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United States Government Accountability Office: 
Washington, DC 20548: 

April 23, 2010: 

The Honorable Brad Miller:
Subcommittee on Investigations and Oversight: 
Committee on Science and Technology: 

House of Representatives: 

Subject: Food Safety: FDA Has Begun to Take Action to Address 
Weaknesses in Food Safety Research, but Gaps Remain: 

Dear Mr. Chairman: 

The United States faces challenges to ensuring food safety. First, 
imported food makes up a substantial and growing portion of the U.S. 
food supply, with 60 percent of fresh fruits and vegetables and 80 
percent of seafood coming from across our borders. In recent years, 
there has been an increase in reported outbreaks of foodborne illness 
associated with both domestic and imported produce. Second, we are 
increasingly eating foods that are consumed raw and that have often 
been associated with foodborne illness outbreaks, including leafy 
greens such as spinach. Finally, shifting demographics means that more 
of the U.S. population is, and increasingly will be, susceptible to 
foodborne illnesses. The risk of severe and life-threatening 
conditions caused by foodborne illnesses is higher for older adults, 
young children, pregnant women, and immune-compromised individuals. In 
January 2007 GAO designated federal oversight of food safety as a high-
risk area needing urgent attention and transformation because of the 
federal government's fragmented oversight of food safety.[Footnote 1] 

The Food and Drug Administration (FDA) is responsible for ensuring the 
safety of roughly 80 percent of the U.S. food supply--virtually all 
domestic and imported foods except for meat, poultry, and processed 
egg products--valued at a total of $466 billion annually, as of June 
2008. In 2007 the FDA Science Board, an advisory board to the agency, 
reported that science at FDA suffers from serious deficiencies. In 
addition, our prior reviews of FDA's food safety programs have 
identified gaps in scientific information, limiting FDA's ability to 
oversee food labeling, fresh produce, and dietary supplements. 
Further, as part of our recent review on the effectiveness of the 
strategic planning and management efforts of FDA, 67 percent of FDA 
managers reported, in response to a GAO survey, that updated 
scientific technologies or other tools would greatly help them to 
contribute to FDA's goals and responsibilities; however, only 36 
percent of managers reported that FDA was making great progress in 
keeping pace with scientific advances.[Footnote 2] In written comments 
responding to our survey, some managers stressed the need to increase 
and stabilize funding, recruit and retain top scientists, and make 
decisions on the basis of scientific evidence. 

In this context, you asked us to examine ways in which FDA may use 
science to more effectively support its regulatory work and to inform 
the public about food content and safety. This report focuses 
primarily on FDA's (1) progress in addressing selected recommendations 
identified by the Science Board; (2) incorporation of scientific and 
risk analysis into its oversight of the accuracy of food labeling, 
fresh produce, and the safety of dietary supplements; and (3) a new 
computer screening tool that may improve its efforts to screen imports 
using a risk-based approach. 

To assess FDA's progress in addressing selected science 
recommendations by the Science Board, we reviewed FDA documents, such 
as subsequent Science Board reports and updates; interviewed FDA 
officials from various centers and offices; and examined FDA's 
progress in addressing these selected science recommendations. To 
determine FDA's ability to incorporate science and risk analysis into 
its oversight, we reviewed our prior work on food labeling, fresh 
produce, and dietary supplements and updated the information where 
appropriate.[Footnote 3] (See enclosures I, II, III, and IV for 
highlights of our prior work.) To determine how FDA is using the 
Predictive Risk-Based Evaluation for Dynamic Import Compliance 
Targeting (PREDICT) to oversee the safety of imported food, we 
reviewed our September 2009 report on imported food safety, reviewed 
and summarized formal assessments of PREDICT conducted by FDA and its 
contractor, and spoke with FDA officials responsible for managing and 
implementing the screening tool to obtain their views.[Footnote 4] We 
also relied on our recent work assessing FDA's efforts to modernize 
its information technology.[Footnote 5] 

We conducted this performance audit from January 2010 to April 2010 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 during these reviews provides a reasonable 
basis for our findings and conclusions based on our audit objectives. 

In Summary: 

FDA has begun to address selected Science Board recommendations. For 
example, FDA reported in May 2008 that it created the Office of Chief 
Scientist and, in May 2009, it added more responsibilities to the 
office to signal a new emphasis on regulatory science. According to 
the Acting Chief Scientist, his office plans to identify major 
scientific cross-cutting opportunities across FDA and to collaborate 
with other government agencies. However, gaps in scientific 
information have hampered FDA's oversight of food labeling, fresh 
produce, and dietary supplements. In addition, FDA's new computer 
tool--PREDICT--is designed to improve its risk-based import screening 
efforts by analyzing food shipments using criteria that include a 
product's inherent food safety risk and the importer's violative 
history, among other things, to estimate each shipment's risk. FDA has 
developed a draft performance measurement plan for evaluating the 
effectiveness of this risk-based approach. 


FDA's 2007 Food Protection Plan lays out the agency's framework for 
overseeing the safety of food and outlines three core elements-- 
prevention, intervention, and response.[Footnote 6] Because no plan 
can prevent all food contamination, FDA reported that it is using a 
targeted, risk-based strategy that relies on statistical sampling and 
risk-detection tools, such as the development of PREDICT, to identify 
safety threats to imported food. In addition, according to FDA 
officials, a research coordinating committee was established to 
develop a collaborative research agenda that supports activities under 
prevention, intervention, and response. We reported that while the 
plan proposes positive first steps, the capacity to carry them out is 
critical and that FDA had provided few details on the resources and 
strategies required to implement its Food Protection Plan.[Footnote 7] 

Recognizing the important role FDA plays in overseeing food safety, 
among other things, FDA's Science Board reported in November 2007 that 
science at FDA suffers from serious deficiencies and is not positioned 
to meet current or emerging regulatory responsibilities.[Footnote 8] 
The report, entitled FDA Science and Mission at Risk, predicted that 
FDA will flounder and ultimately fail without a strong scientific 
foundation. Specifically, in the report, the Science Board found that 
FDA could not fulfill its mission because its scientific base had 
eroded and its scientific organizational structure was weak. Through 
its discussions with FDA staff, the Science Board identified 
consistent themes: (1) the need for an agencywide vision for the role 
of science; (2) the importance of possessing leading-edge skills in 
science and the importance of priorities for the science program; and 
(3) the need for coordinated maximization of science resources, 
oversight of program performance, and an infrastructure to act on this 
vision. The Science Board found that scientific leadership at the 
center level was variable.[Footnote 9] The board made several science-
related recommendations intended to address these weaknesses. Among 
other things, the Science Board recommended that FDA develop a new 
science organization to oversee agencywide goals and standards and 
play an oversight and accountability role. 

FDA Has Begun to Address Selected Science Board Recommendations: 

FDA has taken some steps to implement the selected Science Board's 
recommendations we reviewed. For example, the board recommended that 
FDA rapidly centralize its science programs in order to appropriately 
inform the regulatory process. To this end, the board recommended that 
FDA establish the position of Chief Scientific Officer, as directed by 
the Food and Drug Administration Amendments Act of 2007. In May 2008 
FDA established the Office of Chief Scientist, appointed its first 
chief scientist, and noted that this appointment signaled a new 
emphasis on the importance of science in the agency. In February 2009 
the first chief scientist (1) released a scientific strategy for the 
agency that outlined the efforts FDA had initiated to ensure that the 
scientific base at FDA was effective and targeted to its regulatory 
responsibility; (2) called for FDA to work with academia and industry 
to support and amplify the scientific base that underpins FDA's 
regulatory decisions; and (3) stated that FDA needed strong support 
for science from within FDA and in partnership with others outside of 
FDA, such as academia and industry.[Footnote 10] 

The Science Board also found scientific gaps in areas that are 
important to developing the FDA centers' scientific knowledge. In 
particular, for the two centers that are primarily responsible for 
food safety, the board noted that it was crucial for both centers to 
develop the science needed to fulfill their mandated missions. The 
centers took the following actions: 

* In response to the Science Board's request, the Center for Food 
Safety and Applied Nutrition (CFSAN)--which is responsible for 
ensuring that the nation's food supply is safe, sanitary, wholesome, 
and properly labeled--identified seven areas in which the scientific 
base needed to be strengthened through additional scientific 
expertise, additional resources, or the leveraging of outside 
expertise. For example, CFSAN identified the detection of foodborne 
viruses as an important area for further research. CFSAN has recently 
hired two virologists and two Commissioner's Fellows and is in the 
process of leveraging virology research through academic and inter-
agency collaborations. The board had noted that the development of 
effective prevention strategies is hampered by limited available 
scientific knowledge and resources devoted to the identification of 
these viruses. 

* According to an August 2009 review of the Center for Veterinary 
Medicine (CVM)--which is responsible for the evaluation, approval, and 
surveillance of animal drugs, feed ingredients, and animal devices--
the FDA Science Board noted the commitment to mission and quality 
science exhibited by the center's leadership. For example, the review 
found that CVM had initiated an environmental scan to identify 
emerging scientific and technological issues related to CVM's mission. 
The board also found that CVM has a well-developed internal 
consultative process for developing its 3-year research plan. However, 
the board noted that the consultative process was primarily internal 
and did not have key input from leading scientists and organizations 
in academia and industry. It further noted that, while CVM has some 
excellent researchers and scientists, the center as a whole lacks 
depth in critical positions and in subject matter experts, a 
vulnerability that is likely to become more acute as the demand for 
new experts in leading-edge science increases. Subsequently, CVM has 
instituted a workforce initiative which includes activities such as 
building alliances and partnerships with private and governmental 
groups, attending job fairs at universities and trade shows, and 
learning and development programs. 

Furthermore, the Science Board recommended that FDA strengthen its 
collaboration across the centers and with other government agencies. 
The Acting Chief Scientist agreed with this recommendation. He told us 
that he plans to identify major scientific cross-cutting opportunities 
across the centers and to collaborate with other government agencies, 
such as the National Institutes of Health, and with research 
universities. The Acting Chief Scientist also cited the following as 
examples of ongoing science-related activities: 

* The consolidation of state of the art laboratories in engineering 
and life sciences and co-location of FDA staff to facilitate 
scientific exchange and collaboration. 

* The creation of the Commissioner's Fellowship Program, whose fellows 
are to be trained in regulatory science and participate in targeted 
FDA research and policy activities. 

* Partnerships across government, such as the FDA and Defense Advanced 
Research Projects Agency partnership to develop technologies for rapid 
detection of food pathogens. 

We have reported on leading practices for effective strategic planning 
that could help organizations clarify priorities and communicate 
priorities to stakeholders.[Footnote 11] These practices include 
establishing long-term strategic goals that support the organization's 
mission and developing strategies that address key management 
challenges that threaten their ability to meet strategic goals. For 
strategic planning to be done well, organizations must involve their 
stakeholders; assess their internal and external environments; and 
align their activities, core processes, and resources to support 
mission-related outcomes. Leading practices also include developing 
results-oriented performance measures to gauge an agency's progress 
toward achieving its mission or strategic goals. When applying these 
measures, managers can collect and track performance information, 
which can then be used to guide decision making and improve results. 

Gaps in Scientific Information and Risk Analysis Have Hampered FDA's 
Oversight of Food Labeling, Fresh Produce, and Dietary Supplements: 

Generally, FDA relies on available scientific research to inform 
regulatory decisions and considers the risk level of different food 
products when deciding where to focus resources. However, we found 
that FDA was hampered in its ability to carry out some food safety 
responsibilities--oversight of food labels, fresh produce, and dietary 
supplements--because it lacked certain scientific information. For 
food labels, we found that FDA's research on their accuracy, 
consumers' perceptions of them, and other labeling options was 
limited. For fresh produce, we found that gaps in scientific knowledge 
have limited FDA's efforts to integrate science and risk analysis into 
its oversight. Finally, for dietary supplements, we found that FDA 
lacked information to better identify safety concerns associated with 
dietary supplements. 

FDA's Research Plans on Food Labeling Have Been Limited: 

Two-thirds of U.S. adults are overweight, and childhood obesity and 
diabetes are on the rise. In an effort to reverse these growing public 
health problems, the Department of Health and Human Services and the 
U.S. Department of Agriculture (USDA) issued dietary guidelines 
providing science-based dietary direction for consumers to limit their 
sugar, fat, and salt intake; eat more whole grains, fruits, and 
vegetables; and monitor portion size. Consumers who want to make 
healthy food choices look to food labels for information to help them 
eat better. Federal law prohibits food labeling that, among other 
things, is false or misleading or fails to list the amounts of certain 

The Nutrition Facts panel on a food product's label has important 
information for consumers about a product. This panel contains the 
serving size; the number of servings per container; the number of 
calories per serving; and the amount of certain nutrients, such as 
dietary fiber, vitamins, fat, and sodium. As we reported in September 
2008, however, the nutrition information provided in the required 
Nutrition Facts panel may be inaccurate.[Footnote 12] In addition, 
according to many stakeholders we interviewed--including key health, 
medical, and consumer organizations--consumers find the range of 
information on labels confusing and misleading. We identified three 
areas in which FDA's oversight contributes to inadequate labeling: 

* Accuracy of Nutrition Facts panel information. FDA's research to 
determine the accuracy of nutrient information is limited and outdated 
and shows varying degrees of compliance. FDA has not conducted random 
sampling on food labeling since 1996. While FDA found that most of the 
randomly selected products tested were within allowable ranges, 
compliance rates varied significantly for a few nutrients, such as 
vitamins A and C and iron. These variances are important because 
consuming too much or too little of certain vitamins and iron may 
impair health. FDA officials cited resource constraints and other 
priorities as reasons for not updating these studies and told us that 
FDA has no plans for future studies. In addition, from fiscal years 
2000 through 2006, FDA conducted nonrandom sampling--collecting 
targeted samples to test for compliance with nutrition labeling 
regulations. FDA investigators often selected the nonrandom samples 
because of obvious labeling violations, such as a candy bar with a 
Nutrition Facts panel that did not identify any fat or sugar. About 21 
percent and 28 percent, respectively, of the domestic and imported 
foods that were tested were in violation. One type of food with a high 
percentage of violations was infant formula. Of the 10 formula 
products sampled over the 7 years, 4 were in violation because they 
lacked the vitamins, minerals, or other nutrients required by law. 

* Misleading food labeling. FDA does not have empirical research on 
consumer perceptions to support enforcement against misleading food 
labels. For example, stakeholders from health, medical, and consumer 
organizations reported that "whole grain" labels can be misleading 
because the product may contain little whole grain, "transfat free" 
products may still be high in saturated fat, and "natural" products 
may be highly processed. According to FDA officials, the agency 
generally does not enforce the prohibition against misleading food 
labeling because it lacks the resources to conduct the substantive, 
empirical research on consumer perceptions that it believes it would 
need to legally demonstrate that a label is misleading. 

* Options for a front-of-package nutrition labeling system. As we 
reported, more collaborative research is needed to help FDA with its 
broad research agenda for evaluating options for a front-of-package 
nutrition labeling system. The National Academies' Institute of 
Medicine, which is often called on to advise federal agencies on 
health issues, recommended that FDA and others increase research on 
the nutrition label and pointed out that manufacturers' use of 
nutrition symbols underscores the need to improve strategies for using 
the food label as an educational tool. Our 2008 report noted that 
FDA's broad research agenda on front-of-package symbol systems was 
ambitious and would likely require extensive resources over several 
years. FDA officials recently stated they will soon begin analyzing 
the data collected for its first studies. We recommended that FDA 
collaborate with other federal agencies and stakeholders to evaluate 
options for a simplified, empirically valid system that conveys 
overall nutritional quality and that mitigates labels that are 
misleading to consumers. FDA agreed with the need to evaluate the 
communication effects of nutrition symbols and presented a research 
agenda. In October 2009 the FDA Commissioner announced that the agency 
is drafting a proposed regulation to establish nutritional criteria 
that would have to be met by manufacturers' front-of-package labels to 
ensure that consumers are not led to believe that foods are healthier 
than they are. 

We recommended among other things that FDA (1) maintain data on 
labeling violations and the corrective actions taken in a searchable 
format; (2) analyze violation data in routine management reports; and 
(3) track regulatory meetings on labeling violations to assess whether 
they are an effective use of resources. Such data can help managers 
set priorities and allocate resources, such as for food safety 
research. FDA noted in its comments to this correspondence that it has 
implemented a process to issue, and post to its website, closeout 
letters when a firm has sufficiently addressed violations cited in a 
Warning Letter FDA had sent to the firm. While this appears to address 
part of our first recommendation, FDA did not indicate whether the 
closeout letters and other data on violations and corrective actions 
are in a searchable format. FDA commented that it has not taken 
actions to implement the other two recommendations. 

Knowledge Gaps Make It Difficult for FDA to Integrate Science into a 
Risk-Based Approach to Oversee Fresh Produce: 

In recent years, there has been an increase in reported outbreaks of 
foodborne illness associated with both domestic and imported produce. 
In addition to harming human health, such outbreaks can undermine 
consumer confidence in the safety of the nation's food supply and have 
serious economic consequences. The importance of safe, fresh produce 
is growing because consumption 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. As we reported in September 
2008, FDA officials noted that gaps in science have impeded their 
ability to make some decisions on how to regulate fresh produce. 
[Footnote 13] For example, cattle are known carriers of E. coli 
O157:H7, but scientists do not fully know how E. coli is passed from 
animals to produce and thus cannot say how far cattle should be kept 
from a field of leafy greens. Furthermore, FDA lacked 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 relied on qualitative 
information--such as the history of past outbreaks--to rank the risk 
levels of fresh produce. 

We also found that FDA had taken limited steps to fill some of the 
science gaps. To fill some gaps, FDA conducts laboratory research on 
fresh produce commodities and their associated pathogens. For example, 
at the time of our review, FDA had a study underway to improve its 
understanding of how one type of Salmonella contaminated tomatoes. In 
response to recurring outbreaks of foodborne illness, FDA implemented 
ongoing multiyear initiatives to study farming practices and 
environmental conditions that could lead to the contamination of leafy 
greens and tomatoes. FDA also participates in four research centers in 
cooperation with academic institutions,[Footnote 14] but the Science 
Board noted that the overall output from these centers has been modest 
because of budget constraints. Finally, FDA directly funds projects 
carried out by other research institutions, but it had suspended this 
extramural research grant program in some recent years because it 
lacked resources. 

Because FDA's efforts address only some of its research needs, it 
relies heavily on the research of other federal agencies for 
scientific knowledge, such as USDA and the National Institutes of 
Health. However, it can be difficult to get other agencies to conduct 
research that meets FDA's needs, such as developing baseline data on 
contamination in lettuce in different regions and seasons. Such 
research would aid FDA's regulatory work but is extremely expensive to 
conduct. Therefore, gaps in science remain. 

At the time of our review, FDA was (1) working with university 
researchers on a USDA-funded project that looked at options for 
reducing the risk of E. coli O157:H7 in leafy greens; (2) planning to 
strengthen its risk ranking of food commodities and pathogens, 
starting with fresh produce items; (3) planning to fund about $1 
million in extramural research on the safety of fresh produce; (4) 
developing a plan outlining priority research needs, including the 
safety of fresh produce; and (5) exploring ways to obtain voluntary 
access to proprietary data from producers for research purposes, such 
as fresh produce firms' testing records showing when they found E. 
coli O157:H7 or Salmonella in product samples. FDA noted in its 
comments to this correspondence that it has taken several steps to 
address science gaps in produce safety. These include forming a 
Produce Safety Staff within CFSAN and making progress in detecting or 
analyzing pathogens in produce, among other things. 

To enhance FDA's oversight of the safety of fresh produce, we 
recommended that the agency develop a plan to identify research 
priorities and facilitate research related to fresh produce. FDA 
agreed with our recommendation and said that CFSAN and the agency were 
developing strategic plans for research, including fresh produce- 
related research. CFSAN's plan would identify regulatory research 
priorities that can be addressed through intramural and extramural 
research, as well as future research needs that cannot be addressed 
owing to resource limitations. FDA noted in its comments to this 
correspondence that it organizes and participates in meetings on fresh 
produce research. However, FDA provided no information specific to our 
recommendation whether they had developed a research plan. We also 
recommended that FDA identify approaches for obtaining testing and 
other information from industry members to inform its research agenda. 
FDA agreed with our recommendation, but it noted 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. FDA officials 
told us that the agency is currently exploring the potential for FDA 
to access and use industry data and noted in its comments to this 
correspondence that it has worked with produce industry members to 
discuss wash water modeling data and is in contact with the Department 
of Defense to access the department's Procurement Produce Testing 
Data. Although, this appears to show progress in data sharing, it does 
not directly address our recommendation to identify broader approaches 
for attaining such information. 

FDA Lacks Information to Identify Safety Concerns Associated with 
Dietary Supplements: 

According to a recent Centers for Disease Control and Prevention 
survey, more than half of all adults in the United States consume 
dietary supplements. From 1994 to 2008, the number of dietary 
supplements available to consumers increased from about 4,000 to an 
industry estimate of 75,000. In addition, food products--such as 
fortified cereals and energy drinks--that contain added dietary 
ingredients are in the marketplace in unprecedented numbers, and 
consumers are expected to spend increasing amounts on these products 
over the next several years. However, unlike drugs, which require 
FDA's premarket approval, dietary supplements are presumed safe under 
law unless FDA can establish significant or unreasonable risk. Once 
FDA has identified a safety concern, the agency's ability to remove a 
product from the market is hindered by a lack of mandatory recall 
authority and the difficult process of demonstrating significant or 
unreasonable risk for specific ingredients. 

In January 2009 we reported that FDA's ability to identify safety 
concerns associated with dietary supplements is undermined by a lack 
of scientific information available for other regulated products, such 
as drugs.[Footnote 15] For example, it took FDA almost 10 years after 
issuing its first advisory about ephedra--a dietary supplement 
ingredient used to help in weight loss that had been implicated in 
thousands of adverse events and a number of deaths--to gather 
sufficient data to meet the statutory burden of proof for banning it 
from the market. Given the data limitations, the difficult process of 
establishing significant or unreasonable risk for dietary supplement 
ingredients with known safety concerns has raised doubts among some 
experts about FDA's ability to adequately protect the public. 

In the absence of scientific research, we recommended that FDA request 
authority to require dietary supplement companies to (1) identify 
themselves as a dietary supplement company as part of the existing 
registration requirements and update this information annually, (2) 
provide a list of their products and a copy of the labels and update 
this information annually, and (3) report all adverse events related 
to dietary supplements. In general, FDA agreed with our 
recommendations and commented that FDA's ability to ensure the safety 
of dietary supplements could be improved if FDA had this type of 
information. As of April 10, 2010, FDA has not taken any action on 
this recommendation. However, FDA noted in its comments to this 
correspondence, that bills pending in Congress,[Footnote 16] if passed 
in their present form, would provide FDA with the authority to require 
dietary supplement companies to identify themselves as dietary 
supplement companies as part of the existing registration 
requirements. In addition, if passed in their present form, the bills 
would require dietary supplement companies to update information 
pertaining to their company annually. 

FDA's Risk-Based Approach to Better Target Imported Food Shows 
Promise, but Further Actions Are Needed: 

Owing in part to the volume of imported products it regulates (i.e., 
food, drugs, and medical devices), FDA physically examines only 
approximately 1 percent of imported food. However, FDA has spent about 
$9 million and plans to spend an additional $14 million developing 
PREDICT, its new computer screening tool, which uses criteria--such as 
a product's violative history, country of origin, foreign facility 
inspections, or lack of a track record--to estimate the risk of 
imported food shipments and potentially improve the agency's ability 
to target for inspection shipments of imported products that are more 
likely to violate FDA's regulations.[Footnote 17] PREDICT generates a 
numerical risk score for all FDA-regulated products by analyzing 
importers' shipment information. According to FDA, after PREDICT 
estimates the risk that an imported food shipment poses, it either 
clears the shipment to proceed or alerts FDA officials that the 
shipment needs further review. 

FDA's PREDICT 2007 pilot test suggested that PREDICT could enhance 
FDA's risk-based import screening efforts. According to FDA, PREDICT 
could potentially decrease the incidence of imported foodborne 
illnesses. However, although the PREDICT pilot produced positive 
results and demonstrated the tool's potential to improve import 
screening efforts, we recommended that the agency take further actions 
to help ensure that the tool is effective. In particular, we 
recommended that FDA develop a performance measurement plan to help 
ensure that PREDICT is effectively targeting high-risk imported food 
shipments for field and laboratory examinations. FDA agreed with our 
recommendation to develop a performance measurement plan and reported 
that a draft plan is currently in review to test the efficacy of 
PREDICT. Agency officials noted that they have to collect 6 to 9 
months of data after deployment to conduct a proper review. The agency 
is currently deploying PREDICT on a district-by-district basis at all 
ports and for all FDA-regulated products. FDA noted in its comments to 
this correspondence that PREDICT is fully operational in the Los 
Angeles and New York districts, but due to technical problems FDA has 
not determined when the Seattle district will be deployed. In 
addition, FDA officials stated that a scheduled nationwide rollout 
this summer of PREDICT has been delayed primarily due to information 
technology infrastructure problems, such as server crashes and 
overloads, which are affecting FDA field data systems nationwide. 

More broadly, we recently identified information technology management 
concerns that might hinder the rollout of FDA modernization projects 
such as PREDICT.[Footnote 18] Specifically, we reported that FDA does 
not have a final comprehensive strategic plan for information 
technology to coordinate and manage its numerous information 
technology initiatives and projects. FDA officials stated that the 
agency drafted a strategic plan, which includes PREDICT, for 
information management. Such a plan would provide a comprehensive 
picture of what the organization seeks to accomplish, identify the 
strategies it will use to achieve desired results, provide results-
oriented goals and performance measures that permit it to determine 
whether it is succeeding, and describe interdependencies within and 
across projects so that these can be understood and managed. 

Agency Comments: 

We provided FDA with a draft of this report for review and comment. 
FDA provided written comments which are presented in enclosure V. We 
incorporated updated information and technical comments as appropriate. 

As agreed with your office, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies to the 
appropriate congressional committees, the Commissioner of the Food and 
Drug Administration, and other interested parties. In addition, the 
report will be available at no charge on the GAO Web site at 

If you or your staff have any questions about this report, please 
contact me at (202) 512-3841 or 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 enclosure VI. 

Sincerely yours, 

Signed by: 

Lisa Shames:
Director, Natural Resources and Environment: 

Enclosures (6): 

[End of section] 

Enclosure I: Highlights from Food Safety: Agencies Need to Address 
Gaps in Enforcement and Collaboration to Enhance Safety of Imported 
Food (GAO-09-873): 

GAO Highlights: 

Highlights of GAO-09-873, a report to congressional committees. 

Why GAO Did This Study: 

Imported food makes up a substantial and growing portion of the U.S. 
food supply. To ensure imported food safety, federal agencies must 
focus their resources on high risk foods and coordinate efforts. 

In this context, GAO was asked to (1) assess how Customs and Border 
Protection (CBP), the Food and Drug Administration (FDA), and the U.S. 
Department of Agriculture’s (USDA’s) Food Safety and Inspection Service 
(FSIS) are addressing challenges in overseeing the safety of imported 
food; (2) assess how FDA leverages resources by working with other 
entities, such as state and foreign governments; and (3) determine how 
FDA is using its Predictive Risk-Based Evaluation for Dynamic Import 
Compliance Targeting (PREDICT) system to oversee imported food safety. 
GAO analyzed CBP, FDA, and FSIS procedures, reports, and regulations 
and interviewed agency officials and key stakeholders. 

What GAO Found: 

CBP, FDA, and FSIS have taken steps to address challenges in ensuring 
the safety of the increasing volume of imported food. For example, CBP 
maintains the system that importers use to provide information to FDA 
on food shipments; FDA electronically reviews food imports and inspects 
some foreign food production facilities to prevent violative food from 
reaching U.S. shores; and FSIS employs an equivalency system that 
requires countries to demonstrate that their food safety systems 
provide the same level of protection as the U.S. system. However, gaps 
in enforcement and collaboration undermine these efforts. First, CBP’s 
computer system does not currently notify FDA or FSIS when imported 
food shipments arrive at U.S. ports, although efforts are underway to 
provide this information to FDA for air and truck shipments. This lack 
of communication may potentially increase the risk that unsafe food 
could enter U.S. commerce without FDA review, particularly at truck 
ports. Second, FDA has limited authority to ensure importers’ 
compliance with its regulations. Third, CBP and FDA do not identify 
importers with a unique number; as a result, FDA cannot always target 
food shipments originating from high risk importers. Finally, CBP faces 
challenges in managing in-bond shipments—those that move within the 
United States without formally entering U.S. commerce—and such 
shipments possibly could be diverted into commerce. 

FDA generally collaborates with select states and foreign governments 
on imported food safety. FDA has entered into a contract, several 
cooperative agreements, and informal partnerships for imported food 
with certain states, and some state officials told GAO that they would 
like to collaborate further with FDA on food imports. However, citing 
legal restrictions, FDA does not fully share certain information, such 
as product distribution lists, with states during a recall. This 
impedes states’ efforts to quickly remove contaminated products from 
grocery stores and warehouses. FSIS has begun to make available to the 
public a list of retail establishments that have likely received food 
products that are subject to a serious recall. FDA is also expanding 
efforts to coordinate with other countries. In particular, through its 
Beyond Our Borders initiative, FDA intends to station investigators and 
technical experts in China, Europe, and India, to provide technical 
assistance and gather information about food manufacturing practices to 
improve risk-based screening at U.S. ports. 

According to FDA, PREDICT will analyze food shipments using criteria 
that include a product’s inherent food safety risk and the importer’s 
violative history, among other things, to estimate each shipment’s 
risk. A 2007 pilot test of PREDICT indicated that the system improved 
FDA’s ability to identify products it considers to be high risk while 
allowing a greater percentage of products it considers low risk to 
enter U.S. commerce without a manual review. However, FDA has not yet 
developed a plan to measure the system’s performance, and GAO 
previously identified shortcomings in FDA’s information technology 
modernization efforts. FDA plans to begin deploying PREDICT at all 
ports and for all FDA-regulated products in September 2009. 

What GAO Recommends: 

GAO recommends, among other things, that FDA seek authority from the 
Congress to assess civil penalties on firms and persons who violate FDA 
laws, and that the FDA Commissioner explore ways to improve the 
agency’s ability to identify foreign firms with a unique identifier. 
CBP and FDA generally agreed with our recommendations. FSIS provided 
technical comments only. 

View [hyperlink,] or key 
components. For more information, contact Lisa Shames at (202) 512-3841 

[End of section] 

Enclosure II: Highlights from Dietary Supplements: FDA Should Take 
Further Actions to Improve Oversight and Consumer Understanding (GAO- 

GAO Highlights: 

Highlights of GAO-09-250, a report to congressional requesters. 

Why GAO Did This Study: 

Dietary supplements and foods with added dietary ingredients, such as 
vitamins and herbs, constitute multibillion dollar industries. Past 
reports on the Food and Drug Administration’s (FDA) regulation of these 
products raised concerns about product safety and the availability of 
reliable information. Since then, FDA published draft guidance on 
requirements for reporting adverse events—which are harmful effects or 
illnesses—and Current Good Manufacturing Practice regulations for 
dietary supplements. GAO was asked to examine FDA’s (1) actions to 
respond to the new serious adverse event reporting requirements, (2) 
ability to identify and act on concerns about the safety of dietary 
supplements, (3) ability to identify and act on concerns about the 
safety of foods with added dietary ingredients, and (4) actions to 
ensure that consumers have useful information about the safety and 
efficacy of supplements. 

What GAO Found: 

FDA has made several changes in response to the new serious adverse 
event reporting requirements and has subsequently received an increased 
number of reports. For example, FDA has modified its data system, 
issued draft guidance, and conducted outreach to industry. Since 
mandatory reporting went into effect on December 22, 2007, FDA has seen 
a threefold increase in the number of all adverse event reports 
received by the agency compared with the previous year. For example, 
from January through October 2008, FDA received 948 adverse event 
reports—596 of which were mandatory reports submitted by 
industry—compared with 298 received over the same time period in 2007. 
Although FDA has received a greater number of reports since the 
requirements went into effect, underreporting remains a concern, and 
the agency has further actions planned to facilitate adverse event 

FDA has taken some steps to identify and act upon safety concerns 
related to dietary supplements; however, several factors limit the 
agency’s ability to detect concerns and remove products from the 
market. For example, FDA has limited information on the number and 
location of dietary supplement firms, the types of products currently 
available in the marketplace, and information about moderate and mild 
adverse events reported to industry. Additionally, FDA dedicates 
relatively few resources to oversight activities, such as providing 
guidance to industry regarding notification requirements for products 
containing new dietary ingredients. Also, once FDA has identified a 
safety concern, the agency’s ability to remove a product from the 
market is hindered by a lack of mandatory recall authority and the 
difficult process of demonstrating significant or unreasonable risk for 
specific ingredients. 

Although FDA has taken some actions when foods contain unsafe dietary 
ingredients, certain factors may allow potentially unsafe products to 
reach consumers. FDA may not know when a company has made an 
unsupported or incorrect determination about whether an added dietary 
ingredient in a product is generally recognized as safe until after the 
product becomes available to consumers because companies are not 
required to notify FDA of their self-determinations. In addition, the 
boundary between dietary supplements and conventional foods containing 
dietary ingredients is not always clear, and some food products could 
be marketed as dietary supplements to circumvent the safety standard 
required for food additives. 

FDA has taken limited steps to educate consumers about dietary 
supplements, and studies and experts indicate that consumer 
understanding is lacking. While FDA has conducted some outreach, these 
initiatives have reached a relatively small proportion of dietary 
supplement consumers. Additionally, surveys and experts indicate that 
consumers are not well-informed about the safety and efficacy of 
dietary supplements and have difficulty interpreting labels on these 
products. Without a clear understanding of the safety, efficacy, and 
labeling of dietary supplements, consumers may be exposed to greater 
health risks associated with the uninformed use of these products. 

What GAO Recommends: 

GAO recommends that the Secretary of Health and Human Services direct 
the Commissioner of the FDA to request additional authority to oversee 
dietary supplements, issue guidance on new dietary ingredients and to 
clarify the boundary between dietary supplements and foods with added 
dietary ingredients, and take steps to improve consumer understanding 
of dietary supplements. In commenting on this report, FDA generally 
agreed with GAO’s recommendations. 

To view the full product, including the scope and methodology, click on 
[hyperlink,]. For more 
information, contact Lisa Shames at (202) 512-3841 or 

[End of section] 

Enclosure III: Highlights from Food Safety: Improvements Needed in DFA 
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 

To view the full product, including the scope and methodology, click on 
[hyperlink,]. For more 
information, contact Lisa Shames at (202) 512-3841 or 

[End of section] 

Enclosure IV: Highlights page from Food Labeling: FDA Needs to Better 
Leverage Resources, Improve Oversight, and Effectively Use Available 
Data to Help Consumers Select Healthy Foods (GAO-08-597): 

GAO Highlights: 

Highlights of GAO-08-597, a report to the Chair, Subcommittee on 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies, Committee on Appropriations, House of 

Why GAO Did This Study: 

Two thirds of U.S. adults are overweight, and childhood obesity and 
diabetes are on the rise. To reverse these health problems, experts are 
urging Americans to eat healthier. Food labels contain information to 
help consumers who want to make healthy food choices. The Food and Drug 
Administration (FDA) oversees federal labeling rules for 80 percent of 
foods. GAO was asked to examine (1) FDA’s efforts to ensure that 
domestic and imported foods comply with labeling rules, (2) the 
challenges FDA faces in these efforts, and (3) the views of key 
stakeholders on FDA actions needed to mitigate misleading labeling. GAO 
analyzed FDA data, reports, and requirements on food labeling oversight 
and compliance and interviewed agency and key stakeholder group 

What GAO Found: 

FDA’s oversight and enforcement efforts have not kept pace with the 
growing number of food firms. As a result, FDA has little assurance 
that companies comply with food labeling laws and regulations for, 
among other things, preventing false or misleading labeling. 

* FDA does not have reliable data on the number of labels reviewed; the 
number of inspections, which include label reviews, has declined. For 
example, of the tens of thousands of foreign food firms in over 150 
countries, just 96 were inspected by FDA in 11 countries in fiscal year 
2007—down from 211 inspections in 26 countries in 2001. 

* FDA’s testing for the accuracy of nutrition information on labels in 
2000 through 2006 was limited. FDA could not provide data for 2007. 

* Although the number of food firms in FDA’s jurisdiction has 
increased, the number of warning letters FDA issued to firms that cited 
food labeling violations has held fairly steady. 

* FDA does not track the complete and timely correction of labeling 
violations or analyze these and other labeling oversight data in 
routine reports to inform managers’ decisions, or ensure the complete 
and timely posting of information on its Web site to inform the public. 

* In addition to its official recalls database, FDA’s Center for Food 
Safety and Applied Nutrition has continued to waste resources on a 
second recall database that FDA had agreed to eliminate in 2004, as GAO 
had recommended. 

FDA has reported that limited resources and authorities challenge its 
efforts to carry out its food safety responsibilities—these challenges 
also impact efforts to oversee food labeling laws. FDA’s Food 
Protection Plan cites the need for authority to, among other things, 
collect a reinspection user fee, accredit third-party inspectors, and 
require recalls when voluntary recalls are not effective. 

Stakeholders from health, medical, and consumer groups identified 
actions they believe will mitigate misleading labeling and help 
consumers identify healthy food. Several stakeholders support a 
simplified, uniform front-of-package symbol system to convey 
nutritional quality to consumers. The United Kingdom, Sweden, and the 
Netherlands have developed voluntary nutrition symbols, while the 
European Commission has proposed requiring front-of-package labeling of 
key nutrients. 

What GAO Recommends: 

GAO is recommending actions for FDA to ensure that labeling office 
managers have the information they need to oversee compliance with 
labeling laws; ensure the public has timely access to information on 
labeling violations on FDA’s public Web site; and better leverage 
resources to achieve its mission. In commenting on a draft of this 
report, FDA stated that the report raised important issues, and agreed, 
with qualifications, with some of GAO’s recommendations, but did not 
comment on others. 

To view the full product, including the scope and methodology, click on 
[[hyperlink,]. For more 
information, contact Lisa Shames at (202) 512-3841 or 

[End of section] 

Enclosure V: Comments from the Department of Health & Human Services: 

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

April 9, 2010: 

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

Dear Ms. Shames: 

Enclosed are comments on the U.S. Government Accountability Office's 
(GAO) report entitled: "Food Safety: FDA Has Begun to Take Action to 
Address Weaknesses in Food Safety Research, but Gaps Remain" (GAO-10-

The Department appreciates the opportunity to review this report 
before its publication. 


Signed by: 

Andrea Palm: 
Acting Assistant Secretary for Legislation: 


[End of letter] 

FDA's General Comments to GAO's Draft Report Entitled, Food Safety: 
FDA Has Begun to Take Action to Address Weaknesses in Food Safety 
Research, but Gaps Remain (GAO-10-182R): 

The Food and Drug Administration (FDA) appreciates the opportunity to 
review and comment on the Government Accountability Office's (GAO's) 
draft report. 

Ensuring that foods are safe and secure is a vital part of the FDA 
mission, and FDA is committed to ensuring that the food supply in the 
United States continues to be among the safest in the world. To that 
end, the Commissioner of Food and Drugs, Margaret Hamburg, created the 
Office of Foods (OF) in August 2099, to lead a functionally unified 
FDA Foods Program and enhance the Agency's ability to meet today's 
great challenges and opportunities in food and feed safety, nutrition, 
and other critical areas. The FDA Foods Program, lead by, the newly 
appointed Deputy Commissioner for Foods, includes three major 
operating units—the Center for Food Safety and Applied Nutrition 
(CFSAN), the Center for Veterinary Medicine (CVM), and the foods-
related activities of the Office of Regulatory Affairs (ORA). It also 
draws on the resources and expertise of FDA's National Center for 
Toxicological Research (NCTR) and key Office of the Commissioner staff 
offices. The new Office of Foods is responsible, on behalf of the 
Commissioner, for providing all elements of FDA's Foods Program 
leadership, guidance, and support to achieve the Agency's public 
health goals. The Office of Foods also, is the focal point for 
planning and implementing the recommendations of the President's Food 
Safety Working Group and the new food safety authorities being 
considered by Congress. 

The FDA Foods Program protects and promotes the health of humans and 
animals by: 

* ensuring the safety of foods for humans, including dietary 

* ensuring the safety of animal feed and the safety and effectiveness 
of animal drugs; 

* setting science-based standards for preventing foodborne illness and 
ensuring compliance with these standards; 

* protecting the food and feed supply from intentional contamination; 

* ensuring that food labels contain reliable information that 
consumers can use to choose healthy diets. 

A strong science-based foundation is vital to all 4of these areas and 
FDA recognizes that several of these, areas–-food labeling, fresh 
produce safety, dietary supplements, import safety, and information 
technology-—are highlighted in this GAO report. FDA is taking steps to 
address public health concerns related to all of the areas identified 
in this report, as well as many others. In December 2009, the 
Commissioner of Food and Drugs and the Deputy Commissioner for Foods 
launched the One Mission, One Program" Initiative, and charged FDA 
leadership with designing the future, unified Foods PrOgram at FDA. 
Organized into ten core groups, they are addressing cross-cutting 
areas that affect more than one organizational element of the Foods 
Program. The groups are as follows: 

* Preventive controls; 
* Risk-informed decision-making Inspection and compliance strategy; 
* Import safety; 
* Federal/state integration; 
* Incident preparedness and response; 
* Science, technology, and research integration; 
* Information systems; 
* Strategic communications; 
* Resource planning. 

FDA leadership is fully committed to transforming food safety to 
reflect President Obama's vision of a new food safety system — based 
on the core principles of the President's Food Safety Working Group: 
prioritizing prevention, strengthening surveillance and enforcement, 
and improving response and recovery — to protect the American public. 
Pending legislation, if enacted, would strengthen FDA's efforts in 
this regard. The legislation would also enable FDA to implement 
further preventative measures, such as by issuing new food safety 
regulations, and would provide mechanisms to help ensure such measures 
are appropriately implemented. The Food Safety Enhancement Act (H.R. 
2749) as passed by the House and the pending food safety bill (S. 510) 
under consideration in the Senate illustrate the broad agreement on 
the general direction of the fOod safety reform toward an improvement 
of risk-based preventive controls to reduce foodborne illness as a 
major public health goal. 

Consumer groups are fighting for improvements--in the food safety 
system along with major sectors in the food industry; however, the 
efforts of the federal agencies and our state, local, tribal and 
territorial food safety partners will fall short unless Congress 
modernizes food safety laws to deal with the challenges of the 21st 
century and provides the necessary resources to sustain a modem 
integrated food safety system. 

Food Labeling: 

GAO states that FDA has not taken any actions on GAO's recommendations 
that FDA (1) maintain data on labeling violations and the corrective 
actions taken in a searchable format; (2) analyze violation data in 
routine management reports; and (3) track regulatory meetings on 
labeling violation to assess whether they are an effective use of 

As resources permit, FDA will consider implementing a routine review 
of violation data to inform its compliance activities in the labeling 
area. FDA uses the Mission Accomplishments and Regulatory Compliance 
Services-Compliance Management System (MARCS-CMS) to track all 
enforcement work, including those that involve labeling. For the past 
two years, the system has included data on the specific charge used in 
an action. In addition to the information related to the actions, the 
system has an area to include the firm's responses. In October 2008, 
the system was expanded to include import actions. 

To further provide transparency in FDA's enforcement actions, FDA 
implemented a process whereby it issues and posts a Warning Letter 
close out letter when a firm has sufficiently addressed deviations 
cited in a Warning Letter. This process began with Warning Letters 
issued on or after September 1, 2009. The close out letter the firm is 
posted on FDA's website directly linked to the Warning Letter, 
including those issued for labeling violations. Although the Agency 
does not track regulatory meetings on labeling, it has been-working 
diligently to mine its field data to best prioritize inspection and 
sampling work planning with respect to domestic and foreign firms and 
products. That process is continually being informed and refined. 
Complementing that effort with analyses of labeling and other data 
will further enhance efficiencies in Our monitoring and surveillance 

Fresh Produce: 

GAO states that it previously recommended that FDA develop a plan for 
identifying research priorities and facilitating research related to 
fresh produce. GAO also recommended that FDA identify approaches for 
obtaining testing and other information from industry members to 
inform its research agenda. GAO found that FDA has taken limited-steps 
to fill some of the science gaps. 

FDA believes that it has taken significant steps to address science 
gaps in produce safety. FDA offers the following list of activities in 
addition to the examples cited in the GAO draft report. 

FDA formed the Produce Safety Staff (PSS) within CFSAN's Office of 
Food Safety in 2008. In 2008 and 2009 CFSAN recruited highly sought-
after experts with extensive technical experience in produce safety 
from academia and industry to staff the PSS. The PSS is now comprised 
of seven permanent, and ten total staff members with science and 
regulatory expertise. FDA also hired a Senior Advisor on Produce 
Safety to advise the Agency on policies and programs affecting the 
safety of fresh produce. The role of the PSS is to assess produce 
safety hazards from farm to table, identify and address science gaps, 
and develop appropriate regulatory instruments to eliminate or 
mitigate hazards associated with fresh produce. PSS leadership had a 
significant role in the development of the CFSAN research strategic 
plan, which identifies and prioritizes produce safety knowledge gaps 
using the Carver-shock model, and links these needs with intramural 
and extramural research programs. 

CFSAN has also devoted scientific resources and made progress in 
methods for pathogen recovery from produce, a significant obstacle to 
effective surveillance programs. Other examples of progress in 
addressing science gaps in produce safety include the following: 

* Recent scientific accomplishments include the development and, 
validation of a rapid molecular screening method for the detection of 
viable Salmonella directly from several high-risk produce commodities 
including tomatoes, spinach, and peppers (Jalapeno and Serrano). This 
accomplishment is significant because the new method detects only 
living Salmonella, by targeting short-lived RNA within Salmonella 
cells, avoiding potential false-positive results inherent to previous 
molecular methods. JFDA scientists continue to develnp, assess, and 
explore technologies for the detection of pathogens in produce both in 
the field and in the laboratory. 

* FDA scientists, in collaboration with bioscience industry partners, 
developed and implemented a Pathogen Annotated Tracking Resource 
Network (PATRN) System to aid analysis of foodborne pathogens. PATRN 
is a transparent, web-based database system which captures both the 
global expertise and surveillance data on foodborne pathogens. This 
system is an important improvement in FDA intervention and response 

* FDA scientists developed and released for public health application 
a custom Affyrnetrix3DNA microarray design (E. coli-Shigella 
GeneChip - ECSG) for identifying and discriminating strains of 
Escherichia coli and Shigella spp. This advanced methodology will 
significantly improve sample through-put and accuracy M the detection 
of contaminated food products. 

* In collaboration with bioscience industry partners, FDA scientists 
developed a series of diagnostic detection assays in a self-contained 
biosensor system. The system allows for the specific targeting of 
Salmonella stains, and rapid (less than two hour) screening for key 
foodborne pathogens including Salmonella, E. coli 0157:H7, Listeria 
monocytogenes, and all four groups of Shigella. The advantages of this 
system include its ability to detect multiple and minute amounts of 
pathogens directly from suspect foods, a significant improvement over 
conventional methods. 

* FDA scientists determined the inactivation rate of hepatitis A virus 
in fresh produce. This knowledge is an important factor for risk 
assessments, and for improvement of detection methods for efficient 
source attribution. 

FDA also organizes and participates in meetings to encourage and 
facilitate the sharing of research ideas and techniques and to 
minimize duplication of efforts. A summary of recent and future 
meetings are provided below: 

* Leafy Greens Industry: Microbial Data Trends and Practices 
Symposium: FDA participated in a September 16, 2009 meeting sponsored 
by the University of California Davis Center for Produce Safety, 
Salinas, CA. This meeting brought together produce industry scientists 
and academic researchers to discuss on-going produce industry data 
gathering efforts and to explore means of data mining current industry 
data sets. 

* Data Mining to Populate Produce Risk Assessment Models: A March 15, 
2010, meeting was conducted with a national produce trade association 
to consider FDA access to industry,microbiological testing data Access 
to industry data would inform the CFSAN research agenda, augment CFSAN 
risk assessment modeling, and fill data gaps, such as;
i) Leafy greens/E. coli Predictive Risk Assessment (Research Triangle 
Institute contract); 
ii) Produce Risk Ranking Tool; 
iii) Pilot of deciSion analysis tool to identify research needs for 
Leafy greens/E. coli (interagency risk consortium workshop); 
iv) iRISK (online comparative risk assessment tool) pilot of 50 
commodities/20 hazards under development and includes produce examples. 

* Produce Microbial Testing A March 16, 2010 meeting between a 
national produce trade association, a leading produce company, and FDA 
was held to discuss the utility and limitations of microbial testing 
in the fresh produce industry. Also discussed was the ability to 
access industry data sets. 

* FDA CFSAN/United States Department of Agriculture Beltsville 
Agriculture Research Center (BARC) Science Day: A half-day meeting was 
conducted March 18, 2010; to assemble leading produce researchers from 
CFSAN and BARC to discuss on-going and future produce safety research. 

* Produce Safety Research Summit: The FDA Western Center for Food 
Safety in collaboration with the University of California — Davis, 
Center for Produce Safety is planning a produce research summit for 
June 24, 2010. Industry, government and academic research leaders will 
identify and rank produce food safety priority research needs. 

Furthermore, FDA continues to work with industry partners to share 

* Wash Water Modeling: FDA has met on numerous occasions with a 
leading fresh-cut produce processor to discuss the company's wash 
water microbial risk model and the associated industry data set. 

* Accessing U.S. Department of Defense (DOD) Procurement Produce 
Testing Data: DOD Logistics is a significant purchaser of fresh 
produce and routinely performs microbial testing of fresh produce for 
the presence of human pathogens. FDA is in contact with DOD to develop 
a data sharing agreement to allow FDA access to this database. 

CFSAN's science program includes formal and informal relationships 
with academic institutions, other scientific organizations and 
research agencies. These interactions assist CFSAN and FDA in 
fulfilling its public health mission and expand the science-base upon 
which future regulatory programs are developed. The attached CY 2008 
Annual CFSAN Leveraging Report reflects the contributions made by the 
consortia and leveraging partners during 2008 to FDA's mission. 

Dietary Supplements: 

GAO reports that FDA has not taken any action on its recommendation 
that FDA request authority to require dietary supplement companies to 
identify themselves as a dietary supplement company as part of the 
existing registration requirements and update this information annually,
provide a list of their products and a copy of the labels and update 
this information annually, and report all adverse events related to 
dietary supplements. 

As noted it FDA's response to the 2009 GAO report en Dietary 
Supplements, FDA stated that although receiving all adverse events on 
dietary supplements could theoretically enhance our ability to detect 
signals of potential toxicity over time we:are uncertain whether, in 
practice, such information would advance the Agency's ability to 
identify unsafe dietary supplements or to do so quickly. FDA would 
develop an approach to reviewing all adverse events reports if 
Congress were to require such reporting. 

The Food Safety Enhancement Act (HR. 2749) as passed by the House and 
the pending food safety bill (S. 510) under consideration in the 
Senate would require food companies (including dietary supplement 
manufacturers) to renew their registrations annually and allow FDA to 
create new food registration categories, which could include one or 
more categories specific to dietary supplements., This legislation, if 
passed, would address GAO's recommendations that FDA require dietary 
supplement companies to identify themselves as dietary supplement 
companies and update registration information annually. 

[End of section] 

Enclosure VI: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3841 or 

Staff Acknowledgments: 

Key contributors to this report were José Alfredo Gómez, Assistant 
Director; Kathryn Smith; Kevin Bray; Candace Carpenter; Jeff C. 
Jensen; Anne Johnson; Erin Lansburgh; Susan Malone; Karine McClosky; 
Barbara Patterson; Beverly Peterson; Carol Herrnstadt Shulman; Kiki 
Theodoropoulos; Lisa Van Arsdale; and Rebecca Yurman. 

[End of section] 


[1] GAO, High-Risk Series: An Update, [hyperlink,] (Washington, D.C.: January 

[2] The percentages represent survey responses of a "great extent" and 
"very great extent" and have a margin of error of plus or minus 10 
percentage points or less. See GAO, Food and Drug Administration: 
Opportunities Exist to Better Address Management Challenges, 
[hyperlink,] (Washington, D.C.: 
Feb. 19, 2010) for more information; and Food and Drug Administration: 
2009 FDA Managers Survey on Performance and Management Issues, an E-
supplement to GAO-10-279, [hyperlink,] (Washington, D.C.: Feb. 
2010) for survey results. 

[3] GAO, Dietary Supplements: FDA Should Take Further Actions to 
Improve Oversight and Consumer Understanding, [hyperlink,] (Washington D.C.: Jan. 29, 
2009); Food Safety: Improvements Needed in FDA Oversight of Fresh 
Produce, [hyperlink,] 
(Washington, D.C.: Sept. 26, 2008); and Food Labeling: FDA Needs to 
Better Leverage Resources, Improve Oversight, and Effectively Use 
Available Data to Help Consumers Select Healthy Food, [hyperlink,] (Washington, D.C.: Sept. 9, 

[4] GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and 
Collaboration to Enhance Safety of Imported Food, [hyperlink,] (Washington, D.C.: Sept. 15, 

[5] GAO, Information Technology: FDA Needs to Establish Key Plans and 
Processes for Guiding Systems Modernizations Efforts, [hyperlink,] (Washington, D.C.: June 2, 

[6] U.S. 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). 

[7] GAO, Federal Oversight of Food Safety: FDA Has Provided Few 
Details on the Resources and Strategies Needed to Implement its Food 
Protection Plan, [hyperlink,] 
(Washington, D.C.: June 12, 2008); and Federal Oversight of Food 
Safety: FDA's Food Protection Plan Proposes Positive First Steps, but 
Capacity to Carry Them Out is Critical, [hyperlink,] (Washington, D.C.: Jan. 29, 

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

[9] FDA's public health responsibilities are, among other things, to 
ensure the safety and effectiveness of medical products--drugs, 
biologics, and medical devices--marketed in the United States; ensure 
the safety of nearly all food products other than meat and poultry; 
and regulate tobacco products. FDA carries out these responsibilities 
through six regulatory product centers; its Office of Regulatory 
Affairs, which performs fieldwork, such as inspections and enforcement 
activities, on behalf of all the product centers; and its research 
arm, the National Center for Toxicological Research. 

[10] Office of the Chief Scientist and Principal Deputy Commissioner, 
U.S. Food and Drug Administration, Report on Status of Regulatory 
Science at FDA: Progress, Plans and Challenges (Washington, D.C., 
February 2009). 

[11] GAO, Agencies' Strategic Plans Under GPRA: Key Questions to 
Facilitate Congressional Review, [hyperlink,] (Washington, D.C.: May 

[12] [hyperlink,]. 

[13] [hyperlink,]. 

[14] Centers include the National Center for Food Safety and 
Technology at the Illinois Institute of Technology; the Joint 
Institute for Food Safety and Applied Nutrition at the University of 
Maryland; the National Center for Natural Products Research at the 
University of Mississippi; and the Western Center for Food Safety at 
the University of California, Davis, which was just established at the 
time of our review. 

[15] [hyperlink,]. 

[16] The Food Safety Enhancement Act (H.R. 2749) and the FDA Food 
Safety Modernization Act (S. 510). 

[17] [hyperlink,]. 

[18] [hyperlink,]. 

[End of section] 

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