Food Safety and Security: Fundamental Changes Needed to Ensure	 
Safe Food (10-OCT-01, GAO-02-47T).				 
								 
Tens of millions of Americans become ill and thousands die each  
year from eating unsafe foods. The current food safety system is 
a patchwork structure that cannot address existing and emerging  
food safety risks. The current system 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. 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 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.						 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-02-47T 					        
    ACCNO:   A02229						        
  TITLE:     Food Safety and Security: Fundamental Changes Needed to  
Ensure Safe Food						 
     DATE:   10/10/2001 
  SUBJECT:   Consumer protection				 
	     Contaminated foods 				 
	     Food and drug legislation				 
	     Food industry					 
	     Food inspection					 
	     Health hazards					 
	     Import regulation					 
	     Interagency relations				 
	     Safety regulation					 
	     Safety standards					 
	     Customs Service/FDA Operation Bad Apple		 
	     FSIS Hazard Analysis and Critical			 
	     Control Point System				 
								 

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GAO-02-47T
     
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) prohibit the use of processing equipment
that may potentially contaminate food products, and (3) 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. 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 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

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

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.

 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

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

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.

 Fragmented organizational structure poses challenges to U. S. efforts to
address barriers to agricultural trade. The organizational

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

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 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.

9 Agricultural Exports: U. S. Needs a More Integrated Approach to Address
Sanitary/ Phytosanitary Issues (GAO/ NSIAD- 98- 32, Dec. 11, 1997) 10 Food
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

 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 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.

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

(GAO/ RCED- 92- 69, Apr. 21, 1992). 12 Food Safety: U. S. Lacks a Consistent
Farm- to- Table Approach to Egg Safety

(GAO/ RCED- 99- 184, July 1, 1999). 13 Food 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

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 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.

14 Food Safety: U. S. Needs a Single Agency to Administer a Unified, Risk-
Based, Inspection System (GAO/ T- RCED- 99- 256, Aug. 4, 1999). 15 Ensuring
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

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.

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

16 Making 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).

17 The 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.

Page 13 GAO- 02- 47T Food Safety and Security

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.

18 The 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.

19 Food 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

20 A 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.

21 Food Safety: Agencies Should Further Test Plans for Responding to
Deliberate Contamination (GAO/ RCED- 00- 3, Oct. 27, 1999). 22 Combating
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.

23 Bioterrorism: 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 funding a 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.

$323 b 2,828 b 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.

649 c 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.

13 e 26 e

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 funding a 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 165 f 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).

(360133)
*** End of document. ***