GAO-01-177

Report to Congressional Requesters

United States General Accounting Office

GAO

February 2001 FOOD SAFETY

Overview of Federal

and State

Expenditures
Page i GAO-01-177 Food Safety Expenditures

Letter 1

Appendix I Objectives, Scope, and Methodology 23

Appendix II The Food Safety and Inspection Service’s Fiscal

Years 1998 and 1999 Food Safety Expenditures 26

Appendix III The Food and Drug Administration’s Fiscal Year

1998 and 1999 Food Safety Expenditures 38

Appendix IV States’ Fiscal Years 1998 and 1999 Food Safety

Expenditures 52

Appendix V Responses to GAO’s Survey of State Agencies

Responsible for Food Safety Activities 61

Appendix VI Comments from the Food Safety and Inspection

Service 75

Appendix VII Comments from the Food and Drug Administration 79

Appendix VIII GAO Contacts and Staff Acknowledgements 83

Tables

Table 1: FSIS’ Expenditures and Staff Years for Food Safety

Activities by Office, Fiscal Years 1998 and 1999 27

Table 2: Office of Field Operations Headquarters Activities,

Expenditures, and Staff Years, Fiscal Years 1998 and 1999 28

Contents
Page ii GAO-01-177 Food Safety Expenditures

Table 3: Office of Field Operations District Office Expenditures

and Staff Years, Fiscal Years 1998 and 1999 30

Table 4: District Office Inspection Responsibilities by

Establishment Type, Fiscal Year 2000 31

Table 5: Office of Management Activities, Expenditures, and Staff

Years, Fiscal Years 1998 and 1999 32

Table 6: Office of Public Health and Science Activities,

Expenditures, and Staff Years, Fiscal Years 1998 and 1999 33

Table 7: Office of Policy, Program Development and Evaluation

Activities, Expenditures, and Staff Years, Fiscal Years 1998

and 1999 35

Table 8: Office of the Administrator Activities, Expenditures, and

Staff Years, Fiscal Years 1998 and 1999 36

Table 9: FDA’s Expenditures and Staff Years for Food Safety

Activities by Center, Fiscal Years 1998 and 1999 39

Table 10: Number of FDA Food Safety Field Inspections,

Examinations, and Samples Analyzed, Fiscal Years 1998

and 1999 41

Table 11: Food Field Activities Accounting for Over $1 Million in

Expenditures and Staff Years, Fiscal Years 1998 and 1999 42

Table 12: Animal Drugs and Feeds Field Activities Accounting for

Over $1 Million in Expenditures and Staff Years, Fiscal

Years 1998 and 1999 45

Table 13: CFSAN Headquarters Activities, Expenditures, and Staff

Years, Fiscal Years 1998 and 1999 47

Table 14: CVM Headquarters Activities, Expenditures, and Staff

Years, Fiscal Years 1998 and 1999 49

Table 15: Aggregate Agriculture and Health Department Food

Safety Expenditures and Staff Years by State, Fiscal Years

1998 and 1999 52

Table 16: State Agriculture and Health Department Expenditures

for Food Safety Activity Categories, Fiscal Years 1998 and

1999 55

Table17: Number of Food Establishments Under State Inspection

Jurisdiction and Most Common Inspection Frequency,

Fiscal Years 1998 and 1999 56

Table 18: State Allocation of Resources to Food Safety Licensing

and Inspection Activities, Fiscal Years 1998 and 1999 57

Table 19: State Allocation of Expenditures in Response to Food

Safety Problems, Fiscal Years 1998 and 1999 58

Table 20: State Allocation of Expenditures for Food Safety

Laboratory Analysis, Fiscal Years 1998 and 1999 58

Table 21: State Allocation of Expenditures for Food Safety Training

and Technical Assistance, Fiscal Years 1998 and 1999 59
Page iii GAO-01-177 Food Safety Expenditures

Figures

Figure 1: FSIS’ and FDA’s Food Safety Expenditures and Foods

Under Each Agency’s Regulatory Jurisdiction 3

Figure 2: FSIS’ Expenditures for Field and Headquarters Food

Safety Activities, Fiscal Year 1999 10

Figure 3: FDA’s Expenditures for Field and Headquarters Food

Safety Activities, Fiscal Year 1999 14

Figure 4: Aggregate State Agriculture and Health Department

Expenditures for Food Safety Activities, Fiscal Year 1999 18

Abbreviations

CDC Centers for Disease Control and Prevention

CFSANCenter for Food Safety and Applied Nutrition

CVM Center for Veterinary Medicine

FDA Food and Drug Administration

FSIS Food Safety and Inspection Service

HHS Department of Health and Human Services

NCTR National Center for Toxicological Research

ORA Office of Regulatory Affairs

USDA U.S. Department of Agriculture
Page 1 GAO-01-177 Food Safety Expenditures

February 20, 2001

The Honorable Richard G. Lugar

Chairman

The Honorable Tom Harkin

Ranking Member

Committee on Agriculture,

Nutrition, and Forestry

United States Senate

The Honorable Chuck Hagel

United States Senate

Foodborne illness in the United States is an extensive and expensive

problem. The Centers for Disease Control and Prevention (CDC) estimates

that unsafe foods cause as many as 76 million illnesses annually. The U.S.

Department of Agriculture (USDA) estimates that the costs associated

with foodborne illness due to seven pathogens, including salmonella,

campylobacter, and E. coli O157:H7, range up to $37 billion annually.

Federal and state expenditures for activities to help ensure the safety of

the nation’s food supply are also significant, with federal efforts alone

exceeding $1 billion annually. While there are 12 federal agencies with

food safety responsibilities, USDA’s Food Safety and Inspection Service

(FSIS) and the Department of Health and Human Service’s (HHS) Food

and Drug Administration (FDA) are the primary federal regulatory

agencies responsible for food safety. FSIS is responsible for ensuring that

meat, poultry, and processed egg products moving in interstate and

foreign commerce are safe, wholesome, and marked, labeled, and

packaged correctly. FDA is responsible for ensuring that (1) all foods

moving in interstate and foreign commerce, except those under FSIS’

jurisdiction, are safe, wholesome, and labeled properly; and (2) all animal

drugs and feeds are safe, properly labeled, and produce no human health

hazards when used in food-producing animals. In addition, state agencies

conduct inspection and regulation activities that help ensure the safety of

foods produced, processed, or sold within their borders.

To obtain a better understanding of federal and state food safety efforts,

you asked us to determine for fiscal years 1998 and 1999 the amount of

resources that were expended by FSIS, FDA, and the states for food safety

and how the agencies used these resources.

United States General Accounting Office

Washington, DC 20548
Page 2 GAO-01-177 Food Safety Expenditures

To make this determination for FSIS and FDA, we analyzed their annual

appropriations and financial documentation, which included information

on actual food safety expenditures, activities and accomplishments. For

food safety activities, we obtained and reviewed the associated costs and

staff year levels and supplemented this information with agency

programmatic documents and discussions we had with agency officials.

To determine the amounts that states expended on food safety and how

they used the resources, we surveyed the agriculture and health

departments of all 50 states, 3 territories, the commonwealths of Puerto

Rico and North Mariana Islands, the Federated States of Micronesia, and

the District of Columbia. The survey asked respondents for information on

the scope of food safety activities their departments performed, the costs

and staffing levels of those activities, and the scope and frequency of

inspection activities. We analyzed these data to determine the extent of

state food safety activities and expenditures nationwide. The survey was

limited to state agriculture and health departments and did not include

other state agencies or county and city agencies. Appendix I provides

details on our scope and methodology.

FSIS, FDA, and the state agriculture and health departments expended

about $1.3 billion in fiscal year 1999—FSIS and FDA expended about $1

billion, and the states reported about $300 million. The amounts and

proportions of food safety expenditures for fiscal year 1998 were similar.

Regarding the $1 billion in fiscal year 1999 federal moneys, as shown in

figure 1, FSIS expended about 70 percent, or $712 million, overseeing

about 20 percent of federally regulated foods and FDA expended about 30

percent, or $283 million, overseeing about 80 percent of federally

regulated foods. These expenditures reflect the regulatory approaches or

inspection frequencies contained in the laws under which each agency

operates.

Results in Brief
Page 3 GAO-01-177 Food Safety Expenditures

Figure 1: FSIS’ and FDA’s Food Safety Expenditures and Foods Under Each Agency’s Regulatory Jurisdiction

Food Safety Expenditures Consumer Food Expenditures by Agency Jurisdiction

Source: Prepared by GAO from fiscal year 1999 FSIS and FDA data and fiscal year 1997 U.S.

Bureau of Labor Statistics data.

FSIS food safety expenditures totaled about $678 million in fiscal year

1998 and $712 million in fiscal year 1999. FSIS expended about 85 percent

of its resources on field activities, including in-plant inspection,

compliance, administration, and supervisory activities associated with

overseeing about 6,000 meat, poultry, and egg product establishments,

including about 130 import establishments. FSIS’ expenditures reflect its

legislative mandate for continuous inspection of meat and poultry

slaughter plants—including the examination of every carcass

slaughtered—and of egg processing plants and its interpretation of federal

law as requiring daily inspection of meat and poultry processing plants

72% • FSIS ($712)

•28%

FDA ($283)

22% • FSIS ($622)

78%

•

FDA ($2,258)

Dollars in millions

FSIS

FDA
Page 4 GAO-01-177 Food Safety Expenditures

(e.g., deboning and canning operations).1 About $296 million of fiscal year

1999 inspection expenditures of $486 million went to carcass-by-carcass

slaughter inspections (inspections that cannot detect microbial pathogens,

which are considered the most significant health risk, associated with

foods) and about $145 million was expended on daily inspections of

processing plants regardless of risk. We previously reported that moving

to a risk-based inspection system would allow for a more effective use of

some of the resources currently expended on carcass-by-carcass and daily

inspection activities.2

FDA’s food safety expenditures in fiscal years 1998 and 1999 totaled about

$253 million and $283 million, respectively. FDA expended about 56

percent of its food safety resources on field activities, including

inspection, compliance, administration, and supervisory activities. In

contrast to FSIS, FDA has no legislatively mandated inspection

frequencies for foods or food firms under its jurisdiction and generally

follows a regulatory approach of allowing food products to enter the

market without prior approval. As such, FDA inspects the estimated 57,000

food establishments under its jurisdiction about once every 5 years, on

average, and inspected less than 1 percent of the 3.7 million imported food

entries in fiscal year 1999. The other 44 percent of FDA’s expenditures

were for headquarters-based activities, including activities associated with

the evaluation and approval of certain foods such as infant formula,

ingredients such as colors and additives, and animal drugs and feed before

they are produced for the market, and activities such as surveillance and

research on the safety of food and feed products after they enter the

market.

States (used hereafter to collectively refer to state, territory,

commonwealth, federated state, and the District of Columbia agriculture

and health departments) reported food safety activity expenditures of

about $292 million and $301 million in fiscal years 1998 and 1999,

respectively. Over 50 percent of states’ expenditures, $142 million and

$144 million in fiscal years 1998 and 1999, respectively, were for licensing

and inspection activities for a wide variety of establishments, including

 1

The Federal Meat Inspection Act requires a post-mortem examination and inspection of

the carcasses and parts of all livestock prepared at any slaughtering establishment. The

Poultry Products Inspection Act requires a post-mortem inspection of each bird processed.

2

See Food Safety: Opportunities to Redirect Federal Resources and Funds Can Enhance

Effectiveness (GAO/RCED-98-224, Aug.6, 1998).
Page 5 GAO-01-177 Food Safety Expenditures

continuous and daily inspections at meat and poultry slaughter and

processing plants under the states’ jurisdictions.3

 Each year participating

states matched the approximately $40 million in grants FSIS provided to

the states to conduct meat and poultry inspections under federal

standards, including carcass-by-carcass examination. The states reported

over 1 million establishments under their inspection jurisdiction, including

nearly 700,000 restaurants, groceries, and other retail outlets; 90,000 dairy

farms; 4,800 fish and seafood plants/farms; over 1,900 shellfish operations;

and about 1,500 meat and poultry slaughter plants. In addition to state

agriculture and health departments, which generally have primary food

safety responsibilities at the state level, a wide variety of other state and

local agencies have food safety responsibilities that were not covered in

the scope of our survey.

We provided a draft of the report to FSIS and FDA for their review and

comment. In commenting on the draft, both agencies generally agreed with

the information contained in the report and provided additional

information on specific issues. We modified the report to reflect this

information as appropriate.

The extent of foodborne illness in the United States and its associated

costs are significant. CDC estimates that unsafe foods cause as many as 76

million illnesses, 325,000 hospitalizations, and 5,000 deaths annually.4

 In

terms of medical costs and productivity losses, foodborne illnesses

associated with seven major pathogens cost the nation between $7 billion

and $37 billion annually, according to USDA’s estimates.

According to CDC, almost 12,000 cases of foodborne illness were reported

in 1997, the latest year for which data are available. Of the approximately

7,000 cases in which the food source for the illness was known, about 85

percent were associated with food products that are regulated by FDA,

such as fish, shellfish, fruits, vegetables, and salads. The remaining 15

percent were associated with food products, such as meat and poultry,

that fall under FSIS’ jurisdiction. The relative proportion of illness

 3

States operate federal equivalent inspection programs for intrastate meat and poultry

plants.

4

CDC uses reported illnesses, among other sources, to estimate the extent of foodborne

illnesses each year. Reported data on foodborne illnesses and related deaths are

incomplete and understate the extent of the problem.

Background
Page 6 GAO-01-177 Food Safety Expenditures

associated with foods under each agency’s jurisdiction reflects consumer

expenditures for food products under the jurisdiction of each. Nearly 80

percent of consumer expenditures are for foods under FDA’s jurisdiction,

while FSIS is responsible for the remaining 20 percent.

While 12 different federal agencies located within six federal departments

conduct food safety activities, FSIS and FDA have primary regulatory

responsibility for ensuring the safety of the nation’s food supply.5 FSIS has

responsibility for ensuring the safety of meat, poultry, and processed egg

products, overseeing about 6,000 meat, poultry, egg product and import

establishments.6

 Under the governing inspection acts, FSIS, in effect,

preapproves products before they are marketed. As such, FSIS operates

under a mandated continuous inspection frequency for meat and poultry

slaughter plants and egg processing plants and inspects meat and poultry

processing plants daily. FSIS marks all inspected and approved meat,

poultry, and egg products with a USDA inspection stamp. Without this

marking, the products cannot be legally marketed.

FSIS also reviews and assesses the effectiveness of state intrastate meat,

poultry, and egg product inspection programs to ensure that their

standards are at least equal to federal standards. In addition, FSIS reviews

and assesses foreign inspection systems and facilities that export

FSIS-regulated products to the United States for equivalency with U.S.

standards.7

 In 1998, FSIS reviewed 7 of the 26 states with intrastate

inspection programs for meat and/or poultry and reviewed foreign

inspection programs in 22 of the 37 countries that were eligible to export

 5

The 12 agencies are USDA’s Animal and Plant Health Inspection Service, Grain Inspection,

Packers and Stockyards Administration, Agricultural Marketing Service, Agricultural

Research Service, and FSIS; HHS’ Centers for Disease Control and Prevention and FDA; the

Department of the Treasury’s U.S. Customs Service and the Bureau of Alcohol, Tobacco

and Firearms; the Department of Commerce’s National Marine Fisheries Service; the

Environmental Protection Agency; and the Federal Trade Commission. See Food Safety:

U.S. Needs a Single Agency to Administer a Unified, Risk-Based, Inspection System

(GAO/T-RCED-99-256, Aug. 4, 1999) for information on food safety agencies’ roles and

responsibilities.

6

The Federal Meat Inspection Act regulates meat from cattle, swine, goats, sheep, and

equines (horses); the Poultry Products Inspection Act defines poultry as domesticated

fowl, which FSIS regulations define as chickens, turkeys, ducks, geese, and guineas. The

Egg Products Inspection Act defines egg products as eggs removed from their shells for

processing.

7

FSIS also reinspects imported meat, poultry, and egg products at ports of entry and at

destination or other locations.
Page 7 GAO-01-177 Food Safety Expenditures

to the United States. In addition to the inspection activities, FSIS conducts

emergency responses, including retention, detention, or voluntary recall of

adulterated foods and epidemiological investigations of foodborne hazards

or disease outbreaks. Furthermore, FSIS engages in developing and

implementing cooperative strategies to prevent health hazards associated

with animal production practices, coordinating U.S. participation in

international sanitary standard-setting activities, and providing safety

information to food handlers and consumers.

FDA is responsible for ensuring the safety of a broad range of products,

including foods, animal drugs and feeds, human medicines and vaccines,

radiation-emitting devices, medical devices, blood and blood products, and

cosmetics. Specifically, under the Federal Food, Drug and Cosmetic Act,

FDA is responsible for ensuring that domestic and imported food products

(except meat, poultry, and processed egg products) are safe, wholesome,

and labeled properly. This includes ensuring the safety of ingredients that

make up foods, such as food additives that change a food’s color or taste,

and reviewing and approving new additives unless they are generally

recognized as being safe. In administering the act, which generally follows

the regulatory approach of allowing food products to enter the market

without preapproval, FDA inspects and tests domestic and imported food

products.8

 However, the act does not mandate or specify inspection

frequencies for overseeing an estimated 57,000 food establishments under

FDA’s jurisdiction. Products under FDA’s jurisdiction do not require, and

FDA does not place, any inspection mark on the products before they can

be legally marketed. FDA is also responsible for maintaining surveillance

of all animal drugs and feeds to ensure that they are safe and labeled

properly and produce no human health hazards when used in

food-producing animals and for overseeing more than 9,000 animal drug

and feed establishments.9

 8

Both FDA and FSIS have implemented hazard analysis and critical control point systems

that are designed to identify and control foodborne hazards that are likely to occur. In

December 1997, FDA required seafood establishments to implement such systems, and in

January 1998, FSIS began requiring implementation at meat and poultry establishments.

9

GAO’s recently released report, Food Safety: Controls Can Be Strengthened to Reduce the

Risk of Disease Linked to Unsafe Animal Feed (GAO/RCED-00-255, Sept. 22, 2000)

addresses concerns regarding the extent to which unsafe feed has been linked to human

health problems in the United States and the actions FDA and the Department of

Transportation are taking to ensure the safety of animal feed.
Page 8 GAO-01-177 Food Safety Expenditures

States all have departments that are responsible for the regulation and

enforcement of their own food safety laws to ensure the safety of foods

produced, processed, or sold within their borders. These responsibilities

are primarily within the state departments of agriculture and health and

may involve others, such as state environmental protection agencies and

county departments of health. States and territories may also perform

inspections for FSIS or FDA under contract or form partnerships to report

their results to the federal agencies. For example, in fiscal year 1998, FDA

contracted with 38 states to conduct inspections in accordance with the

federal regulations. Under partnership agreements, 29 states shared the

results of inspections conducted under their own standards with FDA.

FSIS was responsible for food safety expenditures of $678 million in fiscal

year 1998 and $712 million in fiscal year 1999, or about 55 percent of the

nearly $1.3 billion fiscal year 1999 federal and state expenditures. In fiscal

years 1998 and 1999, FSIS employed 11,057 and 10,951 staff years,

respectively. FDA food safety activities accounted for about 22 percent of

the total expenditures—$253 million in fiscal year 1998 and $283 million in

fiscal year 1999—and employed 2,505 and 2,609 staff years, respectively.

State agriculture and health departments reported food safety

expenditures of about $292 million in fiscal year 1998 and $301 million in

fiscal year 1999 and employed 5,617 and 5,717 staff years, respectively.

About 85 percent of FSIS’ expenditures were for field activities, while

FDA’s expenditures were almost evenly divided between field and nonfield

activities. The federal agencies’ expenditures reflect the regulatory

approaches or inspection frequencies contained in the laws under which

they operate.

FSIS, FDA, and State

Agency Food Safety

Expenditures Total

Nearly $1.3 Billion
Page 9 GAO-01-177 Food Safety Expenditures

FSIS expended $678 million in fiscal year 1998 and $712 million in fiscal

year 1999 on food safety.10 FSIS’ food safety activities can be separated

into two major components—operations conducted in the field by district

offices or in direct support of those district offices and operations

conducted primarily in headquarters offices. As shown in figure 2, about

85 percent of FSIS’ fiscal year 1999 expenditures were for field activities

and 15 percent were for headquarters office activities.11 See appendix II for

details on FSIS’ activities, expenditures, and staff years for fiscal years

1998 and 1999.

 10FSIS’ total expenditures included about $47 million in grants to states for inspection and

other activities annually. These funds were likely reported as food safety expenditures by

the state agriculture and health departments and thus may be double-counted in the federal

and state total of $1.3 billion. In addition, in commenting on a draft of this report, FSIS

stated that some of its expenditures were for nonfood safety activities more related to food

wholesomeness and quality issues, but provided no specific examples.

11The proportion of expenditures for each category of activity varied by less than 2 percent

from fiscal years 1998 to 1999.

FSIS’ Field Inspection

Activities Account for

Most of the Agency’s Food

Safety Expenditures
Page 10 GAO-01-177 Food Safety Expenditures

Figure 2: FSIS’ Expenditures for Field and Headquarters Food Safety Activities,

Fiscal Year 1999

Note: Percentages do not add to 100 because of rounding.

Source: Prepared by GAO from FSIS’ data.

In aggregate, FSIS’ field activities accounted for $614 million in fiscal

year1999. Specifically:

• Inspections at more than 6,000 slaughter, processing, and import

establishments accounted for $486 million, or 68 percent, of total agency

expenditures. Of the $486 million, FSIS estimates that slaughter

inspections conducted at 262 establishments accounted for about $324

1%

Administrator ($6.1)

•

9%

Management ($61.8)

2%

Public Health and Science ($11.4)

• 3%

Policy, Program Development 

and Evaluation ($18.9)

11%• Field Operations/Headquarters ($79.9) 

• 5%

Field Operations/District ($34.1)

2%

Laboratory Analysis ($13.8)

68%•

Field Operations/Plant 

Inspections ($486)

Headquarters

Field

•

Dollars in millions
Page 11 GAO-01-177 Food Safety Expenditures

million; daily meat and poultry processing inspections at about 4,300

establishments accounted for about $145 million; continuous inspections

at 75 egg processor establishments accounted for about $8 million; and

inspections at 129 import/export establishments accounted for about $7

million.12 Regarding slaughter inspections, FSIS estimates that carcass-bycarcass organoleptic (see, touch, smell) inspections accounted for about

$296 million of the total inspection expenditures. FSIS does not track

expenditures specifically related to Hazard Analysis and Critical Control

Point system inspections and thus could not provide that information.

• Field office administration, supervision, and compliance activities, such as

following-up on inspection findings, accounted for $34.1 million, or 5

percent, of total expenditures.

• Field office management by the Office of Field Operations located in

Washington, D.C., accounted for $79.9 million, or 11 percent, of total

expenditures. The largest expenditure was for grants to states for

inspections, field automation, and other activities, accounting for almost

$47 million, or over half, of the office’s total expenditures for fiscal year

1999.

• Field laboratory analysis services provided by the Office of Public Health

and Science accounted for $14 million of field activity expenditures, or 2

percent, of total expenditures.

FSIS’ headquarters-based activities accounted for the remaining $98

million of fiscal year 1999 expenditures, or about 15 percent, of total

agency expenditures. Four program offices—Management; Public Health

and Science; Policy, Program Development, and Evaluation; and the Office

of the Administrator—conduct FSIS’ headquarters food safety activities.

Specifically:

• The Office of Management accounted for about $61.8 million, or 9 percent,

of total expenditures. The office is responsible for providing centralized

administrative and support services to all other FSIS program offices,

including functions such as human resource management, strategic

planning, procurement, and financial management.

• The Office of Policy, Program Development, and Evaluation accounted for

about $18.9 million, or 3 percent, of total expenditures. The office is

 12FSIS could only provide estimates because (1) its accounting system does not track

categories of inspection expenditures electronically, and to determine expenditures

manually would be extremely labor-intensive, and (2) the accuracy of inspection

expenditure data is questionable due to a change in accounting systems and management

codes during fiscal year 1999.
Page 12 GAO-01-177 Food Safety Expenditures

responsible for, among other things, coordinating activities, such as

developing and recommending domestic and international policies for

FSIS; reviewing product process standards; product labeling; and

developing and evaluating inspection programs.

• The Office of Public Health and Science accounted for about $11.4 million,

or 2 percent, of total expenditures.13 The office is responsible for

conducting scientific analysis, providing scientific advice and data, and

making recommendations involving all public health and science concerns

relating to products under FSIS’ jurisdiction. This includes mission

activities such as epidemiology and risk assessment, surveillance, and

response to food safety emergencies.

• The Office of the Administrator accounted for about $6.1 million, or 1

percent, of total expenditures. The office is responsible for managing

agency activities such as public affairs, food safety education,

coordinating U.S. involvement in international standard-setting for food

safety, and maintaining liaison with trade organizations.

FSIS’ large proportion of expenditures on field and supporting activities

reflects the mandate of the meat and poultry acts. The two acts require

that meat and poultry slaughter plants be under continuous FSIS

inspection.14 If a federal inspector is not present, the animals cannot be

slaughtered. FSIS inspects animals both before and after slaughter. The

acts also require FSIS inspectors to monitor processing plant operations,

such as deboning and canning, to ensure that plants are sanitary and

adhere to approved procedures and label specifications. The acts do not

explicitly set inspection frequencies for meat- and poultry-processing

plants; however, FSIS has interpreted the acts as requiring the daily

inspection of such plants and has established its regulations accordingly.

That is, an FSIS inspector must visit each meat- and poultry-processing

plant for an unspecified period of time—which may be as little as an

hour—each operating day. As such, the majority of FSIS expenditures are

directed to conducting inspection activities based on frequencies derived

from the regulatory acts, rather than on the food safety risk of a specific

plant or process.

 13This excludes the $14 million expended by this office for field laboratories.

14There has been an ongoing debate regarding the implementation of a system under which

plant workers would assume more responsibility for the carcass inspections now

conducted by federal inspectors. With guidance from recent court rulings, FSIS is working

to establish such a system while still meeting the requirements of the acts.
Page 13 GAO-01-177 Food Safety Expenditures

In 1998, we reported that FSIS’ funds could be used more effectively if

they were redirected using risk-based criteria. Specifically, the

approximate $296 million in fiscal year 1999 expenditures for organoleptic,

carcass-by-carcass slaughter inspections do not optimize federal resources

because these inspections do not detect the most serious public health

threat associated with meat and poultry—microbial contamination.

Rather, some of these funds and funds used for daily inspections of meatand poultry-processing plants could be used, for example, to increase

testing for microbial and other types of contamination, risk assessment,

and scientific research, or could be congressionally redirected to other

food plants, such as seafood processors, based on the health risk posed.

We continue to hold this view.

FDA expended $253 million in fiscal year 1998 and $283 million in fiscal

year 1999 on food safety activities.15 These activities represent the

combined efforts of FDA’s three centers with food safety responsibilities:

the Center for Food Safety and Applied Nutrition, the Center for

Veterinary Medicine, and the National Center for Toxicological Research,

as well as the field activities conducted by the Office of Regulatory Affairs

in support of the centers. As with FSIS, FDA’s food safety activities can be

separated into two major elements: (1) inspection and enforcement

operations conducted in the field by district offices or at headquarters in

direct support of those district offices, and (2) operations conducted

primarily in headquarters offices. As shown in figure 3, about 56 percent of

FDA’s fiscal year 1999 food safety expenditures were for field activities

and about 44 percent were for headquarters-based activities of FDA’s

centers.16 Appendix III provides detailed information on FDA’s fiscal years

1998 and 1999 activities, expenditures, and staff years.

 15FDA’s total expenditures included nearly $3 million of contracts to states for inspection

and other activities annually. These funds were likely reported as food safety expenditures

by the state agriculture and health departments and thus may be double-counted in the

federal and state total of $1.3 billion.

16Each activity’s proportion of total expenditures did not vary by more than 2 percent

between fiscal years 1998 and 1999.

FDA’s Food Safety

Expenditures Are More

Closely Divided Between

Field Inspection and

Headquarters Activities
Page 14 GAO-01-177 Food Safety Expenditures

Figure 3: FDA’s Expenditures for Field and Headquarters Food Safety Activities,

Fiscal Year 1999

Legend:

ORA Office of Regulatory Affairs

CVM Center for Veterinary Medicine

CFSAN Center for Food Safety and Applied Nutrition

Note: Percentages do not add to 100 because of rounding.

Source: Prepared by GAO from FDA’s data.

In aggregate, FDA’s field activities accounted for about $159 million in

fiscal year 1999, or about 56 percent of the agency’s total food safety

expenditures. The Office of Regulatory Affairs (ORA) is responsible for

34% • Center for Food Safety and

Applied Nutrition ($95.6)

1%

National Center for Toxicological

Research ($1.5)

51%•

Field Operations ORA/CFSAN ($145.2)

•

5%

Field Operations ORA/CVM ($13.5)

•

10%

Center for Veterinary Medicine ($27.7)

Headquarters

Field

Dollars in millions
Page 15 GAO-01-177 Food Safety Expenditures

conducting field activities designated by the centers. ORA’s compliance,

inspection, and laboratory field staff manage, supervise, and conduct

enforcement, compliance, inspection, sample collection and analysis

activities, as well as criminal investigation, education, and outreach

activities. Specifically:

• The ORA-conducted field activities in support of the Center for Food

Safety and Applied Nutrition accounted for about $145 million in

expenditures for fiscal year 1999. Using these funds, FDA conducted over

14,600 domestic food establishment inspections, including those

conducted by states under contract with FDA, at a cost of about $2

million; and about 765 inspections of food importers. About $27 million, or

19 percent, of the $145 million went to domestic and imported seafood

hazard analysis and critical control point inspection activities. Also

included in these total expenditures is more than $40 million for

laboratory analysis of about 25,000 domestic and foreign product samples

associated with field inspection activities.

• The ORA-conducted field activities in support of the Center for Veterinary

Medicine accounted for about $13.5 million in expenditures in fiscal year

1999. With these funds, FDA conducted nearly 3,500 domestic animal drug

and feed establishment inspections, including those conducted by states

under contract with FDA at a cost of about $600,000. Also included in

these expenditures is about $2 million for laboratory analysis of about

1,800 feed samples associated with field inspection activities.

In aggregate, the headquarters-based activities of FDA’s centers accounted

for about $125 million in fiscal year 1999, or 44 percent of the agency’s

total food safety expenditures. Specifically:

• The Center for Food Safety and Applied Nutrition’s activities accounted

for about $96 million in fiscal year 1999, or 34 percent of total agency food

safety expenditures. The center operates FDA’s Foods Program, which is

responsible for ensuring that FDA-regulated food is safe, sanitary,

wholesome, and labeled properly. To attain this goal, the center

implements programs that address specific food safety concerns;

premarket review of food and color additives, infant formula and medical

foods accounted for about $10 million in expenditures, and postmarket

monitoring and response activities accounted for about $17 million in

expenditures, and cross-cutting activities that address both premarket and

postmarket concerns, such as regulatory policy development and

education and outreach activities, accounted for about $61 million in

expenditures. Food safety research and risk assessment accounted for

about $32 million, or about half of cross-cutting activity expenditures.
Page 16 GAO-01-177 Food Safety Expenditures

• The Center for Veterinary Medicine’s activities accounted for about $28

million in fiscal year 1999, or 10 percent, of total agency food safety

expenditures. The center operates FDA’s Animal Drugs and Feeds

Program, which has primary goals of ensuring that only safe and effective

animal drugs, feeds, and feed additives are marketed and that foods from

animals that are administered drugs and food additives are safe for human

consumption. The center maintains surveillance over all animal drugs and

feeds to minimize threats to human health. Premarket application review

for new animal drugs accounted for the center’s largest expenditures,

about $12.8 million in fiscal year 1999. In the same year, FDA reviewed 36

original new animal drug applications, approving 17, and reviewed 767

supplemental applications to change the conditions of existing approvals,

approving 421.

• The National Center for Toxicological Research located in Jefferson,

Arkansas, accounted for nearly $1.5 million in fiscal year 1999, or about 1

percent of total agency expenditures.17 The center’s mission is to conduct

peer-reviewed scientific research that provides the basis for FDA to make

sound, science-based regulatory decisions and to protect the public health

through pre- and post-market surveillance. During fiscal year 1999, the

center conducted 10 research projects that contributed to FDA’s food

safety mission; due to the center’s research focus, it did not engage in field

activities related to food safety.

FDA’s relatively small proportion of expenditures on field inspection and

supporting activities in comparison to FSIS’ expenditures for those

activities reflects the absence of specified inspection frequencies in the

Federal Food, Drug and Cosmetics Act. The act, which FDA has primary

responsibility for administering, generally follows the regulatory approach

of allowing almost all food products to enter the market without

preapproval by federal agencies. Therefore, FDA is not required to inspect

foods or food firms on a given schedule. As a result, FDA inspects the

more than 57,000 food establishments under its jurisdiction about once

every 5 years, on average, and according to FDA officials, inspected less

than 1 percent of the 3.7 million imported food entries in fiscal year 1999.

 17In addition, the center conducted food safety research funded through an interagency

agreement with the National Institute of Environmental Health and Safety at a total cost of

$8.4 million in fiscal years 1998 and 1999.
Page 17 GAO-01-177 Food Safety Expenditures

State agriculture and health departments reported expenditures of about

$292 million in fiscal year 1998 and $301 million in fiscal year 1999. As

shown in figure 4, nearly half of the expenditures reported by state

agencies, or about $144 million in fiscal year 1999, were for inspection and

licensing activities.18 Appendix IV provides detailed information on the

state agencies’ fiscal years 1998 and 1999 expenditures and staff years for

food safety activities.

 18Each activity’s proportion of total expenditures did not vary by more than 2 percent

between fiscal years 1998 and 1999. States were able to report about 83 percent of

expenditures by activity category. “Uncategorized activities” represent the 17 percent of

expenditures that were reported as a total amount or pooled together for multiple

categories.

States Report

Expenditures of About

$300 Million Annually for

Food Safety
Page 18 GAO-01-177 Food Safety Expenditures

Figure 4: Aggregate State Agriculture and Health Department Expenditures for

Food Safety Activities, Fiscal Year 1999

Source: Prepared by GAO from state agriculture and health department data.

State agriculture and health departments reported food safety

expenditures in six categories: licensing and inspection, response to food

safety problems, laboratory analysis, technical assistance and training,

administration and support, and other expenditures. Specifically, for fiscal

year 1999:

• Licensing and inspection activities for a wide variety of establishments,

including meat and poultry slaughter and processing plants, fish and

seafood plants, shellfish operations, dairy product and egg product plants,

48% • Licensing and inspections ($144.1)

11%•

Laboratory analysis ($34.1)

• 11%

Administration ($32.9)

•

6%

Technical assistance 

and training ($17.5)

•

5%

Response to food 

safety problems ($15.7)

2%

Other activities ($5)

•17%

Uncategorized activities ($51.6)

Dollars in millions
Page 19 GAO-01-177 Food Safety Expenditures

as well as groceries, restaurants, and institutions, accounted for about

$144 million, or about 48 percent, of state expenditures.

• Laboratory analysis activities, including analysis for microbial

contamination, pesticides and other chemical residues, filth and/or

sanitation, and food label accuracy, accounted for about $34 million, or

about 11 percent, of state expenditures.

• Administration and support for food safety activities accounted for about

$33 million, or about 11 percent, of state expenditures.

• Technical assistance and training activities for a wide variety of recipients,

including farmers, producers, processors, consumers, department staff,

and the staff of outside departments, accounted for about $18 million, or

about 6 percent, of state expenditures.

• Response to food safety problems, including investigation of outbreaks,

recall activities, natural disasters, and regulatory enforcement activities,

accounted for about $16 million, or about 5 percent, of state expenditures.

• Other activities that did not fit into the above categories, such as

committee or council activities, computer or equipment purchases, and

database development, accounted for about $5 million, or about 2 percent,

of state expenditures.

State agriculture and health departments reported in aggregate over 1

million establishments under their collective inspection jurisdictions and

about 2 million inspections conducted each year, not counting continuous

inspections at meat and poultry slaughter plants and other establishments.

Groceries, other retail outlets, and restaurants were by far the largest

proportion of establishments under state inspection jurisdiction,

representing more than 60 percent of all establishments under state

jurisdiction. Dairy farms were the next largest group of establishments

under state inspection jurisdiction, representing almost 10 percent of the

establishments.

While state agriculture and health departments are generally charged with

primary food safety responsibilities, a wide variety of other state and local

agencies that were not included in our survey also have food safety

responsibilities and associated expenditures. About half of the state

departments of agriculture and health that we surveyed reported that

other state departments or agencies had a role in ensuring food safety, but

often only at a specific type of establishment or for a specific food

product. States also reported that local governments are involved in

conducting food safety inspections at some types of establishments, such

as groceries and other retail outlets, restaurants, and at institutions, but

are less involved in conducting laboratory analysis, responding to food

safety problems, or providing technical assistance and training.
Page 20 GAO-01-177 Food Safety Expenditures

We provided FSIS and FDA with a draft of this report for review and

comment. FSIS generally agreed with the information provided but said

that the report should clearly state that FSIS’ responsibilities and

expenditures also involve some nonfood safety activities, such as ensuring

that products meet consumer expectations for wholesomeness and

quality. We believe that the report clearly identifies FSIS’

responsibilities—i.e., ensuring that meat, poultry, and processed egg

products moving in interstate and foreign commerce are safe, wholesome,

and marked, labeled, and packaged correctly. Regarding nonfood safety

expenditures, throughout our review, FSIS officials said that the

expenditure information provided to us was for food safety or food safetyrelated activities. As such, we believe that the FSIS expenditures in this

report are appropriately characterized as “food safety” expenditures.

FSIS also said that it would be useful if we included the size and scope of

the products it regulates. We believe the report adequately describes the

size and scope of FSIS’ activities. For example, the report includes

information on the number of meat, poultry, egg product, and import

establishments FSIS oversees; the number of state and foreign programs it

reviewed; and the number and type of inspections it conducted. The level

of detail provided on FSIS’ responsibilities and activities is similar to that

provided on FDA’s activities.

FSIS also said that the statistics provided in the report regarding the

relative proportions of food purchases and agency food safety

expenditures were misleading due to the high risk of FSIS-regulated

products compared with some of the FDA-regulated products. While the

relative risk of FSIS-regulated products may be greater in some cases than

FDA-regulated products, it was not our intent to analyze or compare the

risk of products. We believe that the data accurately reflect the proportion

of each agency’s expenditures and the proportion of consumer

expenditures for foods under each agency’s jurisdiction. The report also

clearly identifies the food products for which each agency has

responsibility.

Finally, FSIS said that the report should further define its responsibilities

under the Federal Meat Inspection Act and Poultry Products Inspection

Act. FSIS also described court actions related to its efforts to design new

inspection models that would realign roles and responsibilities of industry

and federal inspectors. We modified the report to clearly identify FSIS’

responsibilities under the federal meat and poultry inspection acts and

described its efforts, with guidance from the courts, to realign the

responsibilities and roles of industry and federal inspectors.

Agency Comments

and Our Response
Page 21 GAO-01-177 Food Safety Expenditures

FDA agreed with the report and said that it contained valuable information

on the allocation of food safety resources. FDA applauded the report for

including important information on the efforts and resources expended by

states but believed that the report was incomplete because it did not

include information on the expenditures and efforts of other agencies,

such as USDA’s Agricultural Research Service and Animal and Plant

Health Inspection Service. We have previously reported on the resources

and staffing of the 12 federal agencies involved in food safety activities. By

design, the scope of this report was limited to FSIS and FDA food safety

activities and expenditures.

FSIS and FDA also provided technical clarifications, which we

incorporated into the report as appropriate. FSIS’ comments and our

responses are included in appendix VI; FDA’s comments and our

responses are included in appendix VII.

We conducted our review from March through December 2000 in

accordance with generally accepted government auditing standards.

As agreed with your offices, unless you publicly announce its contents

earlier, we plan no further distribution of this report until 30 days from its

issue date. At that time, we will send copies of this report to the Honorable

Ann Veneman, Secretary of Agriculture; the Honorable Bernard Schwetz,

D.V.M., Ph.D., Acting Principal Deputy Commissioner of the Food and

Drug Administration; the Honorable Mitchell Daniels, Jr., Director, Office

of Management and Budget; and other interested parties. We will also

make copies available to others upon request.
Page 22 GAO-01-177 Food Safety Expenditures

If you have any questions about this report, please contact me at

 (202) 512-3841. Major contributors to this report are listed in appendix

VIII.

Lawrence J. Dyckman

 Director, Natural Resources and Environment
Appendix I: Objectives, Scope, and

Methodology

Page 23 GAO-01-177 Food Safety Expenditures

To determine for fiscal years 1998 and 1999 the amount of resources that

were expended by the Food Safety and Inspection Service (FSIS), the

Food and Drug Administration (FDA), and the states for food safety and

how the agencies actually used these resources, we conducted work at

each of the federal agencies and mailed surveys to food safety agencies in

50 states, 3 territories, the Commonwealths of Puerto Rico and the North

Mariana Islands, the Federated States of Micronesia, and the District of

Columbia (hereafter referred to as states unless specified otherwise).

Regarding FSIS and FDA, we obtained appropriations documentation

showing the amount of funding provided to each agency. We collected

records of expenditures and staff years for specific activities from each of

the agencies as follows:

• FSIS provided expenditure and full-time equivalent staff-year information

from its accounting system for each of its headquarters and field offices

for specific food safety activities within those offices, such as inspection,

education, and laboratory activities. FSIS could not provide expenditure

information from its accounting system for approximately 2 weeks at the

end of fiscal year 1999 because of problems created by the implementation

of a new accounting system. Instead, FSIS determined the allocation of

expenditures for that time period based on other expenditure records. The

Office of Inspector General could not give an opinion on the U.S.

Department of Agriculture’s (USDA) financial statements for fiscal years

1998 and 1999 because of weaknesses in evidence and internal controls.1

We did not verify FSIS’ accounting information, as it was the only

information available, and such an audit was outside of the scope of our

review.

• FDA provided records of expenditures and staff years from the agency’s

Center for Food Safety and Applied Nutrition (CFSAN), Center for

Veterinary Medicine (CVM), National Center for Toxicological Research

(NCTR), and Office of Regulatory Affairs (ORA). Each center used its own

methodology to identify and provide expenditures and staff years for

specific food safety activities, using a combination of accounting system

information, staff activity time records, and estimations. FDA’s Office of

Financial Management reviewed the information provided by the centers

for accuracy and consistency and also provided us with the share of FDA

central administrative costs allocable to each center. We did not verify

 1

For the past 8 years, USDA has reported to the President that it is unable to provide

reasonable assurance that its financial systems conform with certain standards and

principles.

Appendix I: Objectives, Scope, and

Methodology
Appendix I: Objectives, Scope, and

Methodology

Page 24 GAO-01-177 Food Safety Expenditures

FDA’s accounting information; we relied on an independent auditor’s

finding that FDA’s accounting records fairly reported its financial position

and had no internal control weaknesses in fiscal years 1998 and 1999.

At each agency, we gathered documentation and interviewed agency

officials to (1) obtain additional information on the specific activities

funded by the expenditures and accomplishments associated with those

activities and (2) discuss the expenditure and staff-year information they

provided. We also collected documentation and the transfer of funds

between food safety and nonfood safety activities at each agency and

discussed other financial concerns, such as FSIS’ fiscal years 1997 and

1998 anti-deficiency violations caused by the over-obligation of as much as

$4 million each year.2

To determine the amounts that states expended on food safety and how

they actually used the resources, we surveyed the agriculture and health

departments of 50 states, 3 territories, Puerto Rico, and the District of

Columbia; we surveyed the health departments of the Commonwealth of

the North Mariana Islands and the Federated States of Micronesia, which

do not have agriculture departments. In total, we sent out 112 surveys. The

survey requested information on the scope of food safety activities

performed by their departments, the costs and staffing levels of those

activities, the scope and frequency of inspection activities, how the states

allocated expenditures between various activities, and perceptions

regarding the extent of local government involvement in food safety

activities. In developing the survey, we coordinated with staff from FDA’s

Office of Regulatory Affairs, Division of Federal/State Relations, which is

also surveying the states.

We pretested the survey at seven food safety departments in four

states—Colorado, Louisiana, Pennsylvania and Virginia—to ensure that

our questions were clear, unbiased, and precise and that responding to the

survey did not place an undue burden on their agencies. We did not

independently verify the accuracy of the state officials’ responses. We also

reviewed each response to identify internal data inconsistencies and other

issues needing clarification, called respondents to resolve questions, and

made agreed-upon changes to their responses as appropriate. We received

surveys from 98 of the 100 state health and agriculture departments; 6 of

 2

The Congress provided $6 million in the agency’s fiscal year 2001 appropriation to pay

obligations associated with the 1997 and 1998 anti-deficiency violations.
Appendix I: Objectives, Scope, and

Methodology

Page 25 GAO-01-177 Food Safety Expenditures

the 10 food safety agencies in the territories and other entities; and both

the health and agriculture departments in the District of Columbia. Our

overall response rate was 95 percent.

In completing the survey, we asked the states to obtain information from

staff who are most knowledgeable about food safety activities, that they

respond only for their department’s activities, and that they submit only

one survey reflecting the entire department’s activities. Regarding

expenditures, we asked that states report actual expenditures for each

state fiscal year, but if these were not available, to report budget

allocations and to inform us which of the two data types they provided to

us. Of the responding agencies, 37 reported actual expenditures, 9

reported actual budget allocations, and 55 reported estimates. The

majority of the respondents did not report all indirect costs for food safety

activities or in-kind contributions, although some did.

We recognize that the total funding amounts reported for food safety

activities, as well as the amounts reported for specific categories of

activities, could be under- or over-reported because of differences in state

department reporting, budgeting, and accounting practices. In some cases,

states did not report expenditures, staff years, or establishments by the

individual categories provided in the survey; rather, they may have pooled

categories together or reported only a total amount. These amounts are

reported as “uncategorized.” A few state departments sent in several

individual responses from various entities, which we consolidated into a

single departmental response. Some states provided a response for only

one of the two departments. The reported expenditures do not reflect the

full cost of food safety activities within each state, because expenditures

and activities of other state agencies, local agencies, and private industry,

by design, are not included in our scope. However, we believe the

information presented in the report reasonably and conservatively

represents the food safety activities and expenditures of the survey

respondents. Appendix V contains the survey results.

We performed our work from March through December 2000 in

accordance with generally accepted government auditing standards.
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 26 GAO-01-177 Food Safety Expenditures

USDA’s Food Safety and Inspection Service (FSIS) is responsible for

ensuring that meat, poultry, and processed egg products moving in

interstate and foreign commerce are safe, wholesome, and labeled and

packaged correctly. The food safety activities undertaken by FSIS to attain

these goals during fiscal years 1998 and 1999, the costs and staff years

associated with each activity, and outcomes associated with selected

activities are presented in the following sections.

FSIS accomplishes its mission to ensure that the nation’s meat, poultry,

and egg products moving interstate and into foreign commerce are safe,

wholesome, and labeled and packaged correctly through five program

offices located in Washington, D.C. The offices include the Office of the

Administrator; Office of Public Health and Science; Office of Policy,

Program Development and Evaluation; Office of Field Operations

(headquarters and district offices); and Office of Management. In addition,

FSIS operates a Technical Service Center in Omaha, Nebraska; three field

laboratories located in Alameda, California; St. Louis, Missouri, and

Athens, Georgia; and 17 district offices located throughout the United

States.1

FSIS’ food safety activities are funded through annual congressional

appropriations, industry reimbursements, and trust funds for meat and

poultry inspection. In fiscal years 1998 and 1999, funds available to FSIS

totaled about $678 million and $714 million, respectively.

For fiscal years 1998 and 1999, FSIS expended about $678 million and $712

million, respectively, for its food safety activities.2 As shown in table 1,

about 84 percent of the expenditures were for the Office of Field

Operations to conduct headquarters and district office food safety

activities. The other four offices accounted for about 16 percent of

expenditures in aggregate.

 1

During fiscal year 1999, FSIS closed its Boston District Office, which changed the number

of district offices from 18 to 17.

2

FSIS officials explained that the difference between fiscal year 1999 appropriations of $714

million and expenditures of $712 million was due to the specific planning of a $2 million

carryover. This action was taken to prevent any further anti-deficiency violations.

Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Mission, Organization,

and Funding

Food Safety

Activities,

Expenditures, and

Staffing
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 27 GAO-01-177 Food Safety Expenditures

Table 1: FSIS’ Expenditures and Staff Years for Food Safety Activities by Office,

Fiscal Years 1998 and 1999

Dollars in millions

Expenditures

(percent of total)

Staff years

(percent of total)

Office 1998 1999 1998 1999

Field Operations- Plant

Inspections

$463.4

(68)

$486

(68)

9,441

(85)

9,330

(85)

Field Operations- District

Compliance, Supervision,

and Administration

35.4

(5)

34.1

(5)

521

(5)

517

(5)

Field OperationsHeadquarters69.1

(10)

79.9

(11)

222

(2)

211

(2)

Field Operations –

Subtotal

567.9

(83)

600

(84)

10,184

(92)

10,058

(92)

Management 62.7

(9)

61.8

(9)

406

(4)

382

(3)

Public Health and Science 23.9

(4)

25.2

(4)

254

(2)

281

(3)

Policy, Program

Development, and

Evaluation

18

(3)

18.9

(3)

149

(1)

162

(1)

Administrator 5.3

(1)

6.1

(1)

64

(1)

68

(1)

Headquarters Operations

– Subtotal

109.9

(17)

112

(16)

873

(8)

893

(8)

Total $677.8

(100)

$712

(100)

11,057

(100)

10,951

(100)

Source: FSIS.

The Office of Field Operations is responsible for managing a program of

regulatory oversight and inspection for the meat, poultry, and egg product

laws enforced by FSIS. As such, the office was responsible for the largest

proportion of agency expenditures—$568 million and $600 million in fiscal

years 1998 and 1999, respectively, or about 84 percent of agency

expenditures and over 90 percent of staff years. The office is divided into

two components—headquarters operations and field district operations.

The headquarters unit located in Washington, D.C., sets policy and

manages field operations. As shown in table 2, the headquarters unit

accounted for about $69 million and $79 million in fiscal years 1998 and

1999, respectively, or about 10 percent of total FSIS expenditures.

Included within this unit is the Technical Service Center, which serves as

the agency’s center for technical assistance and guidance for field

Office of Field Operations
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 28 GAO-01-177 Food Safety Expenditures

operations personnel and industry. The center also reviews domestic and

foreign inspection programs.

Table 2: Office of Field Operations Headquarters Activities, Expenditures, and Staff

Years, Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Office of Field Operations -

Headquarters 1998 1999 1998 1999

Grants to states – inspection and other

activities

$40,552 $44,359 0 0

Grants to states – field automation 0 2,514 0 0

Technical Service Center – review 9,549 9,474 113 113

Field automation 8,023 13,804 0 0

Resource management 3,246 1,781 46 14

Office of Deputy 2,378 1,231 7 5

District enforcement 2,350 2,294 27 29

District inspection 1,300 1,584 15 15

Technical Service Center – training 727 2,484 4 31

Federal/state relations 507 357 5 5

Emergency programsa 424 0 5 0

Totalb $69,057 $79,881 222 212

a

In fiscal year 1999, the Emergency Planning Program was reassigned from the Office of Field

Operations to the Office of Management, Planning staff.

b

Totals may not add because of rounding.

Source: FSIS.

Three activities—grants provided to states, the Field Automation and

Information Management initiative, and reviews conducted by the

Technical Service Center—accounted for $70 million, or about 88 percent,

of the total office expenditures in fiscal year 1999.

• Grants to states accounted for almost 60 percent of total office

expenditures. Most of the grants, about $40 million, funded up to 50

percent of state costs to operate inspection programs for meat and poultry

plants that are “equivalent to” federal programs. In fiscal year 1999, 26

states received funding through grants.

• The Field Automation and Information Management initiative accounted

for about 17 percent of the Office of Field Operations headquarters

expenditures for fiscal year 1999. This initiative provides for uniform

automation of FSIS’ inspection functions at plants inspected by FSIS and

state inspectors. Expenditures were for the purchase and installation of

the equipment, as well as training inspectors. For example, during fiscal
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 29 GAO-01-177 Food Safety Expenditures

year 1999, over 750 federal inspectors were trained and 700 computers

delivered to FSIS field locations. In addition, over 550 state inspectors

were trained, and states received over 500 computers.

• The Technical Service Center conducted review activities that accounted

for about 12 percent of field operation’s headquarters expenditures for

fiscal year 1999. The center is responsible for designing and implementing

guidelines and procedures for review of foreign, state, and federal

domestic inspection programs. The center also conducts special inquiries

and reviews, such as reviews of state inspection programs, to ensure they

are equivalent to the federal programs. In fiscal year 1999, the center

reviewed the program documentation of 36 countries exporting to the

United States to determine if they had implemented Hazard Analysis and

Critical Control Point systems and Salmonella testing programs equivalent

to U.S. requirements. In that same year, the center’s review staff reviewed

96 state-inspected establishments in 11 states to determine their

effectiveness and whether or not they were equivalent to the federal

inspection programs.

The Office of Field Operation’s field district offices conduct compliance

and inspection activities for meat, poultry, and egg products. As shown in

table 3, the field district offices accounted for expenditures of about $499

million and $520 million in fiscal years 1998 and 1999, respectively, or

about 73 percent, of agency expenditures and about 90 percent of staff

years. Within the district offices, 93 percent of their expenditures were for

in-plant inspections and 7 percent for the administration of those activities

and compliance activities.
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 30 GAO-01-177 Food Safety Expenditures

Table 3: Office of Field Operations District Office Expenditures and Staff Years,

Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Office of Field Operations –

District Office 1998 1999 1998 1999

Jackson, MS $48,857 $51,464 1,078 1,063

Springdale, AR 47,607 52,420 992 982

Des Moines, IA 39,698 40,766 805 801

Atlanta, GA 39,301 41,782 828 866

Dallas, TX 32,432 34,057 660 641

Lawrence, KS 31,715 33,232 650 643

Alameda, CA 30,988 32,104 583 565

Raleigh, NC 29,973 31,585 637 635

Beltsville, MD 26,572 28,166 569 556

Philadelphia, PA 22,960 24,268 442 436

Albany, NY 22,002 22,239 384 383

Minneapolis, MN 20,943 21,560 390 379

Chicago, IL 20,916 21,525 400 398

Madison, WI 19,382 19,226 366 329

Pickerington, OH 19,314 19,851 364 370

Salem, OR 17,506 18,905 309 326

Boulder, CO 16,180 16,230 296 295

Boston, MA 12,426 10,751 212 180

Totala $498,771 $520,133 9,961 9,847

a

Totals may not add because of rounding.

Source: FSIS.

Under the guidance and direction of the Office of Field Operation’s

headquarters District Inspection and District Enforcement offices, the

districts manage and direct both inspection and compliance activities. As

shown in table 4, the district offices direct inspections of meat and poultry

slaughter plants, processing plants, and plants that have combined

slaughter and processing operations, and other establishments such as egg

product plants. In addition, the offices inspect these products at import

points. For example, in fiscal year 1999, they inspected over 99 billion

pounds of meat and poultry and 3 billion pounds of egg products at about

6,000 domestic plants and inspected 3.2 billion pounds of imported meat

and poultry from 34 countries. The district offices also direct compliance

reviews that are designed to (1) monitor businesses engaged in the

production, distribution, and marketing of food products and (2) prevent

the violation of laws and regulations. As a result of these reviews, in fiscal

year 1999, the district offices detained approximately 20 million pounds of
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 31 GAO-01-177 Food Safety Expenditures

adulterated meat and poultry products and initiated 118 enforcement

actions to stop inspection operations in federally inspected plants.

Table 4: District Office Inspection Responsibilities by Establishment Type, Fiscal

Year 2000

Type of establishment

District Offices

Meat and poultry

slaughter

Meat and

poultry

processing

Meat and

poultry

combination

slaughter

and

processing Othera Totalb

Jackson, MS 38 142 44 30 254

Springdale, AR 7 143 70 30 250

Des Moines, IA 4 135 61 60 260

Atlanta, GA 29 336 45 49 459

Dallas, TX 10 188 48 60 306

Lawrence, KS 7 157 80 24 268

Alameda, CA 3 563 55 104 725

Raleigh, NC 14 77 27 19 137

Beltsville, MD 14 123 41 27 205

Philadelphia, PA 38 291 101 25 455

Albany, NY 46 817 74 51 988

Minneapolis, MN 6 148 75 39 268

Chicago, IL 4 314 39 32 389

Madison, WI 1 262 50 36 349

Pickerington, OH 6 217 49 20 292

Salem, OR 12 258 57 62 389

Boulder, CO 8 169 44 20 241

Total 247 4,340 960 688 6,235

a

Other includes egg product, import, and other establishments not included in the other categories.

b

Excludes 244 Talmadge-Aiken establishments that are staffed and inspected by state employees

with FSIS oversight.

Source: FSIS.

The Office of Management is responsible for providing centralized

administrative and support services to all other FSIS program offices,

including human resource management, strategic planning, procurement,

and financial management. As shown in table 5, the office accounted for

expenditures of about $63 million and $62 million in fiscal years 1998 and

1999, respectively, or about 9 percent, of agency expenditures and 4

percent of staff years. About 46 percent of the office’s expenditures were

for “central charges” attributed to the entire agency. Almost one-half of

Office of Management
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 32 GAO-01-177 Food Safety Expenditures

these charges were expenditures for benefits such as worker’s

compensation and unemployment. Other charges included “other services”

such as contractual and consulting services, communications, utilities, and

rent.

Table 5: Office of Management Activities, Expenditures, and Staff Years, Fiscal

Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Office of Management 1998 1999 1998 1999

Central charges $29,563 $27,684 0 0

Administrative services 9,824 11,304 56 49

Human resources 8,830 8,259 151 134

Budgeta 5,092 1,569 103 23

Automated information services 3,738 3,673 38 29

Civil rights 1,478 1,806 16 18

Labor-management relations 997 1,345 11 18

Planning 984 1,218 14 18

Field automation and information

management staffb

690 0 8 0

Reorganization 548 0 0 0

Office of Deputy 518 711 5 7

Internal control 459 496 6 6

Financial management 0 3,720 0 79

Totalc $62,722 $61,784 406 382

a

During fiscal years 1998 and 1999, the Budget and Financial Management Divisions were separated.

b

After fiscal year 1998, Field Automation and Information Management staff expenditures were

charged to the Office of Field Operations rather than the Office of Management.

c

Totals may not add because of rounding.

Source: FSIS.

The Office of Public Health and Science is responsible for conducting

scientific analysis, providing advice, collecting data, and making

recommendations involving all public health and science concerns relating

to products under FSIS’ jurisdiction. This includes mission activities such

as epidemiology and risk assessment, surveillance, response to food safety

emergencies, and laboratory analysis by the agency’s three field

laboratories. As shown in table 6, the office accounted for expenditures of

about $24 million and $25 million in fiscal years 1998 and 1999,

respectively, or about 4 percent, of agency expenditures and 2 to 3 percent

of staff years.

Office of Public Health and

Science
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 33 GAO-01-177 Food Safety Expenditures

Table 6: Office of Public Health and Science Activities, Expenditures, and Staff

Years, Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Office of Public Health and Science 1998 1999 1998 1999

Laboratories $13,325 $13,785 175 190

Office of Deputy 4,868 5,531 10 15

Microbiology 1,689 1,876 22 23

Chemistry and toxicology 910 1,011 11 12

Food hazard surveillance 910 1,019 13 12

Emerging pathogens 853 955 10 9

Emergency response 566 621 6 8

Epidemiology & risk assessment 413 432 4 13

Research oversighta 374 0 4 0

Totalb $23,907 $25,231 254 281

a

In fiscal year 1999, expenditures for Research oversight were charged to the Office of Public Health

and Science’s Office of Deputy.

b

Totals may not add due to rounding.

Source: FSIS.

The combined expenditures for the three field laboratories and the Office

of Public Health and Science’s Office of Deputy accounted for 77 percent

of all expenditures for that program office in fiscal year 1999.

• Three field laboratories located in Alameda, California; Athens, Georgia;

and St. Louis, Missouri, accounted for more than 50 percent of the office

expenditures and almost 70 percent of the staff years. These laboratories

coordinate and conduct analyses in microbiology, chemistry, and

pathology for food safety in meat, poultry, and egg products. Among other

things, they conduct these services to (1) support both domestic and

import inspections done by FSIS, (2) support the agency’s Hazard Analysis

and Critical Control Point initiative, and (3) identify emerging pathogens in

the food supply. In addition, the laboratories provide technical assistance

to FSIS field staff.

• The Office of Deputy accounted for about 22 percent of office

expenditures, with the majority of these being for charges attributed

specifically to the Office of Public Health and Science. Most of these

charges are for “other services” such as facilities renovations, equipment,

or payments to other agencies for studies. For example, in fiscal year 1999,

the Office of Deputy expended $1.2 million to repair its Eastern

Laboratory in Athens, Georgia, and provided the Centers for Disease

Control and Prevention (CDC) with $1.5 million for Food Net surveys.
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 34 GAO-01-177 Food Safety Expenditures

The Office of Policy, Program Development and Evaluation is responsible

for, among other things, coordinating activities such as developing and

recommending domestic and international policies for FSIS; reviewing

product processes, standards, and labeling; and developing and evaluating

inspection programs. As shown in table 7, the office accounted for

expenditures of about $18 million and $19 million in fiscal years 1998 and

1999, respectively, or about 3 percent, of agency expenditures and 1

percent of staff years.

Office of Policy, Program

Development and

Evaluation
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 35 GAO-01-177 Food Safety Expenditures

Table 7: Office of Policy, Program Development and Evaluation Activities,

Expenditures, and Staff Years, Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Office of Policy, Program Development

and Evaluation 1998 1999 1998 1999

Inspection development $4,562 $4,584 30 34

Office of Deputy 2,883 3,614 22 16

Hazard analysis and critical control point

initiativea

2,322 0 2 0

Labeling and standards 2,317 2,101 32 26

International policy 1,436 1,697 14 18

Animal production 1,112 2,029 6 6

Regulatory development 1,070 1,563 16 18

Evaluation and analysis 940 1,279 11 12

Compounds reviewb 719 0 12 0

Codexc 654 40 5 <1

Label reviewb 0 1,542 0 24

Management support staffd 0 500 0 7

Totale $18,014 $18,949 149 162

a

In fiscal year 1999, the hazard analysis and critical control point initiative activity no longer existed.

b

In fiscal year 1999, FSIS eliminated the Compounds Review Office because the agency no longer

does those reviews, and FSIS reorganized its former labeling and compounds review function.

c

 The Codex Office manages and coordinates U.S. involvement and participation in the Codex

Alimentarius Commission, a United Nations’ international standard-setting organization for food safety

and public health.

d

At the end of fiscal year 1998, expenditures by the management support staff were not separately

tracked by FSIS’ accounting system.

e

Totals may not add because of rounding.

Source: FSIS.

The combined expenditures of two offices in the Office of Policy, Program

Development and Evaluation—the Inspection Development Division and

the Office of Deputy— accounted for over 40 percent of all expenditures

for that office in fiscal year 1999.

• The Inspection Systems Development Division designs, develops, and tests

new or modified inspection systems for food safety. This division works

on developing specific changes to FSIS’ inspection procedures, including

work related to hazard analysis and critical control point procedures. For

example, this division has contracted for the collection of microbiological

and organoleptic data in poultry and hog plants to support the proposed
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 36 GAO-01-177 Food Safety Expenditures

Hazard Analysis and Critical Control Point-based Inspection Models

Project.

• The Office of Deputy accounted for about 20 percent of total office

expenditures. Other than personnel expenditures, the majority of these

were for “centrally administered” charges. According to FSIS officials,

these are charges associated with the entire Office of Policy, Program

Development and Evaluation office, rather than a specific division within

that office. Most of these charges are for “other services,” such as

production of food safety educational materials.

The Office of the Administrator is responsible for overall management of

the agency and activities such as public affairs, food safety education, and

coordination of U.S. involvement in international standard setting for food

safety and maintaining liaisons with trade organizations. As shown in table

8, the office accounted for expenditures of about $5 million and $6 million

in fiscal years 1998 and 1999, respectively, or about 1 percent of agency

expenditures and 1 percent of staff years.

Table 8: Office of the Administrator Activities, Expenditures, and Staff Years, Fiscal

Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Office of the Administrator 1998 1999 1998 1999

Education $2,351 $1,822 29 24

Office of the Administrator 1,374 1,777 9 10

Executive management 1,248 1,204 21 21

The Congress and public affairs 309 578 5 7

U.S. Codexa 0 746 0 6

Totalb $5,283 $6,127 64 68

a

All Codex expenditures in fiscal year 1998 were charged to the Office of Policy, Program

Development and Evaluation.

b

Totals may not add because of rounding.

Source: FSIS.

A significant portion of the Office of the Administrator’s funding, about 30

percent in fiscal year 1999, was expended on food safety education. The

functions of the Food Safety Education staff are different from other units

in the office because, while others primarily conduct management and

policy type activities, the food safety education staff provides FSIS food

safety education programs to the public. These programs are designed to

educate producers, distributors, food preparers, and consumers on the

prevention of foodborne illnesses. This office also operates the agency’s

Office of the Administrator
Appendix II: The Food Safety and Inspection

Service’s Fiscal Years 1998 and 1999 Food

Safety Expenditures

Page 37 GAO-01-177 Food Safety Expenditures

Meat and Poultry Hotline to answer consumer inquiries. In fiscal year

1999, this staff coordinated the agency’s food safety education campaign,

FightBAC! tm, and handled about 36,000 consumer calls to the hotline.
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 38 GAO-01-177 Food Safety Expenditures

Food safety is one of the Health and Human Service’s (HHS) Food and

Drug Administration’s (FDA) many responsibilities, shared by multiple

units within the agency. FDA food safety activities undertaken by each

unit during fiscal years 1998 and 1999, the costs and staff years associated

with each activity, and outcomes associated with selected activities are

presented in the following sections.

FDA accomplishes its mission of protecting the public health by ensuring

the safety of a broad range of products, including foods, animal drugs and

feeds, human medicines and vaccines, radiation-emitting devices, medical

devices, blood and blood products, and cosmetics through six centers.

Three of these centers are responsible for food safety activities: the Center

for Food Safety and Applied Nutrition (CFSAN) for the Foods Program;

the Center for Veterinary Medicine (CVM) for the Animal Drugs and Feeds

Program; and the National Center for Toxicological Research (NCTR) for

research into the toxicity of products. In addition, the Office of Regulatory

Affairs conducts inspections and compliance reviews and collects and

analyzes product samples in support of the centers. The three centers and

the Office of Regulatory Affairs are also provided administrative support

through numerous offices, such as the Office of the Commissioner and the

Office of Management and Systems.

FDA food safety facilities are distributed nationwide. FDA headquarters

and CVM are located in Rockville, Maryland, CFSAN is located in

Washington, D.C., and NCTR is located in Jefferson, Arkansas. The two

Centers, CVM and CFSAN, have a research facility in Beltsville, Maryland;

CFSAN has a fishery research center in Dauphin Island, Alabama, and a

food technology research center in Chicago, Illinois. Field facilities,

primarily staffed by Office of Regulatory Affairs personnel conducting

inspections and laboratory activities, are distributed across 5 regional

offices, 19 district offices, and 13 laboratories, and are supported by over

120 resident posts.

FDA’s appropriations for fiscal years 1998 and 1999 were about $1.050

billion and $1.130 billion, respectively. Each of FDA’s programs received a

specified amount of the total appropriation to conduct both their food

safety and nonfood safety-related responsibilities. For example, in fiscal

year 1999, the Foods Program received about $235 million, of which about

$222 million was expended on CFSAN and related field food safety

activities. The difference reflects that while most of the Food Program’s

responsibilities relate to food safety, the program also has other

responsibilities and related expenditures for other activities, such as

Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Mission, Organization,

and Funding
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 39 GAO-01-177 Food Safety Expenditures

cosmetics safety. Similarly, in fiscal year 1999, the Animal Drugs and

Feeds Program received about $43 million, of which about $38 million was

expended on CVM and related field food safety activities. The difference

reflects that while the majority of the Animal Drugs and Feeds Program’s

responsibilities relate to food safety, the program also has responsibilities

and related expenditures for nonfood animals, such as dogs and cats. The

Office of Regulatory Affairs receives a specific amount of the

appropriation for each program to conduct field activities in support of the

centers.

For fiscal years 1998 and 1999, as shown in table 9, about 56 percent of

FDA’s food safety expenditures and over 60 percent of its staff years were

for food safety activities conducted in the field, and the remaining 44

percent of expenditures and nearly 40 percent of the staff years were for

the headquarters-based activities of the centers.

Table 9: FDA’s Expenditures and Staff Years for Food Safety Activities by Center,

Fiscal Years 1998 and 1999

Dollars in millions

Expenditures

(percent of total)

Staff years

 (percent of total)

Center 1998 1999 1998 1999

Field Operations – Center for

Food Safety and Applied

Nutrition

$127.2

(50)

$145.2

(51)

1,426

(57)

1,535

(59)

Field Operations – Center for

Veterinary Medicine

13.7

(5)

13.5

(5)

138

(6)

137

(5)

Field Operations– Subtotal 140.9

(56)

158.7

(56)

1,564

(62)

1,672

(64)

Headquarters Operations –

Center for Food Safety and

Applied Nutrition

85.7

(34)

95.6

(34)

733

(29)

721

(28)

Headquarters Operations –

Center for Veterinary Medicine

25.9

(10)

27.7

(10)

203

(8)

206

(8)

Headquarters Operations –

National Center for

Toxicological Research

0.8

(<1)

1.5

(1)

5

(<1)

10

(<1)

Headquarters Operations –

Subtotal

112.4

(44)

124.8

(44)

941

(38)

937

(36)

Totala $253.4

(100)

$283.4

(100)

2,505

(100)

2,609

(100)

a

Totals may not add because of rounding.

Source: FDA.

FDA Food Safety

Activities,

Expenditures, and

Staffing
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 40 GAO-01-177 Food Safety Expenditures

Field activity expenditures of about $141 million and $159 million in fiscal

years 1998 and 1999, respectively, accounted for about 56 percent of total

FDA food safety expenditures each year and 62 to 64 percent of FDA’s

staff years. CFSAN is responsible for directing field activities related to

food products, and CVM is responsible for field activities related to feeds

and drugs for food animals. These field activities, conducted by FDA’s

Office of Regulatory Affairs, include the inspection of food and animal

feed and drug establishments under the agency’s jurisdiction, field

examination of food and feed products, and the collection and analysis of

product samples to ensure that the products comply with applicable

regulations. The overall results of FDA’s inspection and sample analysis

fieldwork are presented in table 10.

FDA Field Food Safety

Activities for Foods and

Animal Drugs and Feeds
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 41 GAO-01-177 Food Safety Expenditures

Table 10: Number of FDA Food Safety Field Inspections, Examinations, and

Samples Analyzed, Fiscal Years 1998 and 1999

Activity 1998 1999

Inspections

Food importers 940 765

Domestic food establishmentsa 11,922 14,680

Feed establishmentsb 4,182 3,128

Animal drug establishments 439 357

Total Inspectionsc 17,483 18,930

Field Examinations

Imported foods 17,140 15,828

Domestic foods 2,172 1,992

Imported animal drugs/feeds 46 59

Total Field Examinations 19,358 17,879

Sample Analyses

Import food samples 16,802 15,439

Domestic food samples 10,894 9,335

Animal drug/feed samplesd 1,580 1,784

Total Samples Analyzed 29,276 26,558

a

Includes state contract inspections that are funded by the Center for Food Safety and Applied

Nutrition at a cost of a little over $2 million each year.

b

Includes state contract feed mill inspections that are funded by the Center for Veterinary Medicine at

a cost of $833,000 and $614,000 in fiscal years 1998 and 1999, respectively.

c

An individual importer, food, or feed establishment may be inspected more than once a year.

d

FDA and the states also analyzed over 200 Bovine Spongiform Encephalopathy tissue residue

samples each year.

Source: FDA.

Field activities for foods accounted for about $127 million in fiscal year

1998 and $145 million in fiscal year 1999, or about 90 percent of FDA’s

food safety field expenditures. Table 11 lists the fiscal years 1998 and 1999

food field expenditures of $1 million or more. FDA food field activities

accounting for less than $1 million in annual expenditures each, such as

criminal investigations, emergency response to foodborne outbreaks, and

various unplanned activities, represented in aggregate less than $8 million

in expenditures each year. The expenditures reflect the total cost of each

activity, including inspection, investigation, field examination, sample

collection, sample analysis, and other costs, such as Office of Regulatory

Affairs management and administrative support expenditures, associated

with each activity. FDA agencywide support expenditures accounted for

about 8 percent of food product field expenditures.
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 42 GAO-01-177 Food Safety Expenditures

Table 11: Food Field Activities Accounting for Over $1 Million in Expenditures and

Staff Years, Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Food field activities 1998 1999 1998 1999

Imported foods general – import entry

review/refused entries

$24,939 $26,932 312 314

Domestic fish and fishery products

inspection (hazard analysis and critical

control point)

11,371 14,420 142 168

Imported seafood products inspection

(hazard analysis and critical control

point)

11,283 12,755 141 149

Domestic food safety 7,382 10,805 92 126

Pesticides and industrial chemicals in

imported foods

5,361 6,580 67 77

Office of Regulatory Affairs/Center

directed research projects

4,919 4,701 62 55

Other domestic food safety initiative

activities

4,717 1,543 59 18

Consumer complaints 4,270 4,642 53 54

Pesticides and industrial chemicals in

domestic foods

3,597 3,436 45 40

Total diet studies 3,516 4,447 44 52

General retail food protection (state) 3,311 4,318 41 50

Interstate milk shippers 3,005 3,502 38 41

Imports – food and color additives 2,863 3,504 36 41

Import produce assignment (fiscal year

1999)

0 3,023 0 35

Molluscan shellfish evaluation 2,670 2,380 33 28

Toxic elements in foods

(domestic/import)

2,521 2,789 32 33

Interstate travel sanitation 2,365 2,592 30 30

Domestic and import cheese 2,088 1,371 26 16

Mycotoxins in domestic foods 2,084 3,126 26 37

State contract inspection 2,040 2,036 0 0

Short-term assignments 1,512 2,146 19 25

Domestic acidified and low-acid canned

food

1,396 2,375 17 28

Import acidified and low-acid canned

food

1,211 1,110 15 13

Domestic nutrition sampling 1,153 1,703 14 20

Other activities 6,617 7,337 82 85

Agencywide support 11,000 11,600 0 0

Totala $127,191 $145,173 1,426 1,535

a

Totals may not add because of rounding.

Source: FDA.
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 43 GAO-01-177 Food Safety Expenditures

Five of the field activities listed in table 11 accounted for about $71

million, or almost 50 percent, of total food field expenditures in fiscal year

1999.

• Imported foods general activities accounted for about $27 million, or

about 19 percent, of food field expenditures. The objective of this activity

was to ensure that imported foods comply with federal law and with

guidelines for gross and microbiological filth. To attain this objective, FDA

conducted import field examinations of the foods most likely to be out of

compliance, collected samples, and conducted analysis for filth,

decomposition, and microbiological contamination.

• The domestic fish and fish products inspection activity accounted for

about $14 million, or about 10 percent, of food field expenditures. The

objective of this activity was to ensure that domestic establishments

involved in the production, storage, and distribution of fish and fish

products are in compliance with the applicable hazard analysis and critical

control point regulations as well as with federal law. To attain this

objective, FDA conducted establishment inspections, and samples were

collected and analyzed when appropriate, with a priority on firms

processing scombrotoxic products, smoked products, vacuum packed

products, and ready-to-eat products, as well as follow-up on firms found to

be in noncompliance with hazard analysis and critical control point

regulations.

• The imported seafood products inspection activity accounted for about

$13 million, or about 9 percent, of food field expenditures. The objective of

this activity was to ensure a safe imported seafood supply by enforcing

importer compliance with the seafood hazard analysis and critical control

point regulation and federal law, focusing on importers of high-risk

products and firms found in noncompliance with the hazard analysis and

critical control point regulations. To attain this objective, trained

investigators reviewed importers’ written documentation demonstrating

that the product was produced under a hazard analysis and critical control

point program, with priority assigned to firms processing scombrotoxic

products, smoked products, vacuum packed products, and ready-to-eat

products.

• The domestic food safety activity accounted for about $11 million, or

about 7 percent, of food field expenditures. The objective of this activity

was to ensure that domestic establishments involved in the production,

storage and distribution of food products are in compliance with federal

law and that manufacturers produce products under good manufacturing

practices. To attain this objective, FDA conducted inspections (including

hazard analysis and critical control point) and investigations and
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 44 GAO-01-177 Food Safety Expenditures

necessary sample collections and analyses to document and support

inspection findings.

• The pesticides and chemicals in imported foods activity accounted for

about $7 million, or about 5 percent, of food field expenditures. The

objective of this activity was to determine the incidence and level of

pesticides and industrial chemicals in imported food (including seafood

and aquaculture products) and to prevent importation of products not

meeting federal requirements. To attain this objective, FDA developed

pesticide import sampling plans, collected samples, and analyzed samples

for chemical contamination.

Animal drugs and feeds field activity expenditures of about $13.7 million

and $13.5 million in fiscal years 1998 and 1999, respectively, accounted for

about 10 percent of FDA’s total food safety field expenditures each year.

Table 12 lists the fiscal years 1998 and 1999 animal feed and drug field

activity expenditures of $1 million or more. Other field activities, such as

criminal investigations, response to consumer complaints, and various

unplanned activities in aggregate, accounted for just over $3 million in

expenditures each year. The expenditure amounts reflect the total cost of

each activity, including inspection, investigation, field examination,

sample collection, sample analysis, and other costs, such as Office of

Regulatory Affairs management and administrative support expenditures,

associated with each activity. FDA agencywide support expenditures

accounted for about 8 percent of feed and drug field expenditures.
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 45 GAO-01-177 Food Safety Expenditures

Table 12: Animal Drugs and Feeds Field Activities Accounting for Over $1 Million in

Expenditures and Staff Years, Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

Animal drugs and feeds field activities 1998 1999 1998 1999

Medicated feeds $2,316 $2,081 27 24

Feed contaminants 2,222 2,380 26 28

Drug processing and new animal drug

inspection

1,974 1,605 23 19

Illegal residues in meat and poultry 1,412 1,793 17 21

Office of Regulatory Affairs/Center

directed research projects

1,207 1,213 14 14

Other field activities 3,418 3,338 31 31

Agencywide support 1,200 1,100 0 0

Totala $13,749 $13,510 138 137

a

Totals may not add because of rounding.

Source: FDA.

Five of the field activities listed in table 12 accounted for about $9 million,

or almost 70 percent, of total animal drugs and feeds field expenditures in

fiscal year 1999.

• The feed contaminants activity accounted for about $2.4 million, or about

18 percent, of expenditures. The objective of this activity is to monitor

domestic and imported animal feed and feed ingredients to prevent the

widespread contamination of the nation’s food supply. To attain this

objective, FDA conducts inspections and investigations and collects and

analyzes samples of feed and feed ingredients, including chemical and

microbiological testing for mycotoxins, pesticides, industrial chemicals,

metals, and microbiologicals.

• The medicated feeds activity accounted for about $2.1 million, or about 15

percent, of expenditures. The objective of this activity is to ensure the

marketing of safe and effective animal feeds. To attain this objective, FDA

conducts inspections of registered medicated feed establishments, collects

and analyzes feed samples, and audits the results of coordinated state

inspection efforts.

• The illegal residues in meat and poultry activity accounted for about $1.8

million, or about 13 percent, of expenditures. The objective of this activity

is to ensure a safe food supply by conducting follow-up investigations and

inspections when illegal residues are reported to FDA by the Food Safety
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 46 GAO-01-177 Food Safety Expenditures

and Inspection Service,1 and to initiate regulatory sanctions against those

persistently causing residues. To attain this objective, FDA works

cooperatively via memorandums of understanding with the Food Safety

and Inspection Service and the Environmental Protection Agency, as well

as through agreements or contracts with states to inspect first-time

violators.

• The drug processing and new animal drug inspection activity accounted

for about $1.6 million, or about 12 percent, of expenditures. The objective

of this activity is to fulfill FDA’s obligation to inspect animal drug

establishments that are registered with FDA, ensuring that animal drug

products are being manufactured, processed, and controlled under

approved conditions. To attain this objective, FDA conducts inspections of

registered animal drug establishments and chemical and microbiological

examinations to ensure the sterility, purity, identity, and potency of the

drugs.

• Office of Regulatory Affairs/Center directed research projects accounted

for about $1.2 million, or about 9 percent, of expenditures. The objective

of this activity is to develop new and/or improved methodology in support

of regulatory analysis for animal drugs and feeds. To attain this objective,

FDA establishes research goals in its workplan; the research results are

distributed within FDA and/or published in the scientific literature.

CFSAN headquarters operations, which is responsible for FDA’s Foods

Program, accounted for expenditures of about $86 million and $96 million

in fiscal years 1998 and 1999, respectively, or about 34 percent of total

agency food safety expenditures. As shown in table 13, CFSAN’s fiscal

years 1998 and 1999 headquarters activities were divided into four major

categories: premarket, postmarket, crosscutting, and FDA agencywide

support expenditures. CFSAN expenditures for management and

administrative support of food safety activities are included in the

expenditure amount for each activity.

 1

The Food Safety and Inspection Service obtains samples when it fulfills its food safety

responsibilities for meat and poultry.

Center for Food Safety and

Applied Nutrition

Headquarters Food Safety

Activities
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 47 GAO-01-177 Food Safety Expenditures

Table 13: CFSAN Headquarters Activities, Expenditures, and Staff Years, Fiscal

Years 1998 and 1999

Dollars in thousands

Expenditures Staff years

CFSAN headquarters activity 1998 1999 1998 1999

Premarket activities

Food and color additives $6,788 $9,062 75 73

Infant formula and medical foods 1,090 1,246 13 13

Premarket subtotal 7,878 10,308 88 86

Postmarket activities

Planning and policy implementation for

microbial contaminants

3,882 6,726 14 13

Federal/state cooperative programs 2,906 3,537 32 35

Planning and policy implementation for

monitoring imports

1,177 1,184 14 13

Seafood safety (hazard analysis and

critical control point)

1,177 1,511 3 3

Hazard analysis and critical control point

(other than seafood)

931 1,288 7 11

Low-acid canned foods 672 637 8 7

Nutrition monitoring 589 546 4 6

Planning and policy implementation for

chemical and other contaminants

447 346 3 3

Recalls, outbreak investigations and

tracebacks

336 546 4 6

Planning and policy implementation for

pesticide residue monitoring

302 488 2 4

Food labeling 255 157 0 0

Adverse event reporting 84 91 1 1

Postmarket subtotal 12,758 17,057 92 102

Crosscutting activities (pre- and

postmarket)

Food safety research/risk assessment

(intramural)

32,112 32,343 336 310

Regulatory policy development 9,887 9,845 114 106

Education/outreach 6,719 7,560 71 76

Collaborative research with

academia/industry

6,465 7,699 7 11

International activities 2,492 3,166 25 31

Crosscutting subtotala 57,675 60,613 553 534

Agencywide support 7,400 7,600 0 0

Totalb $85,711 $95,578 733 721

a

According to FDA officials, crosscutting activity staff provide significant support to certain premarket

and postmarket activities; for example, the seafood safety (hazard analysis and critical control point)

activity receives support of approximately 30 staff years from various crosscutting activities.

b

Totals may not add because of rounding.
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 48 GAO-01-177 Food Safety Expenditures

Source: FDA.

Premarket activities to evaluate the safety of products before they are

available to consumers accounted for about 11 percent of CFSAN’s

headquarters expenditures in fiscal year 1999. Food and color additive

activity expenditures accounted for about $9 million, or nearly 90 percent,

of premarket expenditures. In addition to its ongoing review of food

additive petitions, CFSAN implemented procedures to expedite the review

of food additives intended to decrease the incidence of foodborne illness

through their antimicrobial actions against pathogens that may be present

in food. Other activities addressed food contact substances and irradiation

labeling.

Postmarket activities to evaluate the safety of products that are in the

marketplace accounted for about 18 percent of CFSAN’s headquarters

expenditures in fiscal year 1999. CFSAN’s planning and policy

implementation for microbial contaminants, which accounted for $6.7

million, or 39 percent, of postmarket expenditures, included surveillance

to assess antimicrobial resistance, microbiological research, and risk

assessment to develop science-based solutions to detect and control

microbial contamination. Another $3.5 million, or 21 percent, of

postmarket expenditures, were for cooperative programs with states

addressing the safety of retail dairy and shellfish products.

Crosscutting activities that address both premarket and postmarket food

safety issues accounted for about 63 percent of CFSAN’s headquarters

expenditures in fiscal year 1999. CFSAN’s food safety research and risk

assessment, which accounted for $32.3 million, or 53 percent of

crosscutting expenditures, included activities such as the completion of

draft risk assessments for Listeria, Vibrio parahaemolytics, and

methylmercury and food safety research in support of the National Food

Safety Initiative.

FDA agencywide support accounted for about 8 percent of CFSAN’s

headquarters expenditures in fiscal year 1999. These expenditures

represent CFSAN’s allocation for its share of central direction and

administrative services to ensure that FDA’s efforts are effectively

managed and that resources are put to the most efficient use. Functions

include agencywide policy, regulatory and legislative development,

scientific coordination, planning and evaluation, consumer

communication and public information, and management expertise and

coordination in financial management, personnel, contracts and grants

administration, and procurement.
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 49 GAO-01-177 Food Safety Expenditures

CVM headquarters operations, responsible for FDA’s Animal Drugs and

Feeds Program, accounted for about $26 million and $28 million in fiscal

years 1998 and 1999, respectively, or about 10 percent of total agency food

safety expenditures. As shown in table 14, for fiscal years 1998 and 1999,

CVM headquarters activities were divided into three major categories:

premarket, postmarket, and FDA agencywide support expenditures.2 CVM

expenditures for management and administrative support for food safety

activities are included in the total cost for each activity.

Table 14: CVM Headquarters Activities, Expenditures, and Staff Years, Fiscal Years

1998 and 1999

Dollars in thousands

Expenditures Staff years

CVM headquarters activities 1998 1999 1998 1999

Premarket activities

Application review $8,097 $8,310 82 78

Intramural research 3,257 3,344 25 26

Education/outreach 691 710 9 10

Risk assessment 0 450 0 3

Premarket subtotal 12,045 12,814 116 117

Postmarket activities

Epidemiology systems and surveillance 4,670 4,360 44 42

Intramural research 3,595 3,849 25 27

Compliance activities 1,400 2,000 15 16

Extramural research 1,100 971 2 2

Education and outreach 876 1,490 2 2

Postmarket subtotal 11,641 12,670 88 89

Agencywide support 2,200 2,200 0 0

Totala $25,886 $27,684 203 206

a

Totals may not add because of rounding.

Source: FDA.

Premarket activities to ensure that products are safe before they are

available to consumers, accounted for about 46 percent of expenditures

each year. CVM’s New Animal Drug Application review and approval

process, including associated education, research and risk assessment

activities, accounted for $12.8, or 100 percent, of its premarket

expenditures. CVM is implementing a phased review process, which will

provide drug application sponsors with more timely feedback and early

 2

Differing from CFSAN, CVM did not identify crosscutting activities as a category.

Center for Veterinary

Medicine Headquarters

Food Safety Activities
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 50 GAO-01-177 Food Safety Expenditures

detection of application deficiencies. CVM approved 523 original or

supplemental new and generic animal drug applications in fiscal year 1999.

Postmarket activities to ensure the safety of products that are in the

marketplace accounted for about 46 percent of expenditures each year.

CVM’s epidemiological systems and surveillance activities, which

accounted for nearly $4.4 million, or about 34 percent, of postmarket

expenditures, included collaborative efforts with other federal agencies to

monitor nationwide changes in susceptibilities to 17 antimicrobial drugs

through the National Antimicrobial Resistance Monitoring System and

efforts to monitor and reduce drug residues in meats. Intramural research

to detect microbial and chemical contaminants that may be present in

animal feeds and animal food products consumed by humans and research

on antibiotic resistance accounted for another $3.6 million, or 30 percent,

of postmarket expenditures. This included the development and validation

of a test for detecting bovine protein in animal feeds, an important

component of its Bovine Spongiform Encephalopathy regulatory strategy.

Agencywide support accounted for about 8 percent of expenditures. These

expenditures represent CVM’s share of central direction and

administrative services, as previously described for CFSAN. These

expenditures represent CVM’s allocation for its share of central direction

and administrative services to ensure that FDA’s efforts are effectively

managed and that resources are put to the most efficient use.

NCTR, FDA’s center for peer-reviewed scientific research upon which the

agency bases its regulatory decisions, was responsible for no more than 1

percent of agency food safety expenditures. In fiscal year 1998, NCTR

expended $842,000, including $75,000 from CVM, and 5 staff years on eight

food safety research projects. In fiscal year 1999, NCTR expended nearly

$1.5 million and 10 staff years on 10 research projects, including $500,000

to expand food safety method development research.3 The annual

 3

NCTR also conducted food safety research funded through an interagency agreement with

the National Institute of Environmental Health and Safety at a total cost of $8.4 million in

fiscal years 1998 and 1999.

National Center for

Toxicological Research

Headquarters Food Safety

Activities
Appendix III: The Food and Drug

Administration’s Fiscal Year 1998 and 1999

Food Safety Expenditures

Page 51 GAO-01-177 Food Safety Expenditures

expenditures include about $100,000 for agencywide support. NCTR’s

expenditures do not include any field activities related to food safety.
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 52 GAO-01-177 Food Safety Expenditures

States (used hereafter to refer collectively to states, territories,

commonwealths, federated states, and the District of Columbia) play an

important role in overseeing the nation’s food supply. State and local (e.g.,

county and city) governments conduct the majority of inspections in the

United States, including food retailers, manufacturers, processors, and

distributors within their state boundaries in accordance with their own

laws and authorities.1

 State agriculture departments and health

departments are the two primary agencies that are responsible for food

safety in states. As shown in table 15, states devoted various amounts of

resources for activities to ensure the safety of foods under its jurisdiction

in fiscal years 1998 and 1999.

Table 15: Aggregate Agriculture and Health Department Food Safety Expenditures

and Staff Years by State, Fiscal Years 1998 and 1999

Expenditures Staff years

Statea

1998 1999 1998 1999

Alaska $4,446,800 $4,363,300 54 55

Alabama 11,270,784 11,833,244 126 130

Arkansas 4,382,183 4,508,055 83 81

American Somoab 255 2,884 16 18

Arizona 1,760,400 1,860,400 41 41

California 15,843,487 17,127,897 207 222

Coloradoc 1,110,519 1,093,953 16 16

Connecticut 679,881 788,866 39 39

District of Columbia 1,200,000 1,250,000 10 24

Delaware 1,251,645 1,243,527 34 34

Florida 17,716,712 17,325,231 349 327

Federated States of Micronesia 176,702 149,693 8 8

Georgia 12,408,865 12,495,507 242 233

Guam 896,034 877,331 42 43

Hawaii 2,684,000 2,684,000 73 73

Iowa 2,679,358 2,693,158 71 71

Idaho 1,349,000 1,397,000 20 21

Illinois 12,332,131 12,612,702 211 214

Indiana 5,808,034 5,553,450 163 164

Kansas 4,498,349 5,118,281 98 111

Kentucky 7,372,977 7,144,475 142 143

Louisiana 13,226,490 13,732,189 224 225

Massachusetts 2,141,935 2,181,490 33 33

 1

While local agencies such as county and city health departments also play an important

role in food safety, they were not included in the scope of this review.

Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 53 GAO-01-177 Food Safety Expenditures

Expenditures Staff years

Statea

1998 1999 1998 1999

Maryland 2,498,984 2,509,984 20 20

Maine 1,794,000 1,938,000 35 35

Michigan 9,342,206 9,782,912 130 133

Minnesotad 5,629,701 5,627,821 77 77

Missouri 640,000 840,000 18 23

Mississippi 5,243,890 5,265,155 83 81

Montana 1,425,193 1,517,160 28 28

North Carolina 13,833,657 14,041,171 271 271

North Dakota 862,000 862,000 13 13

Nebraska 1,813,456 1,851,698 21 21

New Hampshire 777,073 868,174 26 26

New Jersey 2,161,000 2,185,000 37 37

New Mexico 887,681 962,146 14 14

Nevada 410,055 493,465 9 11

New York 19,786,927 20,083,690 504 514

Ohio 14,022,939 14,535,872 254 252

Oklahoma 5,806,533 5,722,518 117 115

Oregon 5,015,442 5,811,711 60 65

Pennsylvania 7,540,000 8,040,000 136 136

Puerto Rico 4,986,990 4,900,810 133 180

Rhode Island 2,146,539 2,342,054 33 33

South Carolina 4,899,643 5,251,946 80 85

South Dakota 1,383,051 1,517,324 38 38

Tennessee 5,390,400 5,744,310 154 159

Texas 14,225,574 15,466,741 373 368

Utah 3,953,870 4,035,571 72 74

Virginia 5,777,810 6,125,182 107 107

Vermont 905,004 1,018,423 21 21

Washington 5,439,265 5,414,274 89 87

Wisconsin 14,538,824 14,440,247 249 254

West Virginia 2,481,000 2,537,000 90 90

Wyoming 1,081,824 1,100,694 25 25

Totale $291,937,072 $300,869,686 5,617 5,717

a

The territories of the Virgin Islands and the Commonwealth of the North Mariana Islands did not

respond to the survey.

b

The agriculture department of American Somoa did not respond to the survey. The American Somoa

Department of Health did not include staff salary and benefits in its reported expenditures.

c

The agriculture department of Colorado did not respond to the survey.

d

The health department of Minnesota did not respond to the survey.

e

Totals may not add because of rounding.

Source: GAO survey of states.
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 54 GAO-01-177 Food Safety Expenditures

State food safety responsibilities can be grouped into four categories that

cover a broad range of activities: licensing and inspection, response to

food safety problems, laboratory analysis, and training and technical

assistance. States reported a high degree of involvement in some activities

within each category and little involvement with others. For example:

• Regarding licensing and inspection activities, more than 40 states reported

that they were involved to a great or very great extent in registering and

licensing food producers, processors, sellers, and others and inspecting

dairy farms and dairy product plants. The number of states engaged in

inspection activities at other types of establishments such as meat and

poultry slaughter and processing plants, egg and egg product plants,

groceries and restaurants varied more widely. Forty-five states reported

that they engaged in little or no inspection activity at nondairy foodproducing farms.

• In response to food safety problems, 48 states reported a great or very

great involvement in activities to enforce food safety regulations, and 45

states reported a great or very great level of involvement in response to

natural disasters that effect food safety, such as tornadoes, hurricanes,

and floods.

• Regarding laboratory analysis, 41 states reported great or very great

involvement in analyzing food products for microbial contamination.

States were generally involved in laboratory analysis for pesticides and

chemical residues, filth, or food labeling accuracy to a lesser extent.

• Fifty-one states reported providing training and technical assistance to a

great or very great extent to staff employed by their own departments, and

more than half reported providing such assistance to grocery, restaurant,

and other retail food service workers to a great or very great extent. States

provided training and technical assistance to farmers, processors,

consumers, health professionals, and others to a lesser extent.

As shown in table 16, state expenditures reported for these categories of

activities, as well as administrative and support, other, and uncategorized

activities, were about $292 million in fiscal year 1998 and about $301

million in fiscal year 1999. In fiscal year 1999, federal funds accounted for

13 percent of state expenditures, other funding sources such as license

fees accounted for 18 percent, and state revenues funded the remaining 65

percent of these expenditures.1

 In aggregate, states dedicated 5,617 staff

 1

States did not categorize the source for about 4 percent of funds each year.

Food Safety

Activities, Funding,

Expenditures, and

Staffing
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 55 GAO-01-177 Food Safety Expenditures

years to food safety activities in fiscal year 1998 and 5,717 staff years in

fiscal year 1999.

Table 16: State Agriculture and Health Department Expenditures for Food Safety

Activity Categories, Fiscal Years 1998 and 1999

Dollars in thousands

Expenditures

 (percent of totals)

Staff years

 (percent of totals)

Activity Category 1998 1999 1998 1999

Licensing and inspections $142,163

(49)

$144,052

(48)

3,075

(55)

3,039

(53)

Response to problems 15,361

(5)

15,701

(5)

291

(5)

343

(6)

Laboratory analysis 32,871

(11)

34,070

(11)

472

(8)

467

(8)

Technical assistance and

training

14,596

(5)

17,484

(6)

322

(6)

371

(6)

Administration and support 31,896

(11)

32,944

(11)

664

(12)

681

(12)

Othera 4,642

(2)

4,978

(2)

38

(1)

37

(1)

Uncategorizedb 50,408

(17)

51,641

(17)

755

(13)

779

(14)

Totalc $291,937

(100)

$300,870

(100)

5,617

(100)

5,717

(100)

a “Other” includes expenditures for items such as committee or council activities, computers and other

equipment, and data base development.

b

“Uncategorized” represents food safety expenditures and staff years that were reported as a total

amount or pooled together for multiple categories.

c

Totals may not add because of rounding.

Source: GAO survey of states.

State expenditures for licensing and inspection food safety activities were

$142 million in fiscal year 1998 and $144 million in fiscal year 1999. As

shown in table 17, states reported over 1 million establishments under

their jurisdiction in fiscal years 1998 and 1999. This includes over 370,000

restaurants, about 300,000 groceries and other retail outlets, and about

90,000 dairy farms. States also reported their typical frequency of

inspection for each type of establishment, which ranged from continuous,

meaning that an inspector is onsite at all times during production, to once

per year. In total, states reported that they actually conducted about 2

million inspections annually, not counting continuous inspections.

Licensing and Inspection

Activities
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 56 GAO-01-177 Food Safety Expenditures

Table17: Number of Food Establishments Under State Inspection Jurisdiction and

Most Common Inspection Frequency, Fiscal Years 1998 and 1999

Establishments under state

inspection jurisdiction

Establishment 1998 1999

Most common

inspection frequencya

Dairy farms 91,797 88,316 Quarterly

Other food producing

farms

9,361 9,773 Otherb

Meat and poultry

slaughter plants

1,371 1,487 Continuous

Meat and poultry

processing plants

2,914 2,906 Daily

Fish and seafood

plants/farms

4,818 4,804 Annually

Shellfish operations 1,904 1,930 Quarterly

Dairy product plants 3,613 3,560 Quarterly

Eggs and egg product

plants

834 837 Quarterly

Plants/facilities that

process commercially

raised or wild game for

food

574 606 Annually

Other food processing

plants

42,522 42,901 Annually

Feed plants for food

producing animals

5,680 5,627 Annually

Groceries and other retail

outlets

302,746 307,429 Twice a year

Restaurants 371,740 379,046 Otherb

Institutions 47,637 50,365 Annually

Food packaging and

storage facilities

31,213 31,552 Annually

Food transport (e.g., vans

and tankers)

9,487 9,902 Otherb

Otherc 35,018 35,309 Annually

Uncategorizedd 98,284 98,774

Total 1,061,513 1,075,124

a

If two departments within a state reported different inspection frequencies for a category, the highest

frequency is reported in the table.

b

Some frequency other than continuous, daily, weekly, monthly, quarterly, twice a year, or annually.

c

“Other” includes establishments such as mobile food operations, daycare centers, youth camps, and

civic organizations.

d

“Uncategorized” represents food establishments under state jurisdiction that were reported as a total

amount or pooled together for multiple categories.

Source: GAO survey of states.
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 57 GAO-01-177 Food Safety Expenditures

As shown in table 18, states reported how much of their expenditures of

over $140 million annually for food safety licensing and inspection were

allocated to specific activities within the category. The activities that were

allocated a large amount of resources by states include inspections at

groceries and other retail outlets and restaurants.

Table 18: State Allocation of Resources to Food Safety Licensing and Inspection

Activities, Fiscal Years 1998 and 1999

Activity

Number of states

reporting resource

expenditures

Average (median)

amount of resources

reported by states for

each activity

(excluding “no

resources”)

a

Registration and licensing 54 Moderate

Inspection of:

Dairy farms 49 Moderate

Other food producing farms 29 Small

Meat and poultry slaughter plants 36 Moderate

Meat and poultry processing plants 37 Moderate

Fish and seafood plants/farms 41 Small

Shellfish operations 31 Small

Dairy and dairy product plants 52 Moderate

Egg and egg product plants 38 Small

Plants/facilities that process

commercially raised or wild game for

food

31 Small

Other food processing plants 48 Moderate

Feed plants for food-producing

animals

31 Moderate

Groceries and other retail outlets 53 Large

Restaurants 49 Large

Institutions 50 Moderate

Food packaging and storage facilities 52 Moderate

Food transport (e.g., vans and tankers) 51 Small

a

When two agencies within a state reported different amounts of resources expended, we used the

largest amount as the state response.

Source: GAO survey of states.

As shown in table 19, states reported how much of their total expenditures

of about $15 million annually to respond to food safety problems were

allocated to specific activities within the category. States allocated a

moderate amount of expenditures to enforcement of food safety

regulations and lesser amounts to other response activities.

Response to Problems
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 58 GAO-01-177 Food Safety Expenditures

Table 19: State Allocation of Expenditures in Response to Food Safety Problems,

Fiscal Years 1998 and 1999

Activity

Number of states

reporting resource

expenditures

Average (median) amount

of resources reported by

states for each activity

(excluding “no

resources”)

a

Tracebacks and other

investigations of outbreaks

54 Small

Activities related to recalls 53 Small

Responses to natural

disasters

52 Small

Enforcement activities 54 Moderate

a

When two agencies within a state reported different amounts of resources expended, we used the

largest amount as the state response.

Source: GAO survey of states.

As shown in table 20, states reported how much of their total expenditures

of more than $30 million annually for food safety laboratory analysis were

allocated to specific activities within the category. The activity that the

states most often allocated a large amount of expenditures was laboratory

analysis for microbial contamination.

Table 20: State Allocation of Expenditures for Food Safety Laboratory Analysis,

Fiscal Years 1998 and 1999

Food safety laboratory

analysis for:

Number of states

reporting resource

expenditures

Average (median) amount

of resources reported by

states for each activity

(excluding “no

resources”)

a

Microbial contamination 54 Large

Pesticides and other

chemicals

49 Moderate

Filth and or sanitation 51 Small

Food label accuracy 46 Small to Moderate

a

When two agencies within a state reported different amounts of resources expended, we used the

largest amount as the state response.

Source: GAO survey of states.

As shown in table 21, states reported how much of their annual

expenditures of about $15 million to $17 million for food safety technical

assistance and training were allocated to specific activities within the

Laboratory Analysis

Food Safety Technical

Assistance and Training
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 59 GAO-01-177 Food Safety Expenditures

category. The states allocated a large amount of expenditures to training

and technical assistance for staff employed by their own agriculture or

health department.

Table 21: State Allocation of Expenditures for Food Safety Training and Technical

Assistance, Fiscal Years 1998 and 1999

Food safety training and

technical assistance for:

Number of states

reporting resource

expenditures

Average (median) amount

of resources reported by

states for each activity

(excluding “no

resources”)

a

Farmers and producers 44 Small

Processors 51 Moderate

Grocery, restaurant, and

other retail foodservice

workers

53 Moderate

Institutional foodservice

workers

48 Moderate

Consumers 51 Small

Health professionals 45 Small

Industry inspectors 42 Small

Staff who are employed by

state departments of health

or agriculture

55 Large

Staff who are employed by

other state departments

46 Small

Staff who are employed by

community governments

47 Moderate

a

When two agencies within a state reported different amounts of resources expended, we used the

largest amount as the state response.

Source: GAO survey of states.

Although state departments of agriculture and health generally have

primary responsibility for overall food safety activities in each of the

states, other state departments and local governments also have

responsibility for such activities. According to the states we surveyed,

these other agencies generally had responsibilities for a specific type of

establishment, such as restaurants, jails or prisons, childcare facilities, and

nursing homes or for specific food products. For example, in the state of

Florida, restaurants are under the jurisdiction of the Department of

Business and Professional Regulations. And, in several states—Delaware,

Louisiana, Maine, Mississippi, New Jersey, New York, and Texas—seafood

or shellfish products are the responsibility of a state agency other than

agriculture or health.

Role of Other State

Agencies and Local

Governments
Appendix IV: States’ Fiscal Years 1998 and

1999 Food Safety Expenditures

Page 60 GAO-01-177 Food Safety Expenditures

States also reported that local governments have an extensive role in food

safety inspection activities at certain types of establishments such as

restaurants, institutions, groceries, and other retail locations. For example,

although Georgia’s health department has jurisdiction over almost 20,000

restaurants and institutions, county staff inspected all of those

establishments under contracts with the state. In some cases, state health

departments reported that local government inspections were conducted

primarily through state contracts or agreements. In a few cases, states

reported large expenditures by local governments. For example, the Idaho

Department of Health reported that most of the state’s expenditures for

food safety were made by local multicounty health districts, which spent

about $1 million on food safety in fiscal year 1999, while the state spent

about $650,000.
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 61 GAO-01-177 Food Safety Expenditures

Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 62 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 63 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 64 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 65 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 66 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 67 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 68 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 69 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 70 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 71 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 72 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 73 GAO-01-177 Food Safety Expenditures
Appendix V: Responses to GAO’s Survey of

State Agencies Responsible for Food Safety

Activities

Page 74 GAO-01-177 Food Safety Expenditures
Appendix VI: Comments from the Food Safety

and Inspection Service

Page 75 GAO-01-177 Food Safety Expenditures

Appendix VI: Comments from the Food

Safety and Inspection Service

Note: GAO’s comments

supplementing those in

the report text appear at

the end of this appendix.

See comment 3.

See comment 2.

See comment 1.
Appendix VI: Comments from the Food Safety

and Inspection Service

Page 76 GAO-01-177 Food Safety Expenditures

See comment 4.
Appendix VI: Comments from the Food Safety

and Inspection Service

Page 77 GAO-01-177 Food Safety Expenditures
Appendix VI: Comments from the Food Safety

and Inspection Service

Page 78 GAO-01-177 Food Safety Expenditures

1. The report clearly identifies FSIS’ responsibilities—i.e., ensuring that

meat, poultry, and processed egg products moving in interstate and

foreign commerce are safe, wholesome, and marked, labeled, and

packaged correctly. Regarding nonfood safety expenditures, FSIS

officials assured us during the review that the expenditure information

that they provided was for food safety or primarily food safety related

activities. As such, we believe the FSIS expenditures in this report are

sufficiently related to food safety to be appropriately characterized as

“food safety” expenditures.

2. We believe the report adequately describes the size and scope of FSIS

activities. For example, the report includes information on the number

of meat, poultry, egg product, and import establishments FSIS

oversees; the number of state and foreign programs it reviewed; and

the number and type of inspections it conducted. The level of detail

provided on FSIS’ responsibilities and activities is similar to that

provided on FDA activities.

3. It was not our intent to analyze or compare the relative risks of

products under the jurisdiction of FSIS and FDA. While the relative

risk of FSIS-regulated products may be greater in some cases than

FDA-regulated products, we believe that the data accurately reflect the

proportion of each agency’s expenditures and the proportion of

consumer expenditures for foods under each agency’s jurisdiction. The

report also clearly identifies the food products for which each agency

has responsibility.

4. We modified the report to clearly identify FSIS’ responsibilities under

the federal meat and poultry inspection acts and to describe its efforts,

with guidance from the courts, to realign the responsibilities and roles

of industry and federal inspectors.

GAO’s Comments
Appendix VII: Comments from the Food and

Drug Administration

Page 79 GAO-01-177 Food Safety Expenditures

Appendix VII: Comments from the Food and

Drug Administration

Note: GAO’s comments

supplementing those in

the report text appear at

the end of this appendix.
Appendix VII: Comments from the Food and

Drug Administration

Page 80 GAO-01-177 Food Safety Expenditures
Appendix VII: Comments from the Food and

Drug Administration

Page 81 GAO-01-177 Food Safety Expenditures

See comment 1.
Appendix VII: Comments from the Food and

Drug Administration

Page 82 GAO-01-177 Food Safety Expenditures

1. By design, the scope of this report was limited to FSIS and FDA food

safety activities and expenditures. However, the report recognizes that

12 federal agencies conduct food safety activities and cites our

testimony Food Safety: U.S. Needs a Single Agency to Administer a

Unified, Risk-Based, Inspection System (GAO/T-RCED-99-256, Aug. 4,

1999), which provides the fiscal year 1998 funding and staffing levels

for these federal agencies.

GAO’s Comments
Appendix VIII: GAO Contacts and Staff

Acknowledgements

Page 83 GAO-01-177 Food Safety Expenditures

Lawrence Dyckman (202) 512-3841

Keith Oleson (415) 904-2218

In addition to those named above, Brad Dobbins, Kathy Colgrove-Stone,

John Nicholson, and Carolyn Boyce made key contributions to this report.

Appendix VIII: GAO Contacts and Staff

Acknowledgements

GAO Contacts

Staff

Acknowledgements

(150172)

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