,
and food and agriculture research laboratories. Experts believe that
terrorists would attack livestock and crops if their primary intent
were to cause severe economic dislocation. Terrorists could decide to
contaminate finished food products if their motive were to harm humans.
Both FDA and USDA have taken steps to protect the food supply against a
terrorist attack, but it is, for the most part, the current food safety
system that the nation must depend on to prevent and respond to
bioterrorist acts against our food supply.
For example, in February 2003, we reported that FDA and USDA determined
that their existing statutes empower them to enforce food safety, but
do not provide them with clear authority to regulate all aspects of
security at food-processing facilities. Neither agency feels that it
has authority to require processors to adopt physical facility security
measures such as installing fences, alarms, or outside lighting. Each
agency, independently of one another, developed and published
guidelines that food processors may voluntarily adopt to help them
identify security measures and mitigate the risk of deliberate
contamination at their production facilities. However, while food
inspectors were instructed to be vigilant, they have not been asked to
enforce, monitor, or document their actions regarding the extent to
which security measures are being adopted. As a result, neither FDA nor
USDA can fully assess the extent to which food processors are following
the security guidelines that the agencies developed. Officials note,
however, that they have taken many steps to address deliberate food
contamination. Both agencies have distributed food security information
to food processors under their jurisdictions and are cochairing the
Food Emergency Response Network, which integrates the nation's
laboratory infrastructure for the detection of threat agents in food at
the local, state, and federal levels. Among other things, USDA
established the Office of Food Security and Emergency Preparedness,
enhanced security at food safety laboratories, and trained employees in
preparedness activities. Similarly, FDA revised emergency response
plans and conducted training for all staff, as well as participated in
various emergency response exercises at FDA's Center for Food Safety
and Applied Nutrition.
Another GAO report documented vulnerabilities in federal efforts to
prevent dangerous animal diseases from entering the United States. Our
2002 report on foot-and-mouth disease concluded that because of the
sheer magnitude of international passengers and cargo that enters this
country daily, completely preventing the entry of foot-and-mouth
disease may not be feasible. During the 2001 outbreak of food-and-mouth
disease in Europe, poor communication between USDA and Customs
officials caused delays in carrying out inspections of international
passengers and cargo arriving from disease-affected countries.
Fundamental Changes Needed to Improve Effectiveness and Efficiency of
the Federal Food Safety System:
To address the problems I have just outlined, a fundamental
transformation of the current food safety system is necessary. As the
Comptroller General has testified, there are no easy answers to the
challenges federal departments and agencies face in transforming
themselves. Changes, such as revamping the U.S. food safety system,
will require a process that involves key congressional stakeholders and
administration officials as well as others, ranging from food
processors to consumers. There are different opinions about the best
organizational model for food safety, but there is widespread national
and international recognition of the need for uniform laws and the
consolidation of food safety activities.
Establishing a single food safety agency responsible for administering
a uniform set of laws would offer the most logical approach to
resolving long-standing problems with the current system, addressing
emerging threats to food safety, and ensuring a safer food supply. This
would ensure that food safety issues are addressed comprehensively by
better preventing contamination throughout the entire food cycle--from
the production and transportation of foods through their processing and
sale until their eventual consumption by consumers. In our view,
integrating the overlapping and duplicative responsibilities for food
safety into a single agency or department can create synergy and
economies of scale that would provide for more focused and efficient
efforts to protect the nation's food supply. A second option would be
to consolidate all food safety inspection activities, but not other
activities,[Footnote 10] under an existing department, such as USDA or
HHS. Other measures have not proven successful. For example, the Farm
Security and Rural Investment Act of 2002 mandated the creation of a
15-member Food Safety Commission charged with making specific
recommendations to improve the U.S. food safety system and delivering a
report to the President and the Congress within a year. The Congress
has thus far not provided funding for the commission.
Simply choosing an organizational structure will not be sufficient,
however. For the nation's food safety system to be successful, it will
also be necessary to reform the current patchwork of food safety
legislation and make it uniform, consistent, and risk-based. As table 1
shows, five of eight former senior food safety officials with whom we
discussed the matter in preparation for this testimony concur with this
view.
Table 1: Former Food Safety Officials Who Support Changes to the
Current System:
Name: Dan Glickman;
Former government position and agency: Secretary of Agriculture, USDA;
Period of Service: 1995-2001;
Consolidation of food safety activities: Yes;
Creation of independent food safety agency: No;
Legislative reform: Yes.
Name: Jane Henney;
Former government position and agency: Commissioner, FDA, HHS;
Period of Service: 1998-2001;
Consolidation of food safety activities: Yes;
Creation of independent food safety agency: No;
Legislative reform: Yes.
Name: Catherine Woteki;
Former government position and agency: Under Secretary for Food Safety,
USDA;
Period of Service: 1997-2001;
Consolidation of food safety activities: Yes;
Creation of independent food safety agency: Yes;
Legislative reform: Yes.
Name: Michael Taylor;
Former government position and agency: Administrator, FSIS, USDA;
Period of Service: 1994-1996;
and Deputy Commissioner for Policy, FDA, HHS;
Period of Service: 1991-1994;
Consolidation of food safety activities: Yes;
Creation of independent food safety agency: No;
Legislative reform: Yes.
Name: Carol Tucker-Foreman;
Former government position and agency: Assistant Secretary for Food and
Consumer Services, USDA;
Period of Service: 1977-1981;
Consolidation of food safety activities: Yes;
Creation of independent food safety agency: Yes;
Legislative reform: Yes.
[End of table]
Three officials had different views on the best approach to address
problems with the current food safety system. Joseph Levitt, director
of the FDA's Center for Food Safety and Applied Nutrition from 1998 to
2003, recommends that the existing agencies be fully funded. Thomas
Billy, administrator of USDA's FSIS from 1996 to 2001 and director of
FDA's Office of Seafood between 1990 and 1994, believes that no changes
should take place until a presidential commission evaluates the
problems, identifies the alternatives, and recommends a specific
approach and strategy for consolidating food safety programs. However,
Mr. Billy supports incremental legislative steps to fix current
shortcomings. Finally, Caren Wilcox, USDA's deputy under secretary for
Food Safety from 1997 to 2001, believes that creating a single food
safety agency would be advisable, but only under certain circumstances.
In 1998, the National Academies similarly recommended modifying the
federal statutory framework for food safety to avoid fragmentation and
to enable the creation and enforcement of risk-based
standards.[Footnote 11] Moreover, our 1999 report on the experiences of
countries that were then consolidating their food safety systems
indicated that foreign officials are expecting long-term benefits in
terms of savings and food safety. Five countries--Canada, Denmark,
Great Britain, Ireland, and New Zealand--have each consolidated their
food safety responsibilities under a single agency. For example, New
Zealand's Food Safety Authority was created in July 2002 to reduce
inconsistencies and lack of coordination in food safety management by
two separate agencies--the Ministry of Health and the Ministry of
Agriculture and Forestry. The new authority anticipates an effective
use of scarce resources and a reduction in duplication of effort.
Conclusions:
In conclusion, given the risks posed by new threats to the food supply,
be they inadvertent or deliberate, we can no longer afford inefficient,
inconsistent, and overlapping programs and operations in the food
safety system. It is time to ask whether a system that developed in a
piecemeal fashion in response to specific problems as they arose over
the course of several decades can efficiently and effectively respond
to today's challenges. We believe that creating a single food safety
agency to administer a uniform, risk-based inspection system is the
most effective way for the federal government to resolve long-standing
problems, address emerging food safety issues, and better ensure the
safety of the nation's food supply. This integration can create synergy
and economies of scale, and provide more focused and efficient efforts
to protect the nation's food supply.
The National Academies and the President's Council on Food Safety have
reported that comprehensive, uniform, and risk-based food safety
legislation is needed to provide the foundation for a consolidated food
safety system. We recognize that consolidating federal responsibilities
for food safety into a single agency or department is a complex
process. Numerous details, of course, would have to be worked out.
However, it is essential that the fundamental decision to create more
uniform standards and a single food safety agency to uphold them is
made and the process for resolving outstanding technical issues is
initiated.
Matters for Congressional Consideration:
To provide more efficient, consistent, and effective federal oversight
of the nation's food supply, we suggest that the Congress consider:
* enacting comprehensive, uniform, and risk-based food safety
legislation and:
* establishing a single, independent food safety agency at the Cabinet
level.
If the Congress does not opt for an entire reorganization of the food
safety system, we suggest that as an alternative interim option it
consider:
* modifying existing laws to designate one current agency as the lead
agency for all food safety inspection matters.
Madam Chairwoman, this completes my prepared statement. I would be
pleased to respond to any questions that you or other Members of the
Committee may have at this time.
Contacts and Staff Acknowledgments:
For further information about this testimony, please contact Lawrence
J. Dyckman, Director, Natural Resources and Environment, (202) 512-
3841. Maria Cristina Gobin, Katheryn Summers Hubbell, Kelli Ann
Walther, Amy Webbink, and John Delicath made key contributions to this
statement.
[End of section]
Appendix I: Federal Agencies' Food Safety Responsibilities:
Department of Health and Human Services;
Agency: Food and Drug Administration (FDA);
Responsible for: All domestic and imported food products except meat,
poultry, and processed egg products.
Department of Health and Human Services;
Agency: Centers for Disease Control and Prevention (CDC);
Responsible for: Protecting the nation's public health.
U.S. Department of Agriculture;
Agency: Food Safety and Inspection Service (FSIS);
Responsible for: All meat, poultry, and processed egg products that are
imported or involved in interstate commerce.
U.S. Department of Agriculture;
Agency: Animal and Plant Health Inspection Service (APHIS);
Responsible for: The health and care of all animals and plants.
U.S. Department of Agriculture;
Agency: Grain Inspection, Packers and Stockyards Administration;
Responsible for: Establishing quality standards, inspection procedures,
and marketing of grain and other related products.
U.S. Department of Agriculture;
Agency: Agricultural Marketing Service (AMS);
Responsible for: Establishing quality and condition standards for
dairy, fruit, vegetable, livestock, meat, poultry, and egg products.
U.S. Department of Agriculture;
Agency: Agricultural Research Service (ARS);
Responsible for: Conducting food safety research.
Department of Commerce;
Agency: National Oceanic and Atmospheric Administration (NOAA);
Responsible for: Examining seafood for safety and quality.
Environmental Protection Agency;
Responsible for: Regulating the use of pesticides and maximum allowable
residue levels on food commodities and animal feed.
Federal Trade Commission;
Responsible for: Prohibiting unfair or deceptive acts or practices.
Department of the Treasury;
Agency: Bureau of Alcohol, Tobacco, and Firearms;
Responsible for: Enforcing laws covering the production, use, and
distribution of alcoholic beverages.
Department of Homeland Security;
Responsible for: Coordinating all agencies' security activities.
Department of Homeland Security;
Agency: U.S. Customs and Border Protection;
Responsible for: Collecting revenues and enforcing various Customs
laws.
Source: GAO.
[End of table]
[End of section]
Appendix II: Differences in Inspection Frequency of Manufacturers of
Similar Products:
Manufacturer inspected by FSIS daily: Open-face meat and poultry
sandwiches;
Manufacturer inspected by FDA on average about once every 5 years:
Closed-face (traditional) meat and poultry sandwiches.
Manufacturer inspected by FSIS daily: Hot dog in pastry dough;
Manufacturer inspected by FDA on average about once every 5 years: Hot
dog in a roll.
Manufacturer inspected by FSIS daily: Corn dog;
Manufacturer inspected by FDA on average about once every 5 years:
Bagel dog.
Manufacturer inspected by FSIS daily: Dehydrated chicken soup;
Manufacturer inspected by FDA on average about once every 5 years:
Dehydrated beef soup.
Manufacturer inspected by FSIS daily: Beef broth;
Manufacturer inspected by FDA on average about once every 5 years:
Chicken broth.
Manufacturer inspected by FSIS daily: Spaghetti sauce with meat stock;
Manufacturer inspected by FDA on average about once every 5 years:
Spaghetti sauce without meat stock.
Manufacturer inspected by FSIS daily: Beans with bacon (2 percent or
more bacon);
Manufacturer inspected by FDA on average about once every 5 years:
Pork and beans (no limit on amount of pork).
Manufacturer inspected by FSIS daily: Pizza with meat topping;
Manufacturer inspected by FDA on average about once every 5 years:
Pizza without meat topping.
Manufacturer inspected by FSIS daily: Soups with more than 2 percent
meat or poultry;
Manufacturer inspected by FDA on average about once every 5 years:
Soups with less than 2 percent meat or poultry.
Source: GAO.
[End of table]
[End of section]
Appendix III: Related GAO Products:
Food Safety: FDA's Imported Seafood Safety Program Shows Some Progress,
but Further Improvements Are Needed. GAO-04-246. Washington, D.C.:
January 30, 2004.
Bioterrorism: A Threat to Agriculture and the Food Supply. GAO-04-259T.
Washington, D.C.: November 19, 2003.
Combating Bioterrorism: Actions Needed to Improve Security at Plum
Island Animal Disease Center. GAO-03-847. Washington, D.C.: September
19, 2003.
Results-Oriented Government: Shaping the Government to Meet 21st
Century Challenges.GAO-03-1168T. Washington, D.C.: September 17, 2003.
School Meal Programs: 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.
Agricultural Conservation: Survey Results on USDA's Implementation of
Food Security Act Compliance Provisions. GAO-03-492SP. Washington,
D.C.: April 21, 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.
Foot and Mouth Disease: To Protect U.S. Livestock, USDA Must Remain
Vigilant and Resolve Outstanding Issues. GAO-02-808. Washington,
D.C.: July 26, 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: Continued Vigilance Needed to Ensure Safety of School
Meals.GAO-02-669T. Washington, D.C.: April 30, 2002.
Mad Cow Disease: Improvements in the Animal Feed Ban and Other
Regulatory Areas Would Strengthen U.S. Prevention Efforts. GAO-02-183.
Washington, D.C.: January 25, 2002.
Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be
Addressed Before Implementation. GAO-02-59. Washington, D.C.: December
17, 2001.
Food Safety and Security: Fundamental Changes Needed to Ensure Safe
Food.GAO-02-47T. Washington, D.C.: October 10, 2001.
Food Safety: CDC Is Working to Address Limitations in Several of Its
Foodborne Disease Surveillance Systems. GAO-01-973. Washington, D.C.:
September 7, 2001.
Food Safety: Overview of Federal and State Expenditures. GAO-01-177.
Washington, D.C.: February 20, 2001.
Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect
Consumers. GAO-01-204. Washington, D.C.: January 31, 2001.
Food Safety: Actions Needed by USDA and FDA to Ensure That Companies
Promptly Carry Out Recalls. GAO/RCED-00-195. Washington, D.C.: August
17, 2000.
Food Safety: Improvements Needed in Overseeing the Safety of Dietary
Supplements and "Functional Foods." GAO/RCED-00-156. Washington, D.C.:
July 11, 2000.
School Meal Programs: Few Outbreaks of Foodborne Illness Reported. GAO/
RCED-00-53. Washington, D.C.: February 22, 2000.
Meat and Poultry: Improved Oversight and Training Will Strengthen New
Food Safety System. GAO/RCED-00-16. Washington, D.C.: December 8, 1999.
Food Safety: Agencies Should Further Test Plans for Responding to
Deliberate Contamination. GAO/RCED-00-3. Washington, D.C.: October 27,
1999.
Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-
Based Inspection System. GAO/T-RCED-99-256. Washington, D.C.: August 4,
1999.
Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg
Safety. GAO/RCED-99-184. Washington, D.C.: July 1, 1999.
Food Safety: Experiences of Four Countries in Consolidating Their Food
Safety Systems. GAO/RCED-99-80. Washington, D.C.: April 20, 1999.
Food Safety: Opportunities to Redirect Federal Resources and Funds Can
Enhance Effectiveness. GAO/RCED-98-224. Washington, D.C.: August 6,
1998.
Food Safety: Federal Efforts to Ensure Imported Food Safety Are
Inconsistent and Unreliable. GAO/T-RCED-98-191. Washington, D.C.: May
14, 1998.
Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are
Inconsistent and Unreliable. GAO/RCED-98-103. Washington, D.C.: April
30, 1998.
Food Safety: Agencies' Handling of a Dioxin Incident Caused Hardships
for Some Producers and Processors. GAO/RCED-98-104. Washington, D.C.:
April 10, 1998.
Food Safety: Fundamental Changes Needed to Improve Food Safety. GAO/
RCED-97-249R. Washington, D.C.: September 9, 1997.
Food Safety: Information on Foodborne Illnesses. GAO/RCED-96-96.
Washington, D.C.: May 8, 1996.
Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food. GAO/
RCED-94-192. Washington, D.C.: September 26, 1994.
Food Safety: A Unified, Risk-Based Food Safety System Needed. GAO/T-
RCED-94-223. Washington, D.C.: May 25, 1994.
Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for
Meat and Poultry. GAO/RCED-94-110. Washington, D.C.: May 19, 1994.
Food Safety and Quality: Uniform, Risk-Based Inspection System Needed
to Ensure Safe Food Supply. GAO/RCED-92-152. Washington, D.C.: June 26,
1992.
Food Safety and Quality: Salmonella Control Efforts Show Need for More
Coordination. GAO/RCED-92-69. Washington, D.C.: April 21, 1992.
FOOTNOTES
[1] Based on 2003 food safety expenditures of the Food and Drug
Administration (FDA) and the U.S. Department of Agriculture (USDA).
[2] Under the Egg Products Inspection Act, the Secretary of Health and
Human Services regulates whole eggs, while the Secretary of Agriculture
regulates egg products.
[3] Appendix III lists relevant GAO reports and testimonies.
[4] The CDC's foodborne outbreak data shows that contaminated seafood
accounts for about 15 percent of the documented foodborne illness
outbreaks--a greater percentage than either meat or poultry, even
though meat and poultry are consumed at 8 and 6 times the rate of
seafood, respectively.
[5] FDA's percentage of the total food safety budget has increased
since our 2001 testimony due to supplemental food security funding.
[6] USDA officials report that rulemaking for shell eggs will be
separate from rulemaking for egg products because shell egg packing
facilities lack the capacity to respond to a Hazard Analysis and
Critical Control Point (HACCP) rule at present. USDA officials explain
that they will likely propose HACCP and sanitation performance standard
regulations for egg product plants, while shell egg facilities will
likely receive guidance and training materials related to HACCP and
sanitation standards.
[7] On March 1, 2003, APHIS's Agriculture Quarantine and Inspection
force became part of the Department of Homeland Security.
[8] FDA, however, does have legislative authority to require recalls
that involve infant formula.
[9] Bioterrorism: A Threat to Agriculture and the Food Supply,
GAO-04-259T (Nov. 19, 2003).
[10] These include, for example, CDC's foodborne illness surveillance
functions and EPA's chemical residue tolerance responsibilities.
[11] Ensuring Safe Food From Production to Consumption, National
Research Council (Washington, D.C.: 1998).
