Overseeing the U.S. Food Supply
Steps Should be Taken to Reduce Overlapping Inspections and Related Activities Gao ID: GAO-05-549T May 17, 2005GAO 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.
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. 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.
GAO-05-549T, Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities
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Testimony:
Before the Subcommittee on the Federal Workforce and Agency
Organization, Committee on Government Reform, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 2:00 p.m. EDT:
Thursday, May 17, 2005:
Overseeing the U.S. 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:
GAO Highlights:
Highlights of GAO-05-549T, a testimony to the Subcommittee on the
Federal Workforce and Agency Organization, Committee on Government
Reform, House of Representatives:
Why GAO Did This Study:
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.
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.
What GAO Recommends:
In the past, GAO has recommended that the Congress consider fundamental
restructuring to ensure the effective use of scarce government
resources. In the report that the Subcommittee is releasing today, GAO
recognizes that, short of reorganization, other improvements can be
made to help reduce overlap and duplication and to leverage existing
resources. For example, the Food and Drug Administration (FDA) could
use existing authority to commission U.S. Department of Agriculture
(USDA) inspections of dual jurisdiction establishments.
www.gao.gov/cgi-bin/getrpt?GAO-05-549T.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Robert A. Robinson at
(202) 512-3841 or robinsonr@gao.gov.
[End of section]
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.[Footnote 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.[Footnote 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--and dedicated 8,733 and 1,812 full-time equivalent staff,
respectively, for these activities.[Footnote 3]
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.[Footnote 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.[Footnote 5] My
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.
Background:
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.[Footnote 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 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.[Footnote
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 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.[Footnote 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.[Footnote 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.
Table 1: Examples of Similar Food Safety Activities:
Food safety program function: Inspection/Enforcement;
Activity: Inspection of domestic food-processing facilities.
Food safety program function: Inspection/Enforcement;
Activity: Visits to foreign countries or firms to conduct inspections
and/or evaluate foreign food safety systems.
Food safety program function: Inspection/Enforcement;
Activity: Inspection of imported food at ports of entry.
Food safety program function: Inspection/Enforcement;
Activity: Training inspectors.
Food safety program function: Inspection/Enforcement;
Activity: Maintenance of inspection record database.
Food safety program function: Inspection/Enforcement;
Activity: Support to state enforcement efforts (retail-level food
safety).
Food safety program function: Inspection/Enforcement;
Activity: Laboratory analysis of samples collected at food-processing
facilities (to identify potential contamination).
Food safety program function: Research;
Activity: Research on pathogen reduction.
Food safety program function: Research;
Activity: Food safety program functionRisk assessment: Research on
foodborne chemical contaminants (such as pesticides or dioxins) or
biological contaminants (such as e-coli or salmonella).
Food safety program function: Risk assessment; Activity: Risk
assessment of food contaminants.
Food safety program function: Research;
Activity: Sample collection and/or analysis of pesticide residues to
inform risk assessment.
Food safety program function: Education/Outreach;
Activity: Development and delivery of consumer education (such as
consumer hotlines or pamphlets).
Food safety program function: Education/Outreach;
Activity: Development and delivery of industry guidance (such as
guidance regarding regulations).
Food safety program function: Education/Outreach;
Activity: International harmonization of standards.
Food safety program function: Surveillance/Monitoring;
Activity: Participation in FoodNet (active surveillance for foodborne
diseases).
Food safety program function: Surveillance/Monitoring;
Activity: Participation in PulseNet (early warning system for food
illness outbreak).
Food safety program function: Rulemaking/Standard setting;
Activity: HACCP rule development and promulgation[A].
Source: GAO analysis of documents obtained from, and discussions with,
USDA, FDA, EPA, and NMFS officials.
[A] Hazard 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.
[B] NMFS participated in developing FDA's seafood HACCP rule.
[End of table]
In fiscal year 2003, the four federal agencies spent nearly $1.7
billion on food safety-related activities.[Footnote 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:
[See PDF for image]
[End of figure]
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 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:
[See PDF for image]
[End of figure]
Federal Food Safety Agencies Conduct Overlapping Activities:
As a result of the multiple laws governing food safety, several federal
agencies conduct activities--inspections of domestic and imported
foods, training, research, risk assessment, education, and rulemaking-
-that can 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:
[See PDF for image]
[End of figure]
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.[Footnote 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. 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.[Footnote
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 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:
* 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 computer-
monitoring 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.
* 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 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,[Footnote 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.
Stakeholders Disagree on the Significance of Overlapping Activities and
on How to Improve the Federal Structure for Performing Food Safety
Inspections and Related Activities:
The stakeholders we contacted--selected industry associations, food-
processing 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 company to paint the same equipment because he determined that it
would be easier to identify sanitation problems on lightly painted
surfaces.
* Academics and Consumer Groups: Academics and consumer groups 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.
Other Countries Have Modified Laws and Consolidated Food Safety
Functions:
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,[Footnote 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.[Footnote 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, high-income countries tend to spend a
smaller percentage of their income on food than low-income countries.
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.[Footnote 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 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:
[See PDF for image]
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.
[End of figure]
Figure 5: Consolidation of Food Safety Entities in Canada:
[See PDF for image]
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.
[End of figure]
Conclusions:
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 FDA-regulated 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.
Contacts and Staff Acknowledgements:
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.
[End of section]
Appendix I Federal Agencies with Food Safety Responsibilities:
Table 2: Federal Agencies' Food Safety Responsibilities:
Department and/or agency: U.S. Department of Agriculture: Food Safety
and Inspection Service;
Responsible for: All domestic and imported meat, poultry, and processed
egg products.
Department and/or agency: U.S. Department of Agriculture: Animal and
Plant Health Inspection Service;
Responsible for: Protecting the health and value of U.S. agricultural
resources (e.g., animals and plants).
Department and/or agency: U.S. Department of Agriculture: Grain
Inspection, Packers and Stockyards Administration;
Responsible for: Establishing quality standards, inspection procedures,
and marketing of grain and other related products.
Department and/or agency: U.S. Department of Agriculture: Agricultural
Marketing Service (AMS)[A];
Responsible for: Establishing quality and condition standards for
dairy, fruit, vegetable, livestock, meat, poultry, and egg products.
Department and/or agency: U.S. Department of Agriculture: Agricultural
Research Service;
Responsible for: Conducting food safety research.
Department and/or agency: U.S. Department of Agriculture: Economic
Research Service;
Responsible for: Providing analyses of the economic issues affecting
the safety of the U.S. food supply.
Department and/or agency: U.S. Department of Agriculture: National
Agricultural Statistics Service;
Responsible for: Providing statistical data, including agricultural
chemical usage data, related to the safety of the food supply.
Department and/or agencyDepartment of Health and Human Services:
Cooperative State Research, Education and Extension Service;
Responsible for: Department and/or agencyDepartment of Health and Human
Services: Supporting food safety research, education, and extension
programs in the land-grant university system and other partner
organizations.
Department and/or agency: Department of Health and Human Services: Food
and Drug Administration (FDA);
Responsible for: All domestic and imported food products except meat,
poultry, or processed egg products.
Department and/or agency: Department of Health and Human Services:
Centers for Disease Control and Prevention (CDC);
Responsible for: Protecting the nation's public health, including
foodborne illness surveillance.
Department and/or agency: Department of Commerce;
National Marine Fisheries Service;
Responsible for: Voluntary, fee-for-service examinations of seafood for
safety and quality.
Department and/or agency: Environmental Protection Agency;
Responsible for: Regulating the use of pesticides and maximum allowable
residue levels on food commodities and animal feed.
Department and/or agency: Department of the Treasury: Alcohol and
Tobacco Tax and Trade Bureau;
Responsible for: Enforcing laws covering the production, use, and
distribution of alcoholic beverages.
Department and/or agency: Department of Homeland Security[B];
Responsible for: Coordinating agencies' food security activities.
Department and/or agency: Federal Trade Commission;
Responsible for: Prohibiting false advertisements for food.
Source: GAO.
[A] According 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.
[B] In 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.
[End of table]
[End of section]
Related GAO Products:
Oversight of Food Safety Activities: Federal Agencies Should Pursue
Opportunities to Reduce Overlap and Better Leverage Resources. GAO-05-
213. 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-05-
101. 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.
FOOTNOTES
[1] GAO, 21st Century Challenges: Reexamining the Base of the Federal
Government, GAO-05-352T (Washington, D.C.: Feb. 16, 2005).
[2] GAO, Federal Food Safety and Security System: Fundamental
Restructuring is Needed to Address Fragmentation and Overlap, GAO-04-
588T (Washington, D.C.: Mar. 30, 2004).
[3] In 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.
[4] GAO, 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).
[5] GAO, 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.
[6] Under the Egg Products Inspection Act, the Secretary of Health and
Human Services regulates whole eggs, while the Secretary of Agriculture
regulates egg products.
[7] Pub. L. No. 107-188, 116 Stat. 594 (2002).
[8] National Research Council and Institute of Medicine, Ensuring Safe
Food From Production to Consumption (Washington, D.C.: 1998).
[9] Report of the National Commission on the Public Service, Urgent
Business For America: Revitalizing the Federal Government For the 21st
Century (Washington, D.C.: 2003).
[10] The 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.
[11] Under 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.
[12] The countries that both USDA and FDA visited were Brazil, Costa
Rica, Germany, Hungary, Mexico, and Canada.
[13] NMFS is located within the Department of Commerce's National
Oceanic and Atmospheric Administration.
[14] GAO, Food Safety: Experiences of Seven Countries in Consolidating
Their Food Safety Systems, GAO-05-212 (Washington, D.C., Feb. 22,
2005).
[15] All seven countries, as well as the United States, are in the
World Bank's high-income category.
[16] In 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.
