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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 
todays 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 nations 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).