Oversight of Food Safety Activities
Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources Gao ID: GAO-05-213 March 30, 2005GAO has documented many problems resulting from the fragmented nature of the federal food safety system and recommended fundamental restructuring to ensure the effective use of scarce government resources. In this report, GAO (1) identified overlaps in food safety activities at USDA, FDA, EPA, and NMFS; (2) analyzed the extent to which the agencies use interagency agreements to leverage resources; and (3) obtained the views of stakeholders.
Several statutes give responsibility for different segments of the food supply to different agencies to ensure that the food supply is safe. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) have the primary responsibility for regulating food safety, with the Environmental Protection Agency (EPA) and the National Marine Fisheries Service (NMFS) also involved. In carrying out their responsibilities, with respect to both domestic and imported food, these agencies spend resources on a number of overlapping activities, such as inspection/enforcement, training, research, or rulemaking. For example, both USDA and FDA conduct similar inspections at 1,451 dual jurisdiction establishments--facilities that produce foods regulated by both agencies. Under authority granted by the Bioterrorism Act of 2002, FDA could authorize USDA inspectors to inspect these facilities, but it has not done so. Furthermore, USDA and FDA maintain separate training programs on similar topics for their inspectors that could be shared. Ultimately, inspection and training resources could be used more efficiently. GAO identified 71 interagency agreements that the agencies entered into to better protect public health and to coordinate their food safety activities. However, the agencies have weak mechanisms for tracking these agreements that, in some cases, lead to ineffective implementation. Specifically, USDA and FDA are not fully implementing an agreement to facilitate the exchange of information about dual jurisdiction establishments, which both agencies inspect. In addition, FDA and NMFS are not implementing an agreement designed to enable each agency to discharge its seafood responsibilities effectively. GAO spoke with selected industry associations, food companies, consumer groups, and academic experts, and they disagree on the extent of overlap and on how best to improve the food safety system. Most of these stakeholders agreed that laws and regulations should be modernized to more effectively and efficiently control food safety hazards, but they differed about whether to consolidate food safety functions into a single agency.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-05-213, Oversight of Food Safety Activities: Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources
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Report to Congressional Requesters:
March 2005:
Oversight of Food Safety Activities:
Federal Agencies Should Pursue Opportunities to Reduce Overlap and
Better Leverage Resources:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-213]:
GAO Highlights:
Highlights of GAO-05-213, a report to congressional requesters:
Why GAO Did This Study:
GAO has documented many problems resulting from the fragmented nature
of the federal food safety system and recommended fundamental
restructuring to ensure the effective use of scarce government
resources. In this report, GAO (1) identified overlaps in food safety
activities at USDA, FDA, EPA, and NMFS; (2) analyzed the extent to
which the agencies use interagency agreements to leverage resources;
and (3) obtained the views of stakeholders.
What GAO Found:
Several statutes give responsibility for different segments of the food
supply to different agencies to ensure that the food supply is safe.
The U.S. Department of Agriculture (USDA) and the Food and Drug
Administration (FDA) within the Department of Health and Human Services
(HHS) have the primary responsibility for regulating food safety, with
the Environmental Protection Agency (EPA) and the National Marine
Fisheries Service (NMFS) also involved. In carrying out their
responsibilities, with respect to both domestic and imported food,
these agencies spend resources on a number of overlapping activities,
such as inspection/enforcement, training, research, or rulemaking. For
example, both USDA and FDA conduct similar inspections at 1,451 dual
jurisdiction establishments”facilities that produce foods regulated by
both agencies. Under authority granted by the Bioterrorism Act of 2002,
FDA could authorize USDA inspectors to inspect these facilities, but it
has not done so. Furthermore, USDA and FDA maintain separate training
programs on similar topics for their inspectors that could be shared.
Ultimately, inspection and training resources could be used more
efficiently.
Common Elements of UDSA and FDA Inspections:
[See PDF for image]
[End of figure]
GAO identified 71 interagency agreements that the agencies entered into
to better protect public health and to coordinate their food safety
activities. However, the agencies have weak mechanisms for tracking
these agreements that, in some cases, lead to ineffective
implementation. Specifically, USDA and FDA are not fully implementing
an agreement to facilitate the exchange of information about dual
jurisdiction establishments, which both agencies inspect. In addition,
FDA and NMFS are not implementing an agreement designed to enable each
agency to discharge its seafood responsibilities effectively.
GAO spoke with selected industry associations, food companies, consumer
groups, and academic experts, and they disagree on the extent of
overlap and on how best to improve the food safety system. Most of
these stakeholders agreed that laws and regulations should be
modernized to more effectively and efficiently control food safety
hazards, but they differed about whether to consolidate food safety
functions into a single agency.
What GAO Recommends:
Recognizing the statutory constraints under which the agencies operate,
GAO, among other things, recommends that (1) if cost effective, FDA use
available authority to enter into an agreement to commission USDA
inspectors at jointly regulated facilities; (2) USDA and FDA consider
joint training programs; and (3) USDA, FDA, EPA and NMFS inventory,
evaluate, and update active interagency agreements. USDA generally did
not appear to agree with GAO‘s recommendations but recognized the
benefits of joint training for food inspectors. HHS (FDA) agreed with
GAO‘s recommendations to inventory, evaluate, and update the
interagency agreements and with GAO‘s recommendation to use USDA‘s
foreign country evaluations, but it disagreed with others. NMFS agreed
with GAO‘s recommendations, and EPA took no position.
www.gao.gov/cgi-bin/getrpt?GAO-05-213.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Robert A. Robinson at
(202) 512-3841 or robinsonr@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Federal Food Safety Agencies Spend Resources on Overlapping Food Safety
Activities:
Agencies Have Numerous Interagency Agreements to Coordinate Food Safety
Activities, but Tracking Mechanisms and Implementation Are Weak:
Industry and Other Stakeholders Disagree on the Significance of Overlap
in the Federal Food Safety System and on How to Improve It:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Response:
Appendixes:
Appendix I: Scope and Methodology:
Appendix II: Food Safety Expenditures and Staffing Levels for Fiscal
Year 2003:
Appendix III: Food Safety-Related Interagency Agreements:
Appendix IV: Principal Federal Laws Related to Food Safety:
Appendix V: Comments from the U.S. Department of Agriculture:
GAO Comments:
Appendix VI: Comments from the Department of Health and Human Services
(FDA):
GAO Comments:
Appendix VII: Comments from the U.S. Department of Commerce (NOAA):
Appendix VIII: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Staff Acknowledgments:
Tables:
Table 1: Federal Agencies' Food Safety Responsibilities:
Table 2: Examples of Similar Food Safety Activities:
Table 3: Food Safety Expenditures and Staffing Levels by Agency, Fiscal
Year 2003:
Table 4: Other Food Safety Expenditures and Staffing Levels by Agency,
Fiscal Year 2003:
Table 5: Food Safety-Related Interagency Agreements by Primary Program
Function:
Table 6: The 30 Principal Laws Related to Food Safety:
Figures:
Figure 1: USDA, FDA, EPA, and NMFS Food Safety Expenditures, Fiscal
Year 2003:
Figure 2: USDA, FDA, EPA, and NMFS Food Safety Expenditures by Program
Function, Fiscal Year 2003:
Figure 3: Food Safety Expenditures (dollars) by Agency and Function,
Fiscal Year 2003:
Figure 4: Location of Food Manufacturers, Warehouses, and Other Types
of Food Establishments Inspected by Both USDA and FDA:
Figure 5: Common Elements of USDA and FDA Inspections:
Figure 6: Food Safety-Related Interagency Agreements by Program
Function:
Figure 7: Diagram of a Jointly Regulated Food Processing Facility:
Abbreviations:
AMS: Agricultural Marketing Service:
APHIS: Animal and Plant Health Inspection Service:
ARS: Agricultural Research Service:
CBP: Customs and Border Protection:
CDC: Centers for Disease Control and Prevention:
CFSAN: Center for Food Safety and Applied Nutrition:
CSREES: Cooperative State Research, Education and Extension Service:
CVM: Center for Veterinary Medicine:
DJE: Dual Jurisdiction Establishment:
DOC: Department of Commerce:
EPA: Environmental Protection Agency:
ERS: Economic Research Service:
GIPSA: Grain Inspection, Packers and Stockyards Administration:
ISSC: Interstate Shellfish Sanitation Conference:
FDA: Food and Drug Administration:
FSIS: Food Safety and Inspection Service:
HACCP: Hazard Analysis and Critical Control Point (system):
NASS: National Agricultural Statistics Service:
NCTR: National Center for Toxicological Research:
NMFS: National Marine Fisheries Service:
ORA: Office of Regulatory Affairs:
USDA: U.S. Department of Agriculture:
Letter March 30, 2005:
The Honorable George V. Voinovich: Chairman, Subcommittee on Oversight
of Government Management, the Federal Workforce, and the District of
Columbia: Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Jon Porter:
Chairman, Subcommittee on the Federal Workforce and Agency
Organization:
Committee on Government Reform:
House of Representatives:
The Honorable Jo Ann Davis:
House of Representatives:
The statutory framework underlying the U.S. federal food safety system
gives responsibility for specific food commodities to different
agencies and provides them with significantly different authorities and
responsibilities. As a result, federal agencies are spending resources
on similar activities to ensure that the food supply is safe,
wholesome, and appropriately labeled. Over the years, we have
documented many problems resulting from the fragmented nature of the
federal food safety system and have recommended streamlining food
safety statutes and consolidating food safety functions into a single
agency.[Footnote 1] As the Comptroller General noted in testimony
before the Congress, redundant, unfocused, and uncoordinated programs
waste scarce resources, confuse and frustrate program customers, and
limit overall program effectiveness.[Footnote 2] The food safety
challenges are more pressing today as we face the potential threat of
deliberate contamination of our food supply.
Multiple federal agencies are involved in food safety activities, but
four agencies play key roles and invest the largest share of resources
to ensure the safety and quality of food. These agencies--the U.S.
Department of Agriculture (USDA), the Food and Drug Administration
(FDA), the Environmental Protection Agency (EPA), and the National
Marine Fisheries Service (NMFS)--expended nearly $1.7 billion and
devoted nearly 15,000 staff in fiscal year 2003,[Footnote 3] the most
recent year for which the agencies could provide complete expenditure
data, on activities that included (1) inspecting food manufacturers,
processors and warehouses; (2) researching and implementing methods to
reduce the prevalence of foodborne pathogens; (3) assessing risks posed
by various food contaminants; and (4) educating industry about new
regulatory requirements and the public about food safety issues. These
agencies operate under 30 primary laws underpinning the legal framework
for ensuring the safety and quality of the food supply. (See app. IV.)
Of the federal agencies involved in food safety activities, USDA and
FDA have most of the regulatory responsibility for overseeing
industry's compliance with federal regulations to ensure food safety
and also account for most federal spending in this area. USDA is
responsible for ensuring the safety of meat, poultry, and certain egg
products under the Federal Meat Inspection Act, the Poultry Products
Inspection Act, and the Egg Products Inspection Act. FDA is responsible
for ensuring the safety of all other food--including whole shell eggs,
seafood, milk, grain products, and fruits and vegetables--under the
Federal Food, Drug and Cosmetic Act and the Public Health Service Act.
In addition, the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act) gave FDA the authority
to commission other federal officials to inspect FDA-regulated
foods.[Footnote 4] USDA and FDA enforce their respective Hazard
Analysis and Critical Control Point (HACCP) regulations. These
regulations require that food processors maintain a plan identifying
critical points in the production line where contamination is more
likely to occur and adopt control techniques to prevent or reduce
contamination. EPA and NMFS also have related food safety and quality
responsibilities. EPA sets pesticide tolerances for food under the
Federal Insecticide, Fungicide, and Rodenticide Act and the Federal
Food, Drug and Cosmetic Act and issues fish consumption advisories
under the Clean Water Act. NMFS conducts voluntary, fee-for-service
inspections of seafood-processing facilities and seafood products under
the Federal Agricultural Marketing Act of 1946, the Fish and Wildlife
Act of 1956, and Reorganization Plan No. 4 of 1970.
To coordinate activities across jurisdictional boundaries, these
federal agencies have entered into dozens of interagency agreements
that address a wide range of food safety-related activities.[Footnote
5] The agreements concern numerous functions and activities, including
how the agencies carry out inspections, public education and outreach,
and research projects.
Because of your continuing interest in the efficient and effective use
of government resources, you asked us to (1) identify overlaps that may
exist in federal food safety functions and activities, (2) examine the
extent to which federal food safety agencies are using interagency
agreements to leverage existing resources and reduce any such overlaps,
and (3) obtain the views of regulated industry and other stakeholders
regarding opportunities to reduce overlap by consolidating federal food
safety functions.
In addressing these questions, we defined overlaps as similar
activities being performed by more than one agency--such as training
food inspectors--and duplication as essentially identical activities
performed by more than one agency--such as inspecting the same food-
processing facility for compliance with sanitation and/or good
manufacturing practices requirements. To identify overlaps, we obtained
and analyzed agency budget data--including actual expenditures and
staffing levels for fiscal year 2003, the most recent year for which
data were complete--and contacted agency budget and program officials
to help us identify what activities the agencies perform and to
determine whether similar activities were performed by more than one
agency. To examine the extent of interagency coordination, we
identified and reviewed all active interagency agreements. We selected
two inspection-related interagency agreements for in-depth review
because the agencies spend most of their resources on inspection
activities; one agreement that pertains to dual jurisdiction
establishments and one that pertains to inspections of fishery
products. In addition, these agreements encompassed a broad range of
intended coordination efforts between the agencies involved. To obtain
information about the agreements' implementation, we conducted site
visits to USDA and FDA field offices in three locations. To identify
key stakeholders and obtain their views on overlapping agency functions
and potential consolidation of these functions, we relied on our
previous work and on the four agencies' recommendations. Based on this
information, we compiled a list of 35 stakeholders from the major
industry associations, consumer groups, and food safety experts from
academia and conducted structured interviews with them. In addition, we
interviewed two to four company representatives in the three states
where we conducted field work. We performed our work between May 2004
and March 2005 in accordance with generally accepted government
auditing standards, which included an assessment of data reliability
and internal controls. Appendix I describes our methodology in greater
detail.
Results in Brief:
We identified several overlapping food safety activities that occur at
multiple agencies because the agencies operate under different
statutes, which give them responsibility for conducting similar
activities for different food products, and different regulatory and
enforcement authorities. As a result, federal agencies are spending
resources on overlapping food safety activities designed to ensure the
safety and quality of domestic and imported food. In some cases, the
agencies conduct these activities at the same locations. For example:
* Domestic inspections. In fiscal year 2003, USDA and FDA spent most of
their food safety resources--about $900 million--on inspection and
enforcement activities. A portion of these activities included
overlapping and even duplicative inspections of 1,451 domestic food-
processing facilities that produce multi-ingredient foods, such as
canned goods and frozen entrees. Both agencies inspect these
facilities, because each agency has statutory responsibility for the
safety of different foods or food ingredients. For example, USDA
inspects canning facilities at least daily if the company produces
canned beans containing meat and poultry. If the facility produces
canned beans without meat or poultry, FDA also inspects it with a
frequency ranging from 1 to 5 years. USDA and FDA inspections have
common features--both agencies spend inspection resources to verify
that facilities are sanitary and follow good manufacturing practices.
Although neither USDA nor FDA could estimate the total costs associated
with inspecting these facilities, FDA estimates that it spends about
$4,000 per inspection. According to some industry officials, having two
different regulatory agencies inspect a single facility can be
burdensome. At a facility we visited that produces crab cakes and
breaded chicken, the manager told us that he must maintain separate
seafood and poultry HACCP plans and that separate inspections are
required for each. The manager said this duplication is confusing
because the agencies are using the same model, but their expectations
for the plans' content differ. Under the Bioterrorism Act, FDA could
commission USDA officials to perform food inspections on its behalf at
those establishments under the jurisdiction of both agencies, thereby
making better use of its resources and reducing industry burden. FDA
has not yet exercised this authority with respect to commissioning USDA
officials.
* Import inspections. USDA and FDA both inspect shipments of imported
food at ports of entry and also visit foreign countries that export
food to the United States. We found that both USDA and FDA maintain
inspectors at 18 U.S. ports of entry to inspect imported food. In
fiscal year 2003, USDA spent almost $16 million on imported food
inspections, and FDA spent more than $115 million. The two agencies do
not share inspection resources at these ports. For example, USDA
officials told us that all USDA-import inspectors are assigned to, and
located at, a USDA-approved import inspection facility. They also told
us that some of these facilities handle and store FDA-regulated
products, but USDA has no jurisdiction over these FDA-regulated
products. Although USDA maintains a daily presence at these facilities,
the FDA-regulated products may remain at the facilities for some time
awaiting FDA inspection. FDA also conducted inspections in 6 of the 34
countries that USDA evaluated in 2004 to determine whether their food
safety systems for ensuring the safety of meat and poultry are
equivalent to that of the United States. FDA officials said they do not
use USDA's evaluations of the foreign countries' food safety systems
and that USDA's findings would be of little use to FDA because they
relate to products under USDA's jurisdiction.
* Inspectors' training. Both USDA and FDA spend resources to provide
similar training to food inspection personnel. USDA spent $7.8 million
and FDA spent about $1.6 million in fiscal year 2003. We found that, to
a considerable extent, food inspection training addresses the same
subjects--such as plant sanitation, good manufacturing practices, and
HACCP principles. However, the programs differ in that they include
HACCP training on specific products, such as seafood or poultry. While
taking into consideration product-specific training differences, the
agencies could explore opportunities to merge training resources, as
has been done by consolidating federal law enforcement training in the
Federal Law Enforcement Training Center.
* Other overlapping activities. We identified overlapping activities in
research and risk assessments, development of education materials for
industry and consumers, and rulemaking. For example, USDA and FDA each
developed and issued separate HACCP rules, which are based on the same
model but applied to different food products. Because different food
products present different risks, separate HACCP plans may be required
to address individual food products. These rules require companies to
maintain a plan that identifies hazards that are most likely to
contaminate food in the production process and establish appropriate
control mechanisms to reduce those hazards. FDA estimates that it spent
between $650,000 and $1 million to develop and promulgate its 1995
seafood HACCP rule; NMFS spent $5 million in efforts that supported
FDA's seafood HACCP rule. USDA was unable to calculate how much it
spent to develop its meat and poultry HACCP rule.
We also identified 71 interagency agreements that the principal food
safety agencies--USDA, FDA, EPA, and NMFS--have entered into that are
designed to better protect the public health by addressing
jurisdictional boundaries, coordinating activities, reducing overlaps,
and leveraging resources. However, the agencies' ability to take full
advantage of these agreements is hampered by the absence of adequate
mechanisms for tracking them and, in some cases, by ineffective
implementation of the agreements' provisions. Agency officials had
difficulty identifying the food safety agreements they are party to
and, in many instances, the agencies did not agree on the number of
agreements they had entered into. For the two comprehensive inspection-
related agreements that we examined in detail, the agencies are not
ensuring that their provisions are adhered to or that the overall
objectives of the agreements are being achieved. For example, USDA and
FDA are not fully implementing an agreement to exchange information to
permit more efficient use of both agencies' resources at jointly
regulated facilities. Under this agreement, the agencies are to share
inspection information, but FDA does not routinely consider compliance
information from USDA when deciding how to target its inspection
resources. Furthermore, an inspection agreement between FDA and NMFS
recognizes the agencies' related responsibilities at seafood-
processing establishments that are inspected by FDA and also inspected
by NMFS under contractual arrangements. The agreement details actions
the agencies can take to enable each agency to discharge its
responsibilities as effectively as possible and minimize FDA
inspections at these facilities. However, contrary to the terms of the
agreement, FDA is not using information from NMFS inspections, which
could allow it to reduce the number of inspections at those facilities.
The stakeholders we contacted--selected industry associations, food-
processing companies, consumer groups, and academic experts--disagree
on the extent to which overlaps exist and on how best to improve the
federal food safety system. However, most of these stakeholders agree
that the laws and regulations governing the system should be modernized
so that scientific and technological advancements can be used to more
effectively and efficiently control current and emerging food safety
hazards, but they differed about whether to consolidate food safety
functions into a single federal agency. Specifically, the academics and
consumer groups support consolidating food safety functions into a
single food safety agency. These groups believe that consolidation
would improve the effectiveness and efficiency of the system and ensure
that food safety inspections are based on the best available science.
Representatives from the individual food companies that both USDA and
FDA inspect concurred with that assessment. In contrast, the industry
association representatives do not see the need to consolidate federal
food safety functions. Proponents and opponents also cited several
roadblocks to consolidation, including the need to maintain food
security during any transition.
We have previously recommended that the Congress consider streamlining
food safety statutes to make them more uniform and risk based and
consolidating federal food safety functions under a single agency. We
also recognize, however, that improvements short of reorganizing the
food safety system can be made to help reduce overlaps and duplication,
and to leverage existing resources. In this report, we make several
recommendations to that end. For example, if cost effective, we
recommend that FDA, as authorized under the Bioterrorism Act,
commission USDA inspectors to carry out FDA's inspection
responsibilities at food establishments that are under their joint
jurisdiction. We also recommend that USDA and FDA examine the
feasibility and cost effectiveness of establishing a joint training
program for their food inspectors.
In commenting on a draft of this report, USDA did not specifically
agree or disagree with the report's recommendations, but the agency's
general comments on the report appear to indicate that the agency
disagrees. USDA asserted that our report oversimplifies food safety
authorities, regulations, inspections, and training activities,
exaggerates the economic impact of overlaps, and does not accurately
address coordination efforts and agreements between USDA and FDA. We
disagree with USDA's characterization. Our report is based on numerous
discussions with knowledgeable officials as well as a thorough review
of the agencies' authorities, regulations, inspections, and training
activities; but it does not assess the economic impact of overlapping
activities. The report provides specific examples of those activities
and information on the expenditures each agency incurred to conduct
these activities. One of USDA's comments indicates that USDA recognizes
the benefits of joint training for food inspectors--one of our report's
recommendations. USDA added, however, that several factors affect the
feasibility of conducting joint training activities, such as the
differences in classification of the job series of individuals
performing inspection duties. USDA also commented that our report
inaccurately characterizes the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act). We
disagree. As the report states, FDA is authorized under the act to
enter into an agreement to commission other agency officials, including
USDA officials, to carry out inspections on its behalf--for FDA-
regulated foods--at establishments under the jurisdiction of both
agencies. USDA also provided technical comments, which we incorporated
in our report, as appropriate. USDA's comments and our detailed
response are contained in appendix V.
In commenting on a draft of this report, HHS agreed with three of the
report's seven recommendations that the agency (1) use USDA's foreign
country evaluations, (2) identify and inventory all food safety-related
interagency agreements, and (3) evaluate and update the agreements. FDA
stated that it has taken steps to inventory these agreements. HHS
disagreed with our recommendation regarding joint training of FDA and
USDA food inspectors. The agency commented on, but did not agree or
disagree with, our recommendation regarding utilization of the
Bioterrorism Act authority to commission USDA officials. Finally, HHS
partially concurred with two other recommendations dealing with
implementation of two interagency agreements. In its comments, HHS
raised concerns about our terminology regarding overlapping activities
and said that the report overstated similar activities without
specifying the differences. For example, HHS noted that training
programs for food inspectors are vastly different due to the fact that
USDA inspectors and FDA investigators have very different academic
backgrounds and conduct very different inspections. We disagree with
HHS's comment. Our report clearly explains the use of terminology as
well as the differences in the agencies' activities. HHS also provided
technical comments, which we have incorporated in this report, as
appropriate. HHS's comments and our detailed response are contained in
appendix VI.
EPA did not provide official written comments, but the agency commented
that it will consider our recommendation for better tracking of
interagency agreements when EPA sets priorities for future investments
in information technology.
The National Oceanic and Atmospheric Administration (NOAA) provided
written comments and agreed with the report's recommendations that
pertain to NMFS. NOAA also commented that our report does a fair and
thorough job of describing NMFS's food safety activities. NOAA's
comments are contained in appendix VII.
Background:
Many federal agencies, as well as state and local entities, play a part
in the U.S. food safety regulatory system. While the federal agencies
regulate the food production chain from farms to food manufacturers,
state and local agencies primarily regulate food safety in retail food
establishments. Table 1 summarizes the food safety responsibilities of
the federal agencies. In addition to their established food safety and
quality responsibilities, following the events of September 11, 2001,
these agencies began to address the potential for deliberate
contamination of agriculture and food products, with the Department of
Homeland Security providing overall coordination on how to protect the
food supply from deliberate contamination.
Table 1: Federal Agencies' Food Safety Responsibilities:
Department: U.S. Department of Agriculture; Agency: Food Safety and
Inspection Service; Responsible for: All domestic and imported meat,
poultry, and processed egg products.
Department: U.S. Department of Agriculture; Agency: Animal and Plant
Health Inspection Service; Responsible for: Protecting the health and
value of U.S. agricultural resources (e.g., animals and plants).
Department: U.S. Department of Agriculture; Agency: Grain Inspection,
Packers and Stockyards Administration; Responsible for: Establishing
quality standards, inspection procedures, and marketing of grain and
other related products.
Department: U.S. Department of Agriculture; Agency: Agricultural
Marketing Service (AMS)[A]; Responsible for: Establishing quality and
condition standards for dairy, fruit, vegetable, livestock, meat,
poultry, and egg products.
Department: U.S. Department of Agriculture; Agency: Agricultural
Research Service; Responsible for: Conducting food safety research.
Department: U.S. Department of Agriculture; Agency: Economic Research
Service; Responsible for: Providing analyses of the economic issues
affecting the safety of the U.S. food supply.
Department: U.S. Department of Agriculture; Agency: National
Agricultural Statistics Service; Responsible for: Providing statistical
data, including agricultural chemical usage data, related to the safety
of the food supply.
Department: U.S. Department of Agriculture; Agency: Cooperative State
Research, Education and Extension Service; Responsible for: Supporting
food safety research, education, and extension programs in the land-
grant university system and other partner organizations.
Department: Department of Health and Human Services; Agency: Food and
Drug Administration (FDA); Responsible for: All domestic and imported
food products except meat, poultry, or processed egg products.
Department: Department of Health and Human Services; Agency: Centers
for Disease Control and Prevention (CDC); Responsible for: Protecting
the nation's public health, including foodborne illness surveillance.
Department: Department of Commerce; Agency: National Marine Fisheries
Service; Responsible for: Voluntary, fee-for-service examinations of
seafood for safety and quality.
Department: Environmental Protection Agency; Responsible for:
Regulating the use of pesticides and maximum allowable residue levels
on food commodities and animal feed.
Department: Department of the Treasury; Agency: Alcohol and Tobacco Tax
and Trade Bureau; Responsible for: Enforcing laws covering the
production, use, and distribution of alcoholic beverages.
Department: Department of Homeland Security[B]; Responsible for:
Coordinating agencies' food security activities.
Agency: Federal Trade Commission;
Responsible for: Prohibiting false advertisements for food.
Source: GAO.
[A] According to USDA, AMS has no statutory authority in the area of
food safety. However, the agency performs some functions related to
food safety for several foods. For example, AMS graders monitor a shell
egg surveillance program that identifies cracked and dirty eggs. In
addition, AMS performs functions related to food safety for the
National School Lunch Program.
[B] In 2001, by executive order, the President stated that the then
Office of Homeland Security, as part of its efforts to protect critical
infrastructures, should coordinate efforts to protect livestock,
agriculture, and food systems from terrorist attacks. In 2002, Congress
enacted the Homeland Security Act of 2002, Pub. L. No. 107-296, 116
Stat. 2135 (2002), setting out the department's responsibility to
protect and secure critical infrastructures and transferring several
food safety-related responsibilities to the Department of Homeland
Security. As a result of the executive order, the Homeland Security Act
of 2002 establishing the Department of Homeland Security, and
subsequent presidential directives, the Department of Homeland Security
provides overall coordination on the protection of the U.S. food supply
from deliberate contamination.
[End of table]
The agencies' food safety authorities stem from 30 principal laws
related to food safety. For a listing of the principal food safety
laws, see appendix IV. As a result of this division of responsibility,
the federal food safety system is fragmented. In some instances,
agencies perform nearly identical activities--both USDA and FDA inspect
food-processing facilities that produce foods under the regulatory
responsibility of each agency, referred to as dual jurisdiction
establishments (DJE). DJEs are those that manufacture or process food
products that contain ingredients regulated by more than one federal
agency. For example, both USDA and FDA inspect facilities that make
canned baked beans with 2 percent or more bacon (a USDA-regulated food)
and canned baked beans without meat (an FDA-regulated food). While
these agencies each perform food safety inspections, the frequency of
their inspections varies.[Footnote 6] Generally, USDA inspectors have a
more regular presence at DJEs. As another example, both FDA and NMFS
inspect seafood-processing facilities, although NMFS's inspections are
conducted at the request of the facility through a contract between the
facility and NMFS.
Four agencies--USDA, FDA, EPA, and NMFS--are involved in key program
functions related to food safety--including inspection and enforcement,
research, risk assessment, education and outreach, rulemaking and
standard setting, surveillance and monitoring, food security, and
administration. Examples of activities under these functions include:
* inspecting domestic food-processing facilities and imported food
items at U.S. ports of entry;
* researching foodborne chemical and biological contaminants, as well
as reducing foodborne pathogens;
* conducting risk assessments of foodborne physical, chemical, and
biological contaminants to inform rulemaking, allocation of agency
resources, or risk communication;
* developing and distributing guidance to consumers and industry
related to food safety topics such as appropriate food temperatures;
and:
* issuing/promulgating HACCP, sanitation, and good manufacturing
practices regulations.
In fiscal year 2003, the four federal agencies spent nearly $1.7
billion on food safety-related activities. USDA and FDA are responsible
for most federal food safety resources (as fig. 1 shows).
Figure 1: USDA, FDA, EPA, and NMFS Food Safety Expenditures, Fiscal
Year 2003:
[See PDF for image]
[End of figure]
These agencies spent about $921 million (55 percent) in fiscal year
2003 on inspection/enforcement functions, including inspections of
domestic and imported food (as fig. 2 shows).
Figure 2: USDA, FDA, EPA, and NMFS Food Safety Expenditures by Program
Function, Fiscal Year 2003:
[See PDF for image]
Notes: Program functions are based on the National Academy of Science's
1998 report Ensuring Safe Food.[Footnote 7] These categories include:
monitoring/surveillance, inspection/enforcement, education/outreach,
research, and risk assessment. To capture other relevant activities, we
include three additional functions--administration, food security, and
rulemaking/standard setting--in the function "other." Expenditures for
these functions were provided by some agencies, but not others. The
agencies that did not provide estimates of these expenditures reported
that they are distributed among other functions.
[End of figure]
USDA's Food Safety and Inspection Service did not provide Surveillance
expenditure data.
The agencies' expenditures vary by program function (as shown in fig.
3). For example, USDA's inspection/enforcement expenditures made up
almost three-quarters of the total spent by these agencies for that
program function. That is, the majority of federal food safety
inspection expenditures are directed toward USDA's programs for
ensuring the safety of meat, poultry, and egg products. In contrast,
FDA accounts for more than half of the agencies' expenditures for food
safety education/outreach programs.
Figure 3: Food Safety Expenditures (dollars) by Agency and Function,
Fiscal Year 2003:
[See PDF for image]
[End of figure]
Appendix II provides detailed information on the agencies' expenditures
and staffing levels devoted to the various program functions in fiscal
year 2003.
Federal Food Safety Agencies Spend Resources on Overlapping Food Safety
Activities:
As a result of the multiple laws and regulations governing food safety,
several federal agencies conduct activities--inspections of domestic
and foreign foods, training, research, risk assessment, education, and
rulemaking--that can serve overlapping, if not identical, purposes. As
a result, federal agencies spend resources on similar food safety
activities. Table 2 illustrates similar activities conducted by the
four federal agencies we examined. These activities, such as laboratory
analysis and risk assessment, may be product specific.
Table 2: Examples of Similar Food Safety Activities:
Food safety program function: Inspection/Enforcement; Activity:
Inspection of domestic food-processing facilities; USDA; FDA; NMFS.
Activity: Visits to foreign countries or firms to conduct inspections
and/or evaluate foreign food safety systems; USDA; FDA; NMFS.
Activity: Inspection of imported food at ports of entry; USDA; FDA.
Activity: Training inspectors; USDA; FDA; NMFS.
Activity: Maintenance of inspection record database; USDA; FDA; NMFS.
Activity: Support to state enforcement efforts (retail-level food
safety); USDA; FDA; EPA.
Activity: Laboratory analysis of samples collected at food-processing
facilities (to identify potential contamination); USDA; FDA; NMFS.
Food safety program function: Research; Activity: Research on pathogen
reduction; USDA; FDA; NMFS.
Activity: Research on foodborne chemical contaminants (such as
pesticides or dioxins) or biological contaminants (such as E. coli or
salmonella); USDA; FDA; EPA; NMFS.
Food safety program function: Risk assessment; Activity: Risk
assessment of food contaminants; USDA; FDA; EPA; NMFS.
Activity: Sample collection and/or analysis of pesticide residues to
inform risk assessment; USDA; FDA; NMFS.
Food safety program function: Education/Outreach; Activity: Development
and delivery of consumer education (such as consumer hotlines or
pamphlets); USDA; FDA; EPA; NMFS.
Activity: Development and delivery of industry guidance (such as
guidance regarding regulations); USDA; FDA; EPA; NMFS.
Activity: International harmonization of standards; USDA; FDA; EPA;
NMFS.
Food safety program function: Surveillance/Monitoring; Activity:
Participation in FoodNet (active surveillance for foodborne diseases);
USDA; FDA.
Activity: Participation in PulseNet (early warning system for food
illness outbreak); USDA; FDA.
Food safety program function: Rulemaking/Standard setting; Activity:
HACCP rule development and promulgation; USDA; FDA; NMFS[A].
Source: GAO analysis of documents obtained from, and discussions with,
USDA, FDA, EPA, and NMFS officials.
[A] NMFS participated in development of FDA's seafood HACCP rule.
[End of table]
Agencies Conduct Overlapping Inspections at Jointly Regulated Food-
Processing Facilities:
USDA and FDA spent $884 million in fiscal year 2003 on inspection and
enforcement activities--roughly 60 percent of their total food safety
expenditures. Neither USDA nor FDA has estimated the total costs
associated with inspecting jointly regulated facilities. FDA estimated
that it spends about $4,000 per inspection. As figure 4 shows, USDA and
FDA both inspect 1,451 known DJEs located across the country.[Footnote
8] USDA and FDA inspect these establishments with different
frequencies. For example, USDA inspects a canning facility at least
daily if it produces food containing meat and poultry. If the facility
also produces canned soups containing beans or seafood, FDA inspects it
every 1 to 5 years.
Figure 4: Location of Food Manufacturers, Warehouses, and Other Types
of Food Establishments Inspected by Both USDA and FDA:
[See PDF for image]
Note: DJEs in Puerto Rico (39), Hawaii (10), and Alaska (18) are not
shown in the figure.
[End of figure]
Because of their split jurisdiction, each agency is responsible for
inspecting different food products at these facilities; but the
agencies' inspections have common key elements, including verifying the
facilities' compliance with sanitation standards (as defined by USDA)
or good manufacturing practices (as defined by FDA). For example, both
agencies' inspectors verify that facilities do not have rodent or
insect infestations. Figure 5 summarizes some of the common elements of
USDA and FDA inspections.
Figure 5: Common Elements of USDA and FDA Inspections:
[See PDF for image]
[End of figure]
At jointly regulated facilities, USDA and FDA inspectors also verify
that HACCP systems are in place. In these instances, each agency
verifies that the facility has created and implemented a HACCP plan
specific to the products that the agency regulates. The regulations
require the facility to maintain separate HACCP plans for each product
and to develop separate analyses of critical control points and
separate strategies to mitigate or eliminate food
contaminants.[Footnote 9] For example, at a facility we visited that
produces both crab cakes and breaded chicken, the manager is required
to maintain a seafood HACCP plan and a poultry HACCP plan. The manager
said that although both plans have similar elements, each agency's
inspectors expect different levels of detail for the plans--something
the manager finds confusing and difficult to comply with.
USDA and FDA have new tools that could help reduce overlaps in
inspections. Under the Bioterrorism Act, FDA could allow USDA
inspectors, who are present every day at these jointly regulated
facilities, to inspect FDA-regulated food.[Footnote 10] In doing so,
FDA could reduce overlapping inspections and redirect resources to
other facilities for which it has sole jurisdiction. While they did not
disagree in principle with the benefits of such an arrangement, FDA
officials said that the savings would be somewhat offset because FDA
would likely have to reimburse USDA for the costs of those inspections.
FDA officials said that they do not currently plan to pursue this
option and have not conducted any analyses of the costs or savings
associated with authorizing USDA officials to conduct FDA inspections
at these facilities. USDA officials commented that their inspectors are
fully occupied and that they would need to be trained before conducting
joint inspections.
Overlaps also occur at seafood-processing facilities that both FDA and
NMFS inspect. NMFS currently inspects approximately 275 domestic
seafood facilities that FDA also inspects. NMFS safety and sanitation
inspections, as well as other product quality inspections are conducted
on a fee-for-service basis. NMFS inspectors verify sanitation
procedures, HACCP compliance, and good manufacturing practices--many of
the same components of an FDA inspection. Although NMFS and FDA seafood
safety inspections are similar, FDA does not take into account whether
NMFS has already inspected a particular facility when determining how
frequently its inspectors should visit that same facility.
FDA officials said they do not rely on NMFS inspections for two
reasons. First, FDA officials believe that NMFS has a potential
conflict of interest because companies pay NMFS for these inspections;
and therefore, as a regulatory agency, FDA should not rely on them.
NMFS officials disagree with FDA's viewpoint, stating that their fee-
for-service structure does not affect their ability to conduct
objective inspections. NMFS officials said that, when NMFS inspectors
find noncompliance with FDA regulations, they refer companies to FDA
and/or to state regulatory authorities. NMFS officials stated that
companies that contract with NMFS need the agency's certification in
order to satisfy their customers. Second, it is difficult for FDA to
determine which facilities NMFS inspects at any given time because NMFS
inspection schedules fluctuate often, according to changes in NMFS's
contracts with individual companies. If FDA were to recognize the
results of NMFS inspection findings in targeting its resources, it
could decrease or eliminate inspections at facilities that NMFS
inspectors find are in compliance with sanitation and HACCP
regulations.
USDA and FDA Conduct Inspections of Food Imports:
Both USDA and FDA maintain inspectors at 18 U.S. ports of entry to
inspect imported food products. In fiscal year 2003, USDA spent almost
$16 million on these inspections, and FDA spent more than $115
million.[Footnote 11] FDA spends about 7 times as much on import
inspections because the agency is responsible for about 80 percent of
the U.S. food supply, including imports from about 250 countries,
compared with USDA's responsibility for inspecting imports that come
from 34 countries. However, the agencies are not leveraging inspection
resources at these ports. USDA officials told us that FDA-regulated,
imported foods are sometimes stored in USDA-approved inspection
facilities at these ports. USDA inspectors have no authority to inspect
FDA-regulated products, although USDA inspectors are present at these
ports more often than FDA inspectors. As a result, some FDA-regulated
products may remain at the facility for some time awaiting inspection.
FDA has the authority to commission federal officials to conduct
inspections at jointly regulated facilities. In 2003, FDA exercised
this authority to conduct inspections by entering into an agreement
with the Department of Homeland Security's Customs and Border
Protection (CBP) so Customs' officials can help FDA inspect products at
ports and other facilities subject to CBP jurisdiction.
FDA could also leverage USDA's efforts to ensure the safety of imported
food by using information that USDA compiles in its determinations that
exporting countries' food safety systems are equivalent to the U.S.
system. Under the Meat and Poultry Products Inspection Acts, the
Secretary of Agriculture is required to certify that countries
exporting meat and poultry to the United States have equivalent food
safety systems for producing meat and poultry products that are
exported to the United States.[Footnote 12] That information could
inform FDA's decision making about which countries to visit for its
overseas inspections. Currently, FDA visits foreign countries to
inspect individual food- processing firms. In 2004, USDA determined
that the food safety systems of 34 countries it evaluated were
equivalent to that of the United States. A substantial portion of what
USDA evaluates--sanitation procedures and compliance with HACCP rules--
could be useful to FDA in deciding what countries to visit when
conducting inspections of foreign firms that export products under its
jurisdiction. FDA officials told us, however, that the agency does not
use that information when deciding which countries to visit. As a
result, FDA at times conducts inspections in the same countries that
USDA has evaluated. For example, USDA and FDA each visited Brazil,
Costa Rica, Germany, Hungary, Mexico, and Canada last year. USDA spent
almost $500,000, and FDA spent almost $5 million, on its foreign
country visits in fiscal year 2003. USDA and FDA officials said these
agencies do not share information from their overseas visits because
their different statutory responsibilities make such information of
little advantage. That is, USDA's focus during foreign country visits
is to evaluate the meat and poultry inspection systems to determine if
they are equivalent to that of the United States, whereas FDA focuses
its visits on specific companies that produce food under the agency's
jurisdiction.[Footnote 13]
Agencies Maintain Similar Inspection Training Programs:
USDA and FDA provide similar training to their inspectors. For example,
both agencies train inspectors on sanitation requirements, good
manufacturing practices, and HACCP. Agency officials agreed that the
training programs have a common foundation but pointed out that there
are differences, as each agency applies these principles to the
specific foods it regulates. USDA spent $7.8 million, while FDA spent
about $1.5 million, during fiscal year 2003 to train their food
inspection personnel.[Footnote 14] FDA's comparatively lower training
costs reflect a contractual agreement with a private firm that has
produced an online curriculum. This curriculum includes over 106
courses that address topics common to both USDA and FDA--ranging from
foodborne pathogens, HACCP requirements, and good manufacturing
practices, to courses that are specific to FDA's regulations and
enforcement authorities. Another agency--NMFS--uses 74 of these online
courses to train its own seafood inspectors. The benefits NMFS
officials cited include accessibility to training materials at times
other than when inspectors are "on duty" and no charge to NMFS for the
training materials. USDA officials said they are exploring the
possibility of entering into an agreement with the company that
developed FDA's online curriculum to allow USDA inspectors access to
some of this training. In addition to the costs associated with
developing inspector training programs, USDA estimates that it spends
an average of about $900,000 per year on training-related travel, not
including other costs related to replacing inspectors in food-
processing facilities while they participate in the training. A joint
USDA-FDA training program could reduce duplication in developing
training materials and in providing instruction, and potentially
achieve some savings.
Other federal agencies have consolidated training activities that have
a common purpose and similar content. For example, in 1970, the
Consolidated Federal Law Enforcement Training Center (the Center)
brought together the training programs of 75 federal law enforcement
agencies that had maintained separate training programs. Specifically,
the Center provides standardized programs for criminal investigators
and uniformed police officers across the federal government. While
standardizing basic training, the Center also offers specialized
courses for individual agencies to address their particular needs. In
addition, according to the Center, the interaction with students from
other agencies promotes greater understanding of other agencies'
missions and duties, and therefore provides for a more cooperative
federal law enforcement system.[Footnote 15]
Agencies Conduct Other Activities That Overlap:
We identified overlapping activities in the areas of food safety
research and risk assessment, consumer and industry education, and
rulemaking.
Food Safety Research and Risk-Assessment Efforts:
USDA and FDA participate in similar food safety research efforts; that
is, both agencies collect and analyze food samples for chemical and
biological contaminants. During fiscal year 2003, the agencies spent
over $245 million on these types of activities. For example, because of
the agencies' split jurisdiction, both USDA and FDA maintain separate
laboratory capability to sample and analyze the foods that they
regulate for chemical contaminants such as pesticides and
dioxins.[Footnote 16] EPA uses USDA and FDA data to inform EPA's risk
assessments on human exposure to pesticides. Specifically, in 2003, FDA
analyzed 11,331 food samples for pesticides and chemical contaminants
to help estimate the dietary intake of pesticide residues. In 2000, the
most recent year for which data are available, USDA's Food Safety and
Inspection Service (FSIS) analyzed over 33,000 samples of meat,
poultry, and egg products. In addition, USDA's Agricultural Marketing
Service's (AMS) Pesticide Data Program samples and tests commodities
across the food spectrum to help inform EPA in making decisions on
acceptable levels of pesticide residues (tolerances). According to EPA
officials, USDA data are their primary source of information. However,
FDA provides additional information on a greater range of foods and
chemicals that EPA also uses to form its decisions. EPA officials said
that the overlap in data collection and analysis adds value because
USDA's data comes from a well-controlled survey of food samples taken
at the wholesale level, and FDA's data helps fill in the gaps with
samples of food at different points in the distribution chain.
USDA and FDA also both conduct risk assessments of foodborne pathogens
that can contaminate food products under their respective
jurisdictions. For example, in 2000, USDA released a draft risk
assessment for Escherichia coli ( E. coli) O157:H7 in ground beef and,
FDA released a draft risk assessment for Vibrio parahaemolyticus in raw
molluscan shellfish. The agencies also conduct joint risk assessments
when addressing the same pathogen or the same food product. In the case
of eggs, regulatory responsibility shifts as eggs make their way from
the farm to the table, with FDA being primarily responsible for the
safe production and processing of eggs still in the shell (known as
shell eggs), and USDA being responsible for food safety at the
processing plants where eggs are broken to produce egg products. In
1996, the agencies began work on a joint risk assessment for salmonella
in eggs to evaluate the risk to human health of salmonella in shell
eggs and in liquid egg products and to identify potential risk
reduction strategies. In 1998, USDA and FDA jointly published an
advance notice of proposed rulemaking, based on this risk assessment,
to identify farm-to-table actions that would decrease the food safety
risks associated with eggs. However, the agencies have not issued a
joint rule to help eliminate foodborne illnesses caused by salmonella
in eggs. In 2004, FDA issued a proposed rule that would require shell
egg producers to implement measures to help prevent salmonella from
contaminating eggs on the farm. Although USDA released a new draft risk
assessment in 2004, the department has not yet issued a proposed rule
to help prevent salmonella from contaminating egg products. Both
agencies have also committed personnel resources to a World Health
Organization effort to conduct a risk assessment of salmonella in eggs
and broiler chickens.
Consumer and Industry Education:
USDA, FDA, and EPA conduct education and outreach on food safety--and
spent more than $107 million in fiscal year 2003.[Footnote 17] In some
cases, these agencies' efforts overlap. For example, these agencies
create and distribute educational materials to consumers, or host
hotlines or other forums that address food safety issues. In some
cases, these efforts target the same food safety topic. For example,
USDA, FDA, and EPA each develop consumer guidance on chemical food
contaminants such as pesticides, dioxin, and mercury. In addition, USDA
and FDA each develop similar food safety guidance for (1) consumers on
general topics, such as cooking and chilling food, and safe handling
practices, such as using a food thermometer and (2) industry, on their
HACCP regulations and sanitation and good manufacturing practices.
These overlapping efforts, caused in part by the agencies' divisions in
jurisdiction, can be confusing to both consumers and industry
representatives. For example, USDA officials said they receive calls
from consumers and industry representatives to their consumer hotline
about FDA-regulated food products. These agencies have made some
efforts to reduce overlaps in their consumer education activities. For
example, USDA and FDA developed the "Fight Bac" program to educate the
public about safe food handling to help reduce foodborne illness. In
addition, for the first time in 2004, FDA and EPA issued a joint
consumer advisory about mercury in fish and shellfish for women who
might become pregnant, who are pregnant, who are nursing, as well as
for young children. However, the joint advisory recommends different
consumption levels, depending on whether the fish is commercially
caught (regulated by FDA) or recreationally caught (regulated by EPA).
Specifically, for fish purchased from a store, the guidance recommends
up to 12 ounces per week. However, if the fish is recreationally
caught, the guidance recommends that women consume up to 6 ounces per
week. EPA said that the consumption guidance differs due to different
mercury levels in recreationally and commercially caught fish.
Rule-Making Activities Vary but Share Some Similarities:
As the principal agencies responsible for food safety, both USDA and
FDA engage in rule-making and standard-setting activities under their
respective statutes. While the rulemakings USDA and FDA undertake vary
under those statutes, there are some similarities. For example, USDA
and FDA promulgated separate HACCP regulations for industry, but both
agencies' regulations require food processors to incorporate certain
sanitation processes into their HACCP systems. The HACCP rules are
based on the same model, though applied to the different food products
each agency regulates.[Footnote 18] For example, FDA requires seafood-
processing facilities to address contaminants that are likely to be
found in seafood, such as Vibrio vulnificus (a bacteria found in raw
seafood, particularly in oysters). USDA requires all meat and poultry
processing facilities to address contaminants, such as E. coli and
salmonella, which are likely to be found in these products. While
quantifying the resources dedicated to rule-making activities is
difficult for the agencies, the costs are significant. FDA estimates
that it spent between $650,000 and almost $1 million to issue its
seafood HACCP rule in 1995.[Footnote 19] NMFS officials said they spent
$5 million to support the FDA rule by developing a model seafood
surveillance project. USDA was unable to calculate how much it spent to
develop its meat and poultry HACCP rule.
In some cases, the agencies collaborate in the early stages of
rulemaking. For example, USDA and FDA participated in a joint Listeria
monocytogenes (listeria) risk analysis of ready-to-eat foods. However,
the agencies will promulgate separate listeria rules for the products
under their jurisdiction.
Agencies Have Numerous Interagency Agreements to Coordinate Food Safety
Activities, but Tracking Mechanisms and Implementation Are Weak:
The principal food safety agencies--USDA, FDA, EPA, and NMFS--have
entered into 71 interagency agreements to coordinate the full range of
their food safety activities and to support their mission to protect
the public health. About one-third of the agreements include as
objectives, the coordination of activities, reductions in overlaps,
and/or leveraging of resources. The agencies' ability to take full
advantage of these agreements is hampered by the absence of adequate
mechanisms for tracking them and, in some cases, by ineffective
implementation of the provisions of these agreements.
Many Interagency Agreements Address Inspection and Enforcement and One-
Third Highlight the Need to Reduce Duplication and Overlap:
Of the 71 interagency agreements we identified, the largest proportion
(43 percent) reflect the agencies agreement to increase cooperation on
inspection and enforcement activities. The agencies also spent the
largest share of their food safety resources on these activities (as
fig. 2 showed). Other agreements address activities such as
education/outreach, food security, and monitoring/surveillance related
to food safety and quality (as shown in fig. 6). Furthermore, 24
agreements specifically highlight the need to reduce duplication of
effort by clarifying responsibilities, reducing overlaps, and/or making
efficient and effective use of resources. Appendix III provides
additional information about the 71 agreements.
Figure 6: Food Safety-Related Interagency Agreements by Program
Function:
[See PDF for image]
[End of figure]
In some instances, the agencies entered into multiple agreements to
coordinate and ensure the safety of a single type of food. For example,
we identified seven agreements that focus on seafood inspection and
enforcement activities; signatories to one or more of these agreements
include USDA, FDA, NMFS, the Department of Defense, and the Interstate
Shellfish Sanitation Conference (ISSC).[Footnote 20]
In addition to these formal interagency agreements, the agencies
cooperate through other mechanisms such as the Foodborne Diseases
Active Surveillance Network (also known as FoodNet) that USDA, FDA, and
the Centers for Disease Control and Prevention use to help track the
incidence of foodborne illness and track the effectiveness of food
safety programs in reducing foodborne illness. Agency officials also
noted that they informally cooperate and collaborate with one another
on a regular basis.
Controls for Tracking Food Safety Agreements Are Weak:
USDA, FDA, EPA, and NMFS do not have adequate mechanisms to track
interagency food safety agreements. Consequently, the agencies could
not readily identify the agreements that they have entered into, could
not determine which agreements are still in effect, and were unable to
determine which are still needed. As a result, we could not determine
which agreements are currently being used by the agencies. Agency
officials did not agree on the number of food safety-related agreements
they have entered into, and only 7 of the 71 agreements that we
ultimately compiled were identified to us by all signatory agencies.
For example, FDA and EPA provided a copy of an agreement they had
entered into with USDA about residues in drugs, pesticides, and
environmental contaminants in foods; however, USDA officials said the
agency is not party to any agreement on residues. Forty-one additional
agreements were identified to us by only one of the multiple
signatories. In addition, we found three agreements--through our prior
work or Internet searches--that none of the agencies had identified to
us.
Of the agencies we reviewed, only USDA's Animal and Plant Health
Inspection Service maintained a database that allowed it to readily
identify all the agreements it was party to. The other agencies did not
have such databases. During the course of our review, EPA officials
said that, without such tools, they had difficulty identifying the
agreements they have entered into. Officials also said they are
planning to develop an electronic system to identify and track these
agreements. EPA said that, if developed, this system could offer one
means of tracking and managing information related to, and contained
in, interagency agreements.
The weaknesses in tracking agreements may also affect the agencies'
ability to determine whether these agreements are still needed and
whether specific provisions are still in effect. First, about one-third
of the agreements we identified were created decades ago and may no
longer be relevant to current needs. Technological and scientific
advances have made some provisions of these agreements obsolete.
Second, some agencies that were party to the agreements have ceased to
exist because of internal reorganizations; but the agreements have not
been modified to reflect such changes, indicating that the agencies may
not be actively monitoring the status and relevance of these
agreements. For example, a 1978 agreement between USDA and FDA on
education programs to assist livestock and poultry producers in using
animal drugs has not been modified to reflect the fact that USDA's
Science and Education Administration no longer exists. Also, we found
that some agreements have not been updated to account for changes in a
signatory's responsibilities since they were signed. For example, NMFS
officials said that the ISSC has taken on some responsibilities that
once belonged to NMFS and that the 1985 agreement on shellfish-growing
waters signed by FDA, EPA, NMFS, and the U.S. Department of the
Interior's Fish and Wildlife Service should be updated to reflect this
change.
Agencies Are Not Fully Implementing Two Comprehensive Interagency
Agreements That Could Eliminate Duplication of Effort and Leverage
Resources:
Because the agencies spend most of their food safety resources on
inspection and enforcement, we evaluated the implementation of two
comprehensive inspection and enforcement agreements: one that pertains
to DJEs and one that pertains to inspections of fishery products. These
agreements were established to make more efficient and effective use of
agency resources through improved coordination and information sharing.
Although the agencies are exchanging some information as called for in
the agreements, they are generally missing opportunities to make more
effective and efficient use of their resources, such as leveraging
inspection and enforcement resources.
USDA and FDA Agreement to Exchange Information About Establishments
That Are Subject to the Jurisdiction of Both Agencies and to Permit
More Efficient Use of Resources:
In 1999, USDA and FDA signed an interagency agreement to facilitate the
exchange of information between the agencies about food-processing
facilities that they both inspect. The agreement stated that the
exchange of information will permit more efficient use of both
agencies' resources and contribute to improved public health
protection. The agreement was to be the first step toward allowing
USDA's FSIS inspectors to conduct FDA's inspections at DJEs, according
to a former USDA senior food safety official who signed the agreement.
The agreement was developed in response to a 1997 report by the
President's Food Safety Council,[Footnote 21] which recommended
increased cooperation among agencies. Specifically, the report
recommended that USDA and FDA take steps to ensure that the resources
and experience of FDA and USDA's FSIS be used as efficiently as
possible to avoid duplication of effort and that the agencies consider
using FSIS inspectors to conduct FDA inspections at DJEs. The report
stated that because FSIS inspectors are already in these plants, they
could be used to maximize use of federal resources without loss of
inspection coverage for FSIS-regulated foods.
In 2000, USDA and FDA evaluated the agreement's implementation and
concluded that the experience had been largely successful because the
agencies learned about each other's operations and about ways to
cooperate more effectively. However, the evaluation also included
recommendations to strengthen, clarify, or otherwise improve the
agreement's implementation. Among other things, the evaluation
recommended that FDA provide FSIS with access to FDA's inspection
database, ensure more frequent updates to the list of jointly regulated
facilities, and train inspectors on the provisions of the agreement.
The evaluation cited the potential for significant resource savings
over time as the agreement is implemented, particularly in personnel,
administrative, and travel costs. Since the 2000 evaluation, officials
at USDA and FDA said they have not again monitored the agreement's
effectiveness, nor have they implemented their own recommendations to
realize resource savings.
We found that the agencies are not systematically exchanging
information about DJEs, as called for in the agreement. First, the
agreement called for USDA and FDA to develop, maintain, and annually
update a list of such establishments. We found that although the
agencies created such a list in 1999 when the agreement was signed,
they had not updated it until 2004, when we brought the matter to their
attention. As a result, the agencies had great difficulty identifying
the current number of DJEs to which this agreement pertains. For
example, during the course of our review, USDA and FDA provided several
different lists of jointly regulated establishments. The number of
establishments that were listed ranged from 1,152 to 1,867. In December
2004, FDA headquarters officials provided us a list of 1,451 known
DJEs, and the agency is verifying approximately 400 establishments that
may be added to the list.
Second, the agreement calls for the district offices of each agency to
share certain findings with their counterpart district offices and for
the agency receiving a finding of noncompliance to track and use that
information in its program evaluation, work planning, and consideration
of whether action against the facility is warranted. The agreement also
calls for the receiving agency to inform the notifying agency of the
disposition of the notification, including any actions that it plans or
takes, within 30 days. During field visits to three USDA and FDA
district offices that, together, are responsible for food safety in 13
states, we found that USDA and FDA field inspection personnel are not
routinely communicating these findings of mutual concern, such as
sanitation problems at facilities they jointly regulate.[Footnote 22]
Nor have USDA and FDA explored the feasibility of developing a system
to track and exchange information when each agency finds instances of
noncompliance. As a result, work planning by each agency cannot take
advantage of the other agency's inspection findings.
Because FDA inspectors visit DJEs less frequently than USDA inspectors,
we believe that FDA staff could benefit from the compliance information
that USDA inspectors collect.[Footnote 23] Generally, problems with a
facility's manufacturing processes or sanitation procedures affect all
products produced at the establishment. As a USDA district official
told us, "a rodent doesn't distinguish between FDA-regulated products
and USDA-regulated products, so a problem affecting one agency's
product is likely to affect the other agency's product."
Third, the agreement calls for the agencies to explore the feasibility
of granting each other access to appropriate computer-monitoring
systems so each agency can track inspection findings. However, the
agencies maintain separate databases, and the inspectors with whom we
spoke continue to be largely unaware of a facility's past history of
compliance with the other agency's regulations. Inspectors told us that
compliance information might be helpful when inspecting DJEs so that
they could focus attention on past violations.
Fourth, the agreement calls for the agencies to develop and provide
appropriate training in the inspectional techniques and processes of
each agency to ensure that the contacts for each agency have an
appropriate understanding of the working of the other agency. In
addition, the 2000 evaluation found that more training was needed,
particularly at the field level, to achieve the results of the
agreement. Although USDA and FDA held 28 joint training sessions during
the first year of the agreement's implementation, no additional
training has been provided since then. Because USDA and FDA on-site
inspectors are often the first agency staff to become aware of
deficiencies at a plant, effective sharing of this type of information
depends upon those inspectors being adequately trained.
According to agency officials, the agreement has helped agency
coordination and communication, particularly when major public health
concerns arise. USDA and FDA headquarters officials identified
instances of major enforcement actions resulting from FDA's
notification to USDA of problems with products under its jurisdiction.
For example, in one case, FDA investigators learned that a sample of
chicken salad tested positive for listeria and alerted USDA, resulting
in a voluntary recall. In a second case, USDA and FDA cooperated by
exchanging information on a severe rodent infestation at a DJE,
resulting in the seizure of millions of pounds of USDA-and FDA-
regulated product. In addition, USDA and FDA district managers were
able to assist each other during the recall of beef and beef products,
after the December 2003 discovery of a cow infected with bovine
spongiform encephalopathy (BSE, also known as mad cow disease).
However, we found that the stated purpose of the agreement--which is to
facilitate an exchange of information permitting more efficient use of
both agencies' resources and contributing to improved public health
protection--has not been maximized. USDA and FDA are not making better
use of each other's inspection resources to reduce overlap and
duplication of effort, particularly at establishments that both
agencies inspect. Depending on the type and layout of the facility, a
USDA inspector may have a more regular presence in an area where FDA-
regulated products are maintained. For example, at a plant that
produces both meat and seafood products, a USDA inspector told us that
as part of his daily routine inspections he walks through the seafood
processing and storage section of the plant. (See fig. 7). However,
because FDA regulates seafood, the USDA inspector does not monitor or
inspect the seafood storage section. The inspector noted that, with
minimum training on seafood temperature controls, he could inspect this
section of the plant as well. USDA officials at headquarters said the
agency's inspectors are capable of taking on FDA's inspection
responsibilities at jointly regulated facilities, given the proper
resources and training.
Figure 7: Diagram of a Jointly Regulated Food Processing Facility:
[See PDF for image]
[End of figure]
FDA-NMFS Agreement on Common Responsibilities Regarding Inspection
Activities for Fishery Products:
A 1974 agreement between FDA and NMFS recognizes the two agencies'
related responsibilities for inspecting seafood facilities and
standardization activities, and it details actions the agencies can
take to enable each agency to discharge its responsibilities as
effectively as possible. The agreement states that these actions should
minimize FDA inspections in the approximately 275 domestic seafood
facilities that NMFS inspects under contract, as long as FDA's
inspection requirements are followed. Among other items in the
agreement:
* FDA is to (1) request information about NMFS-inspected products when
FDA is considering an enforcement action, (2) provide timely
notification to NMFS of any products seized from NMFS-inspected plants,
(3) inform NMFS of FDA industry guidelines and its standards for
establishing compliance action levels, and (4) invite NMFS inspectors
to observe FDA inspections of companies under contract to NMFS.
* NMFS is to (1) supply FDA headquarters with a list of all NMFS-
inspected processing and packing establishments; (2) apply FDA
requirements to NMFS-inspected products and establishments and decline
to inspect, grade, or certify products that FDA would consider
adulterated or misbranded; (3) upon request, provide FDA with
information on NMFS-inspected products when FDA is taking or
considering compliance action; and (4) cooperate with FDA in
investigations of food poisoning, product recalls, and problems
concerning food contamination caused by disasters or other phenomena.
* FDA and NMFS may meet periodically and, when appropriate, with
industry to promote better communication and understanding of
regulations, policy, and statutory responsibilities. If either agency
believes that a particular violation is occurring in several seafood-
processing plants, it may request a meeting with the other agency to
consider investigative steps and, when necessary, mutually agreeable
remedial action.
We found that FDA is not using the agreement to minimize its
inspections in seafood plants that NMFS has inspected and certified as
meeting FDA's safety standards. FDA officials said the agency does not
recognize the NMFS inspections as aiding FDA in enforcing pertinent
statutes. As a result, FDA is missing opportunities to leverage
inspection resources and possibly avoid duplication of effort.
In addition, we found that FDA is not carrying out provisions in the
agreement. For example, FDA rarely provides notification of seizure
actions it takes against NMFS-inspected plants, as outlined in the
agreement. Furthermore, according to a senior NMFS official, NMFS
communicates its inspection results to FDA, but FDA does not share its
results with NMFS.
FDA officials recently said they do not rely on NMFS' inspection
information for two reasons. First, NMFS conducts a fee-for-service
inspection, and therefore, FDA officials believe that NMFS could have a
conflict of interest because, as a nonregulatory body, it is paid for
its services by the industry that it inspects. Second, FDA does not
know which firms NMFS is inspecting at any given time. FDA officials
said the list of firms NMFS inspects changes, depending on market
fluctuations that affect each company's need for NMFS' services.
Furthermore, FDA officials said that they already have a risk-based
system in place to determine which firms to inspect, and at what
frequencies, and that NMFS' inspections are not a factor in its
determination of risk.
NMFS officials disagreed with FDA's reasons for not using NMFS
inspection results. First, they pointed out that NMFS's relationship to
industry is similar to USDA's Agricultural Marketing Service, which
also conducts fee-for-service grading and certification of poultry,
meat, eggs, and other agricultural commodities. Second, NMFS officials
said they maintain an up-to-date list of firms that the agency inspects
and post this information on its Web site, most recently revised in
January 2005.[Footnote 24] NMFS readily provided us with a list of the
firms it was inspecting when we spoke with officials during the course
of our review.
Although FDA is not implementing the agreement, the agency has
recognized the potential benefits of working with NMFS to leverage
resources. In a January 2004 letter to the Under Secretary of Commerce
for Oceans and Atmosphere,[Footnote 25] the then-Commissioner of Food
and Drugs proposed ways that the two agencies could enhance
coordination, including commissioning NMFS inspectors to help FDA meet
its public health responsibilities. The Commissioner noted that using
NMFS inspectors could be cost effective because the NMFS inspectors may
already be on-site and the FDA inspector therefore would not have to
travel to conduct an inspection.
FDA has not used NMFS inspection resources under the terms of the
fishery products agreement, nor has the agency used its authority under
the Bioterrorism Act to commission NMFS officials. However, FDA used
this authority to commission CBP officers to assist FDA at ports of
entry. FDA officials said the agency has not yet considered using the
act to enter into similar agreements with other federal agencies. NMFS
officials said the agency would be willing to enter into such an
agreement with FDA, thereby assisting FDA in reaching its goal of
conducting annual inspections at all high-risk facilities.
Industry and Other Stakeholders Disagree on the Significance of Overlap
in the Federal Food Safety System and on How to Improve It:
Industry associations, food-processing companies, consumer groups, and
academic experts we contacted disagree on the significance of
overlapping activities in the federal food safety system. However, most
of these stakeholders agree that the laws and regulations governing the
system should be modernized so that science and technological
advancements can be used to more effectively and efficiently control
current and emerging food safety hazards. While we found agreement
among the stakeholders about the need for modernization, they differed
about whether food safety functions should be consolidated into a
single federal agency.
Stakeholders Disagree about Overlaps in the Federal Food Safety System:
The stakeholders we contacted disagree on whether federal agencies'
food safety functions overlap, specifically with regard to inspections.
Industry associations that we spoke with, such as the Food Products
Association,[Footnote 26] National Fisheries Institute, American Frozen
Food Institute, and Grocery Manufacturers of America, told us that
overlaps occur but do not harm the safety of food and therefore are not
significant. These overlaps, they noted, occur primarily in dual
jurisdiction establishments--those regulated by both USDA and FDA-
-or facilities inspected by both FDA and NMFS. However, some overlaps
occur outside these establishments. For example, although the United
Fresh Fruit and Vegetable Association's (UFFVA) member companies are
primarily inspected and regulated by FDA, companies that sell fruit and
vegetables to the school meals programs are also inspected by USDA.
UFFVA officials pointed out that USDA inspects fruits and vegetables to
be included in school lunches; and the companies, already subject to
FDA inspections, incur additional expenses for these USDA inspections.
UFFVA also cited overlaps in USDA's and FDA's sampling and testing for
pesticides and microbiological contaminants on fruits and vegetables.
Other stakeholders, including the U.S. Tuna Foundation and the American
Meat Institute, reported that they do not think the federal agencies'
programs overlap because USDA and FDA have specific, defined areas of
responsibility for their industries. The U.S. Poultry and Egg
Association added that the regulatory delineations do not always make
sense, citing the split jurisdiction between USDA and FDA over the
regulation of eggs. Specifically, FDA regulates an egg farm as a "food
factory" within its area of jurisdiction, and USDA regulates plants
that process eggs into products such as powdered eggs.
Other stakeholders--generally food companies that are regulated by both
USDA and FDA--told us that overlaps can be burdensome. These
stakeholders did not see the added value of FDA's once-a-year (or less)
inspections, because USDA inspectors already visit their plants daily.
For example, managers at these facilities told us the following:
* At an egg-and potato-processing company, each agency uses different
frequencies for monitoring and ensuring food safety, with USDA
inspecting the physical plant, usually daily, while FDA's inspections
usually take place annually. According to a senior plant manager, FDA's
inspections place more responsibility for food safety on the company.
From the manager's perspective, the most effective inspection strategy
would be to combine elements of both agencies' inspections into a
single inspection program.
* At a facility that produces USDA-and FDA-regulated foods on three
different production lines, the facility must maintain different sets
of paperwork for each food that the company processes in order to meet
USDA and FDA HACCP and sanitation requirements. Since the USDA
inspector is at the facility every day, the manager said he does not
see any value added by FDA's inspection because that inspector examines
the same areas of the facility--the processing lines and the
refrigerated storage area--which are covered by the USDA inspector.
* A facility that cans a variety of soups and bean products experienced
contradictory instructions from USDA and FDA during overlapping
inspections. USDA inspectors did not want the company to paint its
sterilization equipment because they determined that paint chips could
contaminate the food. Subsequently, an FDA inspector told the company
to paint the same equipment because he determined that it would be
easier to identify sanitation problems on lightly painted equipment
than on the dark-colored metal. The manager of the facility said the
company had to paint and then remove the paint from equipment in order
to satisfy both the USDA and FDA inspectors.
In addition, at a seafood-processing plant that is inspected by both
NMFS and FDA, the manager said that when FDA collects product samples
for testing, it does not report test results in a timely fashion.
According to the manager, NMFS inspections are preferable because the
agency is able to provide test results more rapidly than FDA, which,
according to the manager, allows the company to know its products are
safe before they enter the market.
A few stakeholders also saw value in some of the overlapping
activities. For example:
* The American Frozen Food Institute noted that USDA and FDA
inspections and their complementary expertise--independent scientific
assessment, research, and education--provide value in addressing food
safety issues.
* The quality assurance manager at a dual jurisdiction establishment
with whom we spoke said he liked having a "second pair of eyes"
inspecting the facilities for food safety. The company produces smoked
salmon--a high-risk food--and the manager noted that having inspections
by FDA and NMFS helps to ensure that products are safe and of high
quality.
Most Stakeholders Recognize the Need to Modernize the Food Safety
System but Differ on What Approach to Take:
The majority of stakeholders we contacted said they believed that the
federal food safety system needs to be modernized, though they did not
agree on what direction this modernization should take. Stakeholders'
views included (1) minor changes to improve coordination among the food
safety agencies, (2) statutory changes to make the system more science
and risk based, and (3) consolidating federal food safety functions
into a single agency.
Some large industry associations (e.g., the Grocery Manufacturers of
America, the Food Products Association, the American Frozen Food
Institute, the National Fisheries Institute, and the United Fresh Fruit
and Vegetable Association) saw the need for only minor changes within
the existing regulatory framework to enhance communication and
coordination among the existing agencies. Some industry officials said
that the current food safety system protects consumers, and they cited
decreases in illnesses caused by foodborne bacteria, such as salmonella
and listeria. The Grocery Manufacturers of America said that the food
safety system must be flexible enough to allow resources to be directed
toward identifying and addressing serious food safety problems but that
this alteration would not require changing the food safety structure.
The Grocery Manufacturers of America also reported that the current
food safety system could be enhanced, and perhaps made more efficient,
through enhanced interagency coordination.
Other stakeholders--including representatives from industry
associations, academia, consumer groups, public policy organizations,
and individual food companies--believe that the system needs to be
modernized through statutory changes to make it more science and risk
based. According to the Consumer Federation of America, a science-or
risk-based system should consider not only the risk posed by the food
but also the history of the plant--whether is has a track record for
producing high quality, safe food. Resources for the Future[Footnote
27] stated that the current food safety laws undermine a successful
food safety system. That is, the laws do not build prevention into the
farm-to-table continuum and divide responsibility and accountability
for food safety among federal agencies. Further, the laws prevent risk-
based allocation of resources across the federal food safety agencies.
Further, USDA's carcass-by-carcass organoleptic inspections exemplify
the outmoded requirements of the current food safety system and cannot
identify and control the microbiological hazards associated with meat
and poultry products, such as E. coli O157:H7. Additionally, such
inspections waste resources because new technologies are more efficient
and effective. For example, the manager at a jointly regulated canned-
goods company told us that daily inspections of meat and poultry
products is wasteful and inefficient for most, if not all, heat-
processed meat and poultry products, such as canned chicken or pork,
since the canning process kills all the bacteria. Some stakeholders,
including the Institute for Food Technologists, believe that
modernizing the food safety system could be accomplished by rewriting
the food safety statutes.
Finally, some of the stakeholders that cited the need for modernization
also believe that these changes should be accompanied by consolidation
of federal food safety programs into a single agency for the following
reasons:
* Consolidation of functions could allow a single food agency to manage
the safety of the whole food chain, not just its parts, according to
food safety experts at the Center for Science in the Public Interest,
the Consumer Federation of America, and the University of Illinois.
* Consolidation would eliminate overlap between the agencies,
especially at DJEs, according to several individual companies, and
could generate substantial savings in terms of administrative
efficiency and overall consistency in the application of policy,
according to the Food Marketing Institute and food safety experts at
Kansas State University and the University of Georgia.
* The legislative changes needed to accomplish consolidation could also
be used as the vehicle for modernizing the food safety statutes or
establish a scientific basis for distributing food safety resources,
according to several individual food companies and food safety experts
at the Center for Science at the Public Interest and Resources for the
Future.
The stakeholders we contacted also identified a number of roadblocks to
changing the system, whether or not they supported such consolidation.
First, industry is reluctant to change from a familiar regulatory
framework to one that is untested. According to the Food Marketing
Institute, food companies tend to prefer the inspection process that is
known to them. Second, according to some industry associations, a
transition to a single agency could create a period of uncertainty, as
limited resources are diverted from the existing programs, and could
therefore cause vulnerabilities in the food supply. Third, the
transition costs to a single agency would be higher in the short term,
according to food safety experts at the University of Illinois and the
University of California. Fourth, current agency employees would be
concerned that a consolidation would adversely change their working
lives and that institutional knowledge would be lost. Finally, some
stakeholders, including the Consumer Federation of America, said that
some congressional committees may be reluctant to lose jurisdiction
over food safety functions.
Conclusions:
We recognize that current statutory authorities require the food safety
agencies to carry out regulatory activities that have resulted in some
overlapping or duplicative activities. We have recommended in the past
that federal food safety statutes be streamlined and that food safety
functions be consolidated into a single agency to ensure the logical
and most effective use of government resources and to protect
consumers.
Even within the current statutory framework, the agencies can take
practical steps to reduce overlap and duplication and thereby free
resources for more effective oversight of food safety. The Congress has
recognized this possibility in the Bioterrorism Act by authorizing FDA
to commission other agencies' officials to conduct FDA's inspection
activities. Other avenues are open to the agencies as well. For
example, the two interagency agreements that we examined in detail,
could address problems in duplicative inspections if they were more
effectively implemented. Other interagency agreements designed to
reduce overlap might also prove fruitful. By not effectively
implementing these agreements and by not exercising the new authorities
under the Bioterrorism Act, the agencies are missing opportunities to
make the system more efficient and effective.
Recommendations for Executive Action:
We are making seven recommendations designed to reduce or eliminate
duplication and overlaps, leverage existing resources, and enhance
coordination efforts among the principal federal food safety agencies.
We recommend that the Secretary of Agriculture and the Commissioner of
the Food and Drug Administration work together to:
* ensure the implementation of the interagency agreement that calls
for, among other things, sharing inspection-and enforcement-related
information at food-processing facilities that are under the
jurisdiction of both agencies;
* examine the feasibility of establishing a joint training program for
food inspectors; and:
* consider the findings of USDA's foreign country equivalency
evaluations when determining which countries to visit.
To better use FDA's limited inspection resources and leverage USDA's
resources, we recommend that, if appropriate and cost effective, the
Commissioner of the Food and Drug Administration, as authorized under
the Pubic Health Security and Bioterrorism Preparedness and Response
Act of 2002, 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.
To better use FDA's limited inspection resources and leverage NMFS's
resources, we recommend that the Commissioner of the Food and Drug
Administration and the Under Secretary of Commerce for Oceans and
Atmosphere ensure the implementation of the interagency agreement that
calls for FDA to recognize the results of NMFS inspections when
determining the frequency of its seafood inspections.
To strengthen management controls and maximize the effectiveness of
interagency agreements that are designed to reduce overlap, increase
coordination, and leverage resources, we recommend that the Secretary
of Agriculture, the Commissioner of the Food and Drug Administration,
the Administrator of the Environmental Protection Agency, and the Under
Secretary of Commerce for Oceans and Atmosphere:
* identify and inventory all active interagency food safety-related
agreements and:
* evaluate the need for these agreements and, where necessary, update
the agreements to reflect recent legislative changes, new technological
advances, and current needs.
Agency Comments and Our Response:
We provided USDA, HHS, EPA, and NOAA with a draft of this report for
their review and comment. We received written comments on the report
and its recommendations from USDA, HHS, and NOAA. EPA provided minor
technical comments.
In commenting on a draft of this report, USDA expressed serious
reservations about the report, asserting that it oversimplifies food
safety regulatory functions within USDA and FDA and that it exaggerates
the extent of regulatory overlap. USDA appears to have misinterpreted
the focus of this report, and we disagree with USDA's characterization.
This report examines overlapping activities rather than the regulatory
framework that allows these activities. Nevertheless, the report
contains a clear and accurate acknowledgment that the agencies operate
under a statutory framework that gives them different authorities and
responsibilities to regulate different segments of the food supply.
While we recognize that the agencies operate under different
authorities, the activities they perform under these authorities are
similar in nature, leading us to question why the federal agencies must
continue to spend resources on overlapping, and sometimes duplicative,
food safety activities. For example, we disagree with USDA's assertion
that the agencies' inspection activities are vastly different. As we
identify in the report, these inspections have sufficiently common
features, including the verification of sanitation procedures and good
manufacturing practices at food processing facilities that make them
candidates for consolidation within one agency. USDA's comments and our
detailed response are contained in appendix V.
In commenting on a draft of this report, HHS raised concerns about our
terminology regarding overlapping activities. We disagree with HHS
comment that our report's title should substitute the word duplication
for overlap. That is, our report distinguishes between "overlap"--which
we define as those similar activities being performed by more than one
agency and "duplication"--which we define as essentially identical
activities performed by more than one agency. Given the definitions we
lay out in the report, if we modified the title as HHS suggests, we
would risk implying that the agencies are literally duplicating efforts
in every instance, even though we are fully aware that, under the
current statutory framework, the agencies do not exactly replicate food
safety activities. We also disagree with HHS's comment that our report
overstates similarities in USDA and FDA inspections because, as our
report clearly states, USDA and FDA inspections have similar key
elements: sanitation, good manufacturing practices, and HACCP
compliance oversight. It also makes it clear that USDA and FDA
inspections vary depending on whether the product is a USDA-or FDA-
regulated food product. Furthermore, we disagree with HHS's comment
that the training programs are vastly different. As our report
discusses, FDA's training curriculum includes dozens of courses that
address topics common to USDA and FDA. Overall, HHS agreed with three
of the report's seven recommendations, including (1) the usefulness of
USDA's foreign country evaluations, (2) identifying and inventoring all
interagency agreements, and (3) the need to evaluate and update the
agreements. HHS disagreed with our recommendation regarding joint
training of USDA and FDA food inspectors. HHS took no position on our
recommendation for using the Bioterrorism Act authorities. Finally, HHS
partially concurred with two other recommendations dealing with the
implementation of two interagency agreements. HHS also provided
technical comments which we incorporated in our report, as appropriate.
HHS's comments and our detailed response are contained in appendix VI.
EPA did not provide official comments, but it provided minor technical
comments that we incorporated as appropriate. The technical comments
noted that EPA will consider GAO's recommendation for better tracking
of interagency agreements when the agency sets priorities for future
investments in information technology.
NOAA provided written comments and agreed with the report's
recommendations that pertain to NMFS. NOAA also commented that our
report does a fair and thorough job of describing the food safety
activities of NMFS. NOAA stated that the positions expressed in GAO's
previous work continue to be germane to the issue of coordination with
FDA on inspections of seafood.[Footnote 28] NOAA's comments are
contained in appendix VII.
As agreed with your offices, unless you publicly release the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. We are sending copies of this report to the
Secretary of Agriculture, the Acting Commissioner of the Food and Drug
Administration, the Acting Administrator of the Environmental
Protection Agency, and the Under Secretary of Commerce for Oceans and
Atmosphere. In addition, this report will be available at no charge on
the GAO Web site at [Hyperlink, http://www.gao.gov].
If you or your staffs have any questions concerning this report, I can
be reached at (202) 512-3841, or [Hyperlink, robinsonr@gao.gov]. Major
contributors to this report are included is appendix VIII.
Signed by:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
[End of section]
Appendixes:
Appendix I: Scope and Methodology:
To identify overlaps that may exist in the federal food safety system,
we collected fiscal year 2003 budget data for food safety-related
activities from the U.S. Department of Agriculture (USDA), the Food and
Drug Administration (FDA), the Environmental Protection Agency (EPA),
and the National Marine Fisheries Service (NMFS).[Footnote 29] We
selected these agencies because they have broad food safety-related
inspection and enforcement related responsibilities, the function to
which most federal food safety funding is dedicated. We defined
overlaps as similar activities being performed by more than one agency,
such as training food inspectors. In contrast, we defined duplication
as essentially identical activities performed by more than one agency,
such as inspecting the same food-processing facility for compliance
with sanitation and good manufacturing practices requirements. We used
categories of food safety activities contained in the National Academy
of Science's 1998 report Ensuring Safe Food to group the agencies' food
safety activities.[Footnote 30] These categories include:
monitoring/surveillance, inspection/enforcement, education/outreach,
research, and risk assessment. We included three additional
categories-- food security, administration, and rulemaking/standard
setting--to capture other relevant activities. We defined the
categories of food safety activities into the following program
functions:
* Monitoring/Surveillance: activities related to the monitoring of
foodborne illness or disease, as well as monitoring the agents of
illness in the food supply, including the collection of baseline data
for contaminants;
* Inspection/Enforcement: activities related to ensuring compliance
with agency food safety regulations, including premarket application or
petition approval;
* Education/Outreach: activities related to communicating food safety-
related information or guidance to the public, industry, or agencies'
other clients;
* Research: activities related to the study of food safety-related
topics, which support agency policy decisions;
* Risk assessment: activities related to evaluation of the likelihood
and severity of an adverse event (e.g., illness or death) on the public
health as a result of the likelihood of exposure to a particular hazard;
* Food security: activities related to preparing for and responding to
deliberate attacks on the food supply;
* Administration: supporting activities that enable the agencies to
perform their food safety responsibilities. Examples of administrative
activities include: procurement, human resources support, financial
management, travel management, and information technology support; and:
* Rulemaking/Standard setting: activities related to food safety policy
decisions, development of regulations, and administration of regulatory
review processes.
Specifically, we obtained actual expenditures and staffing level data
in full-time equivalents (FTE) from the following USDA units:
Agricultural Marketing Service; Agricultural Research Service; Animal
and Plant Health Inspection Service; Cooperative State Research,
Education, and Extension Service; Economic Research Service; Grain
Inspection, Packers and Stockyards Administration; Food Safety and
Inspection Service; and National Agricultural Statistics Service. We
also obtained data from the following FDA units: Center for Food Safety
and Applied Nutrition, Center for Veterinary Medicine, National Center
for Toxicological Research, and Office of Regulatory Affairs. EPA's
Office of Pesticide Prevention and Office of Water, as well as the
NMFS's Seafood Inspection Program and Office of Sustainable Fisheries
also provided data. To assess the reliability of the staffing and
expenditure data, we questioned knowledgeable agency officials and
reviewed existing documentation regarding the data and the systems that
produced them. We determined that the data were sufficiently reliable
for the purposes of identifying overlaps.
After the agencies provided budget data, we contacted agency budget and
program officials to determine what activities were linked to the
expenditure and staffing data. We categorized expenditures and staffing
and asked agency officials if they considered our categorizations to be
appropriate. We adjusted our categorization when agency officials told
us it was inaccurate. In some cases, the agencies' preferred
categorization of the same activity varied. For example, FDA considered
inspector training as an education/outreach activity, whereas USDA
considered it an inspection-related activity. These discrepancies are
noted in appendix II. After we categorized the budget and staffing
level data, we identified cases in which more than one agency performed
similar activities. In some instances, the agencies estimated budget
and staffing levels, or they were unable to separate budget data into
specific categories. As a result, some agencies did not provide
expenditures and staffing data for categories such as administration,
food security, and rulemaking. The agencies' officials explained that
these expenditures are distributed among more than one of the other
categories.
To examine the extent to which federal food safety agencies are using
interagency agreements to leverage existing resources to reduce any
such overlaps, we requested that agencies provide copies of all active
interagency food safety-related agreements, and we selected two
agreements to analyze their implementation.[Footnote 31] We compared
the agreements that the agencies provided to determine where there were
differences. In the cases where agency signatories provided us an
agreement, and one or more agency signatories did not, we followed up
with those agencies to reconcile the discrepancies. In some cases, we
provided the agreement to an agency to obtain confirmation that it was
a signatory to the agreement. We asked the agencies to categorize the
agreements according to primary program function. We also independently
categorized the agreements using information from their introduction
and/or background to ensure consistent categorization across the
agencies. If the agencies' categorization differed with ours, we
considered their rationale and changed the categorization as
appropriate.
We selected two inspection-related interagency agreements for in-depth
review because the agencies spend most of their resources on inspection
activities; one agreement that pertains to dual jurisdiction
establishments (DJE) and one that pertains to inspections of fishery
products. In addition, these agreements encompassed a broad range of
intended coordination efforts between the agencies involved. We
conducted site visits to three USDA and FDA field offices to obtain
information related to implementation of the agreements. The site
visits included USDA district offices in Philadelphia, Pennsylvania and
Boulder, Colorado; and FDA district offices in Philadelphia,
Pennsylvania; Denver, Colorado; and Seattle, Washington, which are
responsible for food safety in a total of 13 states. We met with USDA
and FDA district managers, inspectors, and other staff to discuss the
agreement's implementation. We also selected two to four DJEs at each
location and visited them to discuss implementation of the agreements
with plant managers and, in some cases, with USDA or FDA inspectors
assigned to these facilities. In some cases, we accompanied inspectors
as they conducted inspections of the facilities.
To obtain the views of regulated industry and other stakeholders
regarding opportunities to reduce overlap by consolidating federal food
safety functions, we contacted a total of 35 stakeholders from food
industry associations, food manufacturers, consumer groups, and
academic experts using a structured interview format consisting of 22
questions. In selecting associations, organizations, and experts, we
included contacts from our previous reports and testimonies and
considered recommendations from USDA, FDA, EPA, and NMFS. In selecting
which food manufacturers to interview, we used Food Processing's Top
100 Companies to identify the largest food manufacturers. Of those
companies, we selected and contacted food manufacturers that have
facilities that produce food regulated by both USDA and FDA.
We conducted our review from May 2004 through March 2005 in accordance
with generally accepted government auditing standards.
[End of section]
Appendix II: Food Safety Expenditures and Staffing Levels for Fiscal
Year 2003:
We asked agencies within USDA, FDA, EPA, and NMFS to provide all
expenditures and staffing levels, in FTEs, related to food safety
activities they conducted in fiscal year 2003. Tables 3 and 4
categorize these expenditures and staffing levels according to program
function. Though most agencies were able to identify expenditures and
staffing levels related to inspection and enforcement, research, risk
assessment, education and outreach, and monitoring and surveillance--
many were unable to provide expenditures linked to rulemaking and
standard setting, food security, and administration. For this reason,
table 4 containing this data is included separately. As table 3 shows,
inspection and enforcement-related spending accounts for most of these
agencies' food safety-related spending in fiscal year 2003.
[This page left blank intentionally]
Table 3: Food Safety Expenditures and Staffing Levels by Agency, Fiscal
Year 2003:
Dollars in thousands.
Program function: Inspection/Enforcement: Expenditures; USDA: FSIS:
$636,841;
USDA: APHIS: $28,220;
USDA: GIPSA: $100;
Total: $665,162;
FDA: CFSAN: $4,529[B];
FDA: ORA: $214,297[C];
Total: $218,826;
EPA: 21,798;
DoC: NMFS: $15,000;
Grand total: $920,786.
Program function: Inspection/Enforcement: Staffing level; USDA: FSIS:
8,494;
USDA: APHIS: 293;
Total: 8,787;
FDA: CFSAN: 27;
FDA: ORA: 1,817;
Total: 1,844;
EPA: 4;
DoC: NMFS: 155;
Grand total: 10,790.
Program function: Research: Expenditures; USDA: ARS: $88,724;
USDA: CSREES: $18,221;
USDA: NASS: $2,473;
USDA: ERS: $525;
Total: $109,943;
FDA: CFSAN: $33,318[D];
FDA: CVM: $10,571[E];
FDA: NCTR: $7,000[F];
FDA: ORA: $4,197[G];
Total: $55,086;
EPA: 10,813;
Grand total: $175,842.
Program function: Research: Staffing level; USDA: ARS: 243;
USDA: CSREES: 4;
USDA: NASS: 11;
USDA: ERS: 4.5;
Total: 263;
FDA: CFSAN: 192;
FDA: CVM: 53;
FDA: NCTR: 48;
FDA: ORA: 47;
Total: 340;
EPA: 49;
Grand total: 652.
Program function: Risk Assessment: Expenditures; USDA: FSIS: $41,408;
USDA: ARS: $6,208;
USDA: CSREES: $2,516;
USDA: ERS: $25;
USDA: AMS: $21,908;
Total: $72,065;
FDA: CFSAN: $8,553h;
Total: $8,553;
EPA: 61,785;
DoC: NMFS: $7,000;
Grand total: $149,403.
Program function: Risk Assessment: Staffing level; USDA: FSIS: 294;
USDA: ARS: 15;
USDA: CSREES: 0.5;
USDA: ERS: 0.25;
USDA: AMS: 39;
Total: 349;
FDA: CFSAN: 70;
Total: 70;
EPA: 362;
DoC: NMFS: 5 7;
Grand total: 781.
Program function: Education/Outreach: Expenditures; USDA: FSIS: $9,993;
USDA: CSREES: $8,240;
USDA: ERS: $50;
Total: $18,283;
FDA: CVM: $810[I];
FDA: ORA: $59,033[J];
Total: $59,843;
EPA: 29,477;
Grand total: $107,603.
Program function: Education/Outreach: Staffing level; USDA: FSIS: 82;
USDA: CSREES: 2;
USDA: ERS: 0.5;
Total: 85;
FDA: CVM: 11;
FDA: ORA: 502;
Total: 513;
EPA: 116;
Grand total: 714.
Program function: Surveillance/Monitoring: Expenditures; USDA: FSIS:
[A];
USDA: ERS: $25;
USDA: APHIS: $22,438;
Total: $22,463;
FDA: CFSAN: $72,456[K];
FDA: CVM: $17,844l;
Total: $90,300;
Grand total: $112,763.
Program function: Surveillance/Monitoring: Staffing level; USDA: ERS:
0.25;
USDA: APHIS: 94;
Total: 94.25;
FDA: CFSAN: 486;
FDA: CVM: 85;
Total: 578;
Grand total: 665.
Total expenditures:
USDA: FSIS: $688,242;
USDA: ARS: $94,932;
USDA: CSREES: $28,977;
USDA: NASS: $2,473;
USDA: ERS: $625;
USDA: APHIS: $50,658;
USDA: AMS: $21,908;
USDA: GIPSA: $100;
Total: $887,916;
FDA: CFSAN: $118,856;
FDA: CVM: $29,225;
FDA: NCTR: $7,000;
FDA: ORA: $277,527;
Total: $432,608;
EPA: 123,873;
DoC: NMFS: $22,000;
Grand total: $1,466,397.
Total staffing;
USDA: FSIS: 8,870;
USDA: ARS: 258;
USDA: CSREES: 7;
USDA: NASS: 11;
USDA: ERS: 6;
USDA: APHIS: 387;
USDA: AMS: 39;
Total: 9,578;
FDA: CFSAN: 775;
FDA: CVM: 149;
FDA: NCTR: 48;
FDA: ORA: 2,366;
Total: 3,345;
EPA: 531;
DoC: NMFS: 212;
Grand total: 13,659.
Source: GAO analysis of USDA, FDA, EPA, and DOC expenditure and
staffing information.
Notes: Other program functions include rulemaking/standard setting,
food security, and administration. Because many agencies did not
provide expenditure and staffing level data specific to these
functions, they are included in table 4 below for the agencies that
provided these data separately.
FDA's Office of Financial Management's expenditure tracking is
characterized by specific terminology. This terminology is provided
below in table notes b through l, with references to data in the table.
FSIS categorized inspector training activities as
inspection/enforcement, whereas FDA categorized them as
education/outreach.
EPA's budget numbers reflect a greater level of resources than those
directly related to food safety since the numbers include other program
activities integral to pesticide risk assessment and risk management
(e.g., worker protection and environmental assessments).
EPA expenditures and staffing levels include state grants and
Headquarters/Regional resources for pesticide program activities in the
Office of Pesticide Programs, Office of Enforcement & Compliance
Assurance, and Office of Research & Development. Office of Water
resources for shellfish protection and water quality criteria are also
included.
NMFS inspection/enforcement expenditures are financed solely through
revenues generated by user fees.
[A] FSIS did not provide expenditures related specifically to
surveillance and monitoring.
[B] Post market Inspections.
[C] Post market Inspections; a portion of these expenditures relating
to animal drugs and feeds were multiplied by a factor of 0.95 to
account for the percent of these activities that are considered food
safety related.
[D] Premarket applied research and post market applied research.
[E] Premarket applied research and post market applied research,
multiplied by a factor of 0.85 to account for the percent of these
activities that are considered food safety related.
[F] Post market applied research; data provided by FDA officials.
[G] Post market applied research.
[H] Post market laboratory analysis (domestic and imports).
[I] Premarket outreach/coordination (domestic).
[J] Premarket outreach/coordination.
[K] Surveillance estimate provided by FDA officials.
[L] Post market outreach/coordination/compliance, subtracting $950,000
and multiplied by a factor of 0.85 to account for the percent of the
activities that are considered food safety related.
[End of table]
Table 4: Other Food Safety Expenditures and Staffing Levels by Agency,
Fiscal Year 2003:
Dollars in thousands.
Program function: Rulemaking/Standard setting: Expenditures; FDA:
CFSAN: $28,448;
FDA: CVM: $19,322;
FDA: Total: $47,770;
EPA: Total: $36,840;
Grand total: $84,610.
Program function: Rulemaking/Standard setting: Staffing Level; FDA:
CFSAN: 176;
FDA: CVM: 141;
FDA: Total: 310;
EPA: Total: 241;
Grand total: $551.
Program function: Food security: Expenditures; USDA: FSIS: $1,838;
USDA: APHIS: $10,072;
USDA: Total: $11,910;
Grand total: $11,910.
Program function: Food security: Staffing Level; USDA: FSIS: 11;
USDA: Total: 11;
Grand total: $11.
Program function: Administration: Expenditures; USDA: FSIS: $116,027;
USDA: Total: $116,027;
Grand total: $116,027.
Program function: Administration: Staffing Level; USDA: FSIS: 469;
USDA: Total: 469;
Grand total: $469.
Total expenditures;
USDA: FSIS: $117,865;
USDA: APHIS: $10,072;
USDA: Total: $127,937;
FDA: CFSAN: $28,448;
FDA: CVM: $19,322;
FDA: Total: $47,770;
EPA: Total: $36,840;
Grand total: $212,547.
Total staffing;
USDA: FSIS: 480;
USDA: Total: 480;
FDA: CFSAN: 176;
FDA: CVM: 141;
FDA: Total: 310;
EPA: Total: 241;
Grand total: 1,031.
Source: GAO analysis of USDA, FDA, EPA, and DOC expenditure and
staffing information.
Notes: FDA CFSAN's rulemaking expenditures are labeled Premarket Review
in FDA budget documents. CVM's rulemaking expenditures are labeled
Premarket Review, adding $950,000 and multiplied by a factor of 0.85 to
account for the percent of the activities that are considered food
safety related.
CFSAN rulemaking expenditures are mainly premarket approval activities;
FDA's CVM rulemaking expenditures are composed of pre-and post-market
approval activities.
FDA officials estimate that 7 percent of their total expenditures
relate to administrative activities.
[End of table]
[End of section]
Appendix III: Food Safety-Related Interagency Agreements:
We solicited all active food safety-related interagency agreements from
USDA, FDA, EPA, and NMFS. Table 5 categorizes the 71 agreements by
program function. Twenty-four agreements state the need to reduce
duplication of effort, reduce or clarify overlaps, or increase the
efficient or effective use of resources between agencies. Table 5 also
provides the year each agreement became effective and indicates the
signatory agencies. The bolded agreements are the two that were
analyzed in-depth.
Table 5: Food Safety-Related Interagency Agreements by Primary Program
Function:
Program function: (number of agreements): Inspection/Enforcement (31);
Title: Alcohol Labeling Enforcement; Date: 1971;
Agency signatories: FDA;
Other signatories: Treasury.
Title: Responsibility of Alcohol Beverages Adulterated under FFDCA;
Date: 1987;
Agency signatories: FDA;
Other signatories: Bureau of Alcohol, Tobacco, and Firearms.
Title: Inspection, Sampling, & Examination of Imported Dates & Date
Material[A];
Date: 1985[B];
Agency signatories: FDA;
Agency signatories: USDA.
Title: Inspection and Standardization Activities Related to Food
Products[A];
Date: 1975[B];
Agency signatories: FDA;
Agency signatories: USDA.
Title: Inspection, Sampling & Examination of Imported Raisins[A]; Date:
1973;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Import of Biological Specimen under the US-USSR Scientific
Exchange Agreement;
Date: 1974;
Agency signatories: FDA;
Agency signatories: USDA;
Other signatories: National Institutes of Health.
Title: Inspection Program for Fishery Products[A]; Date: (number of
agreements): 1974; Agency signatories: FDA;
Agency signatories: NMFS.
Title: Enforcement of Laws Against Illegal Commerce in Molluscan
Shellfish[A];
Date: (number of agreements): 1986; Agency signatories: FDA;
Agency signatories: NMFS.
Title: Inspection and Certification of Fish and Fishery Products; Date:
(number of agreements): 1980; Agency signatories: NMFS;
Other signatories: (number of agreements): Department of Defense.
Title: Inspection of Industrial Fishery Products Intended for Animal
Feed Use[A];
Date: (number of agreements): 1975; Agency signatories: FDA;
Agency signatories: USDA;
Agency signatories: NMFS.
Title: Inspection of Nonmeat Products for the Child Nutrition Labeling
Program;
Date: (number of agreements): 1988[B]; Agency signatories: USDA;
Agency signatories: NMFS.
Title: To Screen for Chloramphenicol Adulteration of Shrimp for the
FDA's ORA;
Date: (number of agreements): 2003; Agency signatories: FDA;
Agency signatories: NMFS.
Title: Improve Sanitation & Quality of Shellfish; Date: (number of
agreements): 1984; Agency signatories: FDA;
Other signatories: (number of agreements): Interstate Shellfish
Sanitation Conference.
Title: Salmonella Inspection & Sampling Coverage of Dry Milk Products
Plants[A];
Date: (number of agreements): 1987[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Administering and Enforcing the Egg Products Inspection Act;
Date: (number of agreements): 1996[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Recall & Disposal of Class I and II Recalled Products for Human
Consumption;
Date: (number of agreements): 1984; Agency signatories: FDA;
Agency signatories: USDA.
Title: General War Food Inspection[A]; Date: (number of agreements):
1983[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Shipment of Foods, Drugs & Cosmetics[A]; Date: (number of
agreements): 1976; Agency signatories: FDA;
Other signatories: (number of agreements): Interstate Commerce
Commission.
Title: Delineate Areas of Jurisdiction of Signatories for
Administration of CPS Act[A];
Date: (number of agreements): 1976; Agency signatories: FDA;
Other signatories: (number of agreements): U.S. Consumer Product Safety
Commission.
Title: Sanitary Quality of Milk Products Shipped Interstate; Date:
(number of agreements): 1977; Agency signatories: FDA;
Other signatories: (number of agreements): National Conference of
Interstate Milk Shipments.
Title: Inspection & Standardization of Grain, Rice, Pulses & Food
Products;
Date: (number of agreements): 1985[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Exchange of Information on Foods & Cosmetic Recalls and
Hazardous Food Situations;
Date: (number of agreements): 1982; Agency signatories: FDA;
Other signatories: (number of agreements): Department of Defense.
Title: Status of Animal Biological Products[A]; Date: (number of
agreements): 1982; Agency signatories: FDA;
Agency signatories: USDA.
Title: Federal Regulatory Activities Concerning Residues of
Environmental Contaminants[A];
Date: (number of agreements): 1984; Agency signatories: FDA;
Agency signatories: USDA;
Agency signatories: EPA.
Title: Testing of Domestic & Imported Peanuts; Date: (number of
agreements): 1997[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Testing of Imported In-shell Brazil Nuts; Date: (number of
agreements): 1997[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Testing of Imported In-shell Pistachio; Date: (number of
agreements): 1997[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Exchange of Information on Dual Jurisdiction Establishments[A];
Date: (number of agreements): 1999[B]; Agency signatories: FDA;
Agency signatories: USDA.
Title: Cross-Utilization of Inspection and Grading Personnel (meat)[A];
Date: (number of agreements): 1992; Agency signatories: USDA;
Agency signatories: NMFS.
Title: Cross-Utilization of Inspection and Grading Personnel (fruit and
vegetables)[A];
Date: (number of agreements): 1993; Agency signatories: USDA;
Agency signatories: NMFS.
Title: To Allow FDA to Commission CBP Officers; Date: 2003;
Agency signatories: FDA;
Other signatories: Customs and Border Protection.
Program function: (number of agreements): Education/; Outreach (14);
Title: Coordination of Industry Education Efforts; Date: 1978;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Feeding Programs in Head Start Centers[A]; Date: 1989;
Agency signatories: FDA;
Other signatories: Department of Health and Human Services'
Administration for Children, Youth, and Families.
Title: Cooperative Efforts in Food Safety, Nutrition & Veterinary
Medicine;
Date: 1989;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Establish Working Relationship between CFP and FDA; Date: 1993;
Agency signatories: FDA;
Other signatories: Conference for Food Protection.
Title: Foodborne Illness Education Activities of FSIS; Date: (number of
agreements): 1994; Agency signatories: FDA;
Agency signatories: USDA.
Title: Science-Based Consumer-Oriented Messages to Promote Safe Food;
Date: (number of agreements): 1997; Agency signatories: FDA;
Agency signatories: USDA;
Other signatories: (number of agreements): Centers for Disease Control
and Prevention, Department of Education.
Title: Cooperative Training and Research; Date: (number of agreements):
2000; Agency signatories: FDA;
Agency signatories: USDA;
Other signatories: (number of agreements): University of Puerto Rico.
Title: FSIS-Antimicrobial Detection Tests; Date: (number of
agreements): 2003; Agency signatories: FDA;
Agency signatories: USDA.
Title: Interagency Cooperation and Coordination in the Regulatory
Oversight of Biotechnological Products; Date: (number of agreements):
2003; Agency signatories: FDA;
Agency signatories: USDA;
Agency signatories: EPA;
Other signatories: (number of agreements): Department of State, U.S.
Geological Service.
Title: To Enhance the Cross-Training Capabilities of Both Organizations
to Reach Their Audiences[A];
Date: (number of agreements): 2003; Agency signatories: USDA;
Other signatories: (number of agreements): U.S. Fire Administration.
Title: Establishment of Food Product Evaluation Team for Defense Supply
Center;
Date: (number of agreements): 2000; Agency signatories: USDA;
Agency signatories: NMFS.
Title: Shellfish Safety Assistance Project for the Interstate Shellfish
Sanitation Conference;
Date: (number of agreements): 2004[B]; Agency signatories: FDA;
Agency signatories: NMFS.
Title: Support Pesticide Applicator Training Activities by the State
Cooperative Extension Service;
Date: (number of agreements): 2003[B]; Agency signatories: USDA;
Agency signatories: EPA.
Title: USDA/IR-4 Biopesticide Demonstration Grant Program[A]; Date:
2004;
Agency signatories: [Empty];
Agency signatories: USDA;
Agency signatories: EPA;
Agency signatories: [Empty];
Other signatories: [Empty].
Program function: (number of agreements): Food security (7); Title:
Technical Expertise for Radiological Contamination Testing of Meat,
Poultry & Egg Products;
Date: 2004;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Aberdeen Accept and Analyze High-Risk Samples for Biological
Agents;
Date: [C];
Agency signatories: USDA;
Other signatories: U.S. Army.
Title: Development of Interagency Emergency Guidelines and Best
Practices for Response to Food and Agriculture Incidents; Date: 2004;
Agency signatories: FDA;
Agency signatories: USDA;
Other signatories: Department of Homeland Security, National
Association of State Departments of Agriculture.
Title: Develop a Rapid Reverse Trancriptase-Polymerase Chain Reaction
(RT/PCR) Test for the Detection and Serotyping of Vesicular Stomatitis
Virus (VSV);
Date: 2001;
Agency signatories: USDA;
Other signatories: Department of Defense.
Title: To Bring Together Two Workplans regarding the Possible Detection
and Identification of Biological Agents[A]; Date: 2003;
Agency signatories: USDA;
Other signatories: Department of Defense.
Title: To Comply with the Statutory Obligations of the Bioterrorism Act
of 2002;
Date: 2002;
Agency signatories: USDA;
Other signatories: Centers for Disease Control and Prevention.
Title: Transfer of USDA-APHIS inspectors to DHS[A]; Date: 2003;
Agency signatories: USDA;
Other signatories: Department of Homeland Security.
Program function: (number of agreements): Surveillance/; Monitoring
(5);
Title: Joint Salmonella Enteritidis Risk Reduction Program; Date: 1992;
Agency signatories: FDA;
Agency signatories: USDA.
Title: National Antimicrobial Resistance Monitoring Survey (NARMS);
Date: 2004;
Agency signatories: FDA;
Agency signatories: USDA;
Other signatories: Centers for Disease Control and Prevention.
Title: Safe Importation and Biocontainment of Diseases of Livestock and
Poultry;
Date: 2002;
Agency signatories: USDA;
Other signatories: Centers for Disease Control and Prevention.
Title: Mercury in Recreational Finfish of the Gulf of Mexico; Date:
2004;
Agency signatories: EPA;
Agency signatories: NMFS.
Title: Shellfish Growing Waters[A]; Date: 1985;
Agency signatories: FDA;
Agency signatories: EPA;
Agency signatories: NMFS;
Other signatories: U.S. Department of the Interior's Fish and Wildlife
Service.
Program function: (number of agreements): Administration (5); Title:
Animal Production and Food Safety[A]; Date: 1999;
Agency signatories: FDA;
Agency signatories: USDA;
Agency signatories: EPA;
Other signatories: Centers for Disease Control and Prevention,
Department of Defense.
Title: Expand Number of PHS Commissioned Corps Officers Detailed to
FSIS;
Date: 2003;
Agency signatories: USDA;
Other signatories: Department of Health and Human Services.
Title: Standardization Document Preparation & Technical Support for
Food;
Date: (number of agreements): 1981; Agency signatories: USDA;
Agency signatories: NMFS.
Title: To Share Information between Pest Management Programs; Date:
(number of agreements): 2004; Agency signatories: USDA;
Agency signatories: EPA.
Title: To Form the Foodborne Outbreak Response Coordinating Group[A];
Date: 1998;
Agency signatories: FDA;
Agency signatories: USDA;
Agency signatories: EPA;
Other signatories: Centers for Disease Control and Prevention.
Program function: Standard setting (4); Title: To Establish Through
Regulations, Standards for the NLAP; Date: 1996;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Sanctioning of Food Ingredients and Sources of Radiation; Date:
2000;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Sharing Information on Herbicide Tolerant Crops; Date: 2000;
Agency signatories: USDA;
Agency signatories: EPA.
Title: Collaboration with Respect to the Implementation of the Public
Health Pesticides Provisions of FQPA; Date: 2000;
Agency signatories: EPA;
Other signatories: Centers for Disease Control and Prevention.
Program function: (number of agreements): Risk assessment; (3); Title:
National Advisory Committee on Microbiological Criteria for Foods;
Date: 2004;
Agency signatories: FDA[D];
Agency signatories: USDA;
Agency signatories: NMFS.
Title: USDA Pesticide Data Program; Date: (number of agreements): 1992;
Agency signatories: FDA;
Agency signatories: USDA;
Agency signatories: EPA.
Title: NCHS/CDC IAG-NHANES Dietary Consumption & Human Biomonitoring
Data Acquisition & Analysis;
Date: 2003;
Agency signatories: EPA;
Other signatories: Centers for Disease Control and Prevention.
Program function: (number of agreements): Research; (2); Title: Animal
Care & Welfare[A];
Date: 1983;
Agency signatories: FDA;
Agency signatories: USDA.
Title: Collaborative Efforts to Make Alternative Pest Management
Materials and Techniques Available to Producers; Date: 1996[B];
Agency signatories: USDA;
Agency signatories: EPA.
Source: GAO analysis of agreements provided by USDA, FDA, EPA and NMFS
or identified by GAO.
[A] The agreement explicitly recognizes the need to reduce duplication
of effort, reduce or clarify overlaps, or increase the efficient or
effective use of resources between agencies.
[B] Date of the most recent revision or amendment to a previously
existing agreement.
[C] The agreement is undated.
[D] FDA is not a signatory to this agreement; however, the agency is a
sponsor for the committee.
[End of table]
[End of section]
Appendix IV: Principal Federal Laws Related to Food Safety:
As we have noted in this and other reports, the federal framework for
food safety is based on a patchwork of numerous laws. Table 6 lists the
30 laws that we have identified as the principal federal laws related
to food safety in order of their enactment, along with the agency or
agencies that have food safety responsibilities under each law and a
brief discussion or example of each law's food safety-related
provisions. Included in the table are several laws that primarily deal
with health claims or labeling, which we consider to be food-safety
related, as well as some laws that are largely amendments of the
Federal Food, Drug and Cosmetic Act. This table does not provide an
exhaustive list of all food safety-related laws and amendments, nor
does it detail all of the food safety provisions for those laws listed.
Table 6: The 30 Principal Laws Related to Food Safety:
Law: Lacey Act of 1900, ch. 553, 31 Stat. 187 (1900) (codified in part
at 16 U.S.C. § 3371);
Agency: Department of Commerce (NMFS), USDA; Food safety provisions:
The act makes it a federal crime to import, export, sell, or transport
in interstate commerce any plant, fish, or wildlife in violation of
state law. The act has been used to prosecute individuals who sell
plants, fish, or wildlife for human consumption in violation of state
law.
Law: Federal Meat Inspection Act, ch. 2907, 34 Stat. 1256, 1260 (1907)
(codified at 21 U.S.C. § 601);
Agency: USDA;
Food safety provisions: The act governs the slaughtering of livestock
and the processing and distribution of meat products in the United
States, authorizing the Secretary of Agriculture to prescribe the rules
and regulations of sanitation covering slaughtering, meat canning,
salting, packing, rendering, or similar establishments in which cattle,
sheep, swine, goats, horses, mules, and other equines are slaughtered
and the meat and meat food products thereof are prepared for commerce.
Law: Federal Trade Commission Act, ch. 311, 38 Stat. 717 (1914)
(codified at 15 U.S.C. § 41);
Agency: FTC;
Food safety provisions: The act prohibits the dissemination of false
advertisements for the purpose of inducing the purchase or having an
effect upon commerce of foods, drinks, or chewing gum. The act provides
for penalties for such false advertisements if the use of the commodity
may be injurious to health.
Law: United States Grain Standards Act, ch. 313, 39 Stat. 482 (1916)
(codified at 7 U.S.C. § 71);
Agency: USDA;
Food safety provisions: The act provides for the inspection, weighing,
and grading of grain. Under the act, all corn exported from the United
States generally must be tested for aflatoxin contamination.
Law: Import Milk Act of February 15, 1927, ch. 155, 44 Stat. 1101
(1927) (codified at 21 U.S.C. § 141); Agency: FDA;
Food safety provisions: The act prohibits the importation of milk or
cream into the United States without a permit and sets standards for
when milk and cream shall be considered unfit for import.
Law: Perishable Agricultural Commodities Act, 1930, ch. 436, 46 Stat.
531 (1930) (codified at 7 U.S.C. § 499a); Agency: USDA;
Food safety provisions: The act regulates the sale of perishable
agricultural commodities and protects sellers delivering their produce
on essentially cash terms.
Law: Federal Alcohol Administration Act, ch. 814, 49 Stat. 977 (1935)
(codified at 27 U.S.C. § 201);
Agency: Treasury;
Food safety provisions: The act requires that alcoholic beverages for
sale or distribution in the United States have a warning label.
Law: Federal Food, Drug and Cosmetic Act, ch. 675, 52 Stat. 1040 (1938)
(codified at 21 U.S.C. § 301);
Agency: FDA, EPA;
Food safety provisions: The act and its regulations set forth food and
drug labeling requirements, as well as requirements for animal drugs.
The act seeks to ensure the purity of the nation's food supply, and
accordingly bans "adulterated" and "misbranded" food from interstate
commerce. Under the act, EPA regulates the amount of pesticide that may
remain on food products.
Law: Federal Seed Act, ch. 615, 53 Stat. 1275 (1939) (codified at 7
U.S.C. § 1551);
Agency: USDA, DHS;
Food safety provisions: The act establishes seed labeling requirements,
including the requirement for a caution statement such as "Do not use
for food or feed or oil purposes" on seeds that have been chemically
treated when the amount of chemicals remaining with the seeds is
harmful to humans or other vertebrate animals.
Law: Public Health Service Act, ch. 373, 58 Stat. 682 (1944) (codified
at 42 U.S.C. § 201);
Agency: FDA, CDC;
Food safety provisions: Under the act, CDC engages in public health
activities related to food safety and foodborne diseases. FDA is
authorized under the act to promulgate regulations to prevent the
spread of communicable diseases, including foodborne illnesses.
Law: National School Lunch Act, ch. 281, 60 Stat. 230 (1946) (codified
at 42 U.S.C. § 1751);
Agency: USDA;
Food safety provisions: The act required the development of a policy
and procedures to ensure that schools receive information regarding
irradiation technology and any other information necessary to promote
food safety in schools.
Law: Agricultural Marketing Act of 1946, ch. 966, 60 Stat. 1087 (1946)
(codified at 7 U.S.C. § 1621);
Agency: USDA, NMFS;
Food safety provisions: The act promotes a scientific approach to the
problems of marketing, transporting and distributing agricultural
products and authorizes the Secretary of Agriculture to "inspect,
certify, and identify the class, quality, quantity, and condition of
agricultural products." Under the act, USDA has, among other things,
established meat grading and acceptance services. The act also provides
authority for the Seafood Inspection Program, which eventually was
transferred to the Department of Commerce.
Law: Federal Insecticide, Fungicide and Rodenticide Act, ch. 125, 61
Stat. 103 (1947) (codified at 7 U.S.C. § 136); Agency: EPA;
Food safety provisions: The act governs pesticide registration and safe
use of pesticides.
Law: Poultry Products Inspection Act, Pub. L. No. 85-172, 71 Stat. 441
(1957) (codified at 21 U.S.C. § 451); Agency: USDA;
Food safety provisions: The act governs the slaughtering, processing,
and distribution of poultry products.
Law: Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat.
1784 (1958);
Agency: FDA;
Food safety provisions: The act amended the Federal Food, Drug and
Cosmetic Act to prohibit the use in food of additives which have not
been adequately tested to establish their safety.
Law: Fair Packaging and Labeling Act, Pub. L. No. 89-755, 80 Stat. 1296
(1966) (codified at 15 U.S.C. § 1451); Agency: FDA, FTC;
Food safety provisions: The act prescribes the placement, form, and
contents of a label's statement of the quantity of packaged goods. The
act supersedes all local regulation that is less stringent or requires
different information.
Law: Egg Products Inspection Act, Pub. L. No. 91-597, 84 Stat. 1620
(1970) (codified at 21 U.S.C. § 1031); Agency: USDA;
Food safety provisions: The act and its regulations set standards for
the quality, condition, weight, quantity, and grade of eggs produced
for commercial sale.
Law: Safe Drinking Water Act, Pub. L. No. 93-523, § 4, 88 Stat. 1660,
1694 (1974) (codified at 21 U.S.C. § 349); Agency: FDA, EPA;
Food safety provisions: The act, which amended the Federal Food, Drug
and Cosmetic Act, and its regulations establish standards for bottled
drinking water.
Law: Toxic Substances Control Act, Pub. L. No. 94-469, 90 Stat. 2003
(1976) (codified at 15 U.S.C. § 2601); Agency: EPA;
Food safety provisions: Under the act, EPA can regulate the use of
certain chemical substances in foods that present an unreasonable risk
to health. Under the authority granted by the act, EPA's Toxic
Substances Control Act Biotechnology Program regulates microorganisms,
such as biofertilizers, intended for commercial use that contain or
express new combinations of traits.
Law: Infant Formula Act of 1980, Pub. L. No. 96-359, 94 Stat. 1190
(codified at 21 U.S.C. § 350a);
Agency: FDA;
Food safety provisions: The act authorizes the Secretary to establish
requirements for infant formula for quality factors and good
manufacturing practices, including quality control procedures, to
assure that an infant formula provides required nutrients and is
manufactured in a manner designed to prevent adulteration of the infant
formula. The act also authorizes the Secretary to prescribe, by
regulation, the scope and extent of recalls of infant formulas
necessary and appropriate for the degree of risks to human health.
Law: Federal Anti-Tampering Act, Pub. L. No. 98-127, 97 Stat. 831
(1983) (codified at 18 U.S.C. § 1365); Agency: FDA, USDA;
Food safety provisions: The act prohibits tainting a consumer product
with intent to cause serious injury to the business of any person where
the consumer product affects interstate or foreign commerce. The act
also prohibits providing a materially false or misleading label or
container for a consumer product.
Law: Pesticide Monitoring Improvements Act of 1988, Pub. L. No. 100-
418, § 4701, 102 Stat. 1107, 1411 (1988) (codified at 21 U.S.C. §
1401);
Agency: FDA;
Food safety provisions: The act requires FDA to have in place
computerized data management systems to record, summarize, and evaluate
the results of its program for monitoring food products for pesticide
residues and requires FDA to provide information to EPA.
Law: Sanitary Food Transportation Act of 1990, Pub. L. No. 101-500, 104
Stat. 1213 (1990) (codified at 49 U.S.C. § 5701); Agency: DOT;
Food safety provisions: The act calls for the Department of
Transportation to issue regulations prohibiting the transportation of
food and food additives in motor or rail vehicles that are used to
transport refuse or nonfood products.
Law: Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535,
104 Stat. 2353 (1990);
Agency: FDA;
Food safety provisions: The act amended the Federal Food, Drug and
Cosmetic Act to prohibit the application of state quality standards to
foods moving in interstate commerce and to require labels of food
products sold in the United States to display nutritional information.
Law: Dietary Supplement Health and Education Act of 1994, Pub. L. No.
103-417, 108 Stat. 4325 (1994);
Agency: FDA;
Food safety provisions: The act amended the Federal Food, Drug and
Cosmetic Act to allow certain health claims for dietary supplements to
be made without petitioning the FDA. These include (1) statements
asserting a benefit related to a classical nutrient deficiency disease,
(2) claims about the role of a nutrient or dietary ingredient with
respect to the structure or function of the human body
("structure/function claims"), and (3) declarations of general well-
being from consumption of a nutrient or other dietary ingredient. Under
the act such claims are permitted if the manufacturer has
"substantiation" that the assertion is truthful and nonmisleading, if
the label expressly states that FDA has not evaluated the claim, and if
FDA is notified within 30 days of the first marketing of the product
that bears the claim.
Law: Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110
Stat. 1489 (1996);
Agency: EPA, USDA, HHS;
Food safety provisions: The act amended the regulatory scheme under the
Federal Insecticide, Fungicide and Rodenticide Act and the Federal
Food, Drug and Cosmetic Act to require EPA to reevaluate the safety of
pesticide tolerances on a set timetable.
Law: Food and Drug Modernization Act of 1997, Pub. L. No. 105-115, 111
Stat. 2296 (1997);
Agency: FDA;
Food safety provisions: The act amended the Federal Food, Drug and
Cosmetic Act and the Public Health Service Act to authorize health and
nutrient claims to be made for foods when certain criteria are met.
Law: Animal Health Protection Act, Pub. L. No. 107-171, § 10401, 116
Stat. 134, 494 (2002) (codified at 7 U.S.C. § 8301); Agency: USDA, DHS;
Food safety provisions: The act authorizes the Secretary to prohibit or
restrict movements of animals in interstate commerce to prevent the
dissemination of any pest or disease of livestock. The act also permits
the Secretary to order the destruction or removal of such animals.
Law: Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, Pub. L. No. 107-188, 116 Stat. 594 (2002); Agency: USDA,
FDA;
Food safety provisions: The act expands APHIS's authorities, including
activities to enhance methods of protecting against the introduction of
plant and animal disease organisms by terrorists. The act also provides
FDA with detention authority, expanded recordkeeping provisions, and
authorizes FDA to commission other federal officials to conduct
examinations and investigations of FDA-regulated foods at jointly
regulated facilities.
Law: Homeland Security Act of 2002, Pub. L. No. 107-296, 116 Stat. 2135
(2002);
Agency: DHS;
Food safety provisions: The act calls for the securing of critical
infrastructure and transfers functions relating to the agricultural
import and entry inspection activities under certain laws from the
Secretary of Agriculture to the Secretary of the Department of Homeland
Security.
Source: GAO analysis of federal laws.
[End of table]
[End of section]
Appendix V: Comments from the U.S. Department of Agriculture:
USDA:
United States Department of Agriculture: Office of the Secretary:
Washington, D.C. 20250:
MAR 9 2005:
Robert A. Robinson:
Managing Director, Natural Resources and Environment Team: United
States Government Accountability Office: 441 G Street, NW:
Washington, DC 20548:
Dear Mr. Robinson,
Please find the enclosed United States Department of Agriculture's
comments on the Government Accountability Office (GAO) draft report
entitled, "FOOD SAFETY: Federal Agencies Should Pursue Opportunities to
Reduce Overlap and Better Leverage Resources."
Sincerely,
Signed by:
Merle D. Pierson, Ph. D.
Acting Under Secretary for Food Safety:
U.S. Department of Agriculture (UDSA) Comments on Government
Accountability Office (GAO) Draft Report "FOOD SAFETY: Federal Agencies
Should Pursue Opportunities to Reduce Overlap and Better Leverage
Resources" GAO-05-213:
The Food Safety and Inspection Service (FSIS) has serious concerns
regarding both the interpretations of facts and assumptions contained
in this report. The report exaggerates the size and economic impact of
regulatory overlaps that exist between FSIS and the Food and Drug
Administration (FDA). Its recommendations also rely upon overly
simplistic interpretations of food safety authorities, regulations,
inspection requirements and training needs; as well as inaccurate
characterizations of coordination efforts and agreements between FSIS
and FDA.
In terms of food safety authorities, we are concerned that the report
overly simplifies the food safety regulatory functions within FSIS and
the FDA, and disregards the inherent complexities and differences of
our work. The breadth, complexity, and size of the U.S. food production
system lends itself to specialized government oversight. As this draft
report acknowledges, "The statutory framework underlying the U.S.
federal food safety system gives responsibility for specific food
commodities to different agencies and provides them with significantly
different authorities and responsibilities." It is therefore
confounding as to why the report continues on to assert in the
following sentence that, as a result, "federal agencies are spending
resources on similar activities."
As GAO is aware, FSIS operates under the legal and statutory
authorities of the Federal Meat Inspection Act, the Poultry Products
Inspection Act and the Egg Products Inspection Act. Under the
authorities and requirements of these acts, FSIS conducts daily
inspection of all meat, poultry, and egg products sold in interstate
commerce and re-inspects imported products to ensure that they meet
U.S. food safety standards. As a result, FSIS spends the majority of
its yearly funding on staffing and training to support these functions.
FDA, on the other hand, inspects establishments under its jurisdiction
less frequently utilizing an auditing system that relies heavily on
investigations. While FSIS and FDA inspection activities may seem
similar, they are in reality vastly different due to differences in
authorities and responsibilities. The areas of perceived funding and
resource overlap noted in the report actually reflect areas of
difference.
In terms of inspection requirements for dual jurisdiction
establishments (DJEs), GAO states that there is "significant" overlap
in inspection authorities. In actuality, DJEs comprise only a very
small percentage of the total number of establishments subject to
continuous inspection. A significant portion of DJEs are warehouses
which, unlike slaughter and processing facilities, do not require a
grant of inspection from FSIS. In light of the small number of DJE
establishments, and the level of resources dedicated to inspection in
these facilities already, the opportunity for cost savings is quite
small.
GAO also references a perceived regulatory overlap when discussing each
organization's Hazard Analysis and Critical Control Point (HACCP)
regulations. This draft report leaves the impression that FSIS and FDA
have comparable HACCP regulations that cover all products they each
respectively regulate. While it is true that the two sets of HACCP
regulations are quite similar, they diverge in matters that reflect the
different work of the two agencies. The report also seems to confuse
HACCP general principles with food specific hazards. While HACCP's
general principles remain constant, food specific hazards differ
greatly by product, thus necessitating differences in provisions and
how the rules are applied. USDA's HACCP regulations apply to all meat
and poultry products. FDA has two of its inspected commodities (seafood
and juices) under mandatory HACCP. While there are commonalities in the
USDA and FDA rules, there remain significant differences between FSIS
and FDA regulated industries under HACCP that dictate the necessity of
distinctly different regulations.
In discussing inspection requirements for imported products, GAO
asserts that "USDA and FDA both inspect shipments of imported food at
ports of entry and also visit foreign countries that export food to the
United States." This assertion oversimplifies and inaccurately
describes the food safety regulatory functions and systems within FSIS
and FDA, as well as the inherent differences in food products regulated
by FSIS and FDA, and by extension, the complexities of the systems and
processes needed to perform this work. In order for meat, poultry and
egg products to be eligible for import to the U.S., foreign food safety
regulatory systems must employ equivalent sanitary measures that
provide the same level of protection against food safety hazards as is
achieved domestically under USDA regulations. In addition, only a very
small number of USDA certified plants from within those approved
foreign countries may export products to the United States.
USDA shares information obtained during its foreign country equivalence
determinations with other federal agencies and makes available a wealth
of information on the FSIS website including foreign audit reports,
export requirements for U.S. producers, import requirements for foreign
countries, the equivalence process, port-of-entry procedures,
reinspection procedures, and labeling requirements.
Regarding training, FSIS believes the GAO report is misleading and
overly simplistic in its characterizations of the various agencies'
training programs. FSIS disagrees that it is feasible to create one
unified joint training program between FSIS and FDA covering all food
safety verification activities. The draft report cites as a successful
model the Federal Law Enforcement Training Center (FLETC). FSIS is
familiar with the training efforts at FLETC, and in fact, utilizes
training resources provided there. However, in our experience,
extensive work must be done to customize the course to meet the
training needs of FSIS personnel. In addition, FSIS must supply
personnel to conduct FLETC training of FSIS personnel through team
teaching to ensure that the knowledge gained from courses transfers to
the public health regulatory environment in which FSIS personnel
operate. This experience illustrates how an effort that might on the
surface appear to consolidate resources in fact requires constant work
and resources by both FLETC and FSIS in order for the training to be
successful.
Several factors affect the feasibility of conducting joint training
activities. Because the authorities and responsibilities at FDA and
FSIS differ, the policies, procedures, and the training on inspection
and enforcement strategies are by nature quite different. The products
regulated by the two agencies are different, and the hazards and public
health 3 risks associated with those products are different.
Additionally, there are significant differences in classification of
the job series of individuals performing inspection duties. The FSIS
inspection workforce includes technical as well as professional job
series positions, while FDA positions are predominantly professional
series. Moreover, the work environment of the two inspection workforces
is different. As a result, the course content and educational
strategies to train these two vastly different groups must by nature be
significantly different.
In spite of the factors outlined above, FSIS agrees that there is merit
in examining the feasibility of conducting joint training activities
when workable commonalities can be found and, in fact, has actively
sought ways to do just that. FSIS and FDA have recently collaborated to
provide joint training activities. Two retail meat and poultry
processing teleconferences have been conducted and the two agencies
have developed a retail meat and poultry processing training
curriculum. Moreover, FSIS and FDA jointly developed and are currently
implementing food security awareness training for the workforce and
local cooperators.
FSIS believes the implementation of the 1999 MOU has been largely
successful. FSIS and FDA significantly increased the effectiveness of
communications between the two agencies, heightened awareness of each
other's responsibilities and operations, initiated more frequent and
more effective cooperative efforts, and altered inspection and
investigational priorities as a result of the MOU. Additionally, the
FSIS Performance Based Inspection System (PBIS) will be modified to
include a field for indicating that an establishment is under dual
jurisdiction. This will enable FSIS to generate a real time list of
dual jurisdiction establishments. Again, while the areas of overlap are
quite small, the MOU assures that the agencies are communicating
effectively.
Finally, GAO appears to inaccurately characterize the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (the
Bioterrorism Act). While the Bioterrorism Act gave FDA the authority to
commission other federal officials to inspect FDA-regulated foods,
implementing such an agreement between FSIS and FDA would require a
considerable amount of planning and work. We believe the implementation
of such a plan has been oversimplified in the report. In fact, meat and
poultry are exempt under this act, and point that GAO has failed to
recognize. A comprehensive review would be required of the existing
regulatory authorities, training requirements, and reimbursement
issues. FSIS and FDA operate under different regulatory structures, and
roles and responsibilities would need to be carefully defined.
Nevertheless, to date, FSIS has already developed extensive
partnerships with other Federal-level food safety and security
agencies, and States to build a strong and vibrant food security
infrastructure to protect the public from the threat of intentional and
unintentional contamination of the food supply. In light of assessments
that showed significant gaps existed between the federal and state
governments when it came to coordinating efforts for prevention and the
response to any act of intentional contamination, FSIS entered into a
cooperative agreement with FDA, the Department of Homeland Security
(DHS), and the National Association of State Departments of Agriculture
to develop the best practices by which federal assistance can be
provided expeditiously and effectively.
FSIS and FDA also work closely with the White House and DHS to
coordinate our food security efforts, including participating in the
development and implementation of all Homeland Security Presidential
Directives. In order to enhance surveillance and incident response,
FSIS has partnered with other food safety agencies such as FDA and our
state counterparts to build an integrated laboratory system that would
not only monitor the food supply and share data, but also assist in
handling samples in the event of an emergency. This integrated system,
known as the Food Emergency Response Network, consists of federal and
state governmental laboratories responsible for handling the increasing
number of samples in the event of an emergency.
FSIS already works very closely with FDA, the Centers for Disease
Control and Prevention (CDC), and the Environmental Protection Agency,
as well as with State and local health agencies, to share information
about illnesses. FSIS, as well as FDA, are participants in PulseNet, a
national network of public health laboratories supported by the CDC.
PulseNet performs DNA fingerprinting on foodborne bacteria and assists
in the detection of foodborne illness outbreaks and traceback to their
sources, including detection of a linkage among sporadic cases.
PulseNet, combined with epidemiology, has been key in enabling Federal
agencies to rapidly detect and control outbreaks of naturally occurring
or intentionally introduced foodborne illness.
We also have a greater appreciation for interacting more closely with
intelligence and law enforcement communities. In addition to hiring
Import Surveillance Liaison Inspectors to work with DHS's Customs and
Border Patrol at ports of entry around the nation, we are also building
stronger relationships with other intelligence and enforcement
agencies, such as the Federal Bureau of Investigation, the Central
Intelligence Agency, the Transportation Security Agency, and the Coast
Guard.
Additionally, FSIS has made many other strides in protecting food
security. After September 11, 2001, FSIS created the Office of Food
Security and Emergency Preparedness (OFSEP) to lead all food security
activities within the agency. OFSEP works to ensure effective
coordination on food security efforts throughout the Government.
Working with Federal partners, including FDA, CDC, DHS, USDA's Animal
and Plant Health Inspection Service (APHIS), the Department of Defense
(DOD), and the Environmental Protection Agency (EPA), and State
representatives, OFSEP develops preventive activities and rapid
response measures designed to protect the food supply. Through OFSEP's
leadership, the Agency has conducted numerous simulation exercises to
allow for a more efficient and effective response. FSIS has also made
significant enhancements to its Consumer Compliant Monitoring Systems
to allow it to serve as a real-time early warning system of a potential
attack on the food supply and has expanded its capability to test for
threat agents by constructing a biosecurity Level 3 laboratory.
At various times, there has been discussion about consolidating all
food safety, inspection, and labeling functions into one Agency with
the intention of increasing the effectiveness of the food safety
system. In 2002, the White House established a Policy Coordinating
Committee (PCC), led by the Domestic Policy Council and the National
Economic Council, to look into the issue of a single food agency. The
PCC concluded that the goals of the Administration are better advanced
through enhanced interagency coordination rather than through the
development of legislation to create a single food safety agency.
We must never lose sight of the fact that improving food safety and
public health is the one and only goal. The food safety system can be
configured in an endless array of forms, but if food safety and public
health are not improved, the system has failed the American public.
FSIS and FDA bases their policy decisions on science, so the
consolidated food safety agency discussion boils down to one question:
will there be a measurable benefit to public health? In other words,
would such an effort save lives and reduce foodborne illness rates? As
with any new food safety and security effort, we want to make sure that
we maintain and continue to improve public health. We must make sure
that any reconfiguration to the current food safety system effectively
improves food safety and public health. The data from countries that
have consolidated their food safety agencies suggests that there is not
a change in foodborne illness trends, and in some cases, the illness
rates have increased, after the creation of a single food safety
agency.
Conclusion:
In summary, the GAO report erroneously interprets the various agencies'
food safety authorities, regulations, inspection requirements and
training needs. FSIS conducts daily inspection of all meat, poultry,
and egg products sold in interstate commerce and re-inspects imported
products to ensure that they meet U.S. food safety standards. As a
result, FSIS spends the majority of its yearly funding on staffing and
training to support these public health functions. FDA inspects
establishments under its jurisdiction less frequently. While our food
safety systems and processes may seem similar at first glance, the
areas of perceived funding and resource overlap noted in the report are
actually quite different because of significant differences in
authorities and responsibilities. Additionally, the GAO report
exaggerates the size and impact of any overlaps that may exist between
FDA and FSIS.
The draft report states "federal agencies are spending resources on
similar activities," but this statement is flawed. In fact, the
statutory framework underlying the U.S. federal food safety system
gives responsibility for specific food commodities to different
agencies and provides them with significantly different authorities and
responsibilities.
Coordination between FSIS and FDA is very strong. Contrary to the
impression left by the report, FSIS maintains a strong working
relationship with its sister public health agencies. As partners in the
U.S. food safety efforts, FSIS and FDA routinely communicate and
coordinate with one another to ensure a safe and secure food supply.
The draft report highlights several good examples of coordination
between FSIS and FDA. These examples demonstrate that our very close
cooperation has minimized overlaps and redundancies and has promoted
efficiency.
The report overly simplifies the food safety regulatory functions
within the FSIS and FDA without regard to the inherent complexities and
differences of our work. FSIS believes the existing regulatory
framework and operations are working. As a result, the American food
supply continues to be among the safest in the world.
The following are GAO's comments on the U.S. Department of
Agriculture's letter dated March 10, 2005.
GAO Comments:
1. We disagree with USDA's assertion that our report overly simplifies
the food safety regulatory functions within USDA and FDA and that it
exaggerates the extent of regulatory overlap. USDA has misinterpreted
the focus of this report. This report examines overlapping activities
rather than the regulatory framework that allows these activities.
Nevertheless, the report contains a clear and accurate acknowledgment
that the agencies operate under a statutory framework that gives them
different authorities and responsibilities to regulate different
segments of the food supply. While we recognize that the agencies
operate under different authorities, the activities they perform under
these authorities are similar in nature, leading us to question why the
federal agencies must continue to spend resources on overlapping, and
sometimes duplicative, food safety activities.
We also disagree with USDA's assertion that the agencies activities are
vastly different. For example, we find that the agencies' inspection
activities to ensure that food manufacturers comply with regulatory
requirements are quite similar. As we document in our report, these
inspections have sufficiently common features, such as verifying proper
sanitation procedures at food processing facilities, that make these
inspections activities candidates for consolidation under one agency.
We further disagree with USDA's comment that the report's
recommendations rely upon overly simplistic interpretations of food
safety authorities, regulations, inspection requirements, and training
needs. To the contrary, our recommendations address specific areas
where the agencies could improve coordination to better leverage
resources. USDA did not comment directly on these recommendations.
2. We believe that USDA mischaracterizes our report in noting that it
states that a "significant" overlap in inspection authorities exists.
Specifically, our report examines inspection activities, not inspection
authorities, and certainly does not identify "significant" overlaps in
authorities. In fact, the report clearly states that, because of the
agencies' split jurisdiction, they are each responsible for inspecting
different food products at jointly regulated facilities. As a result,
both agencies send inspectors into these facilities--USDA on a daily
basis and FDA less regularly.
While we agree with USDA that the number of jointly regulated
establishments may be a relatively small portion of all regulated food
establishments, USDA and FDA had great difficulty identifying the
current number of jointly regulated facilities. Consequently, the
magnitude of potential savings is difficult to calculate. We continue
to believe that, because USDA maintains a daily presence at hundreds of
these facilities, FDA could make more effective use of its resources--
an average cost of $4,000 per inspection--if it redirected its
inspectors to other facilities for which FDA has sole jurisdiction.
3. Contrary to USDA's assertion, our report does not suggest that USDA
(FSIS) and FDA have comparable HACCP regulations. Instead, our report
clearly distinguishes between the elements of the agencies' HACCP
regulations that are comparable and those that are not. For example,
the report acknowledges that, given the agencies' different statutory
authorities, both require jointly regulated facilities to maintain
separate HACCP plans and states that the contents of these plans differ
because the agencies regulate different products. However, as USDA
itself notes, the two sets of HACCP regulations (USDA and FDA) are
quite similar, and as we point out, they have certain features in
common, such as certain sanitation and manufacturing processes.
Therefore, we continue to believe that USDA and FDA could consolidate
HACCP-based inspections at these jointly regulated facilities. To
provide further clarification on what commodities are currently subject
to HACCP regulations, we modified our report to indicate, as USDA
suggests, that FDA currently requires HACCP plans for seafood and juice
products only.
4. We disagree that our report oversimplifies or inaccurately describes
federal food safety functions at ports of entry. For example, USDA
noted that in order for meat and poultry and egg products to be
eligible for import to the United States, foreign food safety
regulatory systems must employ equivalent sanitary measures that
provide the same level of protection against food safety hazards as is
achieved domestically under USDA regulations. We disagree with USDA's
comment, because our report clearly and accurately describes the
requirement for certification of those countries wishing to export meat
and poultry into the United States, including a finding by the
Secretary of Agriculture that the countries have equivalent food safety
systems. The main point of our report is that the agencies are not
leveraging inspection resources at ports of entry, especially regarding
FDA-regulated imported foods that, according to USDA officials, are
being stored at USDA-approved inspection facilities. Therefore, we
continue to believe that there are opportunities to leverage inspection
resources, as we are recommending.
Furthermore, USDA's comment that it shares the results of its overseas
equivalency determinations contradicts what USDA and FDA officials told
us during the course of our review. However, we note that USDA is now
sharing this information. Indeed, FDA commented that it would consider
the results of USDA's foreign country equivalency determinations.
5. Any successful consolidation of inspectors' training would of course
require work. However, we continue to believe that, as USDA's comments
note, there is merit in examining the feasibility of conducting joint
training activities when workable commonalities can be found. Our
report identifies more than 100 courses in FDA's inspector training
curriculum that include topics common to both USDA and FDA.
6. We disagree with USDA's assertion that implementation of the 1999
interagency agreement has been largely successful. Our report
highlights several deficiencies, even as it gives the agencies credit
for improved communication in times of crisis, such as during major
recalls. These deficiencies include agencies' (1) difficulty
identifying the establishments to which this agreement pertains, (2)
lack of routine communication on inspection findings between agencies'
inspection personnel on such findings of mutual concern as sanitation
problems at jointly regulated facilities, and (3) lack of a system to
track and exchange information when each agency finds instances of
noncompliance. Finally, we also found that the agencies' efforts to
develop and provide training on each other's inspection techniques and
processes did not continue past the first year of the agreement's
implementation. As a result, we continue to believe that the stated
purpose of the agreement--to facilitate an exchange of information
permitting more efficient use of both agencies' resources--has not been
maximized.
We further disagree with USDA's comment that our report inaccurately
characterizes the Bioterrorism Act. As we state in the report, FDA is
authorized under the act to enter into an agreement to commission other
agency officials, including USDA officials, to carry out inspections on
its behalf--for FDA-regulated foods--at establishments under the
jurisdiction of both agencies.
[End of section]
Appendix VI: Comments from the Department of Health and Human Services
(FDA):
DEPARTMENT OF HEALTH & HUMAN SERVICES: Office of Inspector General:
Washington, D.C. 20201:
MAR 11 2005:
Mr. Robert A. Robinson:
Managing Director:
Natural Resources & Environment:
U.S. Government Accountability Office: Washington, DC 20548:
Dear Mr. Robinson:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO's) draft report entitled, "Food Safety-
Federal Agencies Should Pursue Opportunities to Reduce Overlap and
Better Leverage Resources" (GAO-05-213). The comments represent the
tentative position of the Department and are subject to reevaluation
when the final version of this report is received.
The Department provided several technical comments directly to your
staff.
The Department appreciates the opportunity to comment on this draft
report before its publication.
Sincerely,
Signed by:
Daniel R. Levinson:
Acting Inspector General:
Enclosure:
The Office of Inspector General (OIG) is transmitting the Department's
response to this draft report in our capacity as the Department's
designated focal point and coordinator for U.S. Government
Accountability Office reports. OIG has not conducted an independent
assessment of these comments and therefore expresses no opinion on
them.
HHS Comment:
As the draft report points out, these interagency agreements were
developed, some more than 30 years ago, to exchange information that
was of mutual benefit to the agencies. FDA will review all active food
safety agreements and updates will be made, as necessary.
COMMENTS OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES ON THE U.S.
GOVERNMENT ACCOUNTABILITY OFFICE'S DRAFT REPORT: " FOOD SAFETY: FEDERAL
AGENCIES SHOULD PURSUE OPPORTUNITIES TO REDUCE OVERLAP AND BETTER
LEVERAGE RESOURCES" (GAO-05-213):
The Department of Health and Human Services (HHS) appreciates the
opportunity to review and comment on the Government Accountability
Office's (GAO) draft report.
Protecting the food supply is a top priority at HHS's Food and Drug
Administration (FDA). FDA conscientiously plans and implements its food
safety-related programs to assure a safe and wholesome food supply
within its legal authority and financial resources. While FDA and the
U.S. Department of Agriculture's Food Safety and Inspection Service
(FSIS) share responsibility for food safety, each agency regulates
different products and has very different legal authorities,
regulations to administer and enforce, and procedures. Regarding
concerns about overlap and duplication, it is important to note that in
processing establishments, there are no food products that both FDA and
USDA regulate. To the extent we have similar responsibilities, we
strive to leverage each other's efforts to achieve our common
objectives.
Over the years, there has been much discussion about consolidating all
food safety, inspection, and labeling functions into one agency with
the intention of increasing the effectiveness of the food safety
system. In 2002, the Administration looked into food safety issues,
including the single food agency issue, and concluded that the goals of
the Administration are better advanced through enhanced interagency
coordination rather than through the development of legislation to
create a single food agency.
The various Federal agencies with food safety authorities are working
together effectively. The American food supply continues to be among
the safest in the world. Food safety agencies are working more closely
together than ever before, especially in the area of food security. For
example, FDA, USDA's FSIS and Animal and Plant Health Inspection
Service (APHIS), HHS's Centers for Disease Control and Prevention
(CDC), the Environmental Protection Agency (EPA), and the Department of
Defense (DOD) are leading the effort to defend the food and agriculture
supply under the Department of Homeland Security (DHS) Presidential
Directive 9 (HSPD-9) through collective authorities, expertise, and
resources. We also coordinate and collaborate with the DHS, which is
the overall lead for protecting the food supply from deliberate
contamination.
In your draft report, the term, "overlap" is defined as "similar
activities being performed by more than one agency," whereas the term
"duplication" is defined as "essentially identical activities." The
report purports to identify ways to increase efficiency by eliminating
duplicative effort. As long as more than one agency has the legal
authority to secure the food supply generally, they will by necessity
generally conduct similar activities, i.e., each one will have to
inspect those products over which it has jurisdiction, each one will
have to promulgate regulations implementing its statutory authority,
etc. We believe, however, that these similarities are superficial. That
they exist does not, on its own, contribute to understanding whether
and to what extent there is actual duplication of effort among the
agencies. The report title should be changed to: "Federal Agencies
Should Pursue Opportunities to Reduce Duplication and Better Leverage
Resources."
Throughout the report, use of the term, "overlap" is confusing. While
the report defines it at the outset, the term "overlap" connotes
sameness, not simply similarity. As a result, the report would be
clearer if it used the term "similar," which is the report's definition
of "overlap" instead of the term "overlap." In addition, the report
would no longer need to define the term "overlap" if that change were
made.
In assessing whether or not to consolidate certain functions within a
single agency to reduce duplication, the report focuses on what those
functions have in common, i.e., similarities, (termed "overlap")
without assessing how they differ.
The similarities cited in the report are often overstated. For example,
the report states that USDA and FDA inspections have common features,
without specifying the common features or addressing the fact that the
inspections conducted by these agencies are far more different than
they are similar.
The report states that USDA and FDA provide "similar training," without
mentioning that the training programs, in fact, are vastly different
due in large part to the fact that USDA inspectors and FDA
investigators have very different academic backgrounds and conduct very
different inspections.
FDA disagrees that it is cost effective and of benefit to have a single
training program for both FDA and USDA food safety programs. We will
continue to collaborate and cooperate on areas of mutual benefit, but
these are small in relation to training and preparing our employees to
conduct their day-to-day jobs effectively.
Legal authority and scientific and technical expertise are
significantly more important to solving a food safety issue than the
organizational component called upon. For example, the Federal food
safety and animal health agencies have forged a coordinated effort to
prevent, identify, and respond to Bovine Spongiform Encephalopathy
(BSE) contamination in the food and animal supply. If all of the
current resources were to be housed in one organization, it would not
diminish nor eliminate the need for coordination even within that
organization.
To the extent that an establishment processes food products under FDA's
jurisdiction and USDA's jurisdiction, both agencies have regulatory
responsibilities in that facility, referred to as dual jurisdiction
establishments in the draft report. Each agency deals within its own
area of expertise and jurisdiction at facilities that are common to
both agencies. FDA and USDA have signed a Memorandum of Understanding
(MOU) that facilitates the sharing of information between the agencies
about establishments subject to the jurisdiction of both agencies. FDA
and USDA field offices notify their counterpart's office when
significant findings are identified regarding a dual jurisdiction
establishment. Overall, this MOU has been successful in enhancing
collaboration to improve public health protection.
The GAO draft report makes reference to interagency agreements (IAGs)
as a general term. It is important to note the distinct difference
between FDA IAGs and MOUs. At FDA, MOUs do not provide for exchanges of
funds. Exchanges of funds, personnel, or property are part of IAGs, not
MOUs. As written, the GAO draft report is not accurate when referencing
many of the MOUs involving FDA as IAGs.
FDA and USDA work together in many ways to ensure the safety of the
U.S. food supply. In addition to food security, FDA and USDA's FSIS and
APHIS have worked very closely in developing a sound strategy for BSE
prevention, control, and response for both public health and animal
disease. We recognized early on that we needed to agree on and work
under clear jurisdictional authorities at the Federal, as well as State
levels. Accordingly, we established a BSE action and response plan that
identifies the lead Federal agency to take action depending upon the
situation.
The Hazard Analysis Critical Control Point (HACCP) inspection process
is a systematic approach to food production and processing that
requires the identification of specific hazards associated with a
specific food and the process and production system utilized, the means
to mitigate such hazards, steps to do so, and documentation that such
steps are taken. Throughout the report, there seems to be some
confusion about HACCP principles and HACCP plans.
Given the scientific basis upon which HACCP is formulated and the
different types of hazards and production and processing techniques
that are related to a specific food commodity, the expectation is that
each HACCP plan is targeted and specific to the facility and food
commodity and the respective hazards. Hence, while the HACCP principles
are the same, the HACCP plans are different because of the varied
hazards that have been shown to cause illness associated with the
different food products or processes, or both. It is for this reason
that USDA's HACCP rules and FDA's HACCP rules are different because the
scientific knowledge of the hazards associated with certain commodities
and the technology, processing, and equipment associated with those
commodities are different. In our technical comments, we have pointed
out where clarification regarding HACCP plans and principles appear to
be utilized interchangeably, and should be changed.
Every agency must undertake rulemaking to implement its statutory
authority. This is not an activity that can be consolidated unless the
underlying authority is consolidated. However, FDA does seek the review
and input of USDA and other agencies with food safety authority when
promulgating regulations related to food safety.
The GAO draft report includes statements that are opinions expressed by
a few current and former Government employees. These individuals
clearly are not speaking on behalf of their agency and are expressing
their personal opinions, which are not consistent with their agencies'
positions. In our technical comments, we have indicated when we believe
an item was an opinion and that it should be removed from the report.
GAO RECOMMENDATIONS FOR EXECUTIVE ACTION:
GAO recommends that the Secretary of Agriculture and the Commissioner of
FDA work together to:
GAO Recommendation #1:
Ensure the implementation of the interagency agreement that calls for,
among other things, sharing inspection-and enforcement-related
information at those food processing facilities that are under the
jurisdiction of both agencies.
HHS Comment:
The primary focus of the existing 1999 MOU between FDA and FSIS for
dual jurisdiction establishments is to facilitate an exchange of
information between the agencies about establishments that are subject
to the jurisdiction of both agencies. This exchange of information is
to permit more efficient use of both agencies' resources and to
contribute to improved public health protection. The primary
application for this shared information is for enforcement
collaboration when inspections result in unsanitary conditions that cut
across the regulatory authority of both agencies. FDA and FSIS
coordinate these activities at the local level on a regular basis for
those facilities and for those food safety and security activities for
which we each have regulatory authority. FDA believes that this MOU has
been largely successful in enhancing collaborative activities to
improve public health protection.
While only a small percentage, less than 2 percent, of the total food
processing or manufacturing facilities in the U.S. are subject to
inspection by both FDA and USDA, the notification and sharing of
information through this MOU has been productive as it has led to
recalls of both FDA-and USDA-regulated products as well as joint
enforcement activities by the agencies.
The most recent example is the enforcement action by FDA in conjunction
with the U.S. Department of Justice (DoJ), USDA, and the California
Department of Health Services, Food and Drug Branch (CFDB) against
Fay's Foods, Inc., of North Hollywood, CA. This multi-agency
jurisdictional situation resulted in an immediate Class I Recall and a
consent decree for permanent injunction against Fay's Foods, Inc., due
to continuing Listeria monocytogenes contamination of sandwiches and
salads and continuing unsanitary production conditions. Listeria
monocytogenes is a significant pathogenic bacterium capable of causing
serious illness and death in immuno-compromised individuals such as
cancer patients, neonates, and pregnant mothers. FDA worked
collaboratively with the State of California on a State embargo by CFDB
based on FDA's findings of widespread Listeria monocytogenes
contamination of facility and finished products; and worked jointly
with USDA findings of products that were under USDA jurisdiction that
were considered adulterated.
Additionally, during the course of the GAO study, FDA supplied other
examples of where either FDA notified FSIS or FSIS notified FDA, under
the MOU, after determining that the conditions found in the facility
required enforcement action for all products in the warehouse,
regardless of which agency was regulating the product. In these
examples, it is clear that the unsanitary conditions warranted
regulatory action and that these unsanitary conditions did not
differentiate between food products regulated by FDA or FSIS.
The MOU calls for the local FDA and FSIS offices to meet on an annual
basis to share information and called for an evaluation after the first
year to confirm that is was implemented. While no further evaluation
was required, we believe that this annual information sharing of local
FDA and FSIS offices has generally occurred and is evident based on the
annual changes in number of dual jurisdiction firms, as well as the
joint enforcement actions taken over the past years. FDA believes that
this MOU has been largely successful in enhancing collaborative
activities to improve public health protection. FDA and FSIS
significantly increased the effectiveness of communications between the
two agencies, heightened awareness of each other's responsibilities and
operations, and initiated more frequent and more effective cooperative
efforts. HHS recognizes that there are additional actions that may be
taken to further strengthen and enhance collaborative efforts with
FSIS. The signing of the MOU was meant to be only one step in building
a stronger food safety public health infrastructure. Therefore, FDA and
FSIS agreed to conduct some additional joint training to further the
implementation of this MOU.
GAO Recommendation #2:
Examine the feasibility of establishing a joint training program for
food inspectors.
HHS Comment:
HHS agrees that USDA and FDA must collaborate in developing training
from which both agencies can benefit. However the report implies that
FDA and USDA are not collaborating, which is incorrect. We have
collaborated and will continue to do so. A few examples are:
* As recently as February 2005, FDA posted and presently hosts a web-
based training course on food security. FDA and USDA developed this
course jointly. The target audience is FDA staff, USDA staff,
State/tribal/local regulators, and the regulated industry.
* Over the years FDA and USDA have collaborated on numerous satellite
downlinks that benefited the staff of both agencies. Examples of this
collaboration include the conduct of two retail meat and poultry
processing teleconferences, Personal Safety Training for Field
Personnel, Multi-Agency BSE Import Safety Net, FDA/FSIS Memorandum of
Understanding: An Overview, Food Microbiological Control, Foodborne
Illness Investigations, Traceback of Fresh Produce and Other
Commodities, Communication Skills for Regulators, and Plain Language
2000: It's the Write Idea.
* The training director of FSIS and the training director of FDA's
Office of Regulatory Affairs regularly meet to discuss best practices
and opportunities to collaborate.
* USDA and FDA training staffs regularly support each other. For
example, in the fall of 2004 FDA staff trained school lunch officials
on HACCP process. The training was held at the FDA training facility.
* FDA shared a best practice by briefing USDA executives, including the
previous FSIS Administrator, on FDA's Cooperative Research and
Development Agreement (CRADA) with a private learning firm to develop
and deliver web-based training.
* FDA and USDA have collaborated on training related to epidemiology,
tissue residue, retail food, and laboratory science.
HHS agrees that FDA and USDA should continue to identify additional
opportunities to collaborate on training issues when workable
commonalities can be found. An example would be to have a joint
downlink(s) on the FDA/USDA MOU. Also, if USDA does develop a business
relationship with FDA's CRADA partner, existing FDA web courses could
be shared with USDA and future courses could be developed
collaboratively.
HHS disagrees with the recommendation of a unified joint training
program between FDA and USDA. The two agencies enforce different laws
using different procedures. Our staffs are different-having different
backgrounds and experiences. The foods regulated by the two agencies
are different. In order for training to be effective, it must be
focused on the day-to-day needs of the students, providing both theory
and practical application and expectations. By suggesting a unified
program, the report suggests that HACCP is the same for all products
and should be taught jointly. While the seven principles of HACCP are
the same, the practical application of HACCP is different for each
food. Therefore the practical application of HACCP taught to FDA staff
is and must be different than what is taught to USDA staff.
HHS further disagrees with the unified joint training program because
such a unified approach would result in duplication and inefficiency to
FDA. FDA would still have to maintain a training program and training
facilities to train the same investigators in their other work related
to human and veterinary drugs, medical devices, and blood products.
GAO Recommendation #3:
Consider the findings of USDA's foreign country equivalency evaluations
when determining which countries to visit.
HHS Comment:
FDA's enforcement program considers many factors in identifying
domestic and foreign facilities for inspection, including risk-based
product priority, compliance history, current production, product
technology changes, emerging food safety issues and data, or
information provided by others. Accordingly, FDA will also consider
USDA's foreign country equivalency evaluations for facilities and
Government authorities that manufacture and assure safety of FDA-
regulated products.
GAO Recommendation #4:
To better use FDA's limited inspection resources and leverage USDA's
resources, we recommend that, if appropriate and cost effective, the
Commissioner of Food and Drug Administration, as authorized under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002, enter into an agreement to commission USDA inspectors to carry
out FDA's inspection responsibilities for those food establishments
that are under the jurisdiction of both agencies.
HHS Comment:
Section 314 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 provides FDA with the authority to commission
other Federal officials to conduct inspections. This section amends
Section 702 of the Federal Food, Drug, and Cosmetic (FD&C) Act to
authorize the Secretary of HHS to commission other Federal employees to
conduct examinations and inspections. It requires an MOU between the
Secretary and the head of the other Federal agency. The MOU must
address adequate training of officers and employees of such other
department or agency to conduct such examinations and inspections. It
also must address reimbursement for examinations and inspections
conducted under this authority. It is restricted to facilities or other
locations that are jointly regulated by the Secretary and the other
department or agency. Because of the reimbursement and training
requirements, FDA wants to point out that the commissioning of other
Federal agencies may not be resource neutral, as GAO assumes, and will
not necessarily result in a net savings for FDA.
This section also requires the Secretary and the head of the other
Federal department or agency to submit a report to Congress each fiscal
year that provides the number of employees that carried out one or more
activities, the number of additional articles that were inspected or
examined, and the number of additional examinations or investigations
that were carried out pursuant to the memorandum.
The agencies have looked at the issue of commissioning FSIS personnel
preliminarily. One issue that will need to be addressed is the
different legal authority each agency has for the foods it regulates.
The Federal Meat Inspection Act and the Poultry Products Inspection Act
require that food products be approved for sale, i.e., stamped by USDA
inspectors. The FD&C Act does not require premarket approval, in
general, for FDA-regulated food products. These different statutory
mandates might create some issues that will have to be examined
further.
There are other issues to address, including the differences in core
qualifications for each agency's inspectorate. We found that the FSIS
personnel with scientific education comparable to FDA's Consumer Safety
Officer/Investigator were not the in-plant inspectors, but were the
area circuit supervisors and/or FSIS Compliance Officers. These FSIS
personnel are not in the facilities on a continuous operating basis but
rather are present in the facilities on a periodic basis to provide
oversight or compliance review. Additionally, the qualified FSIS
personnel would need to receive training on the FD&C Act, evidence
development, policy and procedures, documentation, and reporting.
Additionally, there are only a relatively small percentage of the total
food establishments in the U.S. that are subject to inspection by both
FDA and USDA. Some of these dual jurisdiction establishments are also
covered by States under existing contracts with FDA.
All of these factors and others would need to be considered in a formal
manner if the agencies were to enter into an agreement to commission
USDA inspectors to carry out FDA's inspection responsibilities. The
agencies will continue to look at all appropriate leveraging
opportunities that enhance our public health responsibilities in an
efficient manner.
GAO Recommendation #5:
To better use FDA's limited inspection resources and leverage NMFS's
resources, we recommend that the Commissioner of the Food and Drug
Administration and the Under Secretary of Commerce for Oceans and
Atmosphere ensure the implementation of the interagency agreement that
calls for FDA to recognize the results of NMFS inspections when
determining the frequency of its seafood inspections.
HHS Comment:
An MOU between the U.S. Department of Commerce, National Oceanic and
Atmospheric Administration (NOAA), NMFS and FDA was signed in 1974
regarding inspection programs for fishery products. We recognize the
report's concerns that agreements created decades ago may no longer be
relevant to current needs, that some provisions of these agreements may
be obsolete and that some agreements do not reflect changes in a
signatory's roles and responsibilities since they were signed. FDA
intends to assess the NMFS MOU in light of these concerns, as well as
in light of the conflict of interest concerns expressed in the report.
GAO Recommendation #6:
To strengthen management controls and maximize the effectiveness of
interagency agreements designed to reduce overlap, increase
coordination, and leverage resources, we recommend that the Secretary
of Agriculture, the Commissioner of the Food and Drug Administration,
the Administrator of the Environmental Protection Agency, and the Under
Secretary of Commerce for Oceans and Atmosphere:
Identify and inventory all active interagency food safety-related
agreements.
HHS Comment:
FDA has identified and inventoried all MOUs with various agencies,
including all active food safety related agreements.
GAO Recommendation #7.
Evaluate the need for these agreements and, where necessary, update the
agreements to reflect recent legislative changes, new technological
advances, and current needs.
The following are GAO's comments on the U.S. Department of Health and
Human Services' (HHS) letter, dated March 11, 2005.
GAO Comments:
1. We disagree with HHS's comment that our report's title should
substitute the word duplication for overlap. Given the definitions we
lay out in the report, if we modified the title as HHS suggests, we
would risk implying that the agencies are undertaking many duplicative
efforts, even though we are fully aware that under the current
statutory framework the agencies do not exactly replicate food safety
activities. That is, our report distinguishes between "overlap"--which
we define as those similar activities being performed by more than one
agency and "duplication"--which we define as essentially identical
activities performed by more than one agency.
We also disagree with HHS's comment that our report overstates
similarities in USDA and FDA inspections. First, our report clearly
states that USDA and FDA inspections have common key elements:
sanitation, good manufacturing practices, and HACCP compliance
oversight. Second, the report makes it clear that USDA and FDA
inspections vary, depending on whether the product is a USDA-or FDA-
regulated food product.
Furthermore, we disagree with HHS's comment that the training programs
are vastly different. As our report discusses, FDA's training
curriculum includes dozens of courses that address topics common to
USDA and FDA. Despite HHS's disagreement with our recommendation that
the agencies examine the feasibility of establishing a joint training
program for food inspectors, we continue to believe that such an
examination has merit. In its comments, USDA agreed that there is merit
in examining the feasibility of conducting joint training activities
when commonalities can be found.
2. We agree with HHS's comment that, if a single agency were to be
responsible for the safety of all food products, different organization
units within that agency may need to coordinate their activities.
However, we believe that some economies of scale would be derived from
combining overlapping activities, including those that our report
highlights. For example, with a single food safety agency, the federal
government would not need to have two separate food inspection
workforces or two separate training programs.
3. We acknowledge that some elements of the 1999 interagency agreement
on dual jurisdiction establishments have been implemented and that the
agreement has enhanced coordination. However, we continue to believe
that the agreement could be better implemented. We further disagree
that the report does not identify the distinct difference between FDA
interagency agreements and memoranda of understanding. We acknowledge
that, as used in our report, the term interagency agreement refers
generally to memoranda of understanding, memoranda of agreement, and
interagency agreements identified by USDA, FDA, EPA, and NMFS. The
report includes a footnote to indicate that FDA makes a distinction,
which the other agencies do not, between interagency agreements and
memoranda of understanding. The footnote explains that, according to
FDA, FDA memoranda of understanding do not provide for exchanges of
funds. FDA refers to agreements that involve exchanges of funds,
personnel, or property as interagency agreements. We did not consider
this type of agreement in our analysis.
4. We understand the differences between HACCP principles and plans.
Our report acknowledges that while HACCP principles are the same for
both FDA and USDA, the HACCP plans are different as they address
different risks associated with different products (i.e., seafood,
juice, meat, or poultry). Our report's identification of HACCP
requirements as another area of overlap between the two agencies refers
to the fact that both agencies have issued HACCP regulations that are
based on a similar HACCP model. We have modified our report to indicate
that, short of consolidating all inspection functions, consolidating
inspections of the similar elements in the agencies' HACCP plans would
reduce overlap. We further note that USDA's HACCP rule applies to both
meat and poultry products, although these products present different
hazards. Thus, we believe it is possible to issue broad regulations
based on common principles that can then be applied to specific
products. We have made minor modifications in the report to avoid
confusion regarding HACCP principles and HACCP plans and to indicate
that different risks are associated with different food products and,
therefore, require different HACCP plans.
[End of section]
Appendix VII: Comments from the U.S. Department of Commerce (NOAA):
UNITED STATES DEPARTMENT OF COMMERCE: The Under Secretary of Commerce
for Oceans and Atmosphere: Washington, D.C. 20230:
MAR 11 2004:
Mr. Robert A. Robinson:
Director, Natural Resources and Environment: United States Government
Accountability Office: Washington, D.C. 20548:
Dear Mr. Robinson:
Thank you for the opportunity to review and comment on the Government
Accountability Office's draft report entitled Food Safety: Federal
Agencies Should Pursue Opportunities to Reduce Overlap and Better
Leverage Resources (GAO-05-213). Enclosed is the National Oceanic and
Atmospheric Administration's comments to this draft report.
Sincerely,
Signed by:
Conrad C. Lautenbacher, Jr.:
Vice Admiral, U.S. Navy (Ret.):
Under Secretary of Commerce for Oceans and Atmosphere:
Enclosure:
NOAA Comments on the Draft GAO Report Entitled "Food Safety: Federal
Agencies Should Pursue Opportunities to Reduce Overlap and Better
Leverage Resources" (GAO-05-213/March 2005):
General Comments:
The draft report regarding overlap in food safety activities among
federal agencies does a fair and thorough job, in general, of
describing the major activities of the National Oceanic and Atmospheric
Administration's (NOAA) National Marine Fisheries Service (NMFS)
relative to food safety.
Recommended Changes for Factual/Technical Information:
Page 11, Table 1, row beginning with Department of Commerce:
In addition to the "Voluntary, fee-for-service examinations of seafood
for safety and quality," NMFS 1) conducts research, including risk
analysis, on levels of contaminants found in target species of fishery
products; and 2) analyzes species impacted by oil spills, including
species that may be harvested for human consumption.
Page 37, first paragraph, last sentence:
"NMFS officials told us that the agency would be willing to enter into
such an agreement with FDA, thereby assisting FDA in reaching its goal
of conducting annual inspections at all high-risk facilities."
NOAA agrees with this statement and believes the positions expressed in
a previous GAO report entitled "Food Safety: FDA's Imported Seafood
Safety Program Shows Some Progress, But Further Improvements Are
Needed" (GAO-04-246/January 2004) continue to be germane to this issue.
The following statements have been extracted from pages 24 to 25 of the
referenced report:
NOAA's Seafood Inspection Personnel and Laboratories Could Augment
FDA's Regulatory Program:
NOAA officials said that they could assist FDA by providing various
Services to augment FDA's regulatory program for imported seafood.
These services include:
* foreign firm inspections,
* HACCP training,
* domestic importer inspections,
* port-of-entry inspection and product sampling, and:
* assistance in developing and verifying equivalence or other types of
agreements with seafood exporting countries.
NOAA officials also said that they could conduct some domestic seafood
inspection services that FDA currently conducts, which would allow FDA
to refocus some of its resources on imported seafood. For example, NOAA
inspectors could certify domestic seafood products shipped to the
European Union and other countries, which is a service that NOAA
provided in the past on a fee-for-service basis. Also, FDA and NOAA
could agree to recognize NOAA's current inspections of approximately
240 domestic processing firms and authorize NOAA to inspect other
domestic firms for compliance with HACCP. NOAA officials estimate that
they could provide FDA with up to 22 full-time-equivalent field
inspectors as well as additional technical support staff in its
headquarters office.
In addition, NOAA and FDA officials are now negotiating the terms of an
agreement to use two NOAA laboratories to screen imported shrimp
samples for the antibiotic chloramphenicol. FDA is taking this action
to increase its testing capacity in response to the detection of the
drug in imported shrimp by food safety authorities in Europe, Canada,
and some U.S. states. Chloramphenicol is banned for use in food-
producing animals because there is no known safe level for human
ingestion of this substance. If the negotiations succeed, FDA would
increase its screening capacity by 400 samples per year.
Although the central focus of the current draft report is food safety,
NOAA believes a better integration of the resources and expertise among
federal agencies could further assist FDA in improving the frequency of
inspections, which is now estimated to be three to five years for
facilities other than high-risk foods (see footnote 17, page 32). Based
on NOAA's experience, adverse consequences (e.g., deterioration of
hygienic practices and economic fraud such as product substitution)
become more probable as the frequency of oversight is lessened.
Page 46, first paragraph after bullets, third sentence:
This sentence should be revised to read: "EPA's Office of Pesticide
Prevention and Office of Water, as well as the NMFS' Seafood Inspection
Program and Office of Sustainable Fisheries also provided data."
Page 49, Table 3, column heading "DOC "; row "Risk Assessment; Staffing
Level "
The staffing level associated with the $7 million expenditure should be
"57". This change will then require the "Total Staffing" figure at the
top of page 50 under the DOC column to be changed from "155" to "212".
Editorial Comments:
Page 13, Figure 1:
Change "NFMS" to "NMFS" in the title.
Page 33, line S:
Insert "of" before "millions of pounds."
NOAA Response to GAO Recommendations:
Recommendation: "To better use FDA's limited inspection resources and
leverage NMFS' resources, we recommend that the Commissioner of the
Food and Drug Administration and the Under Secretary of Commerce for
Oceans and Atmosphere ensure the implementation of the interagency
agreement that calls for FDA to recognize the results of NMFS
inspections when determining the frequency of its seafood inspections."
NOAA Response: NOAA agrees with this recommendation. NOAA will work
with the appropriate components of FDA to answer any questions they may
have to allow them to move expeditiously toward implementation of this
recommendation.
Recommendation: "To strengthen management controls and maximize the
effectiveness of interagency agreements designed to reduce overlap,
increase coordination, and leverage resources, we recommend that the
Secretary of Agriculture, the Commissioner of the Food and Drug
Administration, the Administrator of the Environmental Protection
Agency, and the Under Secretary of Commerce for Oceans and Atmosphere:
* identify and inventory all active interagency food safety-related
agreements; and:
* evaluate the need for these agreements and, where necessary, update
the agreements to reflect recent legislative changes, new technological
advances, and current needs."
NOAA Response: NOAA agrees with this recommendation and will establish
an inventory of active interagency food safety-related agreements where
NOAA is a signatory. In addition, NOAA will contact the applicable
agency or agencies associated with food-safety related agreements
whenever NOAA believes they should be revised.
[End of section]
Appendix VIII: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Robert A. Robinson, (202) 512-3841 Maria Cristina Gobin, (202) 512-8418
Terrance N. Horner, Jr., (202) 512-6910:
Staff Acknowledgments:
In addition to those named above Lawrence J. Dyckman, Katheryn Hubbell,
Jane Kim, Sara Margraf, Carol Herrnstadt Shulman, Michele Fejfar, Amy
Webbink, and Katherine Raheb made key contributions to this report.
(360456):
FOOTNOTES
[1] GAO, Federal Food Safety and Security System: Fundamental
Restructuring Is Needed to Address Fragmentation and Overlap, GAO-04-
588T (Washington, D.C.: Mar. 30, 2004).
[2] GAO, Results-Oriented Government: Shaping the Government to Meet
21ST Century Challenges, GAO-03-1168T (Washington, D.C.: Sept. 17,
2003).
[3] USDA, FDA, EPA and NMFS devoted a combined 14,690 full-time
equivalents to food safety-related activities in fiscal year 2003.
[4] Section 314 of the Bioterrorism Act outlines FDA's authority to
commission other federal officials to conduct inspections. Pub. L. No.
107-188, § 314, 116 Stat. 594, 674 (2002).
[5] Interagency agreements include memoranda of understanding,
memoranda of agreement, and other agreements between agencies. FDA
defines interagency agreements as those that involve an exchange of
funds, personnel, or property. We did not include this type of
agreement in our analysis.
[6] Under its statutes, USDA inspects meat and poultry processing
facilities at least daily, whereas FDA can determine how often it
inspects facilities. FDA's goal is to inspect high-risk facilities at
least annually and other facilities every 3 to 5 years.
[7] National Research Council and Institute of Medicine, Ensuring Safe
Food: From Production to Consumption (Washington, D.C.: 1998).
[8] According to FDA officials, these establishments include 772 food
manufacturers, 539 warehouses, and 140 other types of establishments
such as retailers, importers, packers, and labelers. The agency is
verifying about 400 potential additional DJEs.
[9] Separate HACCP plans are generally necessary to address the
specific hazards associated with specific food products.
[10] Under the act, the agencies would have to enter into a memorandum
of understanding that would include provisions to ensure adequate
training of USDA officials and to address reimbursement.
[11] Ports of entry at which USDA and FDA inspectors are each present
include Baltimore/Dundulk, Maryland; Blaine, Washington;
Boston, Massachusetts;
Buffalo, New York;
Champlain, New York;
Detroit, Michigan;
Eastport/Porthill, Idaho;
Houston, Texas;
Jacksonville, Florida;
Laredo, Texas;
Los Angeles, California;
New Orleans, Louisiana;
New York, New York;
Newark, New Jersey;
Pembina, North Dakota;
Savannah, Georgia;
Seattle/Tacoma, Washington;
and Sweetgrass, Montana.
[12] FDA has no similar requirement.
[13] According to FDA, in some foreign countries, meat and poultry
inspection programs are separate from other food inspections, as they
are in the United States.
[14] FDA officials told us that their training expenditures include
training that can be applied to products other than food, such as
medical devices.
[15] GAO, Federal Law Enforcement Training: Capacity Planning and
Management Oversight Need Improvement, GAO-03-736 (Washington, D.C.:
July 24, 2003). In 2003, we reported that the Center had played a vital
role in training law enforcement personnel since its inception. The
report noted that since the September 11, 2001 attacks, the Center's
overall capacity to provide training was strained and made several
recommendations for addressing this issue.
[16] FDA officials said USDA and FDA look for different levels of
dioxin in food products they regulate.
[17] USDA program offices include the Cooperative State Research,
Education and Extension Service, Economic Research Service, and the
Food Safety and Inspection Service. FDA program offices include the
Center for Veterinary Medicine and the Office of Regulatory Affairs.
EPA program offices include the Office of Pesticide Programs and the
Office of Water.
[18] Currently, FDA requires that seafood and juice processing
facilities comply with mandatory HACCP regulations. Many HACCP
principles are already in place at FDA-regulated low-acid canning
facilities. In addition, HACCP is now an option under the pasteurized
milk ordinance.
[19] FDA's estimate included research, testing means to verify the
standard, legal analysis, economic analysis, policy writing, public
comment activities, as well as reviewing the final rule, based on new
data and comments received.
[20] The ISSC was formed in 1982 by FDA, state regulators, and
shellfish industry representatives to develop policies for the safe
harvesting, processing, and distribution of fresh and frozen shellfish.
FDA must concur with the ISSC's proposed policy changes before they are
incorporated into the National Shellfish Sanitation Program's (NSSP)
model ordinance.
[21] Food Safety from Farm to Table: A National Food Safety Initiative
Report to the President, May 1997. Food and Drug Administration, U.S.
Department of Agriculture, U.S. Environmental Protection Agency,
Centers for Disease Control and Prevention.
http://vm.cfsan.fda.gov/~dms/fsreport.html.
[22] FDA commented that it is the responsibility of district
supervisors and district directors to be aware of this agreement and
communicate to their local USDA counterparts any cases in which
enforcement action was necessary at DJEs. FDA also noted that field
personnel could benefit from additional training on the specifics of
this agreement.
[23] FDA's goal is to inspect high-risk facilities at least annually
and other facilities every 3 to 5 years.
[24] See http://seafood.nmfs.noaa.gov/ApprovedFacilities.htm.
[25] NMFS is located within the Department of Commerce's National
Oceanic and Atmospheric Administration.
[26] Prior to 2005, the Food Products Association was known as the
National Food Processors Association.
[27] Resources for the Future leads the Food Safety Research
Consortium--a multidisciplinary group of academic food safety research
institutions--which is funded, in part, by USDA's Cooperative State
Research, Education, and Extension Service and was formed to create
decision tools needed to build a science-and risk-based food safety
system.
[28] GAO, Food Safety: FDA's Imported Seafood Safety Program Shows Some
Progress, but Further Improvements Are Needed, GAO-04-246 (Washington,
D.C.: Jan. 30, 2004).
[29] Fiscal year 2003 was the most recent year for which data were
complete.
[30] National Research Council and Institute of Medicine, Ensuring Safe
Food: From Production to Consumption (Washington, D.C.: 1998).
[31] USDA, EPA, and NMFS supplied agreements in the form of memoranda
of agreement, interagency agreement, and memoranda of understanding. We
included interagency agreements that, according to FDA do not involve
an exchange of people, property, or funds--what the agency refers to as
memoranda of understanding.
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