Federal Oversight of Food Safety: FDA Has Provided Few Details on
the Resources and Strategies Needed to Implement its Food	 
Protection Plan (12-JUN-08, GAO-08-909T).			 
                                                                 
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.		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-909T					        
    ACCNO:   A82341						        
  TITLE:     Federal Oversight of Food Safety: FDA Has Provided Few   
Details on the Resources and Strategies Needed to Implement its  
Food Protection Plan						 
     DATE:   06/12/2008 
  SUBJECT:   Consumer protection				 
	     Contaminated foods 				 
	     E. coli O157:H7					 
	     Food and drug legislation				 
	     Food industry					 
	     Food inspection					 
	     Food safety					 
	     Food supply					 
	     Program evaluation 				 
	     Proposed legislation				 
	     Public health					 
	     Risk assessment					 
	     Safety regulation					 
	     Safety standards					 
	     Salmonellosis					 
	     Strategic planning 				 
	     Program implementation				 
	     FDA Food Protection Plan				 
	     GAO High Risk Series				 

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GAO-08-909T

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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 FDAï¿½s 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) FDAï¿½s progress 
in implementing the Food Protection Plan, (2) FDAï¿½s proposal to focus 
inspections based on risk, and (3) FDAï¿½s implementation of previously 
issued GAO recommendations intended to improve food safety oversight. 
To address these issues, GAO reviewed FDA documents, such as FDAï¿½s 
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 FDAï¿½s 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 FDAï¿½s 
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 FDAï¿½s 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 
GAOï¿½s 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 FDAï¿½s 
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 
producersï¿½ 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 [email protected]. 

[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 [email protected]. 
Key contributors to this statement were Josï¿½ Alfredo Gï¿½mez, 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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