Food Safety
FDA Has Begun to Take Action to Address Weaknesses in Food Safety Research, but Gaps Remain
Gao ID: GAO-10-182R April 23, 2010
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. 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. 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.
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.
GAO-10-182R, Food Safety: FDA Has Begun to Take Action to Address Weaknesses in Food Safety Research, but Gaps Remain
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GAO-10-182R:
United States Government Accountability Office:
Washington, DC 20548:
April 23, 2010:
The Honorable Brad Miller:
Chairman:
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.
Background:
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
nutrients.
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
[hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. Key contributors to this report are
listed in 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, http://www.gao.gov/products/GAO-09-873] or key
components. For more information, contact Lisa Shames at (202) 512-3841
or shamesl@gao.gov.
[End of section]
Enclosure II: Highlights from Dietary Supplements: FDA Should Take
Further Actions to Improve Oversight and Consumer Understanding (GAO-
09-250):
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
reporting.
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, http://www.gao.gov/products/GAO-09-250]. For more
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov.
[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
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]
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
Representatives.
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
officials.
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.
Specifically:
* 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, http://www.gao.gov/cgi-bin/getrpt?GAO-08-597]. For more
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov.
[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-
182R).
The Department appreciates the opportunity to review this report
before its publication.
Sincerely,
Signed by:
Andrea Palm:
Acting Assistant Secretary for Legislation:
Enclosure:
[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
supplements;
* 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;
and;
* 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
resources.
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
program.
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
capabilities.
* 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
data:
* 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 shamesl@gao.gov:
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]
Footnotes:
[1] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[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, http://www.gao.gov/products/GAO-10-279] (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,
http://www.gao.gov/products/GAO-10-280SP] (Washington, D.C.: Feb.
2010) for survey results.
[3] GAO, Dietary Supplements: FDA Should Take Further Actions to
Improve Oversight and Consumer Understanding, [hyperlink,
http://www.gao.gov/products/GAO-09-250] (Washington D.C.: Jan. 29,
2009); Food Safety: Improvements Needed in FDA Oversight of Fresh
Produce, [hyperlink, http://www.gao.gov/products/GAO-08-1047]
(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,
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9,
2008).
[4] GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Food, [hyperlink,
http://www.gao.gov/products/GAO-09-873] (Washington, D.C.: Sept. 15,
2009).
[5] GAO, Information Technology: FDA Needs to Establish Key Plans and
Processes for Guiding Systems Modernizations Efforts, [hyperlink,
http://www.gao.gov/products/GAO-09-523] (Washington, D.C.: June 2,
2009).
[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, http://www.gao.gov/products/GAO-08-909T]
(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,
http://www.gao.gov/products/GAO-08-435T] (Washington, D.C.: Jan. 29,
2008).
[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,
http://www.gao.gov/products/GAO/GGD-10.1.16] (Washington, D.C.: May
1997).
[12] [hyperlink, http://www.gao.gov/products/GAO-08-597].
[13] [hyperlink, http://www.gao.gov/products/GAO-08-1047].
[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, http://www.gao.gov/products/GAO-09-250].
[16] The Food Safety Enhancement Act (H.R. 2749) and the FDA Food
Safety Modernization Act (S. 510).
[17] [hyperlink, http://www.gao.gov/products/GAO-09-873].
[18] [hyperlink, http://www.gao.gov/products/GAO-09-523].
[End of section]
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