Federal Food Safety Oversight
Food Safety Working Group Is a Positive First Step but Governmentwide Planning Is Needed to Address Fragmentation Gao ID: GAO-11-289 March 18, 2011For more than a decade, GAO has reported on the fragmented nature of federal food safety oversight and how it results in inconsistent oversight, ineffective coordination, and inefficient use of resources. In 2007, GAO added this issue to its high-risk list. In March 2009, the President established the Food Safety Working Group (FSWG) to coordinate federal efforts and establish food safety goals to make food safer. Section 21 of Public Law 111-139 mandated that GAO identify programs, agencies, offices, and initiatives with duplicative goals and activities. This review examines: (1) steps, if any, that the FSWG has taken to increase collaboration among federal food safety agencies, and (2) options we and others have identified to reduce fragmentation, overlap, and potential duplication in food safety oversight. GAO reviewed information about the FSWG and alternative organizational structures for food safety, and conducted interviews.
Creation of the FSWG elevated food safety as a national priority, demonstrated strong commitment and top leadership support, and was designed to foster interagency collaboration on this cross-cutting issue. The FSWG includes officials from the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Office of Management and Budget (OMB), and other federal agencies. Through the FSWG, federal agencies have taken steps designed to increase collaboration in some areas that cross regulatory jurisdictions--in particular, improving produce safety, reducing Salmonella contamination, and developing food safety performance measures. However, the FSWG has not developed a governmentwide performance plan for food safety that provides a comprehensive picture of the federal government's food safety efforts. When GAO added food safety oversight to its high-risk list in 2007, it said that what remains to be done is to develop a governmentwide performance plan for food safety that is mission based, results oriented, and provides a cross-agency perspective. Officials from OMB, FDA, and USDA told us that the FSWG's July 2009 "key findings" represent the governmentwide plan for food safety. However, most of the goals outlined in the key findings are not results oriented and do not include performance measures. Further, the FSWG has not provided information about the resources that are needed to achieve its goals. Our prior work has identified results oriented goals and performance measures and a discussion of strategies and resources as standard elements of performance plans. GAO and other organizations have identified options to reduce fragmentation and overlap in food safety oversight in the form of alternative organizational structures, but a detailed analysis of their advantages, disadvantages, and potential implementation challenges has yet to be conducted. GAO has suggested that Congress consider commissioning the National Academy of Sciences or a blue ribbon panel to conduct a detailed analysis of alternative organizational structures for food safety. Some of the alternative organizational structures include a single food safety agency, a food safety inspection agency, a data collection and risk analysis center, and a coordination mechanism led by a central chair. GAO recognizes that reorganizing federal food safety responsibilities would be a complex process that could have short-term disruptions and transition costs. GAO and other organizations have regularly paired proposals for alternative food safety organizations with calls for comprehensive, unified, risk-based food safety legislation. New food safety legislation that was signed into law in January 2011 strengthens a major part of the food safety system; however, it does not apply to the federal food safety system as a whole or create a new risk-based food safety structure. GAO recommends that the Director of OMB, in consultation with the federal food safety agencies, develop a governmentwide performance plan for food safety that includes results oriented goals and performance measures for food safety oversight and a discussion about strategies and resources. OMB declined to comment on a draft of this report. USDA and Health and Human Services provided technical comments.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Lisa R. Shames Team: Government Accountability Office: Natural Resources and Environment Phone: (202) 512-2649GAO-11-289, Federal Food Safety Oversight: Food Safety Working Group Is a Positive First Step but Governmentwide Planning Is Needed to Address Fragmentation
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United States Government Accountability Office:
GAO:
Report to Congressional Committees:
March 2011:
Federal Food Safety Oversight:
Food Safety Working Group Is a Positive First Step but Governmentwide
Planning Is Needed to Address Fragmentation:
GAO-11-289:
GAO Highlights:
Highlights of GAO-11-289, a report to congressional committees.
Why GAO Did This Study:
For more than a decade, GAO has reported on the fragmented nature of
federal food safety oversight and how it results in inconsistent
oversight, ineffective coordination, and inefficient use of resources.
In 2007, GAO added this issue to its high-risk list. In March 2009,
the President established the Food Safety Working Group (FSWG) to
coordinate federal efforts and establish food safety goals to make
food safer.
Section 21 of Public Law 111-139 mandated that GAO identify programs,
agencies, offices, and initiatives with duplicative goals and
activities. This review examines: (1) steps, if any, that the FSWG has
taken to increase collaboration among federal food safety agencies,
and (2) options we and others have identified to reduce fragmentation,
overlap, and potential duplication in food safety oversight. GAO
reviewed information about the FSWG and alternative organizational
structures for food safety, and conducted interviews.
What GAO Found:
Creation of the FSWG elevated food safety as a national priority,
demonstrated strong commitment and top leadership support, and was
designed to foster interagency collaboration on this cross-cutting
issue. The FSWG includes officials from the Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA), the
Office of Management and Budget (OMB), and other federal agencies.
Through the FSWG, federal agencies have taken steps designed to
increase collaboration in some areas that cross regulatory
jurisdictions––in particular, improving produce safety, reducing
Salmonella contamination, and developing food safety performance
measures.
However, the FSWG has not developed a governmentwide performance plan
for food safety that provides a comprehensive picture of the federal
government‘s food safety efforts. When GAO added food safety oversight
to its high-risk list in 2007, it said that what remains to be done is
to develop a governmentwide performance plan for food safety that is
mission based, results oriented, and provides a cross-agency
perspective. Officials from OMB, FDA, and USDA told us that the FSWG‘s
July 2009 ’key findings“ represent the governmentwide plan for food
safety. However, most of the goals outlined in the key findings are
not results oriented and do not include performance measures. Further,
the FSWG has not provided information about the resources that are
needed to achieve its goals. Our prior work has identified results
oriented goals and performance measures and a discussion of strategies
and resources as standard elements of performance plans.
GAO and other organizations have identified options to reduce
fragmentation and overlap in food safety oversight in the form of
alternative organizational structures, but a detailed analysis of
their advantages, disadvantages, and potential implementation
challenges has yet to be conducted. GAO has suggested that Congress
consider commissioning the National Academy of Sciences or a blue
ribbon panel to conduct a detailed analysis of alternative
organizational structures for food safety. Some of the alternative
organizational structures include a single food safety agency, a food
safety inspection agency, a data collection and risk analysis center,
and a coordination mechanism led by a central chair. GAO recognizes
that reorganizing federal food safety responsibilities would be a
complex process that could have short-term disruptions and transition
costs. GAO and other organizations have regularly paired proposals for
alternative food safety organizations with calls for comprehensive,
unified, risk-based food safety legislation. New food safety
legislation that was signed into law in January 2011 strengthens a
major part of the food safety system; however, it does not apply to
the federal food safety system as a whole or create a new risk-based
food safety structure.
What GAO Recommends:
GAO recommends that the Director of OMB, in consultation with the
federal food safety agencies, develop a governmentwide performance
plan for food safety that includes results oriented goals and
performance measures for food safety oversight and a discussion about
strategies and resources. OMB declined to comment on a draft of this
report. USDA and Health and Human Services provided technical comments.
View [hyperlink, http://www.gao.gov/products/GAO-11-289] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Background:
The FSWG Has Taken Steps Designed to Improve Collaboration among
Federal Agencies but Has Not Developed a Comprehensive Governmentwide
Performance Plan for Food Safety:
We and Others Have Identified Options to Reduce Fragmentation and
Overlap in Food Safety Oversight, but They Have Not Been Analyzed in
Detail:
Conclusions:
Recommendation for Executive Action:
Agency Comments:
Appendix I: Scope and Methodology:
Appendix II: Federal Agencies with Food Safety Responsibilities:
Appendix III: Reports Identifying Options for Alternative
Organizational Structures for Food Safety Oversight:
Appendix IV: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Abbreviations:
AMS: Agricultural Marketing Service:
CDC: Centers for Disease Control and Prevention:
DOD: Department of Defense:
EU: European Union:
FDA: Food and Drug Administration:
FSIS: Food Safety and Inspection Service:
FSWG: Food Safety Working Group:
OMB: Office of Management and Budget:
USDA: Department of Agriculture:
VA: Department of Veterans Affairs:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
March 18, 2011:
Congressional Committees:
For more than a decade, GAO has reported on the fragmented nature of
federal food safety oversight. While the Food and Drug Administration
(FDA) and U.S. Department of Agriculture's (USDA) Food Safety and
Inspection Service (FSIS) have primary oversight responsibilities, a
total of 15 agencies collectively administer at least 30 food-related
laws. In 2007, we added the federal oversight of food safety to our
list of high-risk areas in need of broad-based transformation to
achieve greater economy, efficiency, effectiveness, accountability,
and sustainability.[Footnote 1] We also cited the need to integrate
this fragmented system as a challenge for the 21st century.[Footnote 2]
The 2010 nationwide recall of more than 500 million eggs due to
Salmonella contamination highlights how this fragmentation persists,
with several agencies having different roles and responsibilities
throughout the egg production system. For example, FDA is generally
responsible for ensuring that eggs in their shells--referred to as
shell eggs--including eggs at farms such as those where the outbreak
occurred, are safe, wholesome, and properly labeled. FSIS, on the
other hand, is responsible for the safety of eggs processed into egg
products. In addition, USDA's Agricultural Marketing Service (AMS)
sets quality and grade standards for shell eggs, such as Grade A, but
does not test the eggs for bacteria such as Salmonella. Further, while
USDA's Animal and Plant Health Inspection Service manages the program
that helps ensure laying hens are free from Salmonella at birth, FDA
oversees the safety of the feed they eat.
Many of our reports have found that fragmentation in the nation's food
safety system results in inconsistent oversight, ineffective
coordination, and inefficient use of resources. In 2005, we reported
that federal agencies spend resources on overlapping activities,
including inspections of domestic and imported foods, training,
research, risk assessment, education, and rulemaking.[Footnote 3] We
recommended that federal agencies take a number of steps to reduce
overlap, leverage resources, and enhance coordination. For example, to
better use FDA's limited inspection resources and leverage USDA's
resources, we recommended that, if appropriate and cost effective, the
Commissioner of the FDA enter into an agreement to commission USDA
inspectors to carry out FDA's inspection responsibilities for food
establishments that are under the jurisdiction of both agencies. We
have made several other recommendations intended to address the
fragmented federal oversight of the nation's food supply. In 2001, we
recommended that the Secretary of Agriculture, the Secretary of Health
and Human Services, and the Assistant to the President for Science and
Technology, as joint chairs, reconvene the President's Council on Food
Safety to facilitate interagency coordination on food safety
regulation and programs[Footnote 4]. The council had disbanded earlier
that year. Positively, in March 2009, the President established the
Food Safety Working Group (FSWG), which is co-chaired by the
Secretaries of Agriculture and Health and Human Services, to
coordinate federal efforts and develop goals to make food safer. When
we added food safety oversight to our high-risk list in 2007, we said
that what remains to be done is to develop a governmentwide
performance plan for food safety that is mission based, has a results
orientation, and provides a cross-agency perspective. [Footnote 5]
Finally, in reports dating back to 2001 we have been suggesting that
Congress consider commissioning the National Academy of Sciences or a
blue ribbon panel to conduct a detailed analysis of alternative
organizational food safety structures and consider enacting
comprehensive food safety legislation.[Footnote 6]
New food safety legislation that was signed into law in January 2011--
FDA Food Safety Modernization Act--strengthens a major part of the
food safety system.[Footnote 7] It shifts the focus of FDA regulators
from responding to contamination to preventing it, according to FDA,
and expands FDA's oversight authority. For example, the law directs
FDA to increase the frequency of its inspections, and allocate
resources to inspect facilities according to the facilities' known
safety risks, with high-risk facilities being inspected the most
frequently. The law also has several sections that require interagency
collaboration on food safety oversight in areas such as inspections,
seafood safety, and food imports. While the new law is a positive
development, it does not apply to the federal food safety system as a
whole. In particular, it does not address USDA's authorities, which
remain separate and distinct from FDA's.
A new statutory requirement mandates that GAO identify federal
programs, agencies, offices, and initiatives with duplicative goals
and activities within departments and governmentwide.[Footnote 8]
Under that mandate, this review examines: (1) steps, if any, that the
FSWG has taken to increase collaboration among federal food safety
agencies, and (2) options we and others have identified to reduce
fragmentation, overlap, and potential duplication in food safety
oversight. To complete our work we reviewed food safety reports and
legislation, and interviewed officials from USDA, FDA, and the Office
of Management and Budget (OMB). We also collected and analyzed
information about the FSWG, its activities, and its governmentwide
plan for food safety, as well as alternative organizational structures
for food safety. More detailed information about our scope and
methodology appears in appendix I. We conducted this performance audit
from July 2010 to March 2011 in accordance with generally accepted
government auditing standards. Those standards require that we plan
and perform the audit to obtain sufficient, appropriate evidence to
provide a reasonable basis for our findings and conclusions based on
our audit objectives. We believe that the evidence obtained provides a
reasonable basis for our findings and conclusions based on our audit
objectives.
Background:
The safety and quality of the U.S. food supply is governed by a highly
complex system stemming from at least 30 laws related to food safety
that are collectively administered by 15 agencies. The two primary
food safety agencies are USDA and FDA. USDA is responsible for the
safety of meat, poultry, processed egg products, and, as soon as
recently proposed regulations are finalized, catfish. FDA is
responsible for virtually all other food, including seafood. In fiscal
year 2009, budget obligations for FDA's Foods Program were $685
million and budget obligations for FSIS were approximately $975
million.[Footnote 9] Federal food safety activities include inspecting
domestic food-processing facilities and imported food at ports of
entry, visiting foreign countries or firms to inspect and evaluate
foreign food safety systems, analyzing samples collected at food-
processing facilities to identify possible contamination, rulemaking
and standard setting, and developing guidance for industry, among
other things. Appendix II summarizes the federal agencies' food safety
responsibilities and main authorizing statutes. The federal food
safety system is supplemented by the states, which may have their own
statutes, regulations, and agencies for regulating and inspecting the
safety and quality of food products.
The existing food safety system, like many other federal programs and
policies, evolved piecemeal, typically in response to particular
health threats or economic crises. Existing statutes give agencies
different regulatory and enforcement authorities for different food
products. For example, the 2008 Farm Bill gave USDA responsibility for
inspecting catfish, but left general responsibility for seafood safety
with FDA, making the system more fragmented. According to USDA
officials, USDA estimates it will spend no more than $5 million in
fiscal year 2011 and did not request funding for fiscal year 2012 for
its catfish inspection program.[Footnote 10]
Three major trends also create food safety challenges. First, a
substantial and increasing portion of the U.S. food supply is
imported. Second, consumers are eating more raw and minimally
processed foods. Third, segments of the population that are
particularly susceptible to food-borne illnesses, such as older adults
and immune-compromised individuals, are growing.
The FSWG Has Taken Steps Designed to Improve Collaboration among
Federal Agencies but Has Not Developed a Comprehensive Governmentwide
Performance Plan for Food Safety:
Creation of the FSWG by the President in March 2009 elevated food
safety as a national priority, demonstrated strong commitment and top
leadership support, and was designed to foster interagency
collaboration on this crosscutting issue. However, the FSWG has not
developed a governmentwide performance plan that provides a
comprehensive picture of the federal government's food safety efforts.
The FSWG is co-chaired by the Secretaries of Health and Human Services
and Agriculture. It also includes officials from FDA, FSIS, the
Centers for Disease Control and Prevention (CDC), the Environmental
Protection Agency, the Department of Homeland Security, the Department
of Commerce, the Department of State, and several offices in the
Executive Office of the President, including OMB. Both FDA and FSIS
have created executive positions to focus agency efforts on food
safety, and officials from both agencies told us that the FSWG has
increased interagency collaboration. However, while creating the FSWG
is a positive first step, we have reported that the continuity of food
safety coordination efforts can be hampered by changes in executive
branch leadership.[Footnote 11] As a presidentially appointed working
group, the FSWG's future is uncertain, and the experience of the
former President's Council on Food Safety, which disbanded less than 3
years after it was created, illustrates that this type of approach can
be short lived.
Nevertheless, through the FSWG, federal agencies have taken steps
designed to increase collaboration in some areas that cross regulatory
jurisdictions--in particular, improving produce safety, reducing
Salmonella contamination, and developing food safety performance
measures.
* Produce safety. Preventing contamination of fresh produce is an FSWG
priority. In 2009, FDA issued draft guidance for industry on produce
safety to minimize food safety hazards and contamination of leafy
greens, tomatoes, and melons. FDA has also publicly announced that it
is developing a proposed regulation setting enforceable standards for
fresh produce safety at farms and packing houses, and FDA and AMS
officials told us the agencies are collaborating on the rulemaking
process, as AMS establishes quality and condition standards the food
industry can voluntarily adopt for marketing purposes through
marketing agreements. Specifically, an AMS employee who USDA describes
as having extensive experience working with the produce industry for
over 20 years has been temporarily assigned to work as a Senior Policy
Analyst in FDA's Office of Foods from October 2009 to March 2011 to
help develop the regulation. The AMS employee told us she is providing
FDA with information about practices on farms and in packing houses
that FDA officials are using to inform their rulemaking. She is also
helping FDA leverage existing AMS-industry relationships to conduct
outreach to farms and packing houses before the produce safety
regulation goes into effect. In addition, AMS has publicly announced
that it is developing a proposed national marketing agreement for
leafy greens that will include food safety standards. The purpose of
the proposed marketing agreement is to enhance the quality of fresh
leafy green vegetable products through the application of good
agricultural and handling practices, and to improve consumer
confidence, among other things. Based on our review of Federal
Register documents and interviews with AMS and FDA officials, we found
that AMS is coordinating with FDA to ensure that the standards in the
proposed marketing agreement are consistent with the standards FDA is
setting in the produce safety regulation.
* Salmonella contamination. According to FSIS, FDA, and OMB officials,
FSIS and FDA worked together to establish complementary performance
goals under the High Priority Performance Goal initiative--a White
House management initiative--for reducing illness caused by
Salmonella. FSIS officials told us that staff from FSIS and FDA
communicated on a regular basis to coordinate efforts to develop their
respective agencies' goals, as they are closely intertwined.
Salmonella contamination can occur in poultry and egg products, which
are under FSIS's regulatory jurisdiction, and shell eggs, which are
primarily under FDA's jurisdiction. Both agencies set goals to reduce
illness from Salmonella within their own areas of egg safety
jurisdiction by the end of 2011. According to the FSIS officials, FSIS
and FDA coordinated on ensuring that the goals complemented one
another, utilized the same datasets, and covered the same time period
so that the agencies measure their progress consistently. FSIS's goal
is to reduce the rate of illness due to Salmonella in FSIS-regulated
products to 5.3 cases per 100,000 people by 2011, a reduction of
approximately 22,600 illnesses below the current baseline with an
associated cost reduction of $404 million. FDA's goal is a 10 percent
decrease by 2011 over the 2007-2009 average baseline rate of
Salmonella Enteritidis illness in the population.[Footnote 12] The
agencies have taken additional actions to address Salmonella.
Specifically, in May 2010, FSIS announced new performance standards
that poultry establishments must meet for Salmonella and released a
compliance guide for industry. In July 2009, FDA issued a final rule
requiring shell egg producers to implement measures to prevent
Salmonella Enteritidis from contaminating eggs and, in August 2010,
issued draft guidance for producers on implementing the rule.
* Food safety performance measures. FSWG members have proposed 21
performance measures for assessing the federal government's progress
toward meeting its crosscutting food safety goals. For example, to
assess progress in preventing harm to consumers from unsafe food, one
of the performance measures the FSWG is proposing is to track the
prevalence of selected foodborne hazards in key commodity groups. As a
next step, FSIS and FDA are beginning to set quantitative targets for
the measures. For example, one of FSIS's proposed quantitative targets
is to reduce the prevalence of Salmonella Enteritidis in FSIS
prepasteurized egg products from 14.12 percent (the fiscal year 2009
baseline) to 12.71 percent by fiscal year 2015. FDA is developing its
own quantitative targets. FSWG and agency documents show that both
agencies, with support from CDC, are coordinating to pilot-test a
framework for developing the quantitative targets for Salmonella
Enteritidis that covers multiple agencies' oversight jurisdictions.
FSIS officials told us this framework could identify data gaps and
help target areas where more attention is needed. An FDA official told
us that the agencies plan to use this framework to assess progress
toward other food safety goals, but could not estimate when the
agencies will finish developing a complete set of quantitative targets
for the food safety performance measures.
In addition, we found that federal food safety agencies are taking
actions in two other areas. First, FDA is leading an effort involving
other federal agencies including CDC, USDA, and the Department of
Homeland Security, to increase the inspection, laboratory, and
outbreak-response capacities of state and local food safety agencies.
FDA issued a draft paper describing its vision and established working
groups of federal, state, and local government representatives to
address issues such as national standards for food regulatory programs
and standardized laboratory practices and procedures, among others. It
has also hosted two national meetings that were attended by public
health and food safety officials from federal, state, local, and
territorial government agencies. Second, in February 2011, federal
food safety agencies established a Multi-Agency Coordination group
intended to improve the response to outbreaks of foodborne illness, an
FSWG priority. According to agency documents, the group will be used
to coordinate the response of federal agencies, and state, local, and
tribal governments, in managing large-scale foodborne illness
outbreaks, prioritizing the allocation of critical resources, and
making policy decisions. It is co-chaired by USDA and the Department
of Health and Human Services and participating federal agencies
include FDA, CDC, FSIS, AMS, the Food and Nutrition Service, the
Animal and Plant Health Inspection Service, the Foreign Agricultural
Service, the Environmental Protection Agency, and the Departments of
Homeland Security, State, and Justice.
However, while the FSWG has taken steps to increase interagency
collaboration on food safety, it has not developed a governmentwide
performance plan that provides a comprehensive picture of the federal
government's food safety efforts. When we added food safety oversight
to our high-risk list in 2007, we said that what remains to be done is
to develop a governmentwide performance plan for food safety that is
mission based, results oriented, and provides a cross-agency
perspective.[Footnote 13] We also said this plan could be used to help
decision makers balance trade-offs and compare performance when
resource allocation and restructuring decisions are made. Officials
from OMB, FDA, and USDA told us the FSWG's July 2009 "key findings"
represent the governmentwide plan for food safety.[Footnote 14] The
key findings identify the FSWG's three core principles for improving
the safety of the U.S. food supply--prioritizing prevention,
strengthening surveillance and enforcement, and improving response and
recovery--and outline a number of goals and actions the agencies are
taking, or plan to take, to improve food safety. The key findings are
mission based and offer a cross-agency perspective. For example, both
FSIS and FDA are contributing to goals for reducing illness from
Salmonella and E. coli, and multiple federal agencies are contributing
to goals for improving the response to outbreaks of foodborne illness.
Some of the goals are results oriented, such as FSIS's goal to have 90
percent of poultry establishments meeting its new standards to reduce
Salmonella in turkeys and poultry by the end of 2010, and FDA's goal
to reduce foodborne illness from shell eggs by approximately 60
percent by issuing a final rule to control Salmonella during egg
production. However, most of the goals are not results oriented and do
not include performance measures, focusing instead on specific actions
the agencies plan to take in the near term. For example, to reduce
illness from E. coli, FSIS's goal is to issue improved instructions to
its workforce and increase its sampling. It is not clear the extent to
which these one-time actions will help reduce illness from E. coli.
Further, it is not clear how the key findings align with the 21
performance measures for food safety proposed by the FSWG. Our prior
work has identified results oriented goals and performance measures as
standard elements of performance plans.[Footnote 15] Because the
FSWG's key findings generally lack results oriented goals and
performance measures, they do not provide a concrete statement of the
federal government's expected performance for food safety that can be
used for subsequent comparison with its actual performance.
Identifying performance gaps can help decision makers target scarce
resources. In addition, the key findings do not include information
about the resources that are needed to achieve the FSWG's goals. A
discussion of the strategies and resources needed to achieve annual
goals is also a standard element of performance plans. The key
findings also do not address the entire food supply; for example none
of the goals specifically addresses food imports, which represent 60
percent of fresh fruits and vegetables and 80 percent of seafood.
Although performance plans are to be updated on an annual basis, OMB
officials told us there are currently no plans to update the key
findings, which were issued in 2009. Those officials also told us
that, instead, the intent was to integrate the FSWG's planning into
the agencies' budgeting processes, which include developing
performance goals. While individual agency documents provide important
and useful information, they do not provide a broader and more
integrated picture of food safety oversight throughout the federal
government. Without a governmentwide performance plan for food safety,
decision makers do not have a comprehensive picture of the federal
government's performance on this crosscutting issue. Further,
performance plans provide an opportunity for agencies to identify
factors that influence the accomplishment of their goals and discuss
the strategies they plan to take to leverage or mitigate the influence
such factors can have on achieving results. For example, a
governmentwide plan for food safety could recognize that the federal
agencies' food safety oversight authorities differ and recognize and
address other external factors, such as the actions of state and local
governments, which influence the accomplishment of federal food safety
goals.
Recent legislation reinforces the need for and importance of
governmentwide planning. The GPRA Modernization Act of 2010, which
updates the requirements for strategic plans and performance plans,
also recognizes the importance of governmentwide planning on
crosscutting issues.[Footnote 16] In addition, the recently enacted
FDA Food Safety Modernization Act calls for coordination among federal
agencies. Specifically, the Act directs the Secretary of Health and
Human Services to improve coordination and cooperation with the
Secretaries of Agriculture and Homeland Security to target food
inspection resources and to submit annual reports to Congress
describing those efforts and providing other information about FDA's
inspections. The Act also requires the Secretaries of Health and Human
Services and Agriculture, in consultation with the Secretary of
Homeland Security, to prepare a National Agriculture and Food Defense
Strategy. It also requires the Secretary of Health and Human Services,
in coordination with the Secretaries of Agriculture and Homeland
Security, to submit a comprehensive report to Congress that identifies
programs and practices that are intended to promote the safety and
security of the food supply and prevent foodborne outbreaks. The
information provided in those reports could help inform a
governmentwide performance plan for food safety. Moreover, we have
reported that establishing mutually reinforcing or joint strategies is
a key practice that can help enhance and sustain interagency
collaboration among federal agencies.[Footnote 17] Such strategies
help in aligning the collaborating agencies' activities, core
processes, and resources to accomplish a common outcome. In this
current fiscal environment, we and others have called for agencies to
leverage scarce resources for food safety and other issues.
Our past work on other interagency planning may provide models for
governmentwide planning on food safety. While FDA and USDA have
collaborated on setting food safety goals for Healthy People--a
multiagency initiative to improve public health--they are long-term
goals, set every 10 years, and are not linked to resources. We have
reported on interagency planning for sharing health resources for
military service members and veterans and managing wildland fires.
* Health resource sharing. The Department of Veterans Affairs (VA) and
Department of Defense (DOD) collaborate to use federal health
resources, such as space in medical facilities, under the Veterans
Administration and Department of Defense Health Resources Sharing and
Emergency Operations Act. In addition, the VA/DOD Joint Executive
Council develops a joint strategic plan to shape, focus, and
prioritize the coordination and sharing efforts, as directed by
Congress and recommended by a presidential task force. The council has
developed a new joint strategic plan each year since 2003, which is
included in the council's annual report to the VA and DOD Secretaries
on the status of implementing its collaboration and sharing
activities. We reported that, according to DOD, the joint strategic
plan outlines actionable objectives, assigns accountability, and
establishes performance targets.[Footnote 18]
* Wildland fire management. Five federal agencies that share
responsibility for wildland fire management--the Forest Service at
USDA and the Bureau of Indian Affairs, Bureau of Land Management, Fish
and Wildlife Service, and National Park Service at the Department of
Interior--have long coordinated their fire suppression efforts. The
intergovernmental Wildland Fire Leadership Council, which was
recommended by GAO and established by the Secretaries of Agriculture
and the Interior in 2002, seeks to support implementation of federal
fire management policy by coordinating agency policies and providing
strategic direction.[Footnote 19] In reports dating back to 1999, we
have recommended that the agencies develop a cohesive strategy that
identifies options and funding for preventing and responding to fires.
[Footnote 20] At the direction of Congress, the council began
developing a cohesive wildland fire management strategy in 2010 that
is required to address fire suppression, prevention, and resource
allocation issues.
We and Others Have Identified Options to Reduce Fragmentation and
Overlap in Food Safety Oversight, but They Have Not Been Analyzed in
Detail:
We, the National Academy of Sciences, the Produce Safety Project, and
the former President's Council on Food Safety have identified options
to reduce fragmentation and overlap in food safety oversight in the
form of alternative organizational structures (see app. III), but a
detailed analysis of their advantages and disadvantages and the
potential challenges that could arise if they are implemented has yet
to be conducted.[Footnote 21] In 2001, we first suggested that
Congress consider commissioning the National Academy of Sciences or a
blue ribbon panel to conduct a detailed analysis of alternative
organizational structures for food safety[Footnote 22] and reiterated
the suggestion over the years, most recently in the 2011 high-risk
list update.[Footnote 23]
Some of the alternative organizational structures that we and others
have identified include:
* Single food safety agency. All aspects of food safety at the federal
level could be consolidated into a single food safety agency, either
housed within an existing agency or established as an independent
entity. This consolidation would bring oversight of all foods under a
single administrator and consolidate tasks that are currently
dispersed throughout multiple federal agencies, such as inspections,
risk assessment, standard setting, research, and surveillance.
* Food safety inspection agency. Food safety inspection activities,
but not other activities such as surveillance, could be consolidated
under USDA or FDA. As we reported in the past, any new inspection
system should employ a unified risk-based approach, which would
require Congress to modify the current legislative structure.[Footnote
24]
* Data collection and risk analysis center. Data collection and risk
analysis could be consolidated into a single center that would
disseminate the results of its analyses to the food safety agencies.
For example, this center could consolidate food safety surveillance
data collected from a variety of sources and analyze it at the
national level to support risk-based decision making. While the center
would be independent from the regulatory agencies to give its analyses
scientific credibility, it would also consult with the agencies to
understand their needs, but would not preempt any agency's authority
to develop its own food safety management approach.
* Coordination mechanism. Centralized, executive leadership could be
provided for the existing organizational structure using a
coordination mechanism with representatives from the agencies, similar
to the FSWG. However, unlike the FSWG, the coordination mechanism
would be led by a central chair who would be appointed by the
President and have control over resources.
While a detailed analysis of the alternatives has not been conducted,
organizations have offered some preliminary observations on some of
their benefits. For example, in its strategic plan, the former
President's Council on Food Safety stated that consolidation could
eliminate duplication and fragmentation, create a centralized
leadership, clarify lines of authority, and facilitate priority
setting and resource allocation based on risk. Similarly, in its 2010
report Enhancing Food Safety: The Role of the Food and Drug
Administration, the National Academy of Sciences concluded that the
core federal food safety responsibilities should reside within a
single entity having a unified administrative structure, clear
mandate, dedicated budget, and full responsibility for oversight of
the entire food supply. In its report, the National Academy of
Sciences also stated that centralizing data collection and risk
analysis would eliminate the need for each agency to develop its own
comprehensive expertise in risk and decision analysis; promote
communication, collaboration, and data sharing among federal agencies;
and could be a first step toward accomplishing the more challenging
goal of consolidating all federal food safety activities into a single
agency.
We recognize that reorganizing federal food safety responsibilities
would be a complex process. Further, our work on other agency mergers
and transformations indicates that reorganizing food safety could have
short-term disruptions and transition costs.[Footnote 25] We reported
that a merger or transformation is a substantial commitment that could
take years before it is completed, and therefore must be carefully and
closely managed. In particular, the experience of major private sector
mergers and acquisitions has been that productivity and effectiveness
actually decline initially, in part because attention is concentrated
on critical and immediate integration issues and diverted from longer-
term mission issues. Our work on seven other countries' experiences
between 1997 and 2004 in consolidating their food safety systems found
that while the extent to which those countries consolidated their food
systems varied considerably, they faced similar challenges in deciding
whether to place the new agency within the existing health or
agriculture agency or establish it as a stand-alone agency and in
determining what responsibilities the new agency would have.[Footnote
26] We also reported that the countries experienced benefits, such as
improved public confidence in their food safety systems.[Footnote 27]
In addition, each country modified its existing legal framework to
give legal authority and responsibility to the new food safety agency.
Some European Union (EU) countries were further prompted to
consolidate in order to comply with new EU food safety legislation
that became effective, in large part, in January 2006. The EU adopted
comprehensive food safety legislation in 2004 intended to create a
single, transparent set of food safety rules applicable to both animal
and nonanimal products.
We and other organizations have regularly paired proposals for
alternative food safety organizations with calls for comprehensive,
unified, risk-based food safety legislation. Existing statutes give
agencies different regulatory and enforcement authorities, and we have
reported that legislation governing the agencies' authorities,
jurisdictions, and inspection frequencies is not the product of
strategic design as to how to protect public health.[Footnote 28] In
May 2004, we reported that a critical step in designing and
implementing a risk-based food safety system is identifying the most
important food safety problems across the entire food system from a
public health perspective and concluded that comprehensive, uniform,
and risk-based food safety legislation is needed to provide the
foundation for this approach.[Footnote 29] The National Academy of
Sciences also concluded that to create a science-based food safety
system current laws must be revised, and recommended that Congress
change federal statutes so that inspection, enforcement, and research
efforts can be based on risks to public health. While the new food
safety law strengthens a major part of the food safety system and
expands FDA's oversight authority, it does not apply to the federal
food safety system as a whole or create a new risk-based food safety
structure. In February 2011, we reiterated our suggestion for
comprehensive, unified, risk-based food safety legislation.[Footnote
30]
Conclusions:
We are encouraged by the executive branch's attention to food safety
through the FSWG and its initial efforts designed to improve
interagency collaboration on this very important crosscutting issue.
However, food safety remains fragmented and much work remains to be
done on several of the FSWG initiatives. Further, the collaboration
that has begun under the FSWG may be short lived, putting some of the
longer-term efforts, such as developing results-oriented food safety
goals and measures, at risk of not being completed. Because food
safety oversight faces ongoing challenges, it is important that this
issue be given sustained attention; as we have previously reported,
the continuity of food safety coordination efforts can be hampered
when executive branch leadership changes. Thus, it is critical that
the primary food safety agencies engage in comprehensive,
governmentwide planning to increase interagency collaboration under
the current system. Such a plan, paired with comprehensive risk-based
food safety legislation and a detailed analysis of alternative
organizational structures for food safety oversight, could be an
important tool for addressing fragmentation in federal food safety
oversight. However, without an annually updated governmentwide
performance plan for food safety that contains results-oriented goals
and performance measures and a discussion of strategies and resources
used by the agencies with food safety responsibilities, decision
makers do not have a comprehensive picture of the federal government's
performance on this crosscutting issue. Further, without such
information, decision makers may be hampered in their efforts to make
key resource allocation and restructuring decisions.
Recommendation for Executive Action:
In order to improve collaboration among federal agencies on food
safety oversight and provide an integrated perspective on this
crosscutting issue we are making the following recommendation.
The Director of the Office of Management and Budget, in consultation
with the federal agencies that have food safety responsibilities,
should develop a governmentwide performance plan for food safety. The
performance plan should include results-oriented goals and performance
measures for food safety oversight throughout the federal government,
as well as a discussion about strategies and resources. It should be
updated on an annual basis.
Agency Comments:
We provided USDA, the Department of Health and Human Services, and OMB
with drafts of this report for review. OMB declined to comment on the
draft report. USDA and Health and Human Services provided technical
comments, which we incorporated as appropriate.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Agriculture, Director of the Office of
Management and Budget, Commissioner of the Food and Drug
Administration, and other interested parties. The report also is
available at no charge on the GAO website at [hyperlink,
http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. GAO staff who made key contributions
to this report are listed in appendix IV.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
List of Committees:
The Honorable Deborah Stabenow:
Chair:
The Honorable Patrick Roberts:
Ranking Member:
Committee on Agriculture, Nutrition and Forestry:
United States Senate:
The Honorable Thomas Harkin:
Chairman:
The Honorable Michael Enzi:
Ranking Member:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Joseph Lieberman:
Chairman:
The Honorable Susan Collins:
Ranking Member:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Herb Kohl:
Chairman:
The Honorable Roy Blunt:
Ranking Member:
Subcommittee on Agriculture, Rural Development, Food and Drug
Administration and Related Agencies:
Committee on Appropriations:
United States Senate:
The Honorable Frank Lucas:
Chairman:
The Honorable Collin Peterson:
Ranking Member:
Committee on Agriculture:
House of Representatives:
The Honorable Frederick Upton:
Chairman:
The Honorable Henry Waxman:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Darrell Issa:
Chairman:
The Honorable Elijah Cummings:
Ranking Member:
Committee on Oversight and Government Reform:
House of Representatives:
The Honorable Jack Kingston:
Chairman:
The Honorable Sam Farr:
Ranking Member:
Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies:
Committee on Appropriations:
House of Representatives:
[End of section]
Appendix I: Scope and Methodology:
A new statutory requirement mandates that GAO identify programs,
agencies, offices, and initiatives with duplicative goals and
activities within departments and governmentwide.[Footnote 31] Under
that mandate this review examines: (1) steps, if any, that the Food
Safety Working Group (FSWG) has taken to increase collaboration among
federal food safety agencies, and (2) options we and others have
identified to reduce fragmentation, overlap, and potential duplication
in food safety oversight.
To complete our work we reviewed food safety reports and legislation,
and interviewed officials from the Department of Agriculture (USDA),
the Food and Drug Administration (FDA), and the Office of Management
and Budget (OMB). To address the first question we also collected and
analyzed information about the FSWG, its activities, and its plan for
food safety. We also collected documentation about the FSWG's
activities from the agencies, the Federal Register, and budget
documents. We assessed the FSWG's "key findings," which FSWG officials
told us represent the governmentwide plan for food safety, against
GAO's criteria for performance plans.[Footnote 32] To identify options
for reducing fragmentation, overlap, and potential duplication, we
identified alternative organizational structures for food safety by
reviewing reports by GAO, the National Academy of Sciences, the
Produce Safety Project, and the former President's Council on Food
Safety. We also reviewed reports by GAO about federal agency and
private sector mergers and organizational transformations. We did not
independently verify the foreign laws discussed in this report.
We conducted this performance audit from July 2010 to March 2011 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Federal Agencies with Food Safety Responsibilities:
[Refer to PDF for figure: illustrated table]
Agency: USDA: Food Safety and Inspection Service;
Programs: Meat, Poultry, Egg Products, and Catfish Inspection;
Voluntary Fee for Service Inspections;
Program type: Regulation; Inspection;
Responsibilities and main authorizing statutes:
* Responsible for: Ensuring that the nation‘s domestic and imported
commercial supply of meat, poultry, egg products, and catfish[A] is
safe, wholesome, and correctly labeled and packaged, and for enforcing
the Humane Methods of Slaughter Act of 1978, as amended. Responsible
for providing voluntary fee-for-service inspections for exotic and
other edible animals;
* Main authorizing statutes: Poultry Products Inspection Act, Pub. L.
No. 85-172, 71 Stat. 441 (1957) (codified as amended at 21 U.S.C. ss.
451-472); Federal Meat Inspection Act, ch. 2907, 34 Stat. 1256, 1260
(1907) (codified as amended at 21 U.S.C. ss. 601-695); Egg Products
Inspection Act, Pub. L. No. 91-597, 84 Stat. 1620 (1970) (codified as
amended at 21 U.S.C. ss. 1031-1056). See also, Humane Methods of
Slaughter Act of 1978, Pub. L. No. 95-445, 92 Stat. 1069 (codified as
amended at 7 U.S.C. ss. 1902, 1904, 21 U.S.C. ss. 603, 610, 620);
Federal Anti-Tampering Act, Pub. L. No. 98-127, s. 2. 97 Stat. 831,
831 (1983) (codified as amended at 18 U.S.C. s. 1365); Agricultural
Marketing Act of 1946, ch. 966, tit. II, s. 203, 60 Stat. 1087, 1087
(codified as amended at 7 U.S.C. s. 1622). See also National School
Lunch Act, ch. 281, 60 Stat. 230 (1946) (codified as amended at 42
U.S.C. ss. 1751-1770), as amended by Child Nutrition and WIC
Reauthorization Act of 2004, Pub. L. No. 108-265, s. 118, 118 Stat.
729, 752 (codified as amended at 42 U.S.C. s. 1762a(h)).
Agency: USDA: Animal and Plant Health Inspection Service;
Programs: Plant Protection and Quarantine; Veterinary Services;
Program type: Regulation; Inspection;
Responsibilities and main authorizing statutes:
* Responsible for: Preventing the introduction or dissemination of
plant pests. Responsible for preventing the introduction or
dissemination of livestock pests or diseases;
* Main authorizing statutes: Agricultural Bioterrorism Act of 2002,
Pub. L. No. 107-188, tit. II, subtit. B, 116 Stat. 647 (codified as
amended at 7 U.S.C. s. 8401); Animal Health Protection Act, Pub. L.
No. 107-171, tit. X, 116 Stat. 494 (2002) (codified as amended at 7
U.S.C. ss. 8301-8322); Plant Protection Act, Pub. L. No. 106-224, tit.
IV, 114 Stat. 438 (2000) (codified as amended at 7 U.S.C. ss. 7701-
7721).
Agency: USDA: Grain Inspection, Packers and Stockyards Administration;
Programs: Federal Grain Inspection Service;
Program type: Regulation; Inspection; Enforcement;
Responsibilities and main authorizing statutes:
* Responsible for: Establishing quality standards, inspection
procedures, and marketing of grain and other related products;
* Main authorizing statutes: United States Grain Standards Act, ch.
313, 39 Stat. 482 (1916) (codified as amended at 7 U.S.C. ss. 71-87k).
Agency: USDA: Agricultural Marketing Service;
Programs: Commodity Programs; Science and Technology Programs; School
Lunch Commodity Purchases; Other;
Program type: Regulation; Inspection; Enforcement;
Responsibilities and main authorizing statutes:
* Responsible for: Establishing quality and condition standards for,
among other things, dairy, fruit and vegetables, livestock;
* Main authorizing statutes: Agricultural Marketing Act of 1946, ch.
966, tit. II, 60 Stat. 1087 (codified as amended at 7 U.S.C. ss. 1621-
1638d). See also e.g., Perishable Agricultural Commodities Act, 1930,
ch. 436, 46 Stat. 531 (codified as amended at 7 U.S.C. s. 499a-499s);
Federal Seed Act, Ch. 615, 53 Stat. 1275 (1939) (codified as amended
at 7 U.S.C. ss. 1551-1611).
Agency: USDA: Agricultural Research Service;
Programs: Nutrition, Food Safety, and Quality;
Program type: Research; Grant & Cooperative Agreements Administration;
Responsibilities and main authorizing statutes:
* Responsible for: Providing the scientific research to help ensure
that the food supply is safe and secure and that foods meet foreign
and domestic regulatory requirements;
* Main authorizing statutes: 7 U.S.C. ss. 1622, 2204, 3101, 3121,
3318, 3319a; also e.g., 7 U.S.C. ss. 136i-2, 391, 7654.
Agency: USDA: Economic Research Service;
Programs: Food Safety Research;
Program type: Research; Grant & Cooperative Agreements Administration;
Responsibilities and main authorizing statutes:
* Responsible for: Providing analyses of the economic issues affecting
the safety of the U.S. food supply;
* Main authorizing statutes: 7 U.S.C. ss. 1622, 2204, 3101, 3121,
3318, 3319a; also e.g., 7 U.S.C. ss. 136i-2, 391, 7654.
Agency: USDA: National Agricultural Statistics Service;
Programs: Statistical Program on Food Safety;
Program type: Research; Grant & Cooperative Agreements Administration;
Responsibilities and main authorizing statutes:
* Responsible for: Providing statistical data, including agricultural
chemical usage data, related to the safety of the food supply;
* Main authorizing statutes: 7 U.S.C. ss. 1622, 2204, 3101, 3121,
3318, 3319a; also e.g., 7 U.S.C. ss. 136i-2, 391, 7654.7.
Agency: USDA: National Institute of Food and Agriculture;
Programs: National Integrated Food Safety Research Initiative;
Program type: Regulation; Grant & Cooperative Agreements
Administration;
Responsibilities and main authorizing statutes:
* Responsible for: Supporting food safety projects in the land-grant
university system and other partner organizations that demonstrate an
integrated approach to solving problems in applied food safety
research, education, or extension;
* Main authorizing statutes: 7 U.S.C. ss. 361a-361i, 3121, 3151, 3155,
3318, 3319a, 6971(f); also e.g., 7 U.S.C. ss. 450i, 3902.8.
Agency: HHS: Food and Drug Administration;
Programs: Foods Program; Animal Drugs and Feeds Program; Regional
Operations and Enforcement;
Program type: Regulation; Inspection; Enforcement; Research; Grant &
Cooperative Agreements Administration; Other;
Responsibilities and main authorizing statutes:
* Responsible for: Ensuring that all domestic and imported foods,
excluding meat and poultry products, are safe, wholesome, sanitary,
and properly labeled;
* Main authorizing statutes: Federal Food, Drug, and Cosmetic Act, ch.
675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. ss. 301-
399a), as amended by, among others, Food Additives Amendment of 1958,
Pub. L. No. 85-929, 72 Stat. 1784; Safe Drinking Water Act of 1974,
Pub. L. No. 93-523, 88 Stat. 1660; Infant Formula Act of 1980, Pub. L.
No. 96-359, 94 Stat. 1190; Nutrition Labeling and Education Act of
1990, Pub. L. No. 101-535, 104 Stat. 2353; Dietary Supplement Health
and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325; Food
and Drug Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat.
2296; Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Pub. L. No. 107-188, tit. III, 116 Stat. 594;
Sanitary Food Transportation Act of 2005, Pub. L. No. 109-59, tit.
VII, s. 7202, 119 Stat. 1891, 1911; FDA Food Safety Modernization Act.
Pub. L. No. 111-353, 124 Stat. 3885 (2011). See also, Act of February
15, 1927 (Federal Import Milk Act), ch. 155, 44 Stat. 1101 (codified
as Amended at 21 U.S.C. 141-149); Fair Packaging and Labeling Act,
Pub. L. No. 89-755, 80 Stat. 1296 (1966) (codified as amended at 15
U.S.C. ss. 1451-1461); Federal Anti-Tampering Act, Pub. L. No. 98-127,
s. 2. 97 Stat. 831, 831 (1983) (codified as amended at 18 U.S.C. s.
1365); Pesticide Monitoring Improvements Act of 1988, Pub. L. No. 100-
418, s. 4702, 102 Stat. 1411, 1412 (codified as amended at 21 U.S.C.
s. 1401).
Agency: HHS: Centers for Disease Control and Prevention;
Programs: Food Safety Initiative;
Program type: Regulation; Inspection; Research;
Responsibilities and main authorizing statutes:
* Responsible for: Preventing the transmission, dissemination, and
spread of foodborne illness to protect the public health;
* Main authorizing statutes: Public Health Service Act, ch. 373, 58
Stat. 682 (1944) (codified as amended at 42 U.S.C. ss. 201-300bbb).
Agency: Commerce: National Marine Fisheries Service;
Programs: Seafood Inspection Program;
Program type: Other;
Responsibilities and main authorizing statutes:
* Responsible for: Providing voluntary, fee-for-service examinations
of seafood for safety and quality;
* Main authorizing statutes: Agricultural Marketing Act of 1946, ch.
966, tit. II, s. 203, 205, 60 Stat. 1087, 1087 (codified as amended at
7 U.S.C. ss. 1622, 1624). See also Act of May 25, 1900 (Lacey Act),
ch. 553, 31 Stat. 187 (codified as amended in part at 16 U.S.C. s.
3371).
Agency: EPA;
Programs: Pollution Prevention and Toxins; Pesticides Program; Safe
Drinking Water;
Program type: Regulation;
Responsibilities and main authorizing statutes:
* Responsible for: Regulating the use of certain chemicals and
substances that present an unreasonable risk of injury to health or
the environment. Responsible for issuing regulations to establish,
modify, or revoke tolerances for pesticide chemical residues.
Responsible for setting national drinking water standard of quality
and consulting with FDA before FDA promulgates regulations for
standard of quality for bottled water;
* Main authorizing statutes: Toxic Substance Control Act, Pub. L. No.
94-469, 90 Stat. 2003 (1976) (codified as amended at 15 U.S.C. ss.
2601-2697) Federal Insecticide, Fungicide, and Rodenticide Act, ch.
125, 61 Stat. 163 (1947) (codified as amended at 7 U.S.C. ss. 136-
136y), as amended by the Food Quality Protection Act of 1996, Pub. L.
No. 104-170, 110 Stat. 1489; 21 U.S.C. s. 346a, Safe Drinking Water
Act of 1974, Pub. L. No. 93-523, 88 Stat. 1660 (codified as amended at
21 U.S.C. s. 349 and 42 U.S.C. ss. 300f through 300j-26).
Agency: Treasury: Alcohol, Tobacco, Firearms, and Explosives;
Programs: Alcohol;
Program type: Regulation; Enforcement; Other;
Responsibilities and main authorizing statutes:
* Responsible for: Regulating, enforcing, and issuing permits for the
production, labeling, and distribution of alcoholic beverages;
* Main authorizing statutes: Federal Alcohol Administration Act, ch.
814, 49 Stat. 977 (1935) (codified as amended at 27 U.S.C. ss. 201-
219a).
Agency: Department of Homeland Security: Customs and Border Protection;
Programs: [Empty];
Program type: Inspection; Enforcement;
Responsibilities and main authorizing statutes:
* Responsible for: Inspecting imports, including food products,
plants, and live animals, for compliance with U.S. law and assisting
all federal agencies in enforcing their regulations at the border;
* Main authorizing statutes: Tariff Act of 1930, 19 U.S.C. ss. 1202-
1654. See also Homeland Security Act of 2002, Pub. L. No. 107-296, s.
421, 116 Stat. 2135, 2182.
Agency: Federal Trade Commission;
Programs: [Empty];
Program type: Enforcement;
Responsibilities and main authorizing statutes:
* Responsible for: Enforcing prohibitions against false advertising
for, among other things, food products;
* Main authorizing statutes: Federal Trade Commission Act, ch. 311, 38
Stat. 717 (1914) (codified as amended at 15 U.S.C. ss. 41-58).
Source: GAO analysis.
[A] The 2008 Farm Bill amended the Federal Meat Inspection Act to give
USDA responsibility for the inspection of catfish. The amendments
specified that they would not apply until USDA issues final
regulations implementing them, a process that was not yet complete as
of February 2011.
[End of figure]
[End of section]
Appendix III: Reports Identifying Options for Alternative
Organizational Structures for Food Safety Oversight:
GAO, Food Safety and Security: Fundamental Changes Needed to Ensure
Safe Food. [hyperlink, http://www.gao.gov/products/GAO-02-47T].
Washington, D.C.: October 10, 2001.
Institute of Medicine and National Research Council, Enhancing Food
Safety: The Role of the Food and Drug Administration. The National
Academies Press. Washington, D.C.: 2010.
Institute of Medicine and National Research Council, Ensuring Safe
Food: From Production To Consumption. The National Academies Press.
Washington, D.C.: 1998.
President's Council on Food Safety, Food Safety Strategic Plan.
Washington, D.C.: January 19, 2001.
Batz, Michael and J. Glenn Morris, Jr., Building the Science
Foundation of a Modern Food Safety System: Lessons From Denmark, The
Netherlands, and The United Kingdom on Creating a More Coordinated and
Integrated Approach to Food Safety Information. A report for the
Produce Safety Project. Washington, D.C.: May 10, 2010.
[End of section]
Appendix IV GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841 or shamesl@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, José Alfredo Gómez (Assistant
Director), Annamarie Lopata (Analyst-in-Charge), Kevin Bray, Diana
Goody, Tesfaye Negash, Alison O'Neill, and Katherine Raheb made key
contributions to this report.
[End of section]
Related GAO Products:
Opportunities to Reduce Potential Duplication in Government Programs,
Save Tax Dollars, and Enhance Revenue. [hyperlink,
http://www.gao.gov/products/GAO-11-318SP]. Washington, D.C.: March 1,
2011.
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-11-278]. Washington, D.C.: February
2011.
Live Animal Imports: Agencies Need Better Collaboration to Reduce the
Risk of Animal-Related Diseases. [hyperlink,
http://www.gao.gov/products/GAO-11-9]. Washington, D.C.: November 8,
2010.
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.: September
15, 2009.
Seafood Fraud: FDA Program Changes and Better Collaboration among Key
Federal Agencies Could Improve Detection and Prevention. [hyperlink,
http://www.gao.gov/products/GAO-09-258]. Washington, D.C.: February
19, 2009.
Food Safety: Selected Countries' Systems Can Offer Insights into
Ensuring Import Safety and Responding to Foodborne Illness.
[hyperlink, http://www.gao.gov/products/GAO-08-794]. Washington, D.C.:
June 10, 2008.
Oversight Of Food Safety Activities: Federal Agencies Should Pursue
Opportunities to Reduce Overlap and Better Leverage Resources.
[hyperlink, http://www.gao.gov/products/GAO-05-213]. Washington, D.C.:
March 30, 2005.
Food Safety and Security: Fundamental Changes Needed to Ensure Safe
Food. [hyperlink, http://www.gao.gov/products/GAO-02-47T]. Washington,
D.C.: October 10, 2001.
Agency Performance Plans: Examples of Practices That Can Improve
Usefulness to Decisionmakers. [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-99-69]. Washington, D.C.:
February 26, 1999.
Agencies' Annual Performance Plans Under The Results Act: An
Assessment Guide to Facilitate Congressional Decisionmaking.
[hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18].
Washington, D.C.: February 1998.
Managing For Results: Using the Results Act to Address Mission
Fragmentation and Program Overlap. [hyperlink,
http://www.gao.gov/products/GAO/AIMD-97-146]. Washington, DC: August
29, 1997.
[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] GAO, 21st Century Challenges: Reexamining the Base of the Federal
Government, [hyperlink, http://www.gao.gov/products/GAO-05-325SP]
(Washington, D.C.: February 2005).
[3] GAO, Oversight of Food Safety Activities: Federal Agencies Should
Pursue Opportunities to Reduce Overlap and Better Leverage Resources,
[hyperlink, http://www.gao.gov/products/GAO-05-213] (Washington, D.C.:
Mar. 30, 2005).
[4] GAO, Food Safety and Security: Fundamental Changes Needed to
Ensure Safe Food, [hyperlink, http://www.gao.gov/products/GAO-02-47T]
(Washington, D.C.: Oct. 10, 2001).
[5] [hyperlink, http://www.gao.gov/products/GAO-07-310].
[6] [hyperlink, http://www.gao.gov/products/GAO-02-47T].
[7] Pub. L. No. 111-353, 124 Stat. 3885 (2011).
[8] Pub. L. No. 111-139 § 21, 124 Stat. 8, 29 (2010).
[9] Budget of the U.S. Government, Fiscal Year 2011 (Washington, D.C.:
February 2010). Fiscal year 2009 budget obligations for FDA's Foods
Program include funds that were appropriated to FDA in fiscal year
2008 but available for obligation through fiscal year 2009, according
to FDA officials. Budget obligations for FDA do not include food
safety activities in the Office of the Commissioner through the Office
of Foods, or the Animal Drugs and Feed program. Fiscal year 2009
budget obligations for FSIS do not include additional fees FSIS
collects from establishments, importers, and exporters to offset costs
for overtime inspection services.
[10] In September 2010, USDA officials told us the agency estimated it
would have to spend approximately $30 million in fiscal years 2011 and
2012 to develop and implement its catfish inspection program. Because
of the need for considerable stakeholder engagement and regulatory
development before the program's adoption and implementation, USDA
officials revised their estimate for fiscal year 2011 and no funding
was proposed for the program in the President's fiscal year 2012
budget.
[11] [hyperlink, http://www.gao.gov/products/GAO-02-47T].
[12] According to CDC, Salmonella Enteritidis is one of the most
common variations of Salmonella bacteria reported worldwide.
[13] [hyperlink, http://www.gao.gov/products/GAO-07-310].
[14] See key findings at [hyperlink,
http://www.foodsafetyworkinggroup.gov/].
[15] GAO, Managing For Results: Using the Results Act to Address
Mission Fragmentation and Program Overlap, [hyperlink,
http://www.gao.gov/products/GAO/AIMD-97-146] (Washington, DC: Aug. 29,
1997); Agency Performance Plans: Examples of Practices That Can
Improve Usefulness to Decisionmakers, [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-99-69] (Washington, D.C.:
Feb. 26, 1999); and Agencies' Annual Performance Plans Under The
Results Act: An Assessment Guide to Facilitate Congressional
Decisionmaking, [hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-
10.1.18] (Washington, D.C.: February 1998).
[16] GPRA Modernization Act of 2010, Pub. L. No. 111-352, 124 Stat.
3866.
[17] GAO, Results-Oriented Government: Practices That Can Help Enhance
and Sustain Collaboration among Federal Agencies, [hyperlink,
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21,
2005).
[18] GAO, VA and DOD Health Care: Progress Made on Implementation of
2003 President's Task Force Recommendations on Collaboration and
Coordination, but More Remains to be Done, [hyperlink,
http://www.gao.gov/products/GAO-08-495R] (Washington, D.C.: Apr. 30,
2008).
[19] GAO, Severe Wildland Fires: Leadership and Accountability Needed
to Reduce Risks to Communities and Resources, [hyperlink,
http://www.gao.gov/products/GAO-02-259] (Washington, D.C.: Jan. 31,
2002).
[20] GAO, Western National Forests: A Cohesive Strategy is Needed to
Address Catastrophic Wildfire Threats, [hyperlink,
http://www.gao.gov/products/GAO/RCED-99-65] (Washington, D.C.: Apr. 2,
1999); Wildland Fire Management: Important Progress Has Been Made, but
Challenges Remain to Completing a Cohesive Strategy, [hyperlink,
http://www.gao.gov/products/GAO-05-147] (Washington, D.C.: Jan. 14,
2005, GAO); and Wildland Fire Management: Federal Agencies Have Taken
Important Steps Forward but Additional Strategic Action Is Needed to
Capitalize on Those Steps, [hyperlink,
http://www.gao.gov/products/GAO-09-877] (Washington, D.C.: Sept. 9,
2009).
[21] The Produce Safety Project is an initiative of the Pew Charitable
Trusts at Georgetown University. The President's Council on Food
Safety was created by the President in 1998 and disbanded in 2001.
[22] [hyperlink, http://www.gao.gov/products/GAO-02-47T].
[23] GAO, High Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February
2011).
[24] GAO, Posthearing Questions Related to Fragmentation and Overlap
in the Federal Food Safety System, [hyperlink,
http://www.gao.gov/products/GAO-04-832R] (Washington, D.C: May 26,
2004).
[25] GAO, Results Oriented Cultures: Implementation Steps to Assist
Mergers and Organizational Transformations, [hyperlink,
http://www.gao.gov/products/GAO-03-669] (Washington, D.C.: July 2,
2003).
[26] GAO, Food Safety: Experiences of Seven Countries in Consolidating
Their Food Safety Systems, [hyperlink,
http://www.gao.gov/products/GAO-05-212] (Washington, D.C.: Feb. 22,
2005).
[27] GAO, Food Safety: Selected Countries' Systems Can Offer Insights
into Ensuring Import Safety and Responding to Foodborne Illness,
[hyperlink, http://www.gao.gov/products/GAO-08-794] (Washington, D.C.:
June, 10, 2008).
[28] GAO, Federal Food Safety and Security System: Fundamental
Restructuring Is Needed to Address Fragmentation and Overlap,
[hyperlink, http://www.gao.gov/products/GAO-04-588T] (Washington,
D.C.: Mar. 30, 2004).
[29] [hyperlink, http://www.gao.gov/products/GAO-04-832R].
[30] [hyperlink, http://www.gao.gov/products/GAO-11-278].
[31] Pub. L. No. 111-139 § 21, 124 Stat. 8, 29 (2010).
[32] GAO, Managing For Results: Using the Results Act to Address
Mission Fragmentation and Program Overlap, [hyperlink,
http://www.gao.gov/products/GAO/AIMD-97-146] (Washington, DC: Aug. 29,
1997); Agency Performance Plans: Examples of Practices That Can
Improve Usefulness to Decisionmakers, [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-99-69] (Washington, D.C.:
Feb. 26, 1999); and Agencies' Annual Performance Plans Under The
Results Act: An Assessment Guide to Facilitate Congressional
Decisionmaking, [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18] (Washington, D.C.:
February 1998).
[End of section]
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