Federal Oversight of Food Safety
FDA Has Provided Few Details on the Resources and Strategies Needed to Implement its Food Protection Plan Gao ID: GAO-08-909T June 12, 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. Changing demographics and consumption patterns along with an increase in imports have presented challenges to FDA. At the same time, recent outbreaks, such as E. coli from spinach and Salmonella from tomatoes, have undermined consumer confidence in the safety of the food supply. In November 2007, FDA released its Food Protection Plan, which articulates a framework for improving food safety oversight. In January 2008, GAO expressed concerns about FDA's capacity to implement the Food Protection Plan and noted that more specific information about the strategies and resources needed to implement the plan would facilitate congressional oversight. This testimony focuses on (1) FDA's progress in implementing the Food Protection Plan, (2) FDA's proposal to focus inspections based on risk, and (3) FDA's implementation of previously issued GAO recommendations intended to improve food safety oversight. To address these issues, GAO reviewed FDA documents, such as FDA's operations plan, and FDA data related to the plan. GAO also interviewed FDA officials regarding the progress made. GAO also analyzed FDA data on domestic and foreign food firm inspections. GAO also analyzed the status of past recommendations.
Since FDA's Food Protection Plan was first released in November 2007, FDA has added few details on the resources and strategies required to implement the plan. FDA plans to spend about $90 million over fiscal years 2008 and 2009 to implement several key actions, such as identifying food vulnerabilities and risk. From the information GAO has obtained on the Food Protection Plan, however, it is unclear what FDA's overall resource need is for implementing the plan, which could be significant. For example, based on FDA estimates, if FDA were to inspect each of the approximately 65,500 domestic food firms regulated by FDA once, the total cost would be approximately $524 million. In addition, timelines for implementing the various strategies in the plan are also unclear, although a senior level FDA official estimated that the overall plan will take 5 years to complete. Importantly, GAO has noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people. FDA officials told GAO that they had prepared a draft report on progress made in implementing the Food Protection Plan, but as of June 4, 2008, FDA told GAO that the Department of Health and Human Services had not cleared the report for release. The Food Protection Plan identifies the need to focus safety inspections based on risk, which is particularly important as the numbers of food firms have increased while inspections have decreased. For example, between 2001 and 2007, the number of domestic firms under FDA's jurisdiction increased from about 51,000 to more than 65,500, while the number of firms inspected declined slightly, from 14,721 to 14,566. Thus, conducting safety inspections based on risk has the potential to be an efficient and effective approach for FDA to target scarce resources based on relative vulnerability and risk. FDA has implemented few of GAO's past recommendations to leverage its resources and improve food safety oversight. Since 2004, GAO has made a total of 34 food safety related recommendations to FDA, and as of May 2008, FDA has implemented 7 of these recommendations. For the remaining recommendations, FDA has not fully implemented them, however, in some cases, FDA has taken some steps. However, the planned activities in the Food Protection Plan could help address several of the recommendations that FDA has not implemented. For example, in January 2004, GAO recommended that FDA make it a priority to establish equivalence agreements with other countries. We found that such agreements would shift some of FDA's oversight burden to foreign governments. As of May 2008, 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.
GAO-08-909T, Federal Oversight of Food Safety: FDA Has Provided Few Details on the Resources and Strategies Needed to Implement its Food Protection Plan
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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. EDT:
Thursday, June 12, 2008:
Federal Oversight Of Food Safety:
FDA Has Provided Few Details on the Resources and Strategies Needed to
Implement its Food Protection Plan:
Statement of Lisa Shames, Director:
Natural Resources and Environment:
Food Safety:
GAO-08-909T:
GAO Highlights:
Highlights of GAO-08-909T, 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. Changing demographics and consumption patterns along with an
increase in imports have presented challenges to FDA. At the same time,
recent outbreaks, such as E. coli from spinach and Salmonella from
tomatoes, have undermined consumer confidence in the safety of the food
supply. In November 2007, FDA released its Food Protection Plan, which
articulates a framework for improving food safety oversight. In January
2008, GAO expressed concerns about FDA‘s capacity to implement the Food
Protection Plan and noted that more specific information about the
strategies and resources needed to implement the plan would facilitate
congressional oversight. This testimony focuses on (1) FDA‘s progress
in implementing the Food Protection Plan, (2) FDA‘s proposal to focus
inspections based on risk, and (3) FDA‘s implementation of previously
issued GAO recommendations intended to improve food safety oversight.
To address these issues, GAO reviewed FDA documents, such as FDA‘s
operations plan, and FDA data related to the plan. GAO also interviewed
FDA officials regarding the progress made. GAO also analyzed FDA data
on domestic and foreign food firm inspections. GAO also analyzed the
status of past recommendations.
What GAO Found:
Since FDA‘s Food Protection Plan was first released in November 2007,
FDA has added few details on the resources and strategies required to
implement the plan. FDA plans to spend about $90 million over fiscal
years 2008 and 2009 to implement several key actions, such as
identifying food vulnerabilities and risk. From the information GAO has
obtained on the Food Protection Plan, however, it is unclear what FDA‘s
overall resource need is for implementing the plan, which could be
significant. For example, based on FDA estimates, if FDA were to
inspect each of the approximately 65,500 domestic food firms regulated
by FDA once, the total cost would be approximately $524 million. In
addition, timelines for implementing the various strategies in the plan
are also unclear, although a senior level FDA official estimated that
the overall plan will take 5 years to complete. Importantly, GAO has
noted that public reporting is the means through which the federal
government communicates the results of its work to the Congress and the
American people. FDA officials told GAO that they had prepared a draft
report on progress made in implementing the Food Protection Plan, but
as of June 4, 2008, FDA told GAO that the Department of Health and
Human Services had not cleared the report for release. The Food
Protection Plan identifies the need to focus safety inspections based
on risk, which is particularly important as the numbers of food firms
have increased while inspections have decreased. For example, between
2001 and 2007, the number of domestic firms under FDA‘s jurisdiction
increased from about 51,000 to more than 65,500, while the number of
firms inspected declined slightly, from 14,721 to 14,566. Thus,
conducting safety inspections based on risk has the potential to be an
efficient and effective approach for FDA to target scarce resources
based on relative vulnerability and risk. FDA has implemented few of
GAO‘s past recommendations to leverage its resources and improve food
safety oversight. Since 2004, GAO has made a total of 34 food safety
related recommendations to FDA, and as of May 2008, FDA has implemented
7 of these recommendations. For the remaining recommendations, FDA has
not fully implemented them, however, in some cases, FDA has taken some
steps. However, the planned activities in the Food Protection Plan
could help address several of the recommendations that FDA has not
implemented. For example, in January 2004, GAO recommended that FDA
make it a priority to establish equivalence agreements with other
countries. We found that such agreements would shift some of FDA‘s
oversight burden to foreign governments. As of May 2008, 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.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-909T]. 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 Food and Drug
Administration's (FDA) progress in implementing the Food Protection
Plan, which articulates FDA's plans to improve the oversight of food
safety. FDA is responsible for ensuring the safety of roughly 80
percent of the U.S. food supply--virtually all foods except for meat,
poultry, and processed egg products--including $417 billion worth of
domestic food and $49 billion in imported food annually. As you know,
in January 2007, we designated the federal oversight of food safety as
a high-risk area needing urgent attention and transformation.[Footnote
1] A key reason for that designation is that FDA is one of 15 agencies
that collectively administer at least 30 laws related to food safety.
Around the time of this designation, consumers faced several outbreaks
of foodborne illnesses, including E. coli from spinach and Salmonella
from peanut butter. Subsequently, the U.S. has seen more outbreaks of
foodborne illnesses, such as Salmonella from imported cantaloupes and
raw tomatoes. Not surprisingly, public trust in FDA's ability to
protect the food supply has fallen. A 2008 Harris poll showed that U.S.
adults have little confidence--and less confidence than last year--in
the safety of packaged or prepared foods that have been imported from
countries like China, India, or South Africa. In addition, a recent
public opinion poll conducted by the Trust for America's
Health[Footnote 2] found that 67 percent of Americans are worried about
food safety, ranking it higher than concerns about, for example,
pandemic flu or natural disasters.
Concerns about food safety oversight are not new. GAO and others have
consistently reported on a lack of adequate oversight of food safety by
FDA, and have provided many recommendations for better leveraging FDA's
limited resources and suggestions for additional authorities that would
allow FDA to better fulfill its responsibilities. In 1998, we reported
that limitations in FDA's authority and its need to more effectively
target limited resources could adversely affect its ability to ensure
food safety.[Footnote 3] A decade later, the story remains the same and
has only taken on a greater sense of urgency due to changing
demographics and consumption patterns that, according to FDA, have put
more of the U.S. population at risk of contracting foodborne illnesses.
Populations at high risk of foodborne illnesses--older adults, young
children, pregnant women, and immune compromised individuals--now make
up 20 to 25 percent of the U.S. population. In addition, U.S. consumers
are increasingly eating raw or minimally processed foods, which are
often associated with foodborne illnesses. For example, the consumption
rate of leafy greens--the category of produce most likely to be
associated with an outbreak--increased 180 percent between 1992 and
2005, according to the U.S. Department of Agriculture. Compounding the
challenges, the number of FDA-regulated domestic food establishments
has increased more than 10 percent in the last five years and the
number of food import entry lines has tripled in the past ten
years.[Footnote 4]
To respond to the need for better oversight of food safety, FDA
released its Food Protection Plan in November 2007, which articulates
FDA's framework for overseeing the safety of food and outlines three
core elements--prevention, intervention, and response--that are the
focus of FDA's efforts to improve oversight.[Footnote 5] At the same
time, a twelve-agency working group presented to the President its
Action Plan for Import Safety,[Footnote 6] 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, such as enhanced access to a food company's
records during food safety emergencies.
Also, in November 2007, FDA's Science Board, an advisory board to the
agency, released a report entitled, FDA Science and Mission at
Risk.[Footnote 7] This report 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. According to the Science Board
report, FDA's resources have not kept pace with its increasing
responsibilities, and this disparity has made it increasingly
"impossible" for FDA to maintain its historic public health mission. In
addition, the report finds that food safety resources have increasingly
been diverted away from routine surveillance and other tasks to
managing crises as they arise and the nation's food supply is at risk.
In February 2008, the Science Board estimated that, to implement its
recommendations to protect the nation's food supply, FDA's base budget
would need to increase by a total of $755 million by fiscal year 2013,
phased in over time starting with $128 million in fiscal year 2009.
In response to these concerns, Congress has expressed considerable
interest in enhancing FDA's oversight of food safety, and the House
Energy and Commerce Committee has held hearings to consider a draft
bill entitled The Food and Drug Administration Globalization Act of
2008 which, in part, would provide some of FDA's requested
authorities.[Footnote 8] This draft bill also contains provisions that
are consistent with several past GAO recommendations to FDA and matters
for congressional consideration regarding FDA's food safety programs.
For example, the draft bill contains provisions that would allow FDA to
leverage resources using outside organizations, such as third-party
inspectors.
As part of its congressional oversight of FDA's challenges in meeting
its responsibilities, we testified in January 2008 before this
subcommittee and reported that FDA's Food Protection Plan proposes
positive first steps for FDA.[Footnote 9] For example, FDA requests
authority to order food recalls and issue additional preventive
controls for high-risk foods, both of which we previously recommended.
However, we expressed concerns about FDA's capacity to implement the
plan and noted that more specific information about its strategies and
the resources FDA needs to implement the plan would facilitate
congressional oversight. We recognized that without a clear description
of resources and strategies, it would be difficult for Congress to
assess the likelihood that the plan will achieve its intended results.
In this context, my testimony today focuses on FDA's progress in
implementing the Food Protection Plan, FDA's proposal to focus
inspections based on risk, and FDA's implementation of previously
issued GAO recommendations intended to improve food safety oversight.
In summary, we have found (1) FDA has added few details on the
resources and strategies required to implement its Food Protection
Plan, (2) FDA's proposal to focus inspections based on risk can help
target scarce resources, and (3) FDA has implemented few of our
recommendations intended to help leverage resources and improve
operations. This testimony is based on new and previously issued work.
To assess FDA's progress in implementing the Food Protection Plan, we
reviewed FDA documents, such as FDA's operations plan and work plan,
and FDA data related to the plan. In addition, we interviewed FDA
officials regarding the progress made to date in implementing the Food
Protection Plan. To review FDA's proposal to focus inspections based on
risk, we analyzed FDA's data on past domestic and foreign food firm
inspections. To determine actions that FDA has taken on our past
recommendations, we obtained and analyzed information from FDA on the
status of these recommendations. We conducted our work between May and
June 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 the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
FDA Has Added Few Details on the Resources and Strategies Required to
Implement Its Food Protection Plan:
In light of the federal government's long-term fiscal challenges, it is
critical that agencies can justify the needed resources and develop
effective, efficient strategies to achieve their mission. We testified
in January 2008 that, while FDA officials had acknowledged that
implementing the Food Protection Plan would require additional
resources, FDA had not provided specific information on the resources
it anticipates the agency will need to implement this plan to improve
its oversight of food safety. For example, 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. At that time, FDA
officials stated they would provide specific information on how much
additional funding would be necessary to implement the Food Protection
Plan when the President's budget was publicly released in the coming
weeks.
In its fiscal year 2008 budget, FDA received approximately $620 million
for food protection, an increase of about $56 million over fiscal year
2007, and directed $48 million of that amount toward implementing the
Food Protection Plan, according to FDA. FDA requested approximately
$662 million for food safety for fiscal year 2009, an increase of about
$42 million over fiscal year 2008. According to the Department of
Health and Human Services' budget justification, FDA plans to direct
the $42 million to strategic actions described in its Food Protection
Plan. As shown in table 1, the plan outlines spending on all three core
elements of the Food Protection Plan--a total of about $21 million for
prevention, about $34 million for intervention, and about $23 million
for response for fiscal years 2008 and 2009. FDA also reported that, in
fiscal year 2008, the agency intends to hire nearly 1,500 full time
equivalents (FTE), including approximately 730 to fill vacant
positions. Of these, 161 will be new FTEs funded by congressional
increases dedicated to food safety activities. In addition, in fiscal
year 2009, FDA plans to hire 94 new FTEs for food safety activities.
Table 1: Current and planned spending for Food Protection Plan Core
Elements and Strategic Actions, Fiscal Years 2008 and 2009:
Food Protection Plan core elements and strategic actions: Total for
core element 1: prevention;
Fiscal year 2008 increase: 10,024,000;
Fiscal year 2009 increase: 11,414,000;
Total current/planned spending for fiscal years 2008 and 2009:
21,438,000.
Food Protection Plan core elements and strategic actions: 1.1: Promote
increased corporate responsibility to prevent foodborne illnesses;
Fiscal year 2008 increase: 3,108,000;
Fiscal year 2009 increase: 6,311,000;
Total current/planned spending for fiscal years 2008 and 2009:
9,419,000.
Food Protection Plan core elements and strategic actions: 1.2: Identify
food vulnerabilities and assess risks;
Fiscal year 2008 increase: 5,580,000;
Fiscal year 2009 increase: 4,302,000;
Total current/planned spending for fiscal years 2008 and 2009:
9,882,000.
Food Protection Plan core elements and strategic actions: 1.3: Expand
the understanding and use of effective mitigation measures;
Fiscal year 2008 increase: 1,336,000;
Fiscal year 2009 increase: 801,000;
Total current/planned spending for fiscal years 2008 and 2009:
2,137,000.
Food Protection Plan core elements and strategic actions: Total for
core element 2: intervention;
Fiscal year 2008 increase: 18,509,000;
Fiscal year 2009 increase: 15,606,000;
Total current/planned spending for fiscal years 2008 and 2009:
34,115,000.
Food Protection Plan core elements and strategic actions: 2.1: Focus
inspections and sampling based on risk;
Fiscal year 2008 increase: 16,187,000;
Fiscal year 2009 increase: 14,864,000;
Total current/ planned spending for fiscal years 2008 and 2009:
31,051,000.
Food Protection Plan core elements and strategic actions: 2.2: Enhance
risk-based surveillance of imported foods at the border;
Fiscal year 2008 increase: 2,322,000;
Fiscal year 2009 increase: 742,000;
Total current/planned spending for fiscal years 2008 and 2009:
3,064,000.
Food Protection Plan core elements and strategic actions: 2.3: Improve
the detection of food system "signals" that indicate contamination;
Fiscal year 2008 increase: 0;
Fiscal year 2009 increase: 0;
Total current/planned spending for fiscal years 2008 and 2009: 0.
Food Protection Plan core elements and strategic actions: Total for
core element 3: response;
Fiscal year 2008 increase: 19,589,000;
Fiscal year 2009 increase: 3,174,000;
Total current/planned spending for fiscal years 2008 and 2009:
22,763,000.
Food Protection Plan core elements and strategic actions: 3.1: Improve
immediate response;
Fiscal year 2008 increase: 19,589,000;
Fiscal year 2009 increase: 2,954,000;
Total current/planned spending for fiscal years 2008 and 2009:
22,543,000.
Food Protection Plan core elements and strategic actions: 3.2: Improve
risk communications to the public, industry and other stakeholders;
Fiscal year 2008 increase: 0;
Fiscal year 2009 increase: 220,000;
Total current/planned spending for fiscal years 2008 and 2009: 220,000.
Food Protection Plan core elements and strategic actions: Sub-total;
Fiscal year 2008 increase: 48,122,000;
Fiscal year 2009 increase: 30,194,000;
Total current/planned spending for fiscal years 2008 and 2009:
78,316,000.
Food Protection Plan core elements and strategic actions: Cost of
living pay increase for onboard food protection employees;
Fiscal year 2008 increase: 0;
Fiscal year 2009 increase: 12,038,000;
Total current/ planned spending for fiscal years 2008 and 2009:
12,038,000.
Food Protection Plan core elements and strategic actions: Total for
entire Food Protection Plan;
Fiscal year 2008 increase: 48,122,000;
Fiscal year 2009 increase: 42,232,000;
Total current/planned spending for fiscal years 2008 and 2009:
90,354,000.
Source: FDA.
[End of table]
Furthermore, in May 2008, FDA's Commissioner of Food and Drugs provided
his professional judgment in response to a congressional request of
FDA's immediate resource needs to implement key initiatives across the
core elements of the Food Protection Plan. The Commissioner called for
an additional $125 million for food protection in fiscal year 2008
beyond the $48 million that FDA had already allocated for implementing
the Food Protection Plan in this fiscal year. According to the
Commissioner, this increase will allow FDA to address some of the
plan's strategic actions, such as identifying and targeting the
greatest threats from intentional and unintentional contamination and
conducting more risk-based inspections. The Commissioner's assessment
also calls for 250 additional FTEs to accomplish the goals of the Food
Protection Plan. After the Commissioner provided his assessment of
FDA's resource needs, the Senate passed an Iraq War Supplemental that
included an additional $119 million for food safety to be available
through fiscal year 2009. In addition, on June 9, 2008, the Department
of Health and Human Services announced that the Administration is
amending its fiscal year 2009 budget request to include, in part, a
$125 million increase for food safety. This amount would add to the $42
million increase originally proposed in the fiscal year 2009 budget
justification (see table 1) and appears to be consistent with the
Commissioner's professional judgment response. To accompany this
amendment, FDA has posted information on steps it is taking to invest
in its transformation in areas such as domestic medical products,
import products, and domestic food safety. For example, under
transforming domestic food safety, FDA reports that it issued final
fresh cut produce guidance to limit contamination of fresh-cut fruits
and vegetables. In addition, FDA conducted inspections and took action
against processors of low acid canned foods that were deviating from
required standards.
In addition, in January 2008, we testified that the Food Protection
Plan does not discuss the strategies it needs in the upcoming years to
implement this plan. When we asked FDA for more specificity on the
strategies for implementing the plan, FDA officials told us that they
have internal plans for implementing the Food Protection Plan that
detail timelines, staff actions, and specific deliverables. More
recently, a senior level FDA official provided us with an estimate of 5
years for fully implementing the plan. However, FDA has not provided us
with timelines for the various strategies described in the plan. For
example, under the plan's strategic action 2.3--to improve the
detection of food system "signals" that indicate contamination (see
table 1)--FDA has recently identified three additional action steps
with deliverables that will be needed to identify, develop, and deploy
new screening tools and methods to identify pathogens and other
contaminants. However, FDA could not provide us with an estimate of how
long it would take to implement these steps or the overall strategic
action. Without this type of information, we are not able to assess
whether FDA's estimated 5-year time frame is feasible.
Similarly, while FDA's Food Protection Plan recognizes the need to
partner with Congress to obtain 10 additional statutory authorities to
transform the safety of the nation's food supply, FDA's congressional
outreach strategy is general. When we asked FDA officials if they had a
congressional outreach strategy, FDA officials told us that they had
met with various congressional committees to discuss the Food
Protection Plan. When asked if they had provided draft language to
congressional committees on the various authorities, FDA officials
explained that they only provided technical assistance, such as
commenting on draft bills, to congressional staff when asked.
FDA appears to be refining its implementation plan over time. Most
recently, in June 2008, FDA provided us with a draft work plan that it
characterizes as a dynamic document that changes on a daily basis to
implement the Food Protection Plan. While this draft work plan provides
more information on the action steps and deliverables to achieve the
core elements, we continue to have concerns about FDA's lack of
specificity on the necessary resources and strategies to fully
implement the plan. For example, as part of the plan's strategic action
1.1--to promote increased corporate responsibility to prevent foodborne
illnesses (see table 1)--FDA has identified a goal of analyzing food
import trend data and focusing inspections based on risk, and the draft
work plan shows six deliverables, such as analysis of import data sets
and an import risk ranking, associated with this goal. However, the
timelines for these deliverables are unclear. In addition, the agency
plans to dedicate a total of $673,000 to this goal in fiscal years 2008
and 2009, and FDA officials told us that the agency considers this
funding to be a down payment toward achieving this goal. However, it is
unclear what the total cost will be to meet this goal. While the work
plan provides some basic information, more specific information, such
as estimated resources needed to implement the various strategies--the
core elements, goals, and deliverables--as well as the overall plan and
timeframes for implementing the strategies, are needed to assess FDA's
progress in implementing the plan or in acquiring the resources and
authorities it needs.
Anticipating the cost of the overall plan is important because, while
some activities, such as meeting with industry experts to discuss
corporate responsibility, may be accomplished within one budget cycle,
others, such as the establishment of an FDA field office in China will
likely require a long-term commitment of agency resources. From the
information we have obtained on the Food Protection Plan, it is unclear
what FDA's overall resource need is for implementing the plan. The
overall resource need could be significant. For example, if FDA were to
inspect each of the approximately 65,500 domestic food firms regulated
by FDA, at the Commissioner's May 2008 estimate of $8,000 for a
domestic food safety inspection, it would cost approximately $524
million to inspect all of these facilities once. Similarly, if FDA were
to inspect each of the 189,000 registered foreign facilities (which
includes facilities that manufacture, process, pack, or hold foods
consumed by Americans) at the Commissioner's estimated cost of $16,700
per inspection, it would cost FDA approximately $3.16 billion to
inspect all of these facilities once. These figures underscore the need
for FDA to focus safety inspections based on risk.
Ultimately, a results-oriented organization needs to take a long-term
view of the goals it wants to accomplish and describe them in a
strategic plan. To facilitate congressional oversight, strategic plans
should discuss (1) long-term goals and objectives for all major
functions; (2) approaches to achieve the goals and objectives, and in
particular the required resources including human capital and
information technology; (3) a relationship between the long-term goals
and the annual performance goals; and (4) an identification of key
factors that could significantly affect achievement of the strategic
goals. Such discussions in the Food Protection Plan could help clarify
FDA's organizational priorities to the Congress, other stakeholders,
and the public.
Lastly, when we testified before this subcommittee in January, we
reported that FDA planned to keep the public informed of their progress
on implementing the Food Protection Plan. In addition, in March 2008,
FDA officials indicated that a progress report on actions taken to
implement the Food Protection Plan would be issued in April 2008. In
May, FDA officials told us that they had prepared a draft progress
report, but as of June 4, 2008, FDA had not made this report public.
FDA officials told us that the progress report is still being cleared
by the Department of Health and Human Services, and they could not
provide us with the report until it was cleared by the department.
Instead, FDA officials provided us with a broad overview of FDA's
actions and, subsequently, provided us with a list of accomplishments
drawn out of numerous public documents. For example, FDA issued a
Federal Register Notice to solicit stakeholder comments on the
implementation of the Food Protection Plan as part of a broad outreach
plan.
We have noted that public reporting is the means through which the
federal government communicates the results of its work to the Congress
and the American people. Such reporting is in the public interest and
promotes transparency in government operations. While it is important
to show what progress has been made, having such information in a
consolidated document at a readily accessible location reassures
Congress and the public that actions have been taken.
FDA's Proposal to Focus Inspections Based on Risk Can Help Target
Scarce Resources:
The Food Protection Plan identifies the need to focus safety
inspections based on risk, which is particularly important as the
numbers of food firms have increased while inspections have decreased.
In its Food Protection Plan, FDA has identified some actions to better
identify food vulnerabilities and assess risks. For example, FDA plans
to use enhanced modeling capability, scientific data, and technical
expertise to evaluate and prioritize the relative risks of specific
food and animal feed agents that may be harmful. According to FDA
officials, the agency has assigned a risk-based steering committee to
identify models for ranking and prioritizing risk.
Conducting inspections based on risk has the potential to be an
efficient and effective approach for FDA to target scarce resources,
particularly when the number of inspections has not kept pace with the
growth in firms between 2001 and 2007. Specifically, while the number
of domestic firms under FDA's jurisdiction increased from about 51,000
to more than 65,500, the number of firms inspected declined slightly,
from 14,721 to 14,566. FDA also reported declines in the number of
inspections at overseas firms between 2001 and 2007--even as the United
States has imported hundreds of thousands of different food products
from tens of thousands of foreign food firms in more than 150
countries. Appendix I has information on the number of FDA inspections
of food firms in foreign countries from fiscal years 2001 through 2007.
GAO Has Issued Recommendations Intended to Help Leverage Resources and
Improve Operations, but FDA Has Implemented Few of Them:
FDA has implemented few of our past recommendations to improve food
safety oversight. Our recommendations are designed to correct
identified problems and improve programs and operations. We have made
34 food safety related recommendations to FDA since 2004 and, as of May
2008, FDA has implemented 7. For the remaining recommendations, FDA has
not fully implemented them, however, in some cases, FDA has taken some
steps. As shown in table 2, these recommendations fall into two broad
categories: improving monitoring and enforcement processes and
leveraging resources. The planned activities in the Food Protection
Plan could help address several of these recommendations.
Table 2: FDA's Implementation of GAO's Food Safety Recommendations,
Since 2004:
Category of recommendation: Improving monitoring and enforcement
processes;
Total recommendations: 21;
Recommendations FDA has implemented: 3;
Recommendations FDA has not fully implemented: 18.
Category of recommendation: Leveraging resources;
Total recommendations: 13;
Recommendations FDA has implemented: 4;
Recommendations FDA has not fully implemented: 9.
Category of recommendation: Total Recommendations;
Total recommendations: 34;
Recommendations FDA has implemented: 7;
Recommendations FDA has not fully implemented: 27.
Source: GAO and FDA.
[End of table]
In light of the federal government's long-term fiscal challenges,
agencies, including FDA, need to seek out opportunities to better
leverage their resources. We have made 13 recommendations to help FDA
better leverage its resources since 2004, and FDA has implemented 4 of
them. In a January 2004 report regarding seafood safety, we recommended
that, among other things, FDA make it a priority to establish
equivalence agreements with other countries.[Footnote 10] We found that
such agreements would shift some of FDA's oversight burden to foreign
governments. FDA did not concur with this recommendation, and as of May
2008, has not yet established equivalence agreements with any foreign
countries. In the same report, we recommended that FDA give priority to
taking enforcement actions when violations that pose the most serious
health risk occur; consider the cost and benefits of implementing an
accreditation program for private laboratories; and explore the
potential of implementing a certification program for third-party
inspectors. Although FDA concurred with these recommendations and has
taken some limited action such as requesting public comments on the use
of third-party certification programs, none were fully implemented. The
Food Protection Plan requests that Congress allow the agency to enter
into agreements with exporting countries to certify that foreign
producers' shipments of high-risk products comply with FDA standards.
Since 2004, we have made 21 recommendations to FDA to improve
monitoring and enforcement processes, and FDA has implemented 3 of
them. For example, in October 2004, we recommended that FDA develop a
sound methodology for district staff to verify that companies have
quickly and effectively carried out recalls.[Footnote 11] At the time
of our review, we found that FDA was not calculating the recovery rate
for recalls. As a result, the agency did not know how much food was
actually recovered, although the agency told us recovery was an
important indicator of a successful recall. FDA initially commented
that we had not demonstrated that weaknesses in FDA's recall process
resulted in little recovery of food, but as of May 2008, the agency is
in the process of conducting a quality management system review of its
recall activities and, once the review is completed, it will include
recommendations for verifying that a company's recall was effective,
according to FDA.
To conclude, FDA's release of the Food Protection Plan is a positive
first step toward modernizing FDA's approach to food safety to better
meet the challenges of an increasingly global food supply and respond
to shifting demographics and consumption patterns. Given that FDA's
resources have not kept pace with its increasing responsibilities,
FDA's plan to take a risk-based approach to inspections could help FDA
make the most effective and efficient use of its limited resources.
However, FDA's Food Protection Plan can only be as effective as its
implementation, and without specificity on the resources and strategies
needed to fully implement the plan--and in the absence of public
reporting--neither Congress nor the public can gauge the plan's
progress or assess its likelihood of success in achieving its intended
results. In addition, no one is better poised than FDA to identify the
resources and authorities needed to implement the plan; therefore,
FDA's capacity to provide such information can be questioned.
Meanwhile, as foodborne illness outbreaks continue, FDA is missing
valuable opportunities to reassure Congress and the public that it is
doing all it can to protect 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 José Alfredo Gómez, Assistant
Director; Kevin Bray; Candace Carpenter; Alison Gerry Grantham; Thomas
McCabe; Alison O'Neill; and Barbara Patterson.
[End of section]
Appendix I: Number of FDA Inspections of Food Firms in Foreign
Countries, as of December 2007:
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Mexico;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 17;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 15;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 15;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 16;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 26;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 104.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Ecuador;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 24;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 64.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: Chile;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 13;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 15;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 52.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: Peru;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 13;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 18;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 1;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 50.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Brazil;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 12;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 21;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 46.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Thailand;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 4;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 22;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 46.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Canada;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 13;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 13;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 1;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 4;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 38.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: China;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 2;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 16;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 33.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Taiwan;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 32.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Argentina;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 5;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 19;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 31.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: India;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 30.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: South
Korea;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 14;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 1;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 28.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Australia;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 12;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 27.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: Costa
Rica;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 4;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 5;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 27.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Vietnam;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 27.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Honduras;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 9;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 24.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: Fiji;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 13;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 21.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Singapore;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 18.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Estonia;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 16.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Guatemala;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 10;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 6;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 16.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: South
Africa;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 5;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 16.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Germany;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 5;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 4;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 4;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 1;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 1;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 15.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
Nicaragua;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 7;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007:
[Empty];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 15.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 31
additional countries[A];
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 58;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 61;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 54;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 26;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 40;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 8;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 258.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: Total
number of countries inspected;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 26;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 22;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 22;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 20;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 16;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 15;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 11;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 54.
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: Total
Inspections;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 211;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 169;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 148;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 153;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 132;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 125;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 96;
FDA Inspections of Foreign Food Firms, Fiscal Years 2001 - 2007: 1034.
Source: GAO analysis of FDA data.
Note: [A] Countries with a total of 14 or fewer inspections between
2001 and 2007 are not listed in the table. These countries include: El
Salvador (14 inspections), Jamaica (14), Latvia (14), Uruguay (14),
Venezuela (14), Italy (13), Morocco (13), New Zealand (13), Poland
(13), Norway (11), France (10), Romania (10), Suriname (10), Iceland
(9), Malaysia (9), Bulgaria (8), Columbia (8), Cyprus (7), Panama (7),
Trinidad and Tobago (7), United Kingdom (6), Turkey (5), Spain (4),
Belgium (3), Greece (3), Hungary (3), Finland (2), Haiti (2), Japan
(2), and the Netherlands (2). FDA also inspected food firms in Hong
Kong (8).
[End of table]
[End of section]
Footnotes:
[1] GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.:
January 2007)
[2] Trust for America's Health is a non-profit, non-partisan
organization dedicated to protecting the public's health.
[3] GAO, 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)
[4] 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.
[5] Department of Health and Human Services, U.S. Food and Drug
Administration, Food Protection Plan (Washington, D.C., 2007).
[6] Interagency Working Group on Import Safety, Action Plan for Import
Safety (Washington, D.C., 2007).
[7] FDA Science Board, Subcommittee on Science and Technology, FDA
Science and Mission at Risk (Washington, D.C., November 2007).
[8] Committee on Energy and Commerce, U.S. House of Representatives,
Discussion Draft: The Food and Drug Administration Globalization Act of
2008 (Apr. 16, 2008), available at [hyperlink,
http://energycommerce.house.gov/FDAGlobalAct-08/index.shtml]
[9] GAO, Federal Oversight of Food Safety: FDA's Food Protection Plan
Proposes Positive First Steps, but Capacity to Carry Them Out is
Critical, GAO-08-435T (Washington, D.C.: Jan. 29, 2008).
[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, 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).
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