Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce
Overlapping Inspections and Related Activities (17-MAY-05,
GAO-05-549T).
GAO has issued many reports documenting problems resulting from
the fragmented nature of the federal food safety system--a system
based on 30 primary laws. This testimony summarizes GAO's most
recent work on the federal system for ensuring the safety of the
U.S. food supply. It provides (1) an overview of food safety
functions, (2) examples of overlapping and duplicative inspection
and training activities, and (3) observations on efforts to
better manage the system through interagency agreements. It also
provides information on other countries' experiences with
consolidation and the views of key stakeholders on possible
consolidation in the United States.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-05-549T
ACCNO: A22698
TITLE: Overseeing the U.S. Food Supply: Steps Should be Taken to
Reduce Overlapping Inspections and Related Activities
DATE: 05/17/2005
SUBJECT: Employee training
Food and drug law
Food and drug legislation
Food industry
Food inspection
Food supply
Health hazards
Interagency relations
Redundancy
National preparedness
Food facilities
Meat inspection
Poultry inspection
Product safety
Food safety
FDA Hazard Analysis and Critical Control
Point System
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GAO-05-549T
United States Government Accountability Office
GAO Testimony
Before the Subcommittee on the Federal Workforce and Agency Organization,
Committee on Government Reform, House of Representatives
For Release on Delivery
Expected at 2:00 p.m. EDT OVERSEEING THE U.S.
Tuesday, May 17, 2005 FOOD SUPPLY
Steps Should be Taken to Reduce Overlapping Inspections and Related Activities
Statement of Robert A. Robinson, Managing Director Natural Resources and
Environment
GAO-05-549T
[IMG]
May 17, 2005
OVERSEEING THE U.S. FOOD SUPPLY
Steps Should Be Taken to Reduce Overlapping Federal Inspections and Related
Activities
What GAO Found
USDA and FDA have primary responsibility for overseeing the safety of the
U.S. food supply; the Environmental Protection Agency (EPA) and the
National Marine Fisheries Service also play key roles. In carrying out
their responsibilities, these agencies spend resources on a number of
overlapping activities, particularly inspection/enforcement, training,
research, and rulemaking, for both domestic and imported food. For
example, both USDA and FDA conduct similar inspections at 1,451 dual
jurisdiction establishments-facilities that produce foods regulated by
both agencies, as shown below.
To better manage the fragmented federal system, these agencies have
entered into at least 71 interagency agreements-about a third of them
highlight the need to reduce duplication and overlap or make efficient and
effective use of resources. The agencies do not take full advantage of
these agreements because they do not have adequate mechanisms for tracking
them and, in some cases, do not fully implement them.
Selected industry associations, food companies, consumer groups, and
academic experts disagree on the extent of overlap, on how best to improve
the federal system, and on whether to consolidate food safety-related
functions into a single agency. However, they agreed that laws and
regulations should be modernized to more effectively and efficiently
control food safety hazards.
As GAO recently reported, Canada, Denmark, Ireland, Germany, the
Netherlands, New Zealand, and the United Kingdom also had fragmented
systems. These countries took steps to consolidate food safety functions-
each country modified its food safety laws and established a single agency
to lead food safety management or enforcement of food safety legislation.
United States Government Accountability Office
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today to address the Subcommittee's interest in
examining the potential for reorganizing the federal system for ensuring
the safety of the U.S. food supply. As the Comptroller General recently
testified, there is a need to bring government and its programs in line
with 21st century realities.1 He noted that many, if not most, current
federal programs and policies, were designed decades ago to respond to
trends and challenges that existed at the time. These programs can be
updated and modernized by improving their targeting and efficiency
through, among other things, consolidating facilities and programs and
streamlining and reengineering operations and processes. The Comptroller
General specifically cited the federal food safety system as an area where
opportunities for crosscutting program integration exist.
In testimony last year before this Subcommittee, we described the
fragmented nature of our federal food safety system-one based on 30
principal laws related to food safety that are administered by 15
agencies.2 We stated that the patchwork nature of the system governing
inspection and related activities hampers efforts to address the risks of
inadvertent or deliberate food contamination. Under this system, different
agencies are responsible for specific food commodities and have
significantly different authorities for carrying out these
responsibilities. As a result, federal agencies are spending resources on
similar activities to ensure that the food supply is safe, wholesome, and
appropriately labeled. For example, Food and Drug Administration (FDA)
inspectors examine seafood processors; U.S. Department of Agriculture
(USDA) inspectors examine meat- and poultry-processing facilities; and
both agencies inspect the same food-processing facilities if the
facilities produce food products under the jurisdiction of both agencies.
For example, USDA inspects a canning facility that produces soup
containing meat or poultry; if the facility also produces soup containing
seafood, FDA inspects it as well. USDA spent $665 million and FDA spent
$219 million, totaling $884 million-and dedicated 8,787 and 1,844
full-time equivalent staff, respectively-for inspection and enforcement
activities in fiscal year 2003. USDA and FDA provided updated expenditures
for fiscal year 2004 totaling $958 million-
1GAO, 21st Century Challenges: Reexamining the Base of the Federal
Government, GAO-05-352T (Washington, D.C.: Feb. 16, 2005).
2GAO, Federal Food Safety and Security System: Fundamental Restructuring
is Needed to Address Fragmentation and Overlap, GAO-04-588T (Washington,
D.C.: Mar. 30, 2004).
and dedicated 8,733 and 1,812 full-time equivalent staff, respectively,
for
3
these activities.
We have recommended changes to the federal system for ensuring the safety
of our food supply. In particular, we recommended that the Congress
consider enacting comprehensive, uniform, and risk-based food safety
legislation to streamline inspection and enforcement efforts, and
consolidate food safety functions by establishing a single, independent
food safety agency or by designating one current agency as the lead agency
for all food safety inspection matters. Such an overhaul would enable the
federal system to more effectively and efficiently accomplish its mission
and meet new food safety challenges, such as the emerging concerns about
the deliberate contamination of our food supply through bioterrorism.
In my testimony today, I will discuss GAO's most recent work conducted at
the request of this Subcommittee and other Congressional requesters. This
GAO report, which is being released today, examines the need to reduce
overlap and better leverage resources.4 It provides (1) an overview of the
government's food safety functions, activities, and expenditures, (2)
specific examples of overlapping and, at times, duplicative inspection and
training activities, and (3) observations on the agencies' efforts to
manage this fragmented system through dozens of interagency agreements. At
your request, I will also provide a synopsis of selected industry and
other stakeholders' views on the current federal approach to food
inspection. Finally, I will offer some observations on the experiences of
several countries that have recently undertaken consolidation efforts to
achieve more effective and efficient management of their food safety
programs; these observations are based on our recent report on foreign
countries' experiences consolidating food safety functions and
activities.5 My
3In 2003, USDA inspected about 6,500 meat, poultry, and egg-product
facilities, and FDA inspected approximately 57,000 food-processing
facilities. In 2004, the agencies inspected about 6,000 and 62,000
facilities, respectively.
4GAO, Oversight of Food Safety Activities: Federal Agencies Should Pursue
Opportunities to Reduce Overlap and Better Leverage Resources, GAO-05-213
(Washington, D.C.: Mar. 30, 2005).
5GAO, Food Safety: Experiences of Seven Countries in Consolidating Their
Food Safety Systems, GAO-05-212 (Washington, D.C.: Feb. 22, 2005). The
information on other countries' food safety systems, including
descriptions of laws, is based almost exclusively on interviews with and
documentation provided by high-level food safety officials from the seven
countries we examined, as well as representatives from the food industry
and consumer groups.
Background
testimony also draws on our wide-ranging past reports and testimonies on
the fragmented nature of the federal system and upon completed work and
previous testimonies on issues related to government organization and
transformation. (See app. II.) We conducted our work in accordance with
generally accepted government auditing standards.
In the interest of clarity, I want to note at the outset that we are
defining overlaps as similar food safety-related activities being
performed by more than one agency-such as the training of food inspectors.
We are defining duplication as essentially identical activities performed
by more than one agency-such as inspecting the same food-processing
facility for compliance with sanitation and/or good manufacturing
practices requirements.
The safety and quality of the U.S. food supply is governed by a highly
complex system stemming from 30 principal laws related to food safety that
are administered by 15 agencies. In addition, dozens of interagency
agreements are intended to address a wide range of food safety-related
activities. The federal system is supplemented by the states, which have
their own statutes, regulations, and agencies for regulating and
inspecting the safety and quality of food products. USDA and FDA, within
the Department of Health and Human Services, have most of the regulatory
responsibilities for ensuring the safety of the nation's food supply and
account for most federal food safety spending. Under the Federal Meat
Inspection Act, the Poultry Products Inspection Act, and the Egg Products
Inspection Act, USDA is responsible for the safety of meat, poultry, and
certain egg products. FDA, under the Federal Food, Drug and Cosmetic Act,
and the Public Health Service Act, regulates all other foods, including
whole (or shell) eggs, seafood, milk, grain products, and fruits and
vegetables.6 Appendix 1 summarizes the agencies' food safety
responsibilities.
The existing statutes also give the agencies different regulatory and
enforcement authorities. For example, food products under FDA's
jurisdiction may be marketed without the agency's prior approval. On the
other hand, food products under USDA's jurisdiction must generally be
inspected and approved as meeting federal standards before being sold to
6Under the Egg Products Inspection Act, the Secretary of Health and Human
Services regulates whole eggs, while the Secretary of Agriculture
regulates egg products.
the public. Under current law, UDSA inspectors maintain continuous
inspection at slaughter facilities and examine each slaughtered meat and
poultry carcass. They also visit each processing facility at least once
during each operating day. For foods under FDA's jurisdiction, however,
federal law does not mandate the frequency of inspections (which FDA
typically conducts every 1 to 5 years). Although recent legislative
changes have strengthened FDA's enforcement authorities, the division of
inspection authorities and other food safety responsibilities has not
changed.
As we have reported, USDA traditionally has had more comprehensive
enforcement authority than FDA; however, the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 granted FDA additional
enforcement authorities that are similar to USDA's.7 For example, FDA now
requires all food processors to register with the agency so that they can
be inspected. FDA also has the authority to temporarily detain food
products when it has credible evidence that the products present a threat
of serious adverse health consequences. Moreover, FDA requires that
entities such as the manufacturers, processors, and receivers of imported
foods keep records so that FDA can identify the immediate previous source
and the immediate subsequent recipients of food. This record-keeping
authority is designed to help FDA track foods in the event of future
health emergencies, such as terrorism-related contamination. In addition,
FDA now requires advance notice of imported food shipments under its
jurisdiction. Despite these additional authorities, important differences
remain between the agencies' inspection and enforcement authorities. For
example, the Federal Meat Inspection Act and the Poultry Products
Inspection Act require that meat and poultry products be inspected and
approved for sale (i.e., stamped by USDA inspectors). The Federal Food,
Drug and Cosmetic Act does not require premarket approval, in general, for
FDA-regulated food products.
Finally, following the events of September 11, 2001, in addition to their
established food safety and quality responsibilities, the federal agencies
began to address the potential for deliberate contamination of agriculture
and food products. In 2001, by executive order, the President added the
food industry to the list of critical infrastructure sectors that need
protection from possible terrorist attack. As a result of this order, the
Homeland Security Act of 2002 establishing the Department of Homeland
7Pub. L. No. 107-188, 116 Stat. 594 (2002).
Security, and subsequent presidential directives, the Department of
Homeland Security provides overall coordination on how to protect the U.S.
food supply from deliberate contamination. The Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 also included numerous
provisions to strengthen and enhance food safety and security.
Many proposals have been made to consolidate the U.S. food safety system.
In 2001, parallel Senate and House bills proposed consolidating
inspections and other food safety responsibilities in a single independent
agency. In 2004 and 2005, legislation was again introduced in the Senate
and the House to establish a single food safety agency. This proposed
legislation would combine the two food safety regulatory programs of USDA
and FDA, along with a voluntary seafood inspection program operated by the
National Marines Fisheries Service (NMFS) in the Department of Commerce.
In addition, in 1998, the National Academy of Sciences recommended
integrating the U.S. food safety system and suggested several options,
including a single food safety agency.8 More recently, the National
Commission on the Public Service recommended that government programs
designed to achieve similar outcomes be combined into one agency and that
agencies with similar or related missions be combined into large
departments.9 The commission chairman testified before the Congress that
important health and safety protections fail when responsibility for
regulation is dispersed among several departments, as is the case with the
U.S. system.
Federal Agencies' Food Safety-Related Functions, Activities, and
Expenditures
The four agencies we examined-USDA, FDA, the Environmental Protection
Agency (EPA), and NMFS-are involved in key program functions related to
food safety. These functions include inspection and enforcement, research,
risk assessment, education and outreach, rulemaking and standard setting,
surveillance and monitoring, food security, and administration. These
agencies spend resources on similar food safety activities to ensure the
safety of different food products. Table 1 illustrates similar activities
that these agencies conduct.
8National Research Council and Institute of Medicine, Ensuring Safe Food
From Production to Consumption (Washington, D.C.: 1998).
9Report of the National Commission on the Public Service, Urgent Business
For America: Revitalizing the Federal Government For the 21st Century
(Washington, D.C.: 2003).
Table 1: Examples of Similar Food Safety Activities
Food safety program
function Activity USDA FDA EPA NMFS
Inspection/Enforcement Inspection of domestic o o o
food-processing facilities
Visits to foreign countries or
firms to conduct inspections
and/or
evaluate foreign food safety o o o
systems
Inspection of imported food at o o
ports of entry
Training inspectors o o o
Maintenance of inspection record o o o
database
Support to state enforcement
efforts (retail-level food o o o
safety)
Laboratory analysis of samples
collected at food-processing
facilities (to identify potential o o o
contamination)
Research Research on pathogen reduction o o o
Research on foodborne chemical
contaminants (such as pesticides
or dioxins) or biological
contaminants (such as e-coli or o o o o
salmonella)
Risk assessment Risk assessment of food o o o o
contaminants
Sample collection and/or analysis
of pesticide residues to inform
risk assessment o o o
Development and delivery of
Education/Outreach consumer education (such as
consumer hotlines or pamphlets) o o o o
Development and delivery of
industry guidance (such as
guidance
regarding regulations) o o o o
International harmonization of o o o o
standards
Surveillance/Monitoring Participation in FoodNet (active
surveillance for foodborne
diseases) o o
Participation in PulseNet (early
warning system for food illness
outbreak) o o
aHACCP rule development and o o o b
Rulemaking/Standard setting promulgation
Source: GAO analysis of documents obtained from, and discussions with,
USDA, FDA, EPA, and NMFS officials.
aHazard Analysis and Critical Control Point (HACCP) regulations require
food processors to maintain a plan identifying critical points in the
production line where contamination is more likely to occur and adopt
control techniques to prevent or reduce contamination. Currently, USDA
requires all meat-and poultry-processing facilities to comply with
mandatory HACCP regulations, and FDA requires that seafood-and
juice-processing facilities comply with mandatory HACCP regulations.
bNMFS participated in developing FDA's seafood HACCP rule.
In fiscal year 2003, the four federal agencies spent nearly $1.7 billion
on food safety-related activities.10 As figure 1 shows, USDA and FDA
together are responsible for nearly 90 percent of federal expenditures for
food safety.
Figure 1: USDA, FDA, EPA, and NMFS Food Safety-Related Expenditures,
Fiscal Year 2003
1%
NMFS - $21,999,941
EPA - $160,713,000
FDA - $480,379,000
USDA - $1,015,852,478
Source: GAO analysis of data obtained from, and discussions with, USDA,
FDA, EPA, and NMFS officials.
As figure 2 shows, most of the agencies' expenditures were incurred for
inspection/enforcement activities, including inspections of domestic and
imported food. However, these expenditures are not based on the volume of
foods regulated by the agencies or consumed by the public. USDA's
activities account for almost three-quarters of the agencies' inspection
and enforcement expenditures. That is, the majority of federal
expenditures
10The total food safety expenditures provided in this testimony are
derived by summing data for specific food safety activities
(monitoring/surveillance, inspection/enforcement, education/outreach,
research, and risk assessment) presented in the National Academy of
Sciences' 1998 report Ensuring Safe Food From Production to Consumption.
To capture other relevant activities, we included three additional
activities-administration, food security, and rulemaking/standard
setting-in the agencies' expenditures. At the time GAO initiated its
review in May 2004, the agencies could only provide complete expenditures
by these categories for fiscal year 2003. Because the agencies generally
do not track expenditures in this manner, we were only able to update some
of these data to reflect fiscal year 2004 expenditures.
for food safety inspection are directed toward USDA's programs for
ensuring the safety of meat, poultry, and egg products; however, USDA is
responsible for regulating about 20 percent of the food supply. In
contrast, FDA, which is responsible for regulating about 80 percent of the
food supply, accounted for only about 24 percent of these expenditures.
Figure 2: Food Safety Expenditures by Agency and Function, Fiscal Year
2003
Dollars in millions
900
800
700
600
500
400
300
200
100
0 Inspection/ Research Risk Education/ Surveillance/ enforcement
assessment outreach monitoring
EPA USDA NMFS FDA
Source: GAO analysis of data obtained from, and discussions with, USDA,
FDA, EPA, and NMFS officials.
Federal Food Safety As a result of the multiple laws governing food
safety, several federal
agencies conduct activities-inspections of domestic and imported
foods,Agencies Conduct training, research, risk assessment, education, and
rulemaking-that can Overlapping Activities serve overlapping, if not
identical, purposes.
USDA and FDA Inspections of Jointly Regulated Facilities Overlap
USDA and FDA conduct overlapping, and even duplicative, inspections at
more than 1,400 domestic facilities that produce foods such as canned
goods and frozen entrees. Both agencies inspect these facilities because
each has statutory responsibility for the safety of different foods or
food ingredients. USDA inspects canning facilities at least daily if the
company produces canned beans containing meat and poultry. If the facility
produces canned beans without meat or poultry, FDA also inspects it, with
a frequency ranging from 1 to 5 years. USDA and FDA inspections have
common features-both agencies spend inspection resources to verify that
facilities are sanitary and follow good manufacturing practices, such as
verifying that facilities do not have rodent or insect infestations.
At jointly regulated facilities, both USDA and FDA inspectors verify that
HACCP systems are in place. In these instances, each agency verifies that
the facility has created and implemented a HACCP plan specific to the
products that the agency regulates. Each agency's regulations require the
facility to maintain separate HACCP plans for each product and to develop
separate analyses of critical control points and separate strategies to
mitigate or eliminate food contaminants. While separate HACCP plans are
generally necessary to address the specific hazards associated with
specific food products, maintaining these separate plans, and the
associated inspections and documentation that each agency requires, can be
burdensome. For example, at a facility we visited that produces both crab
cakes and breaded chicken, the manager must maintain a seafood HACCP plan
and a poultry HACCP plan. He said that although both plans have similar
elements, each agency's inspectors expect different levels of detail for
the plans-something the manager finds confusing and difficult to comply
with.
USDA and FDA inspections of the same food-processing facility represent,
in our view, an inefficient use of scarce government resources. For
example, at a plant that produces both meat and seafood products, a USDA
inspector told us that as part of his daily, routine inspections he walks
through the seafood processing and storage section of the plant. (See fig.
3.) However, because FDA regulates seafood, the USDA inspector does not
monitor or inspect the seafood storage section. The inspector noted that,
with minimum training on seafood temperature controls, he
could inspect this section of the plant as well. USDA headquarters
officials said the agency's inspectors are capable of taking on FDA's
inspection responsibilities at jointly regulated facilities, given the
proper resources and training.
Figure 3: Diagram of a Jointly Regulated Food-Processing Facility
Source: GAO observation of a jointly regulated establishment.
USDA and FDA have new tools that could help reduce overlap in inspections.
Under the Bioterrorism Act, FDA could commission USDA inspectors, who are
present every day at these jointly regulated facilities,
to inspect FDA-regulated food.11 In doing so, FDA could reduce overlapping
inspections and redirect resources to other facilities for which it has
sole jurisdiction. While they did not disagree in principle with the
benefits of such an arrangement, FDA officials said that the savings would
be somewhat offset because FDA would likely have to reimburse USDA for the
costs of those inspections. Furthermore, FDA officials said that they do
not currently plan to pursue this option and have not conducted any
analyses of the costs or savings associated with it. USDA officials
commented that their inspectors are fully occupied and that they would
need to be trained before conducting joint inspections.
FDA and NMFS Inspections of Domestic Seafood Processors Overlap
Overlaps also occur at seafood processing facilities that both FDA and
NMFS inspect. NMFS currently inspects approximately 275 domestic seafood
facilities, and FDA inspects some of these plants as part of FDA's
surveillance program. NMFS conducts safety and sanitation inspections, as
well as other product quality inspections, on a fee-for-service basis.
NMFS inspectors verify sanitation procedures, HACCP compliance, and good
manufacturing practices-many of the same components of an FDA inspection.
Although the two agencies' seafood safety inspections are similar, FDA
does not take into account whether NMFS has already inspected a particular
facility when determining how frequently its inspectors should visit that
same facility.
FDA officials said they do not rely on NMFS inspections for two reasons.
First, FDA officials believe that NMFS has a potential conflict of
interest because companies pay NMFS for these inspections; and therefore,
as a regulatory agency, FDA should not rely on them. NMFS officials
disagreed, stating that their fee-for-service structure does not affect
their ability to conduct objective inspections. Furthermore, they noted,
when NMFS inspectors find noncompliance with FDA regulations, they refer
companies to FDA and/or to state regulatory authorities. NMFS officials
stated that companies that contract with NMFS need the agency's
certification in order to satisfy their customers. Second, FDA officials
believe, it is difficult for FDA to determine which facilities NMFS
inspects at any given time because NMFS' inspection schedules fluctuate
often, according to changes in NMFS' contracts with individual companies.
11Under the act, the agencies would have to enter into a memorandum of
understanding that would include provisions to ensure adequate training of
USDA officials and to address reimbursement.
However, we believe that if FDA were to recognize the results of NMFS'
inspection findings in targeting its resources, it could decrease or
eliminate inspections at facilities that NMFS inspectors find are in
compliance with sanitation and HACCP regulations.
USDA and FDA Both Inspect Imported Food
Both USDA and FDA maintain inspectors at 18 U.S. ports of entry to inspect
imported food but do not share inspection resources. In fiscal year 2004,
USDA spent almost $16 million on imported food inspections, and FDA spent
about $121 million. According to USDA inspectors we interviewed,
FDA-regulated imported foods are sometimes handled and stored in
USDA-approved import inspection facilities. Although USDA inspectors are
present at these ports more often than FDA inspectors, USDA inspectors
have no jurisdiction over FDA-regulated products and, therefore, the
FDA-regulated products may remain at the facilities for some time awaiting
FDA inspection.
FDA and USDA are also not sharing information they gather during their
respective evaluations and/or visits to foreign countries to assess food
safety conditions. For example, USDA evaluated 34 countries in 2004 to
determine whether these countries' food safety systems for ensuring the
safety of meat and poultry are equivalent to that of the United States.
FDA conducted inspections in 6 of these countries, but officials said they
do not take USDA's evaluations of the foreign countries' food safety
systems into account when determining which countries to visit and that
USDA's findings would be of little use to FDA because they relate to
products under USDA's jurisdiction.12
USDA and FDA Have Similar Training Programs for Food Inspectors
Both USDA and FDA spend resources to provide similar training to food
inspection personnel. USDA spent about $13.4 million and FDA spent about
$1.7 million in fiscal year 2004. We found that, to a considerable extent,
food inspection training addresses the same subjects-such as plant
sanitation, good manufacturing practices, and HACCP principles, albeit for
different food products. FDA's online curriculum includes over 106 courses
that address topics common to both USDA and FDA, as well as courses that
are specific to FDA's regulations and enforcement authorities. NMFS
currently uses 74 of these courses to train its seafood
12The countries that both USDA and FDA visited were Brazil, Costa Rica,
Germany, Hungary, Mexico, and Canada.
inspectors. NMFS officials cite benefits to using FDA's online training,
such as accessibility to training materials at times other than when their
inspectors are "on duty," as well as cost savings attributable to reduced
expenses for course materials and management.
Interagency Agreements Are Not Reducing Overlaps
We identified 71 interagency agreements that the principal food safety
agencies-USDA, FDA, EPA, and NMFS-have entered into to better protect the
public health by addressing jurisdictional boundaries, coordinating
activities, reducing overlaps, and leveraging resources. About one-third
(24) of the agreements highlight the need to reduce duplication and
overlap or make efficient and effective use of resources. However, the
agencies cannot take full advantage of these agreements because they do
not have adequate mechanisms for tracking them and, in some cases, do not
effectively implement them. Agency officials had difficulty identifying
the food safety agreements they are party to, and in many instances, the
agencies did not agree on the number of agreements they had entered into.
In addition, for the two comprehensive inspection-related agreements that
we examined in detail, the agencies are not ensuring that their provisions
are adhered to or that the overall objectives of the agreements are being
achieved. For example:
o USDA and FDA are not fully implementing an agreement to exchange
information about jointly regulated facilities in order to permit more
efficient use of both their resources and contribute to improved public
health protection. Under this agreement, the agencies are to share
inspection information, but FDA does not routinely consider compliance
information from USDA when deciding how to target its inspection
resources. Also, the agreement calls for the agencies to explore the
feasibility of granting each other access to appropriate
computermonitoring systems so that each agency can track inspection
findings. However, the agencies maintain separate databases and the
inspectors with whom we spoke continue to be largely unaware of a
facility's history of compliance with the other agency's regulations.
Inspectors told us that compliance information might be helpful when
inspecting jointly regulated facilities so they could focus on past
violations.
o An agreement between FDA and NMFS recognizes the agencies' related
responsibilities at seafood-processing establishments. The agreement
details actions the agencies can take to enable each to discharge its
responsibilities as effectively as possible, minimizing FDA inspections at
these facilities. However, we found that FDA is not using information from
Stakeholders Disagree on the Significance of Overlapping Activities and on
How to Improve the Federal Structure for Performing Food
o
Safety Inspections and Related Activities
o
NMFS inspections, which could allow it to reduce the number of inspections
at those facilities. Also, FDA rarely notifies NMFS of seizure actions it
takes against NMFS-inspected plants, as outlined in the agreement.
Although FDA is not implementing the agreement, it has recognized the
potential benefits of working with NMFS to leverage resources. In a
January 2004 letter to the Under Secretary of Commerce for Oceans and
Atmosphere,13 the then-Commissioner of FDA noted,
among other things, that using NMFS inspectors could be cost effective
because the NMFS inspectors may already be on-site and the FDA inspector
therefore would not have to travel to conduct an inspection.
The stakeholders we contacted-selected industry associations,
foodprocessing companies, consumer groups, and academic experts-disagree
on the extent to which overlaps exist and on how best to improve the
federal structure. Most of these stakeholders agree that the laws and
regulations governing the system should be modernized so that scientific
and technological advancements can be used to more effectively and
efficiently control current and emerging food safety hazards. However,
they differed about whether to consolidate food safety inspection and
related functions into a single federal agency.
Industry Associations: Representatives of industry associations do not see
the need to consolidate food safety-related functions, but they see the
need for minor changes within the existing regulatory framework to enhance
communication and coordination among the existing agencies.
Food Processing Companies: Representatives from the individual food
companies inspected by USDA and FDA believe that consolidation would
improve the effectiveness and efficiency of the system and ensure that
food safety resources are distributed based on the best available science.
They also said that overlaps can be burdensome or confusing. The
representatives did not see the added value of FDA's once-a-year (or less)
inspections because USDA inspectors already visit their plants daily. At
one company, USDA and FDA inspectors gave the plant manager contradictory
instructions-the USDA inspector did not want the company to paint
sterilization equipment because he determined that paint chips could
contaminate the food; whereas the FDA inspector told the
13NMFS is located within the Department of Commerce's National Oceanic and
Atmospheric Administration.
company to paint the same equipment because he determined that it would be
easier to identify sanitation problems on lightly painted surfaces.
o Academics and Consumer Groups: Academics and consumer groups
Other Countries Have Modified Laws and Consolidated Food Safety Functions
support consolidating food safety inspection and related functions into a
single agency. One group stated that the laws do not build prevention into
the farm-to-table continuum and divide responsibility and accountability
for food safety among federal agencies. Further, according to this group,
the laws prevent risk-based allocation of resources across the federal
food safety agencies.
The division of responsibility among several government agencies
responsible for food safety is not unique to the United States. According
to food safety officials in seven countries whose consolidations of food
safety systems we examined, they faced similar fragmentation and division
of responsibilities in their systems. As reported in February 2005,14 we
examined the efforts of Canada, Denmark, Ireland, Germany, the
Netherlands, New Zealand, and the United Kingdom to streamline and
consolidate their food safety systems. We found that, in each case, these
countries (1) modified existing laws to achieve the necessary
consolidation and (2) established a single agency to lead food safety
management or enforcement of food safety legislation.
We acknowledge that these countries have smaller populations than the
United States, but they face several similarities in their efforts to
ensure safe food. These countries, like the United States, are high-income
countries in which consumers have very high expectations about the safety
of their food supplies.15 In addition, U.S. consumers' spending on food as
a percentage of total spending is somewhat similar to that of these seven
countries, ranging from about 10 percent in the United States to over 16
percent in Ireland and the United Kingdom. In general, highincome
countries tend to spend a smaller percentage of their income on food than
low-income countries.
14GAO, Food Safety: Experiences of Seven Countries in Consolidating Their
Food Safety Systems, GAO-05-212 (Washington, D.C., Feb. 22, 2005).
15All seven countries, as well as the United States, are in the World
Bank's high-income category.
The seven countries' approaches for modifying their systems, of course,
differed. For example, Denmark created a new federal agency in which it
consolidated almost all food safety functions and activities, including
inspections, which were previously distributed among several government
agencies. In contrast, Germany's new food safety agency functions as a
coordinating body to lead food safety management, while the German federal
states continue to be responsible for overseeing food inspections
performed by local governments. These countries had two primary reasons
for consolidating their food safety systems-public concern about the
safety of the food supply and the need to improve program effectiveness
and efficiency. In addition, an important factor motivating the European
Union (EU) countries' consolidations has been the need to comply with
recently adopted EU legislation. These EU changes aim to harmonize and
simplify its food safety legislation and to create a single, transparent
set of food safety rules that is applicable to all EU-member countries.
As we previously reported, Canada reorganized its food safety system in
1997. As part of its consolidation of food safety functions, Canada also
assigned responsibilities for animal disease control and feed inspections
to the Canadian Food Inspection Agency (CFIA). As a result, CFIA is
responsible for detecting animal diseases that may affect human health,
such as mad cow disease in cattle as well as for preventing the
introduction and spread of the disease through animal feed.16
Not unexpectedly, the countries faced challenges in implementing their new
systems. Many countries had to determine (1) whether to place the new
agency within the existing health or agriculture ministry or establish it
as a stand-alone agency and (2) what responsibilities the new agency would
have. For example, Ireland chose to place its new independent food
16In the United States, USDA is primarily responsible for detecting mad
cow disease, and FDA is primarily responsible for preventing its
introduction and spread through animal feed. As we recently reported, FDA
has not always notified USDA when it has discovered that cattle may have
consumed feed containing prohibited material. This lapse has been
occurring even though FDA's guidance calls for such communication (GAO,
Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but
Oversight Weaknesses Continue to Limit Program Effectiveness, GAO-05-101
(Washington, D.C.: Feb. 25, 2005)). Despite this lapse in communication
regarding animal feed, an international panel that reviewed USDA's
epidemiological investigation conducted in response to an animal that
tested positive for mad cow disease in the United States in December 2003
found that USDA's investigation conformed to international standards. A
separate international panel stated that Canada's investigation of its
first case of the disease was comprehensive, thorough, and timely.
safety agency under its existing Department of Health and Children, in
part, to separate food safety responsibilities from the promotion of the
food industry, which is the responsibility of the Department of
Agriculture and Food. On the other hand, to separate food safety
regulation from political pressures, New Zealand established a
semi-autonomous food safety agency attached to the Ministry of Agriculture
and Forestry. Officials in several countries also cited challenges in
helping employees assimilate into the new agency's culture and support its
priorities.
As expected, most countries incurred start-up costs in reorganizing,
including the costs associated with acquiring buildings and purchasing new
laboratory equipment. Some countries also reported that they experienced a
temporary reduction in the quantity of food safety activities performed
due to consolidation-related disruptions.
None of the countries has conducted an analysis to compare the
effectiveness and efficiency of its consolidated food safety system with
that of the previous system. However, government officials in these
countries as well as other stakeholders consistently stated that
consolidation of their systems has led to significant qualitative
improvements in operations that enhance effectiveness or efficiency.
According to these officials, the benefits included reduced overlaps in
inspections, more targeted inspections based on food safety risk, more
consistent or timely enforcement of food safety laws and regulations, and
greater clarity in responsibilities.
Danish officials stated that consolidation and the accompanying reform of
food safety laws facilitated risk-based inspections. The frequency of most
inspections is now based on an individual food product's safety risk and
on an individual company's food safety record, not on agencies'
jurisdiction, as was the case before consolidation. As a result, the
frequency of inspections at some food processing plants and of lower risk
food products has been reduced, making more resources available for
inspections of higher risk companies and foods.
Government officials in Canada, the Netherlands, and Denmark stated that
some cost savings may be achieved as a result of changes that have already
taken place or are expected from planned changes needed to complete their
consolidation efforts. For example, Dutch officials said that reduced
duplication in food safety inspections would likely result in decreased
spending. In addition, they anticipate savings from an expected 25-percent
reduction in administrative and management personnel and from selling
excess property.
Figures 4 and 5 illustrate key functions and activities that the
governments of Denmark and Canada decided to consolidate in order to
achieve more efficient food safety systems.
Figure 4: Consolidation of Food Safety Entities in Denmark
As of 1997As of
1997
Ministry of
Ministry of Ministry of Municipalities Health
Agriculture Fisheries
Standard setting and Standard setting
Standard setting Inspections for
inspections and (Food processing Municipalities
inspections
(Meat and poultry (All plants,
fish and seafood, warehouses,
processing) including and local retail
on fishing stores)
vessels and in
processing plants)
CurrentCurrent
Ministry of Family and
Consumer Affairs
Danish Veterinary and
Food
Administration
(Standard setting and
inspections)
Source: GAO diagram based on information provided by Danish Food Safety
Officials.
Note: The Danish Veterinary and Food Administration is responsible for
almost all food safety responsibilities. Exceptions are the Plant
Directorate, which is responsible for animal feed inspections, and the
Directorate for Fisheries, which is responsible for inspection of fish on
ships. These two agencies are in the Ministry of Food, Agriculture, and
Fisheries.
Figure 5: Consolidation of Food Safety Entities in Canada
As of 1997
As of 1997
Health Canada Agriculture and
Fisheries and
Agri-Food Canada Oceans Canada
Inspections, food Inspections, food Inspections, food
policy policy policy
and risk assessment and risk assessment and risk assessment
Current
Current
Canadian Food Health Canada Inspection Agency
o Inspections of all food Public health policy,
o Animal and plant disease risk assessment, and control standard setting
Conclusions
Source: GAO diagram based on information provided by Canadian Food Safety
Officials.
Note: The Canadian Food Inspection Agency is responsible for all
inspection/compliance activities, including inspections of
imported/domestic products, laboratory and diagnostic support, crisis
management and product recalls, and export certification. In addition to
the responsibilities listed above, Health Canada is responsible for
research and setting limits on the amount of a substance allowed in a food
product.
In recent years, many proposals from the Congress and others have been
made to reform existing laws and consolidate the governmental structure
for ensuring the safety of the food supply. As we have reported in the
past, the current system is fragmented and causes inefficient use of
resources, inconsistent oversight and enforcement, and ineffective
coordination. We have recommended that the Congress consider statutory and
organizational reforms, and we continue to believe that the benefits of
establishing a single national system for the regulation of our food
supply outweigh the costs. In making these recommendations, we fully
recognize the time and effort needed to develop a reorganization plan and
to transfer authorities, as necessary, under such a reorganization.
We also recognize that improvements short of restructuring the current
system can be made to help reduce overlaps and duplication, and to
leverage existing resources. Therefore, in the report that you are
releasing today, we make several recommendations to that end. For example,
if cost effective, we recommend that FDA, as authorized under the
Bioterrorism Act, commission USDA inspectors to carry out inspections of
FDAregulated foods at food establishments that are under their joint
jurisdiction. We also recommend that USDA and FDA examine the feasibility
and cost effectiveness of establishing a joint training program for their
food inspectors.
For further information about this testimony, please contact Robert A.
Robinson, Managing Director, Natural Resources and Environment, (202)
512-3841. Maria Cristina Gobin, Terrance N. Horner, Jr., Gary Brown,
Katheryn Hubbell, Carol Herrnstadt Shulman, and Katherine Raheb made key
contributions to this statement.
Contacts and Staff Acknowledgements
Appendix I: Federal Agencies with Food Safety Responsibilities
Table 2: Federal Agencies' Food Safety Responsibilities
Department and/or agency Responsible for
U.S. Department of Agriculture Food Safety and Inspection Service All
domestic and imported meat, poultry, and processed egg products
Animal and Plant Health Inspection Service Protecting the health and
value of U.S. agricultural resources (e.g., animals and plants)
Grain Inspection, Packers and Stockyards Establishing quality standards,
inspection
Administration procedures, and marketing of grain and other related
products
Agricultural Marketing Service (AMS)a Establishing quality and condition
standards for dairy, fruit, vegetable, livestock, meat, poultry, and egg
products
Agricultural Research Service Conducting food safety research
Economic Research Service Providing analyses of the economic issues
affecting the safety of the U.S. food supply
National Agricultural Statistics Service Providing statistical data,
including agricultural chemical usage data, related to the safety of the
food supply
Cooperative State Research, Education and Supporting food safety research,
education,
Extension Service and extension programs in the land-grant university
system and other partner organizations
Department of Health and Human Food and Drug Administration (FDA) All
domestic and imported food products except Services meat, poultry, or
processed egg products
Centers for Disease Control and Prevention Protecting the nation's public
health, including (CDC) foodborne illness surveillance
Department of Commerce National Marine Fisheries Service Voluntary,
fee-for-service examinations of seafood for safety and quality
Environmental Protection Agency Regulating the use of pesticides and
maximum allowable residue levels on food commodities and animal feed
Department of the Treasury Alcohol and Tobacco Tax and Trade
Bureau Enforcing laws covering the production, use, and distribution of
alcoholic beverages
Department of Homeland Securityb Coordinating agencies' food security activities
Federal Trade Commission Prohibiting false advertisements for food
Source: GAO.
aAccording to USDA, AMS has no statutory authority in the area of food
safety. However, the agency performs some functions related to food safety
for several foods. For example, AMS graders monitor a shell egg
surveillance program that identifies cracked and dirty eggs. In addition,
AMS performs functions related to food safety for the National School
Lunch Program.
bIn 2001, by executive order, the President stated that the-then Office of
Homeland Security, as part of its efforts to protect critical
infrastructures, should coordinate efforts to protect livestock,
agriculture, and food systems from terrorist attacks. In 2002, Congress
enacted the Homeland Security Act of 2002, Pub. L. No. 107-296, 116 Stat.
2135 (2002), setting out the department's responsibility to protect and
secure critical infrastructures and transferring several food
safety-related responsibilities to the Department of Homeland Security. As
a result of the executive order, the Homeland Security Act of 2002
establishing the Department of Homeland Security, and subsequent
presidential directives, the Department of Homeland Security provides
overall coordination on the protection of the U.S. food supply from
deliberate contamination.
Related GAO Products
Oversight of Food Safety Activities: Federal Agencies Should Pursue
Opportunities to Reduce Overlap and Better Leverage Resources. GAO-05213.
Washington, D.C.: March 30, 2005.
Homeland Security: Much Is Being Done to Protect Agriculture from a
Terrorist Attack, but Important Challenges Remain. GAO-05-214. Washington,
D.C.: March 8, 2005.
Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but
Oversight Weaknesses Continue to Limit Program Effectiveness. GAO-05101.
Washington, D.C.: February 25, 2005.
Food Safety: Experiences of Seven Countries in Consolidating Their Food
Safety Systems. GAO-05-212. Washington, D.C.: February 22, 2005.
Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food. GAO-05-51. Washington, D.C.: October
7, 2004.
Posthearing Questions Related to Fragmentation and Overlap in the Federal
Food Safety System. GAO-04-832R. Washington, D.C.: May 26, 2004.
Federal Food Safety and Security System: Fundamental Restructuring Is
Needed to Address Fragmentation and Overlap. GAO-04-588T. Washington,
D.C.: March 30, 2004.
Food Safety: FDA's Imported Seafood Safety Program Shows Some Progress,
but Further Improvements Are Needed. GAO-04-246. Washington, D.C.: January
30, 2004.
Bioterrorism: A Threat to Agriculture and the Food Supply. GAO-04-259T.
Washington, D.C.: November 19, 2003.
Combating Bioterrorism: Actions Needed to Improve Security at Plum Island
Animal Disease Center. GAO-03-847. Washington, D.C.: September 19, 2003.
Results-Oriented Government: Shaping the Government to Meet 21st Century
Challenges. GAO-03-1168T. Washington, D.C.: September 17, 2003.
School Meal Programs: Few Instances of Foodborne Outbreaks Reported, but
Opportunities Exist to Enhance Outbreak Data and Food Safety Practices.
GAO-03-530. Washington, D.C.: May 9, 2003.
Agricultural Conservation: Survey Results on USDA's Implementation of Food
Security Act Compliance Provisions. GAO-03-492SP. Washington, D.C.: April
21, 2003.
Food-Processing Security: Voluntary Efforts Are Under Way, but Federal
Agencies Cannot Fully Assess Their Implementation. GAO-03-342. Washington,
D.C.: February 14, 2003.
Meat and Poultry: Better USDA Oversight and Enforcement of Safety Rules
Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902. Washington,
D.C.: August 30, 2002.
Foot and Mouth Disease: To Protect U.S. Livestock, USDA Must Remain
Vigilant and Resolve Outstanding Issues. GAO-02-808. Washington, D.C.:
July 26, 2002.
Genetically Modified Foods: Experts View Regimen of Safety Tests as
Adequate, but FDA's Evaluation Process Could Be Enhanced. GAO-02-566.
Washington, D.C.: May 23, 2002.
Food Safety: Continued Vigilance Needed to Ensure Safety of School Meals.
GAO-02-669T. Washington, D.C.: April 30, 2002.
Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory
Areas Would Strengthen U.S. Prevention Efforts. GAO-02-183. Washington,
D.C.: January 25, 2002.
Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be
Addressed Before Implementation. GAO-02-59. Washington, D.C.: December 17,
2001.
Food Safety and Security: Fundamental Changes Needed to Ensure Safe
Food.GAO-02-47T. Washington, D.C.: October 10, 2001.
Food Safety: CDC Is Working to Address Limitations in Several of Its
Foodborne Disease Surveillance Systems. GAO-01-973. Washington, D.C.:
September 7, 2001.
Food Safety: Overview of Federal and State Expenditures. GAO-01-177.
Washington, D.C.: February 20, 2001.
Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect
Consumers. GAO-01-204. Washington, D.C.: January 31, 2001.
Food Safety: Actions Needed by USDA and FDA to Ensure That Companies
Promptly Carry Out Recalls. GAO/RCED-00-195. Washington, D.C.: August 17,
2000.
Food Safety: Improvements Needed in Overseeing the Safety of Dietary
Supplements and "Functional Foods." GAO/RCED-00-156. Washington, D.C.:
July 11, 2000.
School Meal Programs: Few Outbreaks of Foodborne Illness Reported.
GAO/RCED-00-53. Washington, D.C.: February 22, 2000.
Meat and Poultry: Improved Oversight and Training Will Strengthen New Food
Safety System. GAO/RCED-00-16. Washington, D.C.: December 8, 1999.
Food Safety: Agencies Should Further Test Plans for Responding to
Deliberate Contamination. GAO/RCED-00-3. Washington, D.C.: October 27,
1999.
Food Safety: U.S. Needs a Single Agency to Administer a Unified,
Risk-Based Inspection System. GAO/T-RCED-99-256. Washington, D.C.: August
4, 1999.
Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety.
GAO/RCED-99-184. Washington, D.C.: July 1, 1999.
Food Safety: Experiences of Four Countries in Consolidating Their Food
Safety Systems. GAO/RCED-99-80. Washington, D.C.: April 20, 1999.
Food Safety: Opportunities to Redirect Federal Resources and Funds Can
Enhance Effectiveness. GAO/RCED-98-224. Washington, D.C.: August 6, 1998.
Food Safety: Federal Efforts to Ensure Imported Food Safety Are
Inconsistent and Unreliable. GAO/T-RCED-98-191. Washington, D.C.: May 14,
1998.
Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are
Inconsistent and Unreliable. GAO/RCED-98-103. Washington, D.C.: April 30,
1998.
Food Safety: Agencies' Handling of a Dioxin Incident Caused Hardships for
Some Producers and Processors. GAO/RCED-98-104. Washington, D.C.: April
10, 1998.
Food Safety: Fundamental Changes Needed to Improve Food Safety.
GAO/RCED-97-249R. Washington, D.C.: September 9, 1997.
Food Safety: Information on Foodborne Illnesses. GAO/RCED-96-96.
Washington, D.C.: May 8, 1996.
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