Testimony

Before the Subcommittee on Oversight of

Government Management, Restructuring

and the District of Columbia, Committee

on Governmental Affairs, U.S. Senate

United States General Accounting Office

GAO

For Release on Delivery

Expected at 10:00 a.m. EDT

Wednesday, October 10, 2001 FOOD SAFETY AND

SECURITY

Fundamental Changes

Needed to Ensure Safe

Food

Statement of Robert A. Robinson, Managing Director,

Natural Resources and Environment

GAO-02-47T
Page 1 GAO-02-47T Food Safety and Security

Mr. Chairman and Members of the Subcommittee:

We are pleased to be here today to discuss the federal food safety system

and whether the system’s current design can meet the food safety

challenges of today. While the food supply is generally safe, each year tens

of millions of Americans become ill and thousands die from eating unsafe

foods, according to the Centers for Disease Control and Prevention (CDC).

As we have stated in previous reports and testimonies, fundamental

changes are needed to ensure a safer food supply. My testimony today

provides an overview of the nation’s fragmented food safety system, the

problems that it causes, and the changes necessary to create lasting

improvements. In addition, I want to bring to your attention some work

GAO has done addressing deliberate food contamination and federal

research on and preparedness for bioterrorism in light of the tragic events

of September 11, 2001.

In summary, the current food safety system is a patchwork structure that

hampers efforts to adequately address existing and emerging food safety

risks, whether those risks involve inadvertent or deliberate contamination.

The current system is not the product of a comprehensive planning

process; rather, it was cobbled together over many years to address

specific health threats from particular food products. The resulting

fragmented organizational and legal structure causes inefficient use of

resources, inconsistent oversight and enforcement, and ineffective

coordination, which together hamper federal efforts to comprehensively

address food safety concerns. Many states modeled their organizational

structure for food safety on the federal system and thus face the same

issues.

It is now widely recognized that food safety issues must be addressed

comprehensively—that is, by preventing contamination through the entire

food production cycle, from farm to table. A single, food safety agency

responsible for administering a uniform set of laws is needed to resolve

the long-standing problems with the current system; deal with emerging

food safety issues, such as the safety of genetically modified foods or

deliberate acts of contamination; and ensure a safe food supply. While we

believe that an independent agency could offer the most effective

approach, we recognize that there are short-term costs and other

considerations associated with setting up a new government agency. A

second option would be to consolidate food safety activities in an existing

department, such as the U.S. Department of Agriculture (USDA) or the

Department of Health and Human Service (HHS). Regardless, however,

choosing an organizational structure only represents half the job. For any
Page 2 GAO-02-47T Food Safety and Security

single food safety agency to be ultimately successful, it will also be

necessary to rationalize the current patchwork of food safety legislation to

make it uniform and risk-based.

Despite spending more than $1 billion annually on the federal food safety

system, food safety remains a concern. For example, between May and

November 2000, sliced and packaged turkey meat contaminated with

Listeria monocytogenes caused 29 individuals in 10 states to become ill. In

April and May of this year, imported cantaloupes contaminated with a

pathogenic strain of Salmonella were linked to 54 illnesses and 2 deaths in

16 states, and in June six people in California were sickened, two of whom

died, from eating oysters contaminated with Vibrio vulnificus. CDC

estimates that foodborne diseases cause approximately 76 million

illnesses, 325,000 hospitalizations, and 5,000 deaths each year. In medical

costs and productivity losses, foodborne illnesses related to five principal

pathogens cost the nation about $6.9 billion annually, USDA estimates.1

Twelve different agencies administer as many as 35 laws that make up the

federal food safety system. Two agencies account for most federal food

safety spending and regulatory responsibilities: the Food Safety and

Inspection Service (FSIS), in USDA, is responsible for the safety of meat,

poultry, and processed eggs, while the Food and Drug Administration

(FDA), in HHS, is responsible for the safety of most other foods. Other

agencies with food safety responsibilities and/or programs include HHS’

Centers for Disease Control and Prevention; USDA’s Agricultural

Marketing Service (AMS), Animal and Plant Health Inspection Service

(APHIS), Agricultural Research Service (ARS), and Grain Inspection,

Packers and Stockyards Administration (GIPSA); the Department of

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

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

Firearms; the Environmental Protection Agency (EPA); and the Federal

Trade Commission. Appendix I describes the food safety roles and

responsibilities of these 12 agencies and shows each agency’s food safety

funding and staffing level for fiscal year 2000.

State and local governments also conduct inspection and regulation

activities that help ensure the safety of foods produced, processed, or sold

 1

The five principal pathogens are Campylobacter spp., Salmonella (nontyphoidal), E. coli

O157:H7, E. coli non-O157 STEC, and Listeria monocytogenes.

Background
Page 3 GAO-02-47T Food Safety and Security

within their borders. State and local governments would generally be the

first to identify and respond to deliberate acts of food contamination.

During the past 25 years, we and other organizations, such as the National

Academy of Sciences, have issued reports detailing problems with the

federal food safety system and have made numerous recommendations for

change. While many of these recommendations have been acted upon,

food safety problems persist, largely because food safety responsibilities

are still divided among several agencies that continue to operate under

different regulatory approaches.

The federal regulatory system for food safety did not emerge from a

comprehensive design but rather evolved piecemeal, typically in response

to particular health threats or economic crises. Addressing one new worry

after another, legislators amended old laws and enacted new ones. The

resulting organizational and legal patchwork has given responsibility for

specific food commodities to different agencies and provided them with

significantly different regulatory authorities and responsibilities.

The number of agencies involved in regulating a sandwich illustrates the

fragmented nature of the current food safety system. Figure 1 shows the

federal responsibilities for regulating production and processing of a

packaged ham and cheese sandwich and its ingredients. The responsible

regulatory agency as well as the frequency with which inspections occur

depends on how the sandwich is presented. FSIS inspects manufacturers

of packaged open-face meat or poultry sandwiches (e.g., those with one

slice of bread), but FDA inspects manufacturers of packaged closed-face

meat or poultry sandwiches (e.g., those with two slices of bread).

According to FSIS officials, the agency lacked the resources to inspect all

meat and poultry sandwich manufacturers, so it was decided that FSIS

would inspect manufacturers of the less common open-face sandwich,

leaving inspection of other sandwich manufacturers to FDA. Although

there are no differences in the risks posed by these products, wholesale

manufacturers of open-face sandwiches sold in interstate commerce are

inspected by FSIS daily, while wholesale manufacturers of closed-face

sandwiches sold in interstate commerce are generally inspected by FDA

on average once every 5 years. (See app. II for a list of other food products

with similar risks that have different inspection frequencies because they

are regulated by different agencies.)

Fragmented System

Hampers the

Effectiveness of Food

Safety Efforts
Page 4 GAO-02-47T Food Safety and Security

Figure 1: Federal Agencies Responsible for Safety of Packaged Ham and Cheese

Sandwich

Because the nation’s food safety system evolved piecemeal over time, the

nation has essentially two very different approaches to food safety—one at

USDA and the other at FDA—that have led to inefficient use of resources

and inconsistencies in oversight and enforcement. These problems, along

with ineffective coordination between the agencies, have hampered and

continue to impede efforts to address public health concerns associated

with existing and emerging food safety risks. The following examples

represent some of the problems we identified during our reviews of the

nation’s food safety system.

• Federal food safety expenditures are based on legal requirements,

not on risk. As shown in figure 2, funding for ensuring the safety of

products is disproportionate to the level of consumption of those products

because the frequency of inspection is based not on risk but on the

agencies’ legal authority and regulatory approach. Likewise, funding for

ensuring the safety of products is disproportionate to the percentage of

foodborne illnesses linked to those products. For example, to ensure the

safety of meat, poultry, and processed egg products in fiscal year 1999,
Page 5 GAO-02-47T Food Safety and Security

FSIS spent about $712 million to, among other things, inspect more than

6,000 meat, poultry, and egg product establishments and conduct product

inspections at 130 import establishments. FSIS’ expenditures reflect its

interpretation of federal law as requiring daily inspection of meat and

poultry processing plants and its traditional implementation of its

statutory inspection mandate through continuous government inspection

of every egg products plant and every meat and poultry slaughter plant,

including the examination of every carcass slaughtered. These plants

account for about 20 percent of federally regulated foods and 15 percent

of reported foodborne illnesses. In comparison, FDA, which has

responsibility for all foods except meat, poultry, and processed egg

products and has no mandated inspection frequencies, spent about

$283 million to, among other things, oversee some 57,000 food

establishments and 3.7 million imported food entries. These

establishments and entries account for about 80 percent of federally

regulated foods and 85 percent of reported foodborne illnesses.2

Figure 2: FSIS’ and FDA’s Food Safety Expenditures and Consumers’ Annual Food

Expenditures by Agency Jurisdiction

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

Bureau of Labor Statistics data.

 2

Food Safety: Overview of Federal and State Expenditures (GAO-01-177, Feb. 20, 2001)

and Food Safety: Overview of Food Safety and Inspection Service and Food and Drug

Administration Expenditures (GAO/T-RCED-00-300, Sept. 20, 2000).
Page 6 GAO-02-47T Food Safety and Security

• Federal agencies’ authorities to enforce food safety requirements

differ. USDA agencies have the authority to (1) require food firms to

register so that they can be inspected, (2) presume that food firms are

involved in interstate commerce and thereby be subject to federal

regulation, (3) prohibit the use of processing equipment that may

potentially contaminate food products, and (4) temporarily detain any

suspect foods. Conversely, FDA lacks such authority and is often hindered

in its food oversight efforts. For example, both USDA and FDA oversee

recalls when foods they regulate are found to be contaminated or

adulterated.3

 However, if a USDA-regulated company does not voluntarily

conduct the recall, USDA can detain the product for up to 20 days while it

seeks a court order to seize the food. Because FDA does not have

detention authority, it cannot ensure that tainted food is kept out of

commerce while it seeks a court-ordered seizure. As another example,

while FDA is responsible for overseeing all seafood-processing firms

operating in interstate commerce, the agency does not have an effective

system to identify the firms subject to regulation because there is no

registration requirement for seafood firms, and it cannot assume that

seafood firms operate in interstate commerce. As a result, some firms may

not be subjected to FDA oversight, thus increasing the risk of consumers’

contracting a foodborne illness from unsafe seafood.4

• USDA and FDA implementation of the new food safety approach is

inconsistent. Since December 1997, both USDA and FDA have

implemented a new science-based regulatory approach—the Hazard

Analysis and Critical Control Point (HACCP) system—for ensuring the

safety of meat, poultry, and seafood.5

 The HACCP system places the

primary responsibility on industry, not government inspectors, for

identifying and controlling hazards in the production process. However, as

we discussed in previous reports,6

 FDA and USDA implemented the

HACCP system differently. While USDA reported that in 1999, 96 percent

of federally regulated plants were in compliance with the basic HACCP

 3 Food Safety: Actions Needed by USDA and FDA to Ensure That Companies Promptly

Carry Out Recalls (GAO/RCED-00-195, Aug. 17, 2000).

4

Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect Consumers

(GAO-01-204, Jan. 31, 2001).

5

 In January 2001, FDA finalized regulations requiring HACCP for fruit and vegetable juices.

6

Meat and Poultry: Improved Oversight and Training Will Strengthen New Food Safety

System (GAO/RCED-00-16, Dec. 8, 1999) and Food Safety: Federal Oversight of Seafood

Does Not Sufficiently Protect Consumers (GAO-01-204, Jan. 31, 2001).
Page 7 GAO-02-47T Food Safety and Security

requirements for meat and poultry, FDA reported that less than half of

federally regulated seafood firms were in compliance with HACCP

requirements. In addition, while USDA collects data on Salmonella

contamination to assess the effectiveness of its HACCP system for meat

and poultry, FDA does not have similar data for seafood. Without more

effective compliance programs and adequate performance data, the

benefits of HACCP will not be fully realized.

• Oversight of imported food is inconsistent and unreliable. As we

reported in 1998, the meat and poultry acts require that, before a country

can export meat and poultry to the United States, FSIS must make a

determination that the exporting country’s food safety system provides a

level of safety equivalent to the U.S. system.7

 Under the equivalency

requirement, FSIS has shifted most of the responsibility for ensuring

product safety to the exporting country. The exporting country performs

the primary inspection, allowing FSIS to leverage its resources by focusing

its reviews on verifying the efficacy of the exporting countries’ systems. In

addition, until FSIS approves release of imported meat and poultry

products into U.S. commerce, they generally must be kept in an FSISregistered warehouse. In contrast, FDA lacks the legal authority to require

that countries exporting foods to the United States have food safety

systems that provide a level of safety equivalent to ours. Without such

authority, FDA must rely primarily on its port-of-entry inspections to

detect and bar the entry of unsafe imported foods. Such an approach has

been widely discredited as resource-intensive and ineffective. In fiscal year

2000, FDA inspections covered about 1 percent of the imported food

entries under its jurisdiction. In addition, FDA does not control imported

foods or require that they be kept in a registered warehouse prior to FDA

approval for release into U.S. commerce. As a result, some adulterated

imports that were ultimately refused entry by FDA had already been

released into U.S. commerce. For example, in 1998 we reported that in a

U.S. Customs Service operation called “Bad Apple,” about 40 percent of

the imported foods FDA checked and found in violation of U.S. standards

were never redelivered to Customs for disposition. These foods were not

destroyed or reexported as required and presumably were released into

U.S. commerce.

 7 Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent

and Unreliable (GAO/RCED-98-103, Apr. 30, 1998).
Page 8 GAO-02-47T Food Safety and Security

• Claims of health benefits for foods may be treated inconsistently

by different federal agencies. Because three federal agencies are

charged with enforcing different statutes, a product’s claim of health

benefits might be denied by one agency but allowed by another.8

 FDA, the

Federal Trade Commission, and USDA share responsibility for

determining which claims regarding health benefits are allowed in labeling

and advertising of foods and dietary supplements. FDA has authorized

only a limited number of specific health claims for use on product labels.

However, the Federal Trade Commission may allow a health claim in an

advertisement as long as it meets the requirements of the Federal Trade

Commission Act, even if FDA has not approved it for use on a label.

Furthermore, USDA has not issued regulations to adopt any of the FDAapproved health claims for use on the products that it regulates, such as

pot pies, soups, or prepared meals containing over a certain percentage of

meat or poultry. Rather, USDA reviews requests to use a health claim,

including those approved by FDA, on a case-by-case basis.

• Effective enforcement of limits on certain drugs in food-producing

animals is hindered by the regulatory system’s fragmented

organizational structure. FDA has regulatory responsibility for

enforcing animal-drug residue levels in food producing animals. However,

FDA in conjunction with the states have only investigated between 43 and

50 percent of each year’s USDA animal-drug residue referrals made

between fiscal year 1996 and 2000. According to FDA officials, the agency

lacks the resources to conduct prompt follow-up investigations and does

not have an adequate referral assignment and tracking system to ensure

that investigations are made in a timely manner. FDA has relied on the

states, through contracts and cooperative agreements, to conduct the bulk

of the investigations. FDA only has resources to investigate repeat

violators. As a result, animal producers not investigated may continue to

use animal drugs improperly putting consumer health at greater risk.

In the absence of a unified food safety system, federal agencies have

attempted to coordinate their efforts to overcome fragmentation and avoid

duplication or gaps in coverage. While we believe that interagency

coordination is important and should be continued, history has shown that

such efforts are difficult to conduct successfully. The following examples

represent some of the coordination problems we have found.

 8 Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements

and “Functional Foods” (GAO/RCED-00-156, July 11, 2000).
Page 9 GAO-02-47T Food Safety and Security

• Fragmented organizational structure poses challenges to U.S.

efforts to address barriers to agricultural trade. The organizational

structure for food safety complicates U.S. efforts to address foreign

sanitary and phytosanitary (SPS) measures. SPS measures are designed to

protect humans, animals, or the territory of a country from the spread of a

pest or disease, among other things. However, the U.S. Trade

Representative and USDA are concerned that some foreign SPS measures

may be inconsistent with international trade rules and may unfairly

impede the flow of agricultural trade. In 1997, we reported that the federal

structure for addressing foreign SPS measures was complex because 12

federal agencies had some responsibility for addressing problems related

to SPS measures and that no one agency was directing federal efforts.9

 We

found, among other things, that the involvement of multiple agencies with

conflicting viewpoints made it difficult to evaluate, prioritize, and develop

unified approaches to address such measures. While, the U.S. Trade

Representative and USDA took some actions to respond to our report,

including establishing mechanisms to improve interagency coordination

and decision-making, it remains to be seen whether such actions will

effectively address the coordination problems over the long run.

• Different statutory responsibilities may limit the ability of

agencies to coordinate successfully. As we reported in August 1998,

because FDA and FSIS have different statutory responsibilities, important

information about animal feed contaminated with dioxin (a suspected

carcinogen) and animals that had consumed this feed was not effectively

communicated to the food industry.10 FDA and FSIS worked together to

decide on the preferred course of action for handling the contaminated

feed and animals, and each agency was responsible for communicating its

decisions to producers or processors under its jurisdiction. However, the

agencies did not necessarily communicate all required actions to all

affected parties. For example, when officials from FDA, the agency

responsible for regulating animal feed, met with meat and poultry

producers, their primary concern was with the contaminated feed, not

with the animals that had consumed it. Thus, they did not necessarily tell

these producers about the actions they should take for their affected

animals. FSIS, the agency responsible for regulating meat and poultry

 9

Agricultural Exports: U.S. Needs a More Integrated Approach to Address

Sanitary/Phytosanitary Issues (GAO/NSIAD-98-32, Dec. 11, 1997)

10Food Safety: Agencies’ Handling of a Dioxin Incident Caused Hardships for Some

Producers and Processors (GAO/RCED-98-104, Apr. 10, 1998).
Page 10 GAO-02-47T Food Safety and Security

processors, sent word of dioxin-testing requirements to the processors and

trade associations but did not notify meat and poultry producers, over

which it has no jurisdiction.

• The need for extensive coordination may impede prompt resolution

of food safety problems. Despite FSIS’ and FDA’s efforts to coordinate

their efforts on egg safety, more than 10 years have past since the problem

of bacterial contamination of intact shell eggs was first identified and a

comprehensive safety strategy has yet to be implemented. In 1988, for the

first time, some intact shell eggs were discovered to be contaminated

internally with the pathogenic bacteria Salmonella enteritidis. In 1992, we

reported that due to coordination difficulties resulting from the split

regulatory structure for eggs, the federal government had not agreed on a

unified approach to address this problem.11 In July 1999, we reported that

the federal government still had not agreed on a unified approach to

address the problem.12 In July 2000, FDA and FSIS issued a “current

thinking” paper identifying actions that would decrease the food safety

risks associated with eggs. However, as of September 2001,

comprehensive proposed regulations to implement these actions had not

yet been published.

• Continuity of coordination efforts is hampered by changes in

executive branch leadership. The President’s Council on Food Safety,

created in 1998, was tasked with developing a comprehensive strategic

plan for federal food safety activities. In August 2000, the council agreed to

initiate an interagency process to address our recommendation that FDA

and the Department of Transportation,13 among others, enhance food

safety protections by developing a strategy to regulate animal feed while in

transport. While the council published its strategic food safety plan in

January 2001 that included numerous “action items” and

recommendations for improving the federal food safety system, the

council did not address a transport strategy for animal feed. Moreover, the

council has not met since publishing the strategic plan, and it remains to

be seen whether the new administration will act on the council’s

 11Food Safety and Quality: Salmonella Control Efforts Show Need for More Coordination

(GAO/RCED-92-69, Apr. 21, 1992).

12Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety

(GAO/RCED-99-184, July 1, 1999).

13Food Safety: Controls Can Be Strengthened to Reduce the Risk of Disease Linked to

Unsafe Animal Feed (GAO/RCED-00-255, Sept. 22, 2000).
Page 11 GAO-02-47T Food Safety and Security

recommendations. For example, the council’s strategic plan included an

action item to allocate enforcement resources based on the potential risk

to public health, but the President’s fiscal year 2002 budget showed little

change in the allocation of food safety resources among agencies.

We continue to believe, as we testified in 1999,14 that a single, independent

food safety agency administering a unified, risk-based food safety system

is the most effective solution to the current fragmentation of the federal

food safety system. While there are difficulties involved in establishing a

new government agency and opinions differ about the best organizational

model for food safety, there is widespread national and international

recognition of the need for uniform laws and consolidation of food safety

activities under a single organization. Both the National Academy of

Sciences and the President’s Council on Food Safety have joined us in

calling for fundamental changes to the federal food safety system,

including a reevaluation of the system’s organizational structure. Likewise,

several former senior-level government officials that were responsible for

federal food safety activities have called for major organizational and legal

changes. Internationally, four countries—Canada, Denmark, Great Britain,

and Ireland—have each recently consolidated their food safety

responsibilities under a single agency. Several other countries or

government organizations may be considering this option as well,

including Argentina, Chile, Hong Kong, the Netherlands, and the European

Union.

In an August 1998 report, the National Academy of Sciences concluded

that the current fragmented federal food safety system is not well

equipped to meet emerging challenges.15 The academy found that “there

are inconsistent, uneven, and at times archaic food statutes that inhibit use

of science-based decision-making in activities related to food safety, and

these statutes can be inconsistently interpreted and enforced among

agencies.” As such, the academy concluded that to create a science-based

food safety system current laws must be revised. Accordingly, it

recommended that the Congress change federal statutes so that food

safety inspection and enforcement are based on scientific assessments of

 14Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-Based,

Inspection System (GAO/T-RCED-99-256, Aug. 4, 1999).

15Ensuring Safe Food from Production to Consumption (Institute of Medicine, National

Research Council, National Academy Press, Washington, D.C., August 1998).

Fundamental Changes

Needed to the Federal

Food Safety System
Page 12 GAO-02-47T Food Safety and Security

public health risks. The academy also recommended that food safety

programs be administered by a single official in charge of all federal food

safety resources and activities, including outbreak management, standardsetting, inspection, monitoring, surveillance, risk assessment,

enforcement, research, and education.

According to the academy’s report, many members of the committee

tasked to conduct the study believed that a single agency headed by one

administrator was the best way to provide the central, unified framework

critical to improving the food safety system. However, assessing

alternative organizational approaches was not possible in the time

available or part of the committee’s charge. Therefore, the committee did

not recommend a specific organizational structure but instead provided

several possible configurations for illustrative purposes. These were

• forming a Food Safety Council of representatives from the agencies, with a

central chair appointed by the President, reporting to the Congress and

having control of resources;

• designating one current agency as the lead agency and making the head of

that agency the responsible individual;

• establishing a single agency reporting to one current cabinet-level

secretary; and

• establishing an independent single agency at the cabinet level.

The committee also proposed that a detailed examination of specific

organizational changes be conducted as a part of a future study. Such a

study would be in keeping with the Congress’ intent, as expressed in the

fiscal year 1998 conference report on food safety appropriations. This

conference report directed that if the academy’s study recommended an

independent food safety agency,16 a second study be conducted to

determine the agency’s responsibilities to ensure that the food safety

system protects the public health.

 16Making Appropriations for Agriculture, Rural Development, Food and Drug

Administration, and Related Agencies’ Programs for the Fiscal Year Ending

September 30, 1998, and for Other Purposes, Conference Report (H. Rept. 105-252,

Sept. 17, 1997).
Page 13 GAO-02-47T Food Safety and Security

In response to the academy’s report, the President established a Council

on Food Safety and charged it to develop a comprehensive strategic plan

for federal food safety activities, among other things.17 The Council’s Food

Safety Strategic Plan, released on January 19, 2001, recognized the need

for a comprehensive food safety statute and concluded that “the current

organizational structure makes it more difficult to achieve future

improvements in efficiency, efficacy, and allocation of resources based on

risk.”

18 The council analyzed several organizational reform options. Two of

the options involved enhanced coordination within the existing structure,

and the other two involved consolidation of responsibilities, either within

an existing organization or a stand-alone food safety agency. The council’s

analysis of the options found that coordination may lead to marginal

improvements but do little to address the fragmentation, duplication, and

conflict inherent in the current system. The council concluded that

consolidation could eliminate duplication and fragmentation, create a

single voice for food safety, facilitate priority setting and resource

allocation based on risk, and provide greater accountability. The council

recommended the development of comprehensive, unifying food safety

legislation to provide a risk-based, prevention-oriented system for all food,

followed by the development of a corresponding organizational reform

plan.

Former key government food safety officials at USDA and FDA have

acknowledged the limitations of the current regulatory system. As shown

in table 1, many former government officials recognize the need for and

support the transition to a single food safety agency. Some of these

officials believe the single agency could be consolidated within an existing

department, and others favor an independent agency. Regardless, they all

recognize the need for legislative overhaul to provide a uniform, risk-based

approach to food safety.

 17The President’s Council on Food Safety comprises, among others, the Secretaries of

Agriculture, Health and Human Services, and Commerce; the Administrator of the

Environmental Protection Agency; and the Assistant to the President for Science and

Technology.

18The Food Safety Strategic Plan is available on the Internet at

http://www.foodsafety.gov/~fsg/cstrpl-4.html
Page 14 GAO-02-47T Food Safety and Security

Table 1: Former Food Safety Officials Who Support Legislative Reform and Consolidation of Food Safety Activities

Name Former government position and agency Period of service

Mr. Dan Glickman Secretary of Agriculture, USDA 1995-2001

Dr. Jane Henney Commissioner, FDA, HHS 1998-2001

Dr. Catherine Woteki Under Secretary for Food Safety, USDA 1997-2001

Dr. David Kessler Commissioner, FDA, HHS 1990-1997

Mr. Michael Taylor Administrator, FSIS, USDA and

Deputy Commissioner for Policy, FDA, HHS

1994-1996

1991-1994

Dr. Russell Cross Administrator, FSIS, USDA 1992-1994

Dr. Lester Crawford Administrator, FSIS, USDA 1987-1991

Ms. Carol Tucker-Foreman Assistant Secretary for Food and Consumer Services, USDA 1977-1981

Source: GAO

Although in the past the U.S. food safety system has served as a model for

other countries, recently Canada, Denmark, Great Britain, and Ireland

have taken the lead by consolidating much of their food safety

responsibilities in a single agency in each country. As we reported in

1999,19 responding to heightened public concerns about the safety of their

food supplies, Great Britain and Ireland chose to consolidate

responsibilities in agencies that report to or are represented by their

ministers of health. The British consolidated food safety activities into an

independent agency, represented before Parliament by the Minister of

Health, largely because of the agriculture ministry’s perceived mishandling

of an outbreak of Bovine Spongiform Encephalopathy (commonly

referred to as “mad cow” disease). Public opinion viewed the agriculture

ministry, which had the dual responsibilities of promoting agriculture and

the food industry and regulating food safety, as slow to react because it

was too concerned about protecting the cattle industry.

Canada and Denmark were more concerned about program effectiveness

and cost saving and accordingly consolidated activities in agencies that

report to their ministers of agriculture, who already controlled most of the

food safety resources. For example, Canada did not face a loss of public

confidence, as did Great Britain and Ireland, but instead faced a budgetary

crisis; it therefore sought ways to reduce federal expenditures. Denmark

reorganized the whole Ministry of Agriculture, and all food regulation is

now in the newly created Ministry of Food, Agriculture, and Fisheries.

 19Food Safety: Experiences of Four Countries in Consolidating Their Food Safety

Systems (GAO/RCED-99-80, Apr. 20, 1999).
Page 15 GAO-02-47T Food Safety and Security

Recent events have raised the specter of bioterrorism as an emerging risk

factor for our food safety system. Bioterrorism is the threatened or

intentional release of biological agents (viruses, bacteria, or their toxins)

for the purpose of influencing the conduct of government or of

intimidating or coercing a civilian population. These agents can be

released through food as well as the air, water, or insects. To respond to

potential bioterrorism, federal food safety regulatory agencies need to be

prepared to efficiently coordinate their activities and respond quickly to

protect the public health. Under the current structure, we believe that

there are very real doubts about the system’s ability to detect and quickly

respond to any such event.

To date, the only known bioterrorist act in the United States involved

deliberate contamination of food with a biological agent. In 1984, a

religious cult intentionally contaminated salad bars in local restaurants in

Oregon to prevent people from voting in a local election. Although no one

died, 751 people were diagnosed with foodborne illnesses. Since then

federal officials identified only one other act of deliberate food

contamination with a biological agent that affected 13 individuals in 1996,

but numerous threats and hoaxes have been reported. Both FDA and FSIS

have plans and procedures for responding to deliberate food

contamination incidents,20 but the effectiveness of these procedures is

largely untested for contamination involving biological agents. Therefore,

we recommended in 1999 that FDA and FSIS test their plans and

procedures using simulated exercises that evaluate the effectiveness of

federal, state, and local agencies’ and industry’s responses to various types

of deliberate food contamination with a biological agent.21

Moreover, in September 2001 we reported that coordination of federal

terrorism research, preparedness, and response programs is fragmented.22

Separately, we reported that several relevant agencies have not been

 20A number of federal, state, and local agencies have responsibility for responding to

deliberate acts or threats of food contamination. Besides FDA and FSIS, other federal

agencies include CDC, the Federal Bureau of Investigation, and USDA’s Office of Inspector

General.

21Food Safety: Agencies Should Further Test Plans for Responding to Deliberate

Contamination (GAO/RCED-00-3, Oct. 27, 1999).

22Combating Terrorism: Selected Challenges and Related Recommendations (GAO-01-822,

Sept. 20, 2001).

Bioterrorism and

Deliberate Acts of

Food Contamination
Page 16 GAO-02-47T Food Safety and Security

included in bioterrorism-related policy and response planning.23 For

example, USDA officials told us that their department was not involved,

even though it would have key responsibilities if terrorists targeted the

food supply.

To conclude, Mr. Chairman, we believe that creating a single food safety

agency to administer a uniform, risk-based inspection system is the most

effective way for the federal government to resolve long-standing

problems; address emerging food safety issues, including acts of deliberate

contamination involving biological agents; and ensure the safety of the

nation’s food supply. In addition, the National Academy of Sciences and

the President’s Council on Food Safety have reported that comprehensive,

uniform, and risk-based food safety legislation is needed to provide the

foundation for a consolidated food safety system. While we believe the

case for a single food safety agency has been compelling for some time,

recent events make this action more imperative. Numerous details, of

course, remain to be worked out but it is essential that the fundamental

decision to create such an agency be made and the process for resolving

outstanding technical issues be started.

To provide more efficient, consistent, and effective federal oversight of the

nation’s food supply, we recommend that the Congress consider

• enacting comprehensive, uniform and risk-based food safety legislation

and

• commissioning the National Academy of Sciences or a blue ribbon panel

to conduct a detailed analysis of alternative organizational food safety

structures and report the results of such an analysis to the Congress.

Pending Congressional action to establish a single food safety agency and

enact uniform, risk-based legislation, we recommend that the Secretary of

Agriculture, the Secretary of Health and Human Services, and the Assistant

to the President for Science and Technology, as joint chairs of the

President’s Council on Food Safety, reconvene the council to facilitate

interagency coordination on food safety regulation and programs.

 23Bioterrorism: Federal Research and Preparedness Activities (GAO/01-915, Sept. 28,

2001).

Conclusions

Matters for

Congressional

Consideration

Recommendation for

Executive Action
Page 17 GAO-02-47T Food Safety and Security

Contact and Acknowledgments

For future contacts regarding this testimony, please contact

Robert A. Robinson at (202) 512-3841. Individuals making key

contributions to this testimony included Lawrence J. Dyckman,

Keith W. Oleson, Stephen D. Secrist, Diana P. Cheng, Maria C. Gobin,

Natalie H. Herzog, and John M. Nicholson Jr.
Page 18 GAO-02-47T Food Safety and Security

Dollars in millions

Agency

Fiscal year 2000

fundinga

Fiscal year 2000

staffing

Food and Drug Administration (FDA), within the Department of Health and Human

Services (HHS), is responsible for ensuring that domestic and imported food products

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

labeled. The Federal Food, Drug, and Cosmetic Act, as amended, is the major law

governing FDA’s activities to ensure food safety and quality. The act also authorizes FDA

to conduct surveillance of all animal drugs, feeds, and veterinary devices to ensure that

drugs and feeds used in animals are safe, effective, and properly labeled and produce no

human health hazards when used in food-producing animals.

$323b

2,828b

Centers for Disease Control and Prevention (CDC), within HHS, is charged with protecting

the nation’s public health by leading and directing the prevention and control of diseases

and responding to public health emergencies. CDC conducts surveillance for foodborne

diseases; develops new epidemiological and laboratory tools to enhance surveillance and

detection of outbreaks; and performs other activities to strengthen local, state, and

national capacity to identify, characterize, and control foodborne hazards. CDC engages in

public health activities related to food safety under the general authority of the Public

Health Service Act, as amended.

29 66

Food Safety and Inspection Service (FSIS), within the U.S. Department of Agriculture

(USDA), is responsible for ensuring that meat, poultry, and some eggs and egg products

moving in interstate and foreign commerce are safe, wholesome, and correctly marked,

labeled, and packaged. FSIS carries out its inspection responsibilities under the Federal

Meat Inspection Act, as amended, the Poultry Products Inspection Act, as amended, and

the Egg Products Inspection Act, as amended.

649c

9,545

Animal and Plant Health Inspection Service (APHIS), within USDA, is responsible for

ensuring the health and care of animals and plants. APHIS has no statutory authority for

public health issues unless the concern to public health is also a concern to the health of

animals or plants. APHIS identifies research and data needs and coordinates research

programs to protect the animal industry against pathogens or diseases that are a risk to

humans to improve food safety.

d d

Grain Inspection, Packers and Stockyards Administration (GIPSA), within USDA, is

responsible for establishing quality standards and providing for a national inspection

system to facilitate the marketing of grain and other related products. Certain inspection

services, such as testing corn for the presence of aflatoxin and starlink, enable the market

to assess the value of a product on the basis of its compliance with contractual

specifications and FDA requirements. GIPSA has no regulatory responsibility regarding

food safety. Under a memorandum of understanding with FDA, GIPSA reports to FDA

certain lots of grain, rice, pulses, or food products (which were officially inspected as part

of GIPSA’s service functions) that are considered objectionable under the Federal Food,

Drug, and Cosmetic Act, as amended, the U.S. Grain Standards Act, as amended, and the

Agriculture Marketing Act of 1946, as amended.

d d

Agricultural Marketing Service (AMS), within USDA, is primarily responsible for

establishing quality and condition standards and for grading the quality of dairy, fruit,

vegetable, livestock, meat, poultry, and egg products. As part of this grading process,

AMS considers safety factors, such as the cleanliness of the product. AMS also runs a

voluntary pesticide data program and carries out a wide array of programs to facilitate

marketing. It carries out these programs under more than 50 statutes, including the

Agricultural Marketing Agreement Act of 1937, as amended; the Agricultural Marketing Act

of 1946, as amended; the Egg Products Inspection Act, as amended; the Export Apple

and Pear Act, as amended; the Export Grape and Plum Act, as amended; the Federal

Seed Act; and the Food Quality Protection Act. AMS is largely funded with user fees.

13e

26e

Appendix I: Food Safety Responsibilities and

Fiscal Year 2000 Funding and Staffing Levels

at 12 Federal Agencies
Page 19 GAO-02-47T Food Safety and Security

Dollars in millions

Agency

Fiscal year 2000

fundinga

Fiscal year 2000

staffing

Agricultural Research Service (ARS), within USDA, is responsible for conducting a wide

range of research relating to the Department’s mission, including food safety research.

ARS carries out its programs under the Department of Agriculture Organic Act of 1862; the

Research and Marketing Act of 1946, as amended; and the National Agricultural

Research, Extension, and Teaching Policy Act of 1977, as amended.

82 222

National Marine Fisheries Service (NMFS), within the Department of Commerce, conducts

voluntary seafood safety and quality inspection programs under the Agricultural Marketing

Act of 1946, as amended, and the Fish and Wildlife Act of 1956, as amended. NMFS

provides inspection and certification services for fishery products for human consumption,

as well as for animal feeds and pet foods containing a fish base.

f 165f

Environmental Protection Agency (EPA) is responsible for regulating all pesticide products

sold or distributed in the United States and setting maximum allowed residue levels for

pesticides on food commodities and animal feed. EPA conducts these activities under the

Federal Insecticide, Fungicide, and Rodenticide Act, as amended, and the Federal Food,

Drug, and Cosmetic Act, as amended.

171 1,076

Federal Trade Commission (FTC) enforces the Federal Trade Commission Act, which

prohibits unfair or deceptive acts or practices. FTC’s food safety objective is to prevent

consumer deception through the misrepresentation of food.

g g

U.S. Customs Service, within the Department of the Treasury, is responsible for collecting

revenues and enforcing various customs and related laws. Customs assists FDA and FSIS

in carrying out their regulatory roles in food safety.

g g

Bureau of Alcohol, Tobacco, and Firearms, within the Department of the Treasury, is

responsible for administering and enforcing laws covering the production (including

safety), use, and distribution of alcoholic beverages under the Federal Alcohol

Administration Act and the Internal Revenue Code.

g g

Total $1,267 13,928

a

Fiscal year 2000 appropriated funds.

b

FDA’s data includes funding and staffing for various programs across FDA that are involved with

food safety activities, including the Center for Food Safety and Applied Nutrition, the Center for

Veterinary Medicine, the National Center for Toxicological Research, and the field components for

these centers.

c

FSIS’ total funding for fiscal year 2000 was $751 million, which includes appropriated funds,

reimbursements, and trust funds.

d

The agency did not specify its food safety resources.

e

AMS’ funding and staffing are for Food Quality Protection Act information gathering only.

f

NMFS’ activities were funded through $12.4 million in user fees, not appropriated funds. Funding and

staffing levels are for both safety and quality inspection activities.

g

We did not obtain these agencies’ food safety budgets due to the small amount of funds for these

activities in previous years.

Source: Federal agencies’ data.
Page 20 GAO-02-47T Food Safety and Security

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

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

Hot dog in pastry dough Hot dog in a roll

Corn dog Bagel dog

Dehydrated chicken soup Dehydrated beef soup

Beef broth Chicken broth

Spaghetti sauce with meat stock Spaghetti sauce without meat stock

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

Pizza with meat topping Pizza without meat topping

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

Source: Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe

Food Supply (GAO/RCED-92-152, June 26, 1992).

Appendix II: Differences in Inspection

Frequency of Manufacturers of Similar

Products
Page 21 GAO-02-47T Food Safety and Security

Food Safety: CDC Is Working to Address Limitations in Several of Its

Foodborne Disease Surveillance Systems (GAO-01-973, Sept. 7, 2001).

Food Safety: Overview of Federal and State Expenditures (GAO-01-177,

Feb. 20, 2001).

Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect

Consumers (GAO-01-204, Jan. 31, 2001).

Food Safety: Actions Needed by USDA and FDA to Ensure That

Companies Promptly Carry Out Recalls (GAO/RCED-00-195,

Aug. 17, 2000).

Food Safety: Improvements Needed in Overseeing the Safety of Dietary

Supplements and “Functional Foods” (GAO/RCED-00-156, July 11, 2000).

Meat and Poultry: Improved Oversight and Training Will Strengthen

New Food Safety System (GAO/RCED-00-16, Dec. 8, 1999).

Food Safety: Agencies Should Further Test Plans for Responding to

Deliberate Contamination (GAO/RCED-00-3, Oct. 27, 1999).

Food Safety: U.S. Needs a Single Agency to Administer a Unified, RiskBased Inspection System (GAO/T-RCED-99-256, Aug. 4, 1999).

Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg

Safety (GAO/RCED-99-184, July 1, 1999).

Food Safety: Experiences of Four Countries in Consolidating Their Food

Safety Systems (GAO/RCED-99-80, Apr. 20, 1999).

Food Safety: Opportunities to Redirect Federal Resources and Funds

Can Enhance Effectiveness (GAO/RCED-98-224, Aug. 6, 1998).

Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are

Inconsistent and Unreliable (GAO/RCED-98-103, Apr. 30, 1998).

Food Safety: Agencies’ Handling of a Dioxin Incident Caused Hardships

for Some Producers and Processors (GAO/RCED-98-104, Apr. 10, 1998).

Agricultural Exports: U.S. Needs a More Integrated Approach to Address

Sanitary/Phytosanitary Issues (GAO/NSIAD-98-32, Dec. 11, 1997).

Related GAO Products
Page 22 GAO-02-47T Food Safety and Security

Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96,

May 8, 1996).

Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food

(GAO/RCED-94-192, Sept. 26, 1994).

Food Safety: A Unified, Risk-Based Food Safety System Needed

(GAO/T-RCED-94-223, May 25, 1994).

Food Safety: Risk-Based Inspections and Microbial Monitoring Needed

for Meat and Poultry (GAO/RCED-94-110, May 19, 1994).

Food Safety and Quality: Uniform, Risk-Based Inspection System

Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992).

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

Coordination (GAO/RCED-92-69, Apr. 21, 1992).

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