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Report to Congressional Requesters: 

United States Government Accountability Office: 
GAO: 

September 2008: 

Food Safety: 

Improvements Needed in FDA Oversight of Fresh Produce: 

GAO-08-1047: 

GAO Highlights: 

Highlights of GAO-08-1047, a report to congressional requesters. 

Why GAO Did This Study: 

In recent years, both domestic and imported produce have been linked to 
reported outbreaks of foodborne illness. Contamination in produce is of 
particular concern because produce is often consumed raw. The Food and 
Drug Administration (FDA) has primary responsibility for ensuring the 
safety of both domestic and imported fresh produce. GAO was asked to 
examine (1) the resources FDA has spent on fresh produce safety and how 
it has allocated those resources, (2) the effectiveness of FDA’s 
actions to oversee fresh produce safety, and (3) the extent to which 
FDA’s planned actions to enhance fresh produce oversight address 
identified challenges. For this review, GAO analyzed FDA spending data 
and estimates and FDA activities data, reviewed FDA plans, and 
interviewed FDA officials and others. 

What GAO Found: 

While FDA has considered fresh produce safety a priority for many 
years, resource constraints and other work—including counterterrorism 
efforts and unplanned events such as foodborne illness outbreaks—have 
caused FDA to delay key produce safety activities. FDA has no formal 
program devoted exclusively to fresh produce and has not consistently 
and reliably tracked its fresh produce spending. Based on FDA 
estimates, FDA spent at least $20 million and 130 staff years on fresh 
produce in fiscal year 2007—or about 3 percent of its food safety 
dollars and 4 percent of its food safety staff years. In addition, FDA 
had few staff dedicated solely to fresh produce safety. Moreover, FDA 
acknowledged that it has not yet been able to conduct certain fresh 
produce work crucial to understanding the incidence of contamination of 
produce by pathogens such as E. coli O157:H7 or Salmonella, because it 
has lacked the resources to either fund its extramural research grant 
program or perform some critical research internally. Finally, FDA 
delayed issuing final fresh-cut produce guidance at least 6 years 
because it had to shift staff to counterterrorism and outbreak 
investigation work. 

FDA has provided limited oversight of domestic and imported fresh 
produce. For example, while FDA has issued guidance for industry on 
recommended practices for reducing the risk of contamination during the 
processing of fresh-cut produce, it has not issued regulations 
requiring firms to take action to prevent contamination, even though 
some industry groups would like it to do so. FDA’s intervention efforts 
have also been limited. Specifically, domestic fresh produce firms were 
inspected infrequently. Furthermore, FDA examined less than 1 percent 
of the 7.6 million fresh produce lines imported from fiscal years 2002 
through 2007. Finally, FDA has improved some elements of its emergency 
response by, for example, partnering with California on outbreak 
investigations. However, it faces challenges in tracing an outbreak 
involving fresh produce back to its source because produce is highly 
perishable and may no longer be available for testing. Also, when 
product is available, it may be unlabeled or mixed in packages 
containing products from multiple sources. 

FDA has proposed changes through its Food Protection Plan that could 
significantly enhance its fresh produce oversight. However, the agency 
is still in the planning stages for several enhancements and has not 
provided specific information on strategies and resources, making it 
difficult to assess the likelihood of success. To help prevent 
contamination, FDA plans to update its existing guidance on good 
agricultural practices and regulations on current good manufacturing 
practice for food, and has identified a need for explicit authority to 
issue preventive safety regulations for high-risk foods and enhanced 
access to records. To enhance intervention efforts, FDA plans to use 
more rigorous risk-based criteria to target domestic firm inspections 
and is testing a new import screening software tool. To improve 
response efforts, FDA is examining best practices for tracing 
contaminated foods to their source. 

What GAO Recommends: 

GAO recommends, among other things, that the Commissioner of FDA update 
its guidance on good agricultural practices and its regulations on 
current good manufacturing practice for food, and seek explicit 
authority from the Congress to adopt preventive controls for high-risk 
foods and authority for enhanced access to records. 

FDA agreed with most of GAO’s recommendations but believed that it had 
sought authority from the Congress. FDA should continue to take steps 
to obtain these authorities so that it can conduct its oversight 
responsibilities. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-1047]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

FDA Has Spent Relatively Few Resources on Fresh Produce Safety and 
Other Work Has Preempted Fresh Produce Efforts: 

FDA Has Provided Limited Oversight of Domestic and Imported Fresh 
Produce: 

Proposed Actions Could Significantly Enhance Fresh Produce Oversight, 
but More Information Is Needed to Assess the Likelihood of Success: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: FDA Food Safety Spending Information for Fiscal Years 2000 
through 2007: 

Appendix III: Comments from the Department of Health and Human 
Services: 

GAO Comments: 

Appendix IV: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: FDA Domestic and Imported Food Safety and Fresh Produce 
Spending, Fiscal Years 2006 and 2007: 

Table 2: Minimum Estimates of CFSAN Spending on Fresh Produce, Fiscal 
Years 2006 and 2007: 

Table 3: Estimates of ORA Spending on Fresh Produce, Fiscal Years 2006 
and 2007: 

Table 4: Actions Taken on Fresh Produce Entry Lines, Fiscal Years 2002 
through 2007: 

Table 5: Summary of FDA Food Safety Spending, by Organization, Fiscal 
Years 2000 through 2007: 

Table 6: CFSAN Food Safety Spending, by Category, Fiscal Years 2006 and 
2007: 

Table 7: ORA Food Safety Spending in Support of CFSAN, by Category, 
Fiscal Years 2005 through 2007: 

Table 8: Center for Veterinary Medicine Spending on Food Safety, by 
Category, Fiscal Years 2000 through 2007: 

Table 9: ORA Food Safety Spending in Support of CVM, by Category, 
Fiscal Years 2005 through 2007: 

Table 10: National Center for Toxicological Research Spending on Food 
Safety, by Category, Fiscal Years 2000 through 2007: 

Figures: 

Figure 1: FDA Food Safety Spending in Constant and Nominal Dollars, 
Fiscal Years 2000 through 2007: 

Figure 2: FDA's Total Food Safety Staffing Levels, Fiscal Years 2000 
through 2007: 

Figure 3: FDA Organizations Experiencing a Decline in Food Safety Staff 
Years between Fiscal Years 2003 and 2007: 

Figure 4: Domestic Food and Fresh Produce Inspections, Fiscal Years 
2000 through 2007: 

Figure 5: Fresh Produce Inspections Conducted by FDA and States, Fiscal 
Years 2000 through 2007: 

Figure 6: Percentage of Fresh Produce Inspections Uncovering Problems, 
Fiscal Years 2000 through 2007: 

Figure 7: Fresh Produce-Related Warning Letters, Fiscal Years 2000 
through 2007: 

Abbreviations: 

CalFERT: California Food Emergency Response Team: 

CDC: Centers for Disease Control and Prevention: 

CFSAN: Center for Food Safety and Applied Nutrition: 

CVM: Center for Veterinary Medicine: 

FACTS: Field Accomplishment and Compliance Tracking System: 

FDA: Food and Drug Administration: 

NCTR: National Center for Toxicological Research: 

OASIS: Operational and Administrative System for Import Support: 

ORA: Office of Regulatory Affairs: 

PREDICT: Predictive Risk-based Evaluation for Dynamic Import Compliance 
Targeting: 

USDA: U.S. Department of Agriculture: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

September 26, 2008: 

The Honorable Edward M. Kennedy: 
Chairman: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Barbara Boxer: 
United States Senate: 

In recent years, there has been an increase in reported outbreaks of 
foodborne illness associated with both domestic and imported produce. 
Most recently, an outbreak of Salmonella linked to fresh produce, which 
sickened at least 1,440 people in 43 states, the District of Columbia, 
and Canada, has become the largest foodborne illness outbreak reported 
in the last 10 years. According to the Centers for Disease Control and 
Prevention (CDC), fresh produce was linked to 7 percent of all 
outbreaks that had been traced to a specific food source and 14 percent 
of the associated illnesses from 1998 to 2004. In addition to harming 
human health, outbreaks of foodborne illness can undermine consumer 
confidence in the safety of the nation's food supply and have serious 
economic consequences. The 2006 outbreak of E. coli O157:H7 linked to 
bagged spinach, for example, resulted in 205 confirmed illnesses, 3 
deaths, and an estimated $100 million loss to industry. The importance 
of this issue is growing because the consumption of fresh produce has 
increased as both health experts and the U.S. government have 
encouraged Americans to eat fruits and vegetables as part of a healthy 
diet. According to the U.S. Department of Agriculture (USDA), the 
average American annually consumed 13 pounds more fresh fruit and 50 
pounds more fresh vegetables from 2003 through 2005 than from 1983 
through 1985, an increase of about 14 percent and 41 percent, 
respectively. Also, more people have turned to the convenience of fresh-
cut produce, such as bagged salads and cut fruit, and significant 
increases in imported produce have made a greater variety and volume of 
fresh produce available year round. 

Produce is particularly vulnerable to contamination with pathogens 
(microorganisms that can cause disease) because it is grown in a 
natural environment. Moreover, it is often consumed raw, without 
cooking or other treatment that would reduce, control, or eliminate 
pathogens prior to consumption. Processing produce into fresh-cut 
products, the fastest growing segment of the fresh produce market, may 
increase the risk of microbial contamination and growth by breaking the 
surface of the produce and allowing pathogens to enter the product. The 
contamination can then spread to other produce being processed at the 
same time. Fresh produce may also become contaminated after it is 
harvested and processed, such as during transportation, preparation, or 
storage. 

The Food and Drug Administration (FDA) within the Department of Health 
and Human Services has primary responsibility for ensuring the safety 
of food for humans and animals. Specifically, FDA is responsible under 
the Federal Food, Drug, and Cosmetic Act for ensuring that domestic and 
imported human food (except meat, poultry, and processed egg products) 
and animal feed are safe, wholesome, and labeled properly. Under the 
Public Health Service Act, FDA has the authority to take measures to 
prevent the spread of disease. In addition, FDA may enter into 
arrangements with states to do inspections, share resources, or avoid 
duplication of efforts. 

In January 2007, we added the federal oversight of food safety to our 
High-Risk Series, which is intended to raise the priority and 
visibility of government programs that are in need of broad-based 
transformation to achieve greater economy, efficiency, effectiveness, 
accountability, and sustainability.[Footnote 1] In particular, we noted 
that federal spending for food safety oversight has not been 
commensurate with the volume of foods regulated by the agencies or 
consumed by the public. In November 2007, a report for FDA's science 
advisory board, FDA Science and Mission at Risk,[Footnote 2] pointed 
out the erosion in FDA's science base. The report cited numerous 
management challenges that have contributed to FDA's inability to 
fulfill its mission that cannot be addressed with available resources, 
such as the lack of information sciences and infrastructure to support 
new science. That same month, a report by FDA, Food Protection Plan: An 
Integrated Strategy for Protecting the Nation's Food Supply,[Footnote 
3] recognized the need for several changes to ensure the safety of the 
nation's food supply, such as shifting efforts toward prevention, and 
identified new authorities needed to implement the new strategy. We 
have testified that FDA's Food Protection Plan--which presents a three- 
part framework of prevention, intervention, and response--proposes some 
positive first steps toward enhancing FDA's oversight of food safety. 
We also pointed out, however, that more information about strategies 
and the resources FDA needs to implement the plan would facilitate 
congressional oversight.[Footnote 4] In particular, we noted that FDA's 
overall resource needs and timelines for fully implementing the plan 
are unclear. In June 2008, we testified that FDA had implemented few of 
our past recommendations to improve food safety oversight. 
Specifically, we had made a total of 34 food safety-related 
recommendations to FDA since 2004, and as of May 2008, FDA had 
implemented 7 of those recommendations. In commenting on a draft of 
this report, FDA stated that an update on the status of these 
recommendations may allow an additional 15 recommendations to be viewed 
as fully implemented. FDA also stated that two recommendations would 
require congressional action and one would require additional funding 
to implement. Based on our routine update on the status of open 
recommendations, we agree that one additional recommendation can be 
considered fully implemented; however, we disagree with FDA's 
assessment that the remaining recommendations should be considered 
fully implemented. 

As requested, this report examines (1) the dollars and staff years FDA 
has spent on fresh produce safety and how FDA has allocated those 
resources, (2) the effectiveness of FDA's actions to oversee domestic 
and imported fresh produce safety, and (3) the actions FDA plans to 
take to enhance fresh produce oversight and the extent to which FDA's 
planned actions address identified challenges. 

For this report, fresh produce means fruits and vegetables in their 
unpeeled, natural form, as well as fruits and vegetables that have been 
minimally processed (e.g., peeled, sliced, or chopped) before being 
packaged for use by the consumer or a retail establishment. It does not 
include frozen or canned fruits and vegetables or fruit and vegetable 
juices. To conduct this review, we visited produce farms and processing 
facilities in California's Salinas Valley, where we interviewed 
growers, processors, and industry representatives and observed an FDA 
inspection of a fresh-cut produce facility. We selected the Salinas 
Valley because it was the source of the 2006 E. coli O157:H7 outbreak 
linked to bagged spinach. We obtained and analyzed FDA data and 
estimates on food safety and fresh produce safety spending in both 
dollars and staff years and FDA data on fresh produce oversight 
activities. In analyzing FDA's food safety resources, we focused on 
fiscal years 2000 through 2007 to update a previous GAO report that 
detailed food safety spending through fiscal year 1999.[Footnote 5] In 
analyzing FDA's fresh produce resources, we limited our work to fiscal 
years 2005 through 2007 because FDA believed it could only provide 
reliable estimates of fresh produce spending for these years. We 
assessed the reliability of the data used in this report and found it 
to be sufficiently reliable for the purposes used. We reviewed FDA 
plans, such as its November 2007 Food Protection Plan, for information 
on proposed changes that could enhance fresh produce oversight. To 
assess FDA's plans, we reviewed previous GAO reports on food safety and 
GAO guidance for assessing key elements in agencies' performance plans, 
including goals, strategies, and resources.[Footnote 6] We interviewed 
FDA officials about fresh produce resources, oversight activities, and 
planned changes. We also interviewed former FDA officials, food safety 
experts, state food safety officials, industry representatives, and 
others to obtain their views on FDA's current oversight activities and 
planned actions. Appendix I contains a detailed discussion of the scope 
and methodology of our review. 

We conducted this performance audit from June 2007 to September 2008 in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Results in Brief: 

Although FDA has considered fresh produce as a priority over the past 
decade, resource constraints and other work--including counterterrorism 
efforts and unplanned events such as foodborne illness outbreaks--have 
caused FDA to delay key fresh produce safety initiatives. Because FDA 
has no formal program devoted exclusively to fresh produce, it draws 
dollars and staff years to fresh produce from its overall food safety 
program. FDA has not consistently and reliably tracked its spending on 
fresh produce, thus limiting its ability not only to identify its 
actual fresh produce spending but also to plan and manage this 
spending. Based on FDA's estimates, our analysis indicates that 
spending on fresh produce safety was at least $18 million in fiscal 
year 2006 and at least $20 million in 2007, or approximately 3 percent 
of total FDA food safety spending in each year. Similarly, our analysis 
shows that FDA spent at least 132 staff years on produce safety in 
fiscal year 2006 and 130 staff years in 2007, or about 4 percent of its 
total food safety staff years. Additionally, FDA had few staff 
dedicated solely to fresh produce safety. This low level of spending 
relative to total food safety spending is partly the result of resource 
constraints and other work that have delayed fresh produce efforts. For 
example, officials from FDA's Center for Food Safety and Applied 
Nutrition (CFSAN) told us that one of the center's priorities-
-issuing guidance for fresh-cut produce operations--was delayed at 
least 6 years because they had to divert staff with the needed 
expertise to address counterterrorism efforts and outbreaks of 
foodborne illness. 

FDA's actions to oversee domestic and imported fresh produce safety 
have generally been limited. More specifically, within FDA's Food 
Protection Plan framework of prevention, intervention, and response, we 
found the following: 

* Prevention. FDA's prevention efforts have been limited, in part 
because gaps in scientific knowledge have impeded its ability to fully 
integrate science and risk into its oversight of fresh produce safety. 
Moreover, FDA has issued some voluntary guidance for industry, 
including guidelines for minimizing contamination during field and 
fresh-cut operations. However, it has not issued regulations requiring 
firms to take action to prevent contamination, even though some 
industry groups would like it to do so. 

* Intervention. Inspections of domestic firms that handle fresh produce 
have occurred infrequently. Our analysis of FDA data showed that the 
2,002 domestic firms that underwent produce-related inspections were 
inspected twice, on average, from fiscal years 2000 through 2007. 
Problems were observed in 41 percent of these inspections, but most did 
not warrant further regulatory action, according to FDA. Therefore, the 
agency primarily relied on firms to take voluntary corrective action. 
We also found FDA provided minimal oversight of imported produce. 
Although FDA's oversight of imports relies heavily on screening 
products at the border, it examined less than 1 percent of the 7.6 
million fresh produce import entry lines from fiscal years 2002 through 
2007. Additionally, although FDA devoted more resources to import 
oversight, enabling it to conduct more import examinations in fiscal 
year 2007 than in fiscal year 2004, it has not been able to inspect a 
larger share of incoming fresh produce shipments. 

* Response. FDA has improved some elements of its emergency response. 
Successes include improving response coordination through the creation 
of a new Office of Crisis Management, partnering with California on 
outbreak investigations, and developing a pilot program where recall 
notices include photographs of the recalled product. However, tracing 
an outbreak involving fresh produce back to its source remains 
challenging because produce is highly perishable and may no longer be 
available for testing. Also, when product is available, it may be 
unlabeled or mixed in packages with products from multiple sources. 

FDA has proposed changes that could significantly enhance its fresh 
produce oversight and has reported some initial progress, but more 
information on strategies and resources is needed to enhance 
accountability and assess the likelihood of FDA's success. 
Specifically, through its Food Protection Plan, FDA proposed agency 
actions and identified authorities needed to better leverage its 
limited resources and strengthen its oversight of fresh produce, 
including these key actions: 

* Prevention. FDA plans to help fill gaps in scientific knowledge and 
update its 1998 guidance to industry on good agricultural practices. 
Also, FDA has cited a need for explicit authority to issue regulations 
requiring preventive controls for high-risk foods, such as leafy 
greens, which could minimize the risk of contamination before such 
foods enter the market. 

* Intervention. For domestic inspections, when deciding which domestic 
food facilities to inspect, FDA plans to increase the rigor of its risk-
based criteria to focus on the firms of highest risk. For imports, FDA 
officials are also testing a new import screening software tool that 
uses information from a wider variety of sources to more effectively 
screen products at the border. Further, FDA has identified a need for 
explicit authority to accredit third parties to perform inspections, 
which could help FDA leverage its resources, but FDA does not envision 
using such a program for fresh produce until the agency has established 
or assessed the adequacy of clear preventive standards. 

* Response. FDA plans to improve efforts to trace contaminated products 
back to their source by establishing an internal working group to 
examine industry best practices, using new laboratory equipment, and 
obtaining improved records access authority during food-related 
emergencies. FDA also plans to organize more federal-state teams, such 
as the FDA-California team, to respond to outbreaks. In addition, FDA 
has identified the need for the authority to issue mandatory recalls 
when voluntary recalls are not effective and has plans to improve how 
it communicates risk to the public during outbreaks, with help from an 
external advisory group. 

While these efforts have the potential to enhance food safety 
oversight, FDA is still largely in the planning stages for these 
improvements and has not provided specific information on strategies 
and resources. Without this information, it is difficult to assess the 
likelihood of success. 

We are making seven recommendations to FDA, including four 
recommendations to enhance its oversight of fresh produce safety, such 
as updating its good agricultural practices guidance, two 
recommendations to seek authority from the Congress to make explicit 
FDA's authority to adopt preventive controls for high-risk foods and to 
provide enhanced access to firm records during food-related 
emergencies, and one recommendation to provide specific information to 
the Congress and to the public on the strategies and resources for 
implementing the Food Protection Plan. In its written comments on a 
draft of our report that included comments from FDA, the Department of 
Health and Human Services generally agreed with the report's accuracy 
and conclusions and with most of the report's recommendations. While 
FDA agreed with the importance of having explicit authority to adopt 
preventive controls for high-risk foods and having enhanced access to 
firm records during food-related emergencies, the agency believes that 
it has already sought such authorities by outlining legislative needs 
in the Food Protection Plan and testifying on the plan before 
congressional committees. We do not view these actions as seeking 
authority. Rather, as FDA recognized, there is a need for the agency to 
partner with the Congress to make the necessary changes to transform 
the safety of the nation's food supply. FDA should move beyond 
outlining needs and continue to take steps to obtain these legislative 
authorities, such as by suggesting language that provides FDA the 
necessary statutory tools to help the agency conduct its oversight 
responsibilities. In addition, FDA provided technical comments that we 
have incorporated, as appropriate. 

Background: 

FDA has primary responsibility for ensuring the safety of a broad range 
of products, including foods, animal drugs and feeds, human medicines 
and vaccines, radiation-emitting devices, medical devices, blood and 
blood products, and cosmetics. With regard to food safety, FDA is 
responsible under the Federal Food, Drug, and Cosmetic Act for ensuring 
that all human foods introduced into interstate commerce--except meat, 
poultry, and processed egg products--and animal feeds are safe, 
wholesome, and labeled properly. To carry out its responsibilities, FDA 
has the authority to do such things as conduct examinations and 
investigations, inspect food facilities, refuse the entry of imported 
food that appears to be adulterated, and recommend judicial enforcement 
actions to the Department of Justice. Under the Public Health Service 
Act, FDA has the authority to take measures, such as issuing 
regulations, that in its judgment are necessary to prevent the spread 
of communicable diseases, including foodborne illness. 

The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002 (Bioterrorism Act) amended both acts. With regard to food 
safety, the act: 

* provides FDA the authority to administratively detain a food product 
where there is credible evidence or information that the product 
presents a threat of serious adverse health consequences or death to 
humans or animals; 

* directs FDA to issue regulations requiring information regarding food 
that is being imported or offered for import prior to its arrival at a 
U.S. port; 

* directs FDA to issue regulations requiring domestic and foreign 
facilities engaged in manufacturing, processing, packing, or holding 
food for human consumption in the United States to register with FDA; 
and: 

* authorizes FDA to issue regulations requiring food firms, except 
farms and restaurants, to keep records on the immediate previous source 
and the immediate subsequent recipient of their products. 

Within FDA, two centers have primary responsibility for food safety-- 
CFSAN, which is responsible for human food, and the Center for 
Veterinary Medicine, which is responsible for animal feeds and drugs. 
In addition, FDA's Office of Regulatory Affairs (ORA) performs food 
safety and other field work in support of the centers' programs, and 
the National Center for Toxicological Research conducts food safety 
research, among other things. CFSAN and ORA perform most of FDA's fresh 
produce safety activities. CFSAN formulates regulations and guidance, 
conducts research, communicates information to industry and the public, 
and sets program priorities, while ORA carries out produce-related 
field activities, such as conducting inspections, collecting and 
analyzing samples, and taking enforcement action. Further, both CFSAN 
and ORA are involved in responding to emergencies involving fresh 
produce, such as foodborne illness outbreaks, which are coordinated by 
the Office of Crisis Management within the Office of the Commissioner. 
In addition, the Associate Commissioner for Foods, also within the 
Office of the Commissioner, works on food safety issues that may 
directly or indirectly relate to fresh produce. 

Other agencies have responsibilities or programs directly or indirectly 
related to fresh produce safety: 

* CDC within the Department of Health and Human Services conducts 
surveillance of foodborne illness and provides data and information to 
other food safety agencies, including FDA. 

* Environmental Protection Agency regulates the amount of pesticide 
that may safely remain on food, including fresh produce. 

* National Institutes of Health within the Department of Health and 
Human Services researches ways to prevent disease, such as foodborne 
illness. 

* USDA conducts food safety research and also supports food safety 
research, education, and extension programs in the land-grant 
university system and other partner organizations. 

In addition, FDA may enter into formal or informal arrangements with 
states to do inspections, share resources, or avoid duplication of 
efforts. Also, states may play a significant role in detecting and 
responding to outbreaks of foodborne illness. 

Produce can become contaminated at any point in the production cycle, 
and the fact that it is often consumed raw without undergoing a "kill 
step" that would eliminate pathogens prior to consumption contributes 
to its potential for causing foodborne illness. At the time of our 
review, FDA was considering an industry request to allow, among other 
things, fresh produce to undergo higher doses of irradiation. In August 
2008, the agency published a final rule to allow such irradiation for 
fresh iceberg lettuce and fresh spinach. According to an FDA official, 
the levels of irradiation that could be tolerated by some types of 
fresh produce would reduce but not completely eliminate pathogens. 
Produce grown outdoors is particularly vulnerable to contamination. 
Some factors that may contribute to contamination include the presence 
of animals in fields or packing areas, poor water quality, or poor 
worker sanitation practices. Processing produce into fresh-cut 
products, such as cut fruits or mixed salads, increases the risk of 
microbial contamination and growth by breaking down the natural 
exterior barrier of the produce. If pathogens are present, they can 
enter the product and then spread into other products being processed 
at the same time. Produce can also become contaminated after it is 
harvested and processed, such as during transportation or preparation. 
For example, produce can become contaminated when it is transported in 
unclean or improperly refrigerated trucks or when consumers place it on 
surfaces, such as cutting boards, that have not been thoroughly cleaned 
after coming into contact with raw meat or poultry. In addition to 
microbial pathogens, other substances, such as pesticides, may 
contaminate fresh produce. 

According to unpublished FDA data on reported illness associated with 
FDA-regulated foods, from 1996 through 2006, there were at least 96 
outbreaks, 10,253 illnesses, and 14 deaths associated with the 
consumption of fresh produce.[Footnote 7] CDC officials told us that 
available data greatly underestimate the number of foodborne illnesses 
attributable to fresh produce. Many cases are not reported because the 
ill person does not seek medical care or the doctor does not take a lab 
culture. Also, according to CDC officials, in many outbreaks, the 
pathogen is not identified by state or local public health laboratories 
because of delayed or incomplete laboratory investigation, inadequate 
laboratory capacity, or inability to recognize a pathogen as the cause 
of foodborne illness. Fresh produce and pathogens frequently linked to 
foodborne illness outbreaks included sprouts (Salmonella), leafy greens 
(E. coli O157:H7), tomatoes (Salmonella), melons (Salmonella), herbs 
(Cyclospora), berries (Cyclospora), and green onions (hepatitis A). 
Once the pathogen is identified, laboratories may send a sample to 
CDC's PulseNet, a nationwide database that matches pathogen strains. 
Generally, state and local public health authorities conduct 
investigations to link the pathogen and the contaminated food. However, 
CDC may provide assistance. FDA becomes involved when the epidemiology 
indicates there is an outbreak implicating an FDA-regulated product. 

FDA Has Spent Relatively Few Resources on Fresh Produce Safety and 
Other Work Has Preempted Fresh Produce Efforts: 

Although FDA has considered fresh produce a priority area for many 
years, resource constraints and other work--including counterterrorism 
efforts and unplanned events such as outbreaks--have caused FDA to 
delay key fresh produce safety efforts. Because it has no formal 
program devoted exclusively to fresh produce, FDA allocates resources 
to fresh produce as part of its overall food safety planning process. 
Moreover, FDA has not consistently and reliably tracked its spending on 
fresh produce, thus limiting its ability not only to identify how much 
it has spent on fresh produce safety but also to plan and manage this 
spending. Our analysis of FDA estimates and data shows that spending on 
fresh produce safety was approximately 3 percent of total annual FDA 
food safety spending in fiscal years 2006 and 2007. Additionally, FDA 
had few staff solely dedicated to fresh produce. 

FDA Has Identified Fresh Produce as a Priority for Many Years but Has 
No Formal Fresh Produce Program: 

Fresh produce has been a key concern for FDA since at least 1997, when 
the President announced a national food safety initiative that resulted 
in several produce-related recommendations, such as developing fast and 
cost-effective methods for detecting pathogens. That same year, a 
presidential produce safety initiative called for FDA, among other 
things, to enhance its oversight of imported produce and develop 
guidance on good agricultural and manufacturing practices for domestic 
produce. Additionally, CFSAN has listed produce safety activities as 
priorities each fiscal year since 1999. Such priorities have included, 
for example, publishing guidance on fresh-cut produce operations, 
working with industry to develop good agricultural and manufacturing 
practices for commodities such as tomatoes and cantaloupes, and 
conducting initiatives specific to contamination in lettuce and leafy 
greens. CFSAN also highlighted produce safety as a critical issue in 
its 2004 produce safety action plan, which identified steps to prevent 
contamination, minimize public health impacts when contamination 
occurs, improve communication about fresh produce, and facilitate and 
support relevant research. Additionally, FDA officials told us that 
fresh produce safety gained more relevance and prominence within CFSAN 
as a result of the E. coli O157:H7 outbreak in spinach in 2006. 

Despite identifying fresh produce safety as a priority area, FDA has no 
formal program devoted exclusively to fresh produce to which it can 
allocate resources. Instead, FDA directs resources to fresh produce as 
part of the process it uses to identify overall food safety priorities, 
some of which include fresh produce. As part of this process, CFSAN 
develops and publishes its program priorities each year showing the new 
and ongoing work it plans to conduct during the next fiscal year. Using 
these priorities and the President's proposed budget as a starting 
point, ORA consults with CFSAN to develop its own work plans for 
carrying out CFSAN's field activities for the upcoming year. ORA also 
spells out the ideal distribution of field staff, by position and by 
location, needed to implement CFSAN's planned food safety priorities. 
However, planned priorities often shift during the year in response to 
outbreaks of foodborne illness, other emergencies, or resource 
constraints. Also, FDA's informal hiring freeze from fiscal years 2004 
through mid-2007 and lower than expected congressional appropriations 
have meant some field locations lacked positions needed to implement 
planned work. 

FDA Has Not Consistently or Reliably Tracked Resources Spent on Fresh 
Produce Safety: 

In addition to lacking a formal program devoted exclusively to fresh 
produce, FDA has not consistently or reliably tracked the dollars or 
staff years it spent on fresh produce safety, thus limiting its ability 
to plan and manage spending. While the five FDA organizations that 
conducted food safety work--CFSAN, ORA, the Center for Veterinary 
Medicine, the National Center for Toxicological Research, and the 
Office of the Commissioner--were able to provide us with reliable data 
on their overall food safety spending for fiscal years 2000 through 
2007, the three organizations that reported spending resources on fresh 
produce safety--CFSAN, ORA, and the Office of the Commissioner--could 
not provide reliable data on fresh produce. Specifically, the systems 
CFSAN and the Office of the Commissioner use to track their food safety 
spending do not consistently distinguish fresh produce work from other 
efforts. Consequently, CFSAN could only provide estimates for the 
minimum number of dollars and staff years it spent on fresh produce for 
fiscal years 2006 and 2007 and the Office of the Commissioner could 
provide no fresh produce spending data or estimates. While ORA was able 
to track its spending on fresh produce because staff generally enter a 
code to identify the product and processing method when reporting an 
activity in ORA's work tracking system, officials acknowledged that not 
all fresh produce activities are reported as such, and thus ORA also 
provided estimates of fresh produce spending. Because FDA cannot 
identify the actual resources it spends on fresh produce, it lacks the 
information needed to understand whether it is allocating its resources 
in support of produce safety priorities in the most efficient manner. 
As a result, FDA's ability to effectively plan and manage its food 
safety resources is limited. 

Fresh Produce Has Been a Small Part of FDA's Food Safety Efforts: 

Our analysis of FDA's best available spending estimates shows that 
fresh produce amounted to at least $18 million in fiscal year 2006 and 
at least $20 million in 2007, or approximately 3 percent of FDA's total 
annual food safety spending in each year, as shown in table 1. 
Similarly, our analysis indicates that FDA spent at least 132 staff 
years on produce safety in fiscal year 2006 and 130 staff years in 
2007, or about 4 percent of its total food safety staff years. Because 
CFSAN does not require its staff to track work on fresh produce 
specifically, and instead allows its staff to track fresh produce work 
under either a general food safety category or a produce-specific 
category, CFSAN dollar and staff year estimates are minimum amounts. 
Further, based on the estimates FDA provided, ORA spent the vast 
majority of FDA's fresh produce resources. 

Table 1: FDA Domestic and Imported Food Safety and Fresh Produce 
Spending, Fiscal Years 2006 and 2007 (Dollars in millions): 

Organization: Center for Food Safety and Applied Nutrition; 
Fiscal year: 2006: Food safety: Dollars: $150.3; 
Fiscal year: 2006: Food safety: Staff years: 816; 
Fiscal year: 2006: Fresh produce[A]: Dollars: $1.5; 
Fiscal year: 2006: Fresh produce[A]: Staff years: 10; 
Fiscal year: 2007: Food safety: Dollars: $157.1; 
Fiscal year: 2007: Food safety: Staff years: 744; 
Fiscal year: 2007: Fresh produce[A]: Dollars: $3.6; 
Fiscal year: 2007: Fresh produce[A]: Staff years: 23. 

Organization: Office of Regulatory Affairs (Field work in support of 
the Center for Food Safety and Applied Nutrition); 
Fiscal year: 2006: Food safety: Dollars: $283.5; 
Fiscal year: 2006: Food safety: Staff years: 1,950; 
Fiscal year: 2006: Fresh produce[A]: Dollars: $16.8; 
Fiscal year: 2006: Fresh produce[A]: Staff years: 121; 
Fiscal year: 2007: Food safety: Dollars: $296.1; 
Fiscal year: 2007: Food safety: Staff years: 1,793; 
Fiscal year: 2007: Fresh produce[A]: Dollars: $16.6; 
Fiscal year: 2007: Fresh produce[A]: Staff years: 106. 

Fiscal year: 2007: Center for Veterinary Medicine; 
Fiscal year: 2006: Food safety: Dollars: $54.8; 
Fiscal year: 2006: Food safety: Staff years: 321; 
Fiscal year: 2006: Fresh produce[A]: Dollars: 0.0; 
Fiscal year: 2006: Fresh produce[A]: Staff years: 0; 
Fiscal year: 2007: Food safety: Dollars: $58.4; 
Fiscal year: 2007: Food safety: Staff years: 318; 
Fiscal year: 2007: Fresh produce[A]: Dollars: 0.0; 
Fiscal year: 2007: Fresh produce[A]: Staff years: 0. 

Fiscal year: 2007: Office of Regulatory Affairs (Field work in support 
of the Center for Veterinary Medicine); 
Fiscal year: 2006: Food safety: Dollars: $33.0; 
Fiscal year: 2006: Food safety: Staff years: 206; 
Fiscal year: 2006: Fresh produce[A]: Dollars: 0.0; 
Fiscal year: 2006: Fresh produce[A]: Staff years: 0; 
Fiscal year: 2007: Food safety: Dollars: $34.6; 
Fiscal year: 2007: Food safety: Staff years: 208; 
Fiscal year: 2007: Fresh produce[A]: Dollars: 0.0; 
Fiscal year: 2007: Fresh produce[A]: Staff years: 0. 

Fiscal year: 2007: National Center for Toxicological Research[B]; 
Fiscal year: 2006: Food safety: Dollars: $10.3; 
Fiscal year: 2006: Food safety: Staff years: 36; 
Fiscal year: 2006: Fresh produce[A]: Dollars: 0.0; 
Fiscal year: 2006: Fresh produce[A]: Staff years: 0; 
Fiscal year: 2007: Food safety: Dollars: $11.5; 
Fiscal year: 2007: Food safety: Staff years: 37; 
Fiscal year: 2007: Fresh produce[A]: Dollars: 0.0; 
Fiscal year: 2007: Fresh produce[A]: Staff years: 0. 

Fiscal year: 2007: Office of the Commissioner; 
Fiscal year: 2006: Food safety: Dollars: 29.6; 
Fiscal year: 2006: Food safety: Staff years: 184; 
Fiscal year: 2006: Fresh produce[A]: Dollars: [C]; 
Fiscal year: 2006: Fresh produce[A]: Staff years: [C]; 
Fiscal year: 2007: Food safety: Dollars: 31.6; 
Fiscal year: 2007: Food safety: Staff years: 181; 
Fiscal year: 2007: Fresh produce[A]: Dollars: [C]; 
Fiscal year: 2007: Fresh produce[A]: Staff years: [C]. 

Fiscal year: 2007: Total; 
Fiscal year: 2006: Food safety: Dollars: $561.6; 
Fiscal year: 2006: Food safety: Staff years: 3,513; 
Fiscal year: 2006: Fresh produce[A]: Dollars: $18.3; 
Fiscal year: 2006: Fresh produce[A]: Staff years: 132; 
Fiscal year: 2007: Food safety: Dollars: $589.1; 
Fiscal year: 2007: Food safety: Staff years: 3,281; 
Fiscal year: 2007: Fresh produce[A]: Dollars: $20.2; 
Fiscal year: 2007: Fresh produce[A]: Staff years: 130. 

Source: GAO analysis of FDA data and estimates. 

Notes: Totals may not add due to rounding. 

[A] According to FDA officials, fresh produce spending is estimated. 

[B] Food safety spending includes some dollars spent on collaborative 
efforts with other federal agencies and external organizations. 

[C] The Office of the Commissioner could not provide an estimate of its 
fresh produce spending because it could not distinguish fresh produce 
work from other work. 

[End of table] 

CFSAN reported fresh produce spending in two areas--produce safety and 
response to foodborne outbreaks--and provided an estimate of related 
overhead, as shown in table 2. (See app. II for a detailed listing of 
CFSAN's food safety spending.) The produce safety category includes 
efforts specific to fresh produce, such as assessing the growing 
practices and potential contamination pathways in leafy greens and 
tomatoes. However, food safety work with a fresh produce component, 
such as an effort to modernize current good manufacturing practice 
regulations for food, generally falls under the general food safety 
category. The response to foodborne outbreaks category includes 
responses to various outbreaks, such as the 2006 outbreak of E. coli 
O157:H7 in spinach. According to CFSAN officials, CFSAN attributed all 
of its outbreak response spending to fresh produce in fiscal years 2006 
and 2007 because fresh produce spending estimates were understated 
under the produce safety category and outbreak response work--which 
staff sometimes report more generally as food safety work--primarily 
involved fresh produce. 

Table 2: Minimum Estimates of CFSAN Spending on Fresh Produce, Fiscal 
Years 2006 and 2007: 

Activity: Produce safety; 
Fiscal year: 2006: Dollars: $1,290,696; 
Fiscal year: 2006: Staff years: 9.4; 
Fiscal year: 2007: Dollars: $2,330,437; 
Fiscal year: 2007: Staff years: 15.9. 

Activity: Response to foodborne outbreaks; 
Fiscal year: 2006: Dollars: $31,003; 
Fiscal year: 2006: Staff years: 0.2; 
Fiscal year: 2007: Dollars: $883,993; 
Fiscal year: 2007: Staff years: 6.1. 

Activity: Overhead[A]; 
Fiscal year: 2006: Dollars: $176,647; 
Fiscal year: 2006: Staff years: 0.7; 
Fiscal year: 2007: Dollars: $408,048; 
Fiscal year: 2007: Staff years: 1.4. 

Activity: Total; 
Fiscal year: 2006: Dollars: $1,498,346; 
Fiscal year: 2006: Staff years: 10.4; 
Fiscal year: 2007: Dollars: $3,622,478; 
Fiscal year: 2007: Staff years: 23.3. 

Source: FDA estimated data. 

Notes: Totals may not add due to rounding. These estimates represent 
the minimum resources spent on fresh produce. 

[A] Overhead represents CFSAN's portion of shared services, such as 
human resources, information technology, management services, and 
telephone expenses, and excludes rent and facilities. 

[End of table] 

Similarly, ORA reports fresh produce spending across various 
activities. (See app. II for a detailed listing of ORA's food safety 
spending.) Based on ORA's estimates for fiscal years 2006 and 2007, it 
focused most of its produce safety resources on analyzing produce for 
pesticides and industrial chemicals (49 percent and 56 percent), 
sampling domestic and imported produce for microbial contamination (26 
percent and 12 percent), implementing the general program for domestic 
food safety (10 percent and 9 percent), and examining imported foods (9 
percent and 15 percent). Table 3 shows the dollars and staff years 
spent on ORA activities involving fresh produce. 

Table 3: Estimates of ORA Spending on Fresh Produce, Fiscal Years 2006 
and 2007 (Dollars in millions): 

Activity: Chemical safety of foods: Pesticides and industrial chemicals 
in domestic and imported foods; 
Fiscal year: 2006: Dollars: $8.2; 
Fiscal year: 2006: Staff years: 58.9; 
Fiscal year: 2007: Dollars: $9.2; 
Fiscal year: 2007: Staff years: 59.0. 

Activity: Chemical safety of foods: Radionuclides in foods; 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: 0.1; 
Fiscal year: 2007: Dollars: $0.1; 
Fiscal year: 2007: Staff years: 0.4. 

Activity: Chemical safety of foods: Mycotoxins in domestic and imported 
foods; 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: 0.1; 
Fiscal year: 2007: Dollars: <$.1; 
Fiscal year: 2007: Staff years: 0.1. 

Activity: Chemical safety of foods: Food and color additives (imports); 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: <.1; 
Fiscal year: 2007: Dollars: <$.1; 
Fiscal year: 2007: Staff years: 0.1. 

Activity: Chemical safety of foods: Toxic elements in foods (domestic 
and import); 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: <.1; 
Fiscal year: 2007: Dollars: 0.0; 
Fiscal year: 2007: Staff years: 0.0. 

Activity: Microbiological safety of foods: Import and domestic 
microbiological (produce) assignment; 
Fiscal year: 2006: Dollars: $4.4; 
Fiscal year: 2006: Staff years: 31.9; 
Fiscal year: 2007: Dollars: $2.1; 
Fiscal year: 2007: Staff years: 13.2. 

Activity: Microbiological safety of foods: Audits of food contract 
inspections; 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: 0.1; 
Fiscal year: 2007: Dollars: <$.1; 
Fiscal year: 2007: Staff years: 0.1. 

Activity: Microbiological safety of foods: Natural disasters and 
emergencies; 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: <.1; 
Fiscal year: 2007: Dollars: 0.0; 
Fiscal year: 2007: Staff years: 0.0. 

Activity: Nutrient quality and food labeling: Nutrition Labeling and 
Education Act, nutrient sample analysis and general food labeling; 
Fiscal year: 2006: Dollars: $0.1; 
Fiscal year: 2006: Staff years: 1.0; 
Fiscal year: 2007: Dollars: $0.1; 
Fiscal year: 2007: Staff years: 0.8. 

Activity: Nutrient quality and food labeling: Food economics and 
standards; 
Fiscal year: 2006: Dollars: 0.0; 
Fiscal year: 2006: Staff years: 0.0; 
Fiscal year: 2007: Dollars: <$.1; 
Fiscal year: 2007: Staff years: 0.0. 

Activity: Cross-cutting: Domestic food safety program (general); 
Fiscal year: 2006: Dollars: $1.6; 
Fiscal year: 2006: Staff years: 11.7; 
Fiscal year: 2007: Dollars: $1.6; 
Fiscal year: 2007: Staff years: 9.9. 

Activity: Cross-cutting: Imported foods (general); 
Fiscal year: 2006: Dollars: $1.5; 
Fiscal year: 2006: Staff years: 10.9; 
Fiscal year: 2007: Dollars: $2.5; 
Fiscal year: 2007: Staff years: 16.2. 

Activity: Cross-cutting: Emergency response to foodborne outbreaks and 
illnesses; 
Fiscal year: 2006: Dollars: $0.4; 
Fiscal year: 2006: Staff years: 3.0; 
Fiscal year: 2007: Dollars: $0.6; 
Fiscal year: 2007: Staff years: 3.6. 

Activity: Cross-cutting: Counterterrorism activities; 
Fiscal year: 2006: Dollars: $0.3; 
Fiscal year: 2006: Staff years: 2.0; 
Fiscal year: 2007: Dollars: $0.2; 
Fiscal year: 2007: Staff years: 1.5. 

Activity: Cross-cutting: Consumer complaints; 
Fiscal year: 2006: Dollars: $0.1; 
Fiscal year: 2006: Staff years: 0.7; 
Fiscal year: 2007: Dollars: $0.1; 
Fiscal year: 2007: Staff years: 0.5. 

Activity: Cross-cutting: Foreign inspections and technical assistance; 
Fiscal year: 2006: Dollars: $0.1; 
Fiscal year: 2006: Staff years: 0.7; 
Fiscal year: 2007: Dollars: <$.1; 
Fiscal year: 2007: Staff years: 0.2. 

Activity: Cross-cutting: Short-term assignments initiated by CFSAN, ORA 
headquarters, or ORA field offices; 
Fiscal year: 2006: Dollars: <$.1; 
Fiscal year: 2006: Staff years: 0.2; 
Fiscal year: 2007: Dollars: $0.1; 
Fiscal year: 2007: Staff years: 0.4. 

Activity: Cross-cutting: Juice hazard analysis and critical control 
point program; 
Fiscal year: 2006: Dollars: <.1; 
Fiscal year: 2006: Staff years: 0.1; 
Fiscal year: 2007: Dollars: $0.1; 
Fiscal year: 2007: Staff years: 0.3. 

Activity: Cross-cutting: Miscellaneous other food safety work; 
Fiscal year: 2006: Dollars: 0.0; 
Fiscal year: 2006: Staff years: 0.0; 
Fiscal year: 2007: Dollars: <$.1; 
Fiscal year: 2007: Staff years: <.1. 

Activity: Total; 
Fiscal year: 2006: Dollars: $16.8; 
Fiscal year: 2006: Staff years: 121.4; 
Fiscal year: 2007: Dollars: $16.6; 
Fiscal year: 2007: Staff years: 106.2. 

Source: GAO analysis of FDA estimated data. 

Notes: Totals may not add due to rounding. ORA included overhead in the 
dollars and staff years spent for each activity. 

[End of table] 

FDA's Office of the Commissioner also conducts work related to fresh 
produce, primarily through its Office of Crisis Management, which 
manages FDA's response to foodborne illness outbreaks and other 
emergencies. In addition, FDA's Commissioner created a position in 2007 
within the Office of the Commissioner responsible for developing a 
strategic effort to better protect the nation's food supply, which 
includes fresh produce. However, FDA was unable to provide data or 
estimates on the resources spent on fresh produce by the Office of the 
Commissioner. 

Additionally, our analysis indicates that FDA had few staff dedicated 
solely to fresh produce safety. Within CFSAN, two staff have worked 
almost full-time on fresh produce safety issues for several years, and 
approximately 25 staff--primarily researchers--have principally worked 
on fresh produce safety as part of their food safety responsibilities 
in fiscal year 2007. CFSAN staff have worked on a variety of fresh 
produce efforts, such as assessing the growing practices for leafy 
greens and tomatoes, conducting research on contaminants in produce, 
and working on foodborne illness tracebacks involving fresh produce. 
While no ORA field staff work solely on produce safety, they do conduct 
fresh produce-related work as part of other food safety efforts, such 
as inspecting facilities and testing products under CFSAN's domestic 
food safety compliance program--a general food safety program focusing 
on high-risk firms and products not covered by other programs. In 
addition, ORA has conducted some fieldwork exclusively directed at 
fresh produce, such as an annual assignment to collect and analyze up 
to 1,000 samples of domestic and imported fresh produce. While staff 
within the Office of the Commissioner may work on issues related to 
fresh produce, such as responding to outbreaks of foodborne illness 
linked to fresh produce, no staff work solely on fresh produce issues. 

CFSAN officials acknowledged that having a critical mass of at least 
five staff solely working on produce safety, including an expert to 
lead the group, would be a more effective way of overseeing produce 
safety. In 2007 and 2008, CFSAN received funding to hire four 
additional staff to work solely on produce safety. However, CFSAN 
officials told us that they had not been able to fill all of the 
positions at the time of our review, in part due to salary limitations. 

FDA Has Delayed Key Fresh Produce Activities: 

Even though fresh produce safety has been a stated priority for many 
years, other food safety work has preempted produce safety efforts. 
Specifically, resource constraints and other work--including 
counterterrorism efforts and unplanned events such as outbreaks of 
foodborne illness--led FDA to delay key fresh produce safety efforts. 

FDA's food safety responsibilities have increased in recent years as a 
result of the growth in imported food and new regulatory 
responsibilities, among other things. At the same time, our analysis 
shows that, after adjusting for inflation, FDA's total food safety 
spending, which includes fresh produce, remained relatively stable in 
recent years, despite an initial surge after the events of September 
11, 2001. Specifically, FDA's total spending on food safety dropped 
slightly below its peak of $600.8 million in fiscal year 2003 to $600.3 
million in fiscal year 2007 (in constant fiscal year 2008 dollars), as 
shown in figure 1. (See app. II for FDA's food safety spending for 
fiscal years 2000 through 2007.) 

Figure 1: FDA Food Safety Spending in Constant and Nominal Dollars, 
Fiscal Years 2000 through 2007: 

[See PDF for image] 

This figure is a multiple line graph depicting the following data: 

Fiscal year: 2000; 
Nominal dollars: $351 million; 
Constant FY 2008 dollars: $428 million. 

Fiscal year: 2001; 
Nominal dollars: $372 million; 
Constant FY 2008 dollars: $443 million. 

Fiscal year: 2002; 
Nominal dollars: $510 million; 
Constant FY 2008 dollars: $595 million. 

Fiscal year: 2003; 
Nominal dollars: $525 million; 
Constant FY 2008 dollars: $601 million. 

Fiscal year: 2004; 
Nominal dollars: $522 million; 
Constant FY 2008 dollars: $583 million. 

Fiscal year: 2005; 
Nominal dollars: $555 million; 
Constant FY 2008 dollars: $600 million. 

Fiscal year: 2006; 
Nominal dollars: $562 million; 
Constant FY 2008 dollars: $588 million. 

Fiscal year: 2007; 
Nominal dollars: $589 million; 
Constant FY 2008 dollars: $600 million. 

Source: GAO analysis of FDA data. 

Note: Annual totals include some non-FDA funding from collaborations 
between the National Center for Toxicological Research and non-FDA 
entities. 

[End of figure] 

At CFSAN, spending on food safety declined slightly from its peak of 
over $164 million in fiscal year 2003 to approximately $160 million in 
fiscal year 2007 (in constant fiscal year 2008 dollars). As a result, 
CFSAN had to absorb cost-of-living increases for its staff, which 
translated into substantial budget constraints and loss of staff years 
through early retirements and decisions not to fill vacated positions. 
CFSAN incurred these losses despite an increase in responsibilities, 
significantly impairing its ability to fund its priorities, according 
to the document detailing the center's 2006 program priorities. ORA 
spending on food safety during this period remained relatively flat (in 
constant fiscal year 2008 dollars), translating into similar budget 
constraints and absorption of cost of living increases. 

Our analysis also shows that staffing levels for food safety have 
fallen during the last 4 fiscal years, after initially increasing 
following September 11, 2001, as shown in figure 2. (See app. II for 
detailed information on FDA's food safety staffing for fiscal years 
2000 through 2007.) Food safety staffing levels declined 17 percent 
from their peak of 3,969 staff years in fiscal year 2003 to 3,281 in 
fiscal year 2007. In fact, the number of staff years FDA spent on food 
safety had fallen below fiscal year 2002 levels by the end of fiscal 
year 2007. As a result, FDA lost 70 percent of the food safety staff 
years gained since fiscal year 2000. 

Figure 2: FDA's Total Food Safety Staffing Levels, Fiscal Years 2000 
through 2007: 

[See PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Fiscal year: 2000; 
Number of staff years: 2988. 

Fiscal year: 2001; 
Number of staff years: 3082. 

Fiscal year: 2002; 
Number of staff years: 3509. 

Fiscal year: 2003; 
Number of staff years: 3969. 

Fiscal year: 2004; 
Number of staff years: 3853. 

Fiscal year: 2005; 
Number of staff years: 3599. 

Fiscal year: 2006; 
Number of staff years: 3513. 

Fiscal year: 2007; 
Number of staff years: 3281. 

Source: FDA data. 

Note: Staff years are rounded to the nearest whole number. 

[End of figure] 

Specifically, FDA experienced a net decline of 689 food safety staff 
years between fiscal years 2003 and 2007.[Footnote 8] ORA sustained the 
vast majority of these losses, losing 410 staff years, or more than 20 
percent of the staff years it devotes to supporting CFSAN's food safety 
activities. CFSAN lost 177 food safety staff years during this same 
period, or almost 25 percent of its headquarters food safety staff 
years. Figure 3 shows the FDA organizations experiencing a decline in 
food safety staff years between fiscal years 2003 and 2007, and 
appendix II, table 5, shows FDA's total food safety spending, by 
center, during this period. 

Figure 3: FDA Organizations Experiencing a Decline in Food Safety Staff 
Years between Fiscal Years 2003 and 2007: 

[See PDF for image] 

This figure is a pie-chart depicting the following data: 

FDA Organizations Experiencing a Decline in Food Safety Staff Years 
between Fiscal Years 2003 and 2007: 
ORA (CFSAN field): 410; 
CFSAN headquarters: 177; 
Office of the Commissioner: 45; 
ORA (CVM field): 34; 
CVM headquarters: 23. 

Source: GAO analysis of FDA data. 

Notes: Staff years are rounded to the nearest whole number. The 
National Center for Toxicological Research is not included in this 
figure because it gained one staff year between fiscal years 2003 and 
2007. 

[End of figure] 

In our January 2008 testimony on FDA's Food Protection Plan, we noted 
that FDA's resources have not kept pace with an increasing food safety 
workload over the past decade and that funding issues are more acute 
for CFSAN than for other centers because, unlike some other FDA 
programs, it does not have the authority to collect and retain user 
fees. Similarly, CFSAN's former director testified in February 2008 
that the agency's food-related funding has not kept pace with 
inflation, with FDA losing 800 scientists, inspectors, and other 
critical food safety staff since fiscal year 2004. In addition, former 
Secretaries of the Department of Health and Human Services and other 
experts have called on the Congress to dramatically increase the 
agency's budget for protecting the nation's food supply. FDA's 
Commissioner, in a May 2008 letter to the Congress, assessed the agency 
as immediately needing an additional $125 million to achieve its food 
protection goal for fiscal year 2008. However, as we testified in June 
2008, the total costs to fully implement the agency's Food Protection 
Plan are not yet clear,[Footnote 9] and we continue to have concerns 
about the agency's lack of specificity about the resources needed. 

FDA officials acknowledged that, in recent years, resource constraints 
have led FDA to delay work on some key fresh produce safety efforts 
because FDA lacked enough staff with the needed expertise in areas like 
regulatory development, as well as enough staff with the technical and 
subject matter expertise to work on all food safety priorities. For 
example, according to FDA officials, this staff shortage caused the 
agency to delay two key efforts relating to fresh produce--modernizing 
its current good manufacturing practice regulations for food and 
updating its good agricultural practices guidance. In addition, FDA 
acknowledged that because CFSAN has lacked the resources to fund its 
extramural research grant program or perform some critical produce- 
related research internally, it has not yet been able to conduct the 
large-scale surveys of fresh produce that are crucial to understanding 
the incidence of contamination of produce by pathogens such as E. coli 
O157:H7 or Salmonella. 

FDA officials also acknowledged that they have delayed work on fresh 
produce safety efforts because of other work, including 
counterterrorism efforts in response to the Bioterrorism Act and 
unplanned events such as outbreaks of foodborne illness and recalls of 
contaminated foods. Additionally, ORA officials repeatedly told us that 
responding to emergencies, such as foodborne illness outbreaks, takes 
precedence over other work. However, ORA stopped setting aside staff 
time and funding for emergencies beginning with fiscal year 2007. 
Consequently, during the 2007 recall of botulism-contaminated chili, 
ORA diverted staff throughout the country from conducting their ongoing 
work to removing potentially contaminated products from store shelves. 
Further, agency officials stated that the February 2008 release of 
FDA's final guidance for fresh-cut produce operations--designed to 
enhance food safety in a segment of the produce industry frequently 
linked to foodborne illness outbreaks and listed as a CFSAN priority 
since fiscal year 2000--was delayed at least 6 years because CFSAN had 
to divert staff with the needed expertise to address counterterrorism 
efforts and foodborne illness outbreaks. 

FDA Has Provided Limited Oversight of Domestic and Imported Fresh 
Produce: 

FDA's oversight of domestic and imported fresh produce has generally 
been limited, with less focus on prevention and intervention--the first 
two areas of its food safety framework--than on response. This approach 
has limited the effectiveness of FDA's oversight. First, in terms of 
prevention, gaps in scientific knowledge and the lack of regulations 
have limited FDA's efforts to prevent microbial contamination of fresh 
produce. In terms of intervention, FDA has inspected domestic fresh 
produce firms infrequently. In addition, although FDA has allocated 
additional resources to import oversight, it has not been able to 
inspect a larger share of incoming fresh produce shipments. Finally, 
FDA gives top priority to responding to emergencies, such as foodborne 
illness outbreaks, and has had some success in improving its response, 
but tracing contaminated produce back to its source remains 
challenging. 

Gaps in Science and the Lack of Regulations Have Impeded FDA's Efforts 
to Take a Prevention-Based Approach: 

Gaps in scientific knowledge have impeded FDA's efforts to integrate 
science and risk analysis into its oversight of fresh produce safety. 
Food safety experts recommend a system that is science-based and uses 
risk analysis to focus preventive efforts on the foods and processes 
most likely to cause illness. FDA follows this approach by using 
available research to inform regulatory decisions and by considering 
the risk level of different products in making decisions about where to 
focus resources. However, FDA officials have noted that gaps in science 
have impeded their ability to make some decisions on how to regulate 
fresh produce. For example, cattle are known carriers of E. coli 
O157:H7, but scientists do not know exactly how E. coli is passed from 
animals to produce, and thus cannot say how far cattle should be kept 
from a leafy greens field. Furthermore, FDA does not have sufficient 
information to develop robust, science-based risk assessments that 
quantify the relative risks of consuming different types of produce. 
Lacking such information, FDA largely relies on qualitative 
information, such as the history of past outbreaks of foodborne 
illness, to rank the risk levels of fresh produce commodities. 

FDA has taken steps to fill some of the gaps in scientific knowledge, 
but resource constraints have limited the agency's efforts. To fill 
some of the gaps, FDA conducts laboratory research on fresh produce 
commodities and their associated pathogens. For example, FDA has a 
study under way to improve its understanding of how one type of 
Salmonella contaminates tomatoes. However, FDA officials have 
acknowledged that the scope of their research needs exceeds available 
resources. Additionally, in response to recurring outbreaks of 
foodborne illness, FDA implemented a lettuce initiative in 2006 and a 
tomato initiative in 2007 to study farming practices and environmental 
conditions that could lead to contamination. These ongoing multiyear 
initiatives are conducted as part of a risk-based strategy that focuses 
on growing areas most often linked to past outbreaks--California for 
lettuce and leafy greens and Virginia and Florida for tomatoes. FDA 
typically does not inspect farms, so these initiatives also provide an 
opportunity to assess the extent to which growers are following the 
agency's recommended practices. FDA intends to use the information 
obtained through these initiatives to improve guidance and identify 
additional research or outreach needs. FDA also participates in three 
research centers in cooperation with academic institutions.[Footnote 
10] However, FDA's Science Board notes that overall output from these 
centers has been modest because of budget constraints at FDA. Finally, 
FDA directly funds projects carried out by other institutions, but 
agency officials noted that resource constraints led the agency to 
suspend its extramural research grant program for fiscal years 2006 and 
2007. 

Because FDA has limited resources for food safety research, it relies 
heavily on other federal agencies, including USDA and the National 
Institutes of Health, for scientific knowledge. However, a former CFSAN 
director told us that although FDA has worked to identify research 
needs and communicate them to other federal agencies, the agency has so 
far represented a fairly small voice in developing the research agenda, 
and therefore, gaps in science remain. Additionally, FDA officials 
acknowledged that it can be difficult to persuade other federal 
agencies to conduct research that meets FDA's needs. For example, 
obtaining baseline data on contamination levels of lettuce in different 
regions and in different seasons would aid FDA's regulatory work, but 
it is extremely expensive and, according to FDA officials, other 
agencies are uninterested in funding research to obtain such data. In 
addition to communicating research needs through meetings and 
conferences, FDA officials told us that the agency publishes a list of 
its research needs to communicate its priorities to other federal 
agencies. However, according to the director of CFSAN's Office of 
Regulatory Science, the most recent version was last updated 8 years 
ago, and many of the research priorities identified in that document 
still have not been addressed. Nevertheless, FDA is currently exploring 
ways to expand the agency's knowledge on fresh produce safety. 

FDA has issued some voluntary guidance for fresh produce but has not 
issued enforceable regulations to prevent contamination. In 1998, for 
instance, FDA issued guidance for industry on good agricultural 
practices for reducing the risk of microbial contamination when 
growing, packing, and transporting fresh produce. For example, the 
guidance suggests practices that growers should consider to protect the 
quality of agricultural water. FDA has also issued guidance 
specifically for sprouts and for fresh-cut produce, as well as draft 
guidance for controlling Listeria monocytogenes in ready-to-eat foods, 
including fresh-cut produce. In addition, FDA has provided technical 
assistance to industry in developing guidance for melons, lettuce and 
leafy greens, and tomatoes, but the agency has not officially endorsed 
these documents. While guidance provides useful recommendations, it is 
voluntary and unenforceable. Finally, FDA has not issued preventive 
regulations for fresh produce, even though it has done so for other 
high-risk foods--for seafood in 1995 and for fruit juice in 2001. FDA's 
current good manufacturing practice regulations for food, which set out 
basic sanitation rules for food manufacturers, apply to fresh-cut 
produce, but specifically exempt raw agricultural commodities, 
including whole fruits and vegetables. 

In the absence of preventive regulations issued by FDA, industry groups 
and others have undertaken other mechanisms to establish additional 
standards, such as the following: 

* Both California leafy greens handlers and Arizona leafy greens 
shippers have entered into marketing agreements that regulate growing 
and processing practices for those who sign the agreement. 

* USDA issued an advance notice of proposed rulemaking for a national 
marketing agreement for leafy greens. 

* Florida's Department of Agriculture and Consumer Services recently 
adopted requirements related to safe growing and packing practices for 
tomatoes. 

* The Association of Food and Drug Officials is developing a model 
fresh produce regulation for use by states. 

* Some retail establishments have adopted policies requiring suppliers 
to meet specific, and often differing, requirements and to demonstrate 
adherence to these standards through inspections carried out by 
designated third-party auditors. 

While many have praised these efforts as demonstrating a broad base of 
commitment to enhancing fresh produce safety, some have expressed 
concern that they lack national uniformity and create a patchwork of 
requirements that may present problems, both for growers and consumers. 
To address some of these problems, both industry groups and food safety 
experts have advocated for federal fresh produce regulations. 

FDA's Efforts to Inspect and Sample Domestic and Imported Fresh Produce 
Have Generally Been Limited: 

FDA's intervention efforts have been limited. First, FDA infrequently 
inspected domestic firms handling fresh produce. Additionally, FDA 
tested fresh produce samples more frequently for pesticides than for 
microbial contamination. Finally, while FDA has allocated additional 
resources to import oversight, it has not been able to inspect a larger 
percentage of imported fresh produce items. 

Domestic produce inspections have occurred infrequently. The number of 
domestic fresh produce inspections conducted by FDA fluctuated from 
fiscal years 2000 through 2007. Our analysis of FDA data showed that 
the number of domestic fresh produce inspections rose from 327 in 
fiscal year 2000 to a peak of 699 in fiscal year 2005, and then 
declined to 478 inspections in fiscal year 2007. Overall domestic food 
inspections also fluctuated, rising from about 13,300 in fiscal year 
2000 to about 19,800 in fiscal year 2004, and decreasing to about 
15,700 in fiscal year 2007, as shown in figure 4. 

Figure 4: Domestic Food and Fresh Produce Inspections, Fiscal Years 
2000 through 2007: 

[See PDF for image] 

This figure is a stacked vertical bar graph depicting the following 
data: 

Domestic Food and Fresh Produce Inspections, Fiscal Years 2000 through 
2007: 

Fiscal year: 2000; 
Fresh produce: 327; 
All other foods: 12,947. 

Fiscal year: 2001; 
Fresh produce: 463; 
All other foods: 17,015. 

Fiscal year: 2002; 
Fresh produce: 426; 
All other foods: 16,237. 

Fiscal year: 2003; 
Fresh produce: 600; 
All other foods: 18,947. 

Fiscal year: 2004; 
Fresh produce: 672; 
All other foods: 19,104. 

Fiscal year: 2005; 
Fresh produce: 699; 
All other foods: 17,458. 

Fiscal year: 2006; 
Fresh produce: 495; 
All other foods: 15,893. 

Fiscal year: 2007; 
Fresh produce: 478; 
All other foods: 15,169. 

Source: FDA data. 

[End of figure] 

We also found that firms were inspected infrequently. Because FDA's 
database of registered food firms does not capture data that would 
identify all U.S. firms that handle fresh produce, we could not 
determine the percentage of fresh produce firms inspected. 

However, according to our analysis, 2,002 firms had at least one 
produce-related inspection between fiscal years 2000 and 2007. On 
average, each firm was inspected twice during that period. About half 
of the firms had only one fresh produce-related inspection, and only 6 
firms (0.3 percent) had a fresh produce-related inspection every year. 

Additionally, FDA has increasingly coordinated with states to better 
leverage inspection resources. At the end of fiscal year 2007, FDA had 
contracts with 40 states to conduct food inspections on its behalf and 
had less formal partnership agreements with some states to coordinate 
food safety activities, including inspections. We found that states 
conducted 200 of the 600 fresh produce inspections (33 percent) in 
fiscal year 2003--including one conducted jointly with FDA officials-- 
compared with 269 of the 478 (56 percent) in fiscal year 2007, as shown 
in figure 5. FDA officials attributed this increase in the share of 
inspections conducted by states to an overall effort to better leverage 
resources in response to FDA staff losses and resource constraints. FDA 
officials also noted that the agency has tried to maintain consistent 
funding for state-conducted inspections. As a result, when changes in 
FDA funding occurred, the number of FDA-conducted inspections 
fluctuated more than state-conducted inspections. State officials noted 
that increasing the share of domestic inspections performed by the 
states may allow FDA to concentrate on areas where states do not have 
jurisdiction, such as import oversight. However, state officials also 
noted that they have experienced some challenges in partnering with 
FDA. For example, according to one state official, FDA sometimes 
restricts state access to the agency's inspection results because of 
confidentiality concerns. According to the official, such data would 
provide states with useful information on a firm's history and help the 
states' inspection efforts. 

Figure 5: Fresh Produce Inspections Conducted by FDA and States, Fiscal 
Years 2000 through 2007: 

[See PDF for image] 

This figure is a multiple vertical bar graph depicting the following 
data: 

Fresh Produce Inspections Conducted by FDA and States, Fiscal Years 
2000 through 2007: 

Fiscal year: 2000; 
Inspections conducted by FDA: 183; 
Inspections conducted by States: 144. 

Fiscal year: 2001; 
Inspections conducted by FDA: 220; 
Inspections conducted by States: 243. 

Fiscal year: 2002; 
Inspections conducted by FDA: 194; 
Inspections conducted by States: 232. 

Fiscal year: 2003; 
Inspections conducted by FDA: 400; 
Inspections conducted by States: 200. 

Fiscal year: 2004; 
Inspections conducted by FDA: 460; 
Inspections conducted by States: 212. 

Fiscal year: 2005; 
Inspections conducted by FDA: 437; 
Inspections conducted by States: 262. 

Fiscal year: 2006; 
Inspections conducted by FDA: 298; 
Inspections conducted by States: 197. 

Fiscal year: 2007; 
Inspections conducted by FDA: 209; 
Inspections conducted by States: 269. 

Source: GAO analysis of FDA data. 

Note: State-conducted inspections include seven inspections conducted 
jointly with FDA. 

[End of figure] 

FDA and the states found problems in approximately 41 percent of the 
fresh produce inspections conducted between fiscal years 2000 and 2007, 
as shown in figure 6. When inspections find objectionable conditions, 
it is FDA's practice to give firms an opportunity to take voluntary 
corrective action before initiating an enforcement action, unless there 
is significant impact on public health. FDA told us that when an 
inspection uncovers objectionable conditions, the firm should be 
reinspected within 2 to 3 years. While FDA noted that the agency is 
often unable to meet this goal, it also noted that serious problems 
that warrant regulatory action are likely to trigger a reinspection. 
More specifically, we were told the agency prioritizes follow-up 
inspections based on the severity of problems found and a firm's past 
history of compliance. 

Figure 6: Percentage of Fresh Produce Inspections Uncovering Problems, 
Fiscal Years 2000 through 2007: 

[See PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Percentage of Fresh Produce Inspections Uncovering Problems, Fiscal 
Years 2000 through 2007: 

Fiscal year: 2000; 
Percentage: 57.8. 

Fiscal year: 2001; 
Percentage: 44.7. 

Fiscal year: 2002; 
Percentage: 45.3. 

Fiscal year: 2003; 
Percentage: 38.5. 

Fiscal year: 2004; 
Percentage: 34.7. 

Fiscal year: 2005; 
Percentage: 34. 

Fiscal year: 2006; 
Percentage: 41. 

Fiscal year: 2007; 
Percentage: 43.3. 

Source: GAO analysis of FDA data. 

[End of figure] 

We also found that FDA took little enforcement action.[Footnote 11] 
Specifically, we identified 96 warning letters related to fresh 
produce, but their use declined substantially, with 66 issued in fiscal 
year 2000 and none issued in fiscal years 2005 through 2007, as shown 
in figure 7. During the same period, according to FDA, the agency 
seized no fresh produce, sought no injunctions, and prosecuted no firms 
for fresh produce-related violations. We could not determine the number 
of less formal enforcement actions taken at the FDA district level, 
such as sending untitled letters--informal communications used to 
notify firms that corrective actions are needed--or holding meetings to 
inform firms of objectionable conditions, because FDA had not centrally 
compiled such data. 

Figure 7: Fresh Produce-Related Warning Letters, Fiscal Years 2000 
through 2007: 

[See PDF for image] 

This figure is a vertical bar graph depicting the following data: 

Fresh Produce-Related Warning Letters, Fiscal Years 2000 through 2007: 

Fiscal year: 2000; 
Warning letters: 66. 

Fiscal year: 2001; 
Warning letters: 20. 

Fiscal year: 2002; 
Warning letters: 7. 

Fiscal year: 2003; 
Warning letters: 2. 

Fiscal year: 2004; 
Warning letters: 1. 

Fiscal year: 2005; 
Warning letters: 0. 

Fiscal year: 2006; 
Warning letters: 0. 

Fiscal year: 2007; 
Warning letters: 0. 

Source: GAO analysis of warning letters posted on FDA's Web site. 

[End of figure] 

Most of FDA's sample analysis has focused on pesticides. In fiscal year 
2007, 82 percent of all fresh produce samples were tested for 
pesticides, while 17 percent were tested for microbial contamination. 
However, the relative rates of testing differed for domestic and 
imported produce. FDA officials told us that in the late 1990s, 
outbreaks of foodborne illness led the agency to focus its domestic 
food safety program more heavily on microbial contamination, and as a 
result, the focus of its domestic sample analysis also began to shift. 
Specifically, in fiscal year 2000, we found that FDA tested 14 percent 
of domestic produce samples for microbial contamination, compared with 
37 percent in fiscal year 2007. According to FDA officials, pesticides 
remain a larger concern for imported produce, so a significant portion 
of import testing continues to focus on pesticides. For example, in 
fiscal year 2007, 92 percent of imported produce samples were tested 
for pesticides. FDA officials told us that two factors have slowed the 
agency's shift toward microbial testing. First, pesticides are easier 
to detect because they are fairly evenly distributed across products, 
whereas microbial contamination may be sporadic. Second, pesticide 
testing can be more productive because available methods allow FDA to 
test one sample for multiple pesticide residues, whereas similar 
methods are considerably more difficult in microbial testing. 

FDA has provided limited oversight of imported fresh produce. FDA 
primarily relies on an electronic screening process to review imported 
produce at the border--typically only inspecting foreign produce firms 
for cause, such as a potential link to an outbreak of foodborne 
illness. The basic import process consists of two stages--prior notice 
and food safety evaluation. In the first stage, FDA must receive prior 
notice before a food shipment arrives in the United States. Prior 
notice information is screened electronically by FDA's import database, 
the Operational and Administrative System for Import Support (OASIS), 
for potential risks associated with intentional contamination. Once the 
prior notice review has been completed, the food safety evaluation is 
conducted. For this evaluation, OASIS screens each entry line--or 
portion--of the shipment for risk factors associated with unintentional 
contamination to determine whether the shipment may proceed 
automatically or whether it requires further review.[Footnote 12] In 
fiscal year 2007, about one-quarter of all fresh produce entry lines 
received a system "may proceed" designation after this step. If an 
entry line does not receive this designation, an FDA reviewer conducts 
an on-screen evaluation. OASIS alerts the reviewer to factors that may 
prompt further action, such as the existence of an import alert or a 
product meeting the criteria for sampling, and the reviewer then 
decides whether or not to allow the entry line to proceed. According to 
an FDA official, in 2007 this on-screen review took an average of about 
45 seconds, and the vast majority of entry lines are allowed to 
continue into domestic commerce. In fiscal year 2007, nearly 99 percent 
of all fresh produce entry lines were cleared following electronic 
screening. Entry lines that are held by FDA may be physically examined, 
sampled, or detained without physical examination. 

Food imports in general and fresh produce imports in particular have 
increased in recent years, and despite allocating additional resources, 
FDA has not been able to inspect a larger portion of fresh produce 
imports. Specifically, imported food for human consumption increased 84 
percent from fiscal years 2002 through 2007, from about 5.1 million 
lines to about 9.4 million lines. Fresh produce imports increased about 
60 percent over the same period, from about 940,000 lines in fiscal 
year 2002 to over 1.5 million lines in fiscal year 2007. During this 
period, the number of fresh produce lines that FDA examined more than 
quadrupled. Specifically, following the passage of the Bioterrorism Act 
in 2002, the agency received additional resources to oversee both 
domestic and imported food, which allowed it to increase the number of 
imported fresh produce lines examined in fiscal year 2003. 
Additionally, recognizing the substantial growth in imported products, 
the agency decided around fiscal year 2004 to shift additional 
resources to import oversight, according to an FDA official. Doing so 
enabled FDA to increase further the number and percentage of fresh 
produce lines it examined, but it has not been able to sustain its 
inspection rate at the fiscal year 2005 level. Although FDA increased 
fresh produce examinations from about 9,000 lines in fiscal year 2004 
to about 11,000 in fiscal year 2007, the percentage of all fresh 
produce lines inspected remained at about 0.73 percent, as shown in 
table 4. Overall, FDA examined 0.77 percent and sampled 0.22 percent of 
the 7.6 million fresh produce lines imported from fiscal years 2002 
through 2007. 

Table 4: Actions Taken on Fresh Produce Entry Lines, Fiscal Years 2002 
through 2007 (Percentage of total lines in parenthesis): 

Description: Total import lines; 
Fiscal year: 2003: 1,074,076; 
Fiscal year: 2004: 1,249,645; 
Fiscal year: 2005: 1,359,978; 
Fiscal year: 2006: 1,432,316; 
Fiscal year: 2007: 1,503,884. 

Description: Lines examined; 
Fiscal year: 2002: 2,497 (0.27); 
Fiscal year: 2003: 8,439 (0.79); 
Fiscal year: 2004: 9,106 (0.73); 
Fiscal year: 2005: 16,583 (1.22); 
Fiscal year: 2006: 10,674 (0.75); 
Fiscal year: 2007: 11,014 (0.73). 

Description: Lines sampled; 
Fiscal year: 2002: 2,879 (0.31); 
Fiscal year: 2003: 2,681 (0.25); 
Fiscal year: 2004: 2,791 (0.22); 
Fiscal year: 2005: 3,204 (0.24); 
Fiscal year: 2006: 2,321 (0.16); 
Fiscal year: 2007: 2,967 (0.20). 

Description: Lines detained without physical exam; 
Fiscal year: 2002: 1,822 (0.19); 
Fiscal year: 2003: 1,770 (0.16); 
Fiscal year: 2004: 2,161 (0.17); 
Fiscal year: 2005: 1,796 (0.13); 
Fiscal year: 2006: 2,038 (0.14); 
Fiscal year: 2007: 1,807 (0.12). 

Source: GAO analysis of FDA data. 

Note: Percentages may be slightly overstated because some lines may 
have been examined more than once or detained for more than one reason 
and, therefore, double-counted in our annual totals. 

[End of table] 

According to FDA officials, import alerts are the agency's primary 
mechanism for keeping products with a history of violations out of the 
country, and they use them regularly. Through the use of import alerts, 
the agency may detain potentially adulterated products at the border 
without a physical exam. Additionally, import alerts place the burden 
on the importing firm to demonstrate that the product is safe. However, 
we found that import alerts covered a very small percentage of fresh 
produce imports from fiscal years 2002 through 2007. During that 
period, FDA detained 0.15 percent of all imported fresh produce lines 
on the basis of import alerts. Officials attributed the small 
proportion of imports covered by import alerts to the fact that FDA 
only samples a small portion of imports and only issues an import alert 
after it finds a problem. 

FDA Has Taken Steps to Improve Response to Outbreaks and Other 
Emergencies but Continues to Face Challenges: 

FDA has had some success in improving its response to produce-related 
emergencies but continues to face challenges. In particular, FDA has 
had success in improving coordination, partnering with California on 
outbreak investigations, and piloting a program involving recalled 
products. While FDA has taken steps to improve its ability to trace 
outbreaks to their source, it remains extremely difficult to do so for 
fresh produce. Additionally, FDA lacks authorities that could be useful 
in responding to food-related emergencies, including mandatory recall 
authority for foods other than infant formula, and access to certain 
records during emergencies. 

FDA has taken some steps that have helped to improve the agency's 
response to produce-related emergencies. For example, in 2002, FDA 
established an Office of Crisis Management within the Office of the 
Commissioner. Creating this office has enhanced the agency's ability to 
coordinate its emergency response activities internally and with 
others. Also, realizing that they often performed parallel 
investigations for the same outbreak, FDA's Pacific Region and the 
California Department of Public Health decided to leverage resources by 
developing a joint emergency response group, called the California Food 
Emergency Response Team (CalFERT). CalFERT includes highly skilled and 
experienced investigators and scientists from FDA and California who 
regularly train together, allowing them to develop a working 
relationship before an emergency occurs. Both FDA and state officials 
said that CalFERT enabled them to respond quickly to the 2006 E. coli 
O157:H7 outbreak linked to spinach. Finally, in order to improve 
consumer awareness of recalled products, FDA started a pilot program in 
2007 in which they include a photograph of the label of a recalled food 
product on their Web site along with the announcement of the recall. 
FDA is currently evaluating this program, but initial results indicate 
that it has been effective in helping consumers identify recalled 
foods. 

FDA has also taken steps to improve its ability to trace outbreaks to 
the source of contamination, but it remains extremely difficult to do 
so for fresh produce. Traceback investigations are an important part of 
emergency response because they help identify which products should be 
recalled and how contamination occurred. The traceback process 
generally starts at the retail locations implicated in cases of illness 
and follows the implicated product back through the supply chain to 
identify a common source. Such investigations can be particularly 
difficult when they involve fresh produce because produce is highly 
perishable and may no longer be available for testing when an outbreak 
is identified. Even when products are available, they often are 
unlabeled or mixed in packages containing products from multiple 
sources, making it difficult to identify a specific source of 
contamination. For example, tomatoes can be very difficult to trace 
because packing houses often combine shipments from multiple domestic 
and foreign growers in order to create boxes of similar quality or 
size. To address some of these challenges, FDA has developed traceback 
procedures specifically for fresh produce investigations that provide 
techniques for determining and documenting the distribution and 
production chain and the source of the product implicated in an 
outbreak. FDA has also developed farm investigation procedures for 
cases where contamination may have occurred in the field. Additionally, 
FDA offers a course to help familiarize FDA and state inspectors with 
outbreak investigation procedures on farms. Despite these efforts, 
traceback remains very difficult for fresh produce, and it remains 
uncommon for investigations to trace the product back to the field that 
was likely the source of contamination. CalFERT was able to do so 
following the 2006 outbreak of E. coli O157:H7 in spinach because 
contaminated product was found in bags with lot numbers. 

However, FDA lacks some authorities that could improve its response 
efforts, including mandatory recall authority for foods other than 
infant formula and the authority to access some firm records during 
emergencies. FDA provides assistance to industry during voluntary 
recalls but does not have the authority to require a firm to issue a 
recall for any food other than infant formula. When industry issues a 
recall, FDA assists firms in notifying distributors and consumers, 
classifies the recall based on the potential threat to human health, 
and monitors the firm's recall process. Fresh produce recalls are 
voluntary, and FDA officials acknowledge that firms can ignore an FDA 
request to initiate a recall. Additionally, while FDA has the authority 
to access certain records, including processing and shipping records, 
for a product it reasonably believes is adulterated or presents a 
threat of serious adverse health consequences or death, it does not 
necessarily have the authority to access records for related products 
handled in the same facility. FDA officials acknowledged that they 
sometimes obtain records from states, since some have broader authority 
to access firm records. However, having to ask states to obtain records 
could slow an outbreak investigation. 

Proposed Actions Could Significantly Enhance Fresh Produce Oversight, 
but More Information Is Needed to Assess the Likelihood of Success: 

Through the Food Protection Plan, FDA has proposed actions and 
identified additional authorities that could significantly enhance its 
oversight of fresh produce within the plan's framework of prevention, 
intervention, and response. However, FDA has not provided sufficient 
information on strategies and resources for implementing the plan, 
which makes it difficult to assess the likelihood of success. 

FDA's Plans to Help Fill Gaps in Scientific Knowledge and Issue New 
Guidance and Regulations Could Enhance Prevention Efforts: 

To help prevent contamination of fresh produce, FDA plans to help fill 
gaps in scientific knowledge and issue new guidance and regulations, 
and has cited in its Food Protection Plan a need for explicit authority 
to issue regulations that are intended to prevent contamination. 
Specifically, FDA intends to: 

* Help expand scientific information on fresh produce safety. FDA plans 
to expand knowledge on fresh produce safety. For example, FDA is 
working with researchers from several universities to carry out a USDA- 
funded project looking into options for reducing the risk of E. coli 
O157:H7 in leafy greens from production to packaging. Also, in June 
2008, FDA announced the establishment of the Western Center for Food 
Safety at the University of California, Davis, which will create a 
research, education, and outreach program focused on the interface 
between agriculture and food safety. The center plans to focus its 
initial research on produce safety, such as safe agricultural practices 
for domestic and imported commodities. FDA also plans to strengthen its 
current qualitative risk ranking of food commodities and pathogens, 
starting with fresh produce items. In addition, FDA announced in June 
2008 that it will fund approximately $1 million in extramural research 
grants that address fresh produce safety topics, such as how consumer 
handling of fresh-cut produce may compromise microbiological safety and 
problems that occur during transportation. To help shape outside 
research and update its 8-year-old list of research needs, FDA 
officials told us that CFSAN is developing a plan that outlines 
priority research needs, including produce safety research. According 
to FDA officials, CFSAN has just begun to develop this plan, and it may 
take several months before it is available. Finally, FDA officials told 
us that they would like to have voluntary access to data from producers 
for research purposes. For example, some fresh produce firms have 
testing records that show when they have found E. coli O157:H7 or 
Salmonella in product samples. FDA officials noted that they are 
interested in conglomerate data stripped of identifiers, but that in 
order to use industry data, they would need to find ways to effectively 
address industry members' reluctance to share such information. 

* Update existing fresh produce-related guidance and regulations. FDA 
officials told us they plan to update the agency's 1998 good 
agricultural practices guidance to incorporate new knowledge about safe 
growing practices for fresh produce. FDA also has plans to update its 
current good manufacturing practice regulations for food, which were 
last updated in 1986 and which guide, among other things, domestic 
inspections of fresh-cut produce facilities. While both efforts could 
enhance FDA's oversight and assist industry in producing safe produce 
items, at the time of our review, FDA officials said they had not yet 
started to update the agency's good agricultural practices guidance 
because of limited resources. Furthermore, progress on updating the 
current good manufacturing practice regulations for food has been slow 
since the effort began in 2002, and officials could not provide an 
estimate of their completion date. 

* Seek authority to issue preventive safety regulations for foods such 
as fresh produce. FDA, in the Food Protection Plan, identified a need 
for explicit authority from the Congress to issue regulations to 
require preventive measures by firms producing foods that have been 
associated with repeated instances of serious health problems or death. 
FDA already has preventive regulations for seafood and juice, which 
require firms to analyze safety hazards and implement plans to address 
those hazards. According to FDA, such authority would strengthen the 
agency's ability to implement risk-based processes to reduce illnesses 
from high-risk foods. We have previously recommended the use of such 
preventive safety regulations for chemicals,[Footnote 13] and FDA 
officials told us that issuing preventive regulations may be one of the 
most important things they can do to enhance their oversight of fresh 
produce. While some consumer groups, food safety experts, and producers 
agree that uniform standards could enhance safety for targeted foods, 
others have noted that preventive regulations can take a long time to 
develop and it may be difficult to incorporate new scientific knowledge 
into regulations. FDA officials expressed concern about the public 
health benefit of having regulations without the resources to enforce 
them. FDA could not provide us with information on projected costs 
associated with such regulations, but FDA's Science Board noted that 
modernizing safety standards for fresh produce and other raw foods, and 
implementing accompanying inspection programs could total $210 million. 

FDA Has Planned Several Actions to Enhance the Effectiveness of Its 
Intervention Efforts: 

To enhance the effectiveness of its intervention efforts, FDA plans to 
use more systematic, risk-based criteria to more formally target 
domestic inspections and introduce a new import screening tool and has 
identified a need for authority to accredit third parties. All these 
efforts have the potential to increase the effectiveness of fresh 
produce oversight and better leverage resources. Specifically FDA 
intends to: 

* Use more information to target domestic inspections. FDA plans to 
enhance its risk-based criteria for determining which facilities to 
inspect by including more information, such as a firm's previous 
inspection results, recalls, and association with outbreaks and adverse 
events. FDA officials told us that they have already begun to use some 
new risk-based information to plan fiscal year 2009 inspections and 
that, as new information from FDA's ongoing risk-ranking efforts 
becomes available, they will continue to incorporate that as well. 

* Use a new screening tool for imports. FDA officials are testing a 
software tool called Predictive Risk-based Evaluation for Dynamic 
Import Compliance Targeting (PREDICT) that uses information sources and 
automated data mining techniques not available to OASIS to detect 
possible problems in import shipments. For example, PREDICT can use up- 
to-date data from FDA laboratory tests and other information, such as 
weather events that could affect water quality, to identify import 
entries for further review. PREDICT was pilot-tested on seafood imports 
in mid-2007 in FDA's Los Angeles district office, and the pilot test 
received a positive evaluation. Former FDA officials have praised 
PREDICT for its potential to enhance overall food safety oversight, and 
FDA officials noted that the tool may be particularly useful for fresh 
produce imports because PREDICT can make use of the agency's testing 
data for imported fresh produce, which is not currently used in FDA's 
electronic screening. FDA officials plan to increase the number of high-
risk food products and test PREDICT at a border crossing by March 2009. 

* Seek authority to accredit third parties. Obtaining the authority to 
accredit third parties could help FDA leverage its inspection 
resources, and FDA officials told us they believed third-party 
inspections would be especially helpful for imports, as FDA inspects 
few foreign food firms. However, FDA does not envision accrediting 
third parties for fresh produce inspections until the agency has 
established or assessed the adequacy of clear preventive standards. FDA 
has already taken this approach by accrediting third parties to inspect 
manufacturers of medical devices, as authorized by the Congress, and we 
recently reported that few inspections have been conducted under FDA's 
accredited programs.[Footnote 14] However, FDA officials told us that 
an inspection program for foods could be more attractive because 
importers and consumers might be more willing to buy products certified 
by FDA-approved third parties, and third-party certification might 
expedite FDA review and the entry of perishable commodities into the 
United States. While third-party inspectors could provide several 
benefits, FDA officials told us that before consistent, reliable third- 
party inspections would be feasible for fresh produce, the agency would 
first need to establish or assess the adequacy of clear preventive 
standards. For this reason, they told us that FDA would likely use a 
third-party inspection system for items such as seafood and juice 
before expanding a program to fresh produce. While USDA has expressed 
concern that third-party inspections paid for by the companies whose 
facilities were being inspected may not provide effective enforcement 
for noncompliant firms, FDA officials noted that the use of accredited 
third-party inspections would be voluntary and that FDA would not waive 
any of its authorities. 

FDA Has Efforts Under Way That Could Improve Its Response to 
Emergencies: 

FDA has efforts under way to enhance its response to food-related 
emergencies, including enhancing traceback investigations, organizing 
more federal-state emergency response teams, and improving risk 
communications. The agency has also identified the need for mandatory 
recall authority. These efforts could increase the overall 
effectiveness of FDA's response to outbreaks linked to fresh produce. 
Specifically, FDA plans to: 

* Enhance traceback efforts. FDA officials told us they have several 
efforts under way to enhance traceback investigations, including 
establishing a working group and purchasing new laboratory equipment. 
Also, the Food Protection Plan identifies a need for enhanced access to 
firm records. First, the agency has established a working group that 
has been meeting with industry groups and consumers to gather 
information and then report on key elements of effective traceback 
systems. Using this information, FDA plans to develop guidance for 
industry on traceback systems. Also, FDA has purchased equipment that 
will enable the agency to more rapidly screen for and accurately 
identify variants of Salmonella in fresh produce and other foods. Being 
able to identify Salmonella variants will enhance FDA's ability to 
investigate outbreaks. Last, FDA stated in its Food Protection Plan 
that it needs additional authorities to provide improved access to 
companies' records in a food-related emergency to help the agency 
quickly identify sources of contamination and take action. 

* Organize more federal-state emergency response teams. FDA hopes to 
develop additional federal-state emergency response teams. At the time 
of our review, FDA was soliciting interest from states and hoped to 
start developing teams in six states in fiscal year 2009. According to 
FDA officials, training is an important part of developing these teams, 
and FDA is working with the Western Institute for Food Safety and 
Security to create an effective training program for participating 
states. Officials noted, however, that one of the reasons for the 
success of CalFERT during the 2006 outbreak was the high level of 
expertise of CalFERT officials and that similar results may not always 
be replicable in other states. 

* Improve risk communications. In February 2008, FDA first convened an 
expert committee called the Risk Communication Advisory Committee to 
provide information on ways for FDA to enhance communications during 
emergencies, such as foodborne illness outbreaks linked to fresh 
produce. FDA also has plans to conduct studies on consumer 
communications. Using this information, FDA plans to update its risk 
communications plan. While these actions could improve FDA's methods 
for sharing information, the advisory committee has only met twice, and 
other actions have not yet been completed, so it is too early to tell 
what effect they will ultimately have. 

* Seek authority to order a recall. In the Food Protection Plan, FDA 
identified the need for authority to order a recall when FDA has reason 
to believe that food is adulterated and presents a threat of serious 
adverse health consequences, which would be imposed only if a company 
refuses or unduly delays a voluntary recall. Currently, FDA does not 
have the authority to compel companies to recall contaminated food 
other than infant formula. FDA does have the authority, through the 
courts, to seize, condemn, and destroy adulterated or misbranded food 
and to disseminate information about food items that are believed to 
present a danger to public health. We have previously noted that 
limitations in FDA's recall authority heighten the risk that unsafe 
food will remain in the food supply.[Footnote 15] In the case of fresh 
produce, FDA officials told us they were aware of no case where a fresh 
produce firm refused FDA's recall request, and a former FDA official 
told us that mandatory recall authority may be less useful for fresh 
produce items that are highly perishable and may no longer be in 
commerce by the time FDA becomes involved in an outbreak response. 

Limited Information on Strategies and Resources Makes It Difficult to 
Assess the Likelihood of FDA's Success: 

FDA issued its first progress report in July 2008 on its 2007 Food 
Protection Plan, and FDA officials told us that the plan has already 
had a positive effect on food safety by helping to increase the 
visibility of food protection during the agency's internal budget 
process. It has also aided FDA in prioritizing its efforts and has led 
to greater coordination within FDA to address issues that cut across 
different FDA centers. 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. The 
Food Protection Plan contains overarching goals to prevent foodborne 
contamination, intervene at critical points in the food supply chain, 
and respond rapidly to minimize harm. However, FDA has provided limited 
information on strategies and resources, making it difficult to assess 
the likelihood of achieving these goals. While FDA has released 
information on spending priorities on its short and medium term efforts 
for fiscal years 2008 and 2009, it has still not publicly provided 
information on the full costs of implementing the Food Protection Plan 
or committed to timelines for implementing produce-focused elements of 
the plan. Information on strategies and resources is increasingly 
critical, given that important elements of the plan could be highly 
resource-intensive. This lack of information, coupled with FDA's 
resource constraints and slow progress on some food protection efforts, 
such as updating good agricultural practices guidance or issuing 
guidance for fresh-cut produce operations, decreases public 
accountability and raises concerns about whether FDA will have the 
capacity to fully implement the plan. 

Additionally, the Food Protection Plan recognizes that FDA needs to 
partner with the Congress to make the changes necessary to transform 
the safety of the nation's food supply, including legislative changes 
to strengthen FDA's ability to protect Americans from foodborne 
illness. However, as we testified in June 2008, FDA's congressional 
outreach strategy is general. For example, when we asked FDA officials 
if they had a congressional outreach strategy, they 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. 

Conclusions: 

Fresh produce is essential to a healthy diet and to the health of the 
industry that produces it. However, fresh produce poses particular 
safety challenges because it is often consumed raw without any type of 
treatment that would reduce or eliminate pathogens prior to 
consumption. FDA plays a critical role in ensuring the safety of fresh 
produce, yet it has struggled to fulfill that role because of resource 
constraints, gaps in science, and lack of legal authorities. 
Specifically, FDA last set its research priorities 8 years ago and has 
not systematically worked with others to supplement its research 
agenda, including research relating to fresh produce. FDA's 1998 good 
agricultural practices guidance has not been updated, and its current 
good manufacturing practice regulations for food, which includes fresh- 
cut produce operations, was last revised in 1986. Also, through the 
Food Protection Plan, FDA has proposed actions and identified a need 
for additional authorities related to preventive controls for high-risk 
foods and access to certain records that could significantly enhance 
the agency's oversight of fresh produce. However, the timelines and 
resources needed to fully implement the plan are unclear. To increase 
congressional and public confidence and fulfill its mission of 
protecting public health, it is imperative that FDA follow through on 
its planned actions to enhance fresh produce oversight, seek needed 
authorities from the Congress, and foster transparency and 
accountability by providing specific information to the Congress and to 
the public on strategies and resources for implementing its Food 
Protection Plan. 

Recommendations for Executive Action: 

We are making seven recommendations to the Commissioner of FDA. 

To enhance FDA's oversight of fresh produce safety, we recommend that 
the Commissioner of FDA see that the agency takes the following 
actions: 

* develop a plan for identifying research priorities and facilitating 
research related to fresh produce; 

* identify approaches for obtaining testing and other information from 
industry members to inform its research agenda; 

* update its good agricultural practices guidance for fresh produce to 
incorporate new knowledge about safe growing practices; and: 

* update its current good manufacturing practice regulations for food 
to incorporate new knowledge about the food industry and safe 
manufacturing, processing, and holding practices. 

To enhance FDA's authority to oversee fresh produce, we recommend that 
the Commissioner of FDA seek authority from the Congress to: 

* make explicit FDA's authority to adopt preventive controls for high- 
risk foods, and: 

* provide FDA enhanced access to firm records during food-related 
emergencies. 

To foster transparency and accountability, we recommend that the 
Commissioner of FDA provide specific information to the Congress and to 
the public on the strategies and resources for implementing the Food 
Protection Plan. 

Agency Comments and Our Evaluation: 

We provided a draft copy of this report to the Department of Health and 
Human Services for review and comment. We received a written response 
from the Assistant Secretary for Legislation that included comments 
from FDA. FDA generally agreed with the report's accuracy and 
conclusions and appreciated our recognition of the Food Protection Plan 
as a sound framework for advancing food safety and food defense and our 
use of the plan as an organizing feature for this report. FDA generally 
agreed with five of the report's recommendations and disagreed with two 
others. FDA's comments and our detailed responses are presented in 
appendix III of this report. 

FDA agreed with our recommendation to develop a plan for identifying 
research priorities and facilitating research related to fresh produce. 
FDA said that both CFSAN and the agency, as part of the Food Protection 
Plan, were developing strategic plans for research, including fresh 
produce-related research. FDA said that CFSAN's plan will identify 
regulatory research priorities that can be addressed through intramural 
and extramural research, as well as future research needs that cannot 
be addressed due to resource limitations. 

FDA also agreed with our recommendation to identify approaches for 
obtaining testing and other information from industry members to 
supplement its research agenda. FDA noted, however, that the data and 
information from industry would further inform, rather than supplement, 
the agency's research agenda and would also be used in agency risk 
assessments associated with fresh produce. We revised the 
recommendation accordingly. 

FDA agreed with our recommendation to update its good agricultural 
practices guidance for fresh produce to incorporate knowledge about 
safe growing practices. FDA said the agency recognized, when it issued 
the guidance in 1998, that it would need to be updated in light of new 
information and technological advances. FDA added that the agency has 
completed or is doing many of the actions necessary to update the 
guidance. FDA stated that it will update the guidance once it evaluates 
the data and information collected through these efforts. 

FDA also agreed with our recommendation to update its current good 
manufacturing practice regulations for food to incorporate new 
knowledge about the food industry and safe manufacturing, processing, 
and holding practices. FDA said that a working group has examined the 
regulations and identified those areas where risk-based preventive 
controls would have the greatest impact on ensuring food safety. 

While FDA agreed with the importance of having explicit authority to 
adopt preventive controls for high-risk foods and having enhanced 
access to firm records during food-related emergencies, the agency 
believes that it has already sought such authorities by outlining 
legislative needs in the Food Protection Plan and testifying on the 
plan before congressional committees. We do not view these actions as 
seeking authority. Rather, as FDA recognized, there is a need for the 
agency to partner with the Congress to make the necessary changes to 
transform the safety of the nation's food supply. FDA should move 
beyond outlining needs and continue to take steps to obtain these 
legislative authorities such as by suggesting language that provides 
FDA the necessary statutory tools to help the agency conduct its 
oversight responsibilities. FDA proposed that these recommendations be 
redirected to the Congress for action and refers to a prior 
recommendation we made that the Congress enact comprehensive, uniform, 
and risk-based food safety legislation. We reiterated this 
recommendation to the Congress most recently in our High-Risk Series 
[Footnote 16] as one action that can help address the fragmented 
federal oversight of food safety and integrate the myriad food safety 
programs. Our recommendations to FDA are intended to enhance FDA's 
authority to oversee fresh produce for which FDA has primary 
responsibility. We stand by these recommendations. 

Finally, FDA generally agreed with our recommendation to provide 
specific information to the Congress and to the public on the 
strategies and resources for implementing the Food Protection Plan. FDA 
agreed with the need for transparency and accountability and noted that 
the agency has provided information to the Congress on the 
implementation of the Food Protection Plan. In addition, we believe 
that FDA should publicly release information on strategies and 
resources, including information on the full costs of implementing the 
Food Protection Plan and timelines for produce-focused elements of the 
plan. As stated in our report, such information would help the public 
assess the likelihood of achieving the goals stated in the Food 
Protection Plan. 

We are sending copies of this report to interested congressional 
committees, the Secretary of Health and Human Services, and the 
Commissioner of the Food and Drug Administration. We will also provide 
copies to others upon request. In addition, the report will be 
available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. Key contributors to this report are 
listed in appendix IV. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

This report examines (1) the dollars and staff years the Food and Drug 
Administration (FDA) has spent on fresh produce safety and how FDA has 
allocated those resources, (2) the effectiveness of FDA's actions to 
oversee domestic and imported fresh produce safety, and (3) the actions 
FDA plans to take to enhance fresh produce oversight and the extent to 
which FDA's planned actions address identified challenges. For this 
report, fresh produce means fruits and vegetables in their unpeeled, 
natural form, as well as fruits and vegetables that have been minimally 
processed (e.g., peeled, sliced, or chopped), with or without washing, 
before being packaged for use by the consumer or a retail 
establishment. It does not include frozen or canned fruits and 
vegetables or fruit and vegetable juices. Food safety includes work in 
support of FDA's Foods Program, excluding cosmetics, and Animal Drugs 
and Feeds Program, excluding medical products. 

To determine the dollars and staff years FDA has spent on fresh produce 
safety, we obtained and analyzed FDA data on food safety and fresh 
produce safety spending. We used the food safety data to provide 
context for assessing the relative importance of fresh produce spending 
and the decisions leading to food safety resource allocations. For both 
food safety and fresh produce safety spending, some data were obtained 
directly from FDA databases, and others were estimated by FDA 
officials. 

Food safety spending. We requested information on the dollars and staff 
years spent on food safety each fiscal year from 2000 through 2007, as 
well as detailed spending reports showing the dollars and staff years 
spent on specific food safety activities for each fiscal year from 2005 
through 2007, by the five FDA organizations that conducted food safety 
work--the Center for Food Safety and Applied Nutrition (CFSAN), the 
Center for Veterinary Medicine (CVM), the Office of Regulatory Affairs 
(ORA), the National Center for Toxicological Research (NCTR), and the 
Office of the Commissioner. The Office of the Commissioner's work in 
support of the agency's food safety efforts is generally considered 
overhead, except for specific food safety activities such as those 
performed by FDA's Associate Commissioner for Food and the Office of 
Crisis Management. We selected fiscal years 2000 through 2007 to update 
a previous GAO report which detailed food safety spending through 
fiscal year 1999.[Footnote 17] Four organizations used time and 
attendance and workflow management systems to identify hours spent on 
food safety and then converted the hours into staff years. 

* CFSAN used the Resource Reporting System Via Project, its voluntary 
time reporting system, which captures staff hours spent on one of seven 
general categories, including four that fall within GAO's definition of 
food safety,[Footnote 18] and on specific activities within these 
categories. 

* CVM used the Activity Time Reporting system, its mandatory time 
reporting system. 

* ORA used the Field Accomplishment and Compliance Tracking System 
(FACTS), its workflow management system, which captures staff time 
spent on domestic activities, such as inspections or sample analysis, 
as well as certain import activities, such as sample collections or 
field exams. 

* NCTR used the Project Management System, which contains, among other 
things, staff and contractor hours downloaded from its NCTR Experiment 
Activity Tracking System, the center's time and attendance system, as 
well as contractor hours downloaded from its Task Tracking System. 

The Office of the Commissioner calculated its food safety staff years 
to be 34.6 percent of its total staff years--the percentage it 
typically uses in FDA's budget justification documents. 

To determine the dollars CFSAN spent on food safety, FDA ran their food 
safety staff years against the agency's Unified Financial Management 
System. To determine the dollars NCTR spent on food safety, FDA used 
cost data on projects from the center's Project Management System and 
the agency's Unified Financial Management System to summarize spending 
on food safety research projects. To determine dollars ORA spent on 
food safety, FDA ran its food safety staff years against ORA's actual 
budget authority dollars from the All Purpose table of the agency's 
annual budget justification. For the dollars CVM spent on food safety, 
FDA used CVM's budget authority dollars from the All Purpose table to 
reflect GAO's definition of food safety because CVM could not isolate 
medical products spending from other spending. In terms of overhead, 
the Office of the Commissioner estimated that each year's food safety 
spending amounted to 34.6 percent of its annual budget authority--the 
percentage it typically uses in FDA's budget justification documents. 
Additionally, ORA and CVM included overhead in each activity's 
spending, while CFSAN and NCTR reported it as a separate expense. 

Produce safety spending. We requested information on the dollars and 
staff years FDA spent each fiscal year from 2000 through 2007. However, 
due to resource constraints and other limitations within FDA that made 
it unlikely the agency could provide data or estimates prior to fiscal 
year 2005, we agreed to narrow our request to fiscal years 2005 through 
2007. In addition, FDA was unable to provide its actual spending on 
fresh produce safety and instead developed estimates, with each of the 
three organizations involved in produce safety during this period-- 
CFSAN, ORA, and the Office of the Commissioner--employing the same 
sources and methodology it used to prepare food safety spending data. 

* CFSAN could only provide estimates of the dollars and staff years 
spent on fresh produce safety because its time management system is 
voluntary and staff are not required to report their time with the 
specificity needed to distinguish time spent on fresh produce 
activities from time spent on other food safety activities. 
Additionally, due to changes in its voluntary time reporting system, 
CFSAN could provide these estimates only for fiscal years 2006 and 
2007. Further, CFSAN's spending estimates reflect only the minimum 
dollars and staff years spent on fresh produce because staff attributed 
over half of their food safety staff years to the general category 
called "food safety," rather than to a specific activity, such as 
"produce safety." 

* ORA was able to track its spending at the fresh produce level for 
fiscal years 2005 through 2007 because field staff generally enter a 
commodity code into ORA's work management system as they report time 
spent on their work activities. However, ORA officials cautioned that 
their spending data were also estimates because a small number of 
commodities were coded as miscellaneous and certain activities, such as 
reviewing imported items for admissibility, do not require staff to 
report the specific commodity involved. 

* The Office of the Commissioner could provide neither data nor 
estimates of its fresh produce spending. Although some staff--such as 
the Associate Commissioner for Foods and those in the Office of Crisis 
Management--work on fresh produce safety, the office's systems do not 
track spending at the level of specificity needed to, for example, 
distinguish food-related emergencies from nonfood emergencies or 
foodborne illness outbreaks involving fresh produce from outbreaks 
involving other foods. 

We reviewed the methodologies FDA used to develop the data and the 
estimates, interviewed those staff most knowledgeable about the quality 
and completeness of the estimated data, and conducted tests of the data 
for errors and missing information. When errors or missing data were 
found, FDA officials corrected these errors and provided us with 
revised data. On the basis of this information, we assessed the 
reliability of the data on food safety spending and the estimates on 
fresh produce spending and determined that the data and estimates are 
sufficient and appropriate to support the conclusions reached in this 
report. We then summarized and analyzed the data and estimates to 
calculate the total dollars and staff years FDA spent each fiscal year 
on food safety and fresh produce safety. Due to the nature of the 
estimates, we were unable to assess fresh produce spending over time to 
determine whether spending increased or draw specific conclusions about 
the portion of FDA's food safety resources spent on fresh produce. 

To determine how FDA has allocated its resources for fresh produce 
safety, we interviewed staff knowledgeable about the budget and 
priority-setting processes used by CFSAN, ORA, and the Office of the 
Commissioner; obtained and analyzed budget and planning documents on 
agency and center priorities and strategic plans; interviewed current 
and former FDA officials about the agency's food safety and fresh 
produce safety work, as well as the obstacles faced in implementing 
planned work; obtained and analyzed reports from FDA and others on the 
agency's food safety resources; and interviewed food safety experts and 
industry representatives for their perspectives on FDA's ability to 
ensure the safety of fresh produce. 

To assess the effectiveness of FDA's actions to oversee fresh produce, 
we visited produce farms and processing facilities in California's 
Salinas Valley, where we interviewed growers, processors, and industry 
representatives, and observed an FDA inspection of a fresh-cut produce 
facility. We selected the Salinas Valley because it was the source of 
the 2006 E. coli outbreak linked to bagged spinach. Also, we 
interviewed persons knowledgeable about FDA's oversight activities 
related to fresh produce, including current and former FDA officials, 
state food safety officials, industry officials, and food safety 
experts. We reviewed relevant FDA documents, including policies and 
procedures, regulations and guidance documents for industry pertaining 
to fresh produce, and descriptions of research needs and current 
research projects. We also reviewed guidance documents prepared by 
industry and obtained information on fresh produce safety standards 
promoted by other entities. We obtained and analyzed FDA data on 
domestic inspections and domestic and imported sample analyses from the 
FACTS database, and FDA data on imported fresh produce trends and 
activities from the Operational and Administrative System for Import 
Support database. We assessed the reliability of the data used in this 
report and found it to be sufficiently reliable for the purposes used. 
We also obtained and analyzed information on state contracts and 
partnerships from FDA officials and fresh produce-related warning 
letters from FDA's Web site. 

To determine the actions FDA plans to take to enhance fresh produce 
oversight, we reviewed published information from FDA, including its 
Food Protection Plan, Food Protection Operations Plan, and Federal 
Register notices. We also reviewed internal FDA documents and 
interviewed FDA officials for additional details on published 
information. To assess the extent to which FDA's planned actions 
address identified challenges, we reviewed previous GAO reports and 
recommendations on food safety, food safety publications from the 
National Academies, and GAO guidance for assessing key elements in 
agencies' performance plans, including goals, strategies, and 
resources.[Footnote 19] We also interviewed and obtained documents from 
former FDA officials, officials from the U.S. Department of Agriculture 
and state food safety agencies, academics, and representatives of 
industry and consumer groups to obtain information related to FDA's 
planned actions. 

We conducted our work from June 2007 to September 2008 in accordance 
with generally accepted government auditing standards. Those standards 
require that we plan and perform the audit to obtain sufficient, 
appropriate evidence to provide a reasonable basis for our findings and 
conclusions based on our audit objectives. We believe that the evidence 
obtained provides a reasonable basis for our findings and conclusions 
based on our audit objectives. 

[End of section] 

Appendix II: FDA Food Safety Spending Information for Fiscal Years 2000 
through 2007: 

This appendix contains information provided by FDA on the dollars and 
staff years it spent on food safety from fiscal years 2000 through 
2007. For this report, food safety includes work in support of FDA's 
Foods Program, excluding cosmetics, and Animal Drugs and Feeds Program, 
excluding medical products. 

Five organizations within FDA provided food safety spending 
information, including: 

* the Center for Food Safety and Applied Nutrition (CFSAN), which 
administers the FDA Foods Program; 

* the Center for Veterinary Medicine (CVM), which administers the 
Animal Drugs and Feeds Program; 

* the Office of Regulatory Affairs (ORA), which conducts field work in 
support of FDA's centers and their programs; 

* the National Center for Toxicological Research, which conducts 
scientific research and provides technical advice in support of FDA's 
centers; and: 

* the Office of the Commissioner, which provides direction and 
administrative services in managing FDA's food safety efforts. 

The information provided by each organization varies in the level of 
detail and the time period covered. 

Table 5: Summary of FDA Food Safety Spending, by Organization, Fiscal 
Years 2000 through 2007 (Dollars in millions): 

Organization: Center for Food Safety and Applied Nutrition (CFSAN); 
2000 Dollars: $120.9; 
2000: Staff years: 793; 
2001 Dollars: $122.2; 
2001: Staff Years: 842; 
2002 Dollars: $140.3; 
2002: Staff years: 894; 
2003 Dollars: $143.8; 
2003: Staff years: 921; 
2004 Dollars: $140.9; 
2004: Staff Years: 881; 
2005 Dollars: $148.4; 
2005: Staff years: 786; 
2006 Dollars: $150.3; 
2006: Staff Years: 816[A]; 
2007 Dollars: $157.1; 
2007: Staff years: 744. 

Organization: ORA fieldwork in support of CFSAN; 
2000 Dollars: $154.2; 
2000: Staff years: 1,545; 
2001 Dollars: $60.5; 
2001: Staff Years: 1,554; 
2002 Dollars: $248.9; 
2002: Staff years: 1,799; 
2003 Dollars: $257.9; 
2003: Staff years: 2,203; 
2004 Dollars: $260.8; 
2004: Staff Years: 2,157; 
2005 Dollars: $281.4; 
2005: Staff years: 2,045; 
2006 Dollars: $283.5; 
2006: Staff Years: 1,950; 
2007 Dollars: $296.1; 
2007: Staff years: 1,793. 

Organization: Center for Veterinary Medicine (CVM); 
2000 Dollars: $36.5; 
2000: Staff years: 271; 
2001 Dollars: $48.4; 
2001: Staff Years: 290; 
2002 Dollars: $55.7; 
2002: Staff years: 323; 
2003 Dollars: $57.1; 
2003: Staff years: 341; 
2004 Dollars: $54.5; 
2004: Staff Years: 346; 
2005 Dollars: $55.4; 
2005: Staff years: 330; 
2006 Dollars: $54.8; 
2006: Staff Years: 321; 
2007 Dollars: $58.4; 
2007: Staff years: 318. 

Organization: ORA fieldwork in support of CVM; 
2000 Dollars: $12.5; 
2000: Staff years: 128; 
2001 Dollars: $14.8; 
2001: Staff Years: 144; 
2002 Dollars: $28.4; 
2002: Staff years: 235; 
2003 Dollars: $29.0; 
2003: Staff years: 242; 
2004 Dollars: $27.5; 
2004: Staff Years: 234; 
2005 Dollars: $33.4; 
2005: Staff years: 229; 
2006 Dollars: $33.0; 
2006: Staff Years: 206; 
2007 Dollars: $34.6; 
2007: Staff years: 208. 

Organization: National Center for Toxicological Research[B]; 
2000 Dollars: $3.9; 
2000: Staff years: 24; 
2001 Dollars: $3.0; 
2001: Staff Years: 19; 
2002 Dollars: $8.0; 
2002: Staff years: 27; 
2003 Dollars: $7.9; 
2003: Staff years: 36; 
2004 Dollars: $7.4; 
2004: Staff Years: 36; 
2005 Dollars: $6.5; 
2005: Staff years: 34; 
2006 Dollars: $10.3; 
2006: Staff Years: 36; 
2007 Dollars: $11.5; 
2007: Staff years: $37. 

Organization: Office of the Commissioner[C]; 
2000 Dollars: $23.0; 
2000: Staff years: 226; 
2001 Dollars: $23.5; 
2001: Staff Years: 233; 
2002 Dollars: $28.4; 
2002: Staff years: 231; 
2003 Dollars: $29.1; 
2003: Staff years: 226; 
2004 Dollars: $31.2; 
2004: Staff Years: 199; 
2005 Dollars: $30.2; 
2005: Staff years: 176; 
2006 Dollars: $29.6; 
2006: Staff Years: 184; 
2007 Dollars: $31.6; 
2007: Staff years: 181. 

Organization: Total; 
2000 Dollars: $351.1; 
2000: Staff years: 2,988; 
2001 Dollars: $372.4; 
2001: Staff Years: 3,082; 
2002 Dollars: $509.7; 
2002: Staff years: 3,509; 
2003 Dollars: $524.8; 
2003: Staff years: 3,969; 
2004 Dollars: $522.4; 
2004: Staff Years: 3,853; 
2005 Dollars: $555.3; 
2005: Staff years: 3,599; 
2006 Dollars: $561.6; 
2006: Staff Years: 3,513; 
2007 Dollars: $589.1; 
2007: Staff years: 3,281. 

Source: GAO analysis of FDA data. 

Notes: Numbers may not add due to rounding. 

[A] CFSAN's staff years spent in fiscal year 2006 exceeded its budget 
authority due to the inclusion of overtime and credit hours. 

[B] Spending includes dollars received from other government agencies 
and external sources for collaborative efforts. 

[C] The Office of the Commissioner developed an overhead figure of 34.6 
percent of its budget authority to reflect dollars and staff years 
spent on food safety. 

[End of table] 

Table 6: CFSAN Food Safety Spending, by Category, Fiscal Years 2006 and 
2007 (Dollars in millions): 

Category: Food defense; 
Fiscal year: 2006: Dollars: $20.6; 
Fiscal year: 2006: Staff years: 113; 
Fiscal year: 2007: Dollars: $22.5; 
Fiscal year: 2007: Staff years: 89. 

Category: Food safety[A]; 
Fiscal year: 2006: Dollars: $102.3; 
Fiscal year: 2006: Staff years: 550; 
Fiscal year: 2007: Dollars: $108.4; 
Fiscal year: 2007: Staff years: 531. 

Category: Nutrition; 
Fiscal year: 2006: Dollars: $4.7; 
Fiscal year: 2006: Staff years: 36; 
Fiscal year: 2007: Dollars: $4.3; 
Fiscal year: 2007: Staff years: 26. 

Category: Dietary supplements; 
Fiscal year: 2006: Dollars: $5.1; 
Fiscal year: 2006: Staff years: 26; 
Fiscal year: 2007: Dollars: $5.7; 
Fiscal year: 2007: Staff years: 26. 

Category: Overhead[B]; 
Fiscal year: 2006: Dollars: $17.6; 
Fiscal year: 2006: Staff years: 91; 
Fiscal year: 2007: Dollars: $16.2; 
Fiscal year: 2007: Staff years: 71. 

Category: Total; 
Fiscal year: 2006: Dollars: $150.3; 
Fiscal year: 2006: Staff years: 816; 
Fiscal year: 2007: Dollars: $157.1; 
Fiscal year: 2007: Staff years: 744. 

Source: FDA. 

Notes: Numbers may not add due to rounding. CFSAN was not able to 
provide data at this level of detail prior to fiscal year 2006. Also, 
CFSAN's total food safety spending includes $18 million in fiscal year 
2006 and $28 million in fiscal year 2007 in work conducted through 
major contracts--each totaling at least $200,000--with other government 
agencies, as well as external organizations and individuals. 

[A] Food safety refers to CFSAN's traditional definition of food 
safety--the unintentional contamination of food. 

[B] Overhead represents CFSAN's prorated share of the agency's 
overhead, such as human resources, information technology, management 
services, and telephone expenses. 

[End of table] 

Table 7: ORA Food Safety Spending in Support of CFSAN, by Category, 
Fiscal Years 2005 through 2007 (Dollars in millions): 

Category: Chemical safety of foods: Pesticides and industrial chemicals 
in foods (domestic and import); 
Fiscal year: 2005: Dollars: $23.2; 
Fiscal year: 2005: Staff years: 181; 
Fiscal year: 2006: Dollars: $19.2; 
Fiscal year: 2006: Staff years: 139; 
Fiscal year: 2007: Dollars: $21.3; 
Fiscal year: 2007: Staff years: 136. 

Category: Chemical safety of foods: Mycotoxins in foods (domestic and 
import); 
Fiscal year: 2005: Dollars: $5.6; 
Fiscal year: 2005: Staff years: 44; 
Fiscal year: 2006: Dollars: $5.7; 
Fiscal year: 2006: Staff years: 41; 
Fiscal year: 2007: Dollars: $5.9; 
Fiscal year: 2007: Staff years: 38. 

Category: Chemical safety of foods: Food and color additives (import); 
Fiscal year: 2005: Dollars: $4.7; 
Fiscal year: 2005: Staff years: 37; 
Fiscal year: 2006: Dollars: $5.1; 
Fiscal year: 2006: Staff years: 37; 
Fiscal year: 2007: Dollars: $6.1; 
Fiscal year: 2007: Staff years: 39. 

Category: Chemical safety of foods: Toxic elements in foods (domestic 
and import); 
Fiscal year: 2005: Dollars: $4.8; 
Fiscal year: 2005: Staff years: 37; 
Fiscal year: 2006: Dollars: $4.0; 
Fiscal year: 2006: Staff years: 29; 
Fiscal year: 2007: Dollars: $4.2; 
Fiscal year: 2007: Staff years: 27. 

Category: Chemical safety of foods: Chemotherapeutics in seafood; 
Fiscal year: 2005: Dollars: $3.3; 
Fiscal year: 2005: Staff years: 26; 
Fiscal year: 2006: Dollars: $4.1; 
Fiscal year: 2006: Staff years: 29; 
Fiscal year: 2007: Dollars: $3.9; 
Fiscal year: 2007: Staff years: 25. 

Category: Chemical safety of foods: Field assignment for chemical 
contaminants; 
Fiscal year: 2005: Dollars: $2.8; 
Fiscal year: 2005: Staff years: 22; 
Fiscal year: 2006: Dollars: $1.7; 
Fiscal year: 2006: Staff years: 12; 
Fiscal year: 2007: Dollars: $1.3; 
Fiscal year: 2007: Staff years: 8. 

Category: Chemical safety of foods: Forensic analysis[A]; 
Fiscal year: 2005: Dollars: $2.1; 
Fiscal year: 2005: Staff years: 16; 
Fiscal year: 2006: Dollars: $2.0; 
Fiscal year: 2006: Staff years: 15; 
Fiscal year: 2007: Dollars: $1.4; 
Fiscal year: 2007: Staff years: 9. 

Category: Chemical safety of foods: Toxic elements in foodwares 
(domestic and import); 
Fiscal year: 2005: Dollars: $2.0; 
Fiscal year: 2005: Staff years: 15; 
Fiscal year: 2006: Dollars: $1.8; 
Fiscal year: 2006: Staff years: 13; 
Fiscal year: 2007: Dollars: $1.6; 
Fiscal year: 2007: Staff years: 10. 

Category: Chemical safety of foods: Radionuclides in foods; 
Fiscal year: 2005: Dollars: $0.2; 
Fiscal year: 2005: Staff years: 1; 
Fiscal year: 2006: Dollars: $0.3; 
Fiscal year: 2006: Staff years: 2; 
Fiscal year: 2007: Dollars: $0.7; 
Fiscal year: 2007: Staff years: 4. 

Category: Chemical safety of foods: Pet food recall (human foods); 
Fiscal year: 2005: Dollars: 0.0; 
Fiscal year: 2005: Staff years: 0; 
Fiscal year: 2006: Dollars: 0.0; 
Fiscal year: 2006: Staff years: 0; 
Fiscal year: 2007: Dollars: $2.4; 
Fiscal year: 2007: Staff years: 15. 

Category: Microbiological safety of foods: 

Category: Microbiological safety of foods: Cheese program (domestic and 
import); 
Fiscal year: 2005: Dollars: $7.2; 
Fiscal year: 2005: Staff years: 56; 
Fiscal year: 2006: Dollars: $7.1; 
Fiscal year: 2006: Staff years: 51; 
Fiscal year: 2007: Dollars: $7.5; 
Fiscal year: 2007: Staff years: 48. 

Category: Microbiological safety of foods: Retail food protection 
program (general); 
Fiscal year: 2005: Dollars: $5.7; 
Fiscal year: 2005: Staff years: 44; 
Fiscal year: 2006: Dollars: $6.5; 
Fiscal year: 2006: Staff years: 47; 
Fiscal year: 2007: Dollars: $7.1; 
Fiscal year: 2007: Staff years: 46. 

Category: Microbiological safety of foods: Interstate travel program; 
Fiscal year: 2005: Dollars: $5.8; 
Fiscal year: 2005: Staff years: 45; 
Fiscal year: 2006: Dollars: $5.7; 
Fiscal year: 2006: Staff years: 41; 
Fiscal year: 2007: Dollars: $6.0; 
Fiscal year: 2007: Staff years: 38. 

Category: Microbiological safety of foods: Domestic acidified and low 
acid canned food program; 
Fiscal year: 2005: Dollars: $4.2; 
Fiscal year: 2005: Staff years: 33; 
Fiscal year: 2006: Dollars: $5.2; 
Fiscal year: 2006: Staff years: 38; 
Fiscal year: 2007: Dollars: $5.2; 
Fiscal year: 2007: Staff years: 33. 

Category: Microbiological safety of foods: Microbiological assignment 
(domestic and import); 
Fiscal year: 2005: Dollars: $4.0; 
Fiscal year: 2005: Staff years: 31; 
Fiscal year: 2006: Dollars: $4.9; 
Fiscal year: 2006: Staff years: 35; 
Fiscal year: 2007: Dollars: $2.3; 
Fiscal year: 2007: Staff years: 15. 

Category: Microbiological safety of foods: Interstate milk shippers 
program; 
Fiscal year: 2005: Dollars: $4.3; 
Fiscal year: 2005: Staff years: 33; 
Fiscal year: 2006: Dollars: $4.6; 
Fiscal year: 2006: Staff years: 34; 
Fiscal year: 2007: Dollars: $6.1; 
Fiscal year: 2007: Staff years: 39. 

Category: Microbiological safety of foods: Import acidified and low 
acid canned food program; 
Fiscal year: 2005: Dollars: $3.5; 
Fiscal year: 2005: Staff years: 27; 
Fiscal year: 2006: Dollars: $3.9; 
Fiscal year: 2006: Staff years: 28; 
Fiscal year: 2007: Dollars: $4.1; 
Fiscal year: 2007: Staff years: 26. 

Category: Microbiological safety of foods: Molluscan shellfish 
evaluation program; 
Fiscal year: 2005: Dollars: $3.2; 
Fiscal year: 2005: Staff years: 25; 
Fiscal year: 2006: Dollars: $3.6; 
Fiscal year: 2006: Staff years: 26; 
Fiscal year: 2007: Dollars: $4.1; 
Fiscal year: 2007: Staff years: 26. 

Category: Microbiological safety of foods: Audits of state food 
contract inspections; 
Fiscal year: 2005: Dollars: $1.2; 
Fiscal year: 2005: Staff years: 10; 
Fiscal year: 2006: Dollars: $2.0; 
Fiscal year: 2006: Staff years: 14; 
Fiscal year: 2007: Dollars: $2.5; 
Fiscal year: 2007: Staff years: 16. 

Category: Microbiological safety of foods: Natural disasters and 
emergencies; 
Fiscal year: 2005: Dollars: $0.9; 
Fiscal year: 2005: Staff years: 7; 
Fiscal year: 2006: Dollars: $4.7; 
Fiscal year: 2006: Staff years: 34; 
Fiscal year: 2007: Dollars: $0.1; 
Fiscal year: 2007: Staff years: <1. 

Category: Nutrient quality and food labeling: Nutrition Labeling and 
Education Act, nutrient sample analysis, and general food labeling; 
Fiscal year: 2005: Dollars: $7.7; 
Fiscal year: 2005: Staff years: 60; 
Fiscal year: 2006: Dollars: $7.8; 
Fiscal year: 2006: Staff years: 56; 
Fiscal year: 2007: Dollars: $8.5; 
Fiscal year: 2007: Staff years: 54. 

Category: Nutrient quality and food labeling: Dietary supplements 
program; 
Fiscal year: 2005: Dollars: $3.0; 
Fiscal year: 2005: Staff years: 23; 
Fiscal year: 2006: Dollars: $3.0; 
Fiscal year: 2006: Staff years: 22; 
Fiscal year: 2007: Dollars: $2.5; 
Fiscal year: 2007: Staff years: 16. 

Category: Nutrient quality and food labeling: Medical foods (domestic 
and import); 
Fiscal year: 2005: Dollars: $1.5; 
Fiscal year: 2005: Staff years: 12; 
Fiscal year: 2006: Dollars: $0.9; 
Fiscal year: 2006: Staff years: 7; 
Fiscal year: 2007: Dollars: $0.9; 
Fiscal year: 2007: Staff years: 6. 

Category: Nutrient quality and food labeling: Infant formula; 
Fiscal year: 2005: Dollars: $1.1; 
Fiscal year: 2005: Staff years: 9; 
Fiscal year: 2006: Dollars: $1.8; 
Fiscal year: 2006: Staff years: 13; 
Fiscal year: 2007: Dollars: $1.5; 
Fiscal year: 2007: Staff years: 10. 

Category: Nutrient quality and food labeling: Health fraud (foods); 
Fiscal year: 2005: Dollars: $0.6; 
Fiscal year: 2005: Staff years: 5; 
Fiscal year: 2006: Dollars: $0.7; 
Fiscal year: 2006: Staff years: 5; 
Fiscal year: 2007: Dollars: $0.9; 
Fiscal year: 2007: Staff years: 6. 

Category: Nutrient quality and food labeling: Food economics and 
standards; 
Fiscal year: 2005: Dollars: $0.4; 
Fiscal year: 2005: Staff years: 3; 
Fiscal year: 2006: Dollars: $0.4; 
Fiscal year: 2006: Staff years: 3; 
Fiscal year: 2007: Dollars: $0.2; 
Fiscal year: 2007: Staff years: 1. 

Category: Cross-cutting: Imported foods (general); 
Fiscal year: 2005: Dollars: $58.7; 
Fiscal year: 2005: Staff years: 458; 
Fiscal year: 2006: Dollars: $64.2; 
Fiscal year: 2006: Staff years: 464; 
Fiscal year: 2007: Dollars: $72.6; 
Fiscal year: 2007: Staff years: 465. 

Category: Cross-cutting: Domestic food safety program (general); 
Fiscal year: 2005: Dollars: $23.9; 
Fiscal year: 2005: Staff years: 186; 
Fiscal year: 2006: Dollars: $24.9; 
Fiscal year: 2006: Staff years: 180; 
Fiscal year: 2007: Dollars: $22.3; 
Fiscal year: 2007: Staff years: 143. 

Category: Cross-cutting: Domestic seafood hazard analysis and critical 
control point program; 
Fiscal year: 2005: Dollars: $23.2; 
Fiscal year: 2005: Staff years: 181; 
Fiscal year: 2006: Dollars: $20.9; 
Fiscal year: 2006: Staff years: 151; 
Fiscal year: 2007: Dollars: $20.6; 
Fiscal year: 2007: Staff years: 132. 

Category: Cross-cutting: Imported seafood hazard analysis and critical 
control point program; 
Fiscal year: 2005: Dollars: $22.0; 
Fiscal year: 2005: Staff years: 172; 
Fiscal year: 2006: Dollars: $22.3; 
Fiscal year: 2006: Staff years: 161; 
Fiscal year: 2007: Dollars: $21.7; 
Fiscal year: 2007: Staff years: 139. 

Category: Cross-cutting: Total diet studies; 
Fiscal year: 2005: Dollars: $6.8; 
Fiscal year: 2005: Staff years: 53; 
Fiscal year: 2006: Dollars: $8.9; 
Fiscal year: 2006: Staff years: 64; 
Fiscal year: 2007: Dollars: $8.6; 
Fiscal year: 2007: Staff years: 55. 

Category: Cross-cutting: Counterterrorism activities; 
Fiscal year: 2005: Dollars: $6.8; 
Fiscal year: 2005: Staff years: 53; 
Fiscal year: 2006: Dollars: $2.8; 
Fiscal year: 2006: Staff years: 21; 
Fiscal year: 2007: Dollars: $2.3; 
Fiscal year: 2007: Staff years: 15. 

Category: Cross-cutting: Consumer complaints; 
Fiscal year: 2005: Dollars: $4.8; 
Fiscal year: 2005: Staff years: 38; 
Fiscal year: 2006: Dollars: $5.0; 
Fiscal year: 2006: Staff years: 36; 
Fiscal year: 2007: Dollars: $4.3; 
Fiscal year: 2007: Staff years: 28. 

Category: Cross-cutting: Methods validation and development; 
Fiscal year: 2005: Dollars: $4.1; 
Fiscal year: 2005: Staff years: 32; 
Fiscal year: 2006: Dollars: $4.4; 
Fiscal year: 2006: Staff years: 32; 
Fiscal year: 2007: Dollars: $4.7; 
Fiscal year: 2007: Staff years: 30. 

Category: Cross-cutting: Juice hazard analysis and critical control 
point program; 
Fiscal year: 2005: Dollars: $3.1; 
Fiscal year: 2005: Staff years: 24; 
Fiscal year: 2006: Dollars: $3.9; 
Fiscal year: 2006: Staff years: 28; 
Fiscal year: 2007: Dollars: $4.2; 
Fiscal year: 2007: Staff years: 27. 

Category: Cross-cutting: Short-term assignments initiated by CFSAN 
headquarters, ORA headquarters, or ORA field offices; 
Fiscal year: 2005: Dollars: $2.0; 
Fiscal year: 2005: Staff years: 16; 
Fiscal year: 2006: Dollars: $2.0; 
Fiscal year: 2006: Staff years: 14; 
Fiscal year: 2007: Dollars: $1.5; 
Fiscal year: 2007: Staff years: 10. 

Category: Cross-cutting: Foreign inspections and technical assistance; 
Fiscal year: 2005: Dollars: $1.7; 
Fiscal year: 2005: Staff years: 13; 
Fiscal year: 2006: Dollars: $1.6; 
Fiscal year: 2006: Staff years: 12; 
Fiscal year: 2007: Dollars: $1.4; 
Fiscal year: 2007: Staff years: 9. 

Category: Cross-cutting: Emergency response to foodborne outbreaks and 
illnesses; 
Fiscal year: 2005: Dollars: $0.9; 
Fiscal year: 2005: Staff years: 7; 
Fiscal year: 2006: Dollars: $1.2; 
Fiscal year: 2006: Staff years: 8; 
Fiscal year: 2007: Dollars: $7.1; 
Fiscal year: 2007: Staff years: 46. 

Category: Cross-cutting: Miscellaneous other food safety work; 
Fiscal year: 2005: Dollars: $0.6; 
Fiscal year: 2005: Staff years: 5; 
Fiscal year: 2006: Dollars: $0.7; 
Fiscal year: 2006: Staff years: 5; 
Fiscal year: 2007: Dollars: $0.3; 
Fiscal year: 2007: Staff years: 2. 

Category: Cross-cutting: Criminal investigation activities; 
Fiscal year: 2005: Dollars: $0.6; 
Fiscal year: 2005: Staff years: 5; 
Fiscal year: 2006: Dollars: $0.6; 
Fiscal year: 2006: Staff years: 4; 
Fiscal year: 2007: Dollars: $0.4; 
Fiscal year: 2007: Staff years: 2. 

Category: Subtotal; 
Fiscal year: 2005: Dollars: $262.3; 
Fiscal year: 2005: Staff years: 2,045; 
Fiscal year: 2006: Dollars: $270.0; 
Fiscal year: 2006: Staff years: 1,950; 
Fiscal year: 2007: Dollars: $280.3; 
Fiscal year: 2007: Staff years: 1,793. 

Category: State contracts and grants; 
Fiscal year: 2005: Dollars: $19.1; 
Fiscal year: 2005: Staff years: 0; 
Fiscal year: 2006: Dollars: $13.5; 
Fiscal year: 2006: Staff years: 0; 
Fiscal year: 2007: Dollars: $15.8; 
Fiscal year: 2007: Staff years: 0. 

Category: Total; 
Fiscal year: 2005: Dollars: $281.4; 
Fiscal year: 2005: Staff years: 2,045; 
Fiscal year: 2006: Dollars: $283.5; 
Fiscal year: 2006: Staff years: 1,950; 
Fiscal year: 2007: Dollars: $296.1; 
Fiscal year: 2007: Staff years: 1,793. 

Source: GAO analysis of FDA data. 

Notes: Numbers may not add due to rounding. ORA included overhead for 
each activity as part of the activity's total dollars and staff years 
spent. 

[A] Spending on other forensic analysis work is included in activities 
where work occurred. 

[End of table] 

Table 8: Center for Veterinary Medicine Spending on Food Safety, by 
Category, Fiscal Years 2000 through 2007 (Dollars in millions): 

Category: Pre-market: Review;
2000: Dollars: $14.1; 
2000: Staff years: 126; 
2001: Dollars: $19.2; 
2001: Staff Years: 141; 
2002: Dollars: $21.3; 
2002: Staff years: 149; 
2003: Dollars: $21.8; 
2003: Staff years: 158; 
2004: Dollars: $21.4; 
2004: Staff Years: 176; 
2005: Dollars: $21.1; 
2005: Staff years: 152; 
2006: Dollars: $25.2; 
2006: Staff years: 145; 
2007: Dollars: $27.7; 
2007: Staff Years: 149. 

Category: Pre-market: Applied research; 
2000: Dollars: $3.6;
2000: Staff years: 25; 
2001: Dollars: $4.1; 
2001: Staff Years: 25; 
2002: Dollars: $4.3; 
2002: Staff years: 26; 
2003: Dollars: $4.4; 
2003: Staff years: 26; 
2004: Dollars: $4.1; 
2004: Staff Years: 26; 
2005: Dollars: $4.1; 
2005: Staff years: 27; 
2006: Dollars: $1.7; 
2006: Staff years: 9; 
2007: Dollars: $1.8; 
2007: Staff Years: 14. 

Category: Pre-market: Outreach/coordination; 
2000: Dollars: $0.9; 
2000: Staff years: 12; 
2001: Dollars: $0.9; 
2001: Staff Years: 12; 
2002: Dollars: $1.0; 
2002: Staff years: 12; 
2003: Dollars: $1.0; 
2003: Staff years: 13; 
2004: Dollars: $0.8; 
2004: Staff Years: 12; 
2005: Dollars: $0.8; 
2005: Staff years: 12; 
2006: Dollars: $0.5; 
2006: Staff years: 4; 
2007: Dollars: $0.5; 
2007: Staff Years: 4. 

Category: Post-market: Outreach coordination compliance; 
2000: Dollars: $11.8; 
2000: Staff years: 76; 
2001: Dollars: $17.4; 
2001: Staff Years: 79; 
2002: Dollars: $21.2; 
2002: Staff years: 100; 
2003: Dollars: $21.9; 
2003: Staff years: 108; 
2004: Dollars: $20.6; 
2004: Staff Years: 97; 
2005: Dollars: $21.7; 
2005: Staff years: 101; 
2006: Dollars: $22.0; 
2006: Staff years: 132; 
2007: Dollars: $22.2; 
2007: Staff Years: 109. 

Category: Post-market: Applied research; 
2000: Dollars: $6.1; 
2000: Staff years: 32; 
2001: Dollars: $6.8;
2001: Staff Years: 33; 
2002: Dollars: 7.9; 
2002: Staff years: 36; 
2003: Dollars: $8.1; 
2003: Staff years: 36; 
2004: Dollars: $7.6; 
2004: Staff Years: 35; 
2005: Dollars: $7.6; 
2005: Staff years: 38; 
2006: Dollars: $5.3; 
2006: Staff years: 31; 
2007: Dollars: $6.2; 
2007: Staff Years: 42. 

Category: Total; 
2000: Dollars: $36.5; 
2000: Staff years: 271; 
2001: Dollars: $48.4; 
2001: Staff Years: 290; 
2002: Dollars: $55.7; 
2002: Staff years: 323; 
2003: Dollars: $57.1; 
2003: Staff years: 341; 
2004: Dollars: $54.5; 
2004: Staff Years: 346; 
2005: Dollars: $55.4; 
2005: Staff years: 330; 
2006: Dollars: $54.8; 
2006: Staff years: 321; 
2007: Dollars: $58.4; 
2007: Staff Years: 318. 

Source: FDA. 

Note: Numbers may not add due to rounding. 

[End of table] 

Table 9: ORA Food Safety Spending in Support of CVM, by Category, 
Fiscal Years 2005 through 2007 (Dollars in thousands): 

Category: Drug processing and new animal drug inspection program; 
Fiscal year: 2005: Dollars: $2,683; 
Fiscal year: 2005: Staff years: 21; 
Fiscal year: 2006: Dollars: $2,356; 
Fiscal year: 2006: Staff years: 17; 
Fiscal year: 2007: Dollars: $2,558; 
Fiscal year: 2007: Staff years: 18. 

Category: Feed contaminants program; 
Fiscal year: 2005: Dollars: $4,154; 
Fiscal year: 2005: Staff years: 33; 
Fiscal year: 2006: Dollars: $3,564; 
Fiscal year: 2006: Staff years: 26; 
Fiscal year: 2007: Dollars: $3,440; 
Fiscal year: 2007: Staff years: 25. 

Category: Feed manufacturing inspection program; 
Fiscal year: 2005: Dollars: $2,769; 
Fiscal year: 2005: Staff years: 22; 
Fiscal year: 2006: Dollars: $2,710; 
Fiscal year: 2006: Staff years: 20; 
Fiscal year: 2007: Dollars: $1,763; 
Fiscal year: 2007: Staff years: 13. 

Category: Illegal residues in meat and poultry; 
Fiscal year: 2005: Dollars: $3,087; 
Fiscal year: 2005: Staff years: 25; 
Fiscal year: 2006: Dollars: $4,065; 
Fiscal year: 2006: Staff years: 30; 
Fiscal year: 2007: Dollars: $2,343; 
Fiscal year: 2007: Staff years: 17. 

Category: Ruminant feed ban rule and BSE inspection program; 
Fiscal year: 2005: Dollars: $11,510; 
Fiscal year: 2005: Staff years: 91; 
Fiscal year: 2006: Dollars: $9,720; 
Fiscal year: 2006: Staff years: 72; 
Fiscal year: 2007: Dollars: $6,019; 
Fiscal year: 2007: Staff years: 43. 

Category: Methods validation and development; 
Fiscal year: 2005: Dollars: $952; 
Fiscal year: 2005: Staff years: 8; 
Fiscal year: 2006: Dollars: $766; 
Fiscal year: 2006: Staff years: 6; 
Fiscal year: 2007: Dollars: $688; 
Fiscal year: 2007: Staff years: 5. 

Category: Forensic analysis[A]; 
Fiscal year: 2005: Dollars: 0; 
Fiscal year: 2005: Staff years: 0; 
Fiscal year: 2006: Dollars: 0; 
Fiscal year: 2006: Staff years: 0; 
Fiscal year: 2007: Dollars: 0; 
Fiscal year: 2007: Staff years: 0. 

Category: Audits of state contract inspections; 
Fiscal year: 2005: Dollars: 0; 
Fiscal year: 2005: Staff years: 0; 
Fiscal year: 2006: Dollars: $295; 
Fiscal year: 2006: Staff years: 2; 
Fiscal year: 2007: Dollars: $516; 
Fiscal year: 2007: Staff years: 4. 

Category: Import entry review and refused entry tracking;
Fiscal year: 2005: Dollars: $1,904; 
Fiscal year: 2005: Staff years: 15; 
Fiscal year: 2006: Dollars: $2,121; 
Fiscal year: 2006: Staff years: 16; 
Fiscal year: 2007: Dollars: $1,333; 
Fiscal year: 2007: Staff years: 10. 

Category: Illegal sales, compounding, counterfeit animal drugs; 
Fiscal year: 2005: Dollars: $404; 
Fiscal year: 2005: Staff years: 3; 
Fiscal year: 2006: Dollars: $265; 
Fiscal year: 2006: Staff years: 2; 
Fiscal year: 2007: Dollars: $64; 
Fiscal year: 2007: Staff years: 1. 

Category: Animal feed short-term assignments, ORA or field directed; 
Fiscal year: 2005: Dollars: $663; 
Fiscal year: 2005: Staff years: 5; 
Fiscal year: 2006: Dollars: $1,001; 
Fiscal year: 2006: Staff years: 7; 
Fiscal year: 2007: Dollars: $537; 
Fiscal year: 2007: Staff years: 4. 

Category: Animal feed consumer complaints; 
Fiscal year: 2005: Dollars: $202; 
Fiscal year: 2005: Staff years: 2; 
Fiscal year: 2006: Dollars: $265; 
Fiscal year: 2006: Staff years: 2; 
Fiscal year: 2007: Dollars: $2,107; 
Fiscal year: 2007: Staff years: 15. 

Category: Animal feed criminal investigation activities; 
Fiscal year: 2005: Dollars: $144; 
Fiscal year: 2005: Staff years: 1; 
Fiscal year: 2006: Dollars: $501; 
Fiscal year: 2006: Staff years: 4; 
Fiscal year: 2007: Dollars: $107; 
Fiscal year: 2007: Staff years: 1. 

Category: Miscellaneous other activities; 
Fiscal year: 2005: Dollars: $375; 
Fiscal year: 2005: Staff years: 3; 
Fiscal year: 2006: Dollars: $324; 
Fiscal year: 2006: Staff years: 2; 
Fiscal year: 2007: Dollars: $322; 
Fiscal year: 2007: Staff years: 2. 

Category: Pet food recall activities; 
Fiscal year: 2005: Dollars: 0; 
Fiscal year: 2005: Staff years: 0; 
Fiscal year: 2006: Dollars: 0; 
Fiscal year: 2006: Staff years: 0; 
Fiscal year: 2007: Dollars: $7,288; 
Fiscal year: 2007: Staff years: 52. 

Category: Subtotal; 
Fiscal year: 2005: Dollars: $28,848; 
Fiscal year: 2005: Staff years: 229; 
Fiscal year: 2006: Dollars: $27,952; 
Fiscal year: 2006: Staff years: 206; 
Fiscal year: 2007: Dollars: $29,086; 
Fiscal year: 2007: Staff years: 208. 

Category: State contracts and grants; 
Fiscal year: 2005: Dollars: $4,520; 
Fiscal year: 2005: Staff years: 0; 
Fiscal year: 2006: Dollars: $5,066; 
Fiscal year: 2006: Staff years: 0; 
Fiscal year: 2007: Dollars: $5,482; 
Fiscal year: 2007: Staff years: 0. 

Category: Total; 
Fiscal year: 2005: Dollars: $33,368; 
Fiscal year: 2005: Staff years: 229; 
Fiscal year: 2006: Dollars: $33,018; 
Fiscal year: 2006: Staff years: 206; 
Fiscal year: 2007: Dollars: $34,568; 
Fiscal year: 2007: Staff years: 208. 

Source: FDA. 

Notes: Numbers may not add due to rounding. 

[A] Forensic analysis work is included in activities where work 
occurred. 

[End of table] 

Table 10: National Center for Toxicological Research Spending on Food 
Safety, by Category, Fiscal Years 2000 through 2007 (Dollars in 
thousands): 

Category: Food safety; 
2000: Dollars: $1,015; 
2000: Staff years: 12; 
2001: Dollars: $325; 
2001: Staff Years: 3; 
2002: Dollars: $694; 
2002: Staff years: 7; 
2003: Dollars: $293; 
2003: Staff years: 8; 
2004: Dollars: $1,832; 
2004: Staff Years: 13; 
2005: Dollars: $1,463; 
2005: Staff years: 10; 
2006: Dollars: $3,874; 
2006: Staff years: 10; 
2007: Dollars: $3,718; 
2007: Staff Years: 7. 

Category: Antimicrobial resistance; 
2000: Dollars: $785; 
2000: Staff years: 7; 
2001: Dollars: $791; 
2001: Staff Years: 10; 
2002: Dollars: $1,172; 
2002: Staff years: 12; 
2003: Dollars: $1,114; 
2003: Staff years: 17; 
2004: Dollars: $1,298; 
2004: Staff Years: 16; 
2005: Dollars: $1,404; 
2005: Staff years: 17; 
2006: Dollars: $1,510; 
2006: Staff years: 15; 
2007: Dollars: $1,682; 
2007: Staff Years: 17. 

Category: Bioterrorism; 
2000: Dollars: $141; 
2000: Staff years: 1; 
2001: Dollars: $65; 
2001: Staff Years: 1; 
2002: Dollars: $3,178; 
2002: Staff years: 3; 
2003: Dollars: $2,842; 
2003: Staff years: 6; 
2004: Dollars: $424; 
2004: Staff Years: 2; 
2005: Dollars: $113; 
2005: Staff years: 1; 
2006: Dollars: $551; 
2006: Staff years: 5; 
2007: Dollars: $797; 
2007: Staff Years: 7. 

Category: Dietary supplements; 
2000: Dollars: $560; 
2000: Staff years: 4; 
2001: Dollars: $786; 
2001: Staff Years: 5; 
2002: Dollars: $925; 
2002: Staff years: 5; 
2003: Dollars: $1,126; 
2003: Staff years: 5; 
2004: Dollars: $1,023; 
2004: Staff Years: 5; 
2005: Dollars: $1,530; 
2005: Staff years: 6; 
2006: Dollars: $1,774; 
2006: Staff years: 6; 
2007: Dollars: $2,439; 
2007: Staff Years: 6. 

Category: Overhead; 
2000: Dollars: $1,432; 
2000: Staff years: [A]; 
2001: Dollars: $1,010; 
2001: Staff Years: [A]; 
2002: Dollars: $2,002; 
2002: Staff years: [A]; 
2003: Dollars: $2,518; 
2003: Staff years: [A]; 
2004: Dollars: $2,832; 
2004: Staff Years: [A]; 
2005: Dollars: $2,033; 
2005: Staff years: [A]; 
2006: Dollars: $2,599; 
2006: Staff years: [A]; 
2007: Dollars: $2,848; 
2007: Staff Years: [A]. 

Category: Total; 
2000: Dollars: $3,933; 
2000: Staff years: 24; 
2001: Dollars: $2,977; 
2001: Staff Years: 19; 
2002: Dollars: $7,971; 
2002: Staff years: 27; 
2003: Dollars: $7,893; 
2003: Staff years: 36; 
2004: Dollars: $7,409; 
2004: Staff Years: 36; 
2005: Dollars: $6,542; 
2005: Staff years: 34; 
2006: Dollars: $10,308; 
2006: Staff years: 36; 
2007: Dollars: $11,483; 
2007: Staff Years: 37. 

Source: FDA. 

Notes: Numbers may not add due to rounding. Spending includes dollars 
received from other government agencies and external sources for 
collaborative efforts. 

[A] Information not provided. 

[End of table] 

[End of section] 

Appendix III: Comments from the Department of Health and Human 
Services: 

Note: GAO comments supplementing those in the report text appear at the 
end of this appendix. 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

September 10, 2008: 

Lisa Shams: 
Director, Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street N.W. 
Washington, DC 20548: 

Dear Ms. Shams: 

Thank you for the opportunity to review and comment on the U.S. 
Government Accountability Office's (GAO) report entitled: "Food Safety: 
Improvements Needed in FDA Oversight of Fresh Produce" (GAO-08-1047). 
This is to notify you that we have reviewed the subject final report, 
and we have no additional comments to offer since the publication of 
the GAO draft report. 

The Department appreciates the effort that went into this report. 

Sincerely, 

Signed by: 

Jennifer R. Luong, for: 
Vincent J. Ventimiglia, Jr. 
Assistant Secretary for Legislation: 

Attachment: 

Comments Of The Department Of Health And Human Services (HHS) On The 
U.S. Government Accountability Office's (GAO) Draft Report Entitled: 
"Food Safety - Improvements Needed In FDA Oversight Of Fresh Produce" 
(GAO-08-1047): 

The Food and Drug Administration (FDA) appreciates the opportunity to 
review and comment on the Government Accountability Office's (GAO) 
draft report, Food Safety: Improvements Needed in FDA Oversight of 
Fresh Produce (GAO-08-1047). The Agency will offer both general and 
specific comments. Of significant importance to FDA is GAO's 
recognition of the Food Protection Plan (FPP) as a sound framework for 
advancing food safety and food defense[Footnote 20] and that the GAO 
utilized the plan's framework as an organizing feature in this report. 

In November 2007 FDA released the FPP which provides a national 
strategy to identify and counter potential hazards in both domestic and 
imported food. The FPP was developed to address the changes and 
challenges in protecting the U.S. food supply. The FPP places a greater 
emphasis on prevention by building in safety at the source of food 
production, regardless of whether food is produced domestically or 
outside the U.S. Prevention is facilitated through targeted risk-based 
intervention strategies that involve risk-based inspections and 
testing. The FPP also seeks to develop faster response and enhanced 
communication with stakeholders during food related events. While the 
focus of the current GAO report is on fresh produce safety, the 
elements of the FPP encompass all foods for humans and animals. Many of 
the specific actions in the FPP to improve prevention, intervention and 
response are being applied to fresh produce. Achieving the food safety 
enhancements identified by the FPP will require the involvement of all 
our food safety partners - Federal, state, local, tribal, and foreign 
governments; industry; academia; consumers; and Congress. 

GAO's approach, using the FPP framework, helps solidify a common food 
vision toward protecting the food supply and provides a framework for 
discussion of the issues such that all stakeholders can work uniformly 
to advance food protection. 

In this draft report, GAO makes 7 recommendations to FDA, including 4 
recommendations to enhance its oversight of fresh produce safety, such 
as updating its good agricultural practices guidance, 2 recommendations 
to seek authority from Congress to make explicit FDA's authority to 
adopt preventive controls for high-risk foods and to provide enhanced 
access to firm records during food related emergencies, and one 
recommendation to provide specific information to Congress and to the 
public on the strategies and resources for implementing the FPP. As 
part of the FPP, FDA made 10 legislative proposals and while none of 
them are exclusively focused on fresh produce they are all important in 
ensuring that the food supply in the U.S. is protected. FDA's response 
to the specific GAO recommendations follows: 

Recommendations to Enhance Oversight of Fresh Produce Safety: 

First GAO recommendation - that FDA develop a plan for identifying 
research priorities and facilitating research related to fresh produce. 

FDA agrees with this recommendation. Both CFSAN and the Agency, as part 
of the Food Protection Plan, are currently developing strategic plans 
for research which will include but not be limited to fresh produce 
related research. The Agency's regulatory food safety research needs 
are far broader than fresh produce; therefore, fresh produce research 
needs must, out of necessity, compete for limited resources. CFSAN 's 
plan will identify regulatory research priorities that can be addressed 
through (1) intramural research (2) extramural research leveraged 
through our Centers of Excellence or (3) through a competitive 
extramural research program. The plan also will identify future 
research needs that currently cannot be addressed due to resource 
(funding and expertise) limitations. 

The 2004 Produce Safety Action Plan [hyperlink, 
http://www.cfsan.fda.gov/-dms/prodpla2.html] identified broad research 
needs relevant to the contamination of fresh produce. CFSAN has 
systematically worked with our stakeholders and other research 
organizations (USDA, ARS and CSREES; WIFSS; NCFST and JIFSAN[Footnote 
21]) to leverage research resources and identify more specific research 
needs associated with fresh produce. These activities included 
participating in workshops such as the Tomato Safety Research Needs 
Workshop [hyperlink, http://www.lifsan.umd.edu/tomato_wkp2007.htm]; the 
International Lettuce and Leafy Greens Food Safety Research Conference 
[hyperlink, 
http://www.unitedfresh.org/newsviews/leafy_greens_food_safety_research];
and identifying appropriate research focus areas for the USDA's 
National Research Initiative [hyperlink, 
http://www.csrees.usda.govifundinginri/nri.html] and the National 
Integrated Food Safety Initiative [hyperlink, 
http://www.csrees.usda.govifunding/rfasifood_safety.html] programs. 

Second GAO recommendation --that FDA identify approaches for obtaining 
testing and other information from industry members to supplement its 
research agenda 

FDA agrees with the recommendation to identify approaches for obtaining 
testing and other information from industry members. FDA would like to 
note that the data and information from industry would further inform, 
not supplement, FDA's research agenda. Additionally, the data obtained 
would be used in Agency risk assessments associated with fresh produce. 
The Agency is aware of efforts by some produce industry associations 
and UC Davis's Center for Produce Safety regarding how they might serve 
as repositories of such data and information for the purpose of sharing 
with others including FDA. 

Third GAO recommendation - that FDA update its good agricultural 
practices guidance for fresh produce to incorporate knowledge about 
safe growing practices 

FDA agrees with this recommendation. The Agency recognized when it 
issued the good agricultural practices guidance in 1998 that it would 
need to be updated as new information and technological advances expand 
the understanding of those factors associated with identifying and 
reducing microbial food safety hazards. In the 10 years since the 
guidance was released, many changes have occurred in the produce 
industry, and a great deal of new knowledge and information has become 
available. In addition, the Agency now has ten years experience in 
implementing the guidance, and observing how and the extent to which it 
has been implemented. 

Although at the time GAO interviewed FDA, drafting of revised guidance 
had not started, many of the actions necessary to update the guidance 
had been completed or were being done. For example, FDA held public 
hearings on produce safety on March 13 and April 20, 2007, where the 
Agency solicited input from stakeholders on risk factors associated 
with microbial contamination of produce. In addition, the Agency has 
implemented the leafy greens and tomato initiatives, whose goals 
include gaining knowledge on environmental factors that lead to 
contamination of produce, which will inform future policy or guidance. 

More recently, the Agency published a notice in the Federal Register on 
September 2, 2008, requesting comments and scientific data and 
information that may assist the Agency to improve the good agricultural 
practices guidance. Specifically, FDA is seeking information about (1) 
current agricultural practices and conditions used to grow, harvest, 
pack, cool, and transport fresh produce; (2) risk factors for 
contamination of fresh produce associated with these practices; and (3) 
possible measures that FDA could implement that would enhance the 
safety of fresh produce. The Agency will update the guidance after 
evaluating comments it receives together with all the data and 
information it has collected through the other efforts mentioned above. 

Fourth GAO Recommendation -- that FDA update its current good 
manufacturing practice regulations for food to incorporate new 
knowledge about the food industry and safe manufacturing, processing, 
and holding practices 

FDA agrees with this recommendation. Beginning in late 2002, the Center 
for Food Safety and Applied Nutrition formed a Food Current Good 
Manufacturing Practice (CGMP) Modernization Working Group. The 
objective of the group was to examine the general food CGMP regulation 
in 21 CFR Part 110 (hereinafter CGMP regulation) and determine whether 
the regulation was in need of modernization. Also, the group was 
specifically tasked to focus on risk-based preventive controls, i.e. 
those that would have the greatest impact on ensuring food safety. The 
working group concluded that there have been changes in both the food 
industry and in the science of food safety that indicate a need for 
modernization. 

In 2003, the working group initiated research programs to identify 
those areas where GMP-type controls could have the greatest impact on 
ensuring food safety. In 2004, the working group presented its 
preliminary findings from this research and engaged the public in three 
public meetings held across the country and through a Federal Register 
notice calling for comments on food CGMP modernization. This report, 
found at [hyperlink, http://www.ctsan.fda.gov/~dmsicgmps.html], 
summarizes the public comments and details the working group's key 
findings. 

The areas that present opportunities for modernization are training, 
food allergens, Listeria monocytogenes control, sanitation procedures, 
and application of certain CGMPs to agricultural operations, records 
access, and temperature control. 

Recommendations to Seek Authority from Congress 

Fifth and sixth GAO recommendations - that the Commissioner of FDA seek 
authority from the Congress to make explicit FDA's authority to adopt 
preventive controls for high-risk goods, and provide FDA enhanced 
access to firm records during food-related emergencies. [See comment 1] 

FDA has already sought authority from Congress for these and additional 
legislative proposals. These requests are highlighted in the Food 
Protection Plan, as well as Congressional testimony. To date, Congress 
has not acted on the legislative needs outlined in the Food Protection 
Plan. As a package, these proposals will not only enhance food safety 
overall but will specifically contribute to enhanced produce safety. 
For example, additional authority to authorize FDA to accredit highly-
qualified third parties for voluntary food inspection is outlined in 
the Food Protection Plan, but not referenced above in the GAO 
recommendation. This authority would allow FDA to leverage its 
inspectional capabilities without relinquishing any of its regulatory 
or enforcement authority. As noted in the GAO report, a voluntary third 
party accreditation program focused on fresh produce could provide 
several benefits while increasing oversight of a high risk food 
category. 

FDA refers GAO to its own outstanding recommendation that Congress 
enact comprehensive, uniform, and risk-based food safety legislation. 
[Footnote 22] FDA supports GAO's recommendation for Congress to act on 
food safety legislation and proposes that the recommendation above be 
redirected to Congress for action. 

Recommendation to Provide Information to Congress: 

Seventh GAO recommendation - that the Commissioner of FDA provide 
specific information to the Congress on the strategies and resources 
for implementing the Food Protection Plan. 

FDA agrees with the need for transparency and accountability in 
implementing the Food Protection Plan. FDA has provided extensive 
detail to Congress on the implementation plan - including resources - 
for the Food Protection Plan. FDA intends to continue to be as 
transparent as possible in its implementation of the FPP in order to 
enable FDA, Congress, and the public to track progress on the Food 
Protection Plan. 

The following are GAO's comments on FDA's written comments provided by 
the Department of Health and Human Service's Assistant Secretary for 
Legislation in a letter dated September 10, 2008. 

GAO Comments: 

1. FDA did not agree with our recommendations to seek authority from 
the Congress to make explicit FDA's authority to adopt preventive 
controls for high-risk foods and to provide FDA enhanced access to firm 
records during food-related emergencies. FDA believes that the agency 
has already sought authority from the Congress for these and additional 
legislative authorities. Specifically, FDA said that the agency has 
sought authority by outlining these legislative needs in the Food 
Protection Plan and highlighting them in congressional testimony. We do 
not view these actions as seeking authority because FDA has not drafted 
legislative language or formally submitted a legislative proposal to 
the Congress, nor has it worked directly with the Congress to help 
initiate these authorities. FDA proposed that these recommendations be 
redirected to the Congress for action and refers to a prior 
recommendation we made that the Congress enact comprehensive, uniform, 
and risk-based food safety legislation. We reiterated this 
recommendation to the Congress most recently in our High-Risk Series 
[Footnote 23] as one action that can help address the fragmented 
federal oversight of food safety and integrate the myriad food safety 
programs. Our recommendations to FDA are intended to enhance FDA's 
authority to oversee fresh produce for which FDA has primary 
responsibility. 

[End of section] 

Appendix IV: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3841 or shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Vondalee Hunt (Assistant 
Director), Kevin Bray, Candace Carpenter, Susan Malone, Kara Marshall, 
Katherine Raheb, Matthew Reilly, Anne Rhodes-Kline, Ben Shouse, Jena 
Sinkfield, and Tama Weinberg made key contributions to this report. 

[End of section] 

Footnotes: 

[1] GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-07-310] (Washington, D.C.: 
January 2007). 

[2] FDA Science Board, Subcommittee on Science and Technology, FDA 
Science and Mission at Risk (Washington, D.C., November 2007). 

[3] Department of Health and Human Services, U.S. Food and Drug 
Administration, Food Protection Plan: An Integrated Strategy for 
Protecting the Nation's Food Supply (Washington, D.C., November 2007). 

[4] GAO, Federal Oversight of Food Safety: FDA's Food Protection Plan 
Proposes Positive First Steps, but Capacity to Carry Them Out Is 
Critical, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-435T] 
(Washington, D.C.: Jan. 29, 2008) and GAO, Federal Oversight of Food 
Safety: FDA Has Provided Few Details on the Resources and Strategies 
Needed to Implement its Food Protection Plan, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-08-909T] (Washington, D.C.: June 
12, 2008). 

[5] GAO, Food Safety: Overview of Federal and State Expenditures, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-01-177 (Washington, 
D.C.: Feb. 20, 2001). 

[6] GAO, Agencies' Annual Performance Plans under the Results Act: An 
Assessment Guide to Facilitate Congressional Decisionmaking, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO/GGD/AIMD-10.1.18] 
(Washington, D.C.: February 1998). 

[7] According to FDA, these data do not include (1) outbreaks and 
illnesses where the point of contamination is the retail food setting 
or home, (2) illnesses transmitted from person-to-person, and (3) 
illnesses or deaths that may have occurred but were not captured by the 
outbreak reporting process. 

[8] According to ORA, it hired an additional 597 people in fiscal year 
2002 to help conduct work related to the Bioterrorism Act. 

[9] [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-909T]. 

[10] These centers are the National Center for Food Safety and 
Technology at the Illinois Institute for Technology, the Joint 
Institute for Food Safety and Applied Nutrition at the University of 
Maryland, and the National Center for Natural Products Research at the 
University of Mississippi. FDA is in the process of developing a fourth 
center, the Western Center for Food Safety, at the University of 
California, Davis. 

[11] According to FDA's Office of Chief Counsel, formal enforcement 
actions available to FDA include initiating a seizure of an adulterated 
product, obtaining an injunction to stop a company from engaging in a 
certain behavior, or referring a firm for criminal prosecution. Warning 
letters are intended to prompt voluntary corrections for violations of 
regulatory significance. Additionally, FDA may issue a less formal, 
untitled letter or request a regulatory meeting for less severe 
violations. 

[12] According to FDA, an entry line means each portion of an import 
shipment that is listed as a separate item on an import document. Items 
in an import entry having different tariff descriptions must be listed 
separately. 

[13] GAO, Food Safety: Changes Needed to Minimize Unsafe Chemicals in 
Food, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO/RCED-94-192] 
(Washington, D.C.: Sept. 26, 1994). 

[14] GAO, Medical Devices: Challenges for FDA in Conducting 
Manufacturer Inspections, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-08-428T] (Washington, D.C.: Jan. 29, 2008). 

[15] GAO, Federal Oversight of Food Safety: High-Risk Designation Can 
Bring Attention to Limitations in the Federal Government's Food Recall 
Programs, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-785T] 
(Washington, D.C.: Apr. 24, 2007) and GAO, Food Safety: USDA and FDA 
Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe 
Food, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-51] 
(Washington, D.C.: Oct. 6, 2004). 

[16] [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-310]. 

[17] GAO, Food Safety: Overview of Federal and State Expenditures, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-01-177] (Washington, 
D.C.: Feb. 20, 2001). 

[18] These four categories are food safety, food defense, dietary 
supplements, and nutrition and labeling. 

[19] GAO, Agencies' Annual Performance Plans under the Results Act: An 
Assessment Guide to Facilitate Congressional Decisionmaking, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO/GGD/AIMD-10.1.18] 
(Washington, D.C.: February 1998). 

[20] GAO, Federal Oversight of Food Safety: FDA Has Provided Few 
Details on the Resources and Strategies Needed to Implement its Food 
Protection Plan. [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-
909T] (Washington, D.C.: July 12, 2008). 

[21] Acronyms: United States Department of Agriculture (USDA), 
Agricultural Research Service and Cooperative State Research, 
Education, and Education Service (ARS and CSREES), Western Institute 
for Food Safety and Security (WIFSS), National Center for Food Safety 
and Technology (NCFST), and Joint Institute for Food Safety and 
Nutrition (JIFSAN). 

[22] GAO Testimony Before the Subcommittee on Oversight and 
Investigations, Committee on Energy and Commerce, House of 
Representatives, Federal Oversight of Food Safety: High-Risk 
Designation Can Bring Attention to the Limitations in the Government's 
Food Recall Programs, April 24, 2007. 

[23] GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-07-310] (Washington, D.C.: 
January 2007). 

[End of section] 

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