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 
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. 

Highlights of GAO-04-588T, testimony 

before the House Subcommittee on Civil 

Service and Agency Organization, 

Committee on Government Reform 

March 30, 2004

FEDERAL FOOD SAFETY AND SECURITY 

SYSTEM 

Fundamental Restructuring Is Needed to 

Address Fragmentation and Overlap 

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. 

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. 

GAO suggests that the Congress 

consider (1) enacting 

comprehensive, uniform, and riskbased 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. 
Page 1 GAO-04-588T 

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 annually1

 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 

 1

Based on 2003 food safety expenditures of the Food and Drug Administration (FDA) and 

the U.S. Department of Agriculture (USDA). 
Page 2 GAO-04-588T 

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. 

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 

Background 
Page 3 GAO-04-588T 

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.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. 

 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. 
Page 4 GAO-04-588T 

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. 

As we have stated in numerous reports and testimonies, the fragmented 

federal food safety system is not the product of strategic design.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. 

 3

Appendix III lists relevant GAO reports and testimonies. 

Fragmented System 

Hampers the 

Efficiency and 

Effectiveness of Food 

Safety Efforts 
Page 5 GAO-04-588T 

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 

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 
Page 6 GAO-04-588T 

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 
Page 7 GAO-04-588T 

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.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 

 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. 
Page 8 GAO-04-588T 

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. 
Page 9 GAO-04-588T 

Figure 2: Comparison of Agencies’ Food Safety Expenditures Versus Consumers’ Annual Food Expenditures5

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. 

 5

FDA’s percentage of the total food safety budget has increased since our 2001 testimony 

due to supplemental food security funding. 
Page 10 GAO-04-588T 

Figure 3: Percentage of Foodborne Outbreaks Associated with Products Regulated 

by FDA and USDA from 1993-1997 

Note: Only major food categories under each agency’s jurisdiction are included. 

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 
Page 11 GAO-04-588T 

• 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 

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 
Page 12 GAO-04-588T 

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.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 

 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. 
Page 13 GAO-04-588T 

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.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. 

 7

On March 1, 2003, APHIS’s Agriculture Quarantine and Inspection force became part of the 

Department of Homeland Security. 
Page 14 GAO-04-588T 

Figure 6: Federal Government Agencies Involved in Bovine Spongiform Encephalopathy (BSE) Oversight 

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 
Page 15 GAO-04-588T 

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.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. 

 8

FDA, however, does have legislative authority to require recalls that involve infant 

formula. 
Page 16 GAO-04-588T 

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,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 

 9

Bioterrorism: A Threat to Agriculture and the Food Supply, GAO-04-259T (Nov. 19, 

2003). 

Emerging Terrorist 

Threats Highlight the 

Need to Reorganize 

the Federal Food 

Safety System 
Page 17 GAO-04-588T 

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. 

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 

Fundamental Changes 

Needed to Improve 

Effectiveness and 

Efficiency of the 

Federal Food Safety 

System 
Page 18 GAO-04-588T 

nation’s food supply. A second option would be to consolidate all food 

safety inspection activities, but not other activities,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 

Former government position 

 and agency 

Period of 

Service 

Consolidation 

of food safety 

activities 

Creation of 

independent food 

safety agency 

Legislative 

reform 

Dan Glickman Secretary of Agriculture, USDA 1995-2001 X X 

Jane Henney Commissioner, FDA, HHS 1998-2001 X X 

Catherine Woteki Under Secretary for Food Safety, 

USDA 

1997-2001 X X X 

Michael Taylor Administrator, FSIS, USDA and 

Deputy Commissioner for Policy, 

FDA, HHS 

1994-1996 

1991-1994 

X X 

Carol TuckerForeman Assistant Secretary for Food and 

Consumer Services, 

USDA 

1977-1981 X X X 

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, 

 10These include, for example, CDC’s foodborne illness surveillance functions and EPA’s 

chemical residue tolerance responsibilities. 
Page 19 GAO-04-588T 

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.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. 

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, 

 11Ensuring Safe Food From Production to Consumption, National Research Council 

(Washington, D.C.: 1998). 

Conclusions 
Page 20 GAO-04-588T 

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. 

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. 

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. 

Matters for 

Congressional 

Consideration 

Contacts and Staff 

Acknowledgments 
Page 21 GAO-04-588T 

 Agency Responsible for 

Department of Health and 

Human Services 

Food and Drug Administration (FDA) All domestic and imported food products except meat, 

poultry, and processed egg products 

 Centers for Disease Control and Prevention 

(CDC) 

Protecting the nation’s public health 

U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) All meat, poultry, and processed egg products that are

imported or involved in interstate commerce 

 Animal and Plant Health Inspection Service 

(APHIS) 

The health and care of all animals and plants 

 Grain Inspection, Packers and Stockyards 

Administration 

Establishing quality standards, inspection procedures, 

and marketing of grain and other related products 

 Agricultural Marketing Service (AMS) Establishing quality and condition standards for dairy, 

fruit, vegetable, livestock, meat, poultry, and egg 

products 

 Agricultural Research Service (ARS) Conducting food safety research 

Department of Commerce National Oceanic and Atmospheric 

Administration (NOAA) 

Examining seafood for safety and quality 

Environmental Protection 

Agency 

 Regulating the use of pesticides and maximum 

allowable residue levels on food commodities and 

animal feed 

Federal Trade Commission Prohibiting unfair or deceptive acts or practices 

Department of the Treasury Bureau of Alcohol, Tobacco, and Firearms Enforcing laws covering the production, use, and 

distribution of alcoholic beverages 

Department of Homeland 

Security 

 Coordinating all agencies’ security activities 

 U.S. Customs and Border Protection Collecting revenues and enforcing various Customs 

laws. 

Source: GAO. 

Appendix I: Federal Agencies’ Food Safety 

Responsibilities 
Page 22 GAO-04-588T 

Manufacturer inspected by FSIS daily Manufacturer inspected by FDA on average about once every 5 years 

Open-face meat and poultry sandwiches Closed-face (traditional) meat and poultry sandwiches 

Hot dog in pastry dough Hot dog in a roll 

Corn dog Bagel dog 

Dehydrated chicken soup Dehydrated beef soup 

Beef broth Chicken broth 

Spaghetti sauce with meat stock Spaghetti sauce without meat stock 

Beans with bacon (2 percent or more bacon) Pork and beans (no limit on amount of pork) 

Pizza with meat topping Pizza without meat topping 

Soups with more than 2 percent meat or poultry Soups with less than 2 percent meat or poultry 

Source: GAO. 

Appendix II: Differences in Inspection 

Frequency of Manufacturers of Similar 

Products 
Page 23 GAO-04-588T 

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. 

Appendix III: Related GAO Products 
Page 24 GAO-04-588T 

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, RiskBased Inspection System. GAO/T-RCED-99-256. Washington, D.C.: August 

4, 1999. 
Page 25 GAO-04-588T 

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/TRCED-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. 
Page 26 GAO-04-588T 

Food Safety and Quality: Salmonella Control Efforts Show Need for More 

Coordination. GAO/RCED-92-69. Washington, D.C.: April 21, 1992. 

(360435) 
This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately. 
The General Accounting Office, the audit, evaluation and investigative arm of 

Congress, exists to support Congress in meeting its constitutional responsibilities 

and to help improve the performance and accountability of the federal 

government for the American people. GAO examines the use of public funds; 

evaluates federal programs and policies; and provides analyses, 

recommendations, and other assistance to help Congress make informed 

oversight, policy, and funding decisions. GAO’s commitment to good government 

is reflected in its core values of accountability, integrity, and reliability. 

The fastest and easiest way to obtain copies of GAO documents at no cost is 

through the Internet. GAO’s Web site (www.gao.gov) contains abstracts and fulltext files of current reports and testimony and an expanding archive of older 

products. The Web site features a search engine to help you locate documents 

using key words and phrases. You can print these documents in their entirety, 

including charts and other graphics. 

Each day, GAO issues a list of newly released reports, testimony, and 

correspondence. GAO posts this list, known as “Today’s Reports,” on its Web site 

daily. The list contains links to the full-text document files. To have GAO e-mail 

this list to you every afternoon, go to www.gao.gov and select “Subscribe to e-mail 

alerts” under the “Order GAO Products” heading. 

The first copy of each printed report is free. Additional copies are $2 each. A 

check or money order should be made out to the Superintendent of Documents. 

GAO also accepts VISA and Mastercard. Orders for 100 or more copies mailed to a 

single address are discounted 25 percent. Orders should be sent to: 

U.S. General Accounting Office 

441 G Street NW, Room LM 

Washington, D.C. 20548 

To order by Phone: Voice: (202) 512-6000 

TDD: (202) 512-2537 

Fax: (202) 512-6061 

Contact: 

Web site: www.gao.gov/fraudnet/fraudnet.htm 

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470 

Jeff Nelligan, Managing Director, NelliganJ@gao.gov (202) 512-4800 

U.S. General Accounting Office, 441 G Street NW, Room 7149 

Washington, D.C. 20548 

GAO’s Mission 

Obtaining Copies of 

GAO Reports and 

Testimony 

Order by Mail or Phone 

To Report Fraud, 

Waste, and Abuse in 

Federal Programs 

Public Affairs