Oversight of Food Safety Activities: Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources

Oversight of Food Safety Activities: Federal Agencies Should
Pursue Opportunities to Reduce Overlap and Better Leverage
Resources (30-MAR-05, GAO-05-213).

GAO has documented many problems resulting from the fragmented
nature of the federal food safety system and recommended
fundamental restructuring to ensure the effective use of scarce
government resources. In this report, GAO (1) identified overlaps
in food safety activities at USDA, FDA, EPA, and NMFS; (2)
analyzed the extent to which the agencies use interagency
agreements to leverage resources; and (3) obtained the views of
stakeholders.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-05-213
ACCNO: A20378
TITLE: Oversight of Food Safety Activities: Federal Agencies
Should Pursue Opportunities to Reduce Overlap and Better Leverage
Resources
DATE: 03/30/2005
SUBJECT: Employee training
Food and drug law
Food inspection
General management reviews
Interagency relations
Monitoring
Program management
Redundancy
Regulatory agencies
Food safety
Standards (food)
Program coordination
Stakeholder consultations
FDA Hazard Analysis and Critical Control
Point System

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GAO-05-213

United States Government Accountability Office

GAO Report to Congressional Requesters

March 2005

OVERSIGHT OF FOOD SAFETY ACTIVITIES

Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better
Leverage Resources

GAO-05-213

[IMG]

March 2005

OVERSIGHT OF FOOD SAFETY ACTIVITIES

Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better
Leverage Resources

What GAO Found

Several statutes give responsibility for different segments of the food
supply to different agencies to ensure that the food supply is safe. The
U.S. Department of Agriculture (USDA) and the Food and Drug Administration
(FDA) within the Department of Health and Human Services (HHS) have the
primary responsibility for regulating food safety, with the Environmental
Protection Agency (EPA) and the National Marine Fisheries Service (NMFS)
also involved. In carrying out their responsibilities, with respect to
both domestic and imported food, these agencies spend resources on a
number of overlapping activities, such as inspection/enforcement,
training, research, or rulemaking. For example, both USDA and FDA conduct
similar inspections at 1,451 dual jurisdiction establishments-facilities
that produce foods regulated by both agencies. Under authority granted by
the Bioterrorism Act of 2002, FDA could authorize USDA inspectors to
inspect these facilities, but it has not done so. Furthermore, USDA and
FDA maintain separate training programs on similar topics for their
inspectors that could be shared. Ultimately, inspection and training
resources could be used more efficiently.

Common Elements of UDSA and FDA Inspections

Source: GAO analysis of FSIS and FDA documents.

GAO identified 71 interagency agreements that the agencies entered into to
better protect public health and to coordinate their food safety
activities. However, the agencies have weak mechanisms for tracking these
agreements that, in some cases, lead to ineffective implementation.
Specifically, USDA and FDA are not fully implementing an agreement to
facilitate the exchange of information about dual jurisdiction
establishments, which both agencies inspect. In addition, FDA and NMFS are
not implementing an agreement designed to enable each agency to discharge
its seafood responsibilities effectively.

GAO spoke with selected industry associations, food companies, consumer
groups, and academic experts, and they disagree on the extent of overlap
and on how best to improve the food safety system. Most of these
stakeholders agreed that laws and regulations should be modernized to more
effectively and efficiently control food safety hazards, but they differed
about whether to consolidate food safety functions into a single agency.

United States Government Accountability Office

Contents

Letter

Results in Brief
Background
Federal Food Safety Agencies Spend Resources on Overlapping

Food Safety Activities

Agencies Have Numerous Interagency Agreements to Coordinate Food Safety
Activities, but Tracking Mechanisms and Implementation Are Weak

Industry and Other Stakeholders Disagree on the Significance of Overlap in
the Federal Food Safety System and on How to Improve It

Conclusions
Recommendations for Executive Action
Agency Comments and Our Response

1 4 9

35 39 40 41

Appendixes

Appendix I:

Appendix II:

Appendix III: Appendix IV: Appendix V:

Appendix VI:

Appendix VII: Appendix VIII: Scope and Methodology

Food Safety Expenditures and Staffing Levels for Fiscal Year 2003

Food Safety-Related Interagency Agreements

Principal Federal Laws Related to Food Safety

Comments from the U.S. Department of Agriculture

GAO Comments

Comments from the Department of Health and Human Services (FDA)

GAO Comments

Comments from the U.S. Department of Commerce (NOAA)

GAO Contacts and Staff Acknowledgments

GAO Contacts
Staff Acknowledgments

63 70

74 84

90 90 90

Tables Table 1: Federal Agencies' Food Safety Responsibilities 10
Table 2: Examples of Similar Food Safety Activities 15
Table 3: Food Safety Expenditures and Staffing Levels by Agency,
Fiscal Year 2003 50

Contents

Table 4: Other Food Safety Expenditures and Staffing Levels by Agency,
Fiscal Year 2003 53 Table 5: Food Safety-Related Interagency Agreements by
Primary Program Function 54 Table 6: The 30 Principal Laws Related to Food
Safety 59

Figures Figure 1: Figure 2: Figure 3: Figure 4:

Figure 5: Figure 6:

Figure 7:

USDA, FDA, EPA, and NMFS Food Safety Expenditures,
Fiscal Year 2003 12
USDA, FDA, EPA, and NMFS Food Safety Expenditures
by Program Function, Fiscal Year 2003 13
Food Safety Expenditures (dollars) by Agency and
Function, Fiscal Year 2003 14
Location of Food Manufacturers, Warehouses, and Other
Types of Food Establishments Inspected by Both USDA
and FDA 16
Common Elements of USDA and FDA Inspections 17
Food Safety-Related Interagency Agreementsby Program
Function 26
Diagram of a Jointly Regulated Food Processing
Facility 32

Contents

Abbreviations

AMS Agricultural Marketing Service
APHIS Animal and Plant Health Inspection Service
ARS Agricultural Research Service
CBP Customs and Border Protection
CDC Centers for Disease Control and Prevention
CFSAN Center for Food Safety and Applied Nutrition
CSREES Cooperative State Research, Education and Extension Service
CVM Center for Veterinary Medicine
DJE Dual Jurisdiction Establishment
DOC Department of Commerce
EPA Environmental Protection Agency
ERS Economic Research Service
GIPSA Grain Inspection, Packers and Stockyards Administration
ISSC Interstate Shellfish Sanitation Conference
FDA Food and Drug Administration
FSIS Food Safety and Inspection Service
HACCP Hazard Analysis and Critical Control Point (system)
NASS National Agricultural Statistics Service
NCTR National Center for Toxicological Research
NMFS National Marine Fisheries Service
ORA Office of Regulatory Affairs
USDA U.S. Department of Agriculture

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separately.

United States Government Accountability Office Washington, D.C. 20548

March 30, 2005

The Honorable George V. Voinovich

Chairman, Subcommittee on Oversight of Government Management, the Federal
Workforce, and the District of Columbia Committee on Homeland Security and
Governmental Affairs United States Senate

The Honorable Jon Porter

Chairman, Subcommittee on the Federal Workforce and Agency Organization
Committee on Government Reform House of Representatives

The Honorable Jo Ann Davis House of Representatives

The statutory framework underlying the U.S. federal food safety system
gives responsibility for specific food commodities to different agencies
and provides them with significantly different authorities and
responsibilities. As a result, federal agencies are spending resources on
similar activities to ensure that the food supply is safe, wholesome, and
appropriately labeled. Over the years, we have documented many problems
resulting from the fragmented nature of the federal food safety system and
have recommended streamlining food safety statutes and consolidating food
safety functions into a single agency.1 As the Comptroller General noted
in testimony before the Congress, redundant, unfocused, and uncoordinated
programs waste scarce resources, confuse and frustrate program customers,
and limit overall program effectiveness.2 The food safety challenges are
more pressing today as we face the potential threat of deliberate
contamination of our food supply.

Multiple federal agencies are involved in food safety activities, but four
agencies play key roles and invest the largest share of resources to
ensure the safety and quality of food. These agencies-the U.S. Department
of Agriculture (USDA), the Food and Drug Administration (FDA), the

1GAO, Federal Food Safety and Security System: Fundamental Restructuring
Is Needed to Address Fragmentation and Overlap, GAO-04-588T (Washington,
D.C.: Mar. 30, 2004).

2GAO, Results-Oriented Government: Shaping the Government to Meet 21st
Century Challenges, GAO-03-1168T (Washington, D.C.: Sept. 17, 2003).

Environmental Protection Agency (EPA), and the National Marine Fisheries
Service (NMFS)-expended nearly $1.7 billion and devoted nearly 15,000
staff in fiscal year 2003,3 the most recent year for which the agencies
could provide complete expenditure data, on activities that included (1)
inspecting food manufacturers, processors and warehouses; (2) researching
and implementing methods to reduce the prevalence of foodborne pathogens;
(3) assessing risks posed by various food contaminants; and (4) educating
industry about new regulatory requirements and the public about food
safety issues. These agencies operate under 30 primary laws underpinning
the legal framework for ensuring the safety and quality of the food
supply. (See app. IV.)

Of the federal agencies involved in food safety activities, USDA and FDA
have most of the regulatory responsibility for overseeing industry's
compliance with federal regulations to ensure food safety and also account
for most federal spending in this area. USDA is responsible for ensuring
the safety of meat, poultry, and certain egg products under the Federal
Meat Inspection Act, the Poultry Products Inspection Act, and the Egg
Products Inspection Act. FDA is responsible for ensuring the safety of all
other food-including whole shell eggs, seafood, milk, grain products, and
fruits and vegetables-under the Federal Food, Drug and Cosmetic Act and
the Public Health Service Act. In addition, the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)
gave FDA the authority to commission other federal officials to inspect
FDA-regulated foods.4 USDA and FDA enforce their respective Hazard
Analysis and Critical Control Point (HACCP) regulations. These regulations
require that food processors maintain a plan identifying critical points
in the production line where contamination is more likely to occur and
adopt control techniques to prevent or reduce contamination. EPA and NMFS
also have related food safety and quality responsibilities. EPA sets
pesticide tolerances for food under the Federal Insecticide, Fungicide,
and Rodenticide Act and the Federal Food, Drug and Cosmetic Act and issues
fish consumption advisories under the Clean Water Act. NMFS conducts
voluntary, fee-for-service inspections of seafood-processing facilities
and seafood products under the Federal Agricultural Marketing Act of 1946,
the Fish and Wildlife Act of 1956, and Reorganization Plan No. 4 of 1970.

3USDA, FDA, EPA and NMFS devoted a combined 14,690 full-time equivalents
to food safety-related activities in fiscal year 2003.

4Section 314 of the Bioterrorism Act outlines FDA's authority to
commission other federal officials to conduct inspections. Pub. L. No.
107-188, S: 314, 116 Stat. 594, 674 (2002).

To coordinate activities across jurisdictional boundaries, these federal
agencies have entered into dozens of interagency agreements that address a
wide range of food safety-related activities.5 The agreements concern
numerous functions and activities, including how the agencies carry out
inspections, public education and outreach, and research projects.

Because of your continuing interest in the efficient and effective use of
government resources, you asked us to (1) identify overlaps that may exist
in federal food safety functions and activities, (2) examine the extent to
which federal food safety agencies are using interagency agreements to
leverage existing resources and reduce any such overlaps, and (3) obtain
the views of regulated industry and other stakeholders regarding
opportunities to reduce overlap by consolidating federal food safety
functions.

In addressing these questions, we defined overlaps as similar activities
being performed by more than one agency-such as training food
inspectors-and duplication as essentially identical activities performed
by more than one agency-such as inspecting the same food-processing
facility for compliance with sanitation and/or good manufacturing
practices requirements. To identify overlaps, we obtained and analyzed
agency budget data-including actual expenditures and staffing levels for
fiscal year 2003, the most recent year for which data were complete-and
contacted agency budget and program officials to help us identify what
activities the agencies perform and to determine whether similar
activities were performed by more than one agency. To examine the extent
of interagency coordination, we identified and reviewed all active
interagency agreements. We selected two inspection-related interagency
agreements for in-depth review because the agencies spend most of their
resources on inspection activities; one agreement that pertains to dual
jurisdiction establishments and one that pertains to inspections of
fishery products. In addition, these agreements encompassed a broad range
of intended coordination efforts between the agencies involved. To obtain
information about the agreements' implementation, we conducted site visits
to USDA and FDA field offices in three locations. To identify key
stakeholders and obtain their views on overlapping agency functions and
potential

5Interagency agreements include memoranda of understanding, memoranda of
agreement, and other agreements between agencies. FDA defines interagency
agreements as those that involve an exchange of funds, personnel, or
property. We did not include this type of agreement in our analysis.

consolidation of these functions, we relied on our previous work and on
the four agencies' recommendations. Based on this information, we compiled
a list of 35 stakeholders from the major industry associations, consumer
groups, and food safety experts from academia and conducted structured
interviews with them. In addition, we interviewed two to four company
representatives in the three states where we conducted field work. We
performed our work between May 2004 and March 2005 in accordance with
generally accepted government auditing standards, which included an
assessment of data reliability and internal controls. Appendix I describes
our methodology in greater detail.

Results in Brief We identified several overlapping food safety activities
that occur at multiple agencies because the agencies operate under
different statutes, which give them responsibility for conducting similar
activities for different food products, and different regulatory and
enforcement authorities. As a result, federal agencies are spending
resources on overlapping food safety activities designed to ensure the
safety and quality of domestic and imported food. In some cases, the
agencies conduct these activities at the same locations. For example:

o Domestic inspections. In fiscal year 2003, USDA and FDA spent most of
their food safety resources-about $900 million-on inspection and
enforcement activities. A portion of these activities included overlapping
and even duplicative inspections of 1,451 domestic foodprocessing
facilities that produce multi-ingredient foods, such as canned goods and
frozen entrees. Both agencies inspect these facilities, because each
agency has statutory responsibility for the safety of different foods or
food ingredients. For example, USDA inspects canning facilities at least
daily if the company produces canned beans containing meat and poultry. If
the facility produces canned beans without meat or poultry, FDA also
inspects it with a frequency ranging from 1 to 5 years. USDA and FDA
inspections have common features-both agencies spend inspection resources
to verify that facilities are sanitary and follow good manufacturing
practices. Although neither USDA nor FDA could estimate the total costs
associated with inspecting these facilities, FDA estimates that it spends
about $4,000 per inspection. According to some industry officials, having
two different regulatory agencies inspect a single facility can be
burdensome. At a facility we visited that produces crab cakes and breaded
chicken, the manager told us that he must maintain separate seafood and
poultry HACCP plans and that separate inspections are required for each.
The manager said this duplication is

confusing because the agencies are using the same model, but their
expectations for the plans' content differ. Under the Bioterrorism Act,
FDA could commission USDA officials to perform food inspections on its
behalf at those establishments under the jurisdiction of both agencies,
thereby making better use of its resources and reducing industry burden.
FDA has not yet exercised this authority with respect to commissioning
USDA officials.

o Import inspections. USDA and FDA both inspect shipments of imported
food at ports of entry and also visit foreign countries that export food
to the United States. We found that both USDA and FDA maintain inspectors
at 18 U.S. ports of entry to inspect imported food. In fiscal year 2003,
USDA spent almost $16 million on imported food inspections, and FDA spent
more than $115 million. The two agencies do not share inspection resources
at these ports. For example, USDA officials told us that all USDA-import
inspectors are assigned to, and located at, a USDAapproved import
inspection facility. They also told us that some of these facilities
handle and store FDA-regulated products, but USDA has no jurisdiction over
these FDA-regulated products. Although USDA maintains a daily presence at
these facilities, the FDA-regulated products may remain at the facilities
for some time awaiting FDA inspection. FDA also conducted inspections in 6
of the 34 countries that USDA evaluated in 2004 to determine whether their
food safety systems for ensuring the safety of meat and poultry are
equivalent to that of the United States. FDA officials said they do not
use USDA's evaluations of the foreign countries' food safety systems and
that USDA's findings would be of little use to FDA because they relate to
products under USDA's jurisdiction.

o Inspectors' training. Both USDA and FDA spend resources to provide
similar training to food inspection personnel. USDA spent $7.8 million and
FDA spent about $1.6 million in fiscal year 2003. We found that, to a
considerable extent, food inspection training addresses the same
subjects-such as plant sanitation, good manufacturing practices, and HACCP
principles. However, the programs differ in that they include HACCP
training on specific products, such as seafood or poultry. While taking
into consideration product-specific training differences, the agencies
could explore opportunities to merge training resources, as has been done
by consolidating federal law enforcement training in the Federal Law
Enforcement Training Center.

o Other overlapping activities. We identified overlapping activities in
research and risk assessments, development of education materials for
industry and consumers, and rulemaking. For example, USDA and FDA each
developed and issued separate HACCP rules, which are based on the same
model but applied to different food products. Because different food
products present different risks, separate HACCP plans may be required to
address individual food products. These rules require companies to
maintain a plan that identifies hazards that are most likely to
contaminate food in the production process and establish appropriate
control mechanisms to reduce those hazards. FDA estimates that it spent
between $650,000 and $1 million to develop and promulgate its 1995 seafood
HACCP rule; NMFS spent $5 million in efforts that supported FDA's seafood
HACCP rule. USDA was unable to calculate how much it spent to develop its
meat and poultry HACCP rule.

We also identified 71 interagency agreements that the principal food
safety agencies-USDA, FDA, EPA, and NMFS-have entered into that are
designed to better protect the public health by addressing jurisdictional
boundaries, coordinating activities, reducing overlaps, and leveraging
resources. However, the agencies' ability to take full advantage of these
agreements is hampered by the absence of adequate mechanisms for tracking
them and, in some cases, by ineffective implementation of the agreements'
provisions. Agency officials had difficulty identifying the food safety
agreements they are party to and, in many instances, the agencies did not
agree on the number of agreements they had entered into. For the two
comprehensive inspection-related agreements that we examined in detail,
the agencies are not ensuring that their provisions are adhered to or that
the overall objectives of the agreements are being achieved. For example,
USDA and FDA are not fully implementing an agreement to exchange
information to permit more efficient use of both agencies' resources at
jointly regulated facilities. Under this agreement, the agencies are to
share inspection information, but FDA does not routinely consider
compliance information from USDA when deciding how to target its
inspection resources. Furthermore, an inspection agreement between FDA and
NMFS recognizes the agencies' related responsibilities at
seafoodprocessing establishments that are inspected by FDA and also
inspected by NMFS under contractual arrangements. The agreement details
actions the agencies can take to enable each agency to discharge its
responsibilities as effectively as possible and minimize FDA inspections
at these facilities. However, contrary to the terms of the agreement, FDA
is not using information from NMFS inspections, which could allow it to
reduce the number of inspections at those facilities.

The stakeholders we contacted-selected industry associations,
foodprocessing companies, consumer groups, and academic experts-disagree
on the extent to which overlaps exist and on how best to improve the
federal food safety system. However, most of these stakeholders agree that
the laws and regulations governing the system should be modernized so that
scientific and technological advancements can be used to more effectively
and efficiently control current and emerging food safety hazards, but they
differed about whether to consolidate food safety functions into a single
federal agency. Specifically, the academics and consumer groups support
consolidating food safety functions into a single food safety agency.
These groups believe that consolidation would improve the effectiveness
and efficiency of the system and ensure that food safety inspections are
based on the best available science. Representatives from the individual
food companies that both USDA and FDA inspect concurred with that
assessment. In contrast, the industry association representatives do not
see the need to consolidate federal food safety functions. Proponents and
opponents also cited several roadblocks to consolidation, including the
need to maintain food security during any transition.

We have previously recommended that the Congress consider streamlining
food safety statutes to make them more uniform and risk based and
consolidating federal food safety functions under a single agency. We also
recognize, however, that improvements short of reorganizing the food
safety system can be made to help reduce overlaps and duplication, and to
leverage existing resources. In this report, we make several
recommendations to that end. For example, if cost effective, we recommend
that FDA, as authorized under the Bioterrorism Act, commission USDA
inspectors to carry out FDA's inspection responsibilities at food
establishments that are under their joint jurisdiction. We also recommend
that USDA and FDA examine the feasibility and cost effectiveness of
establishing a joint training program for their food inspectors.

In commenting on a draft of this report, USDA did not specifically agree
or disagree with the report's recommendations, but the agency's general
comments on the report appear to indicate that the agency disagrees. USDA
asserted that our report oversimplifies food safety authorities,
regulations, inspections, and training activities, exaggerates the
economic impact of overlaps, and does not accurately address coordination
efforts and agreements between USDA and FDA. We disagree with USDA's
characterization. Our report is based on numerous discussions with
knowledgeable officials as well as a thorough review of the agencies'

authorities, regulations, inspections, and training activities; but it
does not assess the economic impact of overlapping activities. The report
provides specific examples of those activities and information on the
expenditures each agency incurred to conduct these activities. One of
USDA's comments indicates that USDA recognizes the benefits of joint
training for food inspectors-one of our report's recommendations. USDA
added, however, that several factors affect the feasibility of conducting
joint training activities, such as the differences in classification of
the job series of individuals performing inspection duties. USDA also
commented that our report inaccurately characterizes the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (the
Bioterrorism Act). We disagree. As the report states, FDA is authorized
under the act to enter into an agreement to commission other agency
officials, including USDA officials, to carry out inspections on its
behalf-for FDA-regulated foods-at establishments under the jurisdiction of
both agencies. USDA also provided technical comments, which we
incorporated in our report, as appropriate. USDA's comments and our
detailed response are contained in appendix V.

In commenting on a draft of this report, HHS agreed with three of the
report's seven recommendations that the agency (1) use USDA's foreign
country evaluations, (2) identify and inventory all food safety-related
interagency agreements, and (3) evaluate and update the agreements. FDA
stated that it has taken steps to inventory these agreements. HHS
disagreed with our recommendation regarding joint training of FDA and USDA
food inspectors. The agency commented on, but did not agree or disagree
with, our recommendation regarding utilization of the Bioterrorism Act
authority to commission USDA officials. Finally, HHS partially concurred
with two other recommendations dealing with implementation of two
interagency agreements. In its comments, HHS raised concerns about our
terminology regarding overlapping activities and said that the report
overstated similar activities without specifying the differences. For
example, HHS noted that training programs for food inspectors are vastly
different due to the fact that USDA inspectors and FDA investigators have
very different academic backgrounds and conduct very different
inspections. We disagree with HHS's comment. Our report clearly explains
the use of terminology as well as the differences in the agencies'
activities. HHS also provided technical comments, which we have
incorporated in this report, as appropriate. HHS's comments and our
detailed response are contained in appendix VI.

EPA did not provide official written comments, but the agency commented
that it will consider our recommendation for better tracking of
interagency

agreements when EPA sets priorities for future investments in information
technology.

The National Oceanic and Atmospheric Administration (NOAA) provided
written comments and agreed with the report's recommendations that pertain
to NMFS. NOAA also commented that our report does a fair and thorough job
of describing NMFS's food safety activities. NOAA's comments are contained
in appendix VII.

Background Many federal agencies, as well as state and local entities,
play a part in the U.S. food safety regulatory system. While the federal
agencies regulate the food production chain from farms to food
manufacturers, state and local agencies primarily regulate food safety in
retail food establishments. Table 1 summarizes the food safety
responsibilities of the federal agencies. In addition to their established
food safety and quality responsibilities, following the events of
September 11, 2001, these agencies began to address the potential for
deliberate contamination of agriculture and food products, with the
Department of Homeland Security providing overall coordination on how to
protect the food supply from deliberate contamination.

Table 1: Federal Agencies' Food Safety Responsibilities

Department and/or agency Responsible for

U.S. Department of Food Safety and Inspection All domestic and imported
Service meat, poultry, and processed
Agriculture egg products
Animal and Plant Health Protecting the health and
Inspection Service value of U.S. agricultural
resources (e.g., animals and
plants)
Establishing quality
Grain Inspection, Packers standards, inspection
and Stockyards procedures,
Administration and marketing of grain and
other related products
Establishing quality and
Agricultural Marketing condition standards for
Service (AMS)a dairy,
fruit, vegetable, livestock,
meat, poultry, and egg
products
Agricultural Research Conducting food safety
Service research
Providing analyses of the
Economic Research Service economic issues affecting
the
safety of the U.S. food
supply
Providing statistical data,
National Agricultural including agricultural
Statistics Service chemical
usage data, related to the
safety of the food supply
Cooperative State Supporting food safety
Research, Education and research, education, and
Extension Service extension programs in the
land-grant university system
and other partner
organizations

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

Centers for Disease Control and Prevention Protecting the nation's public
health, including foodborne (CDC) illness surveillance

Department of Commerce National Marine Fisheries Service Voluntary,
fee-for-service examinations of seafood for safety and quality

Environmental Protection Regulating the use of pesticides and maximum
allowable Agency residue levels on food commodities and animal feed

Department of the Alcohol and Tobacco Enforcing laws covering the
Tax and Trade Bureau production, use, and
Treasury distribution of alcoholic
beverages
Department of Coordinating agencies' food
Homeland security activities
Securityb

Federal Trade Commission Prohibiting false advertisements for food

Source: GAO.

aAccording to USDA, AMS has no statutory authority in the area of food
safety. However, the agency performs some functions related to food safety
for several foods. For example, AMS graders monitor a shell egg
surveillance program that identifies cracked and dirty eggs. In addition,
AMS performs functions related to food safety for the National School
Lunch Program.

bIn 2001, by executive order, the President stated that the then Office of
Homeland Security, as part of its efforts to protect critical
infrastructures, should coordinate efforts to protect livestock,
agriculture, and food systems from terrorist attacks. In 2002, Congress
enacted the Homeland Security Act of 2002, Pub. L. No. 107-296, 116 Stat.
2135 (2002), setting out the department's responsibility to protect and
secure critical infrastructures and transferring several food
safety-related responsibilities to the Department of Homeland Security. As
a result of the 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 coordination on the protection of the U.S. food supply from
deliberate contamination.

The agencies' food safety authorities stem from 30 principal laws related
to food safety. For a listing of the principal food safety laws, see
appendix IV. As a result of this division of responsibility, the federal
food safety system is fragmented. In some instances, agencies perform
nearly identical activities-both USDA and FDA inspect food-processing
facilities that produce foods under the regulatory responsibility of each
agency, referred to as dual jurisdiction establishments (DJE). DJEs are
those that manufacture or process food products that contain ingredients
regulated by more than one federal agency. For example, both USDA and FDA
inspect facilities that make canned baked beans with 2 percent or more
bacon (a USDA-regulated food) and canned baked beans without meat (an
FDA-regulated food). While these agencies each perform food safety
inspections, the frequency of their inspections varies.6 Generally, USDA
inspectors have a more regular presence at DJEs. As another example, both
FDA and NMFS inspect seafood-processing facilities, although NMFS's
inspections are conducted at the request of the facility through a
contract between the facility and NMFS.

Four agencies-USDA, FDA, EPA, and NMFS-are involved in key program
functions related to food safety-including inspection and enforcement,
research, risk assessment, education and outreach, rulemaking and standard
setting, surveillance and monitoring, food security, and administration.
Examples of activities under these functions include:

o inspecting domestic food-processing facilities and imported food items
at U.S. ports of entry;

o researching foodborne chemical and biological contaminants, as well as
reducing foodborne pathogens;

o conducting risk assessments of foodborne physical, chemical, and
biological contaminants to inform rulemaking, allocation of agency
resources, or risk communication;

o developing and distributing guidance to consumers and industry related
to food safety topics such as appropriate food temperatures; and

6Under its statutes, USDA inspects meat and poultry processing facilities
at least daily, whereas FDA can determine how often it inspects
facilities. FDA's goal is to inspect highrisk facilities at least annually
and other facilities every 3 to 5 years.

o issuing/promulgating HACCP, sanitation, and good manufacturing
practices regulations.

In fiscal year 2003, the four federal agencies spent nearly $1.7 billion
on food safety-related activities. USDA and FDA are responsible for most
federal food safety resources (as fig. 1 shows).

Figure 1: USDA, FDA, EPA, and NMFS Food Safety Expenditures, Fiscal Year
2003

NMFS - $21,999,941

EPA - $160,713,000

FDA - $480,379,000

USDA - $1,015,852,478

Source: GAO analysis of USDA, FDA, EPA, and NMFS expenditures.

These agencies spent about $921 million (55 percent) in fiscal year 2003
on inspection/enforcement functions, including inspections of domestic and
imported food (as fig. 2 shows).

Figure 2: USDA, FDA, EPA, and NMFS Food Safety Expenditures by Program
Function, Fiscal Year 2003

Inspection/enforcement - $920,785,798

Surveillance/monitoring - $112,763,050 Other - $212,547,684 Education/outreach -
$107,603,184

Research - $175,841,986

Risk assessment - $149,402,717

Source: GAO analysis of data obtained from, and discussions with, USDA,
FDA, EPA, and NMFS officials.

Notes: Program functions are based on the National Academy of Science's
1998 report Ensuring Safe Food.7 These categories include:
monitoring/surveillance, inspection/enforcement, education/outreach,
research, and risk assessment. To capture other relevant activities, we
include three additional functions-administration, food security, and
rulemaking/standard setting-in the function "other." Expenditures for
these functions were provided by some agencies, but not others. The
agencies that did not provide estimates of these expenditures reported
that they are distributed among other functions.

USDA's Food Safety and Inspection Service did not provide Surveillance
expenditure data.

The agencies' expenditures vary by program function (as shown in fig. 3).
For example, USDA's inspection/enforcement expenditures made up almost
three-quarters of the total spent by these agencies for that program
function. That is, the majority of federal food safety inspection
expenditures are directed toward USDA's programs for ensuring the safety
of meat, poultry, and egg products. In contrast, FDA accounts for more
than half of the agencies' expenditures for food safety education/outreach
programs.

7National Research Council and Institute of Medicine, Ensuring Safe Food:
From Production to Consumption (Washington, D.C.: 1998).

Figure 3: Food Safety Expenditures (dollars) by Agency and Function,
Fiscal Year 2003

Dollars in millions

900

800

700

600

500

400

300

200

100

0 Inspection/ Research Risk Education/ Surveillance/ enforcement
assessment outreach monitoring

EPA

USDA

NMFS

FDA

Source: GAO analysis of data obtained from, and discussions with, USDA,
FDA, EPA, and NMFS officials.

Appendix II provides detailed information on the agencies' expenditures
and staffing levels devoted to the various program functions in fiscal
year 2003.

Federal Food Safety Agencies Spend Resources on Overlapping Food Safety
Activities

As a result of the multiple laws and regulations governing food safety,
several federal agencies conduct activities-inspections of domestic and
foreign foods, training, research, risk assessment, education, and
rulemaking-that can serve overlapping, if not identical, purposes. As a
result, federal agencies spend resources on similar food safety
activities. Table 2 illustrates similar activities conducted by the four
federal agencies we examined. These activities, such as laboratory
analysis and risk assessment, may be product specific.

Table 2: Examples of Similar Food Safety Activities Food safety program function
Activity USDA FDA EPA NMFS

Inspection/ Enforcement

Inspection of domestic food-processing facilities o o o Visits to
foreign countries or firms to conduct inspections

o o o

and/or evaluate foreign food safety systems

Inspection of imported food at ports of o o
entry
Training inspectors o o o
Maintenance of inspection record database o o o
Support to state enforcement efforts o o o
(retail-level food safety)
Laboratory analysis of samples collected at o o o
food-processing
facilities (to identify potential
contamination)
Research Research on pathogen reduction o o o
Research on foodborne chemical contaminants o o o o
(such as
pesticides or dioxins) or biological
contaminants (such as
E. coli or salmonella)
Risk assessment Risk assessment of food contaminants o o o o
Sample collection and/or analysis of o o o
pesticide residues to
inform risk assessment
Development and delivery of consumer o o o o
Education/Outreach education (such as
consumer hotlines or pamphlets)
Development and delivery of industry o o o o
guidance (such as
guidance regarding regulations)
International harmonization of standards o o o o

Surveillance/Monitoring Participation in FoodNet (active o o
surveillance for foodborne
diseases)
Participation in PulseNet (early o o
warning system for food illness
outbreak)
HACCP rule development and o o o a
Rulemaking/Standard setting promulgation

Source: GAO analysis of documents obtained from, and discussions with,
USDA, FDA, EPA, and NMFS officials.

aNMFS participated in development of FDA's seafood HACCP rule.

Agencies Conduct Overlapping Inspections at Jointly Regulated
Food-Processing Facilities

USDA and FDA spent $884 million in fiscal year 2003 on inspection and
enforcement activities-roughly 60 percent of their total food safety
expenditures. Neither USDA nor FDA has estimated the total costs
associated with inspecting jointly regulated facilities. FDA estimated
that it spends about $4,000 per inspection. As figure 4 shows, USDA and
FDA both inspect 1,451 known DJEs located across the country.8 USDA and
FDA inspect these establishments with different frequencies. For example,
USDA inspects a canning facility at least daily if it produces food
containing meat and poultry. If the facility also produces canned soups
containing beans or seafood, FDA inspects it every 1 to 5 years.

Figure 4: Location of Food Manufacturers, Warehouses, and Other Types of
Food Establishments Inspected by Both USDA and FDA

Source: GAO analysis of USDA and FDA establishment data.

Note: DJEs in Puerto Rico (39), Hawaii (10), and Alaska (18) are not shown
in the figure.

8According to FDA officials, these establishments include 772 food
manufacturers, 539 warehouses, and 140 other types of establishments such
as retailers, importers, packers, and labelers. The agency is verifying
about 400 potential additional DJEs.

Because of their split jurisdiction, each agency is responsible for
inspecting different food products at these facilities; but the agencies'
inspections have common key elements, including verifying the facilities'
compliance with sanitation standards (as defined by USDA) or good
manufacturing practices (as defined by FDA). For example, both agencies'
inspectors verify that facilities do not have rodent or insect
infestations. Figure 5 summarizes some of the common elements of USDA and
FDA inspections.

Figure 5: Common Elements of USDA and FDA Inspections

Source: GAO analysis of FSIS and FDA documents.

At jointly regulated facilities, USDA and FDA inspectors also verify that
HACCP systems are in place. In these instances, each agency verifies that
the facility has created and implemented a HACCP plan specific to the
products that the agency regulates. The regulations require the facility
to maintain separate HACCP plans for each product and to develop separate
analyses of critical control points and separate strategies to mitigate or
eliminate food contaminants.9 For example, at a facility we visited that
produces both crab cakes and breaded chicken, the manager is required to
maintain a seafood HACCP plan and a poultry HACCP plan. The manager said
that although both plans have similar elements, each agency's inspectors
expect different levels of detail for the plans-something the manager
finds confusing and difficult to comply with.

USDA and FDA have new tools that could help reduce overlaps in
inspections. Under the Bioterrorism Act, FDA could allow USDA

9Separate HACCP plans are generally necessary to address the specific
hazards associated with specific food products.

inspectors, who are present every day at these jointly regulated
facilities, to inspect FDA-regulated food.10 In doing so, FDA could reduce
overlapping inspections and redirect resources to other facilities for
which it has sole jurisdiction. While they did not disagree in principle
with the benefits of such an arrangement, FDA officials said that the
savings would be somewhat offset because FDA would likely have to
reimburse USDA for the costs of those inspections. FDA officials said that
they do not currently plan to pursue this option and have not conducted
any analyses of the costs or savings associated with authorizing USDA
officials to conduct FDA inspections at these facilities. USDA officials
commented that their inspectors are fully occupied and that they would
need to be trained before conducting joint inspections.

Overlaps also occur at seafood-processing facilities that both FDA and
NMFS inspect. NMFS currently inspects approximately 275 domestic seafood
facilities that FDA also inspects. NMFS safety and sanitation inspections,
as well as other product quality inspections are conducted on a
fee-for-service basis. NMFS inspectors verify sanitation procedures, HACCP
compliance, and good manufacturing practices-many of the same components
of an FDA inspection. Although NMFS and FDA seafood safety inspections are
similar, FDA does not take into account whether NMFS has already inspected
a particular facility when determining how frequently its inspectors
should visit that same facility.

FDA officials said they do not rely on NMFS inspections for two reasons.
First, FDA officials believe that NMFS has a potential conflict of
interest because companies pay NMFS for these inspections; and therefore,
as a regulatory agency, FDA should not rely on them. NMFS officials
disagree with FDA's viewpoint, stating that their fee-for-service
structure does not affect their ability to conduct objective inspections.
NMFS officials said that, when NMFS inspectors find noncompliance with FDA
regulations, they refer companies to FDA and/or to state regulatory
authorities. NMFS officials stated that companies that contract with NMFS
need the agency's certification in order to satisfy their customers.
Second, it is difficult for FDA to determine which facilities NMFS
inspects at any given time because NMFS inspection schedules fluctuate
often, according to changes in NMFS's contracts with individual companies.
If FDA were to recognize the

10Under the act, the agencies would have to enter into a memorandum of
understanding that would include provisions to ensure adequate training of
USDA officials and to address reimbursement.

results of NMFS inspection findings in targeting its resources, it could
decrease or eliminate inspections at facilities that NMFS inspectors find
are in compliance with sanitation and HACCP regulations.

USDA and FDA Conduct Inspections of Food Imports

Both USDA and FDA maintain inspectors at 18 U.S. ports of entry to inspect
imported food products. In fiscal year 2003, USDA spent almost $16 million
on these inspections, and FDA spent more than $115 million.11 FDA spends
about 7 times as much on import inspections because the agency is
responsible for about 80 percent of the U.S. food supply, including
imports from about 250 countries, compared with USDA's responsibility for
inspecting imports that come from 34 countries. However, the agencies are
not leveraging inspection resources at these ports. USDA officials told us
that FDA-regulated, imported foods are sometimes stored in USDAapproved
inspection facilities at these ports. USDA inspectors have no authority to
inspect FDA-regulated products, although USDA inspectors are present at
these ports more often than FDA inspectors. As a result, some
FDA-regulated products may remain at the facility for some time awaiting
inspection. FDA has the authority to commission federal officials to
conduct inspections at jointly regulated facilities. In 2003, FDA
exercised this authority to conduct inspections by entering into an
agreement with the Department of Homeland Security's Customs and Border
Protection (CBP) so Customs' officials can help FDA inspect products at
ports and other facilities subject to CBP jurisdiction.

FDA could also leverage USDA's efforts to ensure the safety of imported
food by using information that USDA compiles in its determinations that
exporting countries' food safety systems are equivalent to the U.S.
system. Under the Meat and Poultry Products Inspection Acts, the Secretary
of Agriculture is required to certify that countries exporting meat and
poultry

11Ports of entry at which USDA and FDA inspectors are each present include
Baltimore/Dundulk, Maryland; Blaine, Washington; Boston, Massachusetts;
Buffalo, New York; Champlain, New York; Detroit, Michigan;
Eastport/Porthill, Idaho; Houston, Texas; Jacksonville, Florida; Laredo,
Texas; Los Angeles, California; New Orleans, Louisiana; New York, New
York; Newark, New Jersey; Pembina, North Dakota; Savannah, Georgia;
Seattle/Tacoma, Washington; and Sweetgrass, Montana.

to the United States have equivalent food safety systems for producing
meat and poultry products that are exported to the United States.12 That
information could inform FDA's decision making about which countries to
visit for its overseas inspections. Currently, FDA visits foreign
countries to inspect individual food-processing firms. In 2004, USDA
determined that the food safety systems of 34 countries it evaluated were
equivalent to that of the United States. A substantial portion of what
USDA evaluates- sanitation procedures and compliance with HACCP
rules-could be useful to FDA in deciding what countries to visit when
conducting inspections of foreign firms that export products under its
jurisdiction. FDA officials told us, however, that the agency does not use
that information when deciding which countries to visit. As a result, FDA
at times conducts inspections in the same countries that USDA has
evaluated. For example, USDA and FDA each visited Brazil, Costa Rica,
Germany, Hungary, Mexico, and Canada last year. USDA spent almost
$500,000, and FDA spent almost $5 million, on its foreign country visits
in fiscal year 2003. USDA and FDA officials said these agencies do not
share information from their overseas visits because their different
statutory responsibilities make such information of little advantage. That
is, USDA's focus during foreign country visits is to evaluate the meat and
poultry inspection systems to determine if they are equivalent to that of
the United States, whereas FDA focuses its visits on specific companies
that produce food under the agency's jurisdiction.13

Agencies Maintain Similar Inspection Training Programs

USDA and FDA provide similar training to their inspectors. For example,
both agencies train inspectors on sanitation requirements, good
manufacturing practices, and HACCP. Agency officials agreed that the
training programs have a common foundation but pointed out that there are
differences, as each agency applies these principles to the specific foods
it regulates. USDA spent $7.8 million, while FDA spent about $1.5 million,
during fiscal year 2003 to train their food inspection personnel.14 FDA's
comparatively lower training costs reflect a contractual agreement with a
private firm that has produced an online curriculum. This curriculum
includes over 106 courses that address topics common to both

12FDA has no similar requirement.

13According to FDA, in some foreign countries, meat and poultry inspection
programs are separate from other food inspections, as they are in the
United States.

14FDA officials told us that their training expenditures include training
that can be applied to products other than food, such as medical devices.

USDA and FDA-ranging from foodborne pathogens, HACCP requirements, and
good manufacturing practices, to courses that are specific to FDA's
regulations and enforcement authorities. Another agency-NMFS-uses 74 of
these online courses to train its own seafood inspectors. The benefits
NMFS officials cited include accessibility to training materials at times
other than when inspectors are "on duty" and no charge to NMFS for the
training materials. USDA officials said they are exploring the possibility
of entering into an agreement with the company that developed FDA's online
curriculum to allow USDA inspectors access to some of this training. In
addition to the costs associated with developing inspector training
programs, USDA estimates that it spends an average of about $900,000 per
year on training-related travel, not including other costs related to
replacing inspectors in food-processing facilities while they participate
in the training. A joint USDA-FDA training program could reduce
duplication in developing training materials and in providing instruction,
and potentially achieve some savings.

Other federal agencies have consolidated training activities that have a
common purpose and similar content. For example, in 1970, the Consolidated
Federal Law Enforcement Training Center (the Center) brought together the
training programs of 75 federal law enforcement agencies that had
maintained separate training programs. Specifically, the Center provides
standardized programs for criminal investigators and uniformed police
officers across the federal government. While standardizing basic
training, the Center also offers specialized courses for individual
agencies to address their particular needs. In addition, according to the
Center, the interaction with students from other agencies promotes greater
understanding of other agencies' missions and duties, and therefore
provides for a more cooperative federal law enforcement system.15

Agencies Conduct Other We identified overlapping activities in the areas
of food safety research and Activities That Overlap risk assessment,
consumer and industry education, and rulemaking.

15GAO, Federal Law Enforcement Training: Capacity Planning and Management
Oversight Need Improvement, GAO-03-736 (Washington, D.C.: July 24, 2003).
In 2003, we reported that the Center had played a vital role in training
law enforcement personnel since its inception. The report noted that since
the September 11, 2001 attacks, the Center's overall capacity to provide
training was strained and made several recommendations for addressing this
issue.

Food Safety Research and Risk-Assessment Efforts

USDA and FDA participate in similar food safety research efforts; that is,
both agencies collect and analyze food samples for chemical and biological
contaminants. During fiscal year 2003, the agencies spent over $245
million on these types of activities. For example, because of the
agencies' split jurisdiction, both USDA and FDA maintain separate
laboratory capability to sample and analyze the foods that they regulate
for chemical contaminants such as pesticides and dioxins.16 EPA uses USDA
and FDA data to inform EPA's risk assessments on human exposure to
pesticides. Specifically, in 2003, FDA analyzed 11,331 food samples for
pesticides and chemical contaminants to help estimate the dietary intake
of pesticide residues. In 2000, the most recent year for which data are
available, USDA's Food Safety and Inspection Service (FSIS) analyzed over
33,000 samples of meat, poultry, and egg products. In addition, USDA's
Agricultural Marketing Service's (AMS) Pesticide Data Program samples and
tests commodities across the food spectrum to help inform EPA in making
decisions on acceptable levels of pesticide residues (tolerances).
According to EPA officials, USDA data are their primary source of
information. However, FDA provides additional information on a greater
range of foods and chemicals that EPA also uses to form its decisions. EPA
officials said that the overlap in data collection and analysis adds value
because USDA's data comes from a well-controlled survey of food samples
taken at the wholesale level, and FDA's data helps fill in the gaps with
samples of food at different points in the distribution chain.

USDA and FDA also both conduct risk assessments of foodborne pathogens
that can contaminate food products under their respective jurisdictions.
For example, in 2000, USDA released a draft risk assessment for
Escherichia coli ( E. coli) O157:H7 in ground beef and, FDA released a
draft risk assessment for Vibrio parahaemolyticus in raw molluscan
shellfish. The agencies also conduct joint risk assessments when
addressing the same pathogen or the same food product. In the case of
eggs, regulatory responsibility shifts as eggs make their way from the
farm to the table, with FDA being primarily responsible for the safe
production and processing of eggs still in the shell (known as shell
eggs), and USDA being responsible for food safety at the processing plants
where eggs are broken to produce egg products. In 1996, the agencies began
work on a joint risk assessment for salmonella in eggs to evaluate the
risk to human health of salmonella in shell eggs and in liquid egg
products and to identify

16FDA officials said USDA and FDA look for different levels of dioxin in
food products they regulate.

potential risk reduction strategies. In 1998, USDA and FDA jointly
published an advance notice of proposed rulemaking, based on this risk
assessment, to identify farm-to-table actions that would decrease the food
safety risks associated with eggs. However, the agencies have not issued a
joint rule to help eliminate foodborne illnesses caused by salmonella in
eggs. In 2004, FDA issued a proposed rule that would require shell egg
producers to implement measures to help prevent salmonella from
contaminating eggs on the farm. Although USDA released a new draft risk
assessment in 2004, the department has not yet issued a proposed rule to
help prevent salmonella from contaminating egg products. Both agencies
have also committed personnel resources to a World Health Organization
effort to conduct a risk assessment of salmonella in eggs and broiler
chickens.

Consumer and Industry USDA, FDA, and EPA conduct education and outreach on
food safety-and

Education spent more than $107 million in fiscal year 2003.17 In some
cases, these agencies' efforts overlap. For example, these agencies create
and distribute educational materials to consumers, or host hotlines or
other forums that address food safety issues. In some cases, these efforts
target the same food safety topic. For example, USDA, FDA, and EPA each
develop consumer guidance on chemical food contaminants such as
pesticides, dioxin, and mercury. In addition, USDA and FDA each develop
similar food safety guidance for (1) consumers on general topics, such as
cooking and chilling food, and safe handling practices, such as using a
food thermometer and (2) industry, on their HACCP regulations and
sanitation and good manufacturing practices. These overlapping efforts,
caused in part by the agencies' divisions in jurisdiction, can be
confusing to both consumers and industry representatives. For example,
USDA officials said they receive calls from consumers and industry
representatives to their consumer hotline about FDA-regulated food
products. These agencies have made some efforts to reduce overlaps in
their consumer education activities. For example, USDA and FDA developed
the "Fight Bac" program to educate the public about safe food handling to
help reduce foodborne illness. In addition, for the first time in 2004,
FDA and EPA issued a joint consumer advisory about mercury in fish and
shellfish for women who

17USDA program offices include the Cooperative State Research, Education
and Extension Service, Economic Research Service, and the Food Safety and
Inspection Service. FDA program offices include the Center for Veterinary
Medicine and the Office of Regulatory Affairs. EPA program offices include
the Office of Pesticide Programs and the Office of Water.

might become pregnant, who are pregnant, who are nursing, as well as for
young children. However, the joint advisory recommends different
consumption levels, depending on whether the fish is commercially caught
(regulated by FDA) or recreationally caught (regulated by EPA).
Specifically, for fish purchased from a store, the guidance recommends up
to 12 ounces per week. However, if the fish is recreationally caught, the
guidance recommends that women consume up to 6 ounces per week. EPA said
that the consumption guidance differs due to different mercury levels in
recreationally and commercially caught fish.

Rule-Making Activities Vary but As the principal agencies responsible for
food safety, both USDA and FDA

Share Some Similarities engage in rule-making and standard-setting
activities under their respective statutes. While the rulemakings USDA and
FDA undertake vary under those statutes, there are some similarities. For
example, USDA and FDA promulgated separate HACCP regulations for industry,
but both agencies' regulations require food processors to incorporate
certain sanitation processes into their HACCP systems. The HACCP rules are
based on the same model, though applied to the different food products
each agency regulates.18 For example, FDA requires seafood-processing
facilities to address contaminants that are likely to be found in seafood,
such as Vibrio vulnificus (a bacteria found in raw seafood, particularly
in oysters). USDA requires all meat and poultry processing facilities to
address contaminants, such as E. coli and salmonella, which are likely to
be found in these products. While quantifying the resources dedicated to
rule-making activities is difficult for the agencies, the costs are
significant. FDA estimates that it spent between $650,000 and almost $1
million to issue its seafood HACCP rule in 1995.19 NMFS officials said
they spent $5 million to support the FDA rule by developing a model
seafood surveillance project. USDA was unable to calculate how much it
spent to develop its meat and poultry HACCP rule.

In some cases, the agencies collaborate in the early stages of rulemaking.
For example, USDA and FDA participated in a joint Listeria

18Currently, FDA requires that seafood and juice processing facilities
comply with mandatory HACCP regulations. Many HACCP principles are already
in place at FDAregulated low-acid canning facilities. In addition, HACCP
is now an option under the pasteurized milk ordinance.

19FDA's estimate included research, testing means to verify the standard,
legal analysis, economic analysis, policy writing, public comment
activities, as well as reviewing the final rule, based on new data and
comments received.

monocytogenes (listeria) risk analysis of ready-to-eat foods. However, the
agencies will promulgate separate listeria rules for the products under
their jurisdiction.

Agencies Have Numerous Interagency Agreements to Coordinate Food Safety
Activities, but Tracking Mechanisms and Implementation Are Weak

The principal food safety agencies-USDA, FDA, EPA, and NMFS-have entered
into 71 interagency agreements to coordinate the full range of their food
safety activities and to support their mission to protect the public
health. About one-third of the agreements include as objectives, the
coordination of activities, reductions in overlaps, and/or leveraging of
resources. The agencies' ability to take full advantage of these
agreements is hampered by the absence of adequate mechanisms for tracking
them and, in some cases, by ineffective implementation of the provisions
of these agreements.

Many Interagency Agreements Address Inspection and Enforcement and
One-Third Highlight the Need to Reduce Duplication and Overlap

Of the 71 interagency agreements we identified, the largest proportion (43
percent) reflect the agencies agreement to increase cooperation on
inspection and enforcement activities. The agencies also spent the largest
share of their food safety resources on these activities (as fig. 2
showed). Other agreements address activities such as education/outreach,
food security, and monitoring/surveillance related to food safety and
quality (as shown in fig. 6). Furthermore, 24 agreements specifically
highlight the need to reduce duplication of effort by clarifying
responsibilities, reducing overlaps, and/or making efficient and effective
use of resources. Appendix III provides additional information about the
71 agreements.

Figure 6: Food Safety-Related Interagency Agreements by Program Function

Inspection/enforcement - 31

Surveillance/monitoring - 5 Food security - 7

Administration - 5 Rulemaking/standard setting - 4

Education/outreach - 14

Research - 2

Risk assessment - 3

Source: GAO's analysis of USDA, FDA, EPA, and NMFS documents.

In some instances, the agencies entered into multiple agreements to
coordinate and ensure the safety of a single type of food. For example, we
identified seven agreements that focus on seafood inspection and
enforcement activities; signatories to one or more of these agreements
include USDA, FDA, NMFS, the Department of Defense, and the Interstate
Shellfish Sanitation Conference (ISSC).20

In addition to these formal interagency agreements, the agencies cooperate
through other mechanisms such as the Foodborne Diseases Active
Surveillance Network (also known as FoodNet) that USDA, FDA, and the
Centers for Disease Control and Prevention use to help track the incidence
of foodborne illness and track the effectiveness of food safety programs
in

20The ISSC was formed in 1982 by FDA, state regulators, and shellfish
industry representatives to develop policies for the safe harvesting,
processing, and distribution of fresh and frozen shellfish. FDA must
concur with the ISSC's proposed policy changes before they are
incorporated into the National Shellfish Sanitation Program's (NSSP) model
ordinance.

reducing foodborne illness. Agency officials also noted that they
informally cooperate and collaborate with one another on a regular basis.

Controls for Tracking Food Safety Agreements Are Weak

USDA, FDA, EPA, and NMFS do not have adequate mechanisms to track
interagency food safety agreements. Consequently, the agencies could not
readily identify the agreements that they have entered into, could not
determine which agreements are still in effect, and were unable to
determine which are still needed. As a result, we could not determine
which agreements are currently being used by the agencies. Agency
officials did not agree on the number of food safety-related agreements
they have entered into, and only 7 of the 71 agreements that we ultimately
compiled were identified to us by all signatory agencies. For example, FDA
and EPA provided a copy of an agreement they had entered into with USDA
about residues in drugs, pesticides, and environmental contaminants in
foods; however, USDA officials said the agency is not party to any
agreement on residues. Forty-one additional agreements were identified to
us by only one of the multiple signatories. In addition, we found three
agreements-through our prior work or Internet searches-that none of the
agencies had identified to us.

Of the agencies we reviewed, only USDA's Animal and Plant Health
Inspection Service maintained a database that allowed it to readily
identify all the agreements it was party to. The other agencies did not
have such databases. During the course of our review, EPA officials said
that, without such tools, they had difficulty identifying the agreements
they have entered into. Officials also said they are planning to develop
an electronic system to identify and track these agreements. EPA said
that, if developed, this system could offer one means of tracking and
managing information related to, and contained in, interagency agreements.

The weaknesses in tracking agreements may also affect the agencies'
ability to determine whether these agreements are still needed and whether
specific provisions are still in effect. First, about one-third of the
agreements we identified were created decades ago and may no longer be
relevant to current needs. Technological and scientific advances have made
some provisions of these agreements obsolete. Second, some agencies that
were party to the agreements have ceased to exist because of internal
reorganizations; but the agreements have not been modified to reflect such
changes, indicating that the agencies may not be actively monitoring the
status and relevance of these agreements. For example, a 1978 agreement
between USDA and FDA on education programs to assist livestock and

poultry producers in using animal drugs has not been modified to reflect
the fact that USDA's Science and Education Administration no longer
exists. Also, we found that some agreements have not been updated to
account for changes in a signatory's responsibilities since they were
signed. For example, NMFS officials said that the ISSC has taken on some
responsibilities that once belonged to NMFS and that the 1985 agreement on
shellfish-growing waters signed by FDA, EPA, NMFS, and the U.S. Department
of the Interior's Fish and Wildlife Service should be updated to reflect
this change.

Agencies Are Not Fully Implementing Two Comprehensive Interagency
Agreements That Could Eliminate Duplication of Effort and Leverage
Resources

USDA and FDA Agreement to Exchange Information About Establishments That
Are Subject to the Jurisdiction of Both Agencies and to Permit More
Efficient Use of Resources

Because the agencies spend most of their food safety resources on
inspection and enforcement, we evaluated the implementation of two
comprehensive inspection and enforcement agreements: one that pertains to
DJEs and one that pertains to inspections of fishery products. These
agreements were established to make more efficient and effective use of
agency resources through improved coordination and information sharing.
Although the agencies are exchanging some information as called for in the
agreements, they are generally missing opportunities to make more
effective and efficient use of their resources, such as leveraging
inspection and enforcement resources.

In 1999, USDA and FDA signed an interagency agreement to facilitate the
exchange of information between the agencies about food-processing
facilities that they both inspect. The agreement stated that the exchange
of information will permit more efficient use of both agencies' resources
and contribute to improved public health protection. The agreement was to
be the first step toward allowing USDA's FSIS inspectors to conduct FDA's
inspections at DJEs, according to a former USDA senior food safety
official who signed the agreement. The agreement was developed in response
to a 1997 report by the President's Food Safety Council,21 which
recommended increased cooperation among agencies. Specifically, the report
recommended that USDA and FDA take steps to ensure that the resources and
experience of FDA and USDA's FSIS be used as efficiently as possible to
avoid duplication of effort and that the agencies consider using FSIS
inspectors to conduct FDA inspections at DJEs. The report stated that

21Food Safety from Farm to Table: A National Food Safety Initiative Report
to the President, May 1997. Food and Drug Administration, U.S. Department
of Agriculture, U.S. Environmental Protection Agency, Centers for Disease
Control and Prevention. http://vm.cfsan.fda.gov/~dms/fsreport.html.

because FSIS inspectors are already in these plants, they could be used to
maximize use of federal resources without loss of inspection coverage for
FSIS-regulated foods.

In 2000, USDA and FDA evaluated the agreement's implementation and
concluded that the experience had been largely successful because the
agencies learned about each other's operations and about ways to cooperate
more effectively. However, the evaluation also included recommendations to
strengthen, clarify, or otherwise improve the agreement's implementation.
Among other things, the evaluation recommended that FDA provide FSIS with
access to FDA's inspection database, ensure more frequent updates to the
list of jointly regulated facilities, and train inspectors on the
provisions of the agreement. The evaluation cited the potential for
significant resource savings over time as the agreement is implemented,
particularly in personnel, administrative, and travel costs. Since the
2000 evaluation, officials at USDA and FDA said they have not again
monitored the agreement's effectiveness, nor have they implemented their
own recommendations to realize resource savings.

We found that the agencies are not systematically exchanging information
about DJEs, as called for in the agreement. First, the agreement called
for USDA and FDA to develop, maintain, and annually update a list of such
establishments. We found that although the agencies created such a list in
1999 when the agreement was signed, they had not updated it until 2004,
when we brought the matter to their attention. As a result, the agencies
had great difficulty identifying the current number of DJEs to which this
agreement pertains. For example, during the course of our review, USDA and
FDA provided several different lists of jointly regulated establishments.
The number of establishments that were listed ranged from 1,152 to 1,867.
In December 2004, FDA headquarters officials provided us a list of 1,451
known DJEs, and the agency is verifying approximately 400 establishments
that may be added to the list.

Second, the agreement calls for the district offices of each agency to
share certain findings with their counterpart district offices and for the
agency receiving a finding of noncompliance to track and use that
information in its program evaluation, work planning, and consideration of
whether action against the facility is warranted. The agreement also calls
for the receiving agency to inform the notifying agency of the disposition
of the notification, including any actions that it plans or takes, within
30 days. During field visits to three USDA and FDA district offices that,
together, are responsible for food safety in 13 states, we found that USDA
and FDA field inspection

personnel are not routinely communicating these findings of mutual
concern, such as sanitation problems at facilities they jointly
regulate.22 Nor have USDA and FDA explored the feasibility of developing a
system to track and exchange information when each agency finds instances
of noncompliance. As a result, work planning by each agency cannot take
advantage of the other agency's inspection findings.

Because FDA inspectors visit DJEs less frequently than USDA inspectors, we
believe that FDA staff could benefit from the compliance information that
USDA inspectors collect.23 Generally, problems with a facility's
manufacturing processes or sanitation procedures affect all products
produced at the establishment. As a USDA district official told us, "a
rodent doesn't distinguish between FDA-regulated products and
USDA-regulated products, so a problem affecting one agency's product is
likely to affect the other agency's product."

Third, the agreement calls for the agencies to explore the feasibility of
granting each other access to appropriate computer-monitoring systems so
each agency can track inspection findings. However, the agencies maintain
separate databases, and the inspectors with whom we spoke continue to be
largely unaware of a facility's past history of compliance with the other
agency's regulations. Inspectors told us that compliance information might
be helpful when inspecting DJEs so that they could focus attention on past
violations.

Fourth, the agreement calls for the agencies to develop and provide
appropriate training in the inspectional techniques and processes of each
agency to ensure that the contacts for each agency have an appropriate
understanding of the working of the other agency. In addition, the 2000
evaluation found that more training was needed, particularly at the field
level, to achieve the results of the agreement. Although USDA and FDA held
28 joint training sessions during the first year of the agreement's
implementation, no additional training has been provided since then.
Because USDA and FDA on-site inspectors are often the first agency staff

22FDA commented that it is the responsibility of district supervisors and
district directors to be aware of this agreement and communicate to their
local USDA counterparts any cases in which enforcement action was
necessary at DJEs. FDA also noted that field personnel could benefit from
additional training on the specifics of this agreement.

23FDA's goal is to inspect high-risk facilities at least annually and
other facilities every 3 to 5 years.

to become aware of deficiencies at a plant, effective sharing of this type
of information depends upon those inspectors being adequately trained.

According to agency officials, the agreement has helped agency
coordination and communication, particularly when major public health
concerns arise. USDA and FDA headquarters officials identified instances
of major enforcement actions resulting from FDA's notification to USDA of
problems with products under its jurisdiction. For example, in one case,
FDA investigators learned that a sample of chicken salad tested positive
for listeria and alerted USDA, resulting in a voluntary recall. In a
second case, USDA and FDA cooperated by exchanging information on a severe
rodent infestation at a DJE, resulting in the seizure of millions of
pounds of USDAand FDA-regulated product. In addition, USDA and FDA
district managers were able to assist each other during the recall of beef
and beef products, after the December 2003 discovery of a cow infected
with bovine spongiform encephalopathy (BSE, also known as mad cow
disease).

However, we found that the stated purpose of the agreement-which is to
facilitate an exchange of information permitting more efficient use of
both agencies' resources and contributing to improved public health
protection-has not been maximized. USDA and FDA are not making better use
of each other's inspection resources to reduce overlap and duplication of
effort, particularly at establishments that both agencies inspect.
Depending on the type and layout of the facility, a USDA inspector may
have a more regular presence in an area where FDA-regulated products are
maintained. For example, at a plant that produces both meat and seafood
products, a USDA inspector told us that as part of his daily routine
inspections he walks through the seafood processing and storage section of
the plant. (See fig. 7). However, because FDA regulates seafood, the USDA
inspector does not monitor or inspect the seafood storage section. The
inspector noted that, with minimum training on seafood temperature
controls, he could inspect this section of the plant as well. USDA
officials at headquarters said the agency's inspectors are capable of
taking on FDA's inspection responsibilities at jointly regulated
facilities, given the proper resources and training.

Figure 7: Diagram of a Jointly Regulated Food Processing Facility

FDA-NMFS Agreement on Common Responsibilities Regarding Inspection
Activities for Fishery Products

Source: GAO observation of a jointly regulated establishment.

A 1974 agreement between FDA and NMFS recognizes the two agencies' related
responsibilities for inspecting seafood facilities and standardization
activities, and it details actions the agencies can take to enable each
agency to discharge its responsibilities as effectively as possible. The
agreement states that these actions should minimize FDA inspections in the
approximately 275 domestic seafood facilities that NMFS inspects under
contract, as long as FDA's inspection requirements are followed. Among
other items in the agreement:

o FDA is to (1) request information about NMFS-inspected products when
FDA is considering an enforcement action, (2) provide timely

notification to NMFS of any products seized from NMFS-inspected plants,
(3) inform NMFS of FDA industry guidelines and its standards for
establishing compliance action levels, and (4) invite NMFS inspectors to
observe FDA inspections of companies under contract to NMFS.

o NMFS is to (1) supply FDA headquarters with a list of all NMFSinspected
processing and packing establishments; (2) apply FDA requirements to
NMFS-inspected products and establishments and decline to inspect, grade,
or certify products that FDA would consider adulterated or misbranded; (3)
upon request, provide FDA with information on NMFS-inspected products when
FDA is taking or considering compliance action; and (4) cooperate with FDA
in investigations of food poisoning, product recalls, and problems
concerning food contamination caused by disasters or other phenomena.

o FDA and NMFS may meet periodically and, when appropriate, with industry
to promote better communication and understanding of regulations, policy,
and statutory responsibilities. If either agency believes that a
particular violation is occurring in several seafoodprocessing plants, it
may request a meeting with the other agency to consider investigative
steps and, when necessary, mutually agreeable remedial action.

We found that FDA is not using the agreement to minimize its inspections
in seafood plants that NMFS has inspected and certified as meeting FDA's
safety standards. FDA officials said the agency does not recognize the
NMFS inspections as aiding FDA in enforcing pertinent statutes. As a
result, FDA is missing opportunities to leverage inspection resources and
possibly avoid duplication of effort.

In addition, we found that FDA is not carrying out provisions in the
agreement. For example, FDA rarely provides notification of seizure
actions it takes against NMFS-inspected plants, as outlined in the
agreement. Furthermore, according to a senior NMFS official, NMFS
communicates its inspection results to FDA, but FDA does not share its
results with NMFS.

FDA officials recently said they do not rely on NMFS' inspection
information for two reasons. First, NMFS conducts a fee-for-service
inspection, and therefore, FDA officials believe that NMFS could have a

conflict of interest because, as a nonregulatory body, it is paid for its
services by the industry that it inspects. Second, FDA does not know which
firms NMFS is inspecting at any given time. FDA officials said the list of
firms NMFS inspects changes, depending on market fluctuations that affect
each company's need for NMFS' services. Furthermore, FDA officials said
that they already have a risk-based system in place to determine which
firms to inspect, and at what frequencies, and that NMFS' inspections are
not a factor in its determination of risk.

NMFS officials disagreed with FDA's reasons for not using NMFS inspection
results. First, they pointed out that NMFS's relationship to industry is
similar to USDA's Agricultural Marketing Service, which also conducts
fee-for-service grading and certification of poultry, meat, eggs, and
other agricultural commodities. Second, NMFS officials said they maintain
an up-to-date list of firms that the agency inspects and post this
information on its Web site, most recently revised in January 2005.24 NMFS
readily provided us with a list of the firms it was inspecting when we
spoke with officials during the course of our review.

Although FDA is not implementing the agreement, the agency has recognized
the potential benefits of working with NMFS to leverage resources. In a
January 2004 letter to the Under Secretary of Commerce for Oceans and
Atmosphere,25 the then-Commissioner of Food and Drugs proposed ways that
the two agencies could enhance coordination, including commissioning NMFS
inspectors to help FDA meet its public health responsibilities. The
Commissioner noted that using NMFS inspectors could be cost effective
because the NMFS inspectors may already be on-site and the FDA inspector
therefore would not have to travel to conduct an inspection.

FDA has not used NMFS inspection resources under the terms of the fishery
products agreement, nor has the agency used its authority under the
Bioterrorism Act to commission NMFS officials. However, FDA used this
authority to commission CBP officers to assist FDA at ports of entry. FDA
officials said the agency has not yet considered using the act to enter
into similar agreements with other federal agencies. NMFS officials said
the

24See http://seafood.nmfs.noaa.gov/ApprovedFacilities.htm.

25NMFS is located within the Department of Commerce's National Oceanic and
Atmospheric Administration.

agency would be willing to enter into such an agreement with FDA, thereby
assisting FDA in reaching its goal of conducting annual inspections at all
high-risk facilities.

Industry and Other Stakeholders Disagree on the Significance of Overlap in
the Federal Food Safety System and on How to Improve It

Industry associations, food-processing companies, consumer groups, and
academic experts we contacted disagree on the significance of overlapping
activities in the federal food safety system. However, most of these
stakeholders agree that the laws and regulations governing the system
should be modernized so that science and technological advancements can be
used to more effectively and efficiently control current and emerging food
safety hazards. While we found agreement among the stakeholders about the
need for modernization, they differed about whether food safety functions
should be consolidated into a single federal agency.

Stakeholders Disagree about Overlaps in the Federal Food Safety System

The stakeholders we contacted disagree on whether federal agencies' food
safety functions overlap, specifically with regard to inspections.
Industry associations that we spoke with, such as the Food Products
Association,26 National Fisheries Institute, American Frozen Food
Institute, and Grocery Manufacturers of America, told us that overlaps
occur but do not harm the safety of food and therefore are not
significant. These overlaps, they noted, occur primarily in dual
jurisdiction establishments-those regulated by both USDA and FDA-or
facilities inspected by both FDA and NMFS. However, some overlaps occur
outside these establishments. For example, although the United Fresh Fruit
and Vegetable Association's (UFFVA) member companies are primarily
inspected and regulated by FDA, companies that sell fruit and vegetables
to the school meals programs are also inspected by USDA. UFFVA officials
pointed out that USDA inspects fruits and vegetables to be included in
school lunches; and the companies, already subject to FDA inspections,
incur additional expenses for these USDA inspections. UFFVA also cited
overlaps in USDA's and FDA's sampling and testing for pesticides and
microbiological contaminants on fruits and vegetables. Other stakeholders,
including the U.S. Tuna Foundation and the American Meat Institute,
reported that they do not think the federal agencies' programs overlap
because USDA and FDA have

26Prior to 2005, the Food Products Association was known as the National
Food Processors Association.

specific, defined areas of responsibility for their industries. The U.S.
Poultry and Egg Association added that the regulatory delineations do not
always make sense, citing the split jurisdiction between USDA and FDA over
the regulation of eggs. Specifically, FDA regulates an egg farm as a "food
factory" within its area of jurisdiction, and USDA regulates plants that
process eggs into products such as powdered eggs.

Other stakeholders-generally food companies that are regulated by both
USDA and FDA-told us that overlaps can be burdensome. These stakeholders
did not see the added value of FDA's once-a-year (or less) inspections,
because USDA inspectors already visit their plants daily. For example,
managers at these facilities told us the following:

o At an egg- and potato-processing company, each agency uses different
frequencies for monitoring and ensuring food safety, with USDA inspecting
the physical plant, usually daily, while FDA's inspections usually take
place annually. According to a senior plant manager, FDA's inspections
place more responsibility for food safety on the company. From the
manager's perspective, the most effective inspection strategy would be to
combine elements of both agencies' inspections into a single inspection
program.

o At a facility that produces USDA-and FDA-regulated foods on three
different production lines, the facility must maintain different sets of
paperwork for each food that the company processes in order to meet USDA
and FDA HACCP and sanitation requirements. Since the USDA inspector is at
the facility every day, the manager said he does not see any value added
by FDA's inspection because that inspector examines the same areas of the
facility-the processing lines and the refrigerated storage area-which are
covered by the USDA inspector.

o A facility that cans a variety of soups and bean products experienced
contradictory instructions from USDA and FDA during overlapping
inspections. USDA inspectors did not want the company to paint its
sterilization equipment because they determined that paint chips could
contaminate the food. Subsequently, an FDA inspector told the company to
paint the same equipment because he determined that it would be easier to
identify sanitation problems on lightly painted equipment than on the
dark-colored metal. The manager of the facility said the company had to
paint and then remove the paint from equipment in order to satisfy both
the USDA and FDA inspectors.

In addition, at a seafood-processing plant that is inspected by both NMFS
and FDA, the manager said that when FDA collects product samples for
testing, it does not report test results in a timely fashion. According to
the manager, NMFS inspections are preferable because the agency is able to
provide test results more rapidly than FDA, which, according to the
manager, allows the company to know its products are safe before they
enter the market.

A few stakeholders also saw value in some of the overlapping activities.
For example:

o The American Frozen Food Institute noted that USDA and FDA inspections
and their complementary expertise-independent scientific assessment,
research, and education-provide value in addressing food safety issues.

o The quality assurance manager at a dual jurisdiction establishment with
whom we spoke said he liked having a "second pair of eyes" inspecting the
facilities for food safety. The company produces smoked salmon-a high-risk
food-and the manager noted that having inspections by FDA and NMFS helps
to ensure that products are safe and of high quality.

Most Stakeholders Recognize the Need to Modernize the Food Safety System
but Differ on What Approach to Take

The majority of stakeholders we contacted said they believed that the
federal food safety system needs to be modernized, though they did not
agree on what direction this modernization should take. Stakeholders'
views included (1) minor changes to improve coordination among the food
safety agencies, (2) statutory changes to make the system more science and
risk based, and (3) consolidating federal food safety functions into a
single agency.

Some large industry associations (e.g., the Grocery Manufacturers of
America, the Food Products Association, the American Frozen Food
Institute, the National Fisheries Institute, and the United Fresh Fruit
and Vegetable Association) saw the need for only minor changes within the
existing regulatory framework to enhance communication and coordination
among the existing agencies. Some industry officials said that the current
food safety system protects consumers, and they cited decreases in
illnesses caused by foodborne bacteria, such as salmonella and listeria.
The Grocery Manufacturers of America said that the food safety system must
be flexible enough to allow resources to be directed toward identifying
and addressing serious food safety problems but that

this alteration would not require changing the food safety structure. The
Grocery Manufacturers of America also reported that the current food
safety system could be enhanced, and perhaps made more efficient, through
enhanced interagency coordination.

Other stakeholders-including representatives from industry associations,
academia, consumer groups, public policy organizations, and individual
food companies-believe that the system needs to be modernized through
statutory changes to make it more science and risk based. According to the
Consumer Federation of America, a science-or risk-based system should
consider not only the risk posed by the food but also the history of the
plant-whether is has a track record for producing high quality, safe food.
Resources for the Future27 stated that the current food safety laws
undermine a successful food safety system. That is, the laws do not build
prevention into the farm-to-table continuum and divide responsibility and
accountability for food safety among federal agencies. Further, the laws
prevent risk-based allocation of resources across the federal food safety
agencies. Further, USDA's carcass-by-carcass organoleptic inspections
exemplify the outmoded requirements of the current food safety system and
cannot identify and control the microbiological hazards associated with
meat and poultry products, such as E. coli O157:H7. Additionally, such
inspections waste resources because new technologies are more efficient
and effective. For example, the manager at a jointly regulated cannedgoods
company told us that daily inspections of meat and poultry products is
wasteful and inefficient for most, if not all, heat-processed meat and
poultry products, such as canned chicken or pork, since the canning
process kills all the bacteria. Some stakeholders, including the Institute
for Food Technologists, believe that modernizing the food safety system
could be accomplished by rewriting the food safety statutes.

Finally, some of the stakeholders that cited the need for modernization
also believe that these changes should be accompanied by consolidation of
federal food safety programs into a single agency for the following
reasons:

o Consolidation of functions could allow a single food agency to manage
the safety of the whole food chain, not just its parts, according to food

27Resources for the Future leads the Food Safety Research Consortium-a
multidisciplinary group of academic food safety research
institutions-which is funded, in part, by USDA's Cooperative State
Research, Education, and Extension Service and was formed to create
decision tools needed to build a science-and risk-based food safety
system.

safety experts at the Center for Science in the Public Interest, the
Consumer Federation of America, and the University of Illinois.

o Consolidation would eliminate overlap between the agencies, especially
at DJEs, according to several individual companies, and could generate
substantial savings in terms of administrative efficiency and overall
consistency in the application of policy, according to the Food Marketing
Institute and food safety experts at Kansas State University and the
University of Georgia.

o The legislative changes needed to accomplish consolidation could also
be used as the vehicle for modernizing the food safety statutes or
establish a scientific basis for distributing food safety resources,
according to several individual food companies and food safety experts at
the Center for Science at the Public Interest and Resources for the
Future.

The stakeholders we contacted also identified a number of roadblocks to
changing the system, whether or not they supported such consolidation.
First, industry is reluctant to change from a familiar regulatory
framework to one that is untested. According to the Food Marketing
Institute, food companies tend to prefer the inspection process that is
known to them. Second, according to some industry associations, a
transition to a single agency could create a period of uncertainty, as
limited resources are diverted from the existing programs, and could
therefore cause vulnerabilities in the food supply. Third, the transition
costs to a single agency would be higher in the short term, according to
food safety experts at the University of Illinois and the University of
California. Fourth, current agency employees would be concerned that a
consolidation would adversely change their working lives and that
institutional knowledge would be lost. Finally, some stakeholders,
including the Consumer Federation of America, said that some congressional
committees may be reluctant to lose jurisdiction over food safety
functions.

Conclusions We recognize that current statutory authorities require the
food safety agencies to carry out regulatory activities that have resulted
in some overlapping or duplicative activities. We have recommended in the
past that federal food safety statutes be streamlined and that food safety
functions be consolidated into a single agency to ensure the logical and
most effective use of government resources and to protect consumers.

Even within the current statutory framework, the agencies can take
practical steps to reduce overlap and duplication and thereby free
resources for more effective oversight of food safety. The Congress has
recognized this possibility in the Bioterrorism Act by authorizing FDA to
commission other agencies' officials to conduct FDA's inspection
activities. Other avenues are open to the agencies as well. For example,
the two interagency agreements that we examined in detail, could address
problems in duplicative inspections if they were more effectively
implemented. Other interagency agreements designed to reduce overlap might
also prove fruitful. By not effectively implementing these agreements and
by not exercising the new authorities under the Bioterrorism Act, the
agencies are missing opportunities to make the system more efficient and
effective.

Recommendations for Executive Action

We are making seven recommendations designed to reduce or eliminate
duplication and overlaps, leverage existing resources, and enhance
coordination efforts among the principal federal food safety agencies.

We recommend that the Secretary of Agriculture and the Commissioner of the
Food and Drug Administration work together to

o ensure the implementation of the interagency agreement that calls for,
among other things, sharing inspection-and enforcement-related information
at food-processing facilities that are under the jurisdiction of both
agencies;

o examine the feasibility of establishing a joint training program for
food inspectors; and

o consider the findings of USDA's foreign country equivalency evaluations
when determining which countries to visit.

To better use FDA's limited inspection resources and leverage USDA's
resources, we recommend that, if appropriate and cost effective, the
Commissioner of the Food and Drug Administration, as authorized under the
Pubic Health Security and Bioterrorism Preparedness and Response Act of
2002, enter into an agreement to commission USDA inspectors to carry out
FDA's inspection responsibilities for food establishments that are under
the jurisdiction of both agencies.

To better use FDA's limited inspection resources and leverage NMFS's
resources, we recommend that the Commissioner of the Food and Drug
Administration and the Under Secretary of Commerce for Oceans and
Atmosphere ensure the implementation of the interagency agreement that
calls for FDA to recognize the results of NMFS inspections when
determining the frequency of its seafood inspections.

To strengthen management controls and maximize the effectiveness of
interagency agreements that are designed to reduce overlap, increase
coordination, and leverage resources, we recommend that the Secretary of
Agriculture, the Commissioner of the Food and Drug Administration, the
Administrator of the Environmental Protection Agency, and the Under
Secretary of Commerce for Oceans and Atmosphere

o identify and inventory all active interagency food safety-related
agreements and

o evaluate the need for these agreements and, where necessary, update the
agreements to reflect recent legislative changes, new technological
advances, and current needs.

Agency Comments and Our Response

We provided USDA, HHS, EPA, and NOAA with a draft of this report for their
review and comment. We received written comments on the report and its
recommendations from USDA, HHS, and NOAA. EPA provided minor technical
comments.

In commenting on a draft of this report, USDA expressed serious
reservations about the report, asserting that it oversimplifies food
safety regulatory functions within USDA and FDA and that it exaggerates
the extent of regulatory overlap. USDA appears to have misinterpreted the
focus of this report, and we disagree with USDA's characterization. This
report examines overlapping activities rather than the regulatory
framework that allows these activities. Nevertheless, the report contains
a clear and accurate acknowledgment that the agencies operate under a
statutory framework that gives them different authorities and
responsibilities to regulate different segments of the food supply. While
we recognize that the agencies operate under different authorities, the
activities they perform under these authorities are similar in nature,
leading us to question why the federal agencies must continue to spend
resources on overlapping, and sometimes duplicative, food safety
activities. For example, we disagree with USDA's assertion that the
agencies' inspection

activities are vastly different. As we identify in the report, these
inspections have sufficiently common features, including the verification
of sanitation procedures and good manufacturing practices at food
processing facilities that make them candidates for consolidation within
one agency. USDA's comments and our detailed response are contained in
appendix V.

In commenting on a draft of this report, HHS raised concerns about our
terminology regarding overlapping activities. We disagree with HHS comment
that our report's title should substitute the word duplication for
overlap. That is, our report distinguishes between "overlap"-which we
define as those similar activities being performed by more than one agency
and "duplication"-which we define as essentially identical activities
performed by more than one agency. Given the definitions we lay out in the
report, if we modified the title as HHS suggests, we would risk implying
that the agencies are literally duplicating efforts in every instance,
even though we are fully aware that, under the current statutory
framework, the agencies do not exactly replicate food safety activities.
We also disagree with HHS's comment that our report overstates
similarities in USDA and FDA inspections because, as our report clearly
states, USDA and FDA inspections have similar key elements: sanitation,
good manufacturing practices, and HACCP compliance oversight. It also
makes it clear that USDA and FDA inspections vary depending on whether the
product is a USDA-or FDA-regulated food product. Furthermore, we disagree
with HHS's comment that the training programs are vastly different. As our
report discusses, FDA's training curriculum includes dozens of courses
that address topics common to USDA and FDA. Overall, HHS agreed with three
of the report's seven recommendations, including (1) the usefulness of
USDA's foreign country evaluations, (2) identifying and inventoring all
interagency agreements, and (3) the need to evaluate and update the
agreements. HHS disagreed with our recommendation regarding joint training
of USDA and FDA food inspectors. HHS took no position on our
recommendation for using the Bioterrorism Act authorities. Finally, HHS
partially concurred with two other recommendations dealing with the
implementation of two interagency agreements. HHS also provided technical
comments which we incorporated in our report, as appropriate. HHS's
comments and our detailed response are contained in appendix VI.

EPA did not provide official comments, but it provided minor technical
comments that we incorporated as appropriate. The technical comments noted
that EPA will consider GAO's recommendation for better tracking of
interagency agreements when the agency sets priorities for future
investments in information technology.

NOAA provided written comments and agreed with the report's
recommendations that pertain to NMFS. NOAA also commented that our report
does a fair and thorough job of describing the food safety activities of
NMFS. NOAA stated that the positions expressed in GAO's previous work
continue to be germane to the issue of coordination with FDA on
inspections of seafood.28 NOAA's comments are contained in appendix VII.

As agreed with your offices, unless you publicly release the contents of
this
report earlier, we plan no further distribution until 30 days from the
report
date. We are sending copies of this report to the Secretary of
Agriculture,
the Acting Commissioner of the Food and Drug Administration, the Acting
Administrator of the Environmental Protection Agency, and the Under
Secretary of Commerce for Oceans and Atmosphere. In addition, this
report will be available at no charge on the GAO Web site at
http://www.gao.gov.

If you or your staffs have any questions concerning this report, I can be
reached at (202) 512-3841, or [email protected]. Major contributors to
this
report are included is appendix VIII.

Robert A. Robinson
Managing Director,
Natural Resources and Environment

28GAO, Food Safety: FDA's Imported Seafood Safety Program Shows Some
Progress, but Further Improvements Are Needed, GAO-04-246 (Washington,
D.C.: Jan. 30, 2004).

Appendix I

Scope and Methodology

To identify overlaps that may exist in the federal food safety system, we
collected fiscal year 2003 budget data for food safety-related activities
from the U.S. Department of Agriculture (USDA), the Food and Drug
Administration (FDA), the Environmental Protection Agency (EPA), and the
National Marine Fisheries Service (NMFS).1 We selected these agencies
because they have broad food safety-related inspection and enforcement
related responsibilities, the function to which most federal food safety
funding is dedicated. We defined overlaps as similar activities being
performed by more than one agency, such as training food inspectors. In
contrast, we defined duplication as essentially identical activities
performed by more than one agency, such as inspecting the same
foodprocessing facility for compliance with sanitation and good
manufacturing practices requirements. We used categories of food safety
activities contained in the National Academy of Science's 1998 report
Ensuring Safe Food to group the agencies' food safety activities.2 These
categories include: monitoring/surveillance, inspection/enforcement,
education/outreach, research, and risk assessment. We included three
additional categories-food security, administration, and
rulemaking/standard setting-to capture other relevant activities. We
defined the categories of food safety activities into the following
program functions:

o Monitoring/Surveillance: activities related to the monitoring of
foodborne illness or disease, as well as monitoring the agents of illness
in the food supply, including the collection of baseline data for
contaminants;

o Inspection/Enforcement: activities related to ensuring compliance with
agency food safety regulations, including premarket application or
petition approval;

o Education/Outreach: activities related to communicating food
safetyrelated information or guidance to the public, industry, or
agencies' other clients;

1Fiscal year 2003 was the most recent year for which data were complete.

2National Research Council and Institute of Medicine, Ensuring Safe Food:
From Production to Consumption (Washington, D.C.: 1998).

Appendix I Scope and Methodology

o Research: activities related to the study of food safety-related
topics, which support agency policy decisions;

o Risk assessment: activities related to evaluation of the likelihood and
severity of an adverse event (e.g., illness or death) on the public health
as a result of the likelihood of exposure to a particular hazard;

o Food security: activities related to preparing for and responding to
deliberate attacks on the food supply;

o Administration: supporting activities that enable the agencies to
perform their food safety responsibilities. Examples of administrative
activities include: procurement, human resources support, financial
management, travel management, and information technology support; and

o Rulemaking/Standard setting: activities related to food safety policy
decisions, development of regulations, and administration of regulatory
review processes.

Specifically, we obtained actual expenditures and staffing level data in
fulltime equivalents (FTE) from the following USDA units: Agricultural
Marketing Service; Agricultural Research Service; Animal and Plant Health
Inspection Service; Cooperative State Research, Education, and Extension
Service; Economic Research Service; Grain Inspection, Packers and
Stockyards Administration; Food Safety and Inspection Service; and
National Agricultural Statistics Service. We also obtained data from the
following FDA units: Center for Food Safety and Applied Nutrition, Center
for Veterinary Medicine, National Center for Toxicological Research, and
Office of Regulatory Affairs. EPA's Office of Pesticide Prevention and
Office of Water, as well as the NMFS's Seafood Inspection Program and
Office of Sustainable Fisheries also provided data. To assess the
reliability of the staffing and expenditure data, we questioned
knowledgeable agency officials and reviewed existing documentation
regarding the data and the systems that produced them. We determined that
the data were sufficiently reliable for the purposes of identifying
overlaps.

After the agencies provided budget data, we contacted agency budget and
program officials to determine what activities were linked to the
expenditure and staffing data. We categorized expenditures and staffing
and asked agency officials if they considered our categorizations to be
appropriate. We adjusted our categorization when agency officials told us
it

Appendix I Scope and Methodology

was inaccurate. In some cases, the agencies' preferred categorization of
the same activity varied. For example, FDA considered inspector training
as an education/outreach activity, whereas USDA considered it an
inspectionrelated activity. These discrepancies are noted in appendix II.
After we categorized the budget and staffing level data, we identified
cases in which more than one agency performed similar activities. In some
instances, the agencies estimated budget and staffing levels, or they were
unable to separate budget data into specific categories. As a result, some
agencies did not provide expenditures and staffing data for categories
such as administration, food security, and rulemaking. The agencies'
officials explained that these expenditures are distributed among more
than one of the other categories.

To examine the extent to which federal food safety agencies are using
interagency agreements to leverage existing resources to reduce any such
overlaps, we requested that agencies provide copies of all active
interagency food safety-related agreements, and we selected two agreements
to analyze their implementation.3 We compared the agreements that the
agencies provided to determine where there were differences. In the cases
where agency signatories provided us an agreement, and one or more agency
signatories did not, we followed up with those agencies to reconcile the
discrepancies. In some cases, we provided the agreement to an agency to
obtain confirmation that it was a signatory to the agreement. We asked the
agencies to categorize the agreements according to primary program
function. We also independently categorized the agreements using
information from their introduction and/or background to ensure consistent
categorization across the agencies. If the agencies' categorization
differed with ours, we considered their rationale and changed the
categorization as appropriate.

We selected two inspection-related interagency agreements for in-depth
review because the agencies spend most of their resources on inspection
activities; one agreement that pertains to dual jurisdiction
establishments (DJE) and one that pertains to inspections of fishery
products. In addition, these agreements encompassed a broad range of
intended coordination efforts between the agencies involved. We conducted
site visits to three

3USDA, EPA, and NMFS supplied agreements in the form of memoranda of
agreement, interagency agreement, and memoranda of understanding. We
included interagency agreements that, according to FDA do not involve an
exchange of people, property, or funds-what the agency refers to as
memoranda of understanding.

Appendix I Scope and Methodology

USDA and FDA field offices to obtain information related to implementation
of the agreements. The site visits included USDA district offices in
Philadelphia, Pennsylvania and Boulder, Colorado; and FDA district offices
in Philadelphia, Pennsylvania; Denver, Colorado; and Seattle, Washington,
which are responsible for food safety in a total of 13 states. We met with
USDA and FDA district managers, inspectors, and other staff to discuss the
agreement's implementation. We also selected two to four DJEs at each
location and visited them to discuss implementation of the agreements with
plant managers and, in some cases, with USDA or FDA inspectors assigned to
these facilities. In some cases, we accompanied inspectors as they
conducted inspections of the facilities.

To obtain the views of regulated industry and other stakeholders regarding
opportunities to reduce overlap by consolidating federal food safety
functions, we contacted a total of 35 stakeholders from food industry
associations, food manufacturers, consumer groups, and academic experts
using a structured interview format consisting of 22 questions. In
selecting associations, organizations, and experts, we included contacts
from our previous reports and testimonies and considered recommendations
from USDA, FDA, EPA, and NMFS. In selecting which food manufacturers to
interview, we used Food Processing's Top 100 Companies to identify the
largest food manufacturers. Of those companies, we selected and contacted
food manufacturers that have facilities that produce food regulated by
both USDA and FDA.

We conducted our review from May 2004 through March 2005 in accordance
with generally accepted government auditing standards.

Appendix II

Food Safety Expenditures and Staffing Levels for Fiscal Year 2003

We asked agencies within USDA, FDA, EPA, and NMFS to provide all
expenditures and staffing levels, in FTEs, related to food safety
activities they conducted in fiscal year 2003. Tables 3 and 4 categorize
these expenditures and staffing levels according to program function.
Though most agencies were able to identify expenditures and staffing
levels related to inspection and enforcement, research, risk assessment,
education and outreach, and monitoring and surveillance-many were unable
to provide expenditures linked to rulemaking and standard setting, food
security, and administration. For this reason, table 4 containing this
data is included separately. As table 3 shows, inspection and
enforcement-related spending accounts for most of these agencies' food
safety-related spending in fiscal year 2003.

Appendix II Food Safety Expenditures and Staffing Levels for Fiscal Year
2003

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Appendix II Food Safety Expenditures and Staffing Levels for Fiscal Year 2003

Table 3: Food Safety Expenditures and Staffing Levels by Agency, Fiscal Year
2003

Dollars in thousands

USDA Program function FSIS ARS CSREES NASS ERS APHIS AMS GIPSA Total

Inspection/ Enforcement

Expenditures $636,841 $28,220 $100 $665,162

Staffing level 8,494 293 8,787

Research

Expenditures 88,724 18,221 2,473 525 109,943

Staffing level 243 4 11 4.5

Risk Assessment

Expenditures 41,408 6,208 2,516 25 21,908 72,065

Staffing level 294 15 0.5 0.25 39

Education/ Outreach

Expenditures 9,993 8,240 50 18,283

Staffing level 82 2 0.5

Surveillance/ Monitoring

Expenditures a 25 22,438 22,463
Staffing 0.25 94
level
Total
expenditures $688,242 $94,932 $28,977 $2,473 $625 $50,658 $21,908 $100 $887,916
Total 258 7 11 6 387 39
staffing 8,870 9,578

Appendix II Food Safety Expenditures and Staffing Levels for Fiscal Year
2003

FDA EPA DOC

CFSAN CVM NCTR ORA Total NMFS Grand total

$4,529b $214,297c $218,826 $21,798 $15,000 $920,786
27 1,817 1,844 4 155 10,790
33,318d 10,571e 7,000f 4,197g 55,086 10,813 175,842
192 53 48 47 340 49

8,553h 8,553 61,785 7,000 149,403

70 70 362 57

810i 59,033j 59,843 29,477 107,603

11 502 513 116

72,456k 17,844l 90,300 112,763
486 85 571
$118,856 $29,225 $7,000 $277,527 $432,608 $123,873 $22,000 $1,466,397
775 149 48 2,366 3,338 531 212 13,659

Source: GAO analysis of USDA, FDA, EPA, and DOC expenditure and staffing
information.

Notes: Other program functions include rulemaking/standard setting, food
security, and administration. Because many agencies did not provide
expenditure and staffing level data specific to these functions, they are
included in table 4 below for the agencies that provided these data
separately.

FDA's Office of Financial Management's expenditure tracking is
characterized by specific terminology. This terminology is provided below
in table notes b through l, with references to data in the table.

FSIS categorized inspector training activities as inspection/enforcement,
whereas FDA categorized them as education/outreach.

EPA's budget numbers reflect a greater level of resources than those
directly related to food safety since the numbers include other program
activities integral to pesticide risk assessment and risk management
(e.g., worker protection and environmental assessments).

EPA expenditures and staffing levels include state grants and
Headquarters/Regional resources for pesticide program activities in the
Office of Pesticide Programs, Office of Enforcement & Compliance
Assurance, and Office of Research & Development. Office of Water resources
for shellfish protection and water quality criteria are also included.

NMFS inspection/enforcement expenditures are financed solely through
revenues generated by user fees.

Appendix II Food Safety Expenditures and Staffing Levels for Fiscal Year
2003

aFSIS did not provide expenditures related specifically to surveillance
and monitoring.

bPost market Inspections.

cPost market Inspections; a portion of these expenditures relating to
animal drugs and feeds were multiplied by a factor of 0.95 to account for
the percent of these activities that are considered food safety related.

dPremarket applied research and post market applied research.

ePremarket applied research and post market applied research, multiplied
by a factor of 0.85 to account for the percent of these activities that
are considered food safety related.

fPost market applied research; data provided by FDA officials.

gPost market applied research.

hPost market laboratory analysis (domestic and imports).

iPremarket outreach/coordination (domestic).

jPremarket outreach/coordination.

kSurveillance estimate provided by FDA officials.

lPost market outreach/coordination/compliance, subtracting $950,000 and
multiplied by a factor of 0.85 to account for the percent of the
activities that are considered food safety related.

Appendix II Food Safety Expenditures and Staffing Levels for Fiscal Year 2003

Table 4: Other Food Safety Expenditures and Staffing Levels by Agency, Fiscal
Year 2003

Dollars in thousands

Program USDA USDA USDA FDA FDA FDA EPA Grand function FSIS APHIS Total CFSAN CVM
Total Total total

Rulemaking/ Standard setting

Expenditures $28,448 $19,322 $47,770 $36,840 $84,610

Staffing Level 176 141 310 241

Food security

Expenditures 1,838 10,072 11,910 11,910

Staffing Level 11 11

Administration

Expenditures 116,027 116,027 116,027
Staffing 469 469
Level
Total
expenditures $117,865 $10,072 $127,937 $28,448 $19,322 $47,770 $36,840 $212,547
Total 480 480 176 141 310 241
staffing 1,031

Source: GAO analysis of USDA, FDA, EPA, and DOC expenditure and staffing
information.

Notes: FDA CFSAN's rulemaking expenditures are labeled Premarket Review in
FDA budget documents. CVM's rulemaking expenditures are labeled Premarket
Review, adding $950,000 and multiplied by a factor of 0.85 to account for
the percent of the activities that are considered food safety related.

CFSAN rulemaking expenditures are mainly premarket approval activities;
FDA's CVM rulemaking expenditures are composed of pre- and post-market
approval activities.

FDA officials estimate that 7 percent of their total expenditures relate
to administrative activities.

Appendix III

Food Safety-Related Interagency Agreements

We solicited all active food safety-related interagency agreements from
USDA, FDA, EPA, and NMFS. Table 5 categorizes the 71 agreements by program
function. Twenty-four agreements state the need to reduce duplication of
effort, reduce or clarify overlaps, or increase the efficient or effective
use of resources between agencies. Table 5 also provides the year each
agreement became effective and indicates the signatory agencies. The
bolded agreements are the two that were analyzed in-depth.

Table 5: Food Safety-Related Interagency Agreements by Primary Program
Function

Program
function
(number of
agreements) Title Date Agency signatories Other signatories

Page 54 GAO-05-213 Oversight of Food Safety Activities
Responsibility Bureau Intended
Alcohol of Alcohol of Imported Related National US-USSR Commerce Inspection for Child Adulteration Improve
Inspection/ Labeling 1971 FDA Treasury Enforcement Beverages 1987 FDA Alcohol, Inspection, 1985b FDA USDA Dates & 1975b FDA USDA to Food Inspection, 1973 FDA USDA Imported Import of 1974 FDA USDA Institutes Scientific Agreement Inspection 1974 FDA NMFS Productsa Enforcement 1986 FDA NMFS in Inspection 1980 NMFS Fishery of 1975 FDA USDA NMFS Animal Inspection 1988b USDA NMFS Nutrition 2003 FDA NMFS of Shrimp ORA Sanitation 1984 FDA Interstate
Enforcement (31) Adulterated Tobacco, Sampling, & Date Inspection and Productsa Sampling & Raisinsa Biological of Health Exchange Program of Laws Molluscan and Products Industrial Feed of Nonmeat Labeling for the & Quality Shellfish
under FFDCA and Examination Materiala Standardization Examination Specimen for Against Shellfisha Certification Department Fishery Usea Products Program To Screen for FDA's of Sanitation
Firearms of Activities of under the Fishery Illegal of Fish and of Defense Products for the Chloramphenicol Shellfish Conference

Appendix III Food Safety-Related Interagency Agreements

(Continued From Previous Page)

Program
function
(number of
agreements) Title Date Agency signatories Other signatories

Page 55 GAO-05-213 Oversight of Food Safety Activities
Coverage Cosmetic Testing Testing Testing
Salmonella of Dry Products Recalled General War Signatories National Interstate Rice, Recalls Status of Concerning of of of Grading Grading To Allow Customs
Inspection 1987b FDA USDA Milk 1996b FDA USDA Inspection Recall & 1984 FDA USDA Products Consumption Food 1983b FDA USDA Shipment 1976 FDA Interstate Commission Delineate for Safety Acta Sanitary 1977 FDA Conference Shipped Milk 1985b FDA USDA Pulses & 1982 FDA and Situations Animal 1982 FDA USDA 1984 FDA USDA EPA Residues of Contaminantsa Domestic 1997b FDA USDA Imported 1997b FDA USDA Imported 1997b FDA USDA 1999b FDA USDA Jurisdiction 1992 USDA NMFS Personnel 1993 USDA NMFS Personnel vegetables)a FDA to 2003 FDA and
& Sampling Products Administering Act Disposal for Inspectiona of Foods, Commerce Areas of U.S. Administration Commission Quality of Interstate Shipments Inspection & Food Exchange of Hazardous Biological Federal Environmental & In-shell In-shell Exchange of Establishmentsa (meat)a (fruit Commission Border
Plantsa and Enforcing of Class Human Drugs & Jurisdiction Consumer of CPS of Milk Standardization Products Information Department Food Productsa Regulatory Imported Brazil Pistachio Information Cross-Utilization Cross-Utilization and CBP
the Egg I and II Cosmeticsa of 1976 FDA Product Products of Grain, on Foods & of Defense Activities Peanuts Nuts on Dual of Inspection and of Inspection and Officers Protection

Appendix III Food Safety-Related Interagency Agreements

(Continued From Previous Page)

Program
function
(number of
agreements) Title Date Agency signatories Other signatories

Education/ Outreach (14) Coordination of Industry Education Efforts

1978 FDA USDA

Feeding Programs in Head Start Centersa

1989 FDA Department of Health and Human Services' Administration for
Children, Youth, and Families

Cooperative Efforts in Food 1989 FDA USDA
Safety,
Nutrition & Veterinary
Medicine
Establish Working 1993 FDA Conference for Food
Relationship between
CFP and FDA Protection
Foodborne Illness Education 1994 FDA USDA
Activities of
FSIS
Science-Based 1997 FDA USDA Centers for Disease
Consumer-Oriented Control
and Prevention,
Messages to Promote Safe Food Department
of Education
Cooperative Training and 2000 FDA USDA University of Puerto
Research Rico
FSIS-Antimicrobial Detection 2003 FDA USDA
Tests
2003 FDA USDA EPA Department of State,
Interagency Cooperation and U.S.
Coordination in the Geological Service
Regulatory Oversight
of Biotechnological Products
2003 USDA U.S. Fire
To Enhance the Cross-Training Administration
Capabilities of Both
Organizations to
Reach Their Audiencesa
Establishment of Food Product 2000 USDA NMFS
Evaluation Team for Defense
Supply
Center
Shellfish Safety Assistance 2004b FDA NMFS
Project for
the Interstate Shellfish
Sanitation
Conference
Support Pesticide Applicator 2003b USDA EPA
Training
Activities by the State
Cooperative
Extension Service
USDA/IR-4 Biopesticide 2004 USDA EPA
Demonstration
Grant Programa

Appendix III Food Safety-Related Interagency Agreements

(Continued From Previous Page)

Program
function
(number of
agreements) Title Date Agency signatories Other signatories

Food security Technical Expertise for Radiological 2004 FDA USDA (7)
Contamination Testing of Meat, Poultry &

Egg Products Surveillance/ Monitoring (5) Joint Salmonella Enteritidis
Risk Reduction Program

Aberdeen Accept and Analyze c USDA U.S. Army
High-Risk
Samples for Biological Agents
Development of Interagency 2004 FDA USDA
Emergency Department of Homeland
Guidelines and Best Practices for Security, National
Response to Food and Agriculture Association of State
Incidents Departments of Agriculture

Develop a Rapid Reverse Trancriptase- 2001 USDA Department of Defense
Polymerase Chain Reaction (RT/PCR)
Test for the Detection and Serotyping of
Vesicular Stomatitis Virus (VSV)

To Bring Together Two Workplans 2003 USDA Department of Defense
regarding the Possible Detection and
Identification of Biological Agentsa
2002 USDA Centers for Disease
To Comply with the Statutory Obligations Control
of the Bioterrorism Act of 2002 and Prevention
Transfer of USDA-APHIS inspectors to 2003 USDA Department of Homeland
DHSa Security

1992 FDA USDA

National Antimicrobial Resistance Monitoring Survey (NARMS)

Page 57 GAO-05-213 Oversight of Food Safety Activities
Centers Safe Centers Diseases Centers Corps & To Share To Form Centers
for and Importation for of and Mercury in Gulf Interior's Animal for and of Expand Officers Human Technical Information Management the for and
2004 FDA USDA Disease Prevention and 2002 USDA Disease Livestock Prevention Recreational 2004 EPA NMFS of Shellfish 1985 FDA EPA NMFS U.S. Fish and Service Administration Production 1999 FDA USDA EPA Disease (5) Prevention, Defense Number of 2003 USDA Department Detailed Services Standardization 1981 USDA NMFS Support between 2004 USDA EPA Programs Foodborne 1998 FDA USDA EPA Disease Response Prevention
Control Biocontainment Control and Finfish of Mexico Growing Department Wildlife and Food Control Department PHS of Health to FSIS Document for Food Pest Outbreak Control Coordinating
of Poultry the Watersa of the Safetya Commissioned and Preparation Groupa

Appendix III Food Safety-Related Interagency Agreements

(Continued From Previous Page)

Program
function
(number of
agreements) Title Date Agency signatories Other signatories

Rulemaking/
Standard
setting
(4)

To Establish Through Regulations, Standards for the NLAP

1996 FDA USDA

Sanctioning of Food Ingredients and Sources of Radiation

2000 FDA USDA
Sharing Information on Herbicide 2000 USDA EPA
Tolerant Crops
Collaboration with Respect to 2000 EPA Centers for Disease
the Control
Implementation of the Public and Prevention
Health
Pesticides Provisions of FQPA

Risk National Advisory 2004 FDAd USDA NMFS
Committee on
assessment Microbiological
Criteria for Foods
(3)
USDA Pesticide Data 1992 FDA USDA EPA
Program
NCHS/CDC IAG-NHANES Centers for
Dietary 2003 EPA Disease Control
Consumption & Human and Prevention
Biomonitoring
Data Acquisition &
Analysis

Research Animal Care & Welfarea 1983 FDA USDA
(2) Collaborative Efforts to Make Alternative
Pest Management Materials and
Techniques Available to Producers

1996b USDA EPA

Source: GAO analysis of agreements provided by USDA, FDA, EPA and NMFS or
identified by GAO.

aThe agreement explicitly recognizes the need to reduce duplication of
effort, reduce or clarify overlaps, or increase the efficient or effective
use of resources between agencies.

bDate of the most recent revision or amendment to a previously existing
agreement.

cThe agreement is undated.

dFDA is not a signatory to this agreement; however, the agency is a
sponsor for the committee.

Appendix IV

Principal Federal Laws Related to Food Safety

As we have noted in this and other reports, the federal framework for food
safety is based on a patchwork of numerous laws. Table 6 lists the 30 laws
that we have identified as the principal federal laws related to food
safety in order of their enactment, along with the agency or agencies that
have food safety responsibilities under each law and a brief discussion or
example of each law's food safety-related provisions. Included in the
table are several laws that primarily deal with health claims or labeling,
which we consider to be food-safety related, as well as some laws that are
largely amendments of the Federal Food, Drug and Cosmetic Act. This table
does not provide an exhaustive list of all food safety-related laws and
amendments, nor does it detail all of the food safety provisions for those
laws listed.

Table 6: The 30 Principal Laws Related to Food Safety

Law Agency Food safety provisions

Lacey Act of 1900, ch. 553, 31 Stat. Department of The act makes it a
federal crime to import, export, sell, or transport in interstate 187
(1900) (codified in part at 16 Commerce commerce any plant, fish, or
wildlife in violation of state law. The act has been U.S.C. S: 3371)
(NMFS), USDA used to prosecute individuals who sell plants, fish, or
wildlife for human

consumption in violation of state law.

Federal Meat Inspection The act governs the slaughtering of
Act, ch. USDA livestock and the processing and
distribution
2907, 34 Stat. 1256, 1260 of meat products in the United States,
(1907) authorizing the Secretary of Agriculture to
(codified at 21 U.S.C. S: prescribe the rules and regulations of
601) sanitation covering slaughtering, meat
canning, salting, packing, rendering, or
similar establishments in which cattle,
sheep, swine, goats, horses, mules, and
other equines are slaughtered and the
meat and meat food products thereof are
prepared for commerce.

Federal Trade Commission FTC The act prohibits the dissemination of false
Act, ch. advertisements for the purpose of
311, 38 Stat. 717 (1914) inducing the purchase or having an effect
(codified at upon commerce of foods, drinks, or
15 U.S.C. S: 41) chewing gum. The act provides for penalties
for such false advertisements if the
use of the commodity may be injurious to
health.

United States Grain Standards Act, USDA The act provides for the
inspection, weighing, and grading of grain. Under the ch. 313, 39 Stat.
482 (1916) (codified act, all corn exported from the United States
generally must be tested for at 7 U.S.C. S: 71) aflatoxin contamination.

Import Milk Act of February 15, 1927, ch. 155, 44 Stat. 1101 (1927)
(codified at 21 U.S.C. S: 141)

FDA The act prohibits the importation of milk or cream into the United
States without a permit and sets standards for when milk and cream shall
be considered unfit for import.

Perishable Agricultural Commodities Act, 1930, ch. 436, 46 Stat. 531
(1930) (codified at 7 U.S.C. S: 499a)

USDA The act regulates the sale of perishable agricultural commodities and
protects sellers delivering their produce on essentially cash terms.

Federal Alcohol Administration Act, ch. 814, 49 Stat. 977 (1935) (codified
at 27 U.S.C. S: 201)

Treasury The act requires that alcoholic beverages for sale or
distribution in the United States have a warning label.

Appendix IV
Principal Federal Laws Related to Food
Safety

(Continued From Previous Page)

Law Agency Food safety provisions

Federal Food, Drug and Cosmetic FDA, EPA The act and its regulations set forth
food and drug labeling requirements, as well

Act, ch. 675, 52 Stat. 1040 (1938) (codified at 21 U.S.C. S: 301)

as requirements for animal drugs. The act seeks to ensure the purity of
the nation's food supply, and accordingly bans "adulterated" and
"misbranded" food from interstate commerce. Under the act, EPA regulates
the amount of pesticide that may remain on food products.

Federal Seed Act, ch. 615, 53 Stat. 1275 (1939) (codified at 7 U.S.C. S:
1551)

USDA, DHS The act establishes seed labeling requirements, including the
requirement for a caution statement such as "Do not use for food or feed
or oil purposes" on seeds that have been chemically treated when the
amount of chemicals remaining with the seeds is harmful to humans or other
vertebrate animals.

Public Health Service Act, ch. 373, 58 FDA, CDC Under the act, CDC engages in
public health activities related to food safety and

Stat. 682 (1944) (codified at 42 U.S.C. S: 201)

foodborne diseases. FDA is authorized under the act to promulgate regulations to
prevent the spread of communicable diseases, including foodborne illnesses.

National School Lunch Act, ch. 281, 60 Stat. 230 (1946) (codified at 42
U.S.C. S: 1751)

USDA The act required the development of a policy and procedures to ensure
that schools receive information regarding irradiation technology and any
other information necessary to promote food safety in schools.

Agricultural Marketing Act of 1946, USDA, NMFS The act promotes a
scientific approach to the problems of marketing,

ch. 966, 60 Stat. 1087 (1946) transporting and distributing agricultural
products and authorizes the Secretary

(codified at 7 U.S.C. S: 1621) of Agriculture to "inspect, certify, and
identify the class, quality, quantity, and condition of agricultural
products." Under the act, USDA has, among other things, established meat
grading and acceptance services. The act also provides authority for the
Seafood Inspection Program, which eventually was transferred to the
Department of Commerce.

Federal Insecticide, Fungicide and EPA The act governs pesticide
registration and safe use of pesticides.
Rodenticide Act, ch. 125, 61 Stat.
103 (1947) (codified at 7 U.S.C.
S: 136)

Poultry Products Inspection Act, Pub. USDA The act governs the
slaughtering, processing, and distribution of poultry

L. No. 85-172, 71 Stat. 441 (1957) products. (codified at 21 U.S.C. S:
451)

Food Additives Amendment of 1958, FDA The act amended the Federal Food,
Drug and Cosmetic Act to prohibit the use Pub. L. No. 85-929, 72 Stat.
1784 in food of additives which have not been adequately tested to
establish their (1958) safety.

Fair Packaging and Labeling Act, Pub. L. No. 89-755, 80 Stat. 1296 (1966)
(codified at 15 U.S.C. S: 1451)

FDA, FTC The act prescribes the placement, form, and contents of a label's
statement of the quantity of packaged goods. The act supersedes all local
regulation that is less stringent or requires different information.

Egg Products Inspection Act, Pub. L. No. 91-597, 84 Stat. 1620 (1970)
(codified at 21 U.S.C. S: 1031)

USDA The act and its regulations set standards for the quality, condition,
weight, quantity, and grade of eggs produced for commercial sale.

Safe Drinking Water Act, Pub. L. No. FDA, EPA The act, which amended the
Federal Food, Drug and Cosmetic Act, and its 93-523, S: 4, 88 Stat. 1660,
1694 regulations establish standards for bottled drinking water. (1974)
(codified at 21 U.S.C. S: 349)

Toxic Substances Control Act, Pub. L. EPA Under the act, EPA can regulate
the use of certain chemical substances in foods No. 94-469, 90 Stat. 2003
(1976) that present an unreasonable risk to health. Under the authority
granted by the (codified at 15 U.S.C. S: 2601) act, EPA's Toxic Substances
Control Act Biotechnology Program regulates

microorganisms, such as biofertilizers, intended for commercial use that
contain

or express new combinations of traits.

Appendix IV
Principal Federal Laws Related to Food
Safety

(Continued From Previous Page)

Law Agency Food safety provisions

Infant Formula Act of 1980, Pub. L. FDA The act authorizes the Secretary
to establish requirements for infant formula for No. 96-359, 94 Stat. 1190
(codified at quality factors and good manufacturing practices, including
quality control 21 U.S.C. S: 350a) procedures, to assure that an infant
formula provides required nutrients and is

manufactured in a manner designed to prevent adulteration of the infant
formula. The act also authorizes the Secretary to prescribe, by
regulation, the scope and extent of recalls of infant formulas necessary
and appropriate for the degree of risks to human health.

Federal Anti-Tampering Act, Pub. L. FDA, USDA The act prohibits tainting a
consumer product with intent to cause serious injury No. 98-127, 97 Stat.
831 (1983) to the business of any person where the consumer product
affects interstate or (codified at 18 U.S.C. S: 1365) foreign commerce.
The act also prohibits providing a materially false or

misleading label or container for a consumer product.

Pesticide Monitoring Improvements FDA The act requires FDA to have in
place computerized data management systems Act of 1988, Pub. L. No.
100-418, to record, summarize, and evaluate the results of its program for
monitoring food S: 4701, 102 Stat. 1107, 1411 (1988) products for
pesticide residues and requires FDA to provide information to EPA.
(codified at 21 U.S.C. S: 1401)

Sanitary Food Transportation Act of DOT The act calls for the Department
of Transportation to issue regulations
1990, Pub. L. No. 101-500, 104 Stat. prohibiting the transportation of
food and food additives in motor or rail vehicles
1213 (1990) (codified at 49 U.S.C. that are used to transport refuse or
nonfood products.
S: 5701)

Nutrition Labeling and Education Act FDA The act amended the Federal Food,
Drug and Cosmetic Act to prohibit the of 1990, Pub. L. No. 101-535, 104
application of state quality standards to foods moving in interstate
commerce Stat. 2353 (1990) and to require labels of food products sold in
the United States to display

nutritional information.

Dietary Supplement Health FDA The act amended the Federal Food, Drug and
and Cosmetic Act to allow certain
Education Act of 1994, health claims for dietary supplements to be
Pub. L. No. made without petitioning the FDA.
103-417, 108 Stat. 4325 These include (1) statements asserting a
(1994) benefit related to a classical nutrient
deficiency disease, (2) claims about the
role of a nutrient or dietary ingredient
with respect to the structure or function of
the human body ("structure/function
claims"), and (3) declarations of general
well-being from consumption of a
nutrient or other dietary ingredient. Under
the act such claims are permitted if
the manufacturer has "substantiation" that
the assertion is truthful and
nonmisleading, if the label expressly states
that FDA has not evaluated the
claim, and if FDA is notified within 30 days
of the first marketing of the product
that bears the claim.

Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110 Stat. 1489
(1996)

EPA, USDA, HHS

The act amended the regulatory scheme under the Federal Insecticide,
Fungicide and Rodenticide Act and the Federal Food, Drug and Cosmetic Act
to require EPA to reevaluate the safety of pesticide tolerances on a set
timetable.

Food and Drug Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat.
2296 (1997)

FDA The act amended the Federal Food, Drug and Cosmetic Act and the Public
Health Service Act to authorize health and nutrient claims to be made for
foods when certain criteria are met.

Animal Health Protection Act, Pub. L. USDA, DHS The act authorizes the
Secretary to prohibit or restrict movements of animals in No. 107-171, S:
10401, 116 Stat. 134, interstate commerce to prevent the dissemination of
any pest or disease of 494 (2002) (codified at 7 U.S.C. livestock. The act
also permits the Secretary to order the destruction or removal S: 8301) of
such animals.

Appendix IV
Principal Federal Laws Related to Food
Safety

(Continued From Previous Page)

Law Agency Food safety provisions

The act expands APHIS's authorities,
Public Health Security and USDA, FDA including activities to enhance
methods of
Bioterrorism Preparedness protecting against the introduction
and of plant and animal disease organisms
by
Response Act of 2002, Pub. terrorists. The act also provides FDA
L. No. with detention authority, expanded
107-188, 116 Stat. 594 recordkeeping provisions, and
(2002) authorizes FDA to commission other
federal
officials to conduct examinations and
investigations of FDA-regulated foods
at
jointly regulated facilities.

Homeland Security Act of 2002, Pub. DHS The act calls for the securing of
critical infrastructure and transfers functions

L. No. 107-296, 116 Stat. 2135 relating to the agricultural import and
entry inspection activities under certain

(2002) laws from the Secretary of Agriculture to the Secretary of the
Department of Homeland Security.

Source: GAO analysis of federal laws.

Appendix V

Comments from the U.S. Department of Agriculture

Note: GAO comments supplementing those in the report text appear at the
end of this appendix.

Appendix V
Comments from the U.S. Department of
Agriculture

See comment 1.

See comment 2.

See comment 3.

Appendix V
Comments from the U.S. Department of
Agriculture

See comment 4.

See comment 5.

Appendix V
Comments from the U.S. Department of
Agriculture

See comment 6.

Appendix V
Comments from the U.S. Department of
Agriculture

The following are GAO's comments on the U.S. Department of Agriculture's
letter dated March 10, 2005.

GAO Comments 1.

We disagree with USDA's assertion that our report overly simplifies the
food safety regulatory functions within USDA and FDA and that it
exaggerates the extent of regulatory overlap. USDA has misinterpreted the
focus of this report. This report examines overlapping activities rather
than the regulatory framework that allows these activities. Nevertheless,
the report contains a clear and accurate acknowledgment that the agencies
operate under a statutory framework that gives them different authorities
and responsibilities to regulate different segments of the food supply.
While we recognize that the agencies operate under different authorities,
the activities they perform under these authorities are similar in nature,
leading us to question why the federal agencies must continue to spend
resources on overlapping, and sometimes duplicative, food safety
activities.

We also disagree with USDA's assertion that the agencies activities are
vastly different. For example, we find that the agencies' inspection
activities to ensure that food manufacturers comply with regulatory
requirements are quite similar. As we document in our report, these
inspections have sufficiently common features, such as verifying proper
sanitation procedures at food processing facilities, that make these
inspections activities candidates for consolidation under one agency.

We further disagree with USDA's comment that the report's recommendations
rely upon overly simplistic interpretations of food safety authorities,
regulations, inspection requirements, and training needs. To the contrary,
our recommendations address specific areas where the agencies could
improve coordination to better leverage resources. USDA did not comment
directly on these recommendations.

We believe that USDA mischaracterizes our report in noting that it states
that a "significant" overlap in inspection authorities exists.
Specifically, our report examines inspection activities, not inspection
authorities, and certainly does not identify "significant" overlaps in
authorities. In fact, the report clearly states that, because of the
agencies' split jurisdiction, they are each responsible for inspecting
different food products at jointly regulated facilities. As a result, both

Appendix V
Comments from the U.S. Department of
Agriculture

agencies send inspectors into these facilities-USDA on a daily basis and
FDA less regularly.

While we agree with USDA that the number of jointly regulated
establishments may be a relatively small portion of all regulated food
establishments, USDA and FDA had great difficulty identifying the current
number of jointly regulated facilities. Consequently, the magnitude of
potential savings is difficult to calculate. We continue to believe that,
because USDA maintains a daily presence at hundreds of these facilities,
FDA could make more effective use of its resources- an average cost of
$4,000 per inspection-if it redirected its inspectors to other facilities
for which FDA has sole jurisdiction.

3. Contrary to USDA's assertion, our report does not suggest that USDA
(FSIS) and FDA have comparable HACCP regulations. Instead, our report
clearly distinguishes between the elements of the agencies' HACCP
regulations that are comparable and those that are not. For example, the
report acknowledges that, given the agencies' different statutory
authorities, both require jointly regulated facilities to maintain
separate HACCP plans and states that the contents of these plans differ
because the agencies regulate different products. However, as USDA itself
notes, the two sets of HACCP regulations (USDA and FDA) are quite similar,
and as we point out, they have certain features in common, such as certain
sanitation and manufacturing processes. Therefore, we continue to believe
that USDA and FDA could consolidate HACCP-based inspections at these
jointly regulated facilities. To provide further clarification on what
commodities are currently subject to HACCP regulations, we modified our
report to indicate, as USDA suggests, that FDA currently requires HACCP
plans for seafood and juice products only.

4. We disagree that our report oversimplifies or inaccurately describes
federal food safety functions at ports of entry. For example, USDA noted
that in order for meat and poultry and egg products to be eligible for
import to the United States, foreign food safety regulatory systems must
employ equivalent sanitary measures that provide the same level of
protection against food safety hazards as is achieved domestically under
USDA regulations. We disagree with USDA's comment, because our report
clearly and accurately describes the requirement for certification of
those countries wishing to export meat and poultry into the United States,
including a finding by the Secretary of Agriculture that the countries
have equivalent food safety systems. The main point

Appendix V
Comments from the U.S. Department of
Agriculture

of our report is that the agencies are not leveraging inspection resources
at ports of entry, especially regarding FDA-regulated imported foods that,
according to USDA officials, are being stored at USDA-approved inspection
facilities. Therefore, we continue to believe that there are opportunities
to leverage inspection resources, as we are recommending.

Furthermore, USDA's comment that it shares the results of its overseas
equivalency determinations contradicts what USDA and FDA officials told us
during the course of our review. However, we note that USDA is now sharing
this information. Indeed, FDA commented that it would consider the results
of USDA's foreign country equivalency determinations.

5. Any successful consolidation of inspectors' training would of course
require work. However, we continue to believe that, as USDA's comments
note, there is merit in examining the feasibility of conducting joint
training activities when workable commonalities can be found. Our report
identifies more than 100 courses in FDA's inspector training curriculum
that include topics common to both USDA and FDA.

6. We disagree with USDA's assertion that implementation of the 1999
interagency agreement has been largely successful. Our report highlights
several deficiencies, even as it gives the agencies credit for improved
communication in times of crisis, such as during major recalls. These
deficiencies include agencies' (1) difficulty identifying the
establishments to which this agreement pertains, (2) lack of routine
communication on inspection findings between agencies' inspection
personnel on such findings of mutual concern as sanitation problems at
jointly regulated facilities, and (3) lack of a system to track and
exchange information when each agency finds instances of noncompliance.
Finally, we also found that the agencies' efforts to develop and provide
training on each other's inspection techniques and processes did not
continue past the first year of the agreement's implementation. As a
result, we continue to believe that the stated purpose of the agreement-to
facilitate an exchange of information permitting more efficient use of
both agencies' resources-has not been maximized.

We further disagree with USDA's comment that our report inaccurately
characterizes the Bioterrorism Act. As we state in the report, FDA is

Appendix V
Comments from the U.S. Department of
Agriculture

authorized under the act to enter into an agreement to commission other
agency officials, including USDA officials, to carry out inspections on
its behalf-for FDA-regulated foods-at establishments under the
jurisdiction of both agencies.

Appendix VI

Comments from the Department of Health and Human Services (FDA)

Note: GAO comments supplementing those in the report text appear at the
end of this appendix.

Appendix VI
Comments from the Department of Health
and Human Services (FDA)

See comment 1.

Appendix VI
Comments from the Department of Health
and Human Services (FDA)

See comment 2.

See comment 3.

Appendix VI
Comments from the Department of Health
and Human Services (FDA)

See comment 4.

Appendix VI
Comments from the Department of Health
and Human Services (FDA)

The following are GAO's comments on the U.S. Department of Health and
Human Services' (HHS) letter, dated March 11, 2005.

GAO Comments 1. We disagree with HHS's comment that our report's title
should substitute the word duplication for overlap. Given the definitions
we lay out in the report, if we modified the title as HHS suggests, we
would risk implying that the agencies are undertaking many duplicative
efforts, even though we are fully aware that under the current statutory
framework the agencies do not exactly replicate food safety activities.
That is, our report distinguishes between "overlap"-which we define as
those similar activities being performed by more than one agency and
"duplication"-which we define as essentially identical activities
performed by more than one agency.

We also disagree with HHS's comment that our report overstates
similarities in USDA and FDA inspections. First, our report clearly states
that USDA and FDA inspections have common key elements: sanitation, good
manufacturing practices, and HACCP compliance oversight. Second, the
report makes it clear that USDA and FDA inspections vary, depending on
whether the product is a USDA-or FDAregulated food product.

Furthermore, we disagree with HHS's comment that the training programs are
vastly different. As our report discusses, FDA's training curriculum
includes dozens of courses that address topics common to USDA and FDA.
Despite HHS's disagreement with our recommendation that the agencies
examine the feasibility of establishing a joint training program for food
inspectors, we continue to believe that such an examination has merit. In
its comments, USDA agreed that there is merit in examining the feasibility
of conducting joint training activities when commonalities can be found.

2. We agree with HHS's comment that, if a single agency were to be
responsible for the safety of all food products, different organization
units within that agency may need to coordinate their activities. However,
we believe that some economies of scale would be derived from combining
overlapping activities, including those that our report highlights. For
example, with a single food safety agency, the federal government would
not need to have two separate food inspection workforces or two separate
training programs.

Appendix VI
Comments from the Department of Health
and Human Services (FDA)

3. We acknowledge that some elements of the 1999 interagency agreement on
dual jurisdiction establishments have been implemented and that the
agreement has enhanced coordination. However, we continue to believe that
the agreement could be better implemented. We further disagree that the
report does not identify the distinct difference between FDA interagency
agreements and memoranda of understanding. We acknowledge that, as used in
our report, the term interagency agreement refers generally to memoranda
of understanding, memoranda of agreement, and interagency agreements
identified by USDA, FDA, EPA, and NMFS. The report includes a footnote to
indicate that FDA makes a distinction, which the other agencies do not,
between interagency agreements and memoranda of understanding. The
footnote explains that, according to FDA, FDA memoranda of understanding
do not provide for exchanges of funds. FDA refers to agreements that
involve exchanges of funds, personnel, or property as interagency
agreements. We did not consider this type of agreement in our analysis.

4. We understand the differences between HACCP principles and plans. Our
report acknowledges that while HACCP principles are the same for both FDA
and USDA, the HACCP plans are different as they address different risks
associated with different products (i.e., seafood, juice, meat, or
poultry). Our report's identification of HACCP requirements as another
area of overlap between the two agencies refers to the fact that both
agencies have issued HACCP regulations that are based on a similar HACCP
model. We have modified our report to indicate that, short of
consolidating all inspection functions, consolidating inspections of the
similar elements in the agencies' HACCP plans would reduce overlap. We
further note that USDA's HACCP rule applies to both meat and poultry
products, although these products present different hazards. Thus, we
believe it is possible to issue broad regulations based on common
principles that can then be applied to specific products. We have made
minor modifications in the report to avoid confusion regarding HACCP
principles and HACCP plans and to indicate that different risks are
associated with different food products and, therefore, require different
HACCP plans.

Appendix VII

Comments from the U.S. Department of Commerce (NOAA)

Appendix VII
Comments from the U.S. Department of
Commerce (NOAA)

Appendix VIII

GAO Contacts and Staff Acknowledgments

GAO Contacts Robert A. Robinson, (202) 512-3841 Maria Cristina Gobin,
(202) 512-8418 Terrance N. Horner, Jr., (202) 512-6910

Staff In addition to those named above Lawrence J. Dyckman, Katheryn
Hubbell, Jane Kim, Sara Margraf, Carol Herrnstadt Shulman, Michele Fejfar,
Amy

Acknowledgments Webbink, and Katherine Raheb made key contributions to
this report.

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