FOOD SAFETY

Overview of Food

Safety and Inspection

Service and Food and

Drug Administration

Expenditures

Statement of Lawrence J. Dyckman,

Director, Food and Agriculture Issues

Resources, Community, and Economic

Development Division

United States General Accounting Office

GAO Testimony

Before the Committee on Agriculture, Nutrition, and

Forestry, U.S. Senate

For Release on Delivery

Expected at

9:00 a.m. EDT

Wednesday

September 20, 2000

GAO/T-RCED-00-300
1 GAO/T-RCED-00-300 FSIS and FDA Expenditures

Mr. Chairman and Members of the Committee:

We are pleased to be here today to provide an overview of food safety expenditures by

the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS)

and the Department of Health and Human Service’s Food and Drug Administration

(FDA).1 As you know, FSIS and FDA are the two agencies with primary responsibility for

food safety in the United States. FSIS is responsible for ensuring that meat, poultry, and

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

and correctly marked, labeled and packaged. FDA is responsible for ensuring that (1) all

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

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

properly labeled, and produce no human health hazards when used in food-producing

animals.

As this Committee and Senator Hagel requested, we are conducting a review to

determine, for fiscal years 1998 and 1999, the amount of resources available to FSIS and

FDA for food safety activities, how these resources were expended by the agencies, and

how much the states, territories, and District of Columbia expended on food safety

activities. My testimony today presents an overview of the results of work to date on the

federal agencies’ expenditures. We cannot yet report on nonfederal expenditures

because our surveys of the states, territories, and the District of Columbia are still

ongoing.

In summary, FSIS and FDA in aggregate expended almost $1 billion in fiscal year 1998

and again in fiscal year 1999 on food safety activities. In fiscal year 1999, FSIS expended

about $712 million, of which 16 percent was for headquarters activities and 84 percent

for field activities associated with overseeing more than 6,000 meat, poultry, egg product

and import establishments. FDA expended about $260 million on food safety activities in

1

GAO has previously reported on food safety resources. See Food Safety: Opportunities to Redirect

Federal Resources and Funds Can Enhance Effectiveness (GAO/RCED-98-224, August 6, 1998).
2 GAO/T-RCED-00-300 FSIS and FDA Expenditures

fiscal year 1999, of which 44 percent was for headquarters activities and 56 percent for

field activities associated with overseeing an estimated 57,000 food establishments and

over 9,000 animal drug and feed establishments, and ensuring the safety of FDAregulated imported foods. We found similar expenditures for FSIS and FDA in fiscal year

1998.

Background

Foodborne illness in the United States is an extensive and expensive problem. The

Centers for Disease Control and Prevention estimates that unsafe foods cause as many

as 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths annually.2In terms of

medical costs and productivity losses, foodborne illnesses cost the nation between

$7 billion and $37 billion annually, according to USDA’s estimates.

According to the Centers for Disease Control and Prevention, 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 of illnesses were

associated with food products, such as meat and poultry, which fall under FSIS’

jurisdiction.

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 food supply.3FSIS has responsibility for ensuring the safety of meat,

2

Reported data on foodborne illnesses and related deaths are incomplete and may understate the extent of

the problem. The Centers for Disease Control uses reported illnesses, among other sources, to estimate

the extent of foodborne illnesses each year.

3

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 Tobacco, Alcohol 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-RCED99-256) for information on food safety agency roles and responsibilities.
3 GAO/T-RCED-00-300 FSIS and FDA Expenditures

poultry, and processed egg products.4Under the governing meat, poultry, and egg

products inspection acts, FSIS, in effect, preapproves products under its jurisdiction

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, such as those that run deboning and

canning operations, 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.

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. With regard to food safety,

FDA is responsible under the Federal Food, Drug, and Cosmetic Act for ensuring that

domestic and imported food products (except meat, poultry, and processed egg

products) are safe, wholesome, and properly labeled. In administering the act, which

generally follows the regulatory approach of allowing food products to enter the market

without preapproval, FDA inspects domestic establishments that manufacture, process,

pack or hold food, and inspects and tests imported food products. However, the act

does not mandate or specify inspection frequencies. As such, 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. 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 properly labeled, and produce no human

health hazards when used in food-producing animals.5

4

The meat act regulates meat from cattle, swine, goats, sheep, and equines (horses); the poultry act defines

poultry as domesticated fowl, which FSIS regulations define as chickens, turkeys, ducks, geese, and

guineas. Egg products are eggs removed from their shells for processing.

5

Both FDA and FSIS have implemented Hazard Analysis and Critical Control Point (HACCP) systems that

are designed to identify and control foodborne hazards that are likely to occur. In December 1997 FDA

required seafood establishments to implement HACCP and in January 1998 FSIS began requiring that meat

and poultry establishments implement HACCP.
4 GAO/T-RCED-00-300 FSIS and FDA Expenditures

States, territories, and the District of Columbia also have food safety responsibilities and

operate agencies that regulate and enforce their own food safety laws to ensure the

safety of foods produced, processed, and/or sold within their borders. These

responsibilities generally lie within the departments of agriculture and health, and may

involve others, such as state environmental protection agencies or county health

departments. States and territories may also perform inspections for FSIS or FDA under

contract or partnership agreements and report their inspection results to the federal

agencies.

FSIS’ Food Safety Expenditures

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

respectively, on food safety activities. 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 1, about 84 percent of FSIS’ fiscal year 1999 expenditures

were for field activities, and 16 percent were for headquarters office activities. Each

activity’s proportion of the total expenditures did not vary by more than 1 percent from

fiscal year 1998 through fiscal year 1999. (See app. I for detailed information on

expenditures, staff years, and activities for fiscal years 1998 and 1999.)
5 GAO/T-RCED-00-300 FSIS and FDA Expenditures

Figure 1: FSIS’ Expenditures for Field and Headquarters Activities, Fiscal Year 1999

1%

Administrator ($6.1)

•

9%

Management ($61.8)

•

4%

Public Health and Science ($25.2)

3%

Policy Program Development 

and Evaluation ($18.9)

11%

• Field Operations/Headquarters ($79.9) 

• 5%

Field Operations/District ($34.1)

68%

•

Field Operations/Plant 

Inspections ($486)

Headquarters

Field

Dollars in millions

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

In aggregate, FSIS’ field activities accounted for $600 million in fiscal year 1999, or 84

percent of total agency expenditures. Inspections at slaughter, processing, and import

establishments accounted for $486 million, or 68 percent, of total expenditures; and field

office administration, supervision and compliance activities accounted for
6 GAO/T-RCED-00-300 FSIS and FDA Expenditures

$34.1 million, or 5 percent of total expenditures. In addition, the Office of Field

Operations, the Washington D.C. headquarters office that manages field activities,

accounted for $79.9 million, or 11 percent of total expenditures. The largest expenditure

of the field operations office was for grants to states for inspection activities, accounting

for $44.4 million, or about 57 percent of its total expenditures in fiscal year 1999. This

office also funds the Technical Service Center, located in Omaha, Nebraska, which

serves as the agency’s center for technical assistance and guidance for field operations

personnel and industry and conducts reviews of domestic and foreign inspection

programs.

In aggregate, FSIS’ headquarters-based activities accounted for $112 million in fiscal year

1999, or 16 percent of total agency expenditures. FSIS’ headquarters food safety

activities are conducted by four offices—management; public health and science; policy,

program development, and evaluation; and the office of the administrator. Specifically:

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

expenditures. The management 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 Public Health and Science accounted for about $25.2 million, or 4

percent, of total expenditures. 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. Almost half or $16.6 million of

its expenditures were for laboratory analyses by the agency’s three field laboratories.

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

$18.9 million, or 3 percent, of total expenditures. The policy and program office is
7 GAO/T-RCED-00-300 FSIS and FDA Expenditures

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

recommending domestic and international policies for FSIS; reviewing product

process standards; labeling; and developing and evaluating inspection programs.

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

total expenditures. The office is responsible for management of agency activities

such as public affairs, food safety education, coordination of U.S. involvement in

international standard-setting for food safety, and maintaining liaison with trade

organizations.

FDA’s Food Safety Expenditures

FDA expended about $231 million and $260 million in fiscal years 1998 and 1999,

respectively, on food safety activities.6 These expenditures represent the combined

activities of the three FDA 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 for these

centers by the Office of Regulatory Affairs. As with FSIS, FDA’s 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 56 percent of FDA’s fiscal

year 1999 expenditures were for field activities, and about 44 percent were for

headquarters office activities. Each activity’s proportion of total expenditures did not

vary by more than 1 percent from fiscal year 1998 to 1999. (See app. II for detailed

information on fiscal year 1998 and 1999 expenditures, staff years, and activities.)

6 These figures exclude central agency support costs, which FDA is in the process of determining.
8 GAO/T-RCED-00-300 FSIS and FDA Expenditures

Figure 2: FDA’s Expenditures for Field and Headquarters Activities, Fiscal Year 1999

34% • Center for Food Safety and

Applied Nutrition ($88)

Less than 1%

National Center for Toxicological

Research ($.578)

51%•

Field Operations ORA/CFSAN ($133.6)

•

5%

Field Operations ORA/CVM ($12.4)

•10%

Center for Veterinary Medicine ($25.5)

Headquarters

Field

Dollars in millions

Legend:

ORA Office of Regulatory Affairs

CVM Center for Veterinary Medicine

CFSAN Center for Food Safety and Applied Nutrition

In aggregate, FDA’s field activities accounted for $146 million in fiscal year 1999, or 56

percent of total agency expenditures. FDA’s Office of Regulatory Affairs (ORA) is

responsible for 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. For fiscal year 1999, the ORAconducted field component of the Center for Food Safety and Applied Nutrition’s food
9 GAO/T-RCED-00-300 FSIS and FDA Expenditures

safety activities accounted for $133.6 million in expenditures and the ORA-conducted

field component of the Center for Veterinary Medicine’s food safety activities accounted

for $12.4 million in expenditures.

In aggregate, headquarters-based activities accounted for $114 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 headquarters component

accounted for $88 million in fiscal year 1999, or 34 percent of total expenditures. The

center operates FDA’s Foods Program, which is responsible for ensuring that FDAregulated food is safe, sanitary, wholesome, and honestly labeled. To achieve this

goal, the center implements programs that address specific food safety concerns,

such as food and color additives, infant formula, medical foods, and seafood. The

center also engages in regulatory policy development and education and outreach

activities, and manages federal/state cooperative programs. Food safety research and

risk assessment accounted for the center’s largest expenditures, about $32 million

each year.

• The Center for Veterinary Medicine’s headquarters component accounted for $25.5

million in fiscal year 1999, or 10 percent of total 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 headquarters expenditures, about $12.8

million.

• The National Center for Toxicological Research, located in Jefferson, Arkansas,

accounted for $578,000 in fiscal year 1999, or less than 1 percent of total

expenditures. The center’s mission is to conduct peer-reviewed scientific research
10 GAO/T-RCED-00-300 FSIS and FDA Expenditures

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 years 1998 and 1999, the center conducted research projects that contributed to

FDA’s food safety mission. It did not engage in field activities related to food safety.

----

Mr. Chairman, this completes our prepared statement. We would be happy to respond to

any questions you or Members of the Committee may have.

Contact and Acknowledgement

For future contacts regarding this testimony, please contact Lawrence J. Dyckman at

(202) 512-5138. Individuals making key contributions to this testimony were Keith

Oleson, Brad Dobbins, Kathy Colgrove-Stone, and John Nicholson.
Appendix I

11 GAO/T-RCED-00-300 FSIS and FDA Expenditures

Food Safety and Inspection Service’s Food Safety Expenditures and Staff Years,

Fiscal Years 1998 and 1999

For fiscal years 1998 and 1999, the Food Safety and Inspection Service (FSIS) expended

about $677.8 and $712 million, respectively, for its food safety activities. As shown in

table 1, 84 percent of the expenditures were for field office operation, compliance, and

inspection activities, while the remainder were expended for FSIS headquarters office

activities. Each activity’s proportion of the total expenditures did not vary by more than

1 percent between the 2 fiscal years.

Table 1: FSIS’ Expenditures and Staff Years for Food Safety Activities by Office, Fiscal Years 1998 and 1999

Dollars in millions

Office Expenditures (percent of total) Staff Years (percent of total)

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 Operations—

Headquarters

69.1 (10) 79.9 (11) 222 (2) 211 (2)

Field Operations—

subtotal

$567.9 (83) $600 (84) 10,184 (92) 10,058 (92)

Headquarters—

Management

62.7 (9) 61.8 (9) 406 (4) 382 (3)

Headquarters—

Public Health and

Science

23.9 (4) 25.2 (4) 254 (2) 281 (3)

Headquarters—

Policy, Program

Development and

Evaluation

18 (3) 18.9 (3) 149 (1) 162 (1)

Headquarters—

Administrator

5.3 (1) 6.1 (1) 64 (1) 68 (1)

Headquarters

Operations—

Subtotal

$109.9 (17) $112 (16) 873 (8) 893 (8)

Totala$677.8 (100) $712 (100) 11,057 (100) 10,951 (100)

a:Totals may not add because of rounding.
Appendix I

12 GAO/T-RCED-00-300 FSIS and FDA Expenditures

FSIS’ field activities include inspections of establishments under the agency’s

jurisdiction and compliance work to ensure that the establishments are following

applicable regulations. Table 2 presents selected results from FSIS’ inspection and

compliance field work.

Table 2: Number of Establishments Inspected by FSIS and Selected Compliance Activities, Fiscal Years 1998

and 1999

Activity 1998 1999

Inspections

Slaughter establishments 254 262

Processing establishments 4,297 4,343

Combination slaughter and

processing establishments

985 968

State agreementsa256 254

Import establishments 135 129

Egg product establishments 78 75

Total establishments inspected 6,005 6,031

Compliance activities

Compliance reviews 26,176 43,976

Warnings issued 1,520 2,778

Suspensions for Hazard Analysis

and Critical Control Point violations

77 118

a

Funded through FSIS’ headquarters Office of Field Operations at a cost of $40.6 million and $44.4 million in fiscal

years 1998 and 1999, respectively.
Appendix II

13 GAO/T-RCED-00-300 FSIS and FDA Expenditures

Food and Drug Administration’s Food Safety Expenditures and Staff Years,

Fiscal Years 1998 and 1999

For fiscal years 1998 and 1999, the Food and Drug Administration (FDA) expended about

$231.3 and $260 million, respectively, for its food safety activities. As shown in table 3,

about 56 percent of the expenditures were for field office operation, compliance and

inspection activities, while the remainder were expended for FDA headquarters office

activities. Each activity’s proportion of the total expenditures did not vary by more than

1 percent between the 2 fiscal years 1998 to 1999.

Table 3: FDA’s Fiscal Year 1998 and 1999 Expenditures and Staff Years for Food Safety Activities by Center,

Fiscal Years 1998 and 1999

Dollars in millions

Center Expenditures (percent of total) Staff Years (percent of total)

1998 1999 1998 1999

Field Operations—

Office of Regulatory

Affairs/ Center for

Food Safety and

Applied Nutrition

$116.2 (50) $133.6 (51) 1,426 (57) 1,535 (59)

Field Operations—

Office of Regulatory

Affairs/Center for

Veterinary Medicine

12.5(5) 12.4 (5) 138 (5) 137 (5)

Field Operations—

Subtotal

128.7 (56) 146 (56) 1,564 (62) 1,672 (64)

Headquarters

Operations—Center

for Food Safety and

Applied Nutrition

78.3 (34) 88 (34) 733 (29) 721 (28)

Headquarters

Operations - Center

for Veterinary

Medicine

23.7 (10) 25.5 (10) 203 (8) 206 (8)

Headquarters

Operations—

National Center for

Toxicological

Research

.6 (<1) .6 (<1) 4 (<1) 4 (<1)

Headquarters

Operations—

Subtotal

$102.6 (44) $114 (44) 940 (38) 931 (36)

Totala$231.3 (100) $260 (100) 2,503 (100) 2,603 (100)

a:Totals may not add because of rounding.
Appendix II

14 GAO/T-RCED-00-300 FSIS and FDA Expenditures

FDA’s field activities include inspections of establishments under the agency’s

jurisdiction and analysis of product samples to ensure that the products are in

compliance with applicable regulations. Table 4 presents selected results from FDA’s

inspection and sample analysis field work.

Table 4: Selected FDA Food Safety Inspection and Sample Analysis Activity, Fiscal Years 1998 and 1999

Activity 1998 1999

Inspections

Food importers 940 765

Domestic food establishmentsa11,922 14,680

Feed establishmentsb4,182 3,128

Total inspectionsc17,044 18,573

Sample Analysis

Domestic food samples 10,894 9,335

Import food samples 16,802 15,439

Feed samples 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 in a year.

(150296)
Orders by Internet

For information on how to access GAO reports on the Internet, send an e-mail message

with “info” in the body to

info@www.gao.gov

or visit GAO’s World Wide Web home page at

http://www.gao.gov

To Report Fraud, Waste, and Abuse

in Federal Programs

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

E-mail: fraudnet@gao.gov

Automated answering system: 1-800-424-5454