Food Safety
Improvements Needed in FDA Oversight of Fresh Produce Gao ID: GAO-08-1047 September 26, 2008In 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.
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.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-08-1047, Food Safety: Improvements Needed in FDA Oversight of Fresh Produce
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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:
