Federal Food Safety and Security System: Fundamental		 
Restructuring Is Needed to Address Fragmentation and Overlap	 
(30-MAR-04, GAO-04-588T).					 
                                                                 
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.							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-04-588T					        
    ACCNO:   A09631						        
  TITLE:     Federal Food Safety and Security System: Fundamental     
Restructuring Is Needed to Address Fragmentation and Overlap	 
     DATE:   03/30/2004 
  SUBJECT:   Consumer protection				 
	     Food and drug legislation				 
	     Food inspection					 
	     Product safety					 
	     Regulatory agencies				 
	     Safety regulation					 
	     Safety standards					 
	     Food facilities					 
	     Jurisdictional authority				 
	     Strategic planning 				 
	     Interagency relations				 

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GAO-04-588T

United States General Accounting Office

GAO Testimony

Before the Subcommittee on Civil Service and Agency Organization,
Committee on Government Reform, House of Representatives

For Release on Delivery

Expected at 3:00 p.m. EST 	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

Highlights of GAO-04-588T, testimony before the House Subcommittee on
Civil Service and Agency Organization, Committee on Government Reform

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 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.

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.

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 [email protected].

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

1Based on 2003 food safety expenditures of the Food and Drug
Administration (FDA) and the U.S. Department of Agriculture (USDA).

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.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.

2Under the Egg Products Inspection Act, the Secretary of Health and Human
Services regulates whole eggs, while the Secretary of Agriculture
regulates egg products.

  Fragmented System Hampers the Efficiency and Effectiveness of Food Safety
  Efforts

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.

o  	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.

3Appendix III lists relevant GAO reports and testimonies.

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.

o  	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.

o  	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.

o  	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.

o  	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

4The 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.

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.

o  	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 5

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.

5FDA's percentage of the total food safety budget has increased since our
2001 testimony due to supplemental food security funding.

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

o  	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

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

o  	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.

o  	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

6USDA 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.

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.

7On March 1, 2003, APHIS's Agriculture Quarantine and Inspection force
became part of the Department of Homeland Security.

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

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.

8FDA, however, does have legislative authority to require recalls that
involve infant formula.

  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,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

9Bioterrorism: A Threat to Agriculture and the Food Supply, GAO-04-259T
(Nov. 19, 2003).

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,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

                                        Consolidation Creation of 
                  Former                                                      
                government    Period of of food       independent 
                 position               safety        food        Legislative
     Name       and agency     Service   activities     safety      reform    
                                                        agency    
      Dan      Secretary of                                                   
Glickman    Agriculture,   1995-2001       X                        X
                   USDA                                           
     Jane     Commissioner,   1998-2001       X                        X      
    Henney       FDA, HHS                                         
Catherine Under Secretary  1997-2001       X            X           X      
    Woteki   for Food Safety,                                     
                   USDA                                           
    Michael  Administrator,   1994-1996       X                        X      
    Taylor   FSIS, USDA and                                       
             Deputy                                               
             Commissioner for                                     
             Policy,          1991-1994                           
                 FDA, HHS                                         
     Carol   Assistant                                                        
    Tucker-  Secretary for    1977-1981       X            X           X
             Food and                                             
    Foreman      Consumer                                         
                Services,                                         
                   USDA                                           

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.

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.

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,

11Ensuring Safe Food From Production to Consumption, National Research
Council (Washington, D.C.: 1998).

Matters for Congressional

o

Consideration

o

o

  Contacts and Staff Acknowledgments

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.

Appendix I: Federal Agencies' Food Safety Responsibilities

                             Agency Responsible for

Department of Health and Food and Drug Administration (FDA) All domestic
and imported food products except meat, Human Services poultry, and
processed egg products

Centers for Disease Control and Prevention Protecting the nation's public
health (CDC)

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 The health and care of all
animals and plants (APHIS)

Grain Inspection, Packers and Stockyards Establishing quality standards,
inspection procedures, Administration 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   Examining seafood for safety 
                          Atmospheric                    and quality          
                          Administration (NOAA)  
       Environmental                             Regulating the use of        
         Protection                              pesticides and maximum       
           Agency                                 allowable residue levels on 
                                                         food commodities and 
                                                         animal feed          
       Federal Trade                             Prohibiting unfair or        
         Commission                              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 Coordinating all agencies' security activities
Security

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

Source: GAO.

Appendix II: Differences in Inspection Frequency of Manufacturers of Similar
Products

 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 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.

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