Federal Oversight of Food Safety
FDA's Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical Gao ID: GAO-08-435T January 29, 2008The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. The recent outbreaks of E. coli in spinach, Salmonella in peanut butter, and contamination in pet food highlight the risks posed by the accidental contamination of FDA-regulated food products. Changing demographics and consumption patterns underscore the urgency for effective food safety oversight. In response to these challenges, in November 2007, FDA and others released plans that discuss the oversight of food safety. FDA's Food Protection Plan sets a framework for food safety oversight. In addition, FDA's Science Board released FDA Science and Mission at Risk, which concluded that FDA does not have the capacity to ensure the safety of the nation's food supply. This testimony focuses on (1) federal oversight of food safety as a high-risk area that needs a governmentwide reexamination, (2) FDA's opportunities to better leverage its resources, (3) FDA's Food Protection Plan, and (4) tools that can help agencies to address management challenges. To address these issues, GAO interviewed FDA officials; evaluated the Food Protection Plan using a GAO guide for assessing agencies' performance plans; and reviewed pertinent statutes and reports. GAO also analyzed data on FDA inspections and resources.
FDA is one of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in January 2007 and called for a governmentwide reexamination of the food safety system. We have reported on problems with this system--including inconsistent oversight, ineffective coordination, and inefficient use of resources. FDA has opportunities to better leverage its resources. Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace. GAO has recommended that FDA establish equivalence agreements with other countries to shift some oversight responsibility to foreign governments, explore the potential for certifying third party inspections, and consider accrediting private laboratories to inspect seafood, among other actions. We also reported that FDA and the U.S. Department of Agriculture (USDA) conduct similar inspections at 1,451 facilities that produce foods regulated by both agencies. To reduce overlaps, we recommended that, if cost-effective, FDA enter into an agreement to commission USDA inspectors at such facilities. FDA incorporated some of these recommendations in its Food Protection Plan. FDA's Food Protection Plan also proposes some positive first steps intended to enhance its oversight of food safety. Specifically, FDA requests authority to order food safety recalls and issue additional preventive controls for high-risk foods, both of which GAO has previously recommended. However, more specific information about its strategies and the resources FDA needs to implement the plan would facilitate congressional oversight. FDA officials acknowledge that implementing the Food Protection Plan will require additional resources. Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan's success in achieving its intended results. The Science Board cites numerous management challenges that have contributed to FDA's inability to fulfill its mission, including a lack of a coherent structure and vision, insufficient capacity in risk assessment, and inadequate human capital recruitment and retention. In light of these challenges, GAO has identified through other work some tools that can help agencies improve their performance over time. For example, a Chief Operating Officer/Chief Management Officer can help an agency address longstanding management problems that are undermining its ability to accomplish its mission and achieve results. In addition, a well-designed commission can produce specific practical recommendations that Congress can enact. Critical success factors that can help ensure a commission's success include a statutory basis with adequate authority, a clear purpose and timeframe, leadership support, an open process, a balanced membership, accountability, and resources.
GAO-08-435T, Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical
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Testimony:
Before the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 10:00 a.m. EST:
Tuesday, January 29, 2008:
Federal Oversight Of Food Safety:
FDA's Food Protection Plan Proposes Positive First Steps, but Capacity
to Carry Them Out Is Critical:
Statement of Lisa Shames, Director:
Natural Resources and Environment:
FDA's Food Safety Program:
GAO-08-435T:
GAO Highlights:
Highlights of GAO-08-435T, a testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, House
of Representatives.
Why GAO Did This Study:
The Food and Drug Administration (FDA) is responsible for ensuring the
safety of roughly 80 percent of the U.S. food supply, including $417
billion worth of domestic food and $49 billion in imported food
annually. The recent outbreaks of E. coli in spinach, Salmonella in
peanut butter, and contamination in pet food highlight the risks posed
by the accidental contamination of FDA-regulated food products.
Changing demographics and consumption patterns underscore the urgency
for effective food safety oversight. In response to these challenges,
in November 2007, FDA and others released plans that discuss the
oversight of food safety. FDA‘s Food Protection Plan sets a framework
for food safety oversight. In addition, FDA‘s Science Board released
FDA Science and Mission at Risk, which concluded that FDA does not have
the capacity to ensure the safety of the nation‘s food supply.
This testimony focuses on (1) federal oversight of food safety as a
high-risk area that needs a governmentwide reexamination, (2) FDA‘s
opportunities to better leverage its resources, (3) FDA‘s Food
Protection Plan, and (4) tools that can help agencies to address
management challenges. To address these issues, GAO interviewed FDA
officials; evaluated the Food Protection Plan using a GAO guide for
assessing agencies‘ performance plans; and reviewed pertinent statutes
and reports. GAO also analyzed data on FDA inspections and resources.
What GAO Found:
FDA is one of 15 agencies that collectively administer at least 30 laws
related to food safety. This fragmentation is the key reason GAO added
the federal oversight of food safety to its High-Risk Series in January
2007 and called for a governmentwide reexamination of the food safety
system. We have reported on problems with this system”including
inconsistent oversight, ineffective coordination, and inefficient use
of resources.
FDA has opportunities to better leverage its resources. Efficient use
of resources is particularly important at FDA because we found that its
food safety workload has increased in the past decade, while its food
safety staff and funding have not kept pace. GAO has recommended that
FDA establish equivalence agreements with other countries to shift some
oversight responsibility to foreign governments, explore the potential
for certifying third party inspections, and consider accrediting
private laboratories to inspect seafood, among other actions. We also
reported that FDA and the U.S. Department of Agriculture (USDA) conduct
similar inspections at 1,451 facilities that produce foods regulated by
both agencies. To reduce overlaps, we recommended that, if cost-
effective, FDA enter into an agreement to commission USDA inspectors at
such facilities. FDA incorporated some of these recommendations in its
Food Protection Plan.
FDA‘s Food Protection Plan also proposes some positive first steps
intended to enhance its oversight of food safety. Specifically, FDA
requests authority to order food safety recalls and issue additional
preventive controls for high-risk foods, both of which GAO has
previously recommended. However, more specific information about its
strategies and the resources FDA needs to implement the plan would
facilitate congressional oversight. FDA officials acknowledge that
implementing the Food Protection Plan will require additional
resources. Without a clear description of resources and strategies, it
will be difficult for Congress to assess the likelihood of the plan‘s
success in achieving its intended results.
The Science Board cites numerous management challenges that have
contributed to FDA‘s inability to fulfill its mission, including a lack
of a coherent structure and vision, insufficient capacity in risk
assessment, and inadequate human capital recruitment and retention. In
light of these challenges, GAO has identified through other work some
tools that can help agencies improve their performance over time. For
example, a Chief Operating Officer/Chief Management Officer can help an
agency address longstanding management problems that are undermining
its ability to accomplish its mission and achieve results. In addition,
a well-designed commission can produce specific practical
recommendations that Congress can enact. Critical success factors that
can help ensure a commission‘s success include a statutory basis with
adequate authority, a clear purpose and timeframe, leadership support,
an open process, a balanced membership, accountability, and resources.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.GAO-08-435T]. For more information, contact Lisa
Shames at (202) 512-3841 or ShamesL@gao.gov.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today to discuss the resources the Food and
Drug Administration (FDA) uses to meet one of its key regulatory
responsibilities, the oversight of food safety. FDA is responsible for
ensuring the safety of roughly 80 percent of the U.S. food supply,
including $417 billion worth of domestic food and $49 billion in
imported food annually. Contaminated food can harm human health, have
severe economic consequences, and undermine consumer confidence in the
government's ability to ensure the safety of the U.S. food supply. The
recent outbreaks of E. coli in spinach, Salmonella in peanut butter,
and contamination in pet food, highlight the risks posed by the
accidental contamination of FDA-regulated food products. For example,
according to FDA, the recent California spinach E. coli outbreak
resulted in 205 confirmed illnesses and 3 deaths, and industry
representatives estimate that economic losses ranged from $37 million
to $74 million.
Changing demographics and consumption patterns underscore the urgency
for effective food safety oversight. According to FDA, shifting
demographics mean that more of the U.S. population is, and increasingly
will be, susceptible to foodborne illnesses. The risk of severe and
life-threatening symptoms from infections caused by foodborne pathogens
is higher for older adults, young children, pregnant women, and immune
compromised individuals. According to FDA, these groups make up about
20 to 25 percent of the U.S. population. In addition, we are
increasingly eating foods that are consumed raw or with minimal
processing and often associated with foodborne illness. For example,
according to the U.S. Department of Agriculture (USDA), leafy greens
such as spinach, are the category of produce most likely to be
associated with an outbreak, and the average consumer ate 2.4 pounds of
fresh spinach in 2005--a 180 percent increase over 1992.
In response to these increasing challenges, FDA and other agencies
recently released plans that discuss the oversight of food safety. In
November 2007, FDA released its Food Protection Plan, which sets forth
FDA's framework for overseeing the safety of food.[Footnote 1]
Concurrently, a twelve-agency working group presented to the President
its Action Plan for Import Safety,[Footnote 2] which contains, among
other things, recommendations for improving the safety of food imports
entering the United States. Both plans spell out numerous actions FDA
plans to take to enhance food safety, including writing new food
protection guidelines for industry and helping foreign countries
improve their regulatory systems. The plans also request new
legislative authorities. One requested legislative authority is for
enhanced access to a food company's records during food safety
emergencies. Subsequently, FDA's Science Board, an advisory board to
the agency, released a report titled, FDA Science and Mission at
Risk.[Footnote 3] This report, which is the focus of today's hearing,
concluded that FDA is not positioned to meet current or emerging
regulatory needs, and stated that FDA does not have the capacity, such
as staffing and technology, to ensure the safety of the nation's food
supply. In addition, the report found that FDA's ability to provide its
basic food system inspection, enforcement, and rulemaking functions is
severely eroded, as is its ability to respond to outbreaks of foodborne
illnesses in a timely manner and to develop and keep pace with the
science needed to prevent food safety problems. The report stated that
the system cannot be fixed using available resources, and its primary
food safety recommendation was that FDA needs additional resources to
fulfill its regulatory mandate.
I will focus on four key points: (1) federal oversight of food safety
is a high-risk area that needs a governmentwide reexamination, (2) FDA
has opportunities to better leverage its resources, (3) FDA's Food
Protection Plan proposes some positive first steps but additional
information on the plan's strategies and resources can facilitate
congressional oversight, and (4) tools such as a commission or chief
operating officer can help agencies to address management challenges.
This testimony is based on new and previously issued work. Today, GAO
is also testifying on another FDA regulatory responsibility--
inspections of medical device manufacturers.[Footnote 4] These and
other recent testimonies on food and drug safety offer observations on
FDA's management capacity.
To assess FDA's Food Protection Plan, we interviewed FDA officials;
reviewed pertinent statutes and reports; and evaluated the plan using a
GAO guide for assessing agencies' performance plans. To analyze data on
FDA inspections, we examined data from FDA and determined that they
were sufficiently reliable for our analyses. We also reviewed funding
data from the Science Board and analyzed the data in real terms. To
provide updated information on our previously issued reports, we
gathered information on the status of our recommendations. We conducted
our work in January 2008 in accordance with generally accepted
government auditing standards. Those standards require that we plan and
perform the audit to obtain sufficient, appropriate evidence to provide
a reasonable basis for our findings and conclusions based on our audit
objectives. We believe that the evidence obtained provides a reasonable
basis for our findings and conclusions based on our audit objectives.
Federal Oversight of Food Safety Is a High-Risk Area that Needs a
Governmentwide Reexamination:
While part of today's hearing focuses specifically on FDA's
responsibilities for the oversight of food safety, it is important to
note that FDA is one of 15 federal agencies that collectively
administer at least 30 laws related to food safety. This fragmentation
is a key reason we designated federal oversight of food safety as a
high-risk area. Two agencies have primary responsibility--FDA is
responsible for the safety of virtually all foods except for meat,
poultry, and processed egg products, which are the responsibility of
USDA. In addition, among other agencies, the National Marine Fisheries
Service (NMFS) in the Department of Commerce conducts voluntary, fee-
for-service inspections of seafood safety and quality; the
Environmental Protection Agency (EPA) regulates the use of pesticides
and maximum allowable residue levels on food commodities and animal
feed; and the Department of Homeland Security is responsible for
coordinating agencies' food security activities. This federal
regulatory system for food safety, like many other federal programs and
policies, evolved piecemeal, typically in response to particular health
threats or economic crises.
In January 2007, we added the federal oversight of food safety to our
High-Risk Series,[Footnote 5] which is intended to raise the priority
and visibility of government programs that are in need of broad-based
transformation to achieve greater economy, efficiency, effectiveness,
accountability, and sustainability. Over the past 30 years, we have
reported on issues--for example, the need to transform the federal
oversight framework to reduce risks to public health as well as the
economy--that suggest that the federal oversight of food safety could
be designated as a high-risk area. The fragmented nature of the federal
food oversight system calls into question whether the government can
plan more strategically to inspect food production processes, identify
and react more quickly to outbreaks of foodborne illnesses, and focus
on promoting the safety and integrity of the nation's food supply.
While we have reported on problems with the federal food safety system-
-including inconsistent oversight, ineffective coordination, and
inefficient use of resources--most noteworthy for today's hearing is
that federal expenditures for the oversight of food safety have not
been commensurate with the volume of foods regulated by the agencies or
consumed by the public. We have reported that four agencies--USDA, FDA,
EPA, and NMFS--spent a total of $1.7 billion on food safety-related
activities in fiscal year 2003.[Footnote 6] USDA and FDA were
responsible for nearly 90 percent of those federal expenditures.
However, the majority of federal expenditures for food safety
inspection were directed toward USDA's programs for ensuring the safety
of meat, poultry, and egg products even though USDA is responsible for
regulating only about 20 percent of the food supply. In contrast, FDA
accounted for only 24 percent of expenditures even though it is
responsible for regulating about 80 percent of the food supply.
Others have called for fundamental changes to the federal food safety
system overall. In 1998, the National Academy of Sciences concluded
that the system is not well equipped to meet emerging
challenges.[Footnote 7] In response to the Academy's report, the
President established a Council on Food Safety which released a Food
Safety Strategic Plan in January 2001. The plan recognized the need for
a comprehensive food safety statute and concluded, "the current
organizational structure makes it more difficult to achieve future
improvements in efficiency, efficacy, and allocation of resources based
on risk."
While many of the recommendations we made have been acted upon, a
fundamental reexamination of the federal food safety system is
warranted. Taken as a whole, our work indicates that Congress and the
executive branch can and should create the environment needed to look
across the activities of individual programs within specific agencies,
including FDA, and toward the goals that the federal government is
trying to achieve. To that end, we have recommended, among other
things, that Congress enact comprehensive, uniform, and risk-based food
safety legislation and commission the National Academy of Sciences or a
blue ribbon panel to conduct a detailed analysis of alternative
organizational food safety structures.[Footnote 8] We have also
recommended that the executive branch reconvene the President's Council
on Food Safety to facilitate interagency coordination on food safety
regulation and programs. According to documents on the council's Web
site, the current administration has not reconvened the council.
These actions can begin to address the fragmentation in the federal
oversight of food safety. Going forward, to build a sustained focus on
the safety and integrity of the nation's food supply, Congress and the
executive branch can integrate various expectations for food safety
with congressional oversight and through agencies' strategic planning
processes, including FDA's. We have previously reported that the
development of a governmentwide performance plan that is mission-based,
is results-oriented, and provides a cross-agency perspective offers a
framework to help ensure agencies' goals are complementary and mutually
reinforcing. Further, with pressing fiscal challenges, this plan can
help decision makers balance trade-offs and compare performance when
resource allocation and restructuring decisions are made.
FDA Has Opportunities to Better Leverage its Resources:
In response to the nation's fiscal challenges, agencies may have to
explore new approaches to achieve their missions, and we have
identified options for FDA to better leverage its resources. Efficient
use of resources is particularly important at FDA because, while its
food safety workload has increased in the past decade, resources have
not kept pace. FDA has proposed actions toward implementing some of
these options.
Our analysis of FDA data shows that while FDA received increased
funding for new bioterrorism-related responsibilities in 2003,
subsequent staffing levels and funding have not kept pace with the
agency's growing responsibilities. Specifically, the number of FDA-
regulated domestic food establishments increased more than 10 percent
from fiscal years 2003 to 2007--from about 58,260 in 2003 to about
65,520 in 2007. Additionally, FDA notes that there have been dramatic
changes in the volume, variety, and complexity of FDA-regulated
products arriving at U.S. ports, and recently reported that the number
of food import entry lines has tripled in the past ten years.[Footnote
9] Meanwhile, staffing for FDA's Center for Food Safety and Applied
Nutrition (CFSAN) has decreased. According to the Science Board, the
number of staff years for CFSAN operations at headquarters dropped
about 14 percent, from 950 in fiscal year 2003 to 812 in fiscal year
2006. During that same time period, field-based staff responsible for
carrying out inspection and enforcement activities for CFSAN-regulated
products dropped by 255 staff years, or about 11.5 percent--from 2,217
in fiscal year 2003 to 1,962 in fiscal year 2006. In addition, while
CFSAN-related funding at headquarters and in the field increased from
$407 million in fiscal year 2003 to $439 million in fiscal year 2006,
this represents a decrease in real terms from about $457 million to
about $451 million during that period. One consequence is that foreign
inspections have declined: GAO analysis of FDA data shows that
inspections of foreign food firms, which number almost 190,000,
decreased from 211 in fiscal year 2001 to fewer than 100 in fiscal year
2007. The Science Board considered the funding issues to be more acute
for CFSAN than for other FDA programs: unlike the FDA programs
responsible for drugs, biologics, and medical devices, which charge
manufacturers hundreds of millions of dollars in user fees each year,
CFSAN is not authorized to charge user fees for its services.
Recent GAO work has identified opportunities for FDA to better leverage
its resources. Specifically, in 2004 we reviewed FDA's imported seafood
safety program and identified several options that FDA could consider
to augment its resources and enhance its current program.[Footnote 10]
We found that FDA's seafood safety program had shown some progress from
a 2001 review. For example, FDA increased its laboratory testing of
seafood products at ports of entry from less than 1.0 percent in fiscal
year 1999 to about 1.2 percent in fiscal year 2002. We also recommended
several options for enhancing FDA's oversight of seafood while
leveraging outside resources. Some of these options are presented in
FDA's Food Protection Plan. We recommended that FDA:
* Make it a priority to establish equivalence agreements with other
countries. Subject to its jurisdiction, FDA could certify that
countries exporting food products to the United States have equivalent
food safety systems before food products from those countries can enter
the United States. Such agreements would shift some of FDA's oversight
burden to foreign governments. While FDA has not yet established
equivalence agreements with any foreign countries, the Food Protection
Plan requests that Congress allow the agency to enter into agreements
with exporting countries to certify that foreign producers' shipments
of designated high-risk products comply with FDA standards.
* Explore the potential for certifying third-party inspectors. FDA
could consider developing a program that uses certified third-party
inspectors to conduct inspections on its behalf, both at foreign
processing firms and domestic importers of seafood. FDA's Food
Protection Plan requests authority from Congress to accredit third
parties to conduct voluntary inspections for foods, and FDA officials
told us that they envision using third-party inspectors to inspect
foreign facilities, where FDA conducts few inspections. If FDA receives
this authority, it can take lessons from its own implementation of
third-party inspection programs for medical device manufacturing
establishments. As we are reporting in a separate statement today, few
inspections of these establishments have been conducted through FDA's
two accredited third-party inspection programs.
* Consider accrediting private laboratories to test seafood. Currently,
FDA does not accredit or use any private laboratories to collect or
analyze seafood samples. However, for some seafood violations, it
allows seafood firms to use private laboratories to provide evidence
that imported seafood previously detained because of safety concerns is
now safe and can be removed from the detention list at the port of
entry. We recommended that FDA consider accrediting private
laboratories because it could leverage outside resources while
providing FDA greater assurance about the quality of the laboratories
importers use to demonstrate that their products are safe. FDA has not
formally changed its policies or practices, but the Action Plan for
Import Safety notes that FDA intends to issue guidance by mid-2008 on
sampling and testing of imported products, including the use of
accredited private laboratories submitting data to FDA on food safety.
* Develop a memorandum of understanding with the National Oceanic and
Atmospheric Administration (NOAA) to use NOAA's Seafood Inspection
Program resources to complete inspections on FDA's behalf. NOAA
officials said that they could provide various services to augment
FDA's regulatory program for imported seafood, including inspection,
training, and product sampling services. FDA has been working on a
program to refer certain export-related work to NOAA, and it is in
discussions with NOAA about commissioning its inspectors, but to date,
nothing is finalized or operational.
We have not reviewed these actions to determine whether they adequately
address our recommendations.
We separately reported on overlaps we identified in the federal
oversight of food safety, such as overlapping inspection and training
activities that exist among the agencies conducting food safety
functions.[Footnote 11] Such overlaps mean that federal agencies are
spending resources on similar activities, which may waste scarce
resources and limit effectiveness. Specifically, we found that FDA food
safety activities may overlap with, if not duplicate, the efforts of
other agencies, including USDA and NMFS. FDA could take practical steps
to reduce overlap and duplication and thereby free resources for more
effective oversight of food safety, but FDA has made little progress
since our report. For example:
* Domestic inspections. In fiscal year 2003, FDA and USDA spent most of
their food safety resources--about $900 million--on inspection and
enforcement activities. A portion of these activities included
overlapping and even duplicative inspections of 1,451 domestic food-
processing facilities that produce foods regulated by both agencies.
Under authority granted by the Bioterrorism Act of 2002,[Footnote 12]
FDA could authorize USDA to inspect these facilities on its behalf, but
FDA has not yet reached an agreement with USDA to do this. We
recommended that, if cost effective, FDA enter into an agreement to
commission USDA inspectors at jointly regulated facilities. FDA told us
that they are working with USDA to consider which products might be
covered by each agency under such an agreement.
* Import inspections. FDA and USDA both inspect shipments of imported
food at ports of entry and also visit foreign countries that export
food to the United States. We found that both FDA and USDA maintain
inspectors at 18 U.S. ports of entry to inspect imported food. In
fiscal year 2003, FDA spent more than $115 million on imported food
inspections, and USDA spent almost $16 million. The two agencies do not
share inspection resources at these ports. Although USDA maintains a
daily presence at these facilities, the FDA-regulated products may
remain at the facilities for some time awaiting FDA inspection.
Further, FDA conducted inspections in 6 of the 34 countries that USDA
evaluated in 2004 to determine whether their food safety systems for
ensuring the safety of meat and poultry are equivalent to that of the
United States. We recommended that FDA consider the findings of USDA's
foreign country equivalence agreements when determining which countries
to visit. In their response to our recommendation, the agency noted
that they will consider USDA's foreign country evaluations when making
such determinations.
* Inspectors' training. FDA and USDA spend resources to provide similar
training to food inspection personnel. FDA spent about $1.6 million and
USDA spent $7.8 million in fiscal year 2003. We found that, to a
considerable extent, food inspection training addresses the same
subjects, such as plant sanitation and good manufacturing practices.
While other agencies have consolidated training activities that have a
common purpose and similar content, FDA and USDA have not. We
recommended that USDA and FDA consider joint training programs, but to
date, FDA has told us that they have identified no training needs
common to both agencies.
FDA's Food Protection Plan Proposes Some Positive First Steps, but
Additional Information on the Plan's Strategies and Resources would
Facilitate Congressional Oversight:
FDA's Food Protection Plan proposes several positive first steps that
are intended to enhance food safety oversight, including requesting
several authorities recommended by GAO, but more specific information
about its strategies and the resources needed to implement the plan
would facilitate congressional oversight. Positively, FDA's Food
Protection Plan aims to shift the agency's focus to prevention of
foodborne illness instead of intervention after contamination and
resulting illnesses occur--an important shift given that experts
consider prevention to be a core element of an effective food safety
system. FDA says that its key prevention steps are promoting corporate
responsibility, identifying food vulnerabilities, assessing risks, and
expanding its understanding and use of effective mitigation measures.
In addition to the actions we discuss earlier to address resource
constraints, FDA's Food Protection Plan requests other authorities to
enhance oversight of food safety that begin to respond to prior GAO
recommendations. Specifically, the plan requests authority for FDA to:
* Order food recalls. The Food Protection Plan requests the authority
to order a recall when FDA has reason to believe that food is
adulterated and presents a threat of serious adverse health
consequences or death, to be imposed only if a company refuses or
unduly delays conducting a voluntary recall. Currently, food recalls
are largely voluntary--federal agencies responsible for food safety,
including FDA, have no authority to compel companies to recall
contaminated foods, with the exception of FDA's authority to require a
recall for infant formula. FDA does have authority, through the courts,
to seize, condemn, and destroy adulterated or misbranded food under its
jurisdiction and to disseminate information about foods that are
believed to present a danger to public health. However, government
agencies that regulate the safety of other products, such as toys and
automobile tires, have recall authority not available to FDA for food
and have had to use their authority to ensure that recalls were
conducted when companies did not cooperate. These agencies have the
authority to require a company to notify the agency when the company
has distributed a potentially unsafe product, order a recall, establish
recall requirements, and impose monetary penalties if a company does
not cooperate. In a report and testimony before this
subcommittee,[Footnote 13] we noted that limitations in the FDA's food
recall authorities heighten the risk that unsafe food will remain in
the food supply and have proposed that Congress consider giving FDA
similar authorities. While FDA's Food Protection Plan requests
mandatory recall authority, this request could also include recall
authorities held by other agencies, including establishing recall
requirements and imposing penalties for noncompliance. FDA officials
noted that while recall requirements and penalties for noncompliance
were not explicitly stated in the Food Protection Plan, they are
encompassed in the request. Further, the plan does not propose a
definition of "undue delay" by a company, another critical element of
recall authority given that timing is essential in reacting to
outbreaks, and delays can cost lives.
* Issue additional preventive controls for high-risk foods. FDA is
requesting explicit authority from Congress to issue regulations
requiring foods that have been associated with repeated instances of
serious health problems or death to be prepared, packed, and held under
a system of preventive food safety controls. According to FDA, this
would clarify the agency's ability to require industries to implement
preventive Hazard Analysis and Critical Control Point (HACCP) systems,
which it currently requires for companies that process seafood and
juice. HACCP systems are designed to improve food safety by having
industry identify and control hazards in products before they enter the
market. FDA officials told us that they are asking for explicit
authority to put measures in place for other high-risk foods, such as
leafy greens. Officials told us that this request, if granted, would
allow the agency to focus its preventive efforts on foods that present
the highest risk for contamination, consistent with the agency's risk-
based focus. However, others have expressed concern that requiring a
history of repeated outbreaks before issuing preventive controls would
not allow FDA to proactively establish regulations for foods before
they cause additional illnesses.
While FDA officials have acknowledged that implementing the Food
Protection Plan will require additional resources, FDA has not provided
specific information on the resources it anticipates the agency will
need to implement this plan. For example, the Food Protection Plan
proposes to develop food protection guidelines for industry; however
FDA's Science Board reported that modernizing safety standards for
fresh produce and other raw foods and developing and implementing
inspection programs could cost $210 million. Additionally, the Food
Protection Plan proposes to enhance FDA's information technology
systems related to both domestic and imported foods which the Science
Board report suggests could cost hundreds of millions of dollars. FDA
officials have declined to provide specific information on how much
additional funding it believes will be necessary to implement the Food
Protection Plan, saying that finalizing the amounts will take place
during the budget process. Similarly, the Food Protection Plan does not
discuss the strategies it needs in the upcoming years to implement this
plan. FDA officials told us that they have internal plans for
implementing the Food Protection Plan that detail timelines, staff
actions, and specific deliverables. While FDA officials told us they do
not intend to make these plans public, they do plan to keep the public
informed of their progress. Without a clear description of resources
and strategies, it will be difficult for Congress to assess the
likelihood of the plan's success in achieving its intended results.
Tools that Agencies Can Use to Address Management Challenges:
The Science Board cites numerous management challenges that have
contributed to FDA's inability to fulfill its mission, such as a lack
of a coherent structure and vision, insufficient capacity in risk
assessment, and inadequate human capital recruitment and retention. The
Science Board also noted that public confidence in FDA's abilities has
diminished. In light of these challenges, we have identified through
other work some tools that can help agencies improve their performance,
which may also be relevant to FDA.
For example, we reported on the use of a Chief Operating Officer (COO)/
Chief Management Officer (CMO) as one way to address longstanding
management problems that are undermining agencies' abilities to
accomplish their missions and achieve results.[Footnote 14] Agencies
with such challenges, including FDA, could benefit from a senior leader
serving as a COO/CMO who can elevate, integrate, and institutionalize
responsibility for key management functions. While GAO has long
advocated the need for a COO/CMO position at the Department of Defense
and the Department of Homeland Security, a relatively stable or small
organization could use the existing deputy or related position to carry
out the role. In addition to GAO, a number of other organizations have
supported the need for the creation of COO/CMO positions in federal
agencies. McKinsey & Company recommended that a COO be established in
many federal agencies as the means to help those agencies successfully
achieve transformation.[Footnote 15] In addition, a working group
within the National Academy of Public Administration (NAPA) recommended
creating COO positions in federal agencies to oversee the full range of
management functions, including procurement, finance, information
technology, and human capital.[Footnote 16]
Another tool that can help federal agencies address their management
challenges is a well-designed commission that can produce specific
practical recommendations that Congress can enact. For example,
Congress created the National Commission on Restructuring the Internal
Revenue Service (IRS) in 1995 to review current practices at IRS and
report on requirements for improvement. Congress subsequently passed
the IRS Restructuring and Reform Act of 1998, which was influenced by
the Commission's report, and reorganized the structure and management
of IRS, revised the mission of IRS, and mandated numerous other
detailed changes.[Footnote 17] Based on our recent analysis of several
commissions, there are several critical success factors that can be
applied to ensure a commission's success including:[Footnote 18]
* A statutory basis with adequate authority. When provided with a clear
mandate and adequate authority, a commission can comprehensively access
and analyze information related to a given policy issue and thereby
provide more informed policy options for the President and Congress to
consider.
* A clear purpose and timeframe. A commission should have a clear
purpose for its objectives and activities to help guide the members in
carrying out their responsibilities. In addition, a fixed agenda and
timeframe can help keep a commission focused and on track. However, a
commission should have a broad enough scope to help ensure it has the
authority to address all the issues necessary in order to come up with
a comprehensive and integrated solution without encountering any
constraints in the process as to what it can or cannot consider.
* Key leadership support. Institutional leadership, commitment, and
support from the President and Congress are necessary to help a
commission succeed.
* An open and transparent process. By having an open and transparent
process, such as public hearings, a commission can help build consensus
among the public for its goals by gaining their input and support.
* A balanced and capable membership. Balanced and capable membership
can help lessen political influences and build consensus among the
commission members when carrying out its purpose. Specifically, a
commission should involve current or former Members of Congress as well
as experts and professionals on the topic. Current or former elected
officials can ensure viability of a commission's legislative proposals
due to their experience.
* Accountability. Clear accountability for a commission can help foster
specific, useful outputs that could help inform the public and provide
specific policy options and, hopefully, recommendations for Congress
and the President.
* Resources. The success of the commission is dependent on having the
adequate resources to carry out its purpose and any potential
recommendations.
Generally, one concern regarding commissions may be whether or not
there is sufficient buy-in from key stakeholders on the purpose of the
commission along with a commitment to act on any resulting
recommendations. Any recommendations by a commission in a final report
are generally advisory in nature and may not automatically result in
any public policy changes. Congressional action through subsequent
legislation with Presidential support may be necessary for the
commission's recommendations to be implemented and for any changes to
occur.
Food safety concerns not only continue but will likely become more
urgent in view of changing demographics and consumption patterns.
Clearly, FDA plays a critical role in the federal oversight of food
safety because of the breadth of its responsibilities. Thus its ability
to carry out those responsibilities is necessary to help ensure the
safety of the nation's food supply in the most efficient, effective,
accountable, and sustainable way. Nevertheless, in light of the federal
government's long-term fiscal challenges, agencies, including FDA, need
to seek out opportunities to better leverage their resources. FDA's
Food Protection Plan is a step in the right direction and proposes to
implement many of the recommendations made by GAO. However, additional
information on the strategies and resources needed to implement the
plan can help Congress assess the likelihood of its success. Further,
concerns over FDA's management challenges, such as those identified by
the Science Board could hinder the implementation of the plan. Tools
such as commissions and positions like a COO/CMO can help agencies
address management challenges and make needed progress to achieve their
missions. Continued congressional oversight, including today's hearing,
and additional legislative action are key to achieving that progress
and to promoting the safety and integrity of the nation's food supply.
Mr. Chairman, this concludes my prepared statement. I would be pleased
to respond to any questions that you or other Members of the
Subcommittee may have.
Contact and Staff Acknowledgments:
Contact points for our Offices of Congressional Relations and Public
Affairs may be found on the last page of this statement. For further
information about this testimony, please contact Lisa Shames, Director,
Natural Resources and Environment at (202) 512-3841 or shamesl@gao.gov.
Key contributors to this statement were Candace Carpenter, Bart
Fischer, José Alfredo Gómez, and Alison O'Neill.
Footnotes:
[1] Department of Health and Human Services, U.S. Food and Drug
Administration, Food Protection Plan (Washington, D.C., 2007).
[2] Interagency Working Group on Import Safety, Action Plan for Import
Safety (Washington, D.C., 2007).
[3] FDA Science Board, Subcommittee on Science and Technology, FDA
Science and Mission at Risk (Washington, D.C., November 2007).
[4] GAO, Medical Devices: Challenges for FDA in Conducting Manufacturer
Inspections, GAO-08-428T (Washington, D.C.: Jan. 29, 2008).
[5] GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.:
Jan. 31, 2007).
[6] GAO, Overseeing the U.S. Food Supply: Steps Should be Taken to
Reduce Overlapping Inspections and Related Activities, GAO-05-549T
(Washington, D.C.: May 17, 2005).
[7] Institute of Medicine, Ensuring Safe Food from Production to
Consumption (Washington, D.C., 1998).
[8] GAO, Food Safety and Security: Fundamental Changes Needed to Ensure
Safe Food, GAO-02-47T (Washington, D.C.: Oct. 10, 2001).
[9] According to FDA, an entry line is each portion of an import
shipment that is listed as a separate item on an entry document. Items
in an import entry having different tariff descriptions must be listed
separately.
[10] GAO, Food Safety: FDA's Imported Seafood Safety Program Shows Some
Progress, but Further Improvements Are Needed, GAO-04-246 (Washington,
D.C.: Jan. 30, 2004).
[11] 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).
[12] Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, Pub. L. No. 107-188, 116 Stat. 594.
[13] GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and
Complete Recalls of Potentially Unsafe Food, GAO-05-51 (Washington,
D.C.: Oct. 6, 2004) and Federal Oversight of Food Safety: High Risk
Designation Can Bring Attention to Limitations in the Federal
Government's Food Recall Programs, GAO-07-785T (Washington, D.C.: Apr.
24, 2007).
[14] See for example, GAO, A Call for Stewardship: Enhancing the
Federal Government's Ability to Address Key Fiscal and Other 21st
Century Challenges, GAO-08-93SP (Washington D.C.: November 2007) and
Organizational Transformation: Implementing Chief Operating Officer/
Chief Management Officer Positions in Federal Agencies, GAO-08-34
(Washington, D.C.: Nov. 1, 2007).
[15] McKinsey & Company, How Can American Government Meet its
Productivity Challenge? (July 2006).
[16] NAPA, Moving from Scorecard to Strategic Partner: Improving
Financial Management in the Federal Government (October 2006).
[17] Pub. L. No. 105-206 (July 22, 1998).
[18] GAO, Long-Term Fiscal Challenge: Comments on the Bipartisan Task
Force for Responsible Fiscal Action Act, GAO-08-238T (Washington, D.C.:
Oct. 31, 2007).
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